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>Instructions for use of Atectura Breezhaler inhaler</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet:</p><ol type="1"><li>What Atectura Breezhaler is and what it is used for</li><li>What you need to know before you use Atectura Breezhaler</li><li>How to use Atectura Breezhaler</li><li>Possible side effects</li><li>How to store Atectura Breezhaler</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 Atectura Breezhaler is and how it works Atectura Breezhaler contains two active substances called indacaterol and mometasone furoate.</p><p>Indacaterol belongs to a group of medicines called bronchodilators. It relaxes the muscles of the small airways 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 airways to remain open.</p><p>Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation (inflammation) in the small airways in the lungs and so gradually ease breathing problems. Corticosteroids also help to prevent attacks of asthma.</p><p>What Atectura Breezhaler is used for Atectura Breezhaler is used regularly as treatment for asthma in adults and adolescents (12 years of age and older).</p><p>Asthma is a serious, long-term lung disease where the muscles surrounding the smaller airways become tight (bronchoconstriction) and inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough.</p><p>You should use Atectura Breezhaler every day and not only when you have breathing problems or other symptoms of asthma. This will ensure that it controls your asthma properly. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.</p><p>If you have any questions about how Atectura Breezhaler works or why this medicine has been prescribed for you, ask your doctor.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Follow all the doctor s instructions carefully.</p><p>Do not use Atectura Breezhaler</p><ul><li>if you are allergic to indacaterol, mometasone furoate or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.</li></ul><p>Warnings and precautions Talk to your doctor, pharmacist or nurse before using Atectura Breezhaler if any of the following applies to you:</p><ul><li>if you have heart problems, including an irregular or fast heartbeat.</li><li>if you have thyroid gland problems.</li><li>if you have ever been told you have diabetes or high blood sugar.</li><li>if you suffer from seizures or fits.</li><li>if you have a low level of potassium in your blood.</li><li>if you have severe liver problems.</li><li>if you have tuberculosis (TB) of the lung, or any long-standing or untreated infections.</li></ul><p>During treatment with Atectura Breezhaler Stop using this medicine and get medical help immediately if you have any of the following:</p><ul><li>tightness of the chest, coughing, wheezing or breathlessness immediately after using Atectura Breezhaler (signs the medicine is unexpectedly tightening the airways, known as paradoxical bronchospasm).</li><li>difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction).</li></ul><p>Children and adolescents Do not give this medicine to children below 12 years of age because it has not been studied in this age group.</p><p>Other medicines and Atectura Breezhaler Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, tell your doctor or pharmacist if you are using:</p><ul><li>medicines that decrease the level of potassium in your blood. These include diuretics (which increase urine production and can be used to treat high blood pressure, e.g. hydrochlorothiazide), other bronchodilators such as methylxanthines used for breathing problems (e.g. theophylline) or corticosteroids (e.g. prednisolone).</li><li>tricyclic antidepressants or monoamine oxidase inhibitors (medicines used in the treatment of depression).</li><li>any medicines that may be similar to Atectura Breezhaler (contain similar active substances); using them together may increase the risk of possible side effects.</li><li>medicines called beta blockers used to treat high blood pressure or other heart problems (e.g. propranolol) or to treat glaucoma (e.g. timolol).</li><li>ketoconazole or itraconazole (medicines used to treat fungal infections)</li><li>ritonavir, nelfinavir or cobicistat (medicines used to treat HIV infection).</li></ul><p>Pregnancy and breast-feeding 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. Your doctor will discuss with you whether you can use Atectura Breezhaler.</p><p>Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines.</p><p>Atectura Breezhaler contains lactose This medicine contains about 25 mg of lactose per capsule. If you have been told by your doctor that you have an intolerance to some sugars, speak with your doctor before taking 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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.</p><p>How much Atectura Breezhaler to inhale There are three different strengths of Atectura Breezhaler capsules. Your doctor will decide which is best for you.</p><p>The usual dose is to inhale the content of one capsule each day. You only need to use the medicine once a day. Do not use more than your doctor tells you to use.</p><p>You should use Atectura Breezhaler every day, even when your asthma is not troubling you.</p><p>When to inhale Atectura Breezhaler Inhale Atectura Breezhaler at the same time each day. This will help control your symptoms throughout the day and night. It will also help you to remember to use it.</p><p>How to inhale Atectura Breezhaler</p><ul><li>Atectura Breezhaler is for inhalation use.</li><li>In this pack, you will find an inhaler and capsules that contain the medicine. The inhaler enables you to inhale the medicine in the capsule. Only use the capsules with the inhaler provided in this pack. The capsules should remain in the blister until you need to use them.</li><li>Peel the backing away from the blister to open it, do not push the capsule through the foil.</li><li>When you start a new pack, use the new inhaler supplied in this new pack.</li><li>Dispose of the inhaler in each pack after all capsules in that pack have been used.</li><li>Do not swallow the capsules.</li><li>Please read the instructions for use on the other side of this leaflet for more information on how to use the inhaler.</li></ul><p>If your pack contains a sensor for Atectura Breezhaler</p><ul><li>The sensor for Atectura Breezhaler is for adult use only. It should not be used in adolescents (12 years of age and older) as the App does not have patient consent verification or caregiver account functionality.</li><li>The sensor and App are not required in order for you to take your medicine. The sensor does not need to be connected to the App when taking your medicine.</li><li>Your doctor will decide whether use of the sensor and App is appropriate for you.</li><li>The electronic sensor for Atectura Breezhaler is to be attached to the base of the Atectura Breezhaler inhaler.</li><li>The sensor confirms that you have used the Atectura Breezhaler inhaler by recording and monitoring its actuations and the whirring noise of the spinning capsule during inhalation but it will not monitor whether you have received the dose of your medicine.</li><li>The sensor is to be used with the Propeller App on your smart phone or another suitable device. The sensor links with the Propeller App via Bluetooth.</li><li>Please read the instructions for use provided in the sensor pack and the App for more information on how to use the sensor for Atectura Breezhaler and the App.</li><li>After all Atectura Breezhaler capsules in a pack have been used, move the sensor to the new inhaler in the next Atectura Breezhaler pack.</li></ul><p>If your symptoms do not improve If your asthma is not getting better or if it gets worse after you have started using Atectura Breezhaler, talk to your doctor. If you use more Atectura Breezhaler than you should If you accidently inhale too much of this medicine, contact your doctor or hospital for advice immediately. You may need medical attention.</p><p>If you forget to use Atectura Breezhaler If you forget to inhale a dose at the usual time, inhale one as soon as possible on that day. Then inhale the next dose at the usual time on the next day. Do not inhale two doses on the same day.</p><p>If you stop using Atectura Breezhaler Do not stop using Atectura Breezhaler unless your doctor tells you to. Your asthma symptoms may come back if you stop using it.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist.</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>Some side effects could be serious Stop using Atectura Breezhaler and get medical help immediately if you have any of the following:</p><p>Common: may affect up to 1 in every 10 people</p><ul><li>difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching and hives (signs of allergic reaction).</li></ul><p>Uncommon: may affect up to 1 in every 100 people</p><ul><li>swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).</li></ul><p>Other side effects Other side effects include the following listed below. If these side effects become severe, please tell your doctor, pharmacist or nurse.</p><p>Very common: may affect more than 1 in 10 people</p><ul><li>sore throat</li><li>runny nose</li><li>sudden difficulty breathing and feeling of tightness in chest with wheezing or coughing</li></ul><p>Common: may affect up to 1 in every 10 people</p><ul><li>voice alteration (hoarseness)</li><li>blocked nose</li><li>sneezing, cough</li><li>headache</li><li>pain in muscles, bones or joints (signs of musculoskeletal pain)</li></ul><p>Uncommon: may affect up to 1 in every 100 people</p><ul><li>fast heart beat</li><li>oral thrush (sign of candidiasis)</li><li>high level of sugar in the blood</li><li>muscle spasm</li><li>skin itching</li><li>rash</li><li>clouding of the lens of your eyes (signs of cataract)</li><li>blurred vision</li></ul><p>Reporting of side effects 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 carton and blister after EXP . The expiry date refers to the last day of that month.</li><li>Do not store above 30 C.</li><li>Store the capsules in the original blister in order to protect from light and moisture, and do not remove until immediately before use.</li><li>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.</li><li>If your pack contains an electronic sensor for Atectura Breezhaler, see the Instructions for Use provided in the sensor pack for detailed instructions on how to store and when to discard it.</li></ul></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Atectura Breezhaler contains</p><ul><li>The active substances are indacaterol (as acetate) and mometasone furoate.</li></ul><p>Atectura Breezhaler 125 micrograms/62.5 micrograms Each capsule contains 173 micrograms of indacaterol acetate (equivalent to 150 micrograms of indacaterol) and 80 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol and 62.5 micrograms of mometasone furoate.</p><p>Atectura Breezhaler 125 micrograms/127.5 micrograms Each capsule contains 173 micrograms of indacaterol acetate (equivalent to 150 micrograms of indacaterol) and 160 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol and 127.5 micrograms of mometasone furoate.</p><p>Atectura Breezhaler 125 micrograms/260 micrograms Each capsule contains 173 micrograms of indacaterol acetate (equivalent to 150 micrograms of indacaterol) and 320 micrograms of mometasone furoate. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol and 260 micrograms of mometasone furoate.</p><ul><li>The other ingredient is lactose monohydrate (see Atectura Breezhaler contains lactose in section 2).</li></ul><p>What Atectura Breezhaler looks like and content of the pack In this pack, you will find an inhaler together with capsules in blisters. Some packs also contain a sensor device. The capsules are transparent and contain a white powder.</p><ul><li>Atectura Breezhaler 125 micrograms/62.5 micrograms capsules have a blue product code IM150-80 printed above one blue bar on the body with a logo printed in blue and surrounded by two blue bars on the cap.</li><li>Atectura Breezhaler 125 micrograms/127.5 micrograms capsules have a grey product code IM150-160 printed on the body with a logo printed in grey on the cap.</li><li>Atectura Breezhaler 125 micrograms/260 micrograms capsules have a black product code IM150-320 printed above two black bars on the body with a logo printed in black and surrounded by two black bars on the cap.</li></ul><p>The following pack sizes are available: Single pack containing 10 x 1 or 30 x 1 hard capsules, together with 1 inhaler. Pack containing 30 x 1 hard capsules, together with 1 inhaler and 1 sensor. Multipacks comprising 3 cartons, each containing 30 x 1 hard capsules together with 1 inhaler. Multipacks comprising 15 cartons, each containing 10 x 1 hard capsules together with 1 inhaler.</p><p>Not all pack sizes may be available in your country.</p><p>Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland</p><p>Manufacturer Novartis Farmac utica, S.A. Gran Via de les Corts Catalanes, 08013 Barcelona Spain</p><p>Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16<br/>Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0</p><p>Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20<br/>Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Laboratorios Menarini, S.A. Tel: +34 93 462 88 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133<br/>Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in</p><p>Other sources of information 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_mp888f93180b4dbc4cf7451a0e821152da"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp888f93180b4dbc4cf7451a0e821152da</b></p><a name="mp888f93180b4dbc4cf7451a0e821152da"> </a><a name="hcmp888f93180b4dbc4cf7451a0e821152da"> </a><a name="mp888f93180b4dbc4cf7451a0e821152da-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/20/1439/001-004</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>: Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules</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/1/20/1439/001-004"/>
</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="Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules"/>
<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.
