מדינה: האיחוד האירופי
שפה: אנגלית
מקור: myHealthbox
Indacaterol, glycopyrronium bromide
Novartis Europharm Limited
R03AL04
Indacaterol, glycopyrronium bromide
110 microgram indacaterol and 50 microgram glycopyrronium
Inhalation powder, hard capsule
Inhalation use
6,12 or 30 capsules + 1 inhaler, 90 capsules and 3 inhalers, 96 capsules and 4 inhalers, 150 capsules and 25 inhalers
Subject to medical prescription
Novartis Pharma GmbH
Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics
Pulmonary Disease, Chronic Obstructive
Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
Authorized
2013-11-19
36 PACKAGE LEAFLET: INFORMATION FOR THE USER ULTIBRO BREEZHALER 85 MICROGRAMS/43 MICROGRAMS INHALATION POWDER, HARD CAPSULES Indacaterol/glycopyrronium 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 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 Ultibro Breezhaler is and what it is used for 2. What you need to know before you use Ultibro Breezhaler 3. How to use Ultibro Breezhaler 4. Possible side effects 5. How to store Ultibro Breezhaler 6. Contents of the pack and other information 1. WHAT ULTIBRO BREEZHALER IS AND WHAT IT IS USED FOR WHAT ULTIBRO BREEZHALER IS This medicine contains two active substances called indacaterol and glycopyrronium. These belong to a group of medicines called bronchodilators. WHAT ULTIBRO BREEZHALER IS USED FOR This medicine 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 blocks the tightening of these muscles in קרא את המסמך השלם
2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Ultibro Breezhaler 85 micrograms/43 micrograms, inhalation powder hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 143 µg of indacaterol maleate equivalent to 110 µg of indacaterol and 63 µg of glycopyrronium bromide equivalent to 50 µg of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 110 µg of indacaterol maleate equivalent to 85 µg of indacaterol and 54 µg of glycopyrronium bromide equivalent to 43 µg of glycopyrronium. Excipient(s) with known effect: Each capsule contains 23.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule Capsules with transparent yellow cap and natural transparent body containing a white to almost white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms 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 capsule once daily using the Ultibro Breezhaler inhaler. Ultibro Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should קרא את המסמך השלם