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 Brimica Genuair is and what it is used for</li><li>What you need to know before you use Brimica Genuair</li><li>How to use Brimica Genuair</li><li>Possible side effects</li><li>How to store Brimica Genuair</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What brimica is and what it is used for",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Brimica Genuair is This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of medicines called bronchodilators. Bronchodilators relax the muscles in your airways, which allows the airways to open more widely and helps you to breathe more easily. The Genuair inhaler delivers the active ingredients directly into your lungs as you breathe in.</p><p>What Brimica Genuair is used for Brimica Genuair is used for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD), in which the airways and air sacs in the lungs become damaged or blocked. By opening the airways, the medicine helps relieve symptoms such as shortness of breath. Taking Brimica Genuair regularly will reduce the effects of COPD on your everyday life.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use Brimica Genuair:</p><ul><li>if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in Section 6).</li></ul><p>Warnings and precautions Talk to your doctor, pharmacist or nurse before using Brimica Genuair, if you have any of the following conditions/symptoms:</p><ul><li>If you have asthma. This medicine should not be used for the treatment of asthma.</li><li>If you have heart problems.</li><li>If you have epilepsy.</li><li>If you have thyroid gland problems (thyrotoxicosis).</li><li>If you have a tumour in one of your adrenal glands (phaeochromocytoma).</li><li>If you have difficulty passing urine or problems due to an enlarged prostate.</li><li>If you have an eye condition called narrow angle glaucoma, which results in high pressure in the eye.</li></ul><p>Stop taking Brimica Genuair and seek medical help immediately if you experience any of the following:</p><ul><li>If you get sudden tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. See section 4. Brimica Genuair is used as a maintenance (long-term) treatment for COPD. You should not use this medicine to treat a sudden attack of breathlessness or wheezing.</li></ul><p>If your usual COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse while you are using Brimica Genuair you should continue to use it, but go to see your doctor as soon as possible because you may need another medicine.</p><p>If you see halos around lights or coloured images, have eye pain or discomfort or suffer temporary blurring of vision, go to see your doctor for advice as soon as possible.</p><p>Dry mouth has been observed with medicines like Brimica Genuair. In the long-term, dry mouth can be associated with tooth decay, so it is important to pay attention to oral hygiene.</p><p>Children and adolescents Brimica Genuair is not for use in children or adolescents below 18 years of age.</p><p>Other medicines and Brimica Genuair Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you use Brimica Genuair with some other medicines, the effect of Brimica Genuair or the other medicines may be altered.</p><p>Tell your doctor or pharmacist if you are taking:</p><ul><li>Any medicines that may be similar to Brimica Genuair to treat breathing difficulties.</li><li>Medicines that lower the amount of potassium in your blood. These include: * corticosteroids that you take by mouth (such as prednisolone), * diuretics (such as furosemide or hydrochlorothiazide), * certain medicines used to treat breathing conditions (such as theophylline).</li><li>Medicines called beta blockers that may be used to treat high blood pressure or other heart problems (such as atenolol or propranolol) or to treat glaucoma (such as timolol).</li><li>Medicines which can cause a type of change in the electrical activity of the heart known as QT interval prolongation (observed in an electrocardiogram). These include medicines for the treatment of: * depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), * bacterial infections (such as erythromycin, clarithromycin, telithromycin), * allergic reactions (anti-histamines).</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, nurse or pharmacist for advice before using this medicine. You should not use Brimica Genuair if you are pregnant or are breast-feeding unless your doctor tells you to do so.</p><p>Driving and using machines Brimica Genuair is unlikely to affect your ability to drive or use machines. In some patients, this medicine may cause blurred vision or dizziness. If you are affected by either of these side effects, do not drive or use machines until the dizziness has cleared or your vision has returned to normal.</p><p>Brimica Genuair contains lactose This medicine contains lactose. 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" : "<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><ul><li>The recommended dose is one inhalation in the morning and one inhalation in the evening.</li><li>You can use Brimica Genuair anytime before or after food or drink.</li><li>The effects of Brimica Genuair last for 12 hours; therefore, you should try to use Brimica Genuair at the same time each morning and evening as this will ensure that there is always enough medicine in your body to help you breathe more easily throughout the day and night. Taking your medicine at regular times will also help you to remember to use it.</li><li>The recommended dose can be used for elderly patients and for patients with kidney or liver problems. No dose adjustments are necessary in these patients.</li><li>Brimica Genuair is for inhalation use.</li><li>Instructions for use: Refer to the Instructions for Use at the end of this leaflet for instructions on how to use the Genuair inhaler. If you are not sure of how to use Brimica Genuair, contact your doctor or pharmacist.</li></ul><p>COPD is a long-term disease; therefore, Brimica Genuair is for long-term use. The medicine must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.</p><p>If you use more Brimica Genuair than you should If you think you may have used more Brimica Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, feeling sick, shaking/tremor, headache, palpitations or an increase in blood pressure, therefore you must immediately contact your doctor or go to the nearest emergency unit. Show the packaging of Brimica Genuair. Medical attention may be needed.</p><p>If you forget to use Brimica Genuair If you forget a dose of Brimica Genuair, just take it as soon as possible and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.</p><p>If you stop using Brimica Genuair This medicine is for long-term use. If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.</p><p>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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using the medicine and contact your doctor immediately if you:</p><ul><li><p>develop swelling of the face, throat, lips or tongue (with or without difficulty breathing or swallowing), severe itchy bumps on the skin (hives) as these may be symptoms of an allergic reaction. Frequency of this reactin cannot be estimated from the available data.</p></li><li><p>develop tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called paradoxical bronchospasm , which is an excessive and prolonged contraction of the airway muscles immediately following treatment with a bronchodilator. This reaction may rarely occur (may affect up to 1 in 1,000 people).<br/>Some side effects may be serious: if you get any of these side effects, tell your doctor immediately.</p></li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>Muscle weakness, twitching and/or abnormal heart rhythm, as these may be signs of a decrease in the amount of potassium in your blood</li><li>Tiredness, increased thirst and/or a need to pass urine more frequently than usual, as these may be signs of an increase in the amount of sugar in your blood</li><li>Palpitations, as these may be a sign of an unusually fast heart beat or an abnormal heart rhythm</li></ul><p>Rare (may affect up to 1 in 1,000 people)</p><ul><li>Sudden difficulty in breathing or swallowing, swelling of the tongue, throat, lips or face, skin rash and/or itching - these may be signs of an allergic reaction</li></ul><p>Other side effects which may occur while using Brimica Genuair:</p><p>Common (may affect up to 1 in 10 people)</p><ul><li>Combination of sore throat and runny nose these may be signs of nasopharyngitis</li><li>Headache</li><li>Painful and/or frequent urination these may be signs of a urinary tract infection</li><li>Cough</li><li>Diarrhoea</li><li>A blocked, runny or stuffy nose and/or pain or a feeling of pressure in the cheeks or forehead<br/>these may be symptoms of sinusitis</li><li>Dizziness</li><li>Muscle cramps</li><li>Nausea (feeling sick)</li><li>Difficulty sleeping</li><li>Dry mouth</li><li>Muscle pain</li><li>Abscess (infection) in the tissues at the base of a tooth</li><li>Increased blood levels of a protein found in muscle called creatine phosphokinase</li><li>Shaking/tremor</li><li>Anxiety</li></ul><p>Uncommon</p><ul><li>Fast heart beat (tachycardia)</li><li>Chest pain or tightness in the chest (angina pectoris)</li><li>Blurred vision</li><li>Changes in the sound of the voice (dysphonia)</li><li>Difficulty passing urine or a feeling that your bladder has not completely emptied (urinary retention)</li><li>An abnormal heart trace (QT interval prolongation) potentially leading to an abnormal heart rhythm</li><li>Distorted sense of taste (dysgeusia)</li><li>Throat irritation</li><li>Inflammation of the mouth (stomatitis)</li><li>Increased blood pressure</li><li>Agitation</li><li>Rash</li><li>Itching of the skin</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" : "<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 inhaler label, carton and inhaler bag after EXP . The expiry date refers to the last day of that month.</p><p>This medicine does not require any special temperature storage conditions.</p><p>Keep the Genuair inhaler protected inside the sealed bag until the administration period starts.</p><p>To be used within 60 days of opening the bag.</p><p>Do not use Brimica Genuair if you notice that the pack is damaged or shows signs of tampering.</p><p>After you have taken the last dose, the inhaler has to be disposed of. Do not throw away any medicines via 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 Brimica Genuair contains</p><ul><li>The active substances are aclidinium and formoterol fumarate dihydrate. Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms aclidinium bromide equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.</li><li>The other ingredient is lactose monohydrate (see end of section 2 under Brimica Genuair contains lactose for more information).</li></ul><p>What Brimica Genuair looks like and contents of the pack Brimica Genuair is a white or almost white inhalation powder. The Genuair inhaler is a white device fitted with an integral dose indicator and an orange dosage button. The mouthpiece is covered with a removable orange protective cap. It is supplied in a sealed protective aluminium bag containing a desiccant sachet. After removing the inhaler from the bag, the bag and desiccant sachet should be thrown away.</p><p>Pack sizes supplied:</p><p>Carton containing 1 inhaler with 30 doses. Carton containing 1 inhaler with 60 doses. Carton containing 3 inhalers each with 60 doses.</p><p>Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder<br/>Covis Pharma Europe B.V.<br/>Gustav Mahlerplein 2 1082MA Amsterdam The Netherlands Manufacturer: Industrias Farmac uticas Almirall, S.A. Ctra. de Martorell 41-08740 Sant Andreu de la Barca, Barcelona Spain</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien<br/>Covis Pharma Europe B.V. T l/Tel: 80013Lietuva<br/>UAB BERLIN CHEMIE MENARINI BALTIC<br/>Tel: +370 52 691</p><ul><li>/ . E<br/>.: +359 2 454 09 Luxembourg/Luxemburg<br/>Covis Pharma Europe B.V. T l/Tel: 80024 esk republika<br/>Berlin-Chemie/A.Menarini Ceska republika s.r.o.<br/>Tel: +420 267 199 Magyarorsz g<br/>Berlin-Chemie/A. Menarini Kft.<br/>Tel.: +36 1799 7Danmark<br/>Covis Pharma Europe B.V. Tlf: 80711Malta<br/>Covis Pharma Europe B.V. Tel: 80065Deutschland<br/>Berlin-Chemie AG<br/>Tel: +49 (0) 30 67Covis Pharma Europe B.V. Tel: +49 (0) 3031196Nederland<br/>Covis Pharma Europe B.V.<br/>Tel: 08000270Eesti<br/>O Berlin-Chemie Menarini Eesti<br/>Tel: +372 667 5Norge<br/>Covis Pharma Europe B.V.<br/>Tlf: 80031<br/>MENARINI HELLAS AE<br/>: +30 210 8316111- sterreich<br/>A. Menarini Pharma GmbH Tel: +43 1 879 95 85-0</li></ul><p>Espa a<br/>Laboratorios Menarini S.A.<br/>Tel: +34-93 462 88 Polska<br/>Covis Pharma Europe B.V.<br/>Tel.: 0800919France<br/>MENARINI France<br/>T l: +33 (0)1 45 60 77 Portugal<br/>A. Menarini Portugal Farmac utica, S.A.<br/>Tel: +351 210 935 Hrvatska<br/>Berlin-Chemie Menarini Hrvatska d.o.o.<br/>Tel: + 385 1 4821 Rom nia<br/>Berlin-Chemie A.Menarini S.R.L.<br/>Tel: +40 21 232 34 Ireland<br/>A. Menarini Pharmaceuticals Ireland Ltd<br/>Tel: +353 1 284 6Slovenija<br/>Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2 sland<br/>Covis Pharma Europe B.V.<br/>S mi: 8007Slovensk republika<br/>Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 Italia<br/>Laboratori Guidotti S.p.A.<br/>Tel: +39- 050 971Suomi/Finland<br/>Covis Pharma Europe B.V. Puh/Tel: 0800413<br/>Covis Pharma Europe B.V. : 80091Sverige<br/>Covis Pharma Europe B.V. Tel: 0200898Latvija<br/>SIA Berlin-Chemie/Menarini Baltic<br/>Tel: +371 67103United Kingdom (Northern Ireland) Covis Pharma Europe B.V. Tel: 08004334This 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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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp17d853b2dfc7ae029cc7841c683817ea\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp17d853b2dfc7ae029cc7841c683817ea</b></p><a name=\"mp17d853b2dfc7ae029cc7841c683817ea\"> </a><a name=\"hcmp17d853b2dfc7ae029cc7841c683817ea\"> </a><a name=\"mp17d853b2dfc7ae029cc7841c683817ea-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/14/963/001</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>: Brimica Genuair 340 micrograms /12 micrograms inhalation powder</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>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/identifier",
"value" : "EU/1/14/963/001"
}
],
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-type",
"code" : "MedicinalProduct",
"display" : "Medicinal Product"
}
]
},
"domain" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-domain",
"code" : "Human",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/publication-status",
"code" : "active",
"display" : "active"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/rmswi",
"code" : "100000072084",
"display" : "Medicinal product subject to medical prescription"
}
]
},
"name" : [
{
"productName" : "Brimica Genuair 340 micrograms /12 micrograms inhalation powder",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000001",
"display" : "Full name"
}
]
},
"part" : [
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000005",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "en",
"display" : "en"
}
]
}
}
]
}
]
}
}
]
}
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.
