Irlanda - engleză - HPRA (Health Products Regulatory Authority)

norton waterford - sitagliptin hydrochloride monohydrate; metformin hydrochloride - film-coated tablet - metformin and sitagliptin

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

as grindeks - sitagliptin hydrochloride monohydrate; metformin hydrochloride - film-coated tablet - metformin and sitagliptin

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 850 mg - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets are 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: -   severe renal impairment (egfr below 30 ml/min/1.73 m 2 ) [see warnings and precautions ( 5.1) ]. -   hypersensitivity to metformin. -   acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets or metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published

Uniunea Europeană - engleză - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (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 sulphonylurea.sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist.sitagliptin/metformin hydrochloride mylan is also 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 stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

rebel distributors corp - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride extended - release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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 extended - release tablets 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

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

cipla australia pty ltd - metformin hydrochloride -

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

nucare pharmaceuticals, 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 hydrochlorid

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

actavis pharma, inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets are contraindicated in patients with: 1. severe renal impairment (egfr below 30 ml/min/1.73 m2 ) (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. 

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

megalith pharmaceuticals inc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets are 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: - severe renal impairment (egfr below 30 ml/min/1.73 m 2 ) (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. 

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

qpharma inc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets are 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: