Australia - engelsk - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - metformin hydrochloride, quantity: 1000 mg; saxagliptin, quantity: 2.5 mg - tablet, modified release - excipient ingredients: hypromellose; magnesium stearate; carmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid; iron oxide yellow - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate (see clinical trials and dosing and administration for data on combinations studied).

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - vildagliptin, quantity: 50 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: iron oxide yellow; titanium dioxide; hypromellose; macrogol 4000; hyprolose; purified talc; magnesium stearate - for patients with type 2 diabetes mellitus (t2dm):,galvumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metformin hydrochloride alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. treatment should not be initiated with this fixed-dose combination.,galvumet is indicated in combination with a sulfonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea.,galvumet is indicated as add-on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - metformin hydrochloride, quantity: 500 mg; glibenclamide, quantity: 5 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; quinoline yellow; iron oxide yellow; iron oxide red; macrogol 4000 - second line treatment of diabetes mellitus type ii in adult patients whose glycaemic control is inadequate after diet and exercise alone and where combined therapy with metformin and glibenclamide is appropriate.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - metformin hydrochloride, quantity: 500 mg; glibenclamide, quantity: 2.5 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black - second line treatment of diabetes mellitus type ii in adult patients whose glycaemic control is inadequate after diet and exercise alone and where combined therapy with metformin and glibenclamide is appropriate.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - metformin hydrochloride, quantity: 250 mg; glibenclamide, quantity: 1.25 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; povidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; lactose monohydrate; hypromellose; purified talc; iron oxide yellow; macrogol 4000 - second line treatment of diabetes mellitus type ii in adult patients whose glycaemic control is inadequate after diet and exercise alone and where combined therapy with metformin and glibenclamide is appropriate.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - metformin hydrochloride, quantity: 1000 mg; linagliptin, quantity: 2.5 mg - tablet, film coated - excipient ingredients: copovidone; propylene glycol; magnesium stearate; arginine; iron oxide red; hypromellose; colloidal anhydrous silica; titanium dioxide; maize starch; purified talc - 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 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.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - metformin hydrochloride, quantity: 1000 mg; linagliptin, quantity: 2.5 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; propylene glycol; maize starch; purified talc; hypromellose; iron oxide red; arginine; magnesium stearate; titanium dioxide; copovidone - 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 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.

USA - engelsk - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride tablets and metformin hydrochloride extended-release tablets are contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets and metformin hydrochloride

USA - engelsk - NLM (National Library of Medicine)

solco healthcare u.s., llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: 1.    renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings  and precautions ). 2.  known hypersensitivity to metformin hydrochloride.   3. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also precautions .)

USA - engelsk - NLM (National Library of Medicine)

direct rx - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets usp, is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets usp is contraindicated in patients with: 0.1 renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions). 0.2 known hypersensitivity to metformin hydrochloride. 0.3 acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets usp should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.