Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALBUTAMOL SULPHATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
SALBUTAMOL SULPHATE
1Units Units
GLAXO WELLCOME S.A.
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ _ _ VENTOLIN EVOHALER _ _ _ _ Salbutamol sulphate (100 micrograms) 1 WHAT IS IN THIS LEAFLET 1. What VENTOLIN is used for 2. How VENTOLIN works 3. Before you use VENTOLIN 4. How to use VENTOLIN 5. While you are using it 6. Side Effects 7. Storage and Disposal of VENTOLIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT VENTOLIN IS USED FOR VENTOLIN is used for the relief and prevention of asthma symptoms. It should be used to relieve symptoms when they occur, and to prevent them in those circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure). HOW VENTOLIN WORKS VENTOLIN contains a medicine called salbutamol. This belongs to a group of medicines called bronchodilators. Bronchodilators relax the muscles in the walls of the small airway passages in the lungs. VENTOLIN • helps to open up the airways in your lungs, making it easier for you to breathe. • helps to relieve chest tightness, wheezing and cough associated with asthma. VENTOLIN Inhaler CFC-Free known as VENTOLIN Evohaler contains a propellant called HFA 134a. This is less harmful to the environment than older inhalers. Older inhalers may taste differently to VENTOLIN Evohaler. This will make no difference to how your medicine works. BEFORE YOU USE VENTOLIN - _When you must not use it _ Do not use VENTOLIN: • if you are allergic (hypersensitive) to salbutamol sulphate or any of the other ingredients of VENTOLIN If you think any of these apply to you, do not use VENTOLIN until you have checked with your doctor . _Pregnancy and brestfeeding _ VENTOLIN is not usually recommended for use during pregnancy. If you are pregnant, or think you could be, or if you are planning to become pregnant, do not take VENTOLIN without checking with your doctor. Your doctor will consider the benefit to you and the risk to your baby of taking VENTOLIN while you are pregnant. It is not known whether Les hele dokumentet
CONFIDENTIAL VENTOLIN EVOHALER Salbutamol QUALITATIVE AND QUANTITATIVE COMPOSITION VENTOLIN EVOHALER is a pressurised metered-dose inhaler which delivers 100 micrograms salbutamol (as sulphate) per actuation, into the mouthpiece of a specially designed actuator. The inhaler also contains the CFC-free propellant HFA 134a. Each canister contains at least 200 actuations. PHARMACEUTICAL FORM Pressurised inhalation, solution. CLINICAL PARTICULARS Indications VENTOLIN Evohaler provides short-acting (4 to 6 hour) bronchodilation with fast onset (within 5 minutes) in reversible airway obstruction. It is particularly suitable for the relief and prevention of asthma symptoms. VENTOLIN Evohaler should be used to relieve symptoms when they occur, and to prevent them in those circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure). VENTOLIN Evohaler is particularly valuable as relief medication in mild, moderate or severe asthma, provided that reliance on it does not delay the introduction and use of regular inhaled corticosteroid therapy. Dosage and Administration VENTOLIN has a duration of action of 4 to 6 hours in most patients. Increasing use of beta- 2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered. As there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice. VENTOLIN is administered by the oral inhaled route only. Les hele dokumentet