Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALBUTAMOL SULPHATE
MEDISPEC (M) SDN.BHD
SALBUTAMOL SULPHATE
1Units Units
Jewim Pharmaceutical (Shandong) Co., Ltd
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SALBUTIS (SALBUTAMOL INHALATION AEROSOL 100MCG/DOSE CFC FREE) Salbutamol sulphate (100mcg/dose) 1 WHAT IS IN THIS LEAFLET 1. What SALBUTIS is used for 2. How SALBUTIS works 3. Before you use SALBUTIS 4. How to use SALBUTIS 5. While you are using it 6. Side effects 7. Storage and Disposal of SALBUTIS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SALBUTIS IS USED FOR SALBUTIS provides short-acting (4 to 6 hours) bronchodilatation with fast onset (within 5 minutes) in reversible airways obstruction. It is particularly suitable 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). SALBUTIS 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. HOW SALBUTIS WORKS Salbutamol is a selective β2- adrenoceptor agonist. At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle providing short acting (4-6 hours) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction. BEFORE YOU USE SALBUTIS _-When you must not use it _ • If you are allergic (hypersensitive) to salbutamol sulphate or the other ingredient HFA 134a. _- Before you start to take it _ Check with your doctor, nurse or pharmacist if: • you have high blood pressure • you have an overactive thyroid gland • you have a history of heart problems such as an irregular or fast heartbeat or angina. _ _ _- Taking other medicines _ Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember to take this Lesen Sie das vollständige Dokument
SALBUTIS INHALER 100MCG/DOSE CFC-free NAME Salbutamol Inhalation Aerosol BP CFC-free STRENGTH 200 doses,each dose contains 100mcg Salbutamol BP and 4.5mg Absolute ethanol 300 doses,each dose contains 100mcg Salbutamol BP and 4.5mg Absolute ethanol 400 doses,each dose contains 100mcg Salbutamol BP and 4.5mg Absolute ethanol DOSAGE FORM Aerosol PRODUCT DESCRIPTION Salbutamol Inhalation Aerosol is a kind of white or slight yellow suspension mixed with just right quantity of propellant and kept in a pressurised canister with a metered valve system. PHARMACODYNAMICS Salbutamol is a selective β 2 -adrenoceptor agonist. At therapeutic doses it acts on the β 2 -adrenoceptors of bronchial muscle providing short acting (4-6 hours) bronchodilatation with a fast onset (within 5 minutes) in reversible airways obstruction. PHARMACOKINETICS The inspired aerosol’s effect begins to act in 5 minutes and results in maximum plasma concentrations occurring within 2 to 4 hours. The total effective period lasts for 4-6 hours. Salbutamol has an elimination half-life of 3-8 hours. Approximately 72% of the inhaled dose is excreted within 24 hours in the urine, and consists of 28% as unchanged drug and 44% as metabolite. INDICATION Salbutamol Inhalation Aerosol provides short-acting (4 to 6 hours) bronchodilatation with fast onset (within 5 minutes) in reversible airways obstruction. It is particularly suitable 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). Salbutamol Inhalation Aerosol 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. RECOMMENDED DOSE In acute bronchospasm: Adult dosage : 100 to 200 mcg daily. Children dosage: 100 mcg daily. If required, the dose can be increased t Lesen Sie das vollständige Dokument