USA - engelsk - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - dapagliflozin (unii: 1ull0qj8uc) (dapagliflozin - unii:1ull0qj8uc), saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - qternmet xr (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use qternmet xr is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. qternmet xr initiation is intended only for patients currently taking metformin. qternmet xr is contraindicated in patients with: risk summary based on animal data showing adverse renal effects, from dapagliflozin, qternmet xr is not recommended during the second and third trimesters of pregnancy. the limited available data with qternmet xr or components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see data ). there are risks to the moth

USA - engelsk - 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

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

astrazeneca pty ltd - dapagliflozin propanediol monohydrate, quantity: 12.3 mg (equivalent: dapagliflozin, qty 10 mg); saxagliptin, quantity: 5 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; lactose; croscarmellose sodium; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid - qtern 5/10 is indicated as an adjunct to diet and exercise, in combination with metformin, to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and dapagliflozin is appropriate.

Den europeiske union - svensk - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanediol monohydrat - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - läkemedel som används vid diabetes - qtern, fast dos kombination av saxagliptin och dapagliflozin, är indicerat hos vuxna i åldern 18 år och äldre med typ 2-diabetes mellitus:för att förbättra glykemisk kontroll när metformin och/eller sulphonylurea (su) och en av de monocomponents av qtern inte ger tillräcklig glykemisk kontroll,när du redan behandlas med gratis kombination av dapagliflozin och saxagliptin. (se avsnitt 4. 2, 4. 4, 4. 5 och 5. 1 om det finns tillgängliga uppgifter om kombinationer studerade.

Den europeiske union - tysk - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propandiol monohydrat - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - drogen bei diabetes verwendet - qtern, fest-dosis-kombination von saxagliptin und dapagliflozin, ist indiziert bei erwachsenen im alter von 18 jahren und älter mit typ-2-diabetes mellitus:verbesserung der glykämischen kontrolle bei metformin und/oder sulphonylurea (su) und eine der monocomponents von qtern bieten keine adäquaten glykämischen kontrolle,wenn schon die behandlung mit der freien kombination von dapagliflozin und saxagliptin. (siehe abschnitt 4. 2, 4. 4, 4. 5 und 5. 1 für verfügbare daten über kombinationen untersucht.

Canada - fransk - Health Canada

astrazeneca canada inc - saxagliptine (chlorhydrate de saxagliptine); dapagliflozine (propanediol de dapagliflozine monohydraté) - comprimé - 5mg; 5mg - saxagliptine (chlorhydrate de saxagliptine) 5mg; dapagliflozine (propanediol de dapagliflozine monohydraté) 5mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Canada - fransk - Health Canada

astrazeneca canada inc - saxagliptine (chlorhydrate de saxagliptine); dapagliflozine (propanediol de dapagliflozine monohydraté) - comprimé - 5mg; 10mg - saxagliptine (chlorhydrate de saxagliptine) 5mg; dapagliflozine (propanediol de dapagliflozine monohydraté) 10mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Sveits - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

astrazeneca ag - dapagliflozinum, saxagliptinum - filmtabletten - dapagliflozinum 10 mg ut dapagliflozinum propandiolum monohydricum, saxagliptinum 5 mg ut saxagliptini hydrochloridum, cellulosum microcristallinum, lactosum 40 mg, carmellosum natricum conexum, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, acidum hydrochloridum, natrii hydroxidum, e 171, e 172 (flavum), e 172 (rubrum), drucktinte: e 132, lacca, pro compresso obducto corresp. natrium max. 0.91 mg. - antidiabetikum - synthetika

Sveits - italiensk - Swissmedic (Swiss Agency for Therapeutic Products)

astrazeneca ag - dapagliflozinum, saxagliptinum - compresse rivestite con film - dapagliflozinum 10 mg ut dapagliflozinum propandiolum monohydricum, saxagliptinum 5 mg ut saxagliptini hydrochloridum, cellulosum microcristallinum, lactosum 40 mg, carmellosum natricum conexum, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, acidum hydrochloridum, natrii hydroxidum, e 171, e 172 (flavum), e 172 (rubrum), drucktinte: e 132, lacca, pro compresso obducto corresp. natrium max. 0.91 mg. - antidiabetico - synthetika

Sveits - fransk - Swissmedic (Swiss Agency for Therapeutic Products)

astrazeneca ag - dapagliflozinum, saxagliptinum - comprimés pelliculés - dapagliflozinum 10 mg ut dapagliflozinum propandiolum monohydricum, saxagliptinum 5 mg ut saxagliptini hydrochloridum, cellulosum microcristallinum, lactosum 40 mg, carmellosum natricum conexum, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), macrogolum 3350, talcum, acidum hydrochloridum, natrii hydroxidum, e 171, e 172 (flavum), e 172 (rubrum), drucktinte: e 132, lacca, pro compresso obducto corresp. natrium max. 0.91 mg. - antidiabetikum - synthetika