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 xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What KANUMA is and what it is used for</li><li>What you need to know before you are given KANUMA</li><li>How KANUMA is given</li><li>Possible side effects</li><li>How to store KANUMA</li><li>Contents of the pack and other information</li></ol></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>KANUMA contains the active substance sebelipase alfa. Sebelipase alfa is similar to the naturally occurring enzyme lysosomal acid lipase (LAL), which the body uses to breakdown fats. It is used to treat patients of all ages with lysosomal acid lipase deficiency (LAL deficiency).</p><p>LAL deficiency is a genetic disease that leads to liver damage, high blood cholesterol, and other complications due to a build-up of certain types of fats (cholesteryl esters and triglycerides).</p><p>How KANUMA works This medicine is an enzyme replacement therapy. This means that it replaces the missing or defective LAL enzyme in patients with LAL deficiency. This medicine works by lowering the build-up of fat that causes medical complications, including impaired growth, liver damage and heart complications. It also improves blood levels of fats, including elevated LDL (bad cholesterol) and triglycerides.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>You must not be given KANUMA</p><ul><li>If you or your child has experienced life-threatening allergic reactions to sebelipase alfa that cannot be managed when you or your child receives the medicine again, or to egg or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions</p><ul><li>If treated with KANUMA, you or your child may experience a side effect while you or your child is being given the medicine or during the hours following the infusion (see section 4). This is known as an infusion reaction which can sometimes be severe, and may include an</li></ul><p>allergic reaction that could be life-threatening and require medical treatment. The first time that you or your child are given KANUMA you should be observed by a healthcare professional for 1 hour to watch for any signs of an infusion reaction. If you or your child experiences a severe infusion reaction like this, seek immediate medical attention. If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions. These medicines may include antihistamines, fever-reducing medicines and/or corticosteroids (a type of anti-inflammatory medicines). If the infusion reaction is severe, your doctor may stop KANUMA infusion and start giving you or your child appropriate medical treatment.</p><ul><li>The development of blood proteins against KANUMA, also called anti-drug antibodies, may occur during the treatment. Talk to your doctor if you experience decreased efficacy with KANUMA</li><li>This medicine may contain egg proteins. If you or your child has an egg allergy or a history of allergies to eggs, tell your doctor or nurse (see You must not be given KANUMA).</li></ul><p>Other medicines and KANUMA Tell your doctor if you or your child are using, have recently used or might use any other medicines.</p><p>Pregnancy There are no data from the use of sebelipase alfa in pregnant women. As a precautionary measure, you should not be given KANUMA if you are pregnant.</p><p>Breast-feeding It is not known whether sebelipase alfa passes into breast milk. Tell your doctor if you are breast- feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking KANUMA, considering the benefit of breast-feeding to the baby and the benefit of KANUMA to the mother.</p><p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.</p><p>Driving and using machines KANUMA may have a minor influence on the ability to drive and use machines. Adverse effects of sebelipase alfa include dizziness which could affect the ability to drive or use machines.</p><p>KANUMA contains sodium<br/>This medicine, when diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion for intravenous administration contains 33 mg sodium (main component of cooking/table salt) at the recommended dose. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult. Tell your doctor if you or your child is on a controlled sodium diet.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>The dose you or your child receives is based on your or your child s body weight.</p><p>Infants (< 6 months of age) For patients who have signs and symptoms of the disease when they are infants, the recommended starting dose is 1 mg/kg or 3 mg/kg once weekly. Dose adjustments may be considered based on how well your child responds to treatment.</p><p>Children and adults The recommended dose is 1 mg per kg body weight once every other week through a drip into a vein. Dose adjustments may be considered based on how well you or your child responds to treatment.</p><p>Each infusion will take approximately 1 to 2 hours. You or your child may be monitored by your doctor or nurse for an additional hour after the infusion. KANUMA should be started at as young an age as possible and is intended for long-term use.</p><p>Your doctor or nurse will give KANUMA to you or your child by an infusion (drip) into a vein. The medicine will be diluted before being given to you or your child.</p></div>
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<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>Side effects were seen while patients were being given the medicine or shortly after (infusion reactions). The most serious side effects may include an allergic reaction (seen very commonly [may affect more than 1 in 10 people] in infants younger than 6 months old, or commonly [may affect up to 1 in 10 people] in children and adults) with symptoms including difficulty breathing, rapid breathing, fast heartbeat, chest discomfort, mild swelling of eyelids, red eyes, runny nose, flushing, hives, itching, diarrhoea, paleness, wheezing, low blood oxygen, skin redness and irritability. If you or your child experiences symptoms like these, seek immediate medical attention. If you or your child has an infusion reaction you or your child may be given additional medicines to treat or help prevent future reactions. If the infusion reaction is severe, your doctor may stop the infusion of KANUMA in the vein and start giving appropriate medical treatment.</p><p>Very Common (may affect more than 1 in 10 people) side effects reported in infants (1 to 6 months old) are:<br/>Hypersensitivity (irritability, agitation, vomiting, urticaria, eczema, pruritus, pallor and drug hypersensitivity), severe allergic reactions (anaphylactic reactions) Eyelid swelling Fast heartbeat Difficulty breathing Diarrhoea, vomiting Rash, raised rash Fever Decreased oxygen in the blood, blood pressure increased, rapid breathing, development of blood proteins</p><p>Very Common (may affect 1 in 10 people or more) side effects reported in children and adolescents (4 to 18 years old) and adults are: Hypersensitivity (chills, eczema, laryngeal oedema, nausea, pruritus and urticaria) Dizziness Stomach ache, diarrhoea Tiredness, fever</p><p>Common (may affect up to 1 in 10 people) side effects reported in children and adolescents (4 to 18 years old) and adults are:<br/>Severe allergic reaction (anaphylactic reaction),<br/>Fast heartbeat Skin redness, low blood pressure Shortness in breath Stomach bloating Rash, red swollen skin Chest discomfort, reaction at the infusion site</p><p>Frequency, type and severity of adverse reactions in children are similar to those in adults.</p><p>Reporting of side effects If you or your child gets any side effects, talk to your doctor. 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 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 and carton after EXP. The expiry date refers to the last day of that month.</p><p>Store in a refrigerator (2 C to 8 C). Do not freeze. Do not shake. Store in the original package in order to protect from light.</p><p>For diluted solutions, immediate use is recommended. If not used immediately, the diluted solution may be stored up to 24 hours at 2 C to 8 C or up to 12 hours below 25 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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<div xmlns="http://www.w3.org/1999/xhtml"><p>What KANUMA contains</p><ul><li>The active substance is sebelipase alfa. Each ml of concentrate contains 2 mg sebelipase alfa. Each vial contains 20 mg of sebelipase alfa in 10 ml.</li><li>The other ingredients are sodium citrate (see section 2 under KANUMA contains sodium ), citric acid monohydrate, human serum albumin, and water for injections.</li></ul><p>What KANUMA looks like and contents of the pack KANUMA is supplied as a concentrate for solution for infusion (sterile concentrate). It is a solution that is clear to slightly opalescent, and colourless to slightly coloured.</p><p>Pack size: 1 vial containing 10 ml of concentrate.</p><p>Marketing Authorisation Holder and Manufacturer</p><p>Marketing Authorisation Holder Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France</p><p>Manufacturer: Almac Pharma Services Seagoe Industrial Estate Craigavon BT63 5UA United Kingdom</p><p>Alexion Pharma International Operations Limited College Business and Technology Park Blanchardstown Road North</p><p>Dublin D15 RIreland</p><p>For any information about this medicine, please contact the local representative of the Marketing<br/>Authorisation Holder:</p><p>Belgi /Belgique/Belgien<br/>Alexion Pharma Belgium<br/>T l/Tel: +32 0 800 200 Lietuva<br/>UAB AstraZeneca Lietuva<br/>Tel: +370 5 2660</p><p>Te .: +359 24455Luxembourg/Luxemburg<br/>Alexion Pharma Belgium<br/>T l/Tel: +32 0 800 200 esk republika<br/>AstraZeneca Czech Republic s.r.o.<br/>Tel: +420 222 807 Magyarorsz g<br/>AstraZeneca Kft.<br/>Tel.: +36 1 883 6Danmark<br/>Alexion Pharma Nordics AB<br/>Tlf: +46 0 8 557 727 Malta<br/>Alexion Europe SAS<br/>Tel: +353 1 800 882 Deutschland<br/>Alexion Pharma Germany GmbH<br/>Tel: +49 (0) 89 45 70 91 Nederland<br/>Alexion Pharma Netherlands B.V.<br/>Tel: +32 (0)2 548 36 Eesti<br/>AstraZeneca<br/>Tel: +372 6549 Norge<br/>Alexion Pharma Nordics AB<br/>Tlf: +46 (0)8 557 727<br/>AstraZeneca A.E.<br/>: +30 210 6871 sterreich<br/>Alexion Pharma Austria GmbH<br/>Tel: +41 44 457 40 Espa a<br/>Alexion Pharma Spain, S.L.<br/>Tel: +34 93 272 30 Polska<br/>AstraZeneca Pharma Poland Sp. z o.o.<br/>Tel.: +48 22 245 73 France<br/>Alexion Pharma France SAS<br/>T l: +33 1 47 32 36 Portugal<br/>Alexion Pharma Spain, S.L. - Sucursal em Portugal<br/>Tel: +34 93 272 30 Hrvatska<br/>AstraZeneca d.o.o.<br/>Tel: +385 1 4628 Rom nia<br/>AstraZeneca Pharma SRL<br/>Tel: +40 21 317 60 Ireland<br/>Alexion Europe SAS<br/>Tel: +353 1 800 882 Slovenija<br/>AstraZeneca UK Limited<br/>Tel: +386 1 51 35 sland<br/>Alexion Pharma Nordics AB<br/>S mi: +46 0 8 557 727 Slovensk republika<br/>AstraZeneca AB, o.z.<br/>Tel: +421 2 5737 7Italia<br/>Alexion Pharma Italy srl<br/>Tel: +39 02 7767 9Suomi/Finland<br/>Alexion Pharma Nordics AB<br/>Puh/Tel: +46 0 8 557 727<br/>Alexion Europe SAS<br/>: +357 22490Sverige<br/>Alexion Pharma Nordics AB<br/>Tel: +46 0 8 557 727 Latvija<br/>SIA AstraZeneca Latvija<br/>Tel: +371 67377United Kingdom (Northern Ireland)<br/>Alexion Europe SAS<br/>Tel: +44 (0) 800 028 4This 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
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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.
