Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - linagliptin - film-coated tablet - 5 milligram(s) - linagliptin

Ireland - English - HPRA (Health Products Regulatory Authority)

viatris limited - linagliptin - film-coated tablet - linagliptin

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - linagliptin - film-coated tablet - linagliptin 5 mg - drugs used in diabetes

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

physicians total care, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto tablets are indicated 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 [see dosage and administration (2.1) and clinical studies (14.1)]. jentadueto 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. jentadueto 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 jentadueto [see warnings and precautions (5.2)]. jentadueto is contraindicated in patients with: - renal impairment (e.g., serum creatinine ≥1.5 mg/dl for men, ≥1.4 mg/dl for women, or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia [see warnings and precautions (5.1, 5.3)] - ac

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto is not recommended in patients with type 1 diabetes mellitus. jentadueto 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 jentadueto [see warnings and precautions (5.2)]. jentadueto 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 [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adverse reactions (6.1

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - linagliptin 2.5 mg - jentadueto xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use jentadueto xr is not recommended in patients with type 1 diabetes mellitus. jentadueto xr 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 jentadueto xr [see warnings and precautions (5.2)]. jentadueto 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 [see warnings and precautions (5.1)]. - hypersensitivity to linagliptin, metformin, or any of the excipients in jentadueto xr, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred with linagliptin [see warnings and precautions (5.4) and adve

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

cardinal health 107, llc - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - linagliptin 5 mg - 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 should not be used in patients with type 1 diabetes 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 poor

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

boehringer ingelheim pharmaceuticals, inc. - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - linagliptin 5 mg - 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

Belgium - English - 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

Australia - English - 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: hypromellose; purified talc; colloidal anhydrous silica; magnesium stearate; copovidone; propylene glycol; titanium dioxide; arginine; iron oxide yellow; maize starch; 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.