AFT - Metoprolol CR

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Metoprolol succinate 23.75mg; Metoprolol succinate 23.75mg; Metoprolol succinate 23.75mg

Mevcut itibaren:

AFT Pharmaceuticals Ltd

INN (International Adı):

Metoprolol succinate 23.75 mg

Doz:

23.75 mg

Farmasötik formu:

Modified release tablet

Kompozisyon:

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

Paketteki üniteler:

Blister pack, PVC/PE/PVDC-aluminium blister 30 tablets, 30 tablets

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Moehs Catalana SL

Terapötik endikasyonlar:

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.

Ürün özeti:

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

Yetkilendirme tarihi:

2007-06-18

Ürün özellikleri

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