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 Relvar Ellipta is and what it is used for</li><li>What you need to know before you use Relvar Ellipta</li><li>How to use Relvar Ellipta</li><li>Possible side effects</li><li>How to store Relvar Ellipta</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>Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol. Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.</p><p>The 92/22 micrograms strength is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, and asthma in adults and adolescents 12 years and over.</p><p>The 184/22 micrograms strength is used to treat asthma in adults and adolescents aged 12 years and older. The 184/22 micrograms strength is not approved for the treatment of COPD.</p><p>Relvar Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD and asthma. It should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). If you do not have a quick-acting inhaler contact your doctor.</p><p>Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They reduce the swelling and irritation in the small air passages in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma and aggravation of COPD.</p><p>Vilanterol belongs to a group of medicines called long acting bronchodilators. It relaxes the muscles of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. When it is taken regularly, it helps the small air passages to remain open.</p><p>When you take these two active substances together regularly, they will help to control your breathing difficulties more than either medicine alone.</p><p>Asthma is a serious, long term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction) and swollen and irritated (inflammation). Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough. Relvar Ellipta has been shown to reduce flare-ups and symptoms of asthma.</p><p>Chronic obstructive pulmonary disease (COPD) is a serious, long term lung disease where the airways become inflamed and thickened. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. Relvar Ellipta has been shown to reduce flare-ups of COPD symptoms.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Relvar Ellipta<br/>-if you are allergic to fluticasone furoate, vilanterol or any other ingredients of this medicine (listed in section 6). -if you think the above applies to you, do not use Relvar Ellipta until you have checked with your doctor.</p><p>Warnings and precautions Talk to your doctor before using Relvar Ellipta: -if you have liver disease, as you may be more likely to have side effects. If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Relvar Ellipta (92/22 micrograms once daily).<br/>-if you have heart problems or high blood pressure. -if you have tuberculosis (TB) of the lung, or any long standing or untreated infections. -if you have ever been told you have diabetes or high blood sugar.<br/>-if you have thyroid gland problems. -if you have low potassium in your blood. -if you experience blurred vision or other visual disturbances.</p><p>Check with your doctor before you use this medicine if you think any of these applies to you.</p><p>While you are using Relvar Ellipta</p><p>Immediate breathing difficulties If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your Relvar Ellipta inhaler: stop using this medicine and seek medical help immediately, as you may have a serious condition called paradoxical bronchospasm.</p><ul><li>Contact your doctor if you experience blurred vision or other visual disturbances.</li><li>Contact your doctor if you experience increased thirst, frequent urination or unexplained tiredness (signs of high blood sugar).</li></ul><p>Infection of the lung If you are using this medicine for COPD you may be at an increased risk of developing an infection of the lungs known as pneumonia. See section 4 for information on symptoms to look out for while you are using this medicine. Tell your doctor as soon as possible if you develop any of these symptoms.</p><p>Children and adolescents Do not give this medicine to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD. Other medicines and Relvar Ellipta Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist.</p><p>Some medicines may affect how this medicine works, or make it more likely that you will have side effects. These include:</p><ul><li>medicines called beta-blockers, such as metoprolol, used to treat high blood pressure or a heart problems.</li><li>ketoconazole, to treat fungal infections.</li><li>ritonavir or cobicistat, to treat HIV infections.</li><li>long-acting beta2-adrenergic agonists, such as salmeterol</li></ul><p>Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Relvar Ellipta.</p><p>Pregnancy and breast-feeding<br/>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. Do not use this medicine if you are pregnant unless your doctor tells you that you can.</p><p>It is not known whether the ingredients of this medicine can pass into breast milk. If you are breast- feeding, you must check with your doctor before you use Relvar Ellipta. Do not use this medicine if you are breast-feeding unless your doctor tells you that you can.</p><p>Driving and using machines<br/>This medicine is unlikely to affect your ability to drive or use machines.</p><p>Relvar Ellipta contains lactose<br/>If you have been told by your doctor that you have an intolerance to some sugars, , contact your doctor before using this medicine.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.</p><p>Asthma The recommended dose to treat asthma is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.</p><p>If you have severe asthma, your doctor may decide that you should use one inhalation of the higher strength inhaler (184 micrograms fluticasone furoate and 22 micrograms of vilanterol). This dose is also used once daily at the same time each day.</p><p>COPD The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.</p><p>The higher strength of Relvar Ellipta (184 micrograms fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.</p><p>Relvar Ellipta is for oral inhalation.</p><p>Use Relvar Ellipta at the same time each day as it is effective over 24 hours<br/>It is very important that you use this medicine every day, as instructed by your doctor. This will help to keep you free of symptoms throughout the day and night.</p><p>Relvar Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol).</p><p>If you feel you are getting breathless or wheezy more often than normal, or if you are using your quick-acting inhaler more than usual, see your doctor.</p><p>How to use Relvar Ellipta<br/>See Step-by-step instructions for use after section 6 of this leaflet for full information.</p><p>Relvar Ellipta is for oral inhalation. You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it.</p><p>If your symptoms do not improve If your symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often:</p><p>contact your doctor as soon as possible.</p><p>If you use more Relvar Ellipta than you should<br/>If you accidentally use more Relvar Ellipta than your doctor has instructed, talk to your doctor or pharmacist. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart is beating faster than usual, you feel shaky or have a headache.</p><p>If you have used more than instructed for a long period of time, it is particularly important that you ask your doctor or pharmacist for advice. This is because larger doses of Relvar Ellipta may reduce the amount of steroid hormones produced naturally by your body.</p><p>If you forget to use Relvar Ellipta<br/>Do not inhale a double dose to make up for a forgotten dose. Just take your next dose at the usual time.</p><p>If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your quick-acting inhaler (e.g. salbutamol), then seek medical advice.</p><p>Do not stop using Relvar Ellipta without advice<br/>Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. Do not stop unless your doctor advises you to, even if you feel better.</p><p>If you have 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>Allergic reactions are rare (may affect up to 1 in 1,000 people).<br/>If you have any of the following symptoms after taking Relvar Ellipta stop taking this medicine and tell your doctor immediately. skin rash (hives) or redness<br/>swelling, sometimes of the face or mouth (angioedema) becoming very wheezy, coughing or having difficulty in breathing suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness).</p><p>Immediate breathing difficulties</p><p>Immediate breathing difficulties after using Relvar Ellipta are rare. If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately.</p><p>Pneumonia (infection of the lung) (common side effect, may affect up to 1 in 10 people) Tell your doctor if you have any of the following while taking Relvar Ellipta they could be symptoms of a lung infection:<br/>fever or chills increased mucus production, change in mucus colour increased cough or increased breathing difficulties.</p><p>Other side effects:</p><p>Very common side effects These may affect more than 1 in 10 people: headache common cold.</p><p>Common side effects<br/>These may affect up to 1 in 10 people:<br/>sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth out with water immediately after using Relvar Ellipta may help stop this side effect developing. inflammation of the lungs (bronchitis) infection of the nose sinuses or throat flu (influenza)<br/>pain and irritation in the back of the mouth and throat inflammation of the sinuses itchy, runny or blocked nose<br/>cough voice disorders weakening of the bones, leading to fractures stomach pain<br/>back pain high temperature (fever) joint pain muscle spasms.</p><p>Uncommon side effects<br/>This may affect up to 1 in 100 people:<br/>irregular heartbeat<br/>blurred vision increase in blood sugar (hyperglycaemia).</p><p>Rare side effects These may affect up to 1 in 1,000 people:<br/>heart beating faster (tachycardia) awareness of heart beat (palpitations)<br/>tremor anxiety.</p><p>Reporting of side effects<br/>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 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, tray and inhaler after EXP. The expiry date refers to the last day of that month.</p><p>Keep the inhaler inside the sealed tray to protect from moisture and only remove immediately before first use. Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.</p><p>Do not store above 25 C.</p><p>If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use.</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 Relvar Ellipta contains</p><ul><li>The active substances are fluticasone furoate and vilanterol.</li><li>For the 92/22 mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).</li><li>For the 184/22 mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).</li><li>The other ingredients are lactose monohydrate (See section 2 under Relvar Ellipta contains lactose ) and magnesium stearate.</li></ul><p>What Relvar Ellipta looks like and contents of the pack<br/>Relvar Ellipta is an inhalation powder, pre-dispensed.<br/>The Ellipta inhaler consists of a light grey inhaler with a yellow mouthpiece cover and a dose counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant sachet, to reduce moisture in the packaging. Once you have opened the lid of the tray, throw the desiccant away do not eat or inhale it. The inhaler does not need to be stored in the foil laminate tray once it has been opened.<br/>Relvar Ellipta is available in packs of 1 inhaler containing either 14 or 30 doses (14 or 30 day supply) and in multipacks containing 90 (3 inhalers of 30) doses (90 day supply). Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder:</p><p>GlaxoSmithKline (Ireland) Limited<br/>12 Riverwalk<br/>Citywest Business Campus Dublin Ireland</p><p>Manufacturer:</p><p>Glaxo Wellcome Production Zone Industrielle No.2 23 Rue Lavoisier<br/>27000 Evreux<br/>France</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva UAB BERLIN-CHEMIE MENARINI BALTIC<br/>Tel: +370 52 691 <a href="mailto:lt@berlin-chemie.com">lt@berlin-chemie.com</a></p><ul><li>/ .<br/>E<br/>Te .: +359 2 454 <a href="mailto:0bcsofia@berlin-chemie.com">0bcsofia@berlin-chemie.com</a></li></ul><p>Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 222 001 <a href="mailto:cz.info@gsk.com">cz.info@gsk.com</a> Magyarorsz g Berlin-Chemie/A. Menarini Kft. Tel.: +36 <a href="mailto:23501bc-hu@berlin-chemie.com">23501bc-hu@berlin-chemie.com</a> Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 <a href="mailto:dk-info@gsk.com">dk-info@gsk.com</a></p><p>Malta GlaxoSmithKline (Ireland) Limited<br/>Tel: +356 80065Deutschland BERLIN-CHEMIE AG Tel: +49 (0) 30 67Nederland GlaxoSmithKline BV Tel: + 31 (0) 33 2081Eesti O Berlin-Chemie Menarini Eesti Tel: +372 667 <a href="mailto:5ee@berlin-chemie.com">5ee@berlin-chemie.com</a></p><p>Norge GlaxoSmithKline AS Tlf: + 47 22 70 20<br/>Menarini Hellas A.E. : +30 210 83161 11- sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 <a href="mailto:at.info@gsk.com">at.info@gsk.com</a></p><p>Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 <a href="mailto:es-ci@gsk.com">es-ci@gsk.com</a></p><p>Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l.: + 33 (0)1 39 17 84 <a href="mailto:diam@gsk.com">diam@gsk.com</a></p><p>Portugal GlaxoSmithKline Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 <a href="mailto:FI.PT@gsk.com">FI.PT@gsk.com</a></p><p>Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: +385 1 4821 <a href="mailto:office-croatia@berlin-chemie.com">office-croatia@berlin-chemie.com</a></p><p>Rom nia GlaxoSmithKline (Ireland) Limited<br/>Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 (0)1 300 <a href="mailto:2slovenia@berlin-chemie.com">2slovenia@berlin-chemie.com</a></p><p>sland Vistor hf. S mi: + 354 535 7Slovensk republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 <a href="mailto:slovakia@berlin-chemie.com">slovakia@berlin-chemie.com</a></p><p>Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30<br/>GlaxoSmithKline (Ireland) Limited<br/>: +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 <a href="mailto:info.produkt@gsk.com">info.produkt@gsk.com</a></p><p>Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 <a href="mailto:67103lv@berlin-chemie.com">67103lv@berlin-chemie.com</a> United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 <a href="mailto:221customercontactuk@gsk.com">221customercontactuk@gsk.com</a></p><p>This leaflet was last revised in <{MM/YYYY}></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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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mp40f1959ef0b924c372a2c6eb95894c6a"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp40f1959ef0b924c372a2c6eb95894c6a</b></p><a name="mp40f1959ef0b924c372a2c6eb95894c6a"> </a><a name="hcmp40f1959ef0b924c372a2c6eb95894c6a"> </a><a name="mp40f1959ef0b924c372a2c6eb95894c6a-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/13/886/001</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">en</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/13/886/001"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<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="Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed"/>
<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.
