国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate
Chiesi Limited
R03AK; R03AK08
Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate
200/6 Mcg/Acutuation
Pressurised inhalation, solution
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and beclometasone
Not marketed
2018-04-13
C ONFIDENTIAL Chiesi Farmaceutici S.p.A. Parma-Italy 1.3.1 PL 0871-0874 (V 5.0) 2017-06 BDP+FORMOTEROL 200/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION 1 PACKAGE LEAFLET: INFORMATION FOR THE USER {TRADE NAME} 200/6 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION For use in adults Beclometasone dipropionate/ formoterol fumarate dihydrate _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CON- TAINS 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 with 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 {Trade name} is and what it is used for 2. What you need to know before you use {Trade name} 3. How to use {Trade name} 4. Possible side effects 5. How to store {Trade name} 6. Contents of the pack and other information 1. WHAT {TRADE NAME} IS AND WHAT IT IS USED FOR {Trade name} is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs. The two active substances are: Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids that have an anti-inflammatory action reducing the swelling and irritation in your lungs. Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators that relax the muscles in your airways and helps you to breathe more easily. These two active substances make breathing easier. They also help to prevent asthma symptoms such as shortness of breath, wheezing and coughing. {TRADE NAME} IS USED TO TREAT ASTHMA IN ADULTS._ _ If you are prescribed {Trade name} it is likely that either:_ _ your a 阅读完整的文件
Health Products Regulatory Authority 29 January 2019 CRN008LSK Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex-valve) contains: 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation solution. The canister contains a colourless to yellowish solution. The canisters are fitted into a plastic actuator incorporating a mouthpiece and fitted with dust cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fostair 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 rapid-acting beta 2 -agonist or -patients already adequately controlled on both inhaled corticosteroids and long-acting beta 2 -agonists. Fostair is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY FOSTAIR is not intended for the initial management of asthma. The dosage of the components of Fostair 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 combination inhaler, appropriate doses of beta 2 -agonists and/or corticosteroids by individual inhalers should be prescribed. Health Products Regulatory Authority 29 January 2019 CRN008LSK Page 2 of 19 Beclometasone dipropionate in Fostair is characterised by an extrafine particle size distribution which re 阅读完整的文件