Vulcan ePI FHIR Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p><b>Generated Narrative: Composition</b></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 \"cfsb1651231019151\" (Language \"en\") </p></div><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>date</b>: 2022-04-29 01:28:17+0000</p><p><b>author</b>: <a href=\"#Organization_cfsb1651149636159\">See above (Organization/cfsb1651149636159)</a></p><p><b>title</b>: TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets</p><p><b>confidentiality</b>: U</p><h3>Attesters</h3><table class=\"grid\"><tr><td>-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td>*</td><td>Official <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-composition-attestation-mode.html\">CompositionAttestationMode</a>#official)</span></td><td>2002-08-01 01:28:17+0000</td></tr></table></div>" ];
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">Package leaflet: Information for the patient Dovato 50 mg/300 mg film-coated tablets dolutegravir/lamivudine Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.<ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor or pharmacist.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>" ] ], [
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fhir:Composition.section.title [ fhir:value "What is in this leaflet" ];
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\">What in this leaflet<ol><li>What Dovato is and what it is used for</li><li>What you need to know before you take Dovato</li><li>How to take Dovato</li><li>Possible side effects</li><li>How to store Dovato</li><li>Contents of the pack and other information</li></ol></div>" ] ], [
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fhir:Composition.section.title [ fhir:value "1. What Dovato is and what it is used for" ];
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>1. What Dovato is and what it is used for</b> Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.</div>" ] ], [
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fhir:Composition.section.title [ fhir:value "2. What you need to know before you take Dovato" ];
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>2. What you need to know before you take Dovato</b> Do not take Dovato<ul><li>if you are allergic (hypersensitive) to dolutegravir or lamivudine or any of the other ingredients of this medicine (listed in section 6).</li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>" ] ], [
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>How to take Dovato</b><p>Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure</p><ul><li>The recommended dose of Dovato is <b>one tablet once a day.</b></li><li>If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis).</li></ul></div>" ] ], [
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>4. Possible side effects</b></p><p>Like all medicines, this medicine can cause side effects, although not everybody gets them,<b>so it is very important to talk to your doctor about any changes in your health</b></p></div>" ] ], [
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>5. How to store Dovato</b><p>Keep this medicine out of the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month.</p><p>This medicine does not require any special storage conditions.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>" ] ], [
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fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><b>6. Contents of the pack and other information</b> <b>What Dovato contains</b><ul><li>The active substances are dolutegravir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.</li><li>The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).</li><li>This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.</li></ul></div>" ] ] ]
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fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: MedicinalProductDefinition</b></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 \"cfsb1650904258324\" </p></div><p><b>identifier</b>: id: 498163</p><p><b>type</b>: Medicinal Product <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-medicinal-product-type.html\">MedicinalProductType</a>#MedicinalProduct)</span></p><p><b>domain</b>: Human use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-medicinal-product-domain.html\">MedicinalProductDomain</a>#Human)</span></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/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\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#100000072084)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Dovato 50 mg/300 mg film-coated tablets</p><p><b>type</b>: Full name <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#220000000001)</span></p><h3>NameParts</h3><table class=\"grid\"><tr><td>-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td>*</td><td>film-coated tablets</td><td>Pharmaceutical dose form part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#220000000005)</span></td></tr></table><h3>CountryLanguages</h3><table class=\"grid\"><tr><td>-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td>*</td><td>European Union <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#eu)</span></td><td>European Union <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (unknown#eu)</span></td><td>English <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/3.0.0/CodeSystem-v3-ietf3066.html\">Tags for the Identification of Languages</a>#en)</span></td></tr></table></blockquote></div>" ];
fhir:MedicinalProductDefinition.identifier [
fhir:index 0;
fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/pmswi" ];
fhir:Identifier.value [ fhir:value "498163" ] ];
fhir:MedicinalProductDefinition.type [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/medicinal-product-type" ];
fhir:Coding.code [ fhir:value "MedicinalProduct" ] ];
fhir:CodeableConcept.text [ fhir:value "Medicinal Product" ] ];
fhir:MedicinalProductDefinition.domain [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/medicinal-product-domain" ];
fhir:Coding.code [ fhir:value "Human" ] ];
fhir:CodeableConcept.text [ fhir:value "Human use" ] ];
fhir:MedicinalProductDefinition.status [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/publication-status" ];
fhir:Coding.code [ fhir:value "active" ];
fhir:Coding.display [ fhir:value "Active" ] ] ];
fhir:MedicinalProductDefinition.legalStatusOfSupply [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
fhir:Coding.code [ fhir:value "100000072084" ] ];
fhir:CodeableConcept.text [ fhir:value "Medicinal product subject to medical prescription" ] ];
fhir:MedicinalProductDefinition.name [
fhir:index 0;
fhir:MedicinalProductDefinition.name.productName [ fhir:value "Dovato 50 mg/300 mg film-coated tablets" ];
fhir:MedicinalProductDefinition.name.type [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
fhir:Coding.code [ fhir:value "220000000001" ] ];
fhir:CodeableConcept.text [ fhir:value "Full name" ] ];
fhir:MedicinalProductDefinition.name.namePart [
fhir:index 0;
fhir:MedicinalProductDefinition.name.namePart.part [ fhir:value "film-coated tablets" ];
fhir:MedicinalProductDefinition.name.namePart.type [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
fhir:Coding.code [ fhir:value "220000000005" ] ];
fhir:CodeableConcept.text [ fhir:value "Pharmaceutical dose form part" ] ] ];
fhir:MedicinalProductDefinition.name.countryLanguage [
fhir:index 0;
fhir:MedicinalProductDefinition.name.countryLanguage.country [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:iso:std:iso:3166" ];
fhir:Coding.code [ fhir:value "eu" ] ];
fhir:CodeableConcept.text [ fhir:value "European Union" ] ];
fhir:MedicinalProductDefinition.name.countryLanguage.jurisdiction [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:iso:std:iso:3166" ];
fhir:Coding.code [ fhir:value "eu" ] ];
fhir:CodeableConcept.text [ fhir:value "European Union" ] ];
fhir:MedicinalProductDefinition.name.countryLanguage.language [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "urn:ietf:bcp:47" ];
fhir:Coding.code [ fhir:value "en" ] ];
fhir:CodeableConcept.text [ fhir:value "English" ] ] ] ] ]
], [
fhir:index 6;
fhir:Bundle.entry.resource [
a fhir:PackagedProductDefinition;
fhir:Resource.id [ fhir:value "cfsb1650995718524" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PackagedProductDefinition</b></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 \"cfsb1650995718524\" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>name</b>: Dovato 50 mg/300 mg film-coated tablets</p><p><b>type</b>: Chemical Medicinal Prodcut <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#100000155527)</span></p><p><b>packageFor</b>: <a href=\"#MedicinalProductDefinition_cfsb1650904258324\">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>status</b>: Active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://build.fhir.org/codesystem-publication-status.html\">PublicationStatus</a>#active)</span></p><p><b>statusDate</b>: 2012-02-07 01:28:17+0000</p><p><b>containedItemQuantity</b>: 30 tablets</p><p><b>manufacturer</b>: <a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></p><h3>Packages</h3><table class=\"grid\"><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td>*</td><td>id: 654321</td><td>Child-resistant closure <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#100000073504)</span></td><td>1</td><td>Cardboard <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#200000003529)</span></td></tr></table></div>" ];
fhir:PackagedProductDefinition.identifier [
fhir:index 0;
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "$spor-prod" ];
fhir:Identifier.value [ fhir:value "EU/1/19/1370/001" ] ];
fhir:PackagedProductDefinition.name [ fhir:value "Dovato 50 mg/300 mg film-coated tablets" ];
fhir:PackagedProductDefinition.type [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
fhir:Coding.code [ fhir:value "100000155527" ] ];
fhir:CodeableConcept.text [ fhir:value "Chemical Medicinal Prodcut" ] ];
fhir:PackagedProductDefinition.packageFor [
fhir:index 0;
fhir:Reference.reference [ fhir:value "MedicinalProductDefinition/cfsb1650904258324" ] ];
fhir:PackagedProductDefinition.status [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/publication-status" ];
fhir:Coding.code [ fhir:value "active" ];
fhir:Coding.display [ fhir:value "Active" ] ] ];
fhir:PackagedProductDefinition.statusDate [ fhir:value "2012-02-07T13:28:17Z"^^xsd:dateTime ];
fhir:PackagedProductDefinition.containedItemQuantity [
fhir:index 0;
fhir:Quantity.value [ fhir:value "30"^^xsd:decimal ];
fhir:Quantity.unit [ fhir:value "tablets" ] ];
fhir:PackagedProductDefinition.manufacturer [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ];
fhir:PackagedProductDefinition.package [
fhir:PackagedProductDefinition.package.identifier [
fhir:index 0;
fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/pmswi" ];
fhir:Identifier.value [ fhir:value "654321" ] ];
fhir:PackagedProductDefinition.package.type [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
fhir:Coding.code [ fhir:value "100000073504" ];
fhir:Coding.display [ fhir:value "Child-resistant closure" ] ] ];
fhir:PackagedProductDefinition.package.quantity [ fhir:value "1"^^xsd:integer ];
fhir:PackagedProductDefinition.package.material [
fhir:index 0;
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
fhir:Coding.code [ fhir:value "200000003529" ];
fhir:Coding.display [ fhir:value "Cardboard" ] ] ] ] ]
], [
fhir:index 7;
fhir:Bundle.entry.resource [
a fhir:AdministrableProductDefinition;
fhir:Resource.id [ fhir:value "cfsb1650999516847" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdministrableProductDefinition</b></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 \"cfsb1650999516847\" </p></div><p><b>identifier</b>: id: 123456</p><p><b>status</b>: active</p><p><b>formOf</b>: <a href=\"#MedicinalProductDefinition_cfsb1650904258324\">See above (MedicinalProductDefinition/cfsb1650904258324)</a></p><p><b>administrableDoseForm</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#10219000)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#15054000)</span></p><p><b>producedFrom</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#20053000)</span></p><h3>TargetSpecies</h3><table class=\"grid\"><tr><td>-</td><td><b>Code</b></td></tr><tr><td>*</td><td>Human <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#/#100000109093)</span></td></tr></table></blockquote></div>" ];
fhir:AdministrableProductDefinition.identifier [
fhir:index 0;
fhir:Identifier.system [ fhir:value "https://www.who-umc.org/phpid" ];
fhir:Identifier.value [ fhir:value "123456" ] ];
fhir:AdministrableProductDefinition.status [ fhir:value "active" ];
fhir:AdministrableProductDefinition.formOf [
fhir:index 0;
fhir:Reference.reference [ fhir:value "MedicinalProductDefinition/cfsb1650904258324" ] ];
fhir:AdministrableProductDefinition.administrableDoseForm [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/" ];
fhir:Coding.code [ fhir:value "10219000" ] ];
fhir:CodeableConcept.text [ fhir:value "Tablet" ] ];
fhir:AdministrableProductDefinition.unitOfPresentation [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://standardterms.edqm.eu/browse/get_concepts/UOP/" ];
fhir:Coding.code [ fhir:value "15054000" ] ];
fhir:CodeableConcept.text [ fhir:value "Tablet" ] ];
fhir:AdministrableProductDefinition.producedFrom [
fhir:index 0;
fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ] ];
fhir:AdministrableProductDefinition.routeOfAdministration [
fhir:index 0;
fhir:AdministrableProductDefinition.routeOfAdministration.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://standardterms.edqm.eu/browse/get_concepts/ROA/" ];
fhir:Coding.code [ fhir:value "20053000" ] ];
fhir:CodeableConcept.text [ fhir:value "Oral use" ] ];
fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies [
fhir:index 0;
fhir:AdministrableProductDefinition.routeOfAdministration.targetSpecies.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "/#100000109093" ] ];
fhir:CodeableConcept.text [ fhir:value "Human" ] ] ] ] ]
], [
fhir:index 8;
fhir:Bundle.entry.resource [
a fhir:ManufacturedItemDefinition;
fhir:Resource.id [ fhir:value "cfsb1650998521654" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ManufacturedItemDefinition</b></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 \"cfsb1650998521654\" </p></div><p><b>identifier</b>: id: EU/1/19/1370/001 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>manufacturedDoseForm</b>: Film-coated tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000073665)</span></p><p><b>unitOfPresentation</b>: Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-CodeSystemUvEPIRrmswi.html\">Referentials Management Services CodeSystem</a>#200000002152)</span></p><p><b>manufacturer</b>: <a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></p></div>" ];
fhir:ManufacturedItemDefinition.identifier [
fhir:index 0;
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "https://spor.ema.europa.eu/pmswi/#/" ];
fhir:Identifier.value [ fhir:value "EU/1/19/1370/001" ] ];
fhir:ManufacturedItemDefinition.status [ fhir:value "active" ];
fhir:ManufacturedItemDefinition.manufacturedDoseForm [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "100000073665" ] ];
fhir:CodeableConcept.text [ fhir:value "Film-coated tablet" ] ];
fhir:ManufacturedItemDefinition.unitOfPresentation [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi" ];
fhir:Coding.code [ fhir:value "200000002152" ] ];
fhir:CodeableConcept.text [ fhir:value "Tablet" ] ];
fhir:ManufacturedItemDefinition.manufacturer [
fhir:index 0;
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ] ]
], [
fhir:index 9;
fhir:Bundle.entry.resource [
a fhir:Ingredient;
fhir:Resource.id [ fhir:value "cfsb1651162710491" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651162710491\" </p></div><p><b>identifier</b>: id: 1Q1V9V5WYQ (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#00000072072)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class=\"grid\"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>50 mg</td><td>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>" ];
fhir:Ingredient.identifier [
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Identifier.value [ fhir:value "1Q1V9V5WYQ" ] ];
fhir:Ingredient.status [ fhir:value "active" ];
fhir:Ingredient.for [
fhir:index 0;
fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ] ];
fhir:Ingredient.role [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "00000072072" ] ];
fhir:CodeableConcept.text [ fhir:value "active" ] ];
fhir:Ingredient.manufacturer [
fhir:index 0;
fhir:Ingredient.manufacturer.manufacturer [
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ] ];
fhir:Ingredient.substance [
fhir:Ingredient.substance.code [
fhir:CodeableReference.concept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Coding.code [ fhir:value "1Q1V9V5WYQ" ];
fhir:Coding.display [ fhir:value "DOLUTEGRAVIR SODIUM" ] ] ] ];
fhir:Ingredient.substance.strength [
fhir:index 0;
fhir:Ingredient.substance.strength.presentationQuantity [
fhir:Quantity.value [ fhir:value "50"^^xsd:decimal ];
fhir:Quantity.unit [ fhir:value "mg" ] ];
fhir:Ingredient.substance.strength.basis [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity" ];
fhir:Coding.code [ fhir:value "#ACTIB" ] ];
fhir:CodeableConcept.text [ fhir:value "active ingredient - basis of strength" ] ] ] ] ]
], [
fhir:index 10;
fhir:Bundle.entry.resource [
a fhir:Ingredient;
fhir:Resource.id [ fhir:value "cfsb1651164758053" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651164758053\" </p></div><p><b>identifier</b>: id: 2T8Q726O95 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072072)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p><h3>Strengths</h3><table class=\"grid\"><tr><td>-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td>*</td><td>300 mg</td><td>active ingredient - basis of strength <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (v3-RoleClassIngredientEntity##ACTIB)</span></td></tr></table></blockquote></div>" ];
fhir:Ingredient.identifier [
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Identifier.value [ fhir:value "2T8Q726O95" ] ];
fhir:Ingredient.status [ fhir:value "active" ];
fhir:Ingredient.for [
fhir:index 0;
fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ] ];
fhir:Ingredient.role [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "100000072072" ] ];
fhir:CodeableConcept.text [ fhir:value "active" ] ];
fhir:Ingredient.manufacturer [
fhir:index 0;
fhir:Ingredient.manufacturer.manufacturer [
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ] ];
fhir:Ingredient.substance [
fhir:Ingredient.substance.code [
fhir:CodeableReference.concept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Coding.code [ fhir:value "2T8Q726O95" ];
fhir:Coding.display [ fhir:value "lamivudine" ] ] ] ];
fhir:Ingredient.substance.strength [
fhir:index 0;
fhir:Ingredient.substance.strength.presentationQuantity [
fhir:Quantity.value [ fhir:value "300"^^xsd:decimal ];
fhir:Quantity.unit [ fhir:value "mg" ] ];
fhir:Ingredient.substance.strength.basis [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity" ];
fhir:Coding.code [ fhir:value "#ACTIB" ] ];
fhir:CodeableConcept.text [ fhir:value "active ingredient - basis of strength" ] ] ] ] ]
], [
fhir:index 11;
fhir:Bundle.entry.resource [
a fhir:Ingredient;
fhir:Resource.id [ fhir:value "cfsb1651170791283" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651170791283\" </p></div><p><b>identifier</b>: id: OP1R32D61U (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>" ];
fhir:Ingredient.identifier [
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Identifier.value [ fhir:value "OP1R32D61U" ] ];
fhir:Ingredient.status [ fhir:value "active" ];
fhir:Ingredient.for [
fhir:index 0;
fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ] ];
fhir:Ingredient.role [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "100000072082" ] ];
fhir:CodeableConcept.text [ fhir:value "Excipient" ] ];
fhir:Ingredient.manufacturer [
fhir:index 0;
fhir:Ingredient.manufacturer.manufacturer [
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ] ];
fhir:Ingredient.substance [
fhir:Ingredient.substance.code [
fhir:CodeableReference.concept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Coding.code [ fhir:value "OP1R32D61U" ];
fhir:Coding.display [ fhir:value "microcrystalline cellulose" ] ] ] ] ] ]
], [
fhir:index 12;
fhir:Bundle.entry.resource [
a fhir:Ingredient;
fhir:Resource.id [ fhir:value "cfsb1651229974487" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651229974487\" </p></div><p><b>identifier</b>: id: H8AV0SQX4D (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>" ];
fhir:Ingredient.identifier [
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Identifier.value [ fhir:value "H8AV0SQX4D" ] ];
fhir:Ingredient.status [ fhir:value "active" ];
fhir:Ingredient.for [
fhir:index 0;
fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ] ];
fhir:Ingredient.role [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "100000072082" ] ];
fhir:CodeableConcept.text [ fhir:value "Excipient" ] ];
fhir:Ingredient.manufacturer [
fhir:index 0;
fhir:Ingredient.manufacturer.manufacturer [
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ] ];
fhir:Ingredient.substance [
fhir:Ingredient.substance.code [
fhir:CodeableReference.concept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Coding.code [ fhir:value "H8AV0SQX4D" ];
fhir:Coding.display [ fhir:value "sodium starch glycolate" ] ] ] ] ] ]
], [
fhir:index 13;
fhir:Bundle.entry.resource [
a fhir:Ingredient;
fhir:Resource.id [ fhir:value "cfsb1651230170831" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651230170831\" </p></div><p><b>identifier</b>: id: 70097M6I30 (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>" ];
fhir:Ingredient.identifier [
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Identifier.value [ fhir:value "70097M6I30" ] ];
fhir:Ingredient.status [ fhir:value "active" ];
fhir:Ingredient.for [
fhir:index 0;
fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ] ];
fhir:Ingredient.role [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "100000072082" ] ];
fhir:CodeableConcept.text [ fhir:value "Excipient" ] ];
fhir:Ingredient.manufacturer [
fhir:index 0;
fhir:Ingredient.manufacturer.manufacturer [
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ] ];
fhir:Ingredient.substance [
fhir:Ingredient.substance.code [
fhir:CodeableReference.concept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Coding.code [ fhir:value "70097M6I30" ];
fhir:Coding.display [ fhir:value "magnesium stearate" ] ] ] ] ] ]
], [
fhir:index 14;
fhir:Bundle.entry.resource [
a fhir:Ingredient;
fhir:Resource.id [ fhir:value "cfsb1651230330246" ];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Ingredient</b></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 \"cfsb1651230330246\" </p></div><p><b>identifier</b>: id: 3OWL53L36A (OFFICIAL)</p><p><b>status</b>: active</p><p><b>for</b>: <a href=\"#ManufacturedItemDefinition_cfsb1650998521654\">See above (ManufacturedItemDefinition/cfsb1650998521654)</a></p><p><b>role</b>: Excipient <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (#100000072082)</span></p><h3>Manufacturers</h3><table class=\"grid\"><tr><td>-</td><td><b>Manufacturer</b></td></tr><tr><td>*</td><td><a href=\"#Organization_cfsb1650997423990\">See above (Organization/cfsb1650997423990)</a></td></tr></table><blockquote><p><b>substance</b></p></blockquote></div>" ];
fhir:Ingredient.identifier [
fhir:Identifier.use [ fhir:value "official" ];
fhir:Identifier.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Identifier.value [ fhir:value "3OWL53L36A" ] ];
fhir:Ingredient.status [ fhir:value "active" ];
fhir:Ingredient.for [
fhir:index 0;
fhir:Reference.reference [ fhir:value "ManufacturedItemDefinition/cfsb1650998521654" ] ];
fhir:Ingredient.role [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/rmswi/" ];
fhir:Coding.code [ fhir:value "100000072082" ] ];
fhir:CodeableConcept.text [ fhir:value "Excipient" ] ];
fhir:Ingredient.manufacturer [
fhir:index 0;
fhir:Ingredient.manufacturer.manufacturer [
fhir:Reference.reference [ fhir:value "Organization/cfsb1650997423990" ] ] ];
fhir:Ingredient.substance [
fhir:Ingredient.substance.code [
fhir:CodeableReference.concept [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://gsrs.ncats.nih.gov/ginas/app/beta/" ];
fhir:Coding.code [ fhir:value "3OWL53L36A" ];
fhir:Coding.display [ fhir:value "mannitol" ] ] ] ] ] ]
].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.