Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/test-epi-composition/ and changes regularly. 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:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundlepackageleaflet-en-8f194b3a85e80bebf07798b496672e52"] ; # fhir:meta [ ( 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 "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "None" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-06-27T10:09:22Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "Composition/composition-en-8f194b3a85e80bebf07798b496672e52"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-8f194b3a85e80bebf07798b496672e52> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mp8f194b3a85e80bebf07798b496672e52"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mp8f194b3a85e80bebf07798b496672e52> ) ] ) . # <Composition/composition-en-8f194b3a85e80bebf07798b496672e52> a fhir:Composition ; fhir:id [ fhir:v "composition-en-8f194b3a85e80bebf07798b496672e52"] ; # 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\"><a name=\"Composition_composition-en-8f194b3a85e80bebf07798b496672e52\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-8f194b3a85e80bebf07798b496672e52</b></p><a name=\"composition-en-8f194b3a85e80bebf07798b496672e52\"> </a><a name=\"hccomposition-en-8f194b3a85e80bebf07798b496672e52\"> </a><a name=\"composition-en-8f194b3a85e80bebf07798b496672e52-en-US\"> </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\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/01/183/001</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-mah-ema.html\">Organization ACME industry</a></p><p><b>title</b>: TEST PURPOSES ONLY - hbvaxpro</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/01/183/001" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package Leaflet" ] ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"^^xsd:anyURI ] ; fhir:code [ fhir:v "R" ] ; fhir:display [ fhir:v "Raw" ] ] ) ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mp8f194b3a85e80bebf07798b496672e52" ] ] ) ; # fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/mah-ema" ] ] ) ; # fhir:title [ fhir:v "TEST PURPOSES ONLY - hbvaxpro"] ; # fhir:attester ( [ fhir:mode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ; fhir:code [ fhir:v "official" ] ] ) ] ; fhir:time [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime ] ] ) ; # fhir:section ( [ fhir:title [ fhir:v "B. Package Leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "B. Package Leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ; ( fhir:section [ fhir:title [ fhir:v "Package leaflet: Information for the user" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; 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\"></div>" ] ] [ fhir:title [ fhir:v "What is in this leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; 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\"><p>What is in this leaflet:</p><ol type=\"1\"><li>What HBVAXPRO 5 micrograms is and what it is used for</li><li>What you need to know before you or your child receive HBVAXPRO 5 micrograms</li><li>How HBVAXPRO 5 micrograms is given</li><li>Possible side effects</li><li>How to store HBVAXPRO 5 micrograms</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What hbvaxpro is and what it is used for" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "1. What hbvaxpro 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>This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus. It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D does not occur in the absence of hepatitis B infection. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take hbvaxpro" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "2. What you need to know before you take hbvaxpro" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use HBVAXPRO 5 micrograms</p><ul><li>if you or your child is allergic to hepatitis B surface antigen or to any of the other ingredients of HBVAXPRO (see section 6)</li><li>if you or your child has a severe illness with fever Warnings and precautions The container of this vaccine contains latex rubber. Latex rubber may cause severe allergic reactions. Talk to your doctor, pharmacist or nurse before you or your child receives HBVAXPRO 5 micrograms. Other vaccines and HBVAXPRO 5 micrograms HBVAXPRO can be administered at the same time as with hepatitis B immunoglobulin, at a separate injection site. HBVAXPRO can be used to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine. HBVAXPRO may be administered at the same time as with some other vaccines, using separate sites and syringes. Tell your doctor, pharmacist or nurse if you or your child is taking, or has recently taken, any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Caution should be exercised when prescribing the vaccine to pregnant or breast-feeding women. Ask your doctor, pharmacist or nurse for advice before taking any medicine. Driving and using machines HBVAXPRO is expected to have no, or negligible, influence on the ability to drive and use machines. HBVAXPRO 5 micrograms contains sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .</li></ul></div>" ] ] [ fhir:title [ fhir:v "3. How to take hbvaxpro" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "3. How to take hbvaxpro" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Dosage The recommended dose for each injection (0.5 mL) is 5 micrograms for individuals from birth through 15 years of age. A course of vaccination should include at least three injections. Two immunisation schedules can be recommended:</p><ul><li>two injections with an interval of one month followed by a third injection 6 months after the first administration (0, 1, 6 months).</li><li>if immunity is needed quickly: three injections with an interval of one month and a fourth dose 1 year later (0, 1, 2, 12 months). In case of a recent exposure to the hepatitis B virus, a first dose of HBVAXPRO together with the appropriate dose of immunoglobulin can be given. Some local vaccination schedules currently include recommendations for a booster dose. Your doctor, pharmacist or nurse will inform you if a booster dose should be given. Method of administration The vial should be well shaken until a slightly opaque white suspension is obtained. Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded. The doctor or nurse will give the vaccine as an injection into muscle. The upper side of the thigh is the preferred site for injection in neonates and infants. The upper arm muscle is the preferred site for injection in children and adolescents. This vaccine should never be given into a blood vessel. Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia (diminution of blood platelets) or to persons at risk of haemorrhage. If you or your child forget one dose of HBVAXPRO 5 micrograms If you or your child miss a scheduled injection, talk to your doctor, pharmacist or nurse. Your doctor or nurse will decide when to give the missed dose. If you or your child have any further questions on the use of this product, ask your doctor, pharmacist or nurse.</li></ul></div>" ] ] [ fhir:title [ fhir:v "4. Possible side effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; 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>Like all medicines, this vaccine can cause side effects, although not everybody gets them. As with other hepatitis B vaccines, in many instances, the causal relationship of side effects to the vaccine has not been established. The most common side effects seen are injection-site reactions: soreness, redness and hardening. Other side effects are reported very rarely:</p><p>Low platelet count, Lymph node disease</p><p>Allergic reactions</p><p>Nervous system disorders such as pins and needles, Facial paralysis, Nerve inflammations including Guillain-Barre Syndrome, Inflammation of the nerve of the eye that leads to impaired vision, Brain inflammation, Exacerbation of multiple sclerosis, Multiple sclerosis, Convulsions, Headache, Dizziness and Fainting</p><p>Low blood pressure, Blood vessel inflammation</p><p>Asthma-like symptoms</p><p>Vomiting, Nausea, Diarrhoea, Abdominal pain</p><p>Skin reactions such as eczema, Rash, Itching, Hives and Skin blistering, Hair loss</p><p>Joint pain, Arthritis, Muscle pain, Pain in extremity</p><p>Fatigue, Fever, Vague illness, Flu-like symptoms</p><p>Elevation of liver enzymes</p><p>Inflammation of the eye which causes pain and redness In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.</p></div>" ] ] [ fhir:title [ fhir:v "5. How to store hbvaxpro" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "5. How to store hbvaxpro" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Keep this vaccine out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the label. Store in a refrigerator (2 C - 8 C). Do not freeze. Store in the original package in order to protect from light. 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:title [ fhir:v "6. Contents of the pack and other information" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ 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>What HBVAXPRO 5 micrograms contains The active substance is : Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................<br/>5 micrograms Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)#</p><ul><li>produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.</li></ul><h1 id=\"amorphous-aluminium-hydroxyphosphate-sulfate-is-included-in-this-vaccine-as-an-adsorbant-adsorbants\">Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant. Adsorbants</h1><p>are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine. The other ingredients are sodium chloride (NaCl), borax and water for injections. What HBVAXPRO 5 micrograms looks like and contents of the pack HBVAXPRO 5 micrograms is a suspension for injection in a vial. Pack sizes of 1 and 10 vials without syringe/needle. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien MSD Belgium<br/>T l/Tel: +32(0)<a href=\"mailto:27766dpoc_belux@merck.com\">27766dpoc_belux@merck.com</a> Lietuva UAB Merck Sharp & Dohme Tel.: <a href=\"mailto:+370.5.2780.msd_lietuva@merck.com\">+370.5.2780.msd_lietuva@merck.com</a></p><pre><code> , </code></pre><p>.: + 359 2 819 <a href=\"mailto:3info-msdbg@merck.com\">3info-msdbg@merck.com</a> Luxembourg/Luxemburg MSD Belgium<br/>T l/Tel: +32(0)<a href=\"mailto:27766dpoc_belux@merck.com\">27766dpoc_belux@merck.com</a> esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 <a href=\"mailto:dpoc_czechslovak@merck.com\">dpoc_czechslovak@merck.com</a> Magyarorsz g MSD Pharma Hungary Kft. Tel.: + <a href=\"mailto:36.1.888.5hungary_msd@merck.com\">36.1.888.5hungary_msd@merck.com</a> Danmark MSD Danmark ApS Tlf: + 45 4482 <a href=\"mailto:4dkmail@merck.com\">4dkmail@merck.com</a> Malta Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) <a href=\"mailto:malta_info@merck.com\">malta_info@merck.com</a> Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) <a href=\"mailto:e-mail@msd.de\">e-mail@msd.de</a> Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) <a href=\"mailto:medicalinfo.nl@merck.com\">medicalinfo.nl@merck.com</a> Eesti Merck Sharp & Dohme O , Tel: <a href=\"mailto:+372.614.4msdeesti@merck.com\">+372.614.4msdeesti@merck.com</a> Norge MSD (Norge) AS Tlf: +47 32 20 73 <a href=\"mailto:msdnorge@msd.no\">msdnorge@msd.no</a></p><p>MSD . . . . . : +30 210 98 97 <a href=\"mailto:dpoc_greece@merck.com\">dpoc_greece@merck.com</a> sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 <a href=\"mailto:dpoc_austria@merck.com\">dpoc_austria@merck.com</a> Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 <a href=\"mailto:msd_info@merck.com\">msd_info@merck.com</a> Polska MSD Polska Sp. z o.o. Tel.: <a href=\"mailto:+48.22.549.51.msdpolska@merck.com\">+48.22.549.51.msdpolska@merck.com</a> France MSD France T l: +33 (0)1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 <a href=\"mailto:4465inform_pt@merck.com\">4465inform_pt@merck.com</a> Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 <a href=\"mailto:croatia_info@merck.com\">croatia_info@merck.com</a> Rom nia Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 <a href=\"mailto:msdromania@merck.com\">msdromania@merck.com</a> Ireland Merck Sharp & Dohme Ireland (Human Health) Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Limited Tel: +353 (0)1 <a href=\"mailto:2998medinfo_ireland@merck.com\">2998medinfo_ireland@merck.com</a> Tel: <a href=\"mailto:+386.1.520.4msd.slovenia@merck.com\">+386.1.520.4msd.slovenia@merck.com</a> sland Vistor hf. S mi: + 354 535 7Slovensk republika Merck Sharp & Dohme, s. r.* Tel: +421 2 <a href=\"mailto:58282dpoc_czechslovak@merck.com\">58282dpoc_czechslovak@merck.com</a> Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) <a href=\"mailto:medicalinformation.it@msd.com\">medicalinformation.it@msd.com</a> Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 <a href=\"mailto:info@msd.fi\">info@msd.fi</a></p><p>Merck Sharp & Dohme Cyprus Limited : 800 00 673 (+357 22866700) <a href=\"mailto:cyprus_info@merck.com\">cyprus_info@merck.com</a> Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 <a href=\"mailto:5700medicinskinfo@merck.com\">5700medicinskinfo@merck.com</a> Latvija SIA Merck Sharp & Dohme Latvija Tel: <a href=\"mailto:+371.67364.msd_lv@merck.com\">+371.67364.msd_lv@merck.com</a> United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href=\"mailto:2998medinfoNI@msd.com\">2998medinfoNI@msd.com</a> This leaflet was last approved in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency website: <a href=\"http://www.ema.europa.eu\">http://www.ema.europa.eu</a>. The following information is intended for medical or health care professionals only: Instructions The vaccine should be inspected visually prior to administration for any foreign particulate matter and/or abnormal physical appearance. The vial should be well shaken until a slightly opaque white suspension is obtained. Package leaflet: Information for the user HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA) Read all of this leaflet carefully before you or your child is vaccinated because it contains important information.</p><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor, pharmacist or nurse.</li><li>If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mp8f194b3a85e80bebf07798b496672e52> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp8f194b3a85e80bebf07798b496672e52"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp8f194b3a85e80bebf07798b496672e52\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp8f194b3a85e80bebf07798b496672e52</b></p><a name=\"mp8f194b3a85e80bebf07798b496672e52\"> </a><a name=\"hcmp8f194b3a85e80bebf07798b496672e52\"> </a><a name=\"mp8f194b3a85e80bebf07798b496672e52-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/01/183/001</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: HBVAXPRO 5 micrograms, suspension for injection</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/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>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 EU}\">EU</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">en</span></td></tr></table></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/01/183/001" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "MedicinalProduct" ] ; fhir:display [ fhir:v "Medicinal Product" ] ] ) ] ; # fhir:domain [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ; fhir:code [ fhir:v "Human" ] ; fhir:display [ fhir:v "Human use" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "active" ] ] ) ] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072084" ] ; fhir:display [ fhir:v "Medicinal product subject to medical prescription" ] ] ) ] ; # fhir:name ( [ fhir:productName [ fhir:v "HBVAXPRO 5 micrograms, suspension for injection" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000001" ] ; fhir:display [ fhir:v "Full name" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ; fhir:display [ fhir:v "Invented name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000003" ] ; fhir:display [ fhir:v "Scientific name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ; fhir:display [ fhir:v "Pharmaceutical dose form part" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:jurisdiction [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "en" ] ] ) ] ] ) ] ) . #
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
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The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
