국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Beclometasone dipropionate
Chiesi Farmaceutici S.p.A.
R03BA; R03BA01
Beclometasone dipropionate
250 microgram(s)
Pressurised inhalation, solution
Glucocorticoids; beclometasone
Not marketed
2005-09-30
PACKAGE LEAFLET: INFORMATION FOR USER CLENIL® MODULITE® 50 micrograms per metered dose pressurised inhalation solution CLENIL® MODULITE® 100 micrograms per metered dose pressurised inhalation solution CLENIL® MODULITE® 200 micrograms per metered dose pressurised inhalation solution CLENIL® MODULITE® 250 micrograms per metered dose pressurised inhalation solution 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, 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 CLENIL MODULITE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLENIL MODULITE 3. HOW TO USE CLENIL MODULITE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CLENIL MODULITE 6. CONTENTS OF THE PACK AND OTHER INFORMATION Clenil Modulite is a pressurised inhalation solution used to help PREVENT the symptoms of mild, moderate or severe asthma. The active ingredient, beclometasone dipropionate, is one of a group of medicines called corticosteroids which are often referred to simply as steroids. Steroids have an anti- inflammatory action reducing the swelling and irritation in the walls of the small air passages in the lungs, and so ease breathing problems. DO NOT USE CLENIL MODULITE: • if you are allergic to any of the ingredients of this medicine or to any other medicines used to treat asthma • TO TREAT A SUDDEN ATTACK OF BREATHLESSNESS . It will not help. Use a quick-acting ‘reliever’ inhaler for this purpose and carry it with you at all times. WARNINGS AND PRECAUTIONS: Talk to your doctor, pharmacist or nurse before using Cl 전체 문서 읽기
Health Products Regulatory Authority 16 March 2023 CRN00D81L Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clenil Modulite 250 micrograms per metered dose Pressurised Inhalation Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 50 micrograms of beclometasone dipropionate. Each metered dose contains 100 micrograms of beclometasone dipropionate. Each metered dose contains 200 micrograms of beclometasone dipropionate. Each metered dose contains 250 micrograms of beclometasone dipropionate. Excipient with known effect Clenil Modulite 50 micrograms per metered dose contains 7.683 mg ethanol. Clenil Modulite 100 micrograms per metered dose contains 7.638 mg ethanol. Clenil Modulite 200 micrograms per metered dose contains 8.267 mg ethanol. Clenil Modulite 250 micrograms per metered dose contains 8.929 mg ethanol. 3 PHARMACEUTICAL FORM Pressurised inhalation, solution The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity and Peak Expiratory Flow (PEF) values below 60 % predicted at baseline with greater than 30 % variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled or oral corticosteroid therapy. Sudden worsening of symptoms, which may be potentially life-threatening, may require increased corticosteroid dosage, which should be administered under urgent medical supervision. Clenil Moduilte is indicated for the prophylactic management of mild, moderate, or severe asthma in: Adults _Mild asthma_ (PEF valves greater than 80 % predicted at baseline with less than 20 % variability): Patients requiring intermittent symptomatic bronchodilator asthma medication on a regular basis. _Moderate asthma_ (PEF valves 60 % to 80 % predicted at baseline with 20 % to 30 % variability): Patients w 전체 문서 읽기