फ़िलिपींस - अंग्रेज़ी - FDA (Food And Drug Administration)

takeda healthcare philippines, inc.; distributor: takeda healthcare philippines, inc. - candesartan cilexetil - tablet - 8mg

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat 40 mg - uloric is a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use : uloric is not recommended for the treatment of asymptomatic hyperuricemia. uloric is contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with uloric use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adverse developmental effects were observed in

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86), pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - alogliptin 12.5 mg - oseni is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use oseni should not be used in patients with type 1 diabetes mellitus. serious hypersensitivity reaction to alogliptin or pioglitazone or any of the excipients in oseni, such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see warnings and precautions (5.3), adverse reactions (6.2)] . do not initiate in patients with nyha class iii or iv heart failure [see boxed warning] . risk summary limited data with oseni in pregnant women are not sufficient to inform 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 reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5 and 35 times the 45 mg clinical dose, respectively, based on body surface area. no adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180 and 149 times the 25 mg clinical dose, respectively, based on plasma drug exposure (auc) [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data animal data alogliptin and pioglitazone co-administration of 100 mg/kg alogliptin and 40 mg/kg pioglitazone (39 and 10 times the 25 mg and 45 mg clinical doses, respectively, based on body surface area) to pregnant rats during organogenesis slightly augmented pioglitazone-related fetal effects of delayed development and reduced fetal weights but did not result in embryofetal mortality or teratogenicity. alogliptin alogliptin administered to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at doses of up to 200 mg/kg and 500 mg/kg, or 149 times and 180 times, the 25 mg clinical dose, respectively, based on plasma drug exposure (auc). placental transfer of alogliptin into the fetus was observed following oral dosing to pregnant rats. no adverse developmental outcomes were observed in offspring when alogliptin was administered to pregnant rats during gestation and lactation at doses up to 250 mg/kg (~95 times the 25 mg clinical dose, based on auc). pioglitazone pioglitazone administered to pregnant rats during organogenesis did not cause adverse developmental effects at a dose of 20 mg/kg (~5-times the 45 mg clinical dose), but delayed parturition and reduced embryofetal viability at 40 and 80 mg/kg, or ≥9-times the 45 mg clinical dose, by body surface area. in pregnant rabbits administered pioglitazone during organogenesis, no adverse developmental effects were observed at 80 mg/kg (~35-times the 45 mg clinical dose), but reduced embryofetal viability at 160 mg/kg, or ~69-times the 45 mg clinical dose, by body surface area. when pregnant rats received pioglitazone during late gestation and lactation, delayed postnatal development, attributed to decreased body weight, occurred in offspring at maternal doses of 10 mg/kg and above or ≥2 times the 45 mg clinical dose, by body surface area. risk summary there is no information regarding the presence of pioglitazone or alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. pioglitazone and alogliptin are present in rat milk; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for oseni and any potential adverse effects on the breastfed infant from oseni or from the underlying maternal condition. discuss the potential for unintended pregnancy with premenopausal women as therapy with pioglitazone, like other thiazolidinediones, may result in ovulation in some anovulatory women. safety and effectiveness of oseni in pediatric patients have not been established. oseni is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention and congestive heart failure, fractures and urinary bladder tumors [see warnings and precautions (5.1, 5.5, 5.6, 5.7)] . alogliptin and pioglitazone of the total number of patients (n=1533) in clinical safety and efficacy studies treated with alogliptin and pioglitazone, 248 (16.2%) patients were 65 years and older and 15 (1%) patients were 75 years and older. no overall differences in safety or effectiveness were observed between these patients and younger patients. while this and other reported clinical experiences have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be excluded. alogliptin of the total number of patients (n=9052) in clinical safety and efficacy studies treated with alogliptin, 2257 (24.9%) patients were ≥65 years old and 386 (4.3%) patients were ≥75 years old. no overall differences in safety or effectiveness were observed between patients ≥65 years old and younger patients. pioglitazone a total of 92 patients (15.2%) treated with pioglitazone in the three pooled, 16 to 26 week, double-blind, placebo-controlled, monotherapy trials were ≥65 years old and two patients (0.3%) were ≥75 years old. in the two pooled 16 to 24 week add-on to sulfonylurea trials, 201 patients (18.7%) treated with pioglitazone were ≥65 years old and 19 (1.8%) were ≥75 years old. in the two pooled 16 to 24 week add-on to metformin trials, 155 patients (15.5%) treated with pioglitazone were ≥65 years old and 19 (1.9%) were ≥75 years old. in the two pooled 16 to 24 week add-on to insulin trials, 272 patients (25.4%) treated with pioglitazone were ≥65 years old and 22 (2.1%) were ≥75 years old. in proactive, 1068 patients (41%) treated with pioglitazone were ≥65 years old and 42 (1.6%) were ≥75 years old. in pharmacokinetic studies with pioglitazone, no significant differences were observed in pharmacokinetic parameters between elderly and younger patients. these clinical experiences have not identified differences in effectiveness and safety between the elderly (≥65 years) and younger patients although small sample sizes for patients ≥75 years old limit conclusions [see clinical pharmacology (12.3)] . alogliptin a total of 602 patients with moderate renal impairment (egfr ≥30 and <60 ml/min/1.73 m2 ) and four patients with severe renal impairment/end-stage renal disease (egfr <30 ml/min/1.73 m2 or <15 ml/min/1.73 m2 , respectively) at baseline were treated with alogliptin in clinical trials in patients with type 2 diabetes. reductions in hba1c were generally similar in this subgroup of patients. the overall incidence of adverse reactions was generally balanced between alogliptin and placebo treatments in this subgroup of patients. in the examine trial of high cv risk type 2 diabetes patients, 694 patients had moderate renal impairment and 78 patients had severe renal impairment or end-stage renal disease at baseline. the overall incidences of adverse reactions, serious adverse reactions and adverse reactions leading to study drug discontinuation were generally similar between the treatment groups. alogliptin no dose adjustments are required in patients with mild to moderate hepatic impairment (child-pugh grade a and b) based on insignificant change in systemic exposures (e.g., auc) compared to subjects with normal hepatic function in a pharmacokinetic study. alogliptin has not been studied in patients with severe hepatic impairment (child-pugh grade c). use caution when administering alogliptin to patients with liver disease [see warnings and precautions (5.4)]. pioglitazone no dose adjustments are required in patients with hepatic impairment (child-pugh grade b and c) based on insignificant change in systemic exposures (e.g., auc) compared to subjects with normal hepatic function in a pharmacokinetic study. however, use with caution in patients with liver disease [see warnings and precautions (5.4)].

इसराइल - अंग्रेज़ी - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - metformin hydrochloride; sitagliptin as monohydrate phosphate - tablets - sitagliptin as monohydrate phosphate 50 mg; metformin hydrochloride 1000 mg - metformin - januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. important limitations of use:januet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.januet has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using januet.

इसराइल - अंग्रेज़ी - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - metformin hydrochloride; sitagliptin as monohydrate phosphate - tablets - sitagliptin as monohydrate phosphate 50 mg; metformin hydrochloride 500 mg - metformin - januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. important limitations of use:januet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.januet has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using januet.

इसराइल - अंग्रेज़ी - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - metformin hydrochloride; sitagliptin as monohydrate phosphate - tablets - sitagliptin as monohydrate phosphate 50 mg; metformin hydrochloride 850 mg - metformin - januet is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. important limitations of use:januet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.januet has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using januet.

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - alogliptin benzoate; pioglitazone hcl - tablet, film coated - alogliptin benzoate 12.5 mg; pioglitazone hcl 30 mg

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - alogliptin benzoate; pioglitazone hcl - tablet, film coated - alogliptin benzoate 25 mg; pioglitazone hcl 15 mg

सिंगापुर - अंग्रेज़ी - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - alogliptin benzoate; pioglitazone hcl - tablet, film coated - alogliptin benzoate 25 mg; pioglitazone hcl 30 mg

इसराइल - अंग्रेज़ी - Ministry of Health

takeda israel ltd - albumin human - solution for infusion - albumin human 200 mg / 1 ml - albumin - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.