אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - saxagliptin, quantity: 5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; indigo carmine aluminium lake; ethanol; shellac; sulfuric acid; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; iron oxide red - add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicines, when these together with diet and exercise, do not provide adequate glycaemic control (see clinical trials and precautions for available data on different add-on combination therapies).,initial combination: onglyza is indicated for use as initial combination therapy with metformin, in patients with type 2 diabetes mellitus, to improve glycaemic control as an adjunct to diet and exercise, when dual saxagliptin and metformin therapy is appropriate (i.e. high initial hba1c levels and poor prospects for response to monotherapy).

אוסטרליה - אנגלית - 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.

מלזיה - אנגלית - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; saxagliptin hydrochloride -

מלזיה - אנגלית - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; saxagliptin hydrochloride -

ארצות הברית - אנגלית - 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 development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose (see data) . no adverse developmental effects were observed when saxagliptin was administered to pregnant rats and rabbits (see data) . the estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with an hba1c greater than 7% and has been reported to be as high as 20 to 25% in women with an hba1c greater than 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 embryofetal 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 dapagliflozin dapagliflozin dosed directly to juvenile rats from postnatal day (pnd) 21 until pnd 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. exposure at the lowest dose was 15-times the 10 mg clinical dose (based on auc). the renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. in a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. increased incidence or severity of renal pelvic dilatation was observed in 21 day-old pup offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on auc). dose-related reductions in pup body weights were observed at greater than or equal to 29-times the 10 mg clinical dose (based on auc). no adverse effects on developmental endpoints were noted at 1 mg/kg/day, (19-times the 10 mg clinical dose, based on auc). these outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development. in embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. in rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on auc). dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on auc), which were associated with maternal toxicity. no developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on auc). saxagliptin in embryofetal development studies, saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis, corresponding to the first trimester of human pregnancy. no adverse developmental effects were observed in either species at exposures 1503- and 152-times the 5 mg clinical dose in rats and rabbits, respectively, based on auc. saxagliptin crosses the placenta into the fetus following dosing in pregnant rats. in a prenatal and postnatal development study, no adverse developmental effects were observed in maternal rats administered saxagliptin from gestation day 6 through lactation day 21 at exposures up to 470-times the 5 mg clinical dose, based on auc. risk summary there is no information regarding the presence of qtern or its components (dapagliflozin and saxagliptin) in human milk, the effects on the breastfed infant, or the effects on milk production. dapagliflozin and saxagliptin are present in the milk of lactating rats ( see data) . however, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear. since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in a breastfed infant, advise women that use of qtern is not recommended while breastfeeding. data dapagliflozin dapagliflozin was present at a milk/plasma ratio of 0.49, indicating that dapagliflozin and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. juvenile rats directly exposed to dapagliflozin showed a risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. saxagliptin saxagliptin is secreted in the milk of lactating rats at approximately a 1:1 ratio with plasma drug concentrations. safety and effectiveness of qtern in pediatric patients under 18 years of age have not been established. because elderly patients are more likely to have decreased renal function, care should be taken when using qtern in the elderly based on renal function [see dosage and administration (2.3) ] . dapagliflozin a total of 1424 (24%) of the 5936 dapagliflozin-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical studies assessing the efficacy of dapagliflozin in improving glycemic control. after controlling for level of renal function (egfr), in clinical studies with dapagliflozin, efficacy was similar for patients under age 65 years and those 65 years and older. in patients 65 years and older, a higher proportion of patients treated with dapagliflozin had adverse reactions of hypotension [see warnings and precautions (5.4) ] . saxagliptin in the seven double-blind, controlled clinical safety and efficacy trials of saxagliptin, a total of 4751 (42.0%) of the 11,301 patients randomized to saxagliptin were 65 years and over, and 1210 (10.7%) were 75 years and over. no overall differences in safety or effectiveness were observed between subjects ≥65 years old and younger subjects. while this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. qtern is contraindicated in patients with moderate to severe renal impairment (egfr less than 45 ml/min/1.73 m2 ), esrd, or on dialysis [see dosage and administration (2.3) , contraindications (4) and warnings and precautions (5.4) ]. dapagliflozin dapagliflozin was evaluated in two glycemic control studies that included patients with moderate renal impairment (an egfr of 45 to less than 60 ml/min/1.73 m2 , and an egfr of 30 to less than 60 ml/min/1.73 m2 ). patients with diabetes and renal impairment using dapagliflozin for glycemic control may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion. in the study of patients with an egfr 30 to less than 60 ml/min/1.73 m2 , 13 patients receiving dapagliflozin experienced bone fractures compared to none receiving placebo. qtern may be used in patients with hepatic impairment. however, the benefit-risk for the use of qtern in patients with severe hepatic impairment should be individually assessed since safety and efficacy have not been studied in this population [see clinical pharmacology (12.3) ].

ישראל - אנגלית - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 2.5 mg - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

ישראל - אנגלית - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 5 mg - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

מלזיה - אנגלית - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - saxagliptin hydrochloride; dapagliflozin propanediol -

סינגפור - אנגלית - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - saxagliptin hydrochloride (anhydrous) 2.79 mg eqv saxagliptin - tablet, film coated - 2.5 mg - saxagliptin hydrochloride (anhydrous) 2.79 mg eqv saxagliptin 2.5 mg

סינגפור - אנגלית - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - saxagliptin hydrochloride (anhydrous) 5.58 mg eqv saxagliptin - tablet, film coated - 5 mg - saxagliptin hydrochloride (anhydrous) 5.58 mg eqv saxagliptin 5 mg