Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Budesonide, formoterol fumarate dihydrate
Teva Pharma B.V.
R03AK07
budesonide, formoterol
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive; Asthma
Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Revision: 2
Withdrawn
2014-11-19
43 B. PACKAGE LEAFLET Medicinal product no longer authorised 44 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUDESONIDE/FORMOTEROL TEVA 160 MICROGRAMS/4.5 MICROGRAMS, INHALATION POWDER (budesonide/formoterol fumarate dihydrate) 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 Budesonide/Formoterol Teva is and what it is used for (page 3) 2. What you need to know before you use Budesonide/Formoterol Teva (page 5) 3. How to use Budesonide/Formoterol Teva (page 9) 4. Possible side effects (page 18) 5. How to store Budesonide/Formoterol Teva (page 21) 6. Contents of the pack and other information (page 22) 1. WHAT BUDESONIDE/FORMOTEROL TEVA IS AND WHAT IT IS USED FOR Budesonide/Formoterol Teva contains two different active substances: budesonide and formoterol fumarate dihydrate. Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily. Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β 2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily. BUDESONIDE/FORMOTEROL TEVA IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND OLDER ONLY. BUDESONIDE/FORMOTEROL TEVA IS NOT INDICATED FOR USE IN CHILDREN 12 YEARS OF AGE AND YOUNGER OR ADOLESCENTS 13 TO 17 YEARS OF AGE. Your doctor has Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Budesonide/Formoterol Teva 160 micrograms / 4.5 micrograms inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate. Excipient(s) with known effect: Each dose contains approximately 5 milligrams of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White powder. White inhaler with a semi-transparent wine red mouthpiece cover. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only. Asthma _ _ Budesonide/Formoterol Teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β 2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β 2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β 2 adrenoceptor agonists. COPD _ _ Symptomatic treatment of patients with severe COPD (FEV 1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Budesonide/Formoterol Teva is indicated in adults 18 years of age and older only. Budesonide/Formoterol Teva is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. Medicinal product no longer authorised 3 Posology _Asthma _ _ _ Budesonide/Formoterol Teva is not intended for the initial management of asthma. Budesonide/Formoterol Teva is not an Přečtěte si celý dokument