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\"><p>What is in this leaflet</p><ol type=\"1\"><li>What Xofluza is and what it is used for</li><li>What you need to know before you take Xofluza</li><li>How to take Xofluza</li><li>Possible side effects</li><li>How to store Xofluza</li><li>Contents of the pack and other information</li></ol></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Xofluza is</p><p>Xofluza contains baloxavir marboxil. This is a type of antiviral medicine called a cap-dependent endonuclease inhibitor .</p><p>Xofluza is used for treating and preventing influenza. This medicine stops the influenza virus from spreading in the body and helps shorten the time to recovery from symptoms.</p><p>What Xofluza is used for</p><ul><li>Xofluza is used to treat influenza in patients aged 1 year and above who have had influenza symptoms for less than 48 hours.</li><li>Xofluza is used to prevent influenza in individuals aged 1 year and above who have been in close contact with someone who is known or suspected to have influenza.</li></ul></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take Xofluza if:</p><ul><li>you are allergic to baloxavir marboxil or any of the other ingredients of this medicine (listed in section 6).</li></ul><p>Warnings and precautions</p><p>Talk to your doctor or pharmacist before taking Xofluza. Infants and Children</p><p>Do not give this medicine to children below 1 year of age. This is because the effects of Xofluza in this age group are not known.</p><p>Other medicines and Xofluza</p><p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Do not take Xofluza with:</p><ul><li>laxatives, antacids or oral supplements containing iron, zinc, selenium, calcium, or magnesium</li></ul><p>The medicines listed above may decrease the effect of Xofluza.</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, as a precautionary measure it is preferable to avoid the use of Xofluza. Ask your doctor or pharmacist for advice before taking this medicine.</p><p>Driving and using machines</p><p>Xofluza is not likely to change your ability to drive and to use machines.</p><p>Xofluza contains lactose</p><p>Xofluza contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.</p><p>Xofluza contains sodium</p><p>This medicine contains less than 23 mg of sodium per tablet, that is to say essentially sodium-free .</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>When to take Xofluza</p><p>For treatment of influenza, take Xofluza as a single dose as soon as possible within 48 hours of your flu symptoms starting.</p><p>For prevention of influenza, take Xofluza as a single dose as soon as possible within 48 hours following exposure to an infected person.</p><p>How much Xofluza to take</p><p>Your dose of Xofluza depends on how much you weigh. Your doctor or pharmacist will tell you how much to take.</p><p>Your weight</p><p>Xofluza dose < 20 kg Refer to the Xofluza granules for oral suspension package leaflet . 20 kg - < 80 kg Single dose of 40 mg taken as</p><ul><li>2 x 20 mg tablets</li></ul><p>80 kg or more</p><p>Single dose of 80 mg taken as</p><ul><li>2 x 40 mg tablets</li></ul><p>Xofluza can be taken with or without food. Take all the tablets with some water.</p><p>If you take more Xofluza than you should</p><p>If you accidentally take more of this medicine than you should, talk to your doctor or pharmacist for advice.</p><p>If you forget to take Xofluza</p><p>If you forget to take some or all of your dose, take it as soon as possible.</p><p>For the treatment of influenza, Xofluza should be taken within 48 hours of your flu symptoms starting.</p><p>For the prevention of influenza, Xofluza should be taken within 48 hours of close contact with someone who is known or suspected to have flu.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, it is possible for this medicine to cause side effects, although not everybody gets them.</p><p>Adults, adolescents and children</p><p>Get medical help immediately if you get any of the following serious side effects:</p><ul><li>Severe allergic reaction (anaphylaxis), with signs such as swelling of the face or skin, itchy rashes, low blood pressure and difficulty breathing</li></ul><p>The frequency of these side effects cannot be estimated from the available data.</p><p>Other possible side effects: The following side effect is uncommon (this can affect up to 1 in every 100 patients):</p><ul><li>Itchy rash</li></ul><p>Children (1 to <12 years) The following side effects are common (this can affect up to 1 in every 10 patients)</p><ul><li>Diarrhoea, rash and vomiting</li></ul><p>Reporting of side effects</p><p>If you get 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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"title" : "5. How to store xofluza",
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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 blister and carton after EXP . The expiry date refers to the last day of that month.</p><p>This medicine does not need any special temperature storage conditions.</p><p>Store in the original package in order to protect from moisture. 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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Xofluza contains</p><ul><li>The active substance is baloxavir marboxil.</li><li>Each 20 mg film-coated tablet contains 20 mg baloxavir marboxil. Each 40 mg film-coated tablet contains 40 mg baloxavir marboxil.</li><li>The other ingredients are lactose monohydrate (see Section 2 Xofluza contains lactose ), croscarmellose sodium ((E468) (see Section 2 Xofluza contains sodium )), povidone (K25) (E1201), microcrystalline cellulose (E460), sodium stearyl fumarate in the tablet core, and hypromellose (E464), talc (E553b) and titanium dioxide (E171) in the film-coating.</li></ul><p>What Xofluza looks like and contents of the pack</p><p>Xofluza 20 mg tablets are white to light yellow, oblong shaped film-coated tablets with<br/>772<br/>marked on one side and 20 on the other side.</p><p>Xofluza 20 mg film-coated tablets are available in blister packs of 2. Xofluza 40 mg tablets are white to light yellow, oblong shaped film-coated tablets with BXM40<br/>marked on one side.</p><p>Xofluza 40 mg film-coated tablets are available in blister packs of 2. Marketing Authorisation Holder</p><p>Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany</p><p>Manufacturer</p><p>Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva<br/>Tel: +370 5 2546</p><p>: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)</p><p>esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland)</p><p>Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O<br/>Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90<br/>Roche (Hellas) A.E.<br/>: +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 France Roche T l: +33 (0)1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o. Tel: + 385 1 47 22 Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland<br/>Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika<br/>Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy<br/>Puh/Tel: +358 (0) 10 554 K<br/>. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This 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.
