Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Tiotropium; Olodaterol
Boehringer Ingelheim International GmbH
R03BB; R03BB54
Tiotropium; Olodaterol
2.5 µg/2.5 microgram(s)
Inhalation solution
Inhalation
1, 2, 3, 8 single packages, each containing 1 inhaler providing 60 puffs
Product subject to prescription which may be renewed (B)
Boehringer Ingelheim Pharma GmbH & Co. KG
Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics
Anticholinergics; Anticholinergics
It is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Not marketed
2015-06-19
R1h/IE MT/PI/2 24/05/2019 PACKAGE LEAFLET: INFORMATION FOR THE USER YANIMO RESPIMAT 2.5 MICROGRAM/2.5 MICROGRAM, INHALATION SOLUTION tiotropium/olodaterol This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - 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. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Yanimo Respimat is and what it is used for 2. What you need to know before you take Yanimo Respimat 3. How to take Yanimo Respimat 4. Possible side effects 5. How to store Yanimo Respimat 6. Contents of the pack and other information 1. WHAT YANIMO RESPIMAT IS AND WHAT IT IS USED FOR WHAT YANIMO RESPIMAT IS Yanimo Respimat contains two active substances called tiotropium and olodaterol. These belong to a group of medicines called long-acting bronchodilators. Tiotropium belongs to the subgroup of anticholinergics; olodaterol belongs to the subgroup of long acting beta 2 agonists. WHAT YANIMO RESPIMAT IS USED FOR Yanimo Respimat helps adult patients who have chronic obstructive pulmonary disease (COPD) to breathe more easily. COPD is a long-term lung disease that causes shortness of breath and coughing. The term COPD is associated with the conditions chronic bronchitis and emphysema. Yanimo Respimat helps to open your airways and make it easier to get air in and out of the lungs. Regular use of Yanimo Respimat can also help you when you have on-going shortness of breath rela Прочитать полный документ
HealthProductsRegulatoryAuthority 08July2019 CRN008LK9 Page1of16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT YanimoRespimat2.5microgram/2.5microgram,inhalationsolution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Thedelivereddoseis2.5microgramtiotropium(asbromidemonohydrate)and2.5microgramolodaterol(ashydrochloride) perpuff. Thedelivereddoseisthedosewhichisavailableforthepatientafterpassingthemouthpiece. Excipient with known effect:Thismedicinecontains0.0011mgbenzalkoniumchlorideineachactuation. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Inhalationsolution Clear,colourless,inhalationsolution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS YanimoRespimatisindicatedasamaintenancebronchodilatortreatmenttorelievesymptomsinadultpatientswithchronic obstructivepulmonarydisease(COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Themedicinalproductisintendedforinhalationuseonly.ThecartridgecanonlybeinsertedandusedintheRespimatinhaler. TwopuffsfromtheRespimatinhalercompriseonemedicinaldose. _Adults_ Therecommendeddoseis5microgramtiotropiumand5microgram olodaterolgivenastwopuffsfromtheRespimatinhaler oncedaily,atthesametimeoftheday. Therecommendeddoseshouldnotbeexceeded. _Elderly population_ ElderlypatientscanuseYanimoRespimatattherecommendeddose. _Hepatic impairment and Renal impairment_ YanimoRespimatcontainstiotropiumwhichisapredominantlyrenallyexcreteddrugandolodaterol,whichispredominantly metabolizedintheliver. _Hepatic impairment_ Patients Прочитать полный документ