Country: Հայաստան
language: անգլերեն
source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
indacaterol (indacaterol maleate)
Novartis Farmaceutica S.A.
R03AC18
indacaterol (indacaterol maleate)
300mcg
powder for inhalation, hard capsules
(10/1x10/) in blister and inhaler, (30/3x10/) in blister and inhaler
Prescription
Registered
2016-12-19
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ONBREZ BREEZHALER 150 MICROGRAM INHALATION POWDER, HARD CAPSULES ONBREZ BREEZHALER 300 MICROGRAM INHALATION POWDER, HARD CAPSULES Indacaterol 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 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 Onbrez Breezhaler is and what it is used for 2. What you need to know before you use Onbrez Breezhaler 3. How to use Onbrez Breezhaler 4. Possible side effects 5. How to store Onbrez Breezhaler 6. Contents of the pack and other information 1. WHAT ONBREZ BREEZHALER IS AND WHAT IT IS USED FOR WHAT ONBREZ BREEZHALER IS Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators. When you inhale it, it relaxes the muscles in the walls of the small air passages in the lungs. This helps open up the airways, making it easier to get air in and out. WHAT ONBREZ BREEZHALER IS USED FOR Onbrez Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD the muscles around the airways tighten. This makes breathing difficult. This medicine relaxes these muscles in the lungs, making it easier for air to get in and out of the lungs. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ONBREZ BREEZHALER DO NOT USE ONBREZ BREEZHALER - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Onbrez Breezha read_full_document
1. NAME OF THE MEDICINAL PRODUCT Onbrez Breezhaler 300 microgram inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol. The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 240 microgram indacaterol. Excipient with known effect Each capsule contains 24.6 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule Transparent (uncoloured) capsules containing a white powder, with “IDL 300” printed in blue above a blue bar and company logo ( ) printed in blue below the blue bar. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler. The dose should only be increased on medical advice. The inhalation of the content of one 300 microgram capsule once a day, using the Onbrez Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD. The maximum dose is 300 microgram once daily. Onbrez Breezhaler should be administered at the same time of the day each day. If a dose is missed the next dose should be taken at the usual time the next day. _Special populations _ _Elderly population_ Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients. _Hepatic impairment _ No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment. _Renal impairment _ No dose adjustment is required for patients with renal imp read_full_document