Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Amlodipine besilate 6.93mg equivalent to 5 mg amlodipine
Multichem NZ Limited
Amlodipine besilate 6.93 mg (equivalent to 5 mg amlodipine)
5 mg
Tablet
Active: Amlodipine besilate 6.93mg equivalent to 5 mg amlodipine Excipient: Colloidal silicon dioxide Magnesium stearate Mannitol Microcrystalline cellulose Sodium starch glycolate
Blister pack, PVC/PVdC-PVC/PVdC/aluminium in a acrdboard carton, 100 tablets
Prescription
Prescription
Cadila Pharmaceuticals Ltd
Package - Contents - Shelf Life: Blister pack, PVC/PVdC-PVC/PVdC/aluminium in a acrdboard carton - 100 tablets - 36 months from date of manufacture stored at or below 30°C
2010-11-22
1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Vasorex 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amlodipine besilate 2.5 mg, 5 mg and 10 mg tablets 3 PHARMACEUTICAL FORM Vasorex 2.5 mg tablets are white to off white, round with “C” debossed on one side and “126” on the other side. Alternatively, they are debossed on one side with “3235” and “WPI” on the other side. Each tablet contains amlodipine besilate equivalent to 2.5 mg of amlodipine. Vasorex 5 mg tablets are white to off white, round with “C” debossed on one side and “127” on the other side. Alternatively, they are debossed on one side with “3236” and “WPI” on the other side. Each tablet contains amlodipine besilate equivalent to 5 mg amlodipine. Vasorex 10 mg tablets are white to off white, round with “C” debossed on one side and “128” on the other side. Alternatively, they are debossed on one side with “3237” and “WPI” on the other side. Each tablet contains amlodipine besilate equivalent to 10 mg amlodipine. Do not halve the tablet as dose equivalence when the tablet is divided has not been established. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Vasorex is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor. Vasorex is indicated for the first line treatment of myocardial ischaemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Vasorex may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Vasorex may be used alone as monotherapy, or in combination with other anti Lire le document complet