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 Enspryng is and what it is used for</li><li>What you need to know before you use Enspryng</li><li>How to use Enspryng</li><li>Possible side effects</li><li>How to store Enspryng</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>What Enspryng is</p><p>Enspryng contains the active substance satralizumab. It is a type of protein called a monoclonal antibody. Monoclonal antibodies are designed to recognise and attach to a specific substance in the body.</p><p>What Enspryng is used for</p><p>Enspryng is a medicine for treating neuromyelitis optica spectrum disorders (NMOSD) in adults and young people from 12 years of age.</p><p>What is NMOSD</p><p>NMOSD is a disease of the central nervous system that mainly affects the optic nerves and spinal cord. It is caused by the immune system (the body s defences) working incorrectly and attacking nerves in the body.</p><ul><li>The damage to the optic nerves causes swelling, leading to pain and loss of sight.</li><li>The damage to the spinal cord causes weakness or loss of movement in the legs or arms, loss of feeling, and problems with bladder and bowel function. In an attack of NMOSD, there is swelling in the nervous system. This also happens when the disease comes back (relapse). The swelling causes new symptoms or a return of previous symptoms.</li></ul><p>How Enspryng works</p><p>Enspryng blocks the action of a protein called interleukin-6 (IL-6), which is involved in the processes that lead to damage and swelling in the nervous system. By blocking its effects, Enspryng reduces the risk of a relapse or attack of NMOSD.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Enspryng</p><ul><li>if you are allergic to satralizumab or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>If the above applies to you or you are not sure, do not use Enspryng and talk to your doctor, pharmacist or nurse.</p><p>Warnings and precautions</p><p>Talk to your doctor immediately if you experience any allergic reaction (see section 4. Possible side effects).</p><p>Talk to your doctor, pharmacist or nurse before using Enspryng if any of the below apply to you (or if you are not sure).</p><p>Infections</p><p>You cannot use Enspryng while you have an infection. Tell your doctor or nurse straight away if you think you have any signs of infection before, during, or after Enspryng treatment such as:</p><ul><li>fever or chills</li><li>cough that does not go away</li><li>sore throat</li><li>cold sore or genital sores (herpes simplex)</li><li>shingles (herpes zoster)</li><li>skin redness, swelling, tenderness or pain</li><li>feeling or being sick, diarrhoea or belly pain.</li></ul><p>You will also find this information in the patient alert card you have been given by your doctor. It is important that you keep this alert card with you at all times and show it to any doctor, nurse or caregiver.</p><p>Your doctor will wait until the infection is controlled before giving you Enspryng or allowing you to continue to inject Enspryng.</p><p>Vaccinations</p><p>Tell your doctor if you have recently been given any vaccine or might be given a vaccine in the near future.</p><ul><li>Your doctor will check if you need any vaccines before you start Enspryng.</li><li>Do not have live or live attenuated vaccines (for example BCG for tuberculosis or vaccines against yellow fever) while you are being treated with Enspryng.</li></ul><p>Liver enzymes</p><p>Enspryng can have effects on your liver and increase the amount of some liver enzymes in your blood. Your doctor will do blood tests before you are given Enspryng, and during your treatment, to check how well your liver is working. Tell your doctor or nurse straight away if you have any of these signs of liver damage during or after Enspryng treatment:</p><ul><li>yellowing of the skin and the whites of the eyes (jaundice)</li><li>dark-coloured urine</li><li>feeling and being sick</li><li>abdominal pain</li></ul><p>White blood cell count</p><p>Your doctor will perform blood tests before you are given Enspryng, and during your treatment, to check your white blood cell count.</p><p>Children and young people</p><p>Do not give this medicine to children under 12 years of age. This is because it has not yet been studied in this age group.</p><p>Other medicines and Enspryng</p><p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Tell your doctor or pharmacist if you are taking medicines such as warfarin, carbamazepine, phenytoin and theophylline as doses might need to be adjusted.</p><p>Pregnancy and breast-feeding</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>Your doctor may advise you to stop breast-feeding if you are to be given Enspryng. It is not known whether Enspryng passes into breast milk.</p><p>Driving and using machines</p><p>Enspryng is not likely to affect you being able to drive, cycle or use any tools or machines.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>How much Enspryng to use</p><p>Each injection contains 120 mg of satralizumab. The first injection will be given under the supervision of your doctor or nurse.</p><ul><li>The first three injections are given once every 2 weeks. These are called loading doses .</li><li>After this, the injection is given every 4 weeks. This is called the maintenance dose . Continue with the injections once every 4 weeks for as long as your doctor tells you to.</li></ul><p>How to use Enspryng</p><ul><li>Enspryng is given by injection under the skin (sub-cutaneously).</li><li>Inject the entire content of the syringe each time.</li></ul><p>At the start, your doctor or nurse may inject Enspryng. However, your doctor may decide that you or an adult caregiver can inject Enspryng.</p><ul><li>You or your caregiver will get training on how to inject Enspryng.</li><li>Talk to your doctor or nurse if you or your caregiver have any questions about giving injections.</li></ul><p>Read carefully and follow the Instructions for use at the end of this leaflet on how to inject Enspryng.</p><p>If you use more Enspryng than you should</p><p>Because Enspryng is in a pre-filled syringe, it is unlikely that you will receive too much. However, if you are worried, talk to your doctor, pharmacist or nurse.</p><p>If you accidentally inject more doses than you should, call your doctor. Always take the outer carton with you when you go to see the doctor.</p><p>If you forget to use Enspryng</p><p>For the treatment to be fully effective, it is very important to keep having the injections.</p><p>If your doctor or nurse is giving your injections and you miss an appointment, make another one straight away.</p><p>If you are injecting Enspryng yourself and you miss an injection, inject it as soon as possible. Do not wait until the next planned dose. After you have had the injection for the missed dose, your next injection should be either:</p><ul><li>for loading doses 2 weeks later</li><li>for maintenance doses 4 weeks later</li></ul><p>Check with your doctor, pharmacist or nurse if you are not sure.</p><p>If you stop using Enspryng</p><p>Do not suddenly stop using Enspryng without asking your doctor first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.</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>Allergic reactions</p><p>Tell your doctor straight away or go to the emergency department of your nearest hospital, if you have any signs of allergic reactions during or after the injection. They include:</p><ul><li>tight chest or wheezing</li><li>feeling short of breath</li><li>fever or chills</li><li>severe dizziness or light-headedness</li><li>swelling of the lips, tongue, face</li><li>skin itching, hives or rash. Do not take the next dose until you have spoken with your doctor and your doctor has told you to take the next dose.</li></ul><p>Injection-related reactions (very common: may affect more than 1 in 10 people)</p><p>In most cases these are mild reactions, but some can be serious. Tell your doctor or nurse straight away if you have any of these signs during or after the injection,<br/>particularly in the first 24 hours after the injection:</p><ul><li>redness, itching, pain or swelling where the injection is given</li><li>rash, red or itchy skin or hives</li><li>feeling flushed</li><li>headache</li><li>throat irritation, swelling or pain</li><li>feeling short of breath</li><li>low blood pressure (dizziness and light-headedness)</li><li>fever or chills</li><li>feeling tired</li><li>feeling or being sick, or diarrhoea</li><li>fast heart rate, fluttering or pounding heart (palpitations).</li></ul><p>Tell your doctor or nurse straight away if you have any of the signs above.</p><p>Other side effects:</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li>headache</li><li>joint pain</li><li>high levels of blood lipids (fats)</li><li>low level of white blood cells in tests</li></ul><p>Common (may affect up to 1 in 10 people)</p><ul><li>feeling stiff</li><li>migraine</li><li>slow heart beat (bradycardia)</li><li>increase in blood pressure</li><li>being unable to sleep</li><li>swelling in your lower legs, feet or hands</li><li>rash or itching</li><li>allergies or hay fever</li><li>stomach inflammation (gastritis), including stomach pain and nausea</li><li>weight increase</li><li>blood tests showing:</li></ul><p>low fibrinogen levels (a protein involved in blood clotting)</p><p>high level of liver enzymes (transaminases, possible sign of liver problems)</p><p>high level of bilirubin (possible sign of liver problems)</p><p>low level of platelets (which may lead to bleeding or bruising easily)</p><p>Reporting of side effects</p><p>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>
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<div xmlns="http://www.w3.org/1999/xhtml"><ul><li>Keep this medicine out of the sight and reach of children.</li><li>Do not use this medicine after the expiry date which is stated on the pre-filled syringe label and carton after EXP . The expiry date refers to the last day of that month.</li><li>Store in a refrigerator (2 C 8 C). Do not freeze. Do not use the syringe if it has been frozen. Always keep the syringe dry.</li><li>Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.</li><li>If unopened and kept in the outer carton, Enspryng may be left out of the refrigerator below 30 C for a single period up to 8 days. Do not return Enspryng to the refrigerator.</li><li>Do not use and discard the pre-filled syringe if it has been left out of the refrigerator for longer than 8 days.</li></ul><p>Do not use this medicine if it is cloudy, discoloured or contains particles. Enspryng is a colourless to slightly yellow liquid.</p><p>The medicine must be injected right after removing the cap and no later than 5 minutes to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of removing the cap, you must dispose of it in a puncture-resistant container and use a new pre-filled syringe.</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 Enspryng contains</p><ul><li>The active substance is satralizumab. Each pre-filled syringe contains 120 mg of satralizumab in 1 mL.</li><li>The other ingredients are histidine, aspartic acid, arginine, poloxamer 188, water for injections.</li></ul><p>What Enspryng looks like and contents of the pack</p><ul><li>It is a colourless to slightly yellow liquid.</li><li>Enspryng is a solution for injection.</li><li>Each pack of Enspryng contains 1 pre-filled syringe. Each multipack of Enspryng contains 3 (3 packs of 1) pre-filled syringes. Not all pack sizes may be marketed.</li></ul><p>Marketing Authorisation Holder</p><p>Roche Registration GmbH<br/>Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany</p><p>Manufacturer</p><p>Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien<br/>N.V. Roche S.A.<br/>T l/Tel: +32 (0) 2 525 82 Lietuva<br/>UAB Roche Lietuva<br/>Tel: +370 5 2546</p><p>: +359 2 818 44 Luxembourg/Luxemburg<br/>(Voir/siehe Belgique/Belgien)<br/>esk republika<br/>Roche s. r. o.<br/>Tel: +420 - 2 20382Magyarorsz g<br/>Roche (Magyarorsz g) Kft.<br/>Tel: +36 - 12 794 Danmark<br/>Roche Pharmaceuticals A/S<br/>Tlf: +45 - 36 39 99 Malta<br/>(see Ireland )<br/>Deutschland<br/>Roche Pharma AG<br/>Tel: +49 (0) 7624 Nederland<br/>Roche Nederland B.V.<br/>Tel: +31 (0) 348 438Eesti<br/>Roche Eesti O<br/>Tel: + 372 - 6 177 Norge<br/>Roche Norge AS<br/>Tlf: +47 - 22 78 90<br/>Roche (Hellas) A.E.<br/>: +30 210 61 66 sterreich<br/>Roche Austria GmbH<br/>Tel: +43 (0) 1 27Espa a<br/>Roche Farma S.A.<br/>Tel: +34 - 91 324 81 Polska<br/>Roche Polska Sp.z o.o.<br/>Tel: +48 - 22 345 18 France<br/>Roche<br/>T l: +33 (0) 1 47 61 40 Portugal<br/>Roche Farmac utica Qu mica, Lda<br/>Tel: +351 - 21 425 70 Hrvatska<br/>Roche d.o.o.<br/>Tel: +385 1 4722 Rom nia<br/>Roche Rom nia S.R.L.<br/>Tel: +40 21 206 47 Ireland<br/>Roche Products (Ireland) Ltd.<br/>Tel: +353 (0) 1 469 0Slovenija<br/>Roche farmacevtska dru ba d.o.o.<br/>Tel: +386 - 1 360 26 sland<br/>Roche Pharmaceuticals A/S<br/>c/o Icepharma hf<br/>S mi: +354 540 8Slovensk republika<br/>Roche Slovensko, s.r.o.<br/>Tel: +421 - 2 52638Italia<br/>Roche S.p.A.<br/>Tel: +39 - 039 2Suomi/Finland<br/>Roche Oy<br/>Puh/Tel: +358 (0) 10 554 K<br/>. . & .<br/>: +357 - 22 76 62 Sverige<br/>Roche AB<br/>Tel: +46 (0) 8 726 1Latvija<br/>Roche Latvija SIA<br/>Tel: +371 - 6 7039United Kingdom (Northern Ireland)<br/>Roche Products (Ireland) Ltd.<br/>Tel: +44 (0) 1707 366This leaflet was last revised in</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>
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<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="Enspryng 120 mg solution for injection in pre-filled syringe"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>
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.
