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-b6ced64d25ea2c8da6c6099386f14db1"> </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-b6ced64d25ea2c8da6c6099386f14db1" (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: c9572598c41e29b90725676aab503d61</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>: 2023-04-22 15:15:46+0000</p><p><b>author</b>: <a href="#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">See above (Organization/mah-45fe50eae508b5755dd140ab2093eb5e)</a></p><p><b>title</b>: TEST PURPOSES ONLY - Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</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>2023-04-22 15:15:46+0000</td></tr></table></div>
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Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:3.5pt 0pt 0pt 7.1pt; text-align:center; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Prospecto: información para el usuario</span></strong></p><p style="margin:0.4pt 0pt 0pt 7.1pt; text-align:center; line-height:5pt"><span style="font-family:Times New Roman; font-size:5pt"> </span></p><p style="margin:0pt 0pt 0pt 7.1pt; text-align:center; line-height:10pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 7.1pt; text-align:center; line-height:10pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 0pt 0pt 7.1pt; text-align:center; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Flucelvax Tetra - suspensión inyectable en jeringa precargada</span></strong></p><p style="margin:0pt 0pt 0pt 7.1pt; text-align:center"><span style="font-family:Times New Roman; font-size:11pt">Vacuna contra la gripe (antígeno de superficie, inactivado, preparada en cultivos celulares)</span></p><p style="margin:0.4pt 0pt 0pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0.8pt 0pt 0pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt 31.2pt 0pt 5.9pt; text-align:justify"><strong><span style="font-family:Times New Roman; font-size:11pt;">Lea todo el prospecto detenidamente antes de empezar a recibir este medicamento, porque contiene</span></strong> <strong><span style="font-family:Times New Roman; font-size:11pt;">información importante para usted.</span></strong></p><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">-      </span> <span style="font-family:Times New Roman; font-size:11pt">Conserve este prospecto, ya que puede tener que volver a leerlo.</span></p><p style="margin:0.05pt 0pt 0pt 5.9pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">-     </span> <span style="font-family:Times New Roman; font-size:11pt">Si tiene alguna duda, consulte a su médico, farmacéutico o enfermero.</span></p><p style="margin:0.1pt 14.1pt 0pt 5.95pt; text-indent:-22.4pt; text-align:justify; padding-left:22.4pt"><span style="font-family:Times New Roman; font-size:11pt">-</span><span style="font-family:Times New Roman; font-size:11pt">             </span> <span style="font-family:Times New Roman; font-size:11pt">Si experimenta efectos adversos, consulte a su médico, farmacéutico o enfermero, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.</span></p><p style="margin:0pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:0pt; text-align:justify"><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 5.95pt; text-align:justify"><strong><span style="font-family:Times New Roman; font-size:11pt;">Contenido del prospecto</span></strong></p><p style="margin:0.45pt 0pt 0pt; text-align:justify"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 0pt 0pt 6.3pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">1.    Qué es Flucelvax Tetra y para qué se utiliza</span></p><p style="margin:0pt 0pt 0pt 6.3pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">2.    Qué necesita saber antes de empezar a recibir Flucelvax Tetra</span></p><p style="margin:0pt 0pt 0pt 6.3pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">3.    Cómo se administra Flucelvax Tetra</span></p><p style="margin:0.05pt 0pt 0pt 6.3pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">4.    Posibles efectos adversos</span></p><p style="margin:0pt 0pt 0pt 6.3pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">5.    Conservación de Flucelvax Tetra</span></p><p style="margin:0.05pt 0pt 0pt 6.3pt; text-align:justify"><span style="font-family:Times New Roman; font-size:11pt">6.    Contenido del envase e información adicional</span></p></div>
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<title value="1. What Flucelvax is and what it is used for"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0.6pt 0pt 0pt; line-height:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 11.85pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Flucelvax Tetra es una vacuna contra la gripe. Flucelvax Tetra se prepara en cultivos celulares y, por lo tanto, no contiene huevo.</span></p><p style="margin:0pt 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Cuando una persona recibe la vacuna, el sistema inmunitario (el sistema de defensa natural del organismo) producirá su propia protección frente al virus de la gripe. Ninguno de los componentes de la vacuna puede causar la gripe.</span></p><p style="margin:0pt 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:2.55pt 14.1pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Flucelvax Tetra se usa para prevenir la gripe en adultos y niños a partir de los 2 años de edad.</span></p><p style="margin:2.55pt 41.05pt 0pt 5.95pt; 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; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">La vacuna va dirigida a cuatro cepas del virus de la gripe siguiendo las recomendaciones de la</span> <span style="font-family:Times New Roman; font-size:11pt; vertical-align:0.5pt">Organización Mundial de la Salud para la campaña</span> <span style="font-family:Times New Roman; font-size:11pt">2023/2024.</span></p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0.65pt 0pt 0pt; line-height:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">No debe recibir Flucelvax Tetra:</span></strong></p><p style="margin:0pt 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si es alérgico a:</span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin:0.05pt 16.9pt 0pt 23.05pt; text-indent:0pt; text-align:justify; padding-left:19.5pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">los principios activos o alguno de los demás componentes de esta vacuna (incluidos en la sección 6).</span></li><li style="margin:0pt 0pt 0pt 23.05pt; text-indent:0pt; text-align:justify; padding-left:19.5pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">la beta-propiolactona, al bromuro de cetiltrimetilamonio o al polisorbato 80, que son residuos del proceso de fabricación que pueden estar presentes en cantidades mínimas.</span></li></ul><p style="margin:0.9pt 0pt 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 0pt 0pt 5.95pt; 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 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Consulte a su médico, farmacéutico o enfermero antes de empezar a recibir Flucelvax Tetra.</span></p><p style="margin:0pt 0pt 0pt 5.95pt; 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 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt;">ANTES DE vacunarse</span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin:0.9pt 5pt 0pt 13.36pt; text-indent:0pt; text-align:justify; padding-left:7.94pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">su médico o enfermero comprobará la fácil disponibilidad de tratamiento médico y supervisión adecuados en el caso raro de que se produjera una reacción anafiláctica (una reacción alérgica muy grave con síntomas como dificultad para respirar, mareos, pulso débil y rápido y erupción cutánea) después de la administración. Esta reacción puede presentarse con Flucelvax Tetra, al igual que con todas las vacunas que se inyectan.</span></li><li style="margin:0pt 25.35pt 0pt 13.36pt; text-indent:0pt; text-align:justify; padding-left:7.94pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">debe informar a su médico si tiene una enfermedad aguda que cursa con fiebre. Su médico puede decidir retrasar su vacunación hasta que la fiebre haya desaparecido.</span></li><li style="list-style: none; display: inline"><ul style="margin:0pt; padding-left:0pt"><li style="margin:0pt 5.45pt 0pt 13.36pt; text-indent:0pt; text-align:justify; padding-left:7.94pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">debe informar a su médico si su sistema inmunitario está comprometido o si está recibiendo un tratamiento que afecte al mismo, por ejemplo, medicamento contra el cáncer (quimioterapia) o corticoides (ver sección “Otros medicamentos y Flucelvax Tetra”).</span></li></ul></li><li style="margin:0pt 0pt 0pt 13.36pt; text-indent:0pt; text-align:justify; padding-left:7.94pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">debe informar a su médico si tiene un problema de sangrado o le salen moretones     fácilmente.</span></li><li style="margin:0pt 4.6pt 0pt 13.36pt; text-indent:0pt; text-align:justify; padding-left:7.94pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">puede desmayarse después de la inyección con una aguja, o incluso antes, por lo tanto, informe a su médico o enfermero si se ha desmayado anteriormente con alguna inyección.</span></li></ul><p style="margin:0.7pt 0pt 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 20.05pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Como ocurre con todas las vacunas, Flucelvax Tetra puede no proteger completamente a todas las personas que son vacunadas.</span></p><p style="margin:0.75pt 0pt 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 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Otros medicamentos y Flucelvax Tetra</span></strong></p><p style="margin:0pt 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Informe a su médico o enfermero si está utilizando, ha utilizado recientemente o pudiera tener que utilizar cualquier otro medicamento, incluso los adquiridos sin receta, o si ha recibido recientemente alguna otra vacuna.</span></p><p style="margin:0.55pt 0pt 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 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Flucelvax Tetra se puede administrar al mismo tiempo que otras vacunas.</span></p><p style="margin:0.9pt 0pt 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 0pt 0pt 5.95pt; 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><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt;">Embarazo:</span></p><p style="margin:0.05pt 14.1pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico. Las vacunas antigripales se pueden administrar en cualquier trimestre del embarazo.</span></p><p style="margin:0.5pt 0pt 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 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt;">Lactancia:</span></p><p style="margin:0.15pt 7.5pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">El uso de Flucelvax Tetra durante la lactancia no ha sido estudiado. Flucelvax Tetra se puede administrar durante la lactancia.</span></p><p style="margin:0.75pt 0pt 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 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Conducción y uso de máquinas</span></strong></p><p style="margin:0pt 14.1pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">La influencia de Flucelvax Tetra sobre la capacidad para conducir y utilizar máquinas es nula o insignificante.</span></p><p style="margin:0.75pt 0pt 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 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Flucelvax Tetra contiene cloruro de sodio y cloruro de potasio</span></strong></p><p style="margin:0pt 0pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Esta vacuna contiene menos de 1 mmol de sodio (23 mg) por dosis; 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">Esta vacuna contiene potasio, menos de 1 mmol (39 mg) por dosis; esto es, esencialmente “exento de potasio”.</span></p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:0.6pt 0pt 0pt; line-height:12pt"><a name="_Hlk142925114"><span style="font-family:Times New Roman; font-size:12pt"> </span></a></p><p style="margin:0pt 14.1pt 0pt 5.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Su médico o enfermero le administrará Flucelvax Tetra en forma de inyección en el músculo de la parte superior del brazo (músculo deltoides).</span></p><p style="margin:0.95pt 0pt 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:1.6pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt; vertical-align:-0.5pt">Adultos y niños a partir de 2 años de edad:</span></p><p style="margin:0.3pt 0pt 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; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Una dosis de 0,5 ml</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt; background-color:#ffff00"> </span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Si su hijo es menor de 9 años y nunca ha sido vacunado contra la gripe, se le debe administrar una segunda dosis después, de al menos, 4 semanas.</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:0.4pt 0pt 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 13.75pt 0pt 7.9pt; 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 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Los siguientes efectos adversos se han notificado durante los ensayos clínicos y durante el uso general:</span></p><p style="margin:0.9pt 0pt 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 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Efectos adversos muy graves</span></strong></p><p style="margin:0pt 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Consulte inmediatamente con su médico o acuda al servicio de urgencias del hospital más cercano si presenta el siguiente efecto adverso – puede necesitar urgentemente atención médica u hospitalización:</span></p><p style="margin:0.85pt 0pt 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 20.75pt 0pt 7.95pt; text-indent:-20.4pt; text-align:justify; line-height:115%; padding-left:20.4pt; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">•</span><span style="font-family:Times New Roman; font-size:11pt">             </span> <span style="font-family:Times New Roman; font-size:11pt">Dificultad para respirar, mareos, pulso débil y rápido junto con erupción cutánea, que son los síntomas de una reacción anafiláctica (una reacción alérgica muy grave)</span></p><p style="margin:0.75pt 0pt 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 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Efectos adversos graves</span></strong></p><p style="margin:0pt 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Informe inmediatamente a su médico si presenta cualquiera de los efectos adversos siguientes – puede necesitar atención médica:</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 style="margin:0pt; padding-left:0pt"><li style="margin:0pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Se siente débil, tiene dificultades para moverse o presenta entumecimiento u hormigueo en las extremidades. Estos pueden ser síntomas del síndrome de Guillain-Barré (SGB), una enfermedad autoinmune causada por el propio sistema inmunitario del organismo</span></li><li style="margin:0pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Hinchazón extensa del miembro en el que se ha inyectado</span></li></ul><p style="margin:0.45pt 0pt 0pt; text-align:justify; line-height:115%; font-size:14pt"><span style="font-family:Times New Roman; font-size:14pt"> </span></p><p style="margin:0pt 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Efectos adversos leves</span></strong></p><p style="margin:0pt 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt;">Muy frecuentes</span> <span style="font-family:Times New Roman; font-size:11pt">(pueden afectar a más de 1 de cada 10 personas):</span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin:1.1pt 11.75pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Dolor en la zona de inyección, cardenales, enrojecimiento y endurecimiento o hinchazón en la zona de inyección</span></li><li style="margin:0pt 11.75pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; 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 11.75pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Dolor muscular</span></li><li style="margin:0pt 11.75pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Cansancio</span></li><li style="margin:0pt 11.75pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Pérdida de apetito</span></li><li style="margin:0pt 11.75pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Irritabilidad (notificada solo en niños de 2 a < 6 años)</span></li><li style="margin:0pt 11.75pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Somnolencia (notificada solo en niños de 2 a < 6 años)</span></li></ul><p style="margin:0.1pt 3.2pt 0pt 7.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">En los pacientes de edad avanzada fueron frecuentes el endurecimiento o la hinchazón en el lugar de la inyección, el dolor de cabeza, el dolor muscular y la fatiga.</span></p><p style="margin:0.95pt 0pt 0pt 7.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Los cardenales en el lugar de la inyección fueron frecuentes en adultos, ancianos y niños de 9 a < 18 años.</span></p><p style="margin:0.95pt 0pt 0pt 7.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">El dolor de cabeza fue frecuente en ancianos.</span></p><p style="margin:0.95pt 0pt 0pt 7.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">La pérdida de apetito fue frecuente en adultos, ancianos y niños de 9 a < 18 años.</span></p><p style="margin:1.6pt 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:1.6pt 0pt 0pt 7.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt;">Frecuentes</span> <span style="font-family:Times New Roman; font-size:11pt">(pueden afectar hasta 1 de cada 10 personas):</span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin:0.55pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Náuseas, vómitos, diarrea</span></li><li style="margin:0pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Dolor articular</span></li><li style="margin:0pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tiritona</span></li><li style="margin:0pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Cambios en los hábitos alimenticios (notificados solo en niños de 2 a < 6 años)</span></li><li style="margin:0pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Fiebre (> 38 °C)</span></li></ul><p style="margin:0.55pt 0pt 0pt 7.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Los vómitos fueron poco frecuentes en los pacientes de edad avanzada</span></p><p style="margin:0.55pt 0pt 0pt 7.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">La fiebre fue infrecuente en adultos y ancianos</span></p><p style="margin:0.55pt 0pt 0pt 7.95pt; 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 7.95pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt;">Frecuencia no conocida</span> <span style="font-family:Times New Roman; font-size:11pt">(no puede estimarse a partir de los datos disponibles):</span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin:0.7pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Sensación de hormigueo y</span> <span style="font-family:Times New Roman; font-size:11pt">entumecimiento (parestesia)</span></li><li style="margin:0pt 0pt 0pt 15.95pt; text-indent:0pt; text-align:justify; padding-left:12.4pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Reacciones cutáneas generalizadas incluyendo picor, ampollas en la piel (prurito, urticaria) o erupción cutánea inespecífica</span></li></ul><p style="margin:0.7pt 0pt 0pt 7.95pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:1.6pt 0pt 0pt 7.95pt; 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; 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 profesional sanitario, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto.</span> <span style="font-family:Times New Roman; font-size:11pt">También puede comunicarlos directamente a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano en</span> <a href="http://www.notificaRAM.es"><span style="font-family:Times New Roman; font-size:11pt; color:#0000ff; background-color:#ffffff">www.notificaRAM.es</span></a><span style="font-family:Times New Roman; font-size:11pt">.</span> <span style="font-family:Times New Roman; font-size:11pt">M</span><span style="font-family:Times New Roman; font-size:11pt">ediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.</span></p></div>
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<section>
<title value="5. How to store Flucelvax"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p style="margin:2.45pt 14.1pt 0pt 5.9pt; 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:2.45pt 14.1pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt"> </span></p><p style="margin:2.45pt 14.1pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Conservar en nevera (entre 2 °C y 8 °C). No congelar.</span></p><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt; vertical-align:0.5pt">Mantener la jeringa precargada en el embalaje exterior para protegerla de la luz.</span></p><p style="margin:0.55pt 0pt 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 3.15pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">No utilice esta vacuna después de la fecha de caducidad que aparece en la etiqueta y en la caja después de EXP/CAD. La fecha de caducidad es el último día del mes que se indica.</span></p><p style="margin:0.8pt 0pt 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 8.2pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><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>
<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:0.55pt 0pt 0pt; line-height:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Composición de Flucelvax Tetra</span></strong></p><p style="margin:0.4pt 0pt 0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin:0pt 14.1pt 0pt 11.96pt; text-indent:0pt; text-align:justify; line-height:115%; padding-left:9.34pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Los principios activos son antígenos de superficie del virus de la gripe (hemaglutinina y neuraminidasa), inactivados, de las siguientes cepas*:</span></li></ul><p style="margin:0.5pt 0pt 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 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><a name="_Hlk66283421"></a><a name="_Hlk66283267"><span style="font-family:Times New Roman; font-size:11pt">Cepa similar a</span> <span style="font-family:Times New Roman; font-size:11pt">A/Wisconsin/67/2022 (H1N1)pdm09</span> <span style="font-family:Times New Roman; font-size:11pt">(A/Georgia/12/2022 CVR-167)</span></a></p><p style="margin:0pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">15 microgramos HA**</span></p><p style="margin:0pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><a name="_Hlk66283440"></a><a name="_Hlk66283292"><span style="font-family:Times New Roman; font-size:11pt">Cepa similar a</span> <span style="font-family:Times New Roman; font-size:11pt">A/Darwin/6/2021 (H3N2)</span> <span style="font-family:Times New Roman; font-size:11pt">(A/Darwin/11/2021, wild type)</span></a></p><p style="margin:0pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">15 microgramos HA**</span></p><p style="margin:0pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Cepa similar a B/Austria/1359417/2021</span> <span style="font-family:Times New Roman; font-size:11pt">(</span><span style="font-family:Times New Roman; font-size:11pt">Singapore/WUH4618/2021</span><span style="font-family:Times New Roman; font-size:11pt">, wild type</span><span style="font-family:Times New Roman; font-size:11pt">)</span> <span style="font-family:Times New Roman; font-size:11pt">15 microgramos HA**</span></p><p style="margin:0.55pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Cepa similar a B/Phuket/3073/2013 (B/Singapore/INFTT-16-0610/2016, wild type)</span></p><p style="margin:0.55pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">15 microgramos HA**</span></p><p style="margin:0.55pt 0pt 0pt 21.3pt; 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 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">por dosis de 0,5 ml</span></p><p style="margin:0.05pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">……………………………………….</span></p><p style="margin:0.05pt 26.05pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">*</span><span style="font-family:Times New Roman; font-size:11pt">             </span> <span style="font-family:Times New Roman; font-size:11pt">propagadas en células Madin Darby Canine Kidney (MDCK) (se trata de un cultivo celular especial en el que crece el virus de la gripe)</span></p><p style="margin:0pt 0pt 0pt 21.3pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">** hemaglutinina</span></p><p style="margin:0.85pt 0pt 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 3.3pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Esta vacuna cumple con la recomendación de la Organización Mundial de la Salud (OMS) (hemisferio norte) y con la recomendación de la UE para la CAMPAÑA 2023/2024.</span></p><p style="margin:0.7pt 0pt 0pt; text-align:justify; line-height:115%; font-size:12pt"><span style="font-family:Times New Roman; font-size:12pt"> </span></p><ul style="margin:0pt; padding-left:0pt"><li style="margin:0pt 14.25pt 0pt 15.76pt; text-indent:0pt; text-align:justify; line-height:115%; padding-left:12.59pt; font-family:serif; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Los demás componentes son: cloruro de sodio, cloruro de potasio, cloruro de magnesio hexahidrato, fosfato disódico dihidrato, dihidrogenofosfato de potasio y agua para preparaciones inyectables.</span></li></ul><p style="margin:0.75pt 0pt 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 0pt 0pt 5.9pt; 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:0.6pt 0pt 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 14.1pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Flucelvax Tetra es una suspensión inyectable en jeringa precargada (jeringa lista para usar). Flucelvax Tetra es una suspensión de transparente a ligeramente opalescente.</span></p><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Cada jeringa individual contiene 0,5 ml de suspensión inyectable.</span></p><p style="margin:0pt 0pt 0pt 7.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Flucelvax Tetra está disponible en envases de 1 jeringa precargada con o sin aguja o 10 jeringas</span></p><p style="margin:0pt 0pt 0pt 7.1pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">precargadas con o sin agujas.</span></p><p style="margin:0pt 0pt 0pt 5.9pt; 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:0.9pt 0pt 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 0pt 0pt 5.9pt; 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 y responsable de la fabricación</span></strong></p><p style="margin:0pt 14.1pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Seqirus Netherlands B.V.</span></p><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Paasheuvelweg 28</span></p><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">1105BJ Amsterdam</span></p><p style="margin:0pt 0pt 0pt 5.9pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Países Bajos</span></p><p style="margin:0.85pt 0pt 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 11.4pt 0pt 0pt; 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 11.4pt 0pt 6.9pt; 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; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Seqirus Spain, S.L., Barcelona</span></p><p style="margin:0pt; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Tel: 937 817 884</span></p><p style="margin:0.75pt 0pt 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; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Fecha de la última revisión de este prospecto: 07/2023</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; 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; text-align:justify; line-height:115%; font-size:11pt"><strong><span style="font-family:Times New Roman; font-size:11pt;">Otras fuentes de información</span></strong></p><p style="margin:0.6pt 0pt 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 3.8pt 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:0.55pt 0pt 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 18.1pt 0pt 0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">------------------------------------------------------------------------------------------------------------- Esta información está destinada únicamente a profesionales del sector sanitario:</span></p><p style="margin:0.5pt 0pt 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 4.75pt 0pt 0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Debe estar siempre fácilmente disponible el tratamiento médico y la supervisión apropiados en caso de un episodio anafiláctico, que puede aparecer raramente después de administrar la vacuna.</span></p><p style="margin:0.8pt 0pt 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 50.45pt 0pt 0pt; text-align:justify; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Agitar antes de usar. Después de agitar, el aspecto normal de la vacuna es una suspensión de transparente a ligeramente opalescente.</span></p><p style="margin:0.55pt 0pt 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; line-height:115%; font-size:11pt"><span style="font-family:Times New Roman; font-size:11pt">Se debe inspeccionar visualmente la vacuna en busca de partículas extrañas o cambios de color antes de la administración. Si se observan partículas extrañas y/o cualquier variación del aspecto físico, no administre la vacuna.</span></p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-2e8cb2387c664fb619f6b8914767d38f"/>
<resource>
<Ingredient>
<id value="ingredient-for-2e8cb2387c664fb619f6b8914767d38f"/>
<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-2e8cb2387c664fb619f6b8914767d38f"> </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-2e8cb2387c664fb619f6b8914767d38f" </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: 9V4SVN4JQV (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</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>INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#9V4SVN4JQV)</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>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM code ug = 'ug')</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>
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<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="9V4SVN4JQV"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</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="9V4SVN4JQV"/>
<display
value="INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</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-flucelvax-influenzaavirusadarwin112021h3n2whole"/>
<resource>
<Ingredient>
<id
value="ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole"/>
<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-flucelvax-influenzaavirusadarwin112021h3n2whole"> </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-flucelvax-influenzaavirusadarwin112021h3n2whole" </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: JS7E5ZZ3AC (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li></ul><p><b>role</b>: active <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>INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#JS7E5ZZ3AC)</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>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM code ug = 'ug')</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>
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<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="JS7E5ZZ3AC"/>
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<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="JS7E5ZZ3AC"/>
<display
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</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</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-f4e520e2974f4acb8abe26b607ea5a46"/>
<resource>
<Ingredient>
<id value="ingredient-for-f4e520e2974f4acb8abe26b607ea5a46"/>
<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-f4e520e2974f4acb8abe26b607ea5a46"> </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-f4e520e2974f4acb8abe26b607ea5a46" </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: BFA4LSE5QQ (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li></ul><p><b>role</b>: active <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>INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#BFA4LSE5QQ)</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>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM code ug = 'ug')</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="BFA4LSE5QQ"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="BFA4LSE5QQ"/>
<display
value="INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</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-2c0c197a41a706fb2549601e635da1f3"/>
<resource>
<Ingredient>
<id value="ingredient-for-2c0c197a41a706fb2549601e635da1f3"/>
<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-2c0c197a41a706fb2549601e635da1f3"> </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-2c0c197a41a706fb2549601e635da1f3" </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: B3EV5T8SUF (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li></ul><p><b>role</b>: active <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>INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#B3EV5T8SUF)</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>15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM code ug = 'ug')</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="B3EV5T8SUF"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072082"/>
<display value="active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<code value="B3EV5T8SUF"/>
<display
value="INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE"/>
</coding>
</concept>
</code>
<strength>
<presentationQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</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-flucelvax-sodiumchloride"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-sodiumchloride"/>
<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-flucelvax-sodiumchloride"> </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-flucelvax-sodiumchloride" </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: 451W47IQ8X (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</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>Sodium chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#451W47IQ8X)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="451W47IQ8X"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</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="451W47IQ8X"/>
<display value="Sodium chloride"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumchloride"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-potassiumchloride"/>
<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-flucelvax-potassiumchloride"> </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-flucelvax-potassiumchloride" </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: 660YQ98I10 (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</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>Potassium chloride <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#660YQ98I10)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="660YQ98I10"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</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="660YQ98I10"/>
<display value="Potassium chloride"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-magnesiumchloride"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-magnesiumchloride"/>
<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-flucelvax-magnesiumchloride"> </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-flucelvax-magnesiumchloride" </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: 02F3473H9O (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</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 CHLORIDE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#02F3473H9O)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="02F3473H9O"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</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="02F3473H9O"/>
<display value="MAGNESIUM CHLORIDE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate"/>
<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-flucelvax-sodiumphosphatedibasicdihydrate"> </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-flucelvax-sodiumphosphatedibasicdihydrate" </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: 94255I6E2T (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</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>SODIUM PHOSPHATE, DIBASIC, DIHYDRATE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#94255I6E2T)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="94255I6E2T"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</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="94255I6E2T"/>
<display value="SODIUM PHOSPHATE, DIBASIC, DIHYDRATE"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-potassiumdihydrogenphosphate"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-potassiumdihydrogenphosphate"/>
<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-flucelvax-potassiumdihydrogenphosphate"> </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-flucelvax-potassiumdihydrogenphosphate" </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: 4J9FJ0HL51 (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</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>Potassium dihydrogen phosphate <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#4J9FJ0HL51)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="4J9FJ0HL51"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</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="4J9FJ0HL51"/>
<display value="Potassium dihydrogen phosphate"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-flucelvax-waterforinjections"/>
<resource>
<Ingredient>
<id value="ingredient-for-flucelvax-waterforinjections"/>
<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-flucelvax-waterforinjections"> </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-flucelvax-waterforinjections" </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: 059QF0KO0R (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: </p><ul><li><a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></li><li><a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></li><li><a href="#AdministrableProductDefinition_ap-04c9bd6fb89d38b2d83eced2460c4dc1">See above (AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1)</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>Water for injections <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (beta#059QF0KO0R)</span></td></tr></table></blockquote></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
<value value="059QF0KO0R"/>
</identifier>
<status value="active"/>
<for>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</for>
<for>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</for>
<for>🔗
<reference
value="AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</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="059QF0KO0R"/>
<display value="Water for injections"/>
</coding>
</concept>
</code>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadelaware552019cvr45h1n1whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzaavirusadelaware552019cvr45h1n1whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="substance-influenzaavirusadelaware552019cvr45h1n1whole"> </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 SubstanceDefinition "substance-influenzaavirusadelaware552019cvr45h1n1whole" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-SubstanceDefinition-uv-epi.html">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: id: 9V4SVN4JQV (use: OFFICIAL)</p><p><b>version</b>: 1.0</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>manufacturer</b>: <a href="#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">See above (Organization/mah-45fe50eae508b5755dd140ab2093eb5e)</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="9V4SVN4JQV"/>
</identifier>
<version value="1.0"/>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>🔗
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzaavirusadarwin112021h3n2whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzaavirusadarwin112021h3n2whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="substance-influenzaavirusadarwin112021h3n2whole"> </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 SubstanceDefinition "substance-influenzaavirusadarwin112021h3n2whole" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-SubstanceDefinition-uv-epi.html">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: id: JS7E5ZZ3AC (use: OFFICIAL)</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>manufacturer</b>: <a href="#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">See above (Organization/mah-45fe50eae508b5755dd140ab2093eb5e)</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="JS7E5ZZ3AC"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>🔗
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporewuh46182021whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzabvirusbsingaporewuh46182021whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="substance-influenzabvirusbsingaporewuh46182021whole"> </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 SubstanceDefinition "substance-influenzabvirusbsingaporewuh46182021whole" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-SubstanceDefinition-uv-epi.html">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: id: BFA4LSE5QQ (use: OFFICIAL)</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>manufacturer</b>: <a href="#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">See above (Organization/mah-45fe50eae508b5755dd140ab2093eb5e)</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="BFA4LSE5QQ"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>🔗
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-influenzabvirusbsingaporeinftt1606102016whole"/>
<resource>
<SubstanceDefinition>
<id value="substance-influenzabvirusbsingaporeinftt1606102016whole"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="substance-influenzabvirusbsingaporeinftt1606102016whole"> </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 SubstanceDefinition "substance-influenzabvirusbsingaporeinftt1606102016whole" </p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info//StructureDefinition-SubstanceDefinition-uv-epi.html">SubstanceDefinition (ePI)</a></p></div><p><b>identifier</b>: id: B3EV5T8SUF (use: OFFICIAL)</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>manufacturer</b>: <a href="#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">See above (Organization/mah-45fe50eae508b5755dd140ab2093eb5e)</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
<value value="B3EV5T8SUF"/>
</identifier>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
</coding>
</status>
<manufacturer>🔗
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</manufacturer>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<resource>
<AdministrableProductDefinition>
<id value="ap-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<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-04c9bd6fb89d38b2d83eced2460c4dc1"> </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-04c9bd6fb89d38b2d83eced2460c4dc1" </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: xx</p><p><b>status</b>: active</p><p><b>formOf</b>: <a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></p><p><b>administrableDoseForm</b>: suspension for injection in pre-filled syringe <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000074063)</span></p><p><b>unitOfPresentation</b>: Syringe <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000002150)</span></p><p><b>producedFrom</b>: <a href="#ManufacturedItemDefinition_mid-04c9bd6fb89d38b2d83eced2460c4dc1">See above (ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1)</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Subcutaneous use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000073633)</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="xx"/>
</identifier>
<status value="active"/>
<formOf>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000074063"/>
<display value="suspension for injection in pre-filled syringe"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002150"/>
<display value="Syringe"/>
</coding>
</unitOfPresentation>
<producedFrom>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073633"/>
<display value="Subcutaneous 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/authorization04c9bd6fb89d38b2d83eced2460c4dc10"/>
<resource>
<RegulatedAuthorization>
<id value="authorization04c9bd6fb89d38b2d83eced2460c4dc10"/>
<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="authorization04c9bd6fb89d38b2d83eced2460c4dc10"> </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 "authorization04c9bd6fb89d38b2d83eced2460c4dc10" </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/1/18/1326/001 (use: OFFICIAL)</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</a></p><p><b>type</b>: Marketing Authorisation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000072062)</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>: 2019-01-01</p><p><b>holder</b>: <a href="#Organization_mah-45fe50eae508b5755dd140ab2093eb5e">See above (Organization/mah-45fe50eae508b5755dd140ab2093eb5e)</a></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1326/001"/>
</identifier>
<subject>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072062"/>
<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="2019-01-01"/>
<holder>🔗
<reference
value="Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-45fe50eae508b5755dd140ab2093eb5e"/>
<resource>
<Organization>
<id value="mah-45fe50eae508b5755dd140ab2093eb5e"/>
<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-45fe50eae508b5755dd140ab2093eb5e"> </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-45fe50eae508b5755dd140ab2093eb5e" </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-100013715 (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>: Seqirus Netherlands B.V.</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>Paasheuvelweg 28 1105BJ Amsterdam Netherlands(WORK)</td></tr></table></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/omswi"/>
<value value="ORG-100013715"/>
</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="Seqirus Netherlands B.V."/>
<contact>
<address>
<use value="work"/>
<type value="physical"/>
<text value="Paasheuvelweg 28 1105BJ Amsterdam Netherlands"/>
<line value="Paasheuvelweg 28"/>
<city value="1105BJ Amsterdam"/>
<postalCode value="367061"/>
<country value="Netherlands"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
<resource>
<PackagedProductDefinition>
<id value="ppd-a854b6fee6a8536c78c604a4b9f6c395"/>
<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-a854b6fee6a8536c78c604a4b9f6c395"> </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-a854b6fee6a8536c78c604a4b9f6c395" </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>name</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1</p><p><b>type</b>: 100000155527 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#100000155527)</span></p><p><b>packageFor</b>: <a href="#MedicinalProductDefinition_mpb6ced64d25ea2c8da6c6099386f14db1">See above (MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1)</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>: 2019-01-01</p><p><b>containedItemQuantity</b>: 15 ug<span style="background: LightGoldenRodYellow"> (Details: UCUM code ug = 'ug')</span></p><p><b>copackagedIndicator</b>: true</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: xxxx</p><p><b>type</b>: 100000073498 <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>containedItem</b></p></blockquote></blockquote></blockquote></div>
</text>
<name
value="Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000155527"/>
</coding>
</type>
<packageFor>🔗
<reference
value="MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
</packageFor>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="Active"/>
</coding>
</status>
<statusDate value="2019-01-01"/>
<containedItemQuantity>
<value value="15"/>
<system value="http://unitsofmeasure.org"/>
<code value="ug"/>
</containedItemQuantity>
<copackagedIndicator value="true"/>
<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="xxxx"/>
</identifier>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000073498"/>
<display value="100000073498"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<containedItem>
<item>
<reference>🔗
<reference
value="ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
</reference>
</item>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<fullUrl
value="http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1"/>
<resource>
<MedicinalProductDefinition>
<id value="mpb6ced64d25ea2c8da6c6099386f14db1"/>
<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="mpb6ced64d25ea2c8da6c6099386f14db1"> </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 "mpb6ced64d25ea2c8da6c6099386f14db1" </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/1/18/1326/001, id: 0xF79CABF272B6A7EEF104DDDA44E82717</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#100000000000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</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>: Flucelvax Tetra</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>: Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</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>: 15 ug</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>: Solution for injection</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>Spain <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>#ES)</span></td><td>Spain <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>#ES)</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/1/18/1326/001"/>
</identifier>
<identifier>
<system value="https://www.who-umc.org/phpid"/>
<value value="0xF79CABF272B6A7EEF104DDDA44E82717"/>
</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="100000000000"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="Flucelvax Tetra"/>
<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="Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)"/>
<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="15 ug"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="Solution for injection"/>
<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="ES"/>
<display value="Spain"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="ES"/>
<display value="Spain"/>
</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-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<resource>
<ManufacturedItemDefinition>
<id value="mid-04c9bd6fb89d38b2d83eced2460c4dc1"/>
<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-04c9bd6fb89d38b2d83eced2460c4dc1"> </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-04c9bd6fb89d38b2d83eced2460c4dc1" </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/1/18/1326/001 (use: OFFICIAL)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: suspension for injection in pre-filled syringe <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#100000074063)</span></p><p><b>unitOfPresentation</b>: Syringe <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (rmswi#200000002150)</span></p></div>
</text>
<identifier>
<use value="official"/>
<system value="https://spor.ema.europa.eu/pmswi"/>
<value value="EU/1/18/1326/001"/>
</identifier>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000074063"/>
<display value="suspension for injection in pre-filled syringe"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="200000002150"/>
<display value="Syringe"/>
</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.
