Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Metoprolol succinate 23.75mg; Metoprolol succinate 23.75mg; Metoprolol succinate 23.75mg
AFT Pharmaceuticals Ltd
Metoprolol succinate 23.75 mg
23.75 mg
Modified release tablet
Active: Metoprolol succinate 23.75mg Excipient: Acetone Ethylcellulose Glycerol Isopropyl alcohol Magnesium stearate Maize starch Methylcellulose Microcrystalline cellulose Purified water Sepifilm white LP770 Active: Metoprolol succinate 23.75mg Excipient: Acetone Ethylcellulose Glycerol Isopropyl alcohol Magnesium stearate Maize starch Methylcellulose Microcrystalline cellulose Purified water Sepifilm white 752 Active: Metoprolol succinate 23.75mg Excipient: Acetone Ethylcellulose Glycerol Isopropyl alcohol Magnesium stearate Maize starch Methylcellulose Microcrystalline cellulose Purified water Sepifilm white LP770
Blister pack, PVC/PE/PVDC-aluminium blister 30 tablets, 30 tablets
Prescription
Prescription
Moehs Catalana SL
AFT - Metoprolol is indicated for the following indications: · Hypertension. To reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sudden death), and morbidity. · Angina pectoris. · Symptomatic mild to severe chronic heart failure as an adjunct to other heart failure therapy to: increase survival, reduce hospitalisation, improve left ventricular function, improve New York Heart Association (NYHA) functional class and improve Quality of Life. · Cardiac arrhythmias, especially supraventricular tachycardia, reduction of ventricular rate in atrial fibrillation and ventricular extrasystoles. · Maintenance treatment after myocardial infarction · Hyperthyroidism. · Functional heart disorder with palpitations. · Migraine prophylaxis.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC-aluminium blister 30 tablets - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC-aluminium blister 90 tablets - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC-aluminium blister 100 tablets - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, White HDPE with 38 mm child resistant PP cap, induction sealed with aluminium - 30 tablets - 6 months from date of manufacture stored at or below 25°C
2007-06-18
Page 1 of 11 NEW ZEALAND DATA SHEET 1. AFT-METOPROLOL CR (23.75 MG, 47.5 MG, 95 MG AND 190 MG CONTROLLED- RELEASE TABLETS) AFT-Metoprolol CR 23.75 mg, 47.5 mg, 95 mg and 190 mg controlled release tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Metoprolol – AFT 23.75 mg: Each tablet contains 23.75 mg metoprolol succinate Metoprolol – AFT 47.5 mg: Each tablet contains 47.5 mg metoprolol succinate Metoprolol – AFT 95 mg: Each tablet contains 95 mg metoprolol succinate Metoprolol – AFT 190 mg: Each tablet contains 190 mg metoprolol succinate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Controlled release tablets. AFT-METOPROLOL CR tablets 23.75 mg are white, oval, biconvex, film-coated tablets scored on both sides. Size 9 mm x 5 mm. AFT-METOPROLOL CR tablets 47.5 mg are white, oval, biconvex, film-coated tablets scored on both sides. Size 11 mm x 6 mm. AFT-METOPROLOL CR tablets 95 mg are white, oval, biconvex, film-coated tablets scored on both sides. Size 16 mm x 8 mm. AFT-METOPROLOL CR tablets 190 mg are white, oval, biconvex, film-coated tablets scored on both sides. Size 19 mm x 10 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Hypertension. To reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sudden death), and morbidity. • Angina pectoris. • Symptomatic mild to severe chronic heart failure as an adjunct to other heart failure therapy to: increase survival, reduce hospitalisation, improve left ventricular function, improve New York Heart Association (NYHA) functional class and improve Quality of Life. • Cardiac arrhythmias, especially supraventricular tachycardia, reduction of ventricular rate in atrial fibrillation and ventricular extrasystoles. • Maintenance treatment after myocardial infarction • Hyperthyroidism. • Functional heart disorder with palpitations. • Migraine prophylaxis. 4.2 DOSE AND METHOD OF ADMINISTRATION Page 2 of 11 _DOSE_ Dosage should always be adjusted to the patient's individ Pročitajte cijeli dokument