国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Beclometasone dipropionate
Chiesi Farmaceutici S.p.A.
R03BA; R03BA01
Beclometasone dipropionate
400 millilitre(s)
Nebuliser suspension
Product subject to prescription which may be renewed (B)
Glucocorticoids; beclometasone
Not marketed
2005-03-18
1 Leaflet V(1.1) 01.2018 – Beclospin -400 B. PACKAGE LEAFLET 2 Leaflet V(1.1) 01.2018 – Beclospin -400 PACKAGE LEAFLET: INFORMATION FOR THE USER BECLOSPIN 400 MICROGRAMS NEBULISER SUSPENSION BECLOMETASONE DIPROPIONATE 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. IN THIS LEAFLET: 1. What Beclospin is and what it is used for 2. What you need to know before you use Beclospin 3. How to use Beclospin 4. Possible side effects 5. How to store Beclospin 6. Contents of the pack and other information 1. WHAT BECLOSPIN IS AND WHAT IT IS USED FOR Beclospin contains the active substance beclometasone dipropionate. It belongs to a group of medicines called corticosteroids which have an anti-inflammatory action reducing the swelling and irritation in the walls of the airways (e.g. nose, lungs), and so ease breathing problems. Beclospin is indicated to treat asthma in adults and children up to 18 years of age when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate. Beclospin is also indicated to treat recurrent wheezing in children up to 5 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BECLOSPIN DO NOT USE BECLOSPIN: If you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6. WARNINGS AND PRECAUTIONS Talk to you doctor or pharmacist before using Beclospin if any of the following applies to you: You are being, or have ever been, treated for tuberculosis (TB). Your condition seems to be getting worse. Perhaps you are more wheezy and shor 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beclospin 400 micrograms/1 ml nebuliser suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml single dose unit contains 400 micrograms beclometasone dipropionate anhydrous. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser suspension. A white or almost white suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BECLOSPIN ® is indicated for the: maintenance treatment of asthma, when the use of pressurised metered dose or dry powder inhalers is unsatisfactory or inappropriate, in adults and children up to 18 years of age; treatment of recurrent wheezing in children up to 5 years of age (see sections 4.2 and 4.4 paediatric population). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The starting dose of nebulised beclometasone dipropionate should take into account the frequency and severity of symptoms. The recommended initial doses are: Adults and adolescents (from 12 years of age) : 800-1,600 micrograms twice daily (total daily dose: 1600 – 3200 micrograms) Children (up 11 years of age): 400-800 micrograms twice daily (total daily dose: 800 – 1600 micrograms) Normally, a daily dose of 3200 micrograms in adults and adolescents and 1600 micrograms in children up to 11 years of age should not be exceeded. After improvement of control of asthma or wheezing, the total daily dose should be reduced to the lowest effective dose and a once daily dosing can be applied. In patients with asthma, BECLOSPIN ® must be used regularly on a daily basis; the duration of treatment should be defined on the basis of symptoms. In children with recurrent wheezing, if no treatment benefit of is observed within 2-3 months, BECLOSPIN ® should be discontinued. In addition, the duration of treatment of recurrent wheezing should not exceed 3 months, unless diagnosis of asthma is likely to avoid an unnecessary long-term exposure (see section 4.4). Method of administration H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O 阅读完整的文件