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

merck sharp & dohme llc - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), sitagliptin phosphate (unii: ts63ew8x6f) (sitagliptin - unii:qfp0p1dv7z) - ertugliflozin 5 mg - steglujan® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use - not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1)]. - 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 steglujan [see warnings and precautions (5.2)] . - patients with severe renal impairment (<30 ml/min/1.73 m2 ), end-stage renal disease (esrd), or on dialysis [see warnings and precautions (5.4) and use in specific populations (8.6)] . - hypersensitivity to sitagliptin, ertugliflozin, or any excipient, in steglujan, reactions such as anaphylaxis or angioedema have occurred [see warnings and precautions (5.11) and adverse reactions (6.2)]. risk summary based on animal data showing adverse renal effects, from ertugliflozin, steglujan is

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

merck sharp & dohme llc - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip) - ertugliflozin 5 mg - steglatro® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use - not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1)] . - hypersensitivity to ertugliflozin or any excipient in steglatro, reactions such as angioedema have occurred [see adverse reactions (6.2)]. risk summary based on animal data showing adverse renal effects, steglatro is not recommended during the second and third trimesters of pregnancy. the limited available data with steglatro in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and t

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

merck sharp & dohme llc - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - ertugliflozin 2.5 mg - segluromet® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.2)]. - hypersensitivity to ertugliflozin, metformin, or any excipient in segluromet, reactions such as angioedema or anaphylaxis have occurred [see adverse reactions (6.2)]. - patients with severe renal impairment (egfr less than 30 ml/min/1.73 m2 ), end stage-renal disease (esrd), or on dialysis [see use in specific populations (8.6)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary based on animal data showing adverse renal effects, from ertugliflozin, segluromet is not recommended during the second and third trimesters of pregnancy. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage r

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - ertugliflozin (l-pga); sitagliptin as monohydrate phosphate - film coated tablets - sitagliptin as monohydrate phosphate 100 mg; ertugliflozin (l-pga) 15 mg - sitagliptin and ertugliflozin - steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:• when metformin and/or a sulphonylurea (su) and one of the monocomponents of steglujan do not provide adequate glycaemic control• in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - ertugliflozin (l-pga); sitagliptin as monohydrate phosphate - film coated tablets - sitagliptin as monohydrate phosphate 100 mg; ertugliflozin (l-pga) 5 mg - sitagliptin and ertugliflozin - steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:• when metformin and/or a sulphonylurea (su) and one of the monocomponents of steglujan do not provide adequate glycaemic control• in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:when metformin and/or a sulphonylurea (su) and one of the monocomponents of steglujan do not provide adequate glycaemic control.in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.

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

merck sharp & dohme (australia) pty ltd - ertugliflozin pyroglutamic acid, quantity: 6.48 mg (equivalent: ertugliflozin, qty 5 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; lactose monohydrate; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350 - msd-ertugliflozin (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 pharmacodynamic properties, clinical trials and 4.4 special warnings and precautions for use for available data on different add-on combination therapies].

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

merck sharp & dohme (australia) pty ltd - ertugliflozin pyroglutamic acid, quantity: 19.43 mg (equivalent: ertugliflozin, qty 15 mg) - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350 - msd-ertugliflozin (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 pharmacodynamic properties, clinical trials and 4.4 special warnings and precautions for use for available data on different add-on combination therapies].

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

merck sharp & dohme (australia) pty ltd - ertugliflozin pyroglutamic acid, quantity: 6.48 mg (equivalent: ertugliflozin, qty 5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide red; macrogol 3350 - steglatro (ertugliflozin) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:- - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents,[see 5.1 pharmacodynamic properties, clinical trials and 4.4 special warnings and precautions for use for available data on different add-on combination therapies].