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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"title" : "1. What fabrazyme is and what it is used for",
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"text" : "1. What fabrazyme is and what it is used for"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Fabrazyme contains the active substance agalsidase beta and is used as enzyme replacement therapy in Fabry disease, where the level of -galactosidase enzyme activity is absent or lower than normal. If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs.</p><p>Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.</p><p>Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use Fabrazyme</p><ul><li>if you are allergic to agalsidase beta or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions Talk to your doctor or pharmacist before using Fabrazyme.</p><p>If you are treated with Fabrazyme, you may develop infusion associated reactions. An infusion- associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4). If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent such reactions from occurring.</p><p>Children and adolescents No clinical studies have been performed in children 0-4 years old. The risks and benefits of Fabrazyme in children aged 5 to 7 years have not yet been established and therefore no dose can be recommended for this age group.</p><p>Other medicines and Fabrazyme Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin. There is a theoretical risk of decreased agalsidase beta activity.</p><p>Pregnancy, breast-feeding and fertility Use of Fabrazyme during pregnancy is not recommended. There is no experience with the use of Fabrazyme in pregnant women. Fabrazyme may get into breast milk. Use of Fabrazyme during breast- feeding is not recommended. Studies have not been performed to examine the effects of Fabrazyme on fertility.</p><p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.</p><p>Driving and using machines Do not drive or use machines if you experience dizziness, sleepiness, vertigo or fainting during or shortly after administration of Fabrazyme (see section 4). Talk to your doctor first.</p><p>Fabrazyme contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium- free .</p></div>"
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"title" : "3. How to take fabrazyme",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Fabrazyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals at the end of this leaflet). Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.</p><p>Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease. Your doctor may advise that you can be treated at home provided you meet certain criteria. Please contact your doctor if you would like to be treated at home.</p><p>The recommended dose of Fabrazyme for adults is 1 mg/kg body weight, once every 2 weeks. No changes in dose are necessary for patients with kidney disease.</p><p>Use in children and adolescents The recommended dose of Fabrazyme for children and adolescents 8 16 years is 1 mg/kg body weight, once every 2 weeks. No changes in dose are necessary for patients with kidney disease.</p><p>If you use more Fabrazyme than you should Doses up to 3 mg/kg body weight have shown to be safe.</p><p>If you forget to use Fabrazyme If you have missed an infusion of Fabrazyme, please contact your doctor.</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>In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after ( infusion related reactions ). Severe life-threatening allergic reactions ( anaphylactoid</p><p>reactions ) have been reported in some patients. If you experience any serious side effect, you should contact your doctor immediately.</p><p>Very common symptoms (may affect more than 1 in 10 people) include chills, fever, feeling cold, nausea, vomiting, headache and abnormal feelings in the skin such as burning or tingling. Your doctor may decide to lower the infusion rate or give you additional medicines to prevent such reactions from occurring.</p><p>List of other side effects:</p><p>Common (may affect up to 1 in 10 people):<br/>chest pain sleepiness fatigue difficulty in breathing increased heart beat flushing pallor abdominal pain pain itching back pain throat tightness abnormal tear secretion rash dizziness feeling weak low heart rate palpitations tinnitus lethargy decreased sensitivity to pain nasal congestion syncope burning sensation diarrhoea cough wheezing redness abdominal discomfort urticaria muscle pain swelling face pain at the extremities increased blood pressure joint pain nasopharyngitis sudden swelling of the face or throat decreased blood pressure hot flush oedema in extremities chest discomfort feeling hot<br/>vertigo face oedema<br/>hyperthermia stomach discomfort exacerbated difficulty in breathing decreased mouth sensitivity muscle spasms muscle tightness musculoskeletal stiffness</p><p>Uncommon (may affect up to 1 in 100 people): tremor itching eyes low heart rate due to conduction disturbances red eyes ear swelling increased sensitivity to pain ear pain bronchospasm upper respiratory tract congestion throat pain runny nose red rash fast breathing heart burn (mottled purplish) skin discolouration itchy rash skin discomfort coldness of the extremities feeling hot and cold musculoskeletal pain injection site blood clotting difficulty swallowing rhinitis skin discolouration infusion site pain influenza-like illness oedema infusion site reaction malaise</p><p>Not known (frequency cannot be estimated from the available data):</p><ul><li>lower blood oxygen levels serious inflammation of the vessels</li></ul><p>In some patients initially treated at the recommended dose, and whose dose was later reduced for an extended period, some symptoms of Fabry disease were reported more frequently.</p><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</p><p>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 label after EXP . The expiry date refers to the last day of that month.</p><p>Unopened vials Store in a refrigerator (2 C 8 C).</p><p>Reconstituted and diluted solutions The reconstituted solution cannot be stored and should be promptly diluted. The diluted solution can be held for up to 24 hours at 2 C 8 C.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>"
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"title" : "6. Contents of the pack and other information",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Fabrazyme contains</p><ul><li><p>The active substance is agalsidase beta, one vial contains 35 mg. After reconstitution each vial contains 5 mg of agalsidase beta per ml.</p></li><li><p>The other ingredients are:</p></li><li><p>Mannitol (E421)</p></li><li><p>Sodium dihydrogen phosphate monohydrate (E339)</p></li><li><p>Disodium phosphate heptahydrate (E339).</p></li></ul><p>What Fabrazyme looks like and contents of the pack Fabrazyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted.<br/>Package sizes: 1, 5 and 10 vials per carton. Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder and Manufacturer</p><p>Marketing authorisation holder Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands</p><p>Manufacturer<br/>Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium T l/Tel: + 32 2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91<br/>Swixx Biopharma EOOD .: +359 (0)2 4942 Magyarorsz g SANOFI-AVENTIS Zrt. Tel: +36 1 505 0 esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Malta Sanofi S.r.l. Tel: +39 02 39394Danmark Sanofi A/S Tlf: +45 45 16 70 Nederland Sanofi B.V. Tel: +31 20 245 4Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 Tel. aus dem Ausland: +49 69 305 70 Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 Eesti Swixx Biopharma O<br/>Tel: +372 640 10 sterreich sanofi-aventis GmbH Tel: + 43 1 80 185 - 0</p><p>Sanofi-Aventis AEBE : +30 210 900 1Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Portugal Sanofi Produtos Farmac uticos, Lda.<br/>Tel: +351 21 35 89 France Sanofi Winthrop Industrie T l: 0 800 222 Appel depuis l tranger: +33 1 57 63 23 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Slovenija Swixx Biopharma d.o.o.<br/>Tel: +386 1 235 51 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 sland Vistor hf. S mi: +354 535 7Suomi/Finland Sanofi Oy Puh/Tel: + 358 201 200 Italia Sanofi S.r.l. Tel: 800536Sverige Sanofi AB Tel: +46 (0)8 634 50<br/>C.A. Papaellinas Ltd. : +357 22 741United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2Latvija Swixx Biopharma SIA<br/>Tel: +371 6 616 47 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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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.
