国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Metformin hydrochloride 850mg; ; ; Metformin hydrochloride 850mg
Ipca Pharma (NZ) Pty Limited
Metformin hydrochloride 850 mg
850 mg
Film coated tablet
Active: Metformin hydrochloride 850mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Sodium starch glycolate Titanium dioxide Active: Metformin hydrochloride 850mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000 Magnesium stearate Maize starch Povidone Propylene glycol Purified talc Sodium starch glycolate Titanium dioxide
Blister pack, PVC/PVdC/Al, 14 tablets
Prescription
Prescription
Ipca Laboratories Limited
· Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. · Metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al - 14 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al - 84 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 250 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE bottle and lid - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
2005-03-03
NEW ZEALAND DATA SHEET EMNORM Please refer to Medsafe website (www.medsafe.govt.nz) for the most recent datasheet Page 1 1 EMNORM (500MG, 850MG AND 1000MG TABLETS) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Metformin hydrochloride 500mg Metformin hydrochloride 850mg Metformin hydrochloride 1000mg EXCIPIENT OF KNOWN EFFECT PROPYLENE GLYCOL This excipient may cause skin irritation. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Emnorm 500 mg: White coloured, film coated, round, biconvex tablets with ‘500’ debossing Emnorm 850 mg: White coloured, film coated, round, biconvex tablets with ‘850’ debossing Emnorm 1000mg White to off white, oval shaped, biconvex, film coated tablets debossed with '10' and '00' on either side of deep notch on one side and breakline on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. • Metformin may be used as initial treatment or in sulfonylurea failures either alone or in combination with a sulfonylurea and other oral agents. • Adjuvant therapy in insulin dependent diabetes especially if overweight. 4.2 DOSE AND METHOD OF ADMINISTRATION LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN. RISK FACTORS INCLUDE RENAL IMPAIRMENT, OLD AGE AND DOSES OF METFORMIN ABOVE 2 G PER DAY (SEE SPECIAL WARNINGS AND PRECAUTIONS FOR USE). It is important that the tablets are taken in divided doses with meals. MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS IN ADULTS WITH NORMAL RENAL FUNCTION Initially 500 mg should be taken once or twice a day and, if necessary, increased over a few weeks up to a maximum of 1 g three times per day. The dose should be titrated with gradual dose increments until the desired effect is obtained. 500 mg three times a day is often sufficient to obtain diabetic control. Control may be attained within a few days 阅读完整的文件