Malta - English - Malta Medicines Authority

alfred e. tiefembacher (gmbh &co. kg) van-der-smissen-straße 1, 22767 hamburg, germany - sitagliptin, metformin hydrochloride - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 1000 mg - drugs used in diabetes

Canada - English - Health Canada

apotex inc - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet (extended-release) - 50mg; 500mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg; metformin hydrochloride 500mg

Canada - English - Health Canada

sandoz canada incorporated - sitagliptin (sitagliptin phosphate monohydrate); metformin hydrochloride - tablet (extended-release) - 50mg; 1000mg - sitagliptin (sitagliptin phosphate monohydrate) 50mg; metformin hydrochloride 1000mg

United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - sitagliptin phosphate (unii: ts63ew8x6f) (sitagliptin - unii:qfp0p1dv7z), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - sitagliptin 50 mg - janumet® xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use janumet xr should not be used in patients with type 1 diabetes mellitus. janumet xr has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using janumet xr. [see warnings and precautions (5.2).] janumet xr is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis. - history of a serious hypersensitivity reaction to janumet xr, sitagliptin, or metformin such as anaphylaxis or angioedema. [see warnings and precautions (5.7); adverse reactions (6.2). ] risk summary the limited available data with janumet xr in pregnant women are not sufficient to inform a drug-associated risk for major b

Malta - English - Malta Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 1000 mg - drugs used in diabetes

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg (equivalent: sitagliptin, qty 50 mg); metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; microcrystalline cellulose; sodium stearylfumarate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - velmetia (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

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

merck sharp & dohme (australia) pty ltd - sitagliptin phosphate monohydrate, quantity: 64.25 mg; metformin hydrochloride, quantity: 1000 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; povidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - janumet (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see sections 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration].

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - sitagliptin phosphate; metformin hydrochloride -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

merck sharp & dohme (malaysia) sdn bhd - sitagliptin phosphate; metformin hydrochloride -

Malta - English - Malta Medicines Authority

galenicum health, s.l. avenida diagonal 123, 11ª planta, 08005, barcelona, spain - sitagliptin, metformin hydrochloride - film-coated tablet - sitagliptin 50 milligram(s) ; metformin hydrochloride 850 milligram(s) - drugs used in diabetes