국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
Norton Waterford
R03BA01
BECLOMETASONE DIPROPIONATE
100 Mcg/Acutuation
Pressurised Inhalation Soln
Product subject to prescription which may be renewed (B)
Glucocorticoids
Authorised
1999-07-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER QVAR 50 & 100 MICROGRAMS 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 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. WHAT IS IN THIS LEAFLET 1. WHAT QVAR INHALER IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE QVAR INHALER 3. HOW TO USE QVAR INHALER 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE QVAR INHALER 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT QVAR INHALER IS AND WHAT IT IS USED FOR Qvar Inhaler contains the active substance beclometasone dipropionate, which is one of a group of medicines known as corticosteroids. Qvar Inhaler is used to prevent the symptoms of mild, moderate, or severe asthma in patients who require regular treatment. This medicine is indicated in adults and children aged 5 years and older (see section 3, “How to use Qvar Inhaler”). HOW YOUR MEDICINE WORKS Qvar Inhaler works deep in your lungs to make breathing easier by reducing the inflammation, swelling and irritation in the airways. This type of medicine is known as a ‘preventer’. It needs to be taken regularly every day, even if you have no symptoms. This inhaler will not give immediate relief of wheezing or breathlessness during a sudden asthma attack. You will need to use a ‘reliever’ inhaler, which contains a different medicine. You should still continue to use this inhaler. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE QVAR INHALER DO NOT USE QVAR INHALER IF YOU: are allergic (hypersensitive) to beclometasone dipropionate or any of the other in 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Qvar 100 micrograms pressurised inhalation, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose delivers Beclometasone Dipropionate 100 micrograms ex-valve into the mouthpiece of the actuator. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, solution. Pressurised aluminium container closed with a metering valve containing a pressurised inhalation solution, inserted into a beige plastic actuator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic anti-inflammatory treatment of reversible obstructive airway disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION NOTE: THE RECOMMENDED TOTAL DAILY DOSE OF BECLOMETASONE DIPROPIONATE EXTRAFINE AEROSOL FROM QVAR IS LOWER THAN THAT FOR CURRENT BECLOMETASONE DIPROPIONATE CFC PRODUCT AND SHOULD BE ADJUSTED TO THE INDIVIDUAL PATIENT. Qvar is for inhalation use only. The patient should read the instruction leaflet before use. As the canister is pressurised, no attempt should be made to puncture or dispose of it by burning. For normal hygiene, the mouth piece of your inhaler should be cleaned weekly with a clean dry tissue or cloth. Do not wash or put any part of the inhaler in water. ADULTS STARTING AND MAINTENANCE DOSE: For mild to moderate asthma: 50 µg to 200 µg twice daily. In more severe cases: doses up to 400 µg twice daily. The maximum recommended daily dose in adults is 800 µg. When patients’ symptoms remain under satisfactory control, the dose can be gradually reduced to the minimum effective dose to maintain control. CHILDREN AGES FIVE YEARS AND OVER The recommended dose for Qvar in children is 50 µg twice daily. 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 R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 전체 문서 읽기