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

astrazeneca pharmaceuticals lp - dapagliflozin (unii: 1ull0qj8uc) (dapagliflozin - unii:1ull0qj8uc), saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq) - dapagliflozin 10 mg - qtern is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use qtern is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1) ] . qtern is contraindicated in patients with: risk summary based on animal data showing adverse renal effects from dapagliflozin, qtern is not recommended during the second and third trimesters of pregnancy. the limited available data with qtern or its components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal pelvic and tubular dilatations, that were not fully reversible, were observed in rats when dapagliflozin (a component of qtern) was administered during a period of renal

European Union - English - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Canada - English - Health Canada

auro pharma inc - dapagliflozin; metformin hydrochloride - tablet - 5mg; 850mg - dapagliflozin 5mg; metformin hydrochloride 850mg

Canada - English - Health Canada

auro pharma inc - dapagliflozin; metformin hydrochloride - tablet - 5mg; 1000mg - dapagliflozin 5mg; metformin hydrochloride 1000mg

Canada - English - Health Canada

apotex inc - dapagliflozin; metformin hydrochloride - tablet - 5mg; 850mg - dapagliflozin 5mg; metformin hydrochloride 850mg

Canada - English - Health Canada

apotex inc - dapagliflozin; metformin hydrochloride - tablet - 5mg; 1000mg - dapagliflozin 5mg; metformin hydrochloride 1000mg

Canada - English - Health Canada

taro pharmaceuticals inc - dapagliflozin - tablet - 5mg - dapagliflozin 5mg

Canada - English - Health Canada

taro pharmaceuticals inc - dapagliflozin - tablet - 10mg - dapagliflozin 10mg

Canada - English - Health Canada

pro doc limitee - dapagliflozin - tablet - 5mg - dapagliflozin 5mg

Canada - English - Health Canada

pro doc limitee - dapagliflozin - tablet - 10mg - dapagliflozin 10mg