Singapore - inglese - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - azilsartan medoxomil potassium 42.68mg eqv azilsartan medoxomil - tablet - 40mg

Singapore - inglese - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - azilsartan medoxomil potassium 42.68mg eqv azilsartan medoxomil - tablet - 40mg

Stati Uniti - inglese - 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

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

takeda pharmaceuticals america, inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - alogliptin 12.5 mg - kazano is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use kazano is not recommended for use in patients with type 1 diabetes mellitus. kazano is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. - history of serious hypersensitivity reaction to alogliptin or metformin or any of the excipients in kazano, such as anaphylaxis, angioedema and severe cutaneous adverse reactions [see warnings and precautions (5.4), adverse reactions (6.2)]. risk summary limited available data with kazano or alogliptin in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [se

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

takeda pharmaceuticals america, inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86) - alogliptin 6.25 mg - nesina is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use nesina is not recommended for use in patients with type 1 diabetes mellitus. nesina is contraindicated in patients with a history of serious hypersensitivity to alogliptin or any of the excipients in nesina. reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see warnings and precautions (5.3), adverse reactions (6.2)] . risk summary limited data with nesina 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 mellitus in pregnancy [see clinical considerations] . 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

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

takeda pharmaceuticals america, inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon 8 mg - rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with rozerem should not be rechallenged with the drug. patients should not take rozerem in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with rozerem use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the rec

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

takeda pharmaceuticals america, inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - vortioxetine 5 mg - trintellix is indicated for the treatment of major depressive disorder (mdd) in adults. - hypersensitivity to vortioxetine or any component of the formulation. hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with trintellix [see adverse reactions (6.2)] . - the use of maois intended to treat psychiatric disorders with trintellix or within 21 days of stopping treatment with trintellix is contraindicated because of an increased risk of serotonin syndrome. the use of trintellix within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.4), warnings and precautions (5.2)] . starting trintellix in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monit

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

takeda pharmaceuticals america, inc. - dexlansoprazole (unii: uye4t5i70x) (dexlansoprazole - unii:uye4t5i70x) - dexlansoprazole 30 mg - dexilant is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (ee) for up to eight weeks. dexilant is indicated in patients 12 years of age and older to maintain healing of ee and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. dexilant is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (gerd) for four weeks. - dexilant is contraindicated in patients with known hypersensitivity to any component of the formulation [see description (11)] . hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria [see warnings and precautions (5.2), adverse reactions (6)] . - ppis, including dexilant, are contraindicated with rilpivirine-containing products [see drug interactions (7)] . risk summary there are no studies with dexlansoprazole us

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

takeda malaysia sdn bhd - vonoprazan fumarate -

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

takeda malaysia sdn bhd - vonoprazan fumarate -