Trajentamet

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Linagliptin 2.5 mg;  ; Metformin hydrochloride 850 mg
Available from:
Boehringer Ingelheim (NZ) Ltd
INN (International Name):
Linagliptin 2.5 mg
Dosage:
2.5 mg/850 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Linagliptin 2.5 mg   Metformin hydrochloride 850 mg Excipient: Arginine Colloidal silicon dioxide Copovidone Hypromellose Iron oxide red Iron oxide yellow Magnesium stearate Maize starch Propylene glycol Purified talc Purified water Titanium dioxide
Prescription type:
Prescription
Therapeutic indications:
Trajentamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate in patients inadequately controlled on metformin alone, or those already being treated and well controlled with the free combination of linagliptin and metformin. Trajentamet is indicated in combination with an SGLT2 inhibitor (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and an SGLT2 inhibitor. Trajentamet is indicated in combination with sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and sulfonylurea. Trajentamet is indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin and metformin alone do
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 14 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 56 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 98 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Blister pack, PVC/PCTFE/Alu. blister sheet in printed carton - 120 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture - Bottle, plastic, HDPE with CRC cap, induction seal and desiccant capsule in printed carton - starter pack - 14 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture - Bottle, plastic, HDPE with CRC cap, induction seal and desiccant capsule in printed carton - 60 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture - Bottle, plastic, HDPE with CRC cap, induction seal and desiccant capsule in printed carton - 180 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture
Authorization number:
TT50-9673a
Authorization date:
2014-12-01

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