Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-epi-type3-example-morphine"/>
<language value="en"/>
<type value="document"/>
<timestamp value="2023-11-27T00:00:00Z"/>
<entry>
<resource>
<Composition>
<id value="composition-morphine-type3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type3"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_composition-morphine-type3"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-morphine-type3</b></p><a name="composition-morphine-type3"> </a><a name="hccomposition-morphine-type3"> </a><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"/><p style="margin-bottom: 0px">Profile: <code>http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type3</code></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000155531 100000155538}">Package Leaflet</span></p><p><b>date</b>: 2023-11-27</p><p><b>author</b>: <a href="Bundle-bundle-epi-type1-example-morphine.html#Organization_LOC-100001090">Organization Unimedic Pharma AB</a></p><p><b>title</b>: Package Leaflet: Information for the user - Morphine Unimedic 1 mg/ml</p></div>
</text>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000155531"/>
<code value="100000155538"/>
<display value="Package Leaflet"/>
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</type>
<subject>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</subject>
<date value="2023-11-27"/>
<author>
<reference value="Organization/LOC-100001090"/>
</author>
<title
value="Package Leaflet: Information for the user - Morphine Unimedic 1 mg/ml"/>
<section>
<title
value="1. What Morphine Unimedic is and what it is used for"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029895"/>
<display value="What X is and what it is used for"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Morphine Unimedic contains the active substance morphine hydrochloride. It is an opioid analgesic used for severe pain.</p></div>
</text>
<entry>
<reference value="ClinicalUseDefinition/cud-indication-pain"/>
</entry>
<entry>
<reference value="ClinicalUseDefinition/cud-contra-asthma"/>
</entry>
<entry>
<reference value="ClinicalUseDefinition/cud-interact-alcohol"/>
</entry>
<entry>
<reference value="ClinicalUseDefinition/cud-warning-dependence"/>
</entry>
<entry>
<reference value="ClinicalUseDefinition/cud-side-nausea"/>
</entry>
<entry>
<reference value="MedicationKnowledge/mk-morphine"/>
</entry>
</section>
<section>
<title
value="2. What you need to know before you take Morphine Unimedic"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029896"/>
<display value="What you need to know before you take X"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take if allergic to morphine.</p></div>
</text>
</section>
<section>
<title value="3. How to take Morphine Unimedic"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029905"/>
<display value="How to take X"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Use as directed by your doctor.</p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029906"/>
<display value="Possible side effects"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>May cause nausea, vomiting, or constipation.</p></div>
</text>
</section>
<section>
<title value="5. How to store Morphine Unimedic"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029907"/>
<display value="How to store X"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Keep out of reach of children.</p></div>
</text>
</section>
<section>
<title value="6. Contents of the pack and other information"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029908"/>
<display value="Contents of the pack and other information"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Content: Morphine hydrochloride 1 mg/ml.</p></div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<resource>
<MedicinalProductDefinition>
<id value="MorphineUni-1mgml-Solution-SE-BS-MPD"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:21:19.300+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition MorphineUni-1mgml-Solution-SE-BS-MPD</b></p><a name="MorphineUni-1mgml-Solution-SE-BS-MPD"> </a><a name="hcMorphineUni-1mgml-Solution-SE-BS-MPD"> </a><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">version: 1; Last updated: 2025-11-26 09:21:19+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/SE-100001732-00056117, <code>http://ema.europa.eu/fhir/eurdId</code>/10549</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/200000000004~200000000006~200000000007~200000000008 100000073863}">Solution for injection</span></p><p><b>indication</b>: </p><div><p>Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.</p>
</div><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 100000072085}">Medicinal product subject to special medical prescription</span></p><p><b>classification</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 100000097139}">morphine</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Morphine Unimedic 1 mg/ml injektionsvätska, lösning</p><blockquote><p><b>part</b></p><p><b>part</b>: Morphine Unimedic</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 1 mg/ml</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Injektionsvätska, lösning</p><p><b>type</b>: <span title="Codes:{http://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>
</text>
<identifier>
<system value="http://ema.europa.eu/fhir/mpId"/>
<value value="SE-100001732-00056117"/>
</identifier>
<identifier>
<system value="http://ema.europa.eu/fhir/eurdId"/>
<value value="10549"/>
</identifier>
<domain>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005004"/>
<display value="Current"/>
</coding>
</status>
<combinedPharmaceuticalDoseForm>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000004~200000000006~200000000007~200000000008"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</combinedPharmaceuticalDoseForm>
<indication
value="Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer."/>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
<code value="100000072085"/>
<display
value="Medicinal product subject to special medical prescription"/>
</coding>
</legalStatusOfSupply>
<classification>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
<code value="100000097139"/>
<display value="morphine"/>
</coding>
</classification>
<name>
<productName
value="Morphine Unimedic 1 mg/ml injektionsvätska, lösning"/>
<part>
<part value="Morphine Unimedic"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="1 mg/ml"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="Injektionsvätska, lösning"/>
<type>
<coding>
<system
value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="sv"/>
<display value="Swedish"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<resource>
<RegulatedAuthorization>
<id value="MorphineUni-1mgml-Solution-SE-BS-RA"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:23:15.251+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_MorphineUni-1mgml-Solution-SE-BS-RA"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization MorphineUni-1mgml-Solution-SE-BS-RA</b></p><a name="MorphineUni-1mgml-Solution-SE-BS-RA"> </a><a name="hcMorphineUni-1mgml-Solution-SE-BS-RA"> </a><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">version: 1; Last updated: 2025-11-26 09:23:15+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/marketingAuthorizationNumber</code>/56117</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</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>: 2018-04-06</p><p><b>holder</b>: <a href="Bundle-bundle-epi-type1-example-morphine.html#Organization_LOC-100001090">Organization Unimedic Pharma AB</a></p><h3>Cases</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://ema.europa.eu/fhir/authorisationDateType dateOfFirstAuthorisation}">First Authorisation</span></td><td>2018-04-06</td></tr></table></div>
</text>
<identifier>
<system
value="http://ema.europa.eu/fhir/marketingAuthorizationNumber"/>
<value value="56117"/>
</identifier>
<subject>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000535"/>
<display value="Kingdom of Sweden"/>
</coding>
</region>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="100000072099"/>
<display value="Valid"/>
</coding>
</status>
<statusDate value="2018-04-06"/>
<holder>
<reference value="Organization/LOC-100001090"/>
</holder>
<case>
<type>
<coding>
<system
value="https://ema.europa.eu/fhir/authorisationDateType"/>
<code value="dateOfFirstAuthorisation"/>
<display value="First Authorisation"/>
</coding>
</type>
<dateDateTime value="2018-04-06"/>
</case>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<resource>
<AdministrableProductDefinition>
<id value="MorphineUni-1mgml-Solution-SE-BS-APD"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:23:58.134+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_MorphineUni-1mgml-Solution-SE-BS-APD"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition MorphineUni-1mgml-Solution-SE-BS-APD</b></p><a name="MorphineUni-1mgml-Solution-SE-BS-APD"> </a><a name="hcMorphineUni-1mgml-Solution-SE-BS-APD"> </a><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">version: 1; Last updated: 2025-11-26 09:23:58+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition</code></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>producedFrom</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule</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 100000073633}, {https://spor.ema.europa.eu/v1/lists/100000073345 100000073600}, {https://spor.ema.europa.eu/v1/lists/100000073345 100000073611}, {https://spor.ema.europa.eu/v1/lists/100000073345 100000073572}">Subcutaneous use</span></td></tr></table></div>
</text>
<status value="active"/>
<formOf>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</administrableDoseForm>
<producedFrom>
<reference
value="ManufacturedItemDefinition/MorphineUni-1mgml-Solution-SE-BS-MID"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073633"/>
<display value="Subcutaneous use"/>
</coding>
<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>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073572"/>
<display value="Epidural use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="MorphineUni-1mgml-Solution-SE-BS-PPD"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:26:35.272+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_MorphineUni-1mgml-Solution-SE-BS-PPD"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition MorphineUni-1mgml-Solution-SE-BS-PPD</b></p><a name="MorphineUni-1mgml-Solution-SE-BS-PPD"> </a><a name="hcMorphineUni-1mgml-Solution-SE-BS-PPD"> </a><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">version: 1; Last updated: 2025-11-26 09:26:35+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/?ngen-9?</p><p><b>packageFor</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><p><b>containedItemQuantity</b>: 10 Ampoule<span style="background: LightGoldenRodYellow"> (Details: 200000000014 code200000002164 = '200000002164')</span></p><p><b>description</b>: </p><div><p>Ampull, 10 x 10 ml</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 200000003529}">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073490}">Ampoule</span></p><p><b>quantity</b>: 10</p><p><b>material</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003203}">Glass</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bundle-epi-type2-example-morphine.html#ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule</a></td></tr></table><p><b>amount</b>: 10 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633~200000000014 code100000110662 = '100000110662')</span></p></blockquote></blockquote></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="10"/>
<unit value="Ampoule"/>
<system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002164"/>
</containedItemQuantity>
<description value="Ampull, 10 x 10 ml"/>
<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="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073490"/>
<display value="Ampoule"/>
</coding>
</type>
<quantity value="10"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003203"/>
<display value="Glass"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/MorphineUni-1mgml-Solution-SE-BS-MID"/>
</reference>
</item>
<amount>
<value value="10"/>
<unit value="millilitre(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633~200000000014"/>
<code value="100000110662"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="MorphineUni-1mgml-Solution-SE-BS-ING"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:26:27.892+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_MorphineUni-1mgml-Solution-SE-BS-ING"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient MorphineUni-1mgml-Solution-SE-BS-ING</b></p><a name="MorphineUni-1mgml-Solution-SE-BS-ING"> </a><a name="hcMorphineUni-1mgml-Solution-SE-BS-ING"> </a><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">version: 1; Last updated: 2025-11-26 09:26:27+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient</code></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></li><li><a href="Bundle-bundle-epi-type2-example-morphine.html#ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Ampoule</a></li><li><a href="Bundle-bundle-epi-type2-example-morphine.html#AdministrableProductDefinition_MorphineUni-1mgml-Solution-SE-BS-APD">AdministrableProductDefinition: status = active; administrableDoseForm = Solution for injection</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.azure-api.net/sms/api/v2/SubstanceDefinition 100000090494}">Morphine hydrochloride</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 1 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110662 = '100000110662')</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.azure-api.net/sms/api/v2/SubstanceDefinition 100000091372}">Morphine</span></td></tr></table><p><b>strength</b>: 0.76 milligram(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 millilitre(s)<span style="background: LightGoldenRodYellow"> (Details: 100000110633 code100000110662 = '100000110662')</span></p></blockquote></blockquote></blockquote></div>
</text>
<status value="active"/>
<for>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/MorphineUni-1mgml-Solution-SE-BS-MID"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/MorphineUni-1mgml-Solution-SE-BS-APD"/>
</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.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000090494"/>
<display value="Morphine hydrochloride"/>
</coding>
</concept>
</code>
<strength>
<concentrationRatio>
<numerator>
<value value="1"/>
<unit value="milligram(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="millilitre(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</denominator>
</concentrationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.azure-api.net/sms/api/v2/SubstanceDefinition"/>
<code value="100000091372"/>
<display value="Morphine"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="0.76"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="millilitre(s)"/>
<system
value="http://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110662"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<Organization>
<id value="LOC-100001090"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:20:05.357+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_LOC-100001090"> </a><p class="res-header-id"><b>Generated Narrative: Organization LOC-100001090</b></p><a name="LOC-100001090"> </a><a name="hcLOC-100001090"> </a><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">version: 1; Last updated: 2025-11-26 09:20:05+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization</code></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100001090</p><p><b>name</b>: Unimedic Pharma AB</p></div>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100001090"/>
</identifier>
<name value="Unimedic Pharma AB"/>
</Organization>
</resource>
</entry>
<entry>
<resource>
<ManufacturedItemDefinition>
<id value="MorphineUni-1mgml-Solution-SE-BS-MID"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T09:22:32.799+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_MorphineUni-1mgml-Solution-SE-BS-MID"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition MorphineUni-1mgml-Solution-SE-BS-MID</b></p><a name="MorphineUni-1mgml-Solution-SE-BS-MID"> </a><a name="hcMorphineUni-1mgml-Solution-SE-BS-MID"> </a><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">version: 1; Last updated: 2025-11-26 09:22:32+0000</p><p style="margin-bottom: 0px">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition</code></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073863}">Solution for injection</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002164}">Ampoule</span></p></div>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073863"/>
<display value="Solution for injection"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002164"/>
<display value="Ampoule"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-indication-pain"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-indication-pain"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-indication-pain</b></p><a name="cud-indication-pain"> </a><a name="hccud-indication-pain"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</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:{http://snomed.info/sct 22253000}">Pain</span></td></tr></table></blockquote></div>
</text>
<type value="indication"/>
<subject>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="22253000"/>
<display value="Pain"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-contra-asthma"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-contra-asthma"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-contra-asthma</b></p><a name="cud-contra-asthma"> </a><a name="hccud-contra-asthma"> </a><p><b>type</b>: Contraindication</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><blockquote><p><b>contraindication</b></p><h3>DiseaseSymptomProcedures</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:{http://snomed.info/sct 195967001}">Acute asthma</span></td></tr></table></blockquote></div>
</text>
<type value="contraindication"/>
<subject>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</subject>
<contraindication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="195967001"/>
<display value="Acute asthma"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</contraindication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-interact-alcohol"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-interact-alcohol"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-interact-alcohol</b></p><a name="cud-interact-alcohol"> </a><a name="hccud-interact-alcohol"> </a><p><b>type</b>: Interaction</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><blockquote><p><b>interaction</b></p><h3>Interactants</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://snomed.info/sct 35368007}">Alcohol</span></td></tr></table></blockquote></div>
</text>
<type value="interaction"/>
<subject>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</subject>
<interaction>
<interactant>
<itemCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="35368007"/>
<display value="Alcohol"/>
</coding>
</itemCodeableConcept>
</interactant>
</interaction>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-warning-dependence"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-warning-dependence"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-warning-dependence</b></p><a name="cud-warning-dependence"> </a><a name="hccud-warning-dependence"> </a><p><b>type</b>: Warning</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><h3>Warnings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Description</b></td></tr><tr><td style="display: none">*</td><td><div><p>Risk of opioid dependence.</p>
</div></td></tr></table></div>
</text>
<type value="warning"/>
<subject>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</subject>
<warning>
<description value="Risk of opioid dependence."/>
</warning>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-side-nausea"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ClinicalUseDefinition_cud-side-nausea"> </a><p class="res-header-id"><b>Generated Narrative: ClinicalUseDefinition cud-side-nausea</b></p><a name="cud-side-nausea"> </a><a name="hccud-side-nausea"> </a><p><b>type</b>: Undesirable Effect</p><p><b>subject</b>: <a href="Bundle-bundle-epi-type2-example-morphine.html#MedicinalProductDefinition_MorphineUni-1mgml-Solution-SE-BS-MPD">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001732-00056117,http://ema.europa.eu/fhir/eurdId#10549; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Solution for injection; indication = Morphine Unimedic är indikerat för behandling av svår postoperativ och posttraumatisk smärta och svår opioidkänslig smärta såsom smärta vid cancer.; legalStatusOfSupply = Medicinal product subject to special medical prescription; classification = morphine</a></p><blockquote><p><b>undesirableEffect</b></p><h3>SymptomConditionEffects</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:{http://snomed.info/sct 422587007}">Nausea</span></td></tr></table></blockquote></div>
</text>
<type value="undesirable-effect"/>
<subject>
<reference
value="MedicinalProductDefinition/MorphineUni-1mgml-Solution-SE-BS-MPD"/>
</subject>
<undesirableEffect>
<symptomConditionEffect>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="422587007"/>
<display value="Nausea"/>
</coding>
</concept>
</symptomConditionEffect>
</undesirableEffect>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<MedicationKnowledge>
<id value="mk-morphine"/>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicationKnowledge_mk-morphine"> </a><p class="res-header-id"><b>Generated Narrative: MedicationKnowledge mk-morphine</b></p><a name="mk-morphine"> </a><a name="hcmk-morphine"> </a><p><b>code</b>: <span title="Codes:{http://snomed.info/sct 373465005}">Morphine</span></p><p><b>status</b>: Active</p><blockquote><p><b>indicationGuideline</b></p><blockquote><p><b>dosingGuideline</b></p><p><b>treatmentIntent</b>: <span title="Codes:{http://snomed.info/sct 225339009}">Analgesia</span></p><blockquote><p><b>dosage</b></p><h3>Dosages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>10 mg every 4 hours</td></tr></table></blockquote></blockquote></blockquote></div>
</text>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="373465005"/>
<display value="Morphine"/>
</coding>
</code>
<status value="active"/>
<indicationGuideline>
<dosingGuideline>
<treatmentIntent>
<coding>
<system value="http://snomed.info/sct"/>
<code value="225339009"/>
<display value="Analgesia"/>
</coding>
</treatmentIntent>
<dosage>
<dosage>
<text value="10 mg every 4 hours"/>
</dosage>
</dosage>
</dosingGuideline>
</indicationGuideline>
</MedicationKnowledge>
</resource>
</entry>
</Bundle>
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-01-02
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