Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

: ePI Bundle Type 1 - DrugX Package Insert - TTL Representation

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@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:Bundle ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "bundlepackageleaflet75type1"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2018-06-23T08:38:00+02:00"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:identifier [
fhir:system [ fhir:v "https://www.gravitatehealth.eu/sid/doc"^^xsd:anyURI ] ;
fhir:value [ fhir:v "EU/1/01/001/001" ]
  ] ; # 
  fhir:type [ fhir:v "document"] ; # 
  fhir:timestamp [ fhir:v "2018-06-23T08:38:00+02:00"^^xsd:dateTime] ; # 
  fhir:entry ( [
fhir:fullUrl [ fhir:v "urn:uuid:5467a2fd-2463-4ec7-a6bb-b7322000f867"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:5467a2fd-2463-4ec7-a6bb-b7322000f867> )
  ] [
fhir:fullUrl [ fhir:v "urn:uuid:d71bf884-90eb-47f9-81b7-fa81ecec7e75"^^xsd:anyURI ] ;
    ( fhir:resource <urn:uuid:d71bf884-90eb-47f9-81b7-fa81ecec7e75> )
  ] ) . # 

<urn:uuid:5467a2fd-2463-4ec7-a6bb-b7322000f867> a fhir:Composition ;
  fhir:id [ fhir:v "5467a2fd-2463-4ec7-a6bb-b7322000f867"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p><b>Generated Narrative: Composition</b><a name=\"5467a2fd-2463-4ec7-a6bb-b7322000f867\"> </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 &quot;5467a2fd-2463-4ec7-a6bb-b7322000f867&quot;  (Language &quot;en&quot;) </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: id: 224b31c5-8e48-45c5-b616-29e902642578</p><p><b>status</b>: final</p><p><b>type</b>: Package Leaflet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (example.org#100000155538)</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"#Organization_d71bf884-90eb-47f9-81b7-fa81ecec7e75\">See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)</a></p><p><b>title</b>: Example of Type 1 ePI - DrugX (acetaminophen) 75 mg tablets</p></div>"
  ] ; # 
  fhir:identifier ( [
fhir:system [ fhir:v "https://spor.ema.europa.eu"^^xsd:anyURI ] ;
fhir:value [ fhir:v "224b31c5-8e48-45c5-b616-29e902642578" ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
    ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "100000155538" ] ;
fhir:display [ fhir:v "Package Leaflet" ]     ] )
  ] ; # 
  fhir:subject ( [
fhir:identifier [
fhir:system [ fhir:v "http://example.org/sid/product"^^xsd:anyURI ] ;
fhir:value [ fhir:v "medicinalproduct75" ]     ]
  ] ) ; # 
  fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # 
  fhir:author ( [
fhir:reference [ fhir:v "Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75" ]
  ] ) ; # 
  fhir:title [ fhir:v "Example of Type 1 ePI - DrugX (acetaminophen) 75 mg tablets"] ; # 
  fhir:section ( [
fhir:title [ fhir:v "B. Package Leaflet" ] ;
fhir:code [
      ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000029894" ] ;
fhir:display [ fhir:v "PACKAGE LEAFLET" ]       ] )     ] ;
    ( fhir:section [
fhir:title [ fhir:v "Package leaflet: Information for the user" ] ;
fhir:code [
fhir:text [ fhir:v "Package leaflet: Information for the user" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>DrugX 75 mg tablets</p><p>acetaminophen</p><b>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</b><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:title [ fhir:v "What is in this leaflet" ] ;
fhir:code [
fhir:text [ fhir:v "What is in this leaflet" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>What DrugX is and what it is used for</li><li>What you need to know before you take DrugX</li><li>How to take DrugX</li><li>Possible side effects</li><li>How to store DrugX</li><li>Contents of the pack and other information</li></ul></div>"       ]     ] [
fhir:title [ fhir:v "1. What DrugX is and what it is used for" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000029895" ] ;
fhir:display [ fhir:v "1. What X is and what it is used for" ]         ] )       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"       ]     ] [
fhir:title [ fhir:v "2. What you need to know before you take DrugX" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000029896" ] ;
fhir:display [ fhir:v "2. What you need to know before you <take> <use> X" ]         ] )       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"       ]     ] [
fhir:title [ fhir:v "3. How to take DrugX" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000029905" ] ;
fhir:display [ fhir:v "3. How to <take> <use> X" ]         ] )       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"       ]     ] [
fhir:title [ fhir:v "4. Possible side effects" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000029910" ] ;
fhir:display [ fhir:v "4. Possible side effects" ]         ] ) ;
fhir:text [ fhir:v "4. Possible side effects" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"       ]     ] [
fhir:title [ fhir:v "5. How to store DrugX" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000029913" ] ;
fhir:display [ fhir:v "5. How to store X" ]         ] )       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"       ]     ] [
fhir:title [ fhir:v "6. Contents of the pack and other information" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "200000029914" ] ;
fhir:display [ fhir:v "6. Contents of the pack and other information" ]         ] )       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.</p></div>"       ]     ] )
  ] ) . # 

<urn:uuid:d71bf884-90eb-47f9-81b7-fa81ecec7e75> a fhir:Organization ;
  fhir:id [ fhir:v "d71bf884-90eb-47f9-81b7-fa81ecec7e75"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"d71bf884-90eb-47f9-81b7-fa81ecec7e75\"> </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 &quot;d71bf884-90eb-47f9-81b7-fa81ecec7e75&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Organization-uv-epi.html\">Organization (ePI)</a></p></div><p><b>identifier</b>: id: ORG1 (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\"> (example.org#220000000034)</span></p><p><b>name</b>: acme inc</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>54, Yonge Street, Paris, France(WORK)</td></tr></table></div>"
  ] ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "http://example.org/sid/org"^^xsd:anyURI ] ;
fhir:value [ fhir:v "ORG1" ]
  ] ) ; # 
  fhir:active [ fhir:v "true"^^xsd:boolean] ; # 
  fhir:type ( [
    ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "220000000034" ] ;
fhir:display [ fhir:v "Marketing authorisation holder" ]     ] )
  ] ) ; # 
  fhir:name [ fhir:v "acme inc"] ; # 
  fhir:contact ( [
fhir:address [
fhir:use [ fhir:v "work" ] ;
fhir:type [ fhir:v "physical" ] ;
fhir:text [ fhir:v "54, Yonge Street, Paris, France" ] ;
      ( fhir:line [ fhir:v "54, Yonge Street" ] ) ;
fhir:city [ fhir:v "Paris" ] ;
fhir:country [ fhir:v "FR" ]     ]
  ] ) . #