Trajentamet

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Linagliptin 2.5mg;  ; Metformin hydrochloride 850mg

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 2.5mg   Metformin hydrochloride 850mg 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. TRAJENTAMET is indicated as an adjunct to diet and exercise to improve glycaemic control 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 a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea. 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 maximum tolerated dose of metformin and an SGLT2 inhibitor. 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 not provide adequate glycaemic control.

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 date:

2014-12-01