অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - linagliptin, quantity: 2.5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: arginine; magnesium stearate; purified talc; copovidone; maize starch; iron oxide yellow; titanium dioxide; colloidal anhydrous silica; hypromellose; propylene glycol; iron oxide red - 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.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - linagliptin, quantity: 2.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; iron oxide yellow; hypromellose; titanium dioxide; copovidone; arginine; maize starch; purified talc; magnesium stearate; propylene glycol - 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.

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - linagliptin, quantity: 2.5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: hypromellose; iron oxide yellow; propylene glycol; copovidone; colloidal anhydrous silica; arginine; maize starch; purified talc; magnesium stearate; titanium dioxide - 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.

অস্ট্রেলিয়া - ইংরেজি - 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.

অস্ট্রেলিয়া - ইংরেজি - 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.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

a-s medication solutions - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use tradjenta is not recommended in patients with type 1 diabetes mellitus as it would not be effective. tradjenta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using tradjenta [see warnings and precautions (5.1)]. tradjenta is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in tradjenta, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see warnings and precautions (5.3) and adverse reactions (6)]. risk summary the limited data with tradjenta use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. in animal reproduction studies, no adverse developmental effects were observed when linagliptin was administered to pregnant rats during the period of organogenesis at doses similar to the maximum recommended clinical dose, based on exposure [see data] . the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data no adverse developmental outcome was observed when linagliptin was administered to pregnant wistar han rats and himalayan rabbits during the period of organogenesis at doses up to 240 mg/kg/day and 150 mg/kg/day, respectively. these doses represent approximately 943-times (rats) and 1,943-times (rabbits) the 5 mg maximum clinical dose, based on exposure. no adverse functional, behavioral, or reproductive outcome was observed in offspring following administration of linagliptin to wistar han rats from gestation day 6 to lactation day 21 at a dose 49-times the maximum recommended human dose, based on exposure. linagliptin crosses the placenta into the fetus following oral dosing in pregnant rats and rabbits. risk summary there is no information regarding the presence of linagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. however, linagliptin is present in rat milk. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tradjenta and any potential adverse effects on the breastfed child from tradjenta or from the underlying maternal condition. the safety and effectiveness of tradjenta have not been established in pediatric patients. effectiveness of tradjenta was not demonstrated in a 26-week randomized, double-blind, placebo-controlled trial (nct03429543) in 157 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus. in linagliptin studies, 1,085 linagliptin-treated patients were 65 years of age and older and 131 patients were 75 years of age and older. in these linagliptin studies, no overall differences in safety or effectiveness of linagliptin were observed between geriatric patients and younger adult patients. no dosage adjustment is recommended for patients with renal impairment [see clinical pharmacology (12.3)]. in the tradjenta treatment arm of the carmelina trial [see clinical studies (14)] , 2,200 (63%) patients had renal impairment (egfr <60 ml/min/1.73 m2 ). approximately 20% of the population had egfr ≥45 to <60 ml/min/1.73 m2 , 28% of the population had egfr ≥30 to <45 ml/min/1.73 m2 and 15% had egfr <30 ml/min/1.73 m2 . the overall incidence of adverse reactions were generally similar between the tradjenta and placebo treatment arms. no dose adjustment is recommended for patients with hepatic impairment [see clinical pharmacology (12.3)] .

অস্ট্রেলিয়া - ইংরেজি - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - linagliptin, quantity: 5 mg; empagliflozin, quantity: 25 mg - tablet, film coated - excipient ingredients: purified talc; hypromellose; mannitol; crospovidone; titanium dioxide; magnesium stearate; copovidone; pregelatinised maize starch; macrogol 6000; iron oxide red; maize starch - glyxambi tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties ? clinical trials).

বেলজিয়াম - ইংরেজি - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - linagliptin 5 mg - film-coated tablet - 5 mg - linagliptin 5 mg - linagliptin

ইস্রায়েল - ইংরেজি - Ministry of Health

boehringer ingelheim israel ltd. - linagliptin; metformin hydrochloride - film coated tablets - linagliptin 2.5 mg; metformin hydrochloride 1000 mg - metformin - metformin - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. trajenta-duo should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. trajenta-duo has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using trajenta-duo.

ইস্রায়েল - ইংরেজি - Ministry of Health

boehringer ingelheim israel ltd. - linagliptin; metformin hydrochloride - film coated tablets - linagliptin 2.5 mg; metformin hydrochloride 1000 mg - metformin - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. trajenta-duo should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. trajenta-duo has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using trajenta-duo.