Malesia - inglese - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - metformin hydrochloride; saxagliptin hydrochloride - tablet - 850mg ; 2.5mg

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - metformin hydrochloride; saxagliptin hydrochloride - tablet - 1gram ; 2.5mg

Unione Europea - inglese - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, saxagliptin, dapagliflozin - diabetes mellitus, type 2 - drugs used in diabetes - qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin with or without sulphonylurea (su) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control.when already being treated with metformin and saxagliptin and dapagliflozin.

Stati Uniti - inglese - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - saxagliptin hydrochloride dihydrate (unii: 4n19on48zn) (saxagliptin anhydrous - unii:8i7io46ivq) - saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see  clinical studies (14) ]. saxagliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as they would not be effective in these settings. saxagliptin tablets are contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin tablets, such as anaphylaxis, angioedema, or exfoliative skin conditions [see warnings and precautions (5.4) and adverse reactions (6.2) ]. limited data with saxagliptin tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations ]. no adverse developmental effects independent of maternal toxicity were observed when saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis and in pregnant and lactating rats during the pre- and postnatal period [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. poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. in embryo-fetal 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. there is no information regarding the presence of saxagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. saxagliptin is present in the milk of lactating rats [see data ]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for saxagliptin tablets and any potential adverse effects on the breastfed infant from saxagliptin tablets or from the underlying maternal condition. saxagliptin is secreted in the milk of lactating rats at approximately a 1:1 ratio with plasma drug concentrations. safety and effectiveness of saxagliptin tablets in pediatric patients under 18 years of age have not been established. additionally, studies characterizing the pharmacokinetics of saxagliptin tablets in pediatric patients have not been performed. in the seven, double-blind, controlled clinical safety and efficacy trials of saxagliptin tablets, a total of 4751 (42.0%) of the 11301 patients randomized to saxagliptin tablets 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. saxagliptin and its active metabolite are eliminated in part by the kidney. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function [see dosage and administration (2.2) and clinical pharmacology (12.3) ]. in a 12-week randomized placebo-controlled trial, saxagliptin tablets 2.5 mg were administered to 85 subjects with moderate (n = 48) or severe (n = 18) renal impairment or end-stage renal disease (esrd) (n = 19) [see clinical studies (14) ]. the incidence of adverse events, including serious adverse events and discontinuations due to adverse events, was similar between saxagliptin tablets and placebo. the overall incidence of reported hypoglycemia was 20% among subjects treated with saxagliptin tablets 2.5 mg and 22% among subjects treated with placebo. four saxagliptin tablet-treated subjects (4.7%) and three placebo-treated subjects (3.5%) reported at least one episode of confirmed symptomatic hypoglycemia (accompanying fingerstick glucose ≤ 50 mg/dl).

Canada - inglese - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); metformin hydrochloride - tablet - 2.5mg; 500mg - saxagliptin (saxagliptin hydrochloride) 2.5mg; metformin hydrochloride 500mg - biguanides

Canada - inglese - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); metformin hydrochloride - tablet - 2.5mg; 850mg - saxagliptin (saxagliptin hydrochloride) 2.5mg; metformin hydrochloride 850mg - biguanides

Canada - inglese - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); metformin hydrochloride - tablet - 2.5mg; 1000mg - saxagliptin (saxagliptin hydrochloride) 2.5mg; metformin hydrochloride 1000mg - biguanides

Unione Europea - inglese - EMA (European Medicines Agency)

astrazeneca ab  - metformin hydrochloride, saxagliptin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.

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

astrazeneca pty ltd - saxagliptin, quantity: 2.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; magnesium stearate; lactose monohydrate; 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 - 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).