UnicomIG
0.1.0 - ci-build
UnicomIG
0.1.0 - ci-build
UnicomIG, published by UNICOM. 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/unicom-ig/tree/master and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition</b></p><a name="CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition"> </a><a name="hcCefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition"> </a><a name="CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/eurdId</code>/615</p><p><b>domain</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human use</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000005003 200000005004}">Current</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000116186}">Powder for solution for injection/infusion</span></p><p><b>indication</b>: </p><div><p>Cefuroxim Stragen är avsett för behandling av nedanstående infektioner hos vuxna och barn, även nyfödda (från födelsen). • Samhällsförvärvad pneumoni • Akut exacerbation av kronisk bronkit. • Komplicerade urinvägsinfektioner, även pyelonefrit. • Mjukdelsinfektioner: cellulit, erysipelas och sårinfektioner. • Intraabdominella infektioner. • Profylax mot infektion inför gastrointestinal (även esofageal), ortopedisk, kardiovaskulär och gynekologisk operation (även kejsarsnitt). Vid behandling och förebyggande av infektioner då det är mycket troligt att anaeroba organismer påträffas ska cefuroxim administreras tillsammans med ett lämpligt antianaerobt antibiotikum. Hänsyn ska tas till officiella riktlinjer om lämplig användning av antibakteriella medel.</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 100000072084}">Medicinal product subject to medical prescription</span></p><p><b>classification</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 100000096183}">Cefuroxime</span>, <span title="Codes:{http://www.whocc.no/atc J01DC02}">cefuroxime</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Cefuroxim Stragen 1,5 g Pulver till injektions-/infusionsvätska, lösning</p><blockquote><p><b>part</b></p><p><b>part</b>: Cefuroxim Stragen</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 1,5 g</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Pulver till injektions-/infusionsvätska, lösning</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}">Kingdom of Sweden</span></td><td><span title="Codes:{urn:ietf:bcp:47 sv}">Swedish</span></td></tr></table></blockquote></div>
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<indication
value="Cefuroxim Stragen är avsett för behandling av nedanstående infektioner hos vuxna och barn, även nyfödda (från födelsen). • Samhällsförvärvad pneumoni • Akut exacerbation av kronisk bronkit. • Komplicerade urinvägsinfektioner, även pyelonefrit. • Mjukdelsinfektioner: cellulit, erysipelas och sårinfektioner. • Intraabdominella infektioner. • Profylax mot infektion inför gastrointestinal (även esofageal), ortopedisk, kardiovaskulär och gynekologisk operation (även kejsarsnitt). Vid behandling och förebyggande av infektioner då det är mycket troligt att anaeroba organismer påträffas ska cefuroxim administreras tillsammans med ett lämpligt antianaerobt antibiotikum. Hänsyn ska tas till officiella riktlinjer om lämplig användning av antibakteriella medel. "/>
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<system value="http://www.whocc.no/atc"/>
<code value="J01DC02"/>
<display value="cefuroxime"/>
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<name>
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value="Cefuroxim Stragen 1,5 g Pulver till injektions-/infusionsvätska, lösning"/>
<part>
<part value="Cefuroxim Stragen"/>
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<code value="220000000002"/>
<display value="Invented name part"/>
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<display value="Strength part"/>
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<part>
<part value="Pulver till injektions-/infusionsvätska, lösning"/>
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<display value="Pharmaceutical dose form part"/>
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<country>
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<display value="Kingdom of Sweden"/>
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<system value="urn:ietf:bcp:47"/>
<code value="sv"/>
<display value="Swedish"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_CefuroximStragen-1-5g-Powder-SE-IS-RegulatedAuthorization"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization CefuroximStragen-1-5g-Powder-SE-IS-RegulatedAuthorization</b></p><a name="CefuroximStragen-1-5g-Powder-SE-IS-RegulatedAuthorization"> </a><a name="hcCefuroximStragen-1-5g-Powder-SE-IS-RegulatedAuthorization"> </a><a name="CefuroximStragen-1-5g-Powder-SE-IS-RegulatedAuthorization-en-US"> </a><p><b>identifier</b>: 50006</p><p><b>subject</b>: <a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#MedicinalProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition">Bundle: type = collection</a></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}">Kingdom of Sweden</span></p><p><b>status</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 100000072099}">Valid</span></p><p><b>statusDate</b>: 2014-06-11</p><p><b>holder</b>: <a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#Organization_LOC-100001098-StragenNordic">Bundle: type = collection</a></p></div>
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<display value="Marketing Authorisation"/>
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<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
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<status>
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<code value="100000072099"/>
<display value="Valid"/>
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<statusDate value="2014-06-11"/>
<holder>
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value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/Organization-LOC-100001098-StragenNordic"/>
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<Organization>
<id value="LOC-100001098-StragenNordic"/>
<meta>
<profile
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_LOC-100001098-StragenNordic"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100001098-StragenNordic</b></p><a name="LOC-100001098-StragenNordic"> </a><a name="hcLOC-100001098-StragenNordic"> </a><a name="LOC-100001098-StragenNordic-en-US"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100001098</p><p><b>name</b>: Stragen Nordic A/S</p></div>
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<value value="LOC-100001098"/>
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<name value="Stragen Nordic A/S"/>
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<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/AdministrableProductDefinition-CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef"/>
<resource>
<AdministrableProductDefinition>
<id value="CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef</b></p><a name="CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef"> </a><a name="hcCefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef"> </a><a name="CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef-en-US"> </a><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#MedicinalProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition">Bundle: type = collection</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000074038}">Solution for injection/infusion</span></p><p><b>producedFrom</b>: <a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#ManufacturedItemDefinition_CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition">Bundle: type = collection</a></p><h3>RouteOfAdministrations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073600}, {https://spor.ema.europa.eu/v1/lists/100000073345 100000073611}">Intramuscular use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>
<reference
value="MedicinalProductDefinition/CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000074038"/>
<display value="Solution for injection/infusion"/>
</coding>
</administrableDoseForm>
<producedFrom>
<reference
value="ManufacturedItemDefinition/CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073600"/>
<display value="Intramuscular use"/>
</coding>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073611"/>
<display value="Intravenous use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
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<entry>
<fullUrl
value="https://hl7-eu.github.io/unicom-ig/branches/mpd-r4b/PackagedProductDefinition-CefuroximStragen-1-5g-Powder-SE-IS-PackagedProductDefinition"/>
<resource>
<PackagedProductDefinition>
<id
value="CefuroximStragen-1-5g-Powder-SE-IS-PackagedProductDefinition"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-PackagedProductDefinition"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition CefuroximStragen-1-5g-Powder-SE-IS-PackagedProductDefinition</b></p><a name="CefuroximStragen-1-5g-Powder-SE-IS-PackagedProductDefinition"> </a><a name="hcCefuroximStragen-1-5g-Powder-SE-IS-PackagedProductDefinition"> </a><a name="CefuroximStragen-1-5g-Powder-SE-IS-PackagedProductDefinition-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/?ngen-9?</p><p><b>packageFor</b>: <a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#MedicinalProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition">Bundle: type = collection</a></p><p><b>containedItemQuantity</b>: 10 Vial<span style="background: LightGoldenRodYellow"> (Details: Unit of Presentation EMA code200000002158 = 'Vial')</span></p><p><b>description</b>: </p><div><p>Injektionsflaska, 10 st (10 x 1,5 g)</p>
</div><h3>MarketingStatuses</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000535}">Kingdom of Sweden</span></td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003208}">Plastic</span></p><blockquote><p><b>packaging</b></p></blockquote></blockquote></div>
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<system value="http://ema.europa.eu/example/pcid"/>
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value="MedicinalProductDefinition/CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition"/>
</packageFor>
<containedItemQuantity>
<value value="10"/>
<unit value="Vial"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</containedItemQuantity>
<description value="Injektionsflaska, 10 st (10 x 1,5 g)"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072083"/>
<display value="Marketed"/>
</coding>
</status>
</marketingStatus>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003208"/>
<display value="Plastic"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073563"/>
<display value="Vial"/>
</coding>
</type>
<quantity value="10"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003203"/>
<display value="Glass"/>
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</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition"/>
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</item>
<amount>
<value value="1"/>
<unit value="Vial"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
</amount>
</containedItem>
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<entry>
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<resource>
<ManufacturedItemDefinition>
<id
value="CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition</b></p><a name="CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition"> </a><a name="hcCefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition"> </a><a name="CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition-en-US"> </a><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000116186}">Powder for solution for injection/infusion</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002158}">Vial</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000116186"/>
<display value="Powder for solution for injection/infusion"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002158"/>
<display value="Vial"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<fullUrl
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<resource>
<Ingredient>
<id value="CefuroximStragen-1-5g-Powder-SE-IS-Ingredient"/>
<meta>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_CefuroximStragen-1-5g-Powder-SE-IS-Ingredient"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient CefuroximStragen-1-5g-Powder-SE-IS-Ingredient</b></p><a name="CefuroximStragen-1-5g-Powder-SE-IS-Ingredient"> </a><a name="hcCefuroximStragen-1-5g-Powder-SE-IS-Ingredient"> </a><a name="CefuroximStragen-1-5g-Powder-SE-IS-Ingredient-en-US"> </a><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#MedicinalProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition">Bundle: type = collection</a></li><li><a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#ManufacturedItemDefinition_CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition">Bundle: type = collection</a></li><li><a href="Bundle-003-CefuroximStragen-1-5g-Powder-SE-FullProduct.html#AdministrableProductDefinition_CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef">Bundle: type = collection</a></li></ul><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}">Active</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><span title="Codes:{https://spor.ema.europa.eu/v2/SubstanceDefinition 100000091436}">cefuroxime sodium</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 1.578 gram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110654 = 'gram(s)')</span>/1 countable unit(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code200000027120 = 'countable unit(s)')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://spor.ema.europa.eu/v2/SubstanceDefinition 100000092667}">cefuroxime</span></td></tr></table><p><b>strength</b>: 1.5 gram(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code100000110654 = 'gram(s)')</span>/1 countable unit(s)<span style="background: LightGoldenRodYellow"> (Details: Unit of Measurement EMA code200000027120 = 'countable unit(s)')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>
<reference
value="MedicinalProductDefinition/CefuroximStragen-1-5g-Powder-SE-IS-MedicinalProductDefinition"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/CefuroximStragen-1-5g-Powder-SE-IS-ManufacturedItemDefinition"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/CefuroximStragen-1-5g-Powder-SE-IS-AdminProdDef"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000091436"/>
<display value="cefuroxime sodium"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="1.578"/>
<unit value="gram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110654"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="countable unit(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="200000027120"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000092667"/>
<display value="cefuroxime"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="1.5"/>
<unit value="gram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110654"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="countable unit(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="200000027120"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
</Bundle>
IG © 2022+ UNICOM. Package hl7.eu.fhir.unicom#0.1.0 based on FHIR 5.0.0. Generated 2024-10-11
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QA Report
The UNICOM Innovation Action has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 875299.
