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#> .
# - resource -------------------------------------------------------------------
a fhir:Composition;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "cfsb1651231019151"];
fhir:Resource.language [ fhir:value "en"];
fhir:DomainResource.text [
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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.html\">Organization/cfsb1651149636159</a> \"ViiV Healthcare BV\"</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:CodeableConcept.text [ fhir:value "Package Leaflet" ]
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fhir:Reference.reference [ fhir:value "RegulatedAuthorization/cfsb1651148079894" ]
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fhir:Composition.date [ fhir:value "2022-04-29T13:28:17Z"^^xsd:dateTime];
fhir:Composition.author [
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fhir:Reference.reference [ fhir:value "Organization/cfsb1651149636159" ]
];
fhir:Composition.title [ fhir:value "TEST PURPOSES ONLY - Dovato 50 mg/300 mg film-coated tablets"];
fhir:Composition.confidentiality [ fhir:value "U"];
fhir:Composition.attester [
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fhir:Composition.section [
fhir:index 0;
fhir:Composition.section.title [ fhir:value "B. Package Leaflet" ];
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fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
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fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "additional" ];
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>" ]
], [
fhir:index 1;
fhir:Composition.section.title [ fhir:value "What is in this leaflet" ];
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fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
fhir:Coding.code [ fhir:value "100000155538-0" ] ];
fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
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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>" ]
], [
fhir:index 2;
fhir:Composition.section.title [ fhir:value "1. What Dovato is and what it is used for" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
fhir:Coding.code [ fhir:value "100000155538-1" ] ];
fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
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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>" ]
], [
fhir:index 3;
fhir:Composition.section.title [ fhir:value "2. What you need to know before you take Dovato" ];
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fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
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fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "additional" ];
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>" ]
], [
fhir:index 4;
fhir:Composition.section.title [ fhir:value "3. How to take Dovato" ];
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fhir:CodeableConcept.coding [
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fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
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fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "additional" ];
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>" ]
], [
fhir:index 5;
fhir:Composition.section.title [ fhir:value "4. Possible side effects" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
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fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
fhir:Coding.code [ fhir:value "100000155538-4" ] ];
fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
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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>" ]
], [
fhir:index 6;
fhir:Composition.section.title [ fhir:value "5. How to store Dovato" ];
fhir:Composition.section.code [
fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
fhir:Coding.code [ fhir:value "100000155538-5" ] ];
fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
fhir:Narrative.status [ fhir:value "additional" ];
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>" ]
], [
fhir:index 7;
fhir:Composition.section.title [ fhir:value "6. Contents of the pack and other information" ];
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fhir:CodeableConcept.coding [
fhir:index 0;
fhir:Coding.system [ fhir:value "https://spor.ema.europa.eu/" ];
fhir:Coding.code [ fhir:value "100000155538-6" ] ];
fhir:CodeableConcept.text [ fhir:value "B. PACKAGE LEAFLET" ] ];
fhir:Composition.section.text [
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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>" ]
].
# - ontology header ------------------------------------------------------------
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