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

merck sharp & dohme (australia) pty ltd - metformin hydrochloride, quantity: 1000 mg; ertugliflozin pyroglutamic acid, quantity: 9.713 mg (equivalent: ertugliflozin, qty 7.5 mg) - tablet, film coated - excipient ingredients: povidone; crospovidone; sodium lauryl sulfate; carnauba wax; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; hyprolose; iron oxide red - segluromet (ertugliflozin 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 ertugliflozin and metformin is appropriate [see 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 - metformin hydrochloride, quantity: 1000 mg; ertugliflozin pyroglutamic acid, quantity: 3.238 mg (equivalent: ertugliflozin, qty 2.5 mg) - tablet, film coated - excipient ingredients: povidone; sodium lauryl sulfate; magnesium stearate; crospovidone; microcrystalline cellulose; carnauba wax; titanium dioxide; hypromellose; hyprolose; iron oxide red - segluromet (ertugliflozin 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 ertugliflozin and metformin is appropriate [see 5.1 pharmacodynamic properties, clinical trials and 4.2 dose and method of administration]

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); metformin hydrochloride - film coated tablets - metformin hydrochloride 1000 mg; ertugliflozin (l-pga) 2.5 mg - metformin and ertugliflozin - 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 alone• in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes • in 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); metformin - film coated tablets - metformin 1000 mg; ertugliflozin (l-pga) 7.5 mg - metformin and ertugliflozin - 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 alone• in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

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

a-s medication solutions - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - 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 in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [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 ma

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

a-s medication solutions - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - 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 in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [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 ma

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

a-s medication solutions - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - 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 in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [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 ma

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

merck sharp & dohme (malaysia) sdn bhd - ertuglifozin l-pyroglutamic acid; metformin hydrochloride -

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

merck sharp & dohme (malaysia) sdn bhd - ertuglifozin l-pyroglutamic acid; metformin hydrochloride -