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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - metformin hydrochloride; empagliflozin - tablet - 1gram ; 5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - metformin hydrochloride; empagliflozin - tablet - 850mg ; 12.5mg

Israel - English - Ministry of Health

teva israel ltd - linagliptin - film coated tablets - linagliptin 5 mg - linagliptin - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. linagliptin teva® 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.linagliptin teva® 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 linagliptin teva®.

Namibia - English - Namibia Medicines Regulatory Council

ingelheim pharmaceuticals (pty) ltd - linagliptin, metformin hydrochloride - tablet - each film-coated tablet contains; linagliptin 2,5 mg, metformin hydrochloride 500,0 mg

Namibia - English - Namibia Medicines Regulatory Council

ingelheim pharmaceuticals (pty) ltd - linagliptin, metformin hydrochloride - tablet - each film-coated tablet contains; linagliptin 2,5 mg, metformin hydrochloride 850,0 mg

Namibia - English - Namibia Medicines Regulatory Council

ingelheim pharmaceuticals (pty) ltd - linagliptin, metformin hydrochloride - tablet - each film-coated tablet contains; linagliptin 2,5 mg, metformin hydrochloride 1000,0 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - empagliflozin 12.5mg;  ; metformin hydrochloride 1000mg;   - film coated tablet - 12.5mg/1000mg - active: empagliflozin 12.5mg   metformin hydrochloride 1000mg   excipient: colloidal silicon dioxide copovidone magnesium stearate maize starch opadry purple 02b200006 - glycaemic control jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type 2 diabetes mellitus: · when treatment with both empagliflozin and metformin is appropriate ·inadequately controlled with metformin or empagliflozin alone ·inadequately controlled with empagliflozin or metformin in combination with other glucose-lowering products including insulin · already treated with empagliflozin and metformin co-administered as separate tablets.

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) ltd - empagliflozin 12.5mg;  ; metformin hydrochloride 500mg;   - film coated tablet - 12.5mg/500mg - active: empagliflozin 12.5mg   metformin hydrochloride 500mg   excipient: colloidal silicon dioxide copovidone magnesium stearate maize starch opadry pink 02b20004 - glycaemic control jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients with type 2 diabetes mellitus: · when treatment with both empagliflozin and metformin is appropriate ·inadequately controlled with metformin or empagliflozin alone ·inadequately controlled with empagliflozin or metformin in combination with other glucose-lowering products including insulin · already treated with empagliflozin and metformin co-administered as separate tablets.