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
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-c8101444f2f0d633367049eeed05567a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-c8101444f2f0d633367049eeed05567a</b></p><a name=\"composition-en-c8101444f2f0d633367049eeed05567a\"> </a><a name=\"hccomposition-en-c8101444f2f0d633367049eeed05567a\"> </a><a name=\"composition-en-c8101444f2f0d633367049eeed05567a-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/1/10/646/002</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 - vpriv</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>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What VPRIV is and what it is used for</li><li>What you need to know before VPRIV is used</li><li>How VPRIV is used</li><li>Possible side effects</li><li>How to store VPRIV</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What vpriv is and what it is used for",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.</p><p>Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase. When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body. The build-up of this material causes the signs and symptoms found in Gaucher disease.</p><p>VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use VPRIV</p><ul><li>if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions Talk to your doctor before VPRIV is used</p><ul><li>If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects). These are called infusion related reactions and might appear as a hypersensitivity reaction with symptoms like nausea, rash, difficulty in breathing, back pain, chest discomfort (chest tightness), hives, joint pain or headache.</li><li>Apart from symptoms of hypersensitivity reactions infusion-related reactions might show as dizziness, high blood pressure, tiredness, fever, itching, blurry vision, or vomiting. If you experience any of the symptoms, you must tell your doctor immediately.</li><li>You may be given additional medicines to treat or help prevent future reactions. These medicines may include antihistamines, antipyretics, and corticosteroids.</li><li>If the reaction is severe, your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.</li><li>If the reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies which may affect the outcome of your treatment</li><li>Your doctor or nurse may decide to continue to administer VPRIV even if you experience any infusion related-reaction. Your condition will be closely monitored.</li></ul><p>Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.</p><p>Children Do not use in children under the age of 4 years because there is no experience of using the medicine in this age group.</p><p>Other medicines and VPRIV Tell your doctor if you are taking, have recently taken or might take any other medicines.</p><p>Pregnancy<br/>Gaucher disease may become more active in a woman during pregnancy and for a few weeks after birth. Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.</p><p>Breast-feeding It is not known whether VPRIV can pass into breast milk. If you are breast-feeding or considering breast-feeding, you should talk to your doctor before this medicine is used. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop using VPRIV, considering the benefit of breast-feeding to the baby and the benefit of VPRIV to the mother.</p><p>Driving and using machines VPRIV has no or negligible influence on your ability to drive or use machines.</p><p>VPRIV contains sodium This medicine contains 12.15 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.</p></div>"
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"title" : "3. How to take vpriv",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease. It is given by a doctor or nurse by intravenous infusion.</p><p>Dose The recommended dose is 60 Units/kg given every other week.</p><p>If you are currently being treated for Gaucher disease with another ERT and your doctor wants to change you to VPRIV, you can initially receive VPRIV at the same dose and frequency you had been receiving the other ERT.</p><p>Use in children and adolescents VPRIV may be given to children and adolescents (4 to 17 years of age) at the same dose and frequency as in adults.</p><p>Use in elderly VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults.</p><p>Response to treatment Your doctor will monitor your response to treatment and may change your dose (up or down) over time.</p><p>If you are tolerating your infusions well in the clinic, your doctor or nurse may administer your infusions at home.</p><p>Administration VPRIV is supplied in a vial as a packed powder which is mixed with sterile water and further diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to intravenous infusion.</p><p>After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.</p><p>If you have any further questions on the use of this medicine, ask your doctor.</p></div>"
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"title" : "4. Possible side effects",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>Commonly (may affect up to 1 in 10 people), patients experienced a severe allergic reaction, with difficulty breathing, chest discomfort (chest tightness), feeling sick (nausea), swelling of the face, lips, tongue or throat (anaphylactic/anaphylactoid reactions), common is also an allergic skin reaction such as hives, severe rash or itching. If any of these happen tell your doctor immediately.</p><p>Most side effects, including the allergic reactions, occurred during the infusion or shortly after. These are called infusion related reactions. Other infusion related reactions that occurred very commonly (may affect more than 1 in 10 people) include headache, dizziness, fever/body temperature increased, back pain, joint pain and tiredness, as well as high blood pressure (commonly reported), blurry vision, and vomiting (uncommonly reported). If any of these happen tell your doctor immediately.</p><p>Other side effects include:</p><p>Very common side effects (may affect more than 1 in 10 people) are:</p><ul><li>bone pain</li><li>weakness/loss of strength</li><li>stomach ache</li></ul><p>Common side effects (may affect up to 1 in 10 people) are:</p><ul><li>lengthening of the time it takes for a cut to stop bleeding may lead to easy/spontaneous bleeding/easy bruising</li><li>skin flushing</li><li>rapid heart beat</li><li>developing antibodies to VPRIV (see section 2)</li><li>decreased blood pressure</li></ul><p>Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><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 label after EXP . The expiry date refers to the last day of that month.</p><p>Store in the refrigerator (2 C 8 C). Do not freeze. Keep the vial in the outer carton in order to protect from light.</p><p>Reconstituted and diluted solution for infusion: Use immediately. Do not exceed 24 hours at 2 C to 8 C.</p><p>Do not use if the solution is discoloured or if foreign particles are present.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throwaway medicines you no longer use. These measures will help to protect the environment.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What VPRIV contains</p><ul><li>The active substance is velaglucerase alfa.</li></ul><p>Each vial contains 400 Units of velaglucerase alfa.</p><p>After reconstitution, one ml of solution contains 100 Units of velaglucerase alfa</p><ul><li>The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 VPRIV contains sodium ).</li></ul><p>What VPRIV looks like and contents of the pack 20 ml glass vial containing a white to off-white powder for solution for infusion.</p><p>Packs of 1, 5 or 25 vials. Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder and Manufacturer</p><p>Marketing Authorisation Holder<br/>Takeda Pharmaceuticals International AG Ireland Branch<br/>Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland</p><p>Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50-58 Baggot Street Lower Dublin 2 D02 HWIreland</p><p>Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 Ireland</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Lietuva Takeda, UAB Tel: +370 521 09 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>.: +359 2 958 27 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 <a href=\"mailto:7medinfoEMEA@takeda.com\">7medinfoEMEA@takeda.com</a></p><p>Danmark Takeda Pharma A/S Tlf: +45 46 77 10 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Malta akeda HELLAS S.A. Tel: +30 210 <a href=\"mailto:6387medinfoEMEA@takeda.com\">6387medinfoEMEA@takeda.com</a></p><p>Deutschland Takeda GmbH Tel: +49 (0)800 825 <a href=\"mailto:3medinfoEMEA@takeda.com\">3medinfoEMEA@takeda.com</a></p><p>Nederland Takeda Nederland B.V. Tel: +31 20 203 <a href=\"mailto:5medinfoEMEA@takeda.com\">5medinfoEMEA@takeda.com</a></p><p>Eesti Takeda Pharma AS Tel: +372 6177 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Norge Takeda AS Tlf: +47 800 800 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>akeda . . T : +30 210 <a href=\"mailto:6387medinfoEMEA@takeda.com\">6387medinfoEMEA@takeda.com</a></p><p>sterreich Takeda Pharma Ges.m.b.H.<br/>Tel: +43 (0) 800-20 80 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Espa a Takeda Farmac utica Espa a S.A Tel: +34 917 90 42 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Polska Takeda Pharma Sp. z o.o. Tel.: <a href=\"mailto:+48223062medinfoEMEA@takeda.com\">+48223062medinfoEMEA@takeda.com</a></p><p>France Takeda France SAS T l: + 33 1 40 67 33 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 <a href=\"mailto:1medinfoEMEA@takeda.com\">1medinfoEMEA@takeda.com</a></p><p>Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Ireland Takeda Products Ireland Ltd Tel: 1800 937 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a> Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a> sland Vistor hf. S mi: +354 535 <a href=\"mailto:7medinfoEMEA@takeda.com\">7medinfoEMEA@takeda.com</a></p><p>Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Italia Takeda Italia S.p.A. Tel: +39 06 <a href=\"mailto:502medinfoEMEA@takeda.com\">502medinfoEMEA@takeda.com</a></p><p>Suomi/Finland Takeda Oy Puh/Tel: 0800 774 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>A.POTAMITIS MEDICARE LTD : +357 <a href=\"mailto:22583a.potamitismedicare@cytanet.com.cy\">22583a.potamitismedicare@cytanet.com.cy</a></p><p>Sverige Takeda Pharma AB Tel: 020 795 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>Latvija Takeda Latvia SIA Tel: +371 <a href=\"mailto:67840medinfoEMEA@takeda.com\">67840medinfoEMEA@takeda.com</a></p><p>United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 <a href=\"mailto:medinfoEMEA@takeda.com\">medinfoEMEA@takeda.com</a></p><p>This leaflet was last revised in .</p><p>Other sources of information</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>"
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"code" : "Human",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "active"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"name" : [
{
"productName" : "VPRIV 400 Units powder for solution for infusion",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000001",
"display" : "Full name"
}
]
},
"part" : [
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000005",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "en",
"display" : "en"
}
]
}
}
]
}
]
}
}
]
}
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
Links: Table of Contents |
QA Report
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.
