国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
salbutamol sulfate
Sandoz Pty Ltd
salbutamol sulfate
Registered
SALBUTAMOL SANDOZ ® _salbutamol sulphate inhalation ampoules_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Salbutamol Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT SALBUTAMOL SANDOZ IS USED FOR The name of your medicine is Salbutamol Sandoz. The medicine in your Salbutamol Sandoz is delivered through a device called a nebuliser. It contains the active ingredient salbutamol sulphate. Salbutamol is inhaled into the lungs for the treatment of asthma. Asthma is a disease where the lining of the lungs become inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke, air-borne pollution and other irritants. Salbutamol opens up the air passages in people suffering from asthma, bronchitis and other breathing problems. It may also be used before exercise to keep your air passages open if you start to wheeze or have difficulty breathing each time you exert yourself. Salbutamol Sandoz belongs to a group of medicines called beta-2- agonists. These work rapidly to open up the air passages in your lungs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU USE SALBUTAMOL SANDOZ _WHEN YOU MUST NOT USE IT_ DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • salbutamol, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description • any other medicines used to treat breathing problems or any other beta 阅读完整的文件
_Product Information _ _ _ _Page 1 _ _Salbutamol Sandoz_ _®_ _ 2.5mg/2.5mL, 5mg/2.5mL inhalation ampoules _ 08/2016 _Sandoz Pty Ltd _ PRODUCT INFORMATION SALBUTAMOL SANDOZ ® 2.5MG/2.5ML, 5MG/2.5ML INHALATION AMPOULES NAME OF THE MEDICINE _Generic name:_ Salbutamol sulphate BP _Chemical name:_ di[(RS)-2-(1,1-dimethyl)ethylamino-1-[4-hydroxy-3- (hydroxymethyl)phenyl]ethanol] sulphate _CAS Number:_ 51022-70-9 _Empirical formula:_ (C 13 H 21 NO 3 ) 2 , H 2 SO4 _MW:_ 576.7 DESCRIPTION Salbutamol sulphate is a white or almost white, crystalline, odourless powder with a slightly bitter taste. It is freely soluble in water, slightly soluble in alcohol, chloroform and ether, very slightly soluble in methylene chloride. Salbutamol sulphate 1.2 mg is approximately equivalent to salbutamol 1 mg. Each inhalation ampoule contains Salbutamol 2.5mg/2.5mL or 5mg/2.5mL. Inactive ingredients: Sodium chloride, sulphuric acid (for pH adjustment), water for injection. PHARMACOLOGY Selective beta-2-adrenoceptor agonist Pharmacodynamics Salbutamol is a long acting, relatively selective beta-2-receptor stimulant. Administration by inhalation results in direct stimulation of beta-2-receptors in bronchial smooth muscle and hence bronchodilation. This is thought to be due to stimulation of adenyl cyclase by CH 2 OH OH .H 2 SO 4 OH NH CH C CH 2 CH 3 CH 3 CH 3 _Product Information _ _ _ _Page 2 _ _Salbutamol Sandoz_ _®_ _ 2.5mg/2.5mL, 5mg/2.5mL inhalation ampoules _ 08/2016 _Sandoz Pty Ltd _ salbutamol, resulting in increased levels of cyclic AMP within cells. These are thought to inhibit the entry of calcium ions into the cells, thus inhibiting smooth muscle contraction. High levels of cyclic AMP in mast cells may also inhibit the release of histamine and slow reacting substance-A (SRS-A). After administration of salbutamol, stimulation of both beta-1 and beta-2 receptors occurs because beta-2 selectivity is not absolute. This results in the beta-1 effect of cardiac stimulation, though not so much as with isoprenaline, and beta-2 effects 阅读完整的文件