Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="es" lang="es"><p><b>Generated Narrative: Composition</b><a name="composition-es-2a9c4333cfd126f2e7b73ad3cafd6949"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Composition "composition-es-2a9c4333cfd126f2e7b73ad3cafd6949" (Language "es") </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Composition-uv-epi.html">Composition (ePI)</a></p></div><p><b>identifier</b>: id: c97bc0c62de4cf4143e63299ba73c5a3</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000155538)</span></p><p><b>category</b>: Raw <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-epicategory-cs.html">Category of EPI</a>#R)</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href="#Organization_mah-715f8a161ed438d0584510e5b4512caa">See above (Organization/mah-715f8a161ed438d0584510e5b4512caa)</a></p><p><b>title</b>: TEST PURPOSES ONLY - Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion</p><h3>Attesters</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style="display: none">*</td><td>Official <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-composition-attestation-mode.html">Composition Attestation Mode</a>#official)</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt 0pt 0pt 136pt; line-height:115%; font-size:11pt"><a name="page1" id="page1"></a><strong><span style="font-family:Times New Roman; font-size:11pt;">Prospecto: información para el usuario</span></strong></p><p style="margin:0pt; line-height:12.65pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 0pt 0pt 68pt; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Biktarvy 50 mg/200 mg/25 mg comprimidos recubiertos con película</span></strong></p><p style="margin:0pt; line-height:0.05pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt; text-align:center; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">bictegravir/emtricitabina/tenofovir alafenamida</span></p><p style="margin:0pt; line-height:13.8pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 31.4pt 0pt 1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted.</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 9.56pt; text-indent:0pt; text-align:justify; padding-left:19.44pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Conserve este prospecto, ya que puede tener que volver a leerlo.</span></li><li style="margin:0pt 0pt 0pt 9.56pt; text-indent:0pt; text-align:justify; padding-left:19.44pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si tiene alguna duda, consulte a su médico o farmacéutico.</span></li><li style="margin:0pt 30.4pt 0pt 9.56pt; text-indent:0pt; text-align:justify; padding-left:19.44pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.</span></li><li style="margin:0pt 22.4pt 0pt 9.56pt; text-indent:0pt; text-align:justify; padding-left:19.44pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt 0pt 0pt 1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Contenido del prospecto</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><ol type="1" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 13.25pt; text-indent:0pt; text-align:justify; padding-left:15.1pt; font-family:Times New Roman; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Qué es Biktarvy y para qué se utiliza</span></li><li style="margin:0pt 0pt 0pt 13.25pt; text-indent:0pt; text-align:justify; padding-left:15.1pt; font-family:Times New Roman; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Qué necesita saber antes de empezar a tomar Biktarvy</span></li><li style="margin:0pt 0pt 0pt 13.25pt; text-indent:0pt; text-align:justify; padding-left:15.1pt; font-family:Times New Roman; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Cómo tomar Biktarvy</span></li><li style="margin:0pt 0pt 0pt 13.25pt; text-indent:0pt; text-align:justify; padding-left:15.1pt; font-family:Times New Roman; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Posibles efectos adversos</span></li><li style="margin:0pt 0pt 0pt 13.25pt; text-indent:0pt; text-align:justify; padding-left:15.1pt; font-family:Times New Roman; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Conservación de Biktarvy</span></li><li style="margin:0pt 0pt 0pt 13.25pt; text-indent:0pt; text-align:justify; padding-left:15.1pt; font-family:Times New Roman; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Contenido del envase e información adicional</span></li></ol><p style="margin:0pt; text-indent:-28.35pt; text-align:justify; line-height:115%; padding-left:28.35pt; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt; line-height:12.8pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Biktarvy contiene tres principios activos:</span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 5.4pt 0pt 9.75pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">bictegravir,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">un medicamento antirretroviral conocido como inhibidor de la transferencia de las</span> <span style="font-family:Times New Roman; font-size:11pt">hebras de la integrasa (INI)</span></li><li style="margin:0pt 7.4pt 0pt 9.75pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">emtricitabina,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">un medicamento antirretroviral de un tipo conocido como nucleósido inhibidor</span> <span style="font-family:Times New Roman; font-size:11pt">de la transcriptasa inversa (ITIAN)</span></li><li style="margin:0pt 12.4pt 0pt 9.75pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">tenofovir alafenamida,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">un medicamento antirretroviral de un tipo conocido como nucleótido</span> <span style="font-family:Times New Roman; font-size:11pt">inhibidor de la transcriptasa inversa (ITIANt)</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 75.4pt 0pt 1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Biktarvy es un comprimido único para el tratamiento de la infección por el virus de la inmunodeficiencia humana 1 (VIH-1) en adultos.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 17.4pt 0pt 0pt; text-indent:-1.35pt; text-align:justify; line-height:115%; padding-left:1.35pt; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Biktarvy reduce la cantidad de VIH presente en el organismo. Esto mejora el sistema inmunitario y disminuye el riesgo de desarrollar enfermedades asociadas con la infección por el VIH.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt; line-height:0.05pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 14.4pt 0pt 0pt; line-height:117%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">No tome Biktarvy</span></strong></p><p style="margin:0pt 14.4pt 0pt 0pt; line-height:117%; font-size:11pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 14.4pt 0pt 9.8pt; text-indent:0pt; text-align:justify; padding-left:19.2pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si es alérgico a bictegravir, emtricitabina, tenofovir alafenamida</span></strong> <span style="font-family:Times New Roman; font-size:11pt">o a alguno de los demás</span> <span style="font-family:Times New Roman; font-size:11pt">componentes de este medicamento (incluidos en la sección 6 de este prospecto).</span></li></ul><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><a name="page2" id="page2"></a><strong><span style="font-family:Times New Roman; font-size:11pt;">Si actualmente está tomando alguno de los siguientes medicamentos:</span></strong></li><li style="list-style: none; display: inline"><ul type="circle" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 37.01pt; text-indent:0pt; text-align:justify; padding-left:20.09pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">rifampicina</span></strong> <span style="font-family:Times New Roman; font-size:11pt">utilizada para tratar algunas infecciones bacterianas como la tuberculosis</span></li><li style="margin:0pt 30.4pt 0pt 37.06pt; text-indent:0pt; text-align:justify; padding-left:20.04pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">hierba de San Juan</span></strong> <span style="font-family:Times New Roman; font-size:11pt">(</span><em><span style="font-family:Times New Roman; font-size:11pt;">Hypericum perforatum</span></em><span style="font-family:Times New Roman; font-size:11pt">, hipérico), un medicamento a base de</span> <span style="font-family:Times New Roman; font-size:11pt">plantas utilizado para la depresión y la ansiedad, o productos que la contengan.</span></li></ul></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 36.4pt 0pt 15.77pt; text-indent:0pt; text-align:justify; padding-left:5.53pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si está tomando alguno de estos medicamentos,</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">no tome Biktarvy y consulte a su médico</span></strong> <strong><span style="font-family:Times New Roman; font-size:11pt;">inmediatamente.</span></strong></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Advertencias y precauciones</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Consulte a su médico antes de empezar a tomar Biktarvy:</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 4.4pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si tiene problemas hepáticos o antecedentes de enfermedad hepática, incluida la hepatitis.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">Los pacientes que padecen de enfermedades hepáticas, como la hepatitis B o C crónica, y están en tratamiento con antirretrovirales tienen más riesgo de presentar complicaciones hepáticas graves y potencialmente mortales. Si tiene infección por el virus de la hepatitis B, su médico evaluará detenidamente la mejor pauta terapéutica para usted.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 25.4pt 0pt 8.9pt; text-indent:0pt; text-align:justify; padding-left:19.2pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si tiene hepatitis B.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">Los problemas hepáticos pueden empeorar después de dejar de tomar</span> <span style="font-family:Times New Roman; font-size:11pt">Biktarvy.</span></li></ul><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 18.4pt 0pt 15.77pt; text-indent:0pt; text-align:justify; padding-left:5.53pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">No deje de tomar Biktarvy si tiene hepatitis B. Hable antes con su médico. Puede consultar más detalles en la sección 3,</span> <em><span style="font-family:Times New Roman; font-size:11pt;">No interrumpa el tratamiento con Biktarvy.</span></em></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Mientras esté tomando Biktarvy</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Una vez que empiece a tomar Biktarvy, esté atento a:</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 27pt; text-indent:0pt; text-align:justify; padding-left:1.1pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Signos de inflamación o infección</span></strong></li><li style="margin:0pt 0pt 0pt 27pt; text-indent:0pt; text-align:justify; padding-left:1.1pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Dolor articular, rigidez o problemas óseos</span></strong></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0.4pt 0pt 14.1pt; text-indent:0.1pt; text-align:justify; font-family:serif; font-size:11pt; list-style-position:inside"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si nota cualquiera de estos síntomas, informe a su médico inmediatamente.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">Puede consultar</span> <span style="font-family:Times New Roman; font-size:11pt">más información en la sección 4,</span> <em><span style="font-family:Times New Roman; font-size:11pt;">Posibles efectos adversos</span></em><span style="font-family:Times New Roman; font-size:11pt">.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 28.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Aunque no se han observado problemas renales con Biktarvy, existe la posibilidad de que pueda experimentar problemas renales si toma Biktarvy durante un periodo de tiempo prolongado.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Mientras esté tomando este medicamento</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">aún puede transmitir el VIH a los demás,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">aunque un tratamiento antirretroviral eficaz reduzca el riesgo. Consulte a su médico sobre qué precauciones son necesarias para no infectar a otras personas. Este medicamento no es una cura para la infección por el VIH. Mientras usted esté tomando Biktarvy podrá seguir padeciendo infecciones u otras enfermedades asociadas con la infección por el VIH.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Niños y adolescentes</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 17.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">No administre este medicamento a niños y adolescentes menores de 18 años de edad.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">No se ha</span> <span style="font-family:Times New Roman; font-size:11pt">estudiado todavía el uso de Biktarvy en niños y adolescentes menores de 18 años de edad.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Otros medicamentos y Biktarvy</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 9.4pt 0pt 0.1pt; text-indent:0.05pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">Biktarvy puede interaccionar con otros medicamentos.</span> <span style="font-family:Times New Roman; font-size:11pt">Como consecuencia, los niveles sanguíneos de Biktarvy o de otros medicamentos se pueden ver afectados. Esto puede impedir que sus medicamentos funcionen correctamente o empeorar sus posibles efectos adversos. En algunos casos, su médico puede tener que ajustar la dosis o comprobar sus concentraciones sanguíneas.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><a name="page3" id="page3"></a><strong><span style="font-family:Times New Roman; font-size:11pt;">Medicamentos que nunca se deben tomar con Biktarvy:</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">rifampicina</span></strong> <span style="font-family:Times New Roman; font-size:11pt">utilizada para tratar algunas infecciones bacterianas como la tuberculosis</span></li><li style="margin:0pt 27pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">hierba de San Juan</span></strong> <span style="font-family:Times New Roman; font-size:11pt">(</span><em><span style="font-family:Times New Roman; font-size:11pt;">Hypericum perforatum</span></em><span style="font-family:Times New Roman; font-size:11pt">, hipérico), un medicamento a base de plantas</span> <span style="font-family:Times New Roman; font-size:11pt">utilizado para la depresión y la ansiedad, o productos que lo contengan</span><strong><span style="font-family:Times New Roman; font-size:11pt;">.</span></strong></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 40pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si está tomando alguno de estos medicamentos,</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">no tome Biktarvy e informe a su médico</span></strong> <strong><span style="font-family:Times New Roman; font-size:11pt;">inmediatamente.</span></strong></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Consulte con su médico si está tomando:</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">medicamentos utilizados para tratar el VIH y/o la hepatitis B</span></strong> <span style="font-family:Times New Roman; font-size:11pt">que contengan:</span></li><li style="list-style: none; display: inline"><ul type="circle" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 53pt 0pt 37.06pt; text-indent:0pt; text-align:justify; padding-left:17.04pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">adefovir dipivoxil, atazanavir, bictegravir, emtricitabina, lamivudina, tenofovir alafenamida o tenofovir disoproxilo</span></li></ul></li><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">antibióticos, utilizados para tratar las infecciones bacterianas</span></strong><span style="font-family:Times New Roman; font-size:11pt">, que contengan:</span></li><li style="list-style: none; display: inline"><div type="square" style="margin: 0pt; margin-left: 2em; padding-left: 0pt"><ul type="square" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 44.66pt; text-indent:0pt; text-align:justify; padding-left:9.44pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">azitromicina, claritromicina, rifabutina o rifapentina</span></li></ul></div></li><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">antiepilépticos,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">utilizados para tratar la epilepsia, que contengan:</span></li><li style="list-style: none; display: inline"><ul type="circle" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 37.06pt; text-indent:0pt; text-align:justify; padding-left:17.04pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">carbamazepina, oxcarbazepina, fenobarbital o fenitoína</span></li></ul></li><li style="margin:0pt 22pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">inmunosupresores,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">utilizados para controlar la respuesta inmunitaria del organismo tras un</span> <span style="font-family:Times New Roman; font-size:11pt">trasplante, que contengan ciclosporina</span></li><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">medicamentos para la curación de úlceras</span></strong> <span style="font-family:Times New Roman; font-size:11pt">que contengan sucralfato</span></li></ul><p style="margin:0pt 0pt 0pt 28.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 42pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Informe a su médico si está tomando alguno de estos medicamentos.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">No interrumpa su</span> <span style="font-family:Times New Roman; font-size:11pt">tratamiento sin consultar con su médico.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Consulte a su médico o farmacéutico si está tomando:</span></strong></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 24pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">antiácidos</span></strong> <span style="font-family:Times New Roman; font-size:11pt">para tratar úlceras estomacales, acidez estomacal o reflujo ácido, que contengan</span> <span style="font-family:Times New Roman; font-size:11pt">hidróxido de aluminio y/o de magnesio</span></li><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">suplementos de minerales</span></strong> <span style="font-family:Times New Roman; font-size:11pt">o</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">de vitaminas,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">que contengan magnesio o hierro</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Arial; font-size:11pt"> </span></p><div type="circle" style="margin: 0pt; margin-left: 2em; padding-left: 0pt"><ul type="circle" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 9pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Consulte a su médico o farmacéutico antes de tomar Biktarvy</span></strong> <span style="font-family:Times New Roman; font-size:11pt">si está tomando alguno de estos</span> <span style="font-family:Times New Roman; font-size:11pt">medicamentos.</span></li></ul></div><p style="margin:0pt 3pt 0pt 14.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Antiácidos y suplementos de magnesio:</span></strong> <span style="font-family:Times New Roman; font-size:11pt">tendrá que tomar Biktarvy al menos 2 horas</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">antes</span></strong> <span style="font-family:Times New Roman; font-size:11pt">de</span> <span style="font-family:Times New Roman; font-size:11pt">tomar los antiácidos o suplementos que contengan aluminio y/o magnesio. O puede tomar Biktarvy junto con alimentos al menos 2 horas</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">después</span></strong> <span style="font-family:Times New Roman; font-size:11pt">de la toma del antiácido o suplemento que contenga aluminio y/o magnesio.</span></p><p style="margin:0pt 51pt 0pt 14.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Suplementos de hierro:</span></strong> <span style="font-family:Times New Roman; font-size:11pt">tendrá que tomar Biktarvy al menos 2 horas</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">antes</span></strong> <span style="font-family:Times New Roman; font-size:11pt">de tomar los</span> <span style="font-family:Times New Roman; font-size:11pt">suplementos de hierro o puede tomarlos todos juntos con alimentos.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Embarazo y lactancia</span></strong></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.</span></li><li style="margin:0pt 25pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Informe a su médico inmediatamente si se queda embarazada y pregunte sobre los posibles beneficios y riesgos de su tratamiento antirretroviral para usted y para su hijo.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 5pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si ha tomado Biktarvy durante su embarazo su médico puede solicitar que se haga análisis de sangre periódicos y otras pruebas diagnósticas para controlar el desarrollo de su niño. En niños cuyas madres tomaron nucleósidos inhibidores de la transcriptasa inversa (ITIAN) durante el embarazo, el beneficio de la protección frente al VIH fue mayor que el riesgo de que se produjeran efectos adversos.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 10pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">No dé el pecho a su hijo durante el tratamiento con Biktarvy.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">Esto se debe a que algunos de los</span> <span style="font-family:Times New Roman; font-size:11pt">principios activos de este medicamento pasan a la leche materna. Se recomienda que no dé el pecho para evitar que transmita el virus al niño a través de la leche materna. Si realmente desea amamantar, hable primero con su médico.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><a name="page4" id="page4"></a><strong><span style="font-family:Times New Roman; font-size:11pt;">Conducción y uso de máquinas</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 26.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Biktarvy puede causar mareo. Si nota mareo durante el tratamiento con Biktarvy, no conduzca ni maneje herramientas o máquinas.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Biktarvy contiene sodio</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 60.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Este medicamento contiene menos de 1 mmol de sodio (23 mg) por comprimido; esto es, esencialmente “exento de sodio”.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico.</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">En caso de duda, consulte de nuevo a su médico o farmacéutico.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">La dosis recomendada es:</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 224.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Adultos:</span></strong> <span style="font-family:Times New Roman; font-size:11pt">un comprimido al día, con o sin alimentos</span></p><p style="margin:0pt 224.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">No mastique, triture ni divida el comprimido.</span></p><p style="margin:0pt 224.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Consulte a su médico o farmacéutico si está tomando:</span></strong></li></ul><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 22.4pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">antiácidos</span></strong> <span style="font-family:Times New Roman; font-size:11pt">para tratar úlceras estomacales, acidez estomacal o reflujo ácido, que contengan</span> <span style="font-family:Times New Roman; font-size:11pt">hidróxido de aluminio y/o de magnesio</span></li><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; text-align:justify; padding-left:19.2pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">suplementos de minerales</span></strong> <span style="font-family:Times New Roman; font-size:11pt">o</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">vitaminas</span></strong> <span style="font-family:Times New Roman; font-size:11pt">que contengan magnesio o hierro</span></li></ul><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Vea la sección 2 para más información</span></strong> <span style="font-family:Times New Roman; font-size:11pt">sobre cómo tomar estos medicamentos con Biktarvy.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si toma más Biktarvy del que debe</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si toma más cantidad de la dosis recomendada de Biktarvy puede correr mayor riesgo de experimentar posibles efectos adversos con este medicamento (ver sección 4,</span> <em><span style="font-family:Times New Roman; font-size:11pt;">Posibles efectos adversos</span></em><span style="font-family:Times New Roman; font-size:11pt">).</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 6.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Consulte inmediatamente a su médico o acuda al servicio de urgencias más cercano. Lleve consigo el frasco de comprimidos para que pueda describir fácilmente qué ha tomado.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si olvidó tomar Biktarvy</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Es importante que no olvide una dosis de Biktarvy.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si olvida una dosis:</span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 1.4pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si se da cuenta en las 18 horas</span></strong> <span style="font-family:Times New Roman; font-size:11pt">posteriores a la hora a la que normalmente toma Biktarvy, debe</span> <span style="font-family:Times New Roman; font-size:11pt">tomar el comprimido tan pronto como sea posible. Luego tome la dosis siguiente de la forma habitual.</span></li><li style="margin:0pt 2.4pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si se da cuenta después de 18 horas o más</span></strong> <span style="font-family:Times New Roman; font-size:11pt">de la hora a la que normalmente toma Biktarvy, no</span> <span style="font-family:Times New Roman; font-size:11pt">tome la dosis olvidada. Espere y tome la siguiente dosis a la hora habitual.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 22.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si vomita</span></strong> <span style="font-family:Times New Roman; font-size:11pt">antes de que transcurra 1 hora tras haber tomado Biktarvy, tome otro comprimido. Si</span> <span style="font-family:Times New Roman; font-size:11pt">vomita transcurrida 1 hora de haber tomado Biktarvy, no necesita tomar otro comprimido hasta el momento de la hora habitual.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">No interrumpa el tratamiento con Biktarvy</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 5.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">No interrumpa el tratamiento con Biktarvy sin hablar antes con su médico.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">Interrumpir Biktarvy</span> <span style="font-family:Times New Roman; font-size:11pt">puede afectar gravemente el funcionamiento de tratamientos futuros. Si se interrumpe Biktarvy por algún motivo, consulte con su médico antes de reiniciar la toma de comprimidos de Biktarvy.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 2.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><a name="page5" id="page5"></a><strong><span style="font-family:Times New Roman; font-size:11pt;">Cuando vea que le queda poca cantidad de Biktarvy,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">acuda a su médico o farmacéutico para que le</span> <span style="font-family:Times New Roman; font-size:11pt">proporcione más. Esto es muy importante, ya que la cantidad de virus puede empezar a aumentar si el medicamento se interrumpe incluso durante un corto periodo de tiempo. Es posible que entonces la enfermedad se vuelva más difícil de tratar.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 2.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si tiene infección por VIH y hepatitis B</span></strong> <span style="font-family:Times New Roman; font-size:11pt">es especialmente importante no suspender su tratamiento</span> <span style="font-family:Times New Roman; font-size:11pt">con Biktarvy sin antes hablar con su médico. Puede necesitar hacerse análisis de sangre durante varios meses tras suspender el tratamiento. En algunos pacientes con enfermedad hepática avanzada o cirrosis no se recomienda suspender el tratamiento ya que esto puede producir un empeoramiento de su hepatitis, situación que puede ser potencialmente mortal.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 13.4pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Hable con su médico inmediatamente</span></strong> <span style="font-family:Times New Roman; font-size:11pt">acerca de síntomas nuevos o inusuales tras suspender su</span> <span style="font-family:Times New Roman; font-size:11pt">tratamiento, particularmente síntomas que asocie con la infección por el virus de la hepatitis B.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt; line-height:12.75pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 9.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Posibles efectos adversos: informe a un médico inmediatamente</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 5.4pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Cualquier signo de inflamación o de infección.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">En algunos pacientes con infección avanzada</span> <span style="font-family:Times New Roman; font-size:11pt">por el VIH (sida) y antecedentes de infecciones oportunistas (infecciones que ocurren en personas con un sistema inmunitario débil), se pueden producir signos y síntomas de inflamación por infecciones previas poco después de iniciar el tratamiento contra el VIH. Se cree que estos síntomas se deben a una mejoría de la respuesta inmunitaria del organismo, que le permite combatir infecciones que podrían haber estado presentes sin síntomas obvios.</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 7.4pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Se pueden producir también</span> <strong><span style="font-family:Times New Roman; font-size:11pt;">trastornos autoinmunitarios,</span></strong> <span style="font-family:Times New Roman; font-size:11pt">en los que el sistema inmunitario ataca a los tejidos sanos del organismo, después de que empiece a tomar medicamentos para la infección por el VIH. Los trastornos autoinmunitarios se pueden producir muchos meses después del inicio del tratamiento. Esté atento a cualquier síntoma de infección u otros síntomas, como:</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Arial; font-size:11pt"> </span></p><div type="circle" style="margin: 0pt; margin-left: 2em; padding-left: 0pt"><ul type="circle" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 37.01pt; text-indent:0pt; text-align:justify; padding-left:20.09pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">debilidad muscular</span></li><li style="margin:0pt 0pt 0pt 37.01pt; text-indent:0pt; text-align:justify; padding-left:20.09pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">debilidad que se inicia en las manos y los pies y se desplaza hacia el tronco</span></li><li style="margin:0pt 0pt 0pt 37.01pt; text-indent:0pt; text-align:justify; padding-left:20.09pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">palpitaciones, temblor o hiperactividad</span></li></ul></div><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 5.4pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si nota cualquiera de estos síntomas o cualquier síntoma de inflamación o infección, informe a su médico inmediatamente.</span></strong></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Efectos adversos frecuentes</span></strong></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><em><span style="font-family:Times New Roman; font-size:11pt;">(pueden afectar hasta 1 de cada 10 personas)</span></em></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">depresión</span></li><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">sueños anormales</span></li><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">dolor de cabeza</span></li><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">mareo</span></li><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; text-align:justify; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">diarrea</span></li><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; text-align:justify; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">ganas de vomitar (</span><em><span style="font-family:Times New Roman; font-size:11pt;">náuseas</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; text-align:justify; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">cansancio (</span><em><span style="font-family:Times New Roman; font-size:11pt;">fatiga</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Efectos adversos poco frecuentes</span></strong></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">(</span><em><span style="font-family:Times New Roman; font-size:11pt;">pueden afectar hasta 1 de cada 100 personas</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; text-align:justify; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">anemia</span></li></ul><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.85pt; text-indent:0pt; padding-left:19.25pt; font-family:serif; font-size:11pt"><a name="page6" id="page6"></a><span style="font-family:Times New Roman; font-size:11pt">vómitos</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">dolor de estómago</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">problemas digestivos que generan molestias después de las comidas (</span><em><span style="font-family:Times New Roman; font-size:11pt;">dispepsia</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">gases (</span><em><span style="font-family:Times New Roman; font-size:11pt;">flatulencia</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">hinchazón de la cara, labios, lengua o garganta (</span><em><span style="font-family:Times New Roman; font-size:11pt;">angioedema</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">picazón (</span><em><span style="font-family:Times New Roman; font-size:11pt;">prurito</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">erupción</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">habones (</span><em><span style="font-family:Times New Roman; font-size:11pt;">urticaria</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">dolor en las articulaciones (</span><em><span style="font-family:Times New Roman; font-size:11pt;">artralgia</span></em><span style="font-family:Times New Roman; font-size:11pt">)</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">comportamiento suicida</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">ansiedad</span></li></ul><p style="margin:0pt; line-height:0.7pt"><span style="font-family:Arial; font-size:11pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 8.9pt; text-indent:0pt; padding-left:19.2pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">trastornos del sueño</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><em><span style="font-family:Times New Roman; font-size:11pt;">Los análisis de sangre también pueden mostrar:</span></em></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 65pt; text-indent:-65pt; text-align:justify; font-family:serif; font-size:11pt; list-style-position:inside"><span style="font:7.0pt Times New Roman">            </span> <span style="font-family:Times New Roman; font-size:11pt">Concentraciones más altas de sustancias llamadas bilirrubina y/o creatinina sérica en la sangre</span></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 28.4pt 0pt 65pt; text-indent:-65pt; text-align:justify; font-family:serif; font-size:11pt; list-style-position:inside"><span style="font:7.0pt Times New Roman">        </span> <strong><span style="font-family:Times New Roman; font-size:11pt;">Si considera que alguno de los efectos adversos que sufre es grave, informe a su médico.</span></strong></li></ul><p style="margin:0pt 28.4pt 0pt 0pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Otros efectos que se pueden observar durante el tratamiento contra el VIH</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 11.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">La frecuencia de los siguientes efectos adversos se considera no conocida (la frecuencia no se puede estimar a partir de los datos disponibles).</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 2.4pt 0pt 8.85pt; text-indent:0pt; text-align:justify; padding-left:19.25pt; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Problemas óseos.</span></strong> <span style="font-family:Times New Roman; font-size:11pt">Algunos pacientes tratados con medicamentos antirretrovirales combinados</span> <span style="font-family:Times New Roman; font-size:11pt">como Biktarvy pueden desarrollar una enfermedad de los huesos llamada</span> <em><span style="font-family:Times New Roman; font-size:11pt;">osteonecrosis</span></em> <span style="font-family:Times New Roman; font-size:11pt">(muerte del tejido óseo debida a una pérdida del suministro de sangre al hueso). Tomar este tipo de medicamentos durante un tiempo prolongado, tomar corticosteroides, beber alcohol, tener un sistema inmunitario muy débil y tener sobrepeso, pueden ser algunos de los muchos factores de riesgo para desarrollar esta enfermedad. Los signos de osteonecrosis son:</span></li><li style="list-style: none; display: inline"><ul type="circle" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 37.01pt; text-indent:0pt; text-align:justify; padding-left:20.09pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">rigidez articular</span></li><li style="margin:0pt 0pt 0pt 36.96pt; text-indent:0pt; text-align:justify; padding-left:20.14pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">molestias y dolores articulares (especialmente de la cadera, la rodilla y el hombro)</span></li><li style="margin:0pt 0pt 0pt 37.01pt; text-indent:0pt; text-align:justify; padding-left:20.09pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">dificultad para moverse</span></li></ul></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><ul type="disc" style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 14.1pt; text-indent:0pt; text-align:justify; font-family:serif; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Si nota cualquiera de estos síntomas, informe a su médico.</span></strong></li></ul><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 12.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Durante el tratamiento del VIH puede haber un aumento en el peso y en los niveles de glucosa y lípidos en la sangre. Esto puede estar en parte relacionado con la recuperación de la salud y con el estilo de vida y, en el caso de los lípidos en la sangre, algunas veces con los medicamentos contra el VIH por sí mismos. Su médico le controlará estos cambios.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Comunicación de efectos adversos</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 17.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente</span> <span style="font-family:Times New Roman; font-size:11pt; background-color:#c0c0c0">a través del sistema nacional de notificación incluido en el</span> <a href="http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc"><span style="font-family:Times New Roman; font-size:11pt; background-color:#c0c0c0">Apéndice V.</span></a> <span style="font-family:Times New Roman; font-size:11pt">Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.</span></p><p style="margin:0pt 17.4pt 0pt 0.1pt; text-align:justify; line-height:104%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p></div>
</text>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Mantener este medicamento fuera de la vista y del alcance de los niños.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 17.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">No utilice este medicamento después de la fecha de caducidad que aparece en la caja y en el frasco después de {CAD}. La fecha de caducidad es el último día del mes que se indica.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 14.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Conservar en el embalaje original para protegerlo de la humedad. Mantener el frasco perfectamente cerrado. No utilizar si falta el sello del frasco o está roto.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 5.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><a name="page7" id="page7"></a><span style="font-family:Times New Roman; font-size:11pt">Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p></div>
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<section>
<title value="6. Contents of the pack and other information"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0pt; line-height:0.05pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 12.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Composición de Biktarvy</span></strong></p><p style="margin:0pt 12.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;"> </span></strong></p><p style="margin:0pt 12.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Los principios activos son</span></strong> <span style="font-family:Times New Roman; font-size:11pt">bictegravir, emtricitabina y tenofovir alafenamida. Cada comprimido de</span> <span style="font-family:Times New Roman; font-size:11pt">Biktarvy contiene bictegravir sódico equivalente a 50 mg de bictegravir, 200 mg de emtricitabina y tenofovir alafenamida fumarato equivalente a 25 mg de tenofovir alafenamida.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Los demás componentes son</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><em><span style="font-family:Times New Roman; font-size:11pt;">Núcleo del comprimido</span></em></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Celulosa microcristalina, croscarmelosa sódica, estearato de magnesio.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><em><span style="font-family:Times New Roman; font-size:11pt;">Recubrimiento con película</span></em></p><p style="margin:0pt 3.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Alcohol polivinílico, dióxido de titanio (E171), macrogol, talco, óxido de hierro rojo (E172), óxido de hierro negro (E172).</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Aspecto del producto y contenido del envase</span></strong></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 10.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Los comprimidos recubiertos con película de Biktarvy son comprimidos recubiertos con película de color marrón purpúreo, con forma de cápsula, marcados en una de las caras del comprimido con «GSI» y en la otra cara del comprimido con «9883». Biktarvy se presenta en frascos de 30 comprimidos y en envases de 3 frascos, conteniendo cada uno de ellos 30 comprimidos. Cada frasco contiene un desecante de gel de sílice que debe conservarse en el frasco para ayudar a proteger los comprimidos. El desecante de gel de sílice está contenido en un sobre o recipiente separado, y no se debe tragar.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Puede que solamente estén comercializados algunos tamaños de envases.</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Titular de la autorización de comercialización</span></strong></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Carrigtohill</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">County Cork, T45 DP77</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Irlanda</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Responsable de la fabricación</span></strong></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">IDA Business & Technology Park</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Carrigtohill</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">County Cork</span></p><p style="margin:0pt 0pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Irlanda</span></p><p style="margin:0pt; text-align:justify; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 6.4pt 0pt 0.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Pueden solicitar más información respecto a este medicamento dirigiéndose al representante local del titular de la autorización de comercialización:</span></p><p style="margin:0pt; line-height:8.5pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><table cellspacing="0" cellpadding="0" style="border-collapse:collapse; margin-left:0pt"><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">België/Belgique/Belgien</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Belgium SPRL-BVBA</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tél/Tel: + 32 (0) 24 01 35 50</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Lietuva</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Poland Sp. z o.o.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel.: + 48 (0) 22 262 8702</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">????????</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">???.: + 353 (0) 1 686 1888</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Luxembourg/Luxemburg</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Belgium SPRL-BVBA</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tél/Tel: + 32 (0) 24 01 35 50</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Ceská republika</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences s.r.o.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 420 (0) 910 871 986</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Magyarország</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences</span> <span style="font-family:Times New Roman; font-size:11pt">Ireland UC</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel.: + 353 (0) 1 686 1888</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Danmark</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Sweden AB</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tlf: + 46 (0) 8 5057 1849</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Malta</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 353 (0) 1 686 1888</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Deutschland</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences GmbH</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 49 (0) 89 899890-0</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Nederland</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Netherlands B.V.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 31 (0) 20 718 36 98</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Eesti</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Poland Sp. z o.o.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel.: +48 (0) 22 262 8702</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Norge</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Sweden AB</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tlf: + 46 (0) 8 5057 1849</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Ελλ?δα</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ελλ?ς Μ.ΕΠΕ.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Τηλ: + 30 (0) 210 8930 100</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Österreich</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences GesmbH</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 43 (0) 1 260 830</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">España</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences, S.L.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 34 (0) 91 378 98 30</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Polska</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Poland Sp. z o.o.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel.: + 48 (0) 22 262 870</span><span style="font-family:Times New Roman; font-size:11pt">2</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">France</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tél: + 33 (0) 1 46 09 41 00</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Portugal</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences, Lda.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 351 (0) 21 7928790</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Hrvatska</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 353 (0) 1 686 1888</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">România</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 353 (0) 1 686 1888</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Irlanda</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 353 (0) 214 825 999</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Slovenija</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ireland UC</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 353 (0) 1 686 1888</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Ísland</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Sweden AB</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Sími: + 46 (0) 8 5057 1849</span></p><p style="margin:0pt; line-height:115%; font-size:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Slovenská republika</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Slovakia s.r.o.</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 421 (0) 232 121 210</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Italia</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences S.r.l.</span></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 39 02 439201</span></p><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;"> </span></strong></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Suomi/Finland</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Sweden AB</span></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Puh/Tel: + 46 (0) 8 5057 1849</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Κ?προς</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ελλ?ς Μ.ΕΠΕ.</span></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Τηλ: + 30 (0) 210 8930 100</span></p><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;"> </span></strong></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Sverige</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Sweden A</span><span style="font-family:Times New Roman; font-size:11pt">B</span></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 46 (0) 8 5057 1849</span></p></td></tr><tr><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Latvija</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Poland Sp. z o.o.</span></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Tel.: + 48 (0) 22 262 8702</span></p></td><td style="padding-left:5.4pt; padding-right:5.4pt; vertical-align:top; width:216.1pt"><p style="margin:0pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Reino Unido</span></strong></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Gilead Sciences Ltd.</span></p><p style="margin:0pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: + 44 (0) 8000 113 700</span></p></td></tr></table><p style="margin:0pt; line-height:7.5pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt; line-height:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><a name="page9" id="page9"></a><strong><span style="font-family:Times New Roman; font-size:11pt;">Fecha de la última revisión de este prospecto:</span></strong></p><p style="margin:0pt; line-height:12.8pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt 38.4pt 0pt 0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">La información detallada de este medicamento está disponible en la página web de la Agencia Europea de Medicamentos:</span> <a href="http://www.ema.europa.eu/"><span style="font-family:Times New Roman; font-size:11pt">http://www.ema.europa.eu.</span></a></p><p style="margin:0pt; line-height:10pt"><span style="font-family:Times New Roman; font-size:10pt"> </span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-d79af6e660f456c6c7091803d6bd1a92"/>
<resource>
<ClinicalUseDefinition>
<id value="cud-d79af6e660f456c6c7091803d6bd1a92"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-contraindication-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ClinicalUseDefinition</b><a name="cud-d79af6e660f456c6c7091803d6bd1a92"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ClinicalUseDefinition "cud-d79af6e660f456c6c7091803d6bd1a92" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-ClinicalUseDefinition-contraindication-uv-epi.html">ClinicalUseDefinition Contraindication (ePI)</a></p></div><p><b>identifier</b>: id: pregnancy (use: OFFICIAL)</p><p><b>type</b>: contraindication</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></p><blockquote><p><b>contraindication</b></p><h3>DiseaseSymptomProcedures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>nan <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (mdr#nan)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/rmswi/#/"/>
<value value="pregnancy"/>
</identifier>
<type value="contraindication"/>
<subject>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</subject>
<contraindication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/mdr"/>
<code value="nan"/>
<display value="nan"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</contraindication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-biktarvy-bictegravirsodium"/>
<resource>
<Ingredient>
<id value="ingredient-for-biktarvy-bictegravirsodium"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="ingredient-for-biktarvy-bictegravirsodium"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "ingredient-for-biktarvy-bictegravirsodium" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id: 4L5MP1Y7W7 (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-94a96e39cfdcd8b378d12dd4063065f9">See above (ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9)</a></li><li><a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></li><li><a href="#AdministrableProductDefinition_ap-94a96e39cfdcd8b378d12dd4063065f9">See above (AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9)</a></li></ul><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>BICTEGRAVIR SODIUM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#4L5MP1Y7W7)</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>50 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg = 'mg')</span></td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#ACTIB)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="4L5MP1Y7W7"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="4L5MP1Y7W7"/>
<display value="BICTEGRAVIR SODIUM"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="50"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-biktarvy-emtricitabine"/>
<resource>
<Ingredient>
<id value="ingredient-for-biktarvy-emtricitabine"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="ingredient-for-biktarvy-emtricitabine"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "ingredient-for-biktarvy-emtricitabine" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id: G70B4ETF4S (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-94a96e39cfdcd8b378d12dd4063065f9">See above (ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9)</a></li><li><a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></li><li><a href="#AdministrableProductDefinition_ap-94a96e39cfdcd8b378d12dd4063065f9">See above (AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9)</a></li></ul><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>Emtricitabine <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#G70B4ETF4S)</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>200 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg = 'mg')</span></td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#ACTIB)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="G70B4ETF4S"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="G70B4ETF4S"/>
<display value="Emtricitabine"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="200"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-biktarvy-tenofoviralafenamide"/>
<resource>
<Ingredient>
<id value="ingredient-for-biktarvy-tenofoviralafenamide"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="ingredient-for-biktarvy-tenofoviralafenamide"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "ingredient-for-biktarvy-tenofoviralafenamide" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id: EL9943AG5J (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-94a96e39cfdcd8b378d12dd4063065f9">See above (ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9)</a></li><li><a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></li><li><a href="#AdministrableProductDefinition_ap-94a96e39cfdcd8b378d12dd4063065f9">See above (AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9)</a></li></ul><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>tenofovir alafenamide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#EL9943AG5J)</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>25 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg = 'mg')</span></td><td>active ingredient - basis of strength <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-RoleClass.html">RoleClass</a>#ACTIB)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="EL9943AG5J"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="EL9943AG5J"/>
<display value="tenofovir alafenamide"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="25"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</presentationQuantity>
<basis>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
<code value="ACTIB"/>
<display value="active ingredient - basis of strength"/>
</coding>
</basis>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-biktarvy-microcrystallinecellulose"/>
<resource>
<Ingredient>
<id value="ingredient-for-biktarvy-microcrystallinecellulose"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="ingredient-for-biktarvy-microcrystallinecellulose"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "ingredient-for-biktarvy-microcrystallinecellulose" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id: OP1R32D61U (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-94a96e39cfdcd8b378d12dd4063065f9">See above (ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9)</a></li><li><a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></li><li><a href="#AdministrableProductDefinition_ap-94a96e39cfdcd8b378d12dd4063065f9">See above (AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9)</a></li></ul><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>Microcrystalline cellulose <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#OP1R32D61U)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="OP1R32D61U"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="OP1R32D61U"/>
<display value="Microcrystalline cellulose"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-biktarvy-croscarmellosesodium"/>
<resource>
<Ingredient>
<id value="ingredient-for-biktarvy-croscarmellosesodium"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="ingredient-for-biktarvy-croscarmellosesodium"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "ingredient-for-biktarvy-croscarmellosesodium" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id: M28OL1HH48 (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-94a96e39cfdcd8b378d12dd4063065f9">See above (ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9)</a></li><li><a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></li><li><a href="#AdministrableProductDefinition_ap-94a96e39cfdcd8b378d12dd4063065f9">See above (AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9)</a></li></ul><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>Croscarmellose sodium <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#M28OL1HH48)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="M28OL1HH48"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="M28OL1HH48"/>
<display value="Croscarmellose sodium"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-biktarvy-magnesiumstearate"/>
<resource>
<Ingredient>
<id value="ingredient-for-biktarvy-magnesiumstearate"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Ingredient</b><a name="ingredient-for-biktarvy-magnesiumstearate"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient "ingredient-for-biktarvy-magnesiumstearate" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Ingredient-uv-epi.html">Ingredient (ePI)</a></p></div><p><b>identifier</b>: id: 70097M6I30 (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-94a96e39cfdcd8b378d12dd4063065f9">See above (ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9)</a></li><li><a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></li><li><a href="#AdministrableProductDefinition_ap-94a96e39cfdcd8b378d12dd4063065f9">See above (AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9)</a></li></ul><p><b>role</b>: Excipient <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072082)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td>Magnesium stearate <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#70097M6I30)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="70097M6I30"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="Excipient"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="70097M6I30"/>
<display value="Magnesium stearate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-94a96e39cfdcd8b378d12dd4063065f9"/>
<resource>
<AdministrableProductDefinition>
<id value="ap-94a96e39cfdcd8b378d12dd4063065f9"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdministrableProductDefinition</b><a name="ap-94a96e39cfdcd8b378d12dd4063065f9"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource AdministrableProductDefinition "ap-94a96e39cfdcd8b378d12dd4063065f9" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-AdministrableProductDefinition-uv-epi.html">AdministrableProductDefinition (ePI)</a></p></div><p><b>identifier</b>: id: EU/1/18/1289/001</p><p><b>status</b>: active</p><p><b>formOf</b>: <a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></p><p><b>administrableDoseForm</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073664)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000002152)</span></p><p><b>producedFrom</b>: <a href="#ManufacturedItemDefinition_mid-94a96e39cfdcd8b378d12dd4063065f9">See above (ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9)</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073619)</span></p><h3>TargetSpecies</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Human <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000109093)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1289/001"/>
</identifier>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073619"/>
<display value="Oral use"/>
</coding>
</code>
<targetSpecies>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000109093"/>
<display value="Human"/>
</coding>
</code>
</targetSpecies>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization94a96e39cfdcd8b378d12dd4063065f90"/>
<resource>
<RegulatedAuthorization>
<id value="authorization94a96e39cfdcd8b378d12dd4063065f90"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: RegulatedAuthorization</b><a name="authorization94a96e39cfdcd8b378d12dd4063065f90"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource RegulatedAuthorization "authorization94a96e39cfdcd8b378d12dd4063065f90" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-RegulatedAuthorization-uv-epi.html">RegulatedAuthorization (ePI)</a></p></div><p><b>identifier</b>: id: EU/1/18/1289/001 (use: OFFICIAL)</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></p><p><b>type</b>: Marketing Authorisation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#220000000061)</span></p><p><b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2018-06-21 13:28:17+0000</p><p><b>holder</b>: <a href="#Organization_mah-715f8a161ed438d0584510e5b4512caa">See above (Organization/mah-715f8a161ed438d0584510e5b4512caa)</a></p><p><b>regulator</b>: <a href="#Organization_mra-1133a7374c78f1d40f41885344f06a5a">See above (Organization/mra-1133a7374c78f1d40f41885344f06a5a)</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1289/001"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2018-06-21T13:28:17Z"/>
<holder>🔗
<reference
value="Organization/mah-715f8a161ed438d0584510e5b4512caa"/>
</holder>
<regulator>🔗
<reference
value="Organization/mra-1133a7374c78f1d40f41885344f06a5a"/>
</regulator>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-715f8a161ed438d0584510e5b4512caa"/>
<resource>
<Organization>
<id value="mah-715f8a161ed438d0584510e5b4512caa"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="mah-715f8a161ed438d0584510e5b4512caa"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Organization "mah-715f8a161ed438d0584510e5b4512caa" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: id: ORG-100008368 (use: OFFICIAL)</p><p><b>active</b>: true</p><p><b>type</b>: Marketing authorisation holder <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#220000000034)</span></p><p><b>name</b>: Gilead Sciences Ireland UC</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Carrigtohill, County Cork, T45 County Cork IR(WORK)</td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="ORG-100008368"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000034"/>
<display value="Marketing authorisation holder"/>
</coding>
</type>
<name value="Gilead Sciences Ireland UC"/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text value="Carrigtohill, County Cork, T45 County Cork IR"/>
<line value="Carrigtohill, County Cork, T45"/>
<city value="County Cork"/>
<country value="IR"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Organization/mra-1133a7374c78f1d40f41885344f06a5a"/>
<resource>
<Organization>
<id value="mra-1133a7374c78f1d40f41885344f06a5a"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Organization</b><a name="mra-1133a7374c78f1d40f41885344f06a5a"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Organization "mra-1133a7374c78f1d40f41885344f06a5a" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-Organization-uv-epi.html">Organization (ePI)</a></p></div><p><b>identifier</b>: id: ORG-100013412 (use: OFFICIAL)</p><p><b>active</b>: true</p><p><b>type</b>: Medicines Regulatory Authority <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#220000000032)</span></p><p><b>name</b>: European Medicines Agency</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL(WORK)</td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="ORG-100013412"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="220000000032"/>
<display value="Medicines Regulatory Authority"/>
</coding>
</type>
<name value="European Medicines Agency"/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text
value="Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL"/>
<line
value="Carretera De Martorell 41 61, Poligono Industrial Nord-Est"/>
<city value="Amsterdam"/>
<postalCode value="1083 HS"/>
<country value="NL"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-e34e4b65abd3fd8e667db05606cc25a9"/>
<resource>
<PackagedProductDefinition>
<id value="ppd-e34e4b65abd3fd8e667db05606cc25a9"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b><a name="ppd-e34e4b65abd3fd8e667db05606cc25a9"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PackagedProductDefinition "ppd-e34e4b65abd3fd8e667db05606cc25a9" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-PackagedProductDefinition-uv-epi.html">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: id: EU/1/18/1289/001 (use: OFFICIAL)</p><p><b>name</b>: Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 90</p><p><b>type</b>: Chemical Medicinal Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000155527)</span></p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></p><p><b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2012-02-07 13:28:17+0000</p><blockquote><p><b>packaging</b></p><p><b>type</b>: Box <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073498)</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: Cardboard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000003529)</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: id: 654321</p><p><b>type</b>: Child-resistant closure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073504)</span></p><p><b>quantity</b>: 90</p><p><b>material</b>: PolyVinyl Chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000003222)</span></p><blockquote><p><b>containedItem</b></p></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1289/001"/>
</identifier>
<name
value="Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 90"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155527"/>
<display value="Chemical Medicinal Product"/>
</coding>
</type>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2012-02-07T13:28:17Z"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="654321"/>
</identifier>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073504"/>
<display value="Child-resistant closure"/>
</coding>
</type>
<quantity value="90"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003222"/>
<display value="PolyVinyl Chloride"/>
</coding>
</material>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</reference>
</item>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-6d93344139a7793e7b9bd0f5e32b6c91"/>
<resource>
<PackagedProductDefinition>
<id value="ppd-6d93344139a7793e7b9bd0f5e32b6c91"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PackagedProductDefinition</b><a name="ppd-6d93344139a7793e7b9bd0f5e32b6c91"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PackagedProductDefinition "ppd-6d93344139a7793e7b9bd0f5e32b6c91" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-PackagedProductDefinition-uv-epi.html">PackagedProductDefinition (ePI)</a></p></div><p><b>identifier</b>: id: EU/1/18/1289/001 (use: OFFICIAL)</p><p><b>name</b>: Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 30</p><p><b>type</b>: Chemical Medicinal Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000155527)</span></p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_mp2a9c4333cfd126f2e7b73ad3cafd6949">See above (MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949)</a></p><p><b>status</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2012-02-07 13:28:17+0000</p><blockquote><p><b>packaging</b></p><p><b>type</b>: Box <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073498)</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: Cardboard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000003529)</span></p><blockquote><p><b>packaging</b></p><p><b>identifier</b>: id: 654321</p><p><b>type</b>: Child-resistant closure <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073504)</span></p><p><b>quantity</b>: 30</p><p><b>material</b>: PolyVinyl Chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000003222)</span></p><blockquote><p><b>containedItem</b></p></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1289/001"/>
</identifier>
<name
value="Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 30"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155527"/>
<display value="Chemical Medicinal Product"/>
</coding>
</type>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2012-02-07T13:28:17Z"/>
<packaging>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="654321"/>
</identifier>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073504"/>
<display value="Child-resistant closure"/>
</coding>
</type>
<quantity value="30"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003222"/>
<display value="PolyVinyl Chloride"/>
</coding>
</material>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
</reference>
</item>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
<resource>
<MedicinalProductDefinition>
<id value="mp2a9c4333cfd126f2e7b73ad3cafd6949"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="mp2a9c4333cfd126f2e7b73ad3cafd6949"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource MedicinalProductDefinition "mp2a9c4333cfd126f2e7b73ad3cafd6949" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-MedicinalProductDefinition-uv-epi.html">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: id: EU/1/18/1289/001, id: 0xF79CABF272B6A7EEF104DDDA44E827gy</p><p><b>type</b>: Medicinal Product <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-type.html">Medicinal Product Type</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-domain.html">Medicinal Product Domain</a>#Human)</span></p><p><b>status</b>: active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-publication-status.html">PublicationStatus</a>#active)</span></p><p><b>legalStatusOfSupply</b>: Medicinal product subject to medical prescription <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072084)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion</p><p><b>type</b>: Full name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000001)</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Biktarvy</p><p><b>type</b>: Invented name part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000002)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: bictegravir/emtricitabine/tenofovir alafenamide</p><p><b>type</b>: Scientific name part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000003)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 50 mg/200 mg/25 mg</p><p><b>type</b>: Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000004)</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: film-coated tablets</p><p><b>type</b>: Pharmaceutical dose form part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (220000000000#220000000005)</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td>United Kingdom <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#GBR)</span></td><td>United Kingdom <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#GBR)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1289/001"/>
</identifier>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="0xF79CABF272B6A7EEF104DDDA44E827gy"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="Biktarvy"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="bictegravir/emtricitabine/tenofovir alafenamide"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="50 mg/200 mg/25 mg"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="film-coated tablets"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="GBR"/>
<display value="United Kingdom"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="GBR"/>
<display value="United Kingdom"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="English"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-94a96e39cfdcd8b378d12dd4063065f9"/>
<resource>
<ManufacturedItemDefinition>
<id value="mid-94a96e39cfdcd8b378d12dd4063065f9"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ManufacturedItemDefinition</b><a name="mid-94a96e39cfdcd8b378d12dd4063065f9"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ManufacturedItemDefinition "mid-94a96e39cfdcd8b378d12dd4063065f9" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-ManufacturedItemDefinition-uv-epi.html">ManufacturedItemDefinition (ePI)</a></p></div><p><b>identifier</b>: id: EU/1/18/1289/001 (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000073664)</span></p><p><b>unitOfPresentation</b>: Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000002152)</span></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1289/001"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000073664"/>
<display value="Tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
</Bundle>
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.gh#0.1.0 based on FHIR 5.0.0. Generated 2024-01-21
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
