Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Bisoprolol fumarate 5mg;
Douglas Pharmaceuticals Limited
Bisoprolol fumarate 5 mg
5 mg
Tablet
Active: Bisoprolol fumarate 5mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Sodium starch glycolate
Blister pack, PVC/PVdC-aluminium Sample pack, 10 tablets
Prescription
Prescription
Moehs Catalana SL
Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC-aluminium Sample pack - 10 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVdC-aluminium - 20 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVdC-aluminium - 30 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVdC-aluminium - 90 tablets - 3 years from date of manufacture stored at or below 25°C protect from light and moisture
2010-11-25
Consumer Medicine Information BOSVATE BISOPROLOL FUMARATE Bosvate 2.5 mg, 5 mg, 10 mg tablets WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Bosvate Tablets. This leaflet answers some common questions about Bosvate Tablets. 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 Bosvate Tablets against the benefits they expect it will have for you. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT BOSVATE IS USED FOR The active substance in this medicine is bisoprolol fumarate. Bisoprolol fumarate belongs to a group of medicines called beta-blockers. These medicines work by affecting the body’s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body's needs. Bisoprolol is used: • To treat stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides). • In treatment of coronary heart Прочетете целия документ
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME Bosvate® 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Bosvate 1.25 mg: each tablet contains 1.25 mg bisoprolol fumarate Bosvate 2.5 mg: each tablet contains 2.5 mg bisoprolol fumarate Bosvate 3.75 mg: each tablet contains 3.75 mg bisoprolol fumarate Bosvate 5 mg: each tablet contains 5 mg bisoprolol fumarate Bosvate 7.5 mg: each tablet contains 7.5 mg bisoprolol fumarate Bosvate 10 mg: each tablet contains 10 mg bisoprolol fumarate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Bosvate 1.25 mg: White to off white round biconvex tablet Bosvate 2.5 mg: White to off white round biconvex tablet with a break line on one side Bosvate 3.75 mg: White to off white round biconvex tablet Bosvate 5 mg: White to off white round biconvex tablet with a break line on one side Bosvate 7.5 mg: White to off white round biconvex tablet with a break line on one side Bosvate 10 mg: White to off white round biconvex tablet with a break line on one side. The 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS • Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see section 5.1). • Treatment of chronic, stable angina pectoris. • Treatment of essential hypertension. 4.2. DOSE AND METHOD OF ADMINISTRATION STABLE CHRONIC HEART FAILURE Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and when appropriate cardiac 2 | P a g e glycosides. Patients should be stable (without acute failure) when bisoprolol treatment is initiated. It is recommended that the treating physician should be experienced in the management of chronic heart failure. Transient worsening of heart failure, hypotensi Прочетете целия документ