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 Azomyr is and what it is used for</li><li>What you need to know before you take Azomyr</li><li>How to take Azomyr</li><li>Possible side effects</li><li>How to store Azomyr</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 Azomyr is<br/>Azomyr contains desloratadine which is an antihistamine.</p><p>How Azomyr works<br/>Azomyr is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.</p><p>When Azomyr should be used<br/>Azomyr relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.</p><p>Azomyr is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.</p><p>Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not take Azomyr</p><ul><li>if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.</li></ul><p>Warnings and precautions<br/>Talk to your doctor, pharmacist or nurse before taking Azomyr:</p><ul><li>if you have poor kidney function.</li><li>if you have medical or familial history of seizures.</li></ul><p>Children and adolescents<br/>Do not give this medicine to children less than 12 years of age.</p><p>Other medicines and Azomyr<br/>There are no known interactions of Azomyr with other medicines.<br/>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.</p><p>Azomyr with food, drink and alcohol<br/>Azomyr may be taken with or without a meal.<br/>Use caution when taking Azomyr with alcohol.</p><p>Pregnancy, breast-feeding and fertility<br/>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.<br/>Taking Azomyr is not recommended if you are pregnant or nursing a baby.<br/>There is no data available on male/female fertility.</p><p>Driving and using machines<br/>At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicine.</p><p>Azomyr tablet contains lactose<br/>If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.</p></div>
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<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>Use in adults and adolescents 12 years of age and over<br/>The recommended dose is one tablet once a day with water, with or without food.</p><p>This medicine is for oral use.<br/>Swallow the tablet whole.</p><p>Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr. If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease. If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.</p><p>For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.</p><p>If you take more Azomyr than you should<br/>Take Azomyr only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Azomyr than you were told to, tell your doctor, pharmacist or nurse immediately.</p><p>If you forget to take Azomyr<br/>If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.</p><p>If you stop taking Azomyr<br/>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>During the marketing of Azomyr, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.</p><p>In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.</p><p>In clinical studies with Azomyr, the following side effects were reported as:</p><p>Common: the following may affect up to 1 in 10 people</p><ul><li>fatigue</li><li>dry mouth</li><li>headache</li></ul><p>During the marketing of Azomyr, the following side effects were reported as:</p><p>Very rare: the following may affect up to 1 in 10,000 people</p><ul><li>severe allergic reactions</li><li>rash</li><li>pounding or irregular heartbeat</li><li>fast heartbeat</li><li>stomach ache</li><li>feeling sick (nausea)</li><li>vomiting</li><li>upset stomach</li><li>diarrhoea</li><li>dizziness</li><li>drowsiness</li><li>inability to sleep</li><li>muscle pain</li><li>hallucinations</li><li>seizures</li><li>restlessness with increased body movement</li><li>liver inflammation</li><li>abnormal liver function tests</li></ul><p>Not known: frequency cannot be estimated from the available data</p><ul><li><p>unusual weakness</p></li><li><p>yellowing of the skin and/or eyes</p></li><li><p>increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium</p></li><li><p>changes in the way the heart beats</p></li><li><p>abnormal behaviour</p></li><li><p>aggression</p></li><li><p>weight increased, increased appetite</p></li><li><p>depressed mood</p></li><li><p>dry eyes</p></li></ul><p>Children Not known: frequency cannot be estimated from the available data</p><ul><li>slow heartbeat</li><li>change in the way the heart beats</li><li>abnormal behaviour</li><li>aggression</li></ul><p>Reporting of side effects<br/>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"><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 blister after EXP. The expiry date refers to the last day of that month.</p><p>Do not store above 30 C. Store in the original package.</p><p>Do not use this medicine if you notice any change in the appearance of the tablets.</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 Azomyr contains</p><ul><li>The active substance is desloratadine 5 mg</li><li>The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate (see section 2 Azomyr tablet contains lactose ), hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.</li></ul><p>What Azomyr looks like and contents of the pack<br/>Azomyr 5 mg film-coated tablet is light blue, round and embossed with elongated letters S and P<br/>on one side and plain on the other. Azomyr 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50 or 100 tablets. Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder and Manufacturer<br/>Marketing Authorisation Holder:</p><p>N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands</p><p>Manufacturer: Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium.</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Organon Belgium T l/Tel: 0080066550123 (+32 2 2418100)<br/><a href="mailto:dpoc.benelux@organon.com">dpoc.benelux@organon.com</a></p><p>Lietuva Organon Pharma B.V. Lithuania atstovyb<br/>Tel.: +370 <a href="mailto:52041dpoc.lithuania@organon.com">52041dpoc.lithuania@organon.com</a></p><p>( . .) . . -<br/>.: +359 2 806 <a href="mailto:3dpoc.bulgaria@organon.com">3dpoc.bulgaria@organon.com</a></p><p>Luxembourg/Luxemburg Organon Belgium T l/Tel: 0080066550123 (+32 2 2418100)<br/><a href="mailto:dpoc.benelux@organon.com">dpoc.benelux@organon.com</a></p><p>esk republika Organon Czech Republic s.r.o. Tel.: +420 233 010 <a href="mailto:dpoc.czech@organon.com">dpoc.czech@organon.com</a></p><p>Magyarorsz g Organon Hungary Kft. Tel.: +36 1 766 <a href="mailto:1dpoc.hungary@organon.com">1dpoc.hungary@organon.com</a></p><p>Danmark Organon Denmark ApS Tlf: +45 4484 <a href="mailto:6info.denmark@organon.com">6info.denmark@organon.com</a></p><p>Malta Organon Pharma B.V., Cyprus branch Tel: +356 2277 <a href="mailto:8dpoc.cyprus@organon.com">8dpoc.cyprus@organon.com</a></p><p>Deutschland Organon Healthcare GmbH Tel: 0800 3384 726 (+49 (0) 89 2040022 10) <a href="mailto:dpoc.germany@organon.com">dpoc.germany@organon.com</a></p><p>Nederland N.V. Organon Tel.: 00800 66550123 (+32 2 2418100) <a href="mailto:dpoc.benelux@organon.com">dpoc.benelux@organon.com</a></p><p>Eesti Organon Pharma B.V. Estonian RO Tel: +372 66 61 <a href="mailto:dpoc.estonia@organon.com">dpoc.estonia@organon.com</a></p><p>Norge Organon Norway AS Tlf: +47 24 14 56 <a href="mailto:info.norway@organon.com">info.norway@organon.com</a></p><p>N.V. Organon : +30-216 6008 sterreich Organon Austria GmbH Tel: +43 (0) 1 263 28 <a href="mailto:dpoc.austria@organon.com">dpoc.austria@organon.com</a></p><p>Espa a Organon Salud, S.L. Tel: +34 91 591 12 <a href="mailto:organon_info@organon.com">organon_info@organon.com</a> Polska Organon Polska Sp. z o.o. Tel.: +48 22 105 50 <a href="mailto:organonpolska@organon.com">organonpolska@organon.com</a></p><p>France Organon France T l: +33 (0) 1 57 77 32 Portugal Organon Portugal, Sociedade Unipessoal Lda. Tel: +351 <a href="mailto:218705geral_pt@organon.com">218705geral_pt@organon.com</a></p><p>Hrvatska Organon Pharma d.o.o. Tel: +385 1 638 <a href="mailto:4dpoc.croatia@organon.com">4dpoc.croatia@organon.com</a></p><p>Rom nia Organon Biosciences S.R.L. Tel: +40 21 527 29 <a href="mailto:dpoc.romania@organon.com">dpoc.romania@organon.com</a></p><p>Ireland Organon Pharma (Ireland) Limited Tel: +353 <a href="mailto:15828medinfo.ROI@organon.com">15828medinfo.ROI@organon.com</a></p><p>Slovenija Organon Pharma B.V., Oss, podru nica Ljubljana Tel: +386 1 300 10 <a href="mailto:dpoc.slovenia@organon.com">dpoc.slovenia@organon.com</a></p><p>sland Vistor hf. S mi: +354 535 7Slovensk republika Organon Slovakia s. r. o. Tel: +421 2 44 88 98 <a href="mailto:dpoc.slovakia@organon.com">dpoc.slovakia@organon.com</a></p><p>Italia Organon Italia S.r.l. Tel: +39 06 <a href="mailto:90259dpoc.italy@organon.com">90259dpoc.italy@organon.com</a></p><p>Suomi/Finland Organon Finland Oy Puh/Tel: +358 (0) 29 170 <a href="mailto:3dpoc.finland@organon.com">3dpoc.finland@organon.com</a></p><p>Organon Pharma B.V., Cyprus branch : +357 <a href="mailto:22866dpoc.cyprus@organon.com">22866dpoc.cyprus@organon.com</a></p><p>Sverige Organon Sweden AB Tel: +46 8 502 597 <a href="mailto:dpoc.sweden@organon.com">dpoc.sweden@organon.com</a></p><p>Latvija rvalsts komersanta Organon Pharma B.V.<br/>p rst vniec ba Tel: +371 <a href="mailto:66968dpoc.latvia@organon.com">66968dpoc.latvia@organon.com</a></p><p>United Kingdom (Northern Ireland) Organon Pharma (UK) Limited Tel: +44 (0) 208 159 <a href="mailto:3medicalinformationuk@organon.com">3medicalinformationuk@organon.com</a></p><p>This leaflet was last revised in <{MM/YYYY}><{month YYYY}></p><p>Detailed information on this medicine is available on the European Medicines Agency website <a href="http://www.ema.europa.eu">http://www.ema.europa.eu</a>.</p><p>Package leaflet: Information for the patient</p><p>Azomyr 0.5 mg/ml oral solution<br/>desloratadine</p><p>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</p><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor, pharmacist or nurse.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
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<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<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="Azomyr 5 mg film-coated tablets"/>
<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.
