Saudi - Kiingereza - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

bristol-myers squibb - metformin hydrochloride, saxagliptin - film-coated tablet - 5, 500 mg

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

bristol-myers squibb australia pty ltd - saxagliptin; metformin hydrochloride -

Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

napp pharmaceuticals ltd - canagliflozin hemihydrate; metformin hydrochloride - tablet - 50mg ; 1gram

Marekani - Kiingereza - 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).

Marekani - Kiingereza - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - saxagliptin hydrochloride (unii: z8j84yix6l) (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 it would not be effective in these settings. saxagliptin tablets are contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin, such as anaphylaxis, angioedema, or exfoliative skin conditions [see warnings and precautions (5.4) and adverse reactions (6.2) ]. risk summary limited data with saxagliptin 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

Marekani - Kiingereza - NLM (National Library of Medicine)

amneal pharmaceuticals llc - saxagliptin hydrochloride (unii: z8j84yix6l) (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 it would not be effective in these settings. saxagliptin tablets are contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin, such as anaphylaxis, angioedema, or exfoliative skin conditions [see warnings and precautions (5.4)  and adverse reactions (6.2) ]. risk summary limited data with saxagliptin 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

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

astrazeneca limited - saxagliptin hydrochloride 2.98mg equivalent to saxagliptin 2.5 mg - film coated tablet - 2.5 mg - active: saxagliptin hydrochloride 2.98mg equivalent to saxagliptin 2.5 mg excipient: croscarmellose sodium hydrochloric acid lactose monohydrate magnesium stearate microcrystalline cellulose opacode blue s-1-10619 opadry ii yellow 85f92209 opadry white 85f18422 purified water - onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

astrazeneca limited - saxagliptin hydrochloride 5.95mg equivalent to saxagliptin 5 mg - film coated tablet - 5 mg - active: saxagliptin hydrochloride 5.95mg equivalent to saxagliptin 5 mg excipient: croscarmellose sodium hydrochloric acid lactose monohydrate magnesium stearate microcrystalline cellulose opacode blue s-1-4118 opadry pink 85f14452 opadry white 85f18422 purified water - onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Bahareni - Kiingereza - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

wael pharmacy - metformin hydrochloride, saxagliptin - tablet - 5

Bahareni - Kiingereza - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

wael pharmacy - metformin hydrochloride, saxagliptin - tablet - 5