Страна: Европейский союз
Язык: английский
Источник: EMA (European Medicines Agency)
Budesonide, formoterol fumarate dihydrate, Glycopyrronium bromide
AstraZeneca AB
R03AL11
formoterol fumarate dihydrate, glycopyrronium, budesonide
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2 agonist or combination of a long-acting beta2 agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1).
Revision: 3
Authorised
2022-01-06
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RILTRAVA AEROSPHERE 5 MICROGRAMS/7.2 MICROGRAMS/160 MICROGRAMS, PRESSURISED INHALATION, SUSPENSION formoterol fumarate dihydrate/glycopyrronium/budesonide 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 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 Riltrava Aerosphere is and what it is used for 2. What you need to know before you use Riltrava Aerosphere 3. How to use Riltrava Aerosphere 4. Possible side effects 5. How to store Riltrava Aerosphere 6. Contents of the pack and other information Instructions for use 1. WHAT RILTRAVA AEROSPHERE IS AND WHAT IT IS USED FOR Riltrava Aerosphere contains three active substances: formoterol fumarate dihydrate, glycopyrronium, and budesonide. Formoterol fumarate dihydrate and glycopyrronium belong to a group of medicines called ‘bronchodilators’. They work in different ways to prevent tightening of the muscles around the airways, making it easier for air to get in and out of the lungs. Budesonide belongs to a group of medicines called ‘corticosteroids’. These work by reducing inflammation in your lungs. Riltrava Aerosphere is an inhaler that is used for adults with a lung disease called ‘chronic obstructive pulmonary disease’ (or ‘COPD’), a long-term disease of the airways in the lungs. Riltrava Aerosphere is used to make breathing easier and improve symptoms of COPD such as shortness of breath, wheezing and cough. Riltrava Aerosphere can also prevent flare-ups (exacerbations) of COPD. Riltrava Aerosphe Прочитать полный документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Riltrava Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation (delivered dose, ex-actuator) contains 5 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9 micrograms, equivalent to 7.2 micrograms of glycopyrronium, and budesonide 160 micrograms. This corresponds to a metered dose of 5.3 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 9.6 micrograms, equivalent to 7.7 micrograms of glycopyrronium, and budesonide 170 micrograms. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension. White suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Riltrava Aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended and maximum dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening). If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose. Special populations _Elderly_ No dose adjustments are required in elderly patients (see section 5.2). _Renal impairment_ This medicinal product can be used at the recommended dose in patients with mild to moderate renal impairment. It can also be used at the recommended dose in patients with severe renal impairment or 3 end-stage renal disease requiring dialysis, only if the expected benefit outweighs the potential risk (see Прочитать полный документ