Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
Glycopyrronium bromide
Novartis Europharm Ltd
R03BB06
glycopyrronium bromide
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Revision: 10
Authorised
2012-09-28
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER ENUREV BREEZHALER 44 MICROGRAMS INHALATION POWDER, HARD CAPSULES glycopyrronium (as glycopyrronium bromide) 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 Enurev Breezhaler is and what it is used for 2. What you need to know before you use Enurev Breezhaler 3. How to use Enurev Breezhaler 4. Possible side effects 5. How to store Enurev Breezhaler 6. Contents of the pack and other information 1. WHAT ENUREV BREEZHALER IS AND WHAT IT IS USED FOR WHAT ENUREV BREEZHALER IS This medicine contains an active substance called glycopyrronium bromide. This belongs to a group of medicines called bronchodilators. WHAT ENUREV 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 the lungs, making it easier for air to get in and out of the lungs. If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life. 34 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ENUREV BREEZHALER DO NOT USE ENUREV BREEZHALER - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Enurev Breezhaler, if any of the following appl সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Enurev Breezhaler 44 micrograms inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium. Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule (inhalation powder). Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( ) printed in black below a black bar. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enurev 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 Enurev Breezhaler inhaler. Enurev Breezhaler is recommended to be administered, at the same time of the day each day. If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day. Special populations _Elderly population _ Enurev Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8). _ _ _Renal impairment _ Enurev Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis Enurev Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and সম্পূর্ণ নথি পড়ুন