Ülke: Ermenistan
Dil: İngilizce
Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
indacaterol (indacaterol acetate), mometasone fuorat
Siegfried Barbera S.L.
R03AK14
indacaterol (indacaterol acetate), mometasone fuorat
150mcg+ 320mcg
inhalation powder, capsules hard
(30/3x10/) in blister and inhaler
Prescription
Registered
2022-06-10
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATECTURA BREEZHALER 150 MICROGRAMS/320 MICROGRAMS INHALATION POWDER, HARD CAPSULES indacaterol/mometasone furoate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Atectura Breezhaler is and what it is used for 2. What you need to know before you use Atectura Breezhaler 3. How to use Atectura Breezhaler 4. Possible side effects 5. How to store Atectura Breezhaler 6. Contents of the pack and other information Instructions for use of Atectura Breezhaler inhaler 1. WHAT ATECTURA BREEZHALER_ _IS AND WHAT IT IS USED FOR WHAT ATECTURA BREEZHALER_ _IS AND HOW IT WORKS Atectura Breezhaler _ _ contains two active substances called indacaterol and mometasone furoate. 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. 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. 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). Asthma is a serious, long-term lung disease where the muscles surroun Belgenin tamamını okuyun
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Atectura Breezhaler 150 micrograms/320 micrograms inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atectura Breezhaler 150 micrograms/320 micrograms inhalation powder, hard capsules Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg of mometasone furoate. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 260 mcg of mometasone furoate. Excipient(s) with known effect Each capsule contains approximately 25 mg of lactose monohydrate/ lactose hydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 150 micrograms/320 micrograms inhalation powder, hard capsules Transparent (uncoloured) capsules containing a white powder, with the product code “IM150-320” printed in black above two black bars on the body and with the product logo printed in black and surrounded by two black bars on the cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short-acting beta 2 -agonists. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents aged 12 years and over_ The recommended dose is one capsule to be inhaled once daily. Patients should be given the strength containing the appropriate mometasone furoate dosage for the severity of their disease and should be regularly reassessed by a healthcare professional. The maximum recommended dose is 125 mcg/260 mcg once daily. Treatment should be administered at the same time of the day each day. It can be administered irrespective of the time of the day. If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day. 3 _Special pop Belgenin tamamını okuyun