Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE
Orient Europharma (M) Sdn Bhd
BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE
1units Units; 1 Units
CHIESI FARMACEUTICI SPA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ FOSTER ® NEXTHALER ® INHALATION POWDER _Beclometasone dipropionate/Formoterol Fumarate Dihydrate 100/6 mcg/dose _ 1 __________________________________________________________________________________________ WHAT IS IN THIS LEAFLET 1. What Foster ® NEXThaler ® is used for 2. How Foster ® NEXThaler ® works 3. Before you use Foster ® Nexthaler ® 4. How to use Foster ® NEXThaler ® 5. While you are using Foster ® NEXThaler ® 6. Side effects 7. Storage and Disposal of Foster ® NEXThaler ® 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FOSTER ® NEXTHALER ® IS USED FOR AND HOW IT WORKS Foster ® NEXThaler ® is a powder inhaled through your mouth and delivered deeply into your lungs, containing beclomethasone diproprionate, a glucocorticoid with anti- inflammatory action which reduces swelling and irritation in the walls of the small air passage in the lungs, and formoterol fumarate, a selective β 2 - adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airway obstruction. The combination of these active substances make breathing easier by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma and also help to prevent asthma from worsening. Foster ® NEXThaler ® is indicated in the regular treatment of patients with: _ _ - Asthma not adequately controlled with inhaled corticosteroids and “as needed” rapid-actingβ 2 - agonists or - Asthma already controlled on both inhaled corticosteroid and long acting β 2 -agonists. - Symptomatic treatment of patients with severe Chronic Obstructive Pulmonary Disease (COPD) (FEV 1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators BEFORE YOU USE FOSTER ® NEXTHALER ® _ _ _When you must not use it:_ - If you are allergic or think you are allergic to one or more of the activ Lugege kogu dokumenti
PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Foster ® NEXThaler ® 100 micrograms/6 micrograms per inhalation inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of 10 mg inhalation powder contains: 100 micrograms of beclometasone dipropionate anhydrous and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (the dose leaving the mouthpiece ) of 81.9 micrograms of beclometasone dipropionate anhydrous and 5.0 micrograms of formoterol fumarate dihydrate. Excipients with known effect: Each inhalation contains 9.9 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. The multidose inhaler contains a white or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Foster ® NEXThaler ® is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta 2 -agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta 2 -agonist or - patients already adequately controlled on both inhaled corticosteroids and long-acting beta 2 -agonists. Foster ® NEXThaler ® is indicated for adult patients. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (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 Foster ® NEXThaler ® is for inhalation use. A STHMA Foster ® NEXThaler ® is not intended for the initial management of asthma. The dosage of Foster ® NEXThaler ® is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combina Lugege kogu dokumenti