Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

ailex pharmaceuticals, llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - sodium phenylacetate and sodium benzoate injection, 10%/10% is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. during acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see warnings and precautions (5) ]. none. pregnancy category c. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection, 10%/10%. it is not known whether sodium phenylacetate and sodium benzoate injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, sodium phenylacetate and sodium benzoate injection, 10%/10% should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their conjugation p

Israel - Tiếng Anh - Ministry of Health

teva medical marketing ltd. - sodium chloride - solution for infusion - sodium chloride 0.9 %w/v - sodium chloride - treatment of isotonic extracellular dehydration. treatment of sodium depletion. vehicle or diluent of compatible drugs for parenteral administration.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

american health packaging - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mother. th

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

impax generics - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mother. th

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

bluepoint laboratories - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing moth

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. risk summary available published data on the use of ursodiol in pregnant women derived from randomized controlled trials, observational studies, and case series collected over several decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to ursodiol occurred in the second and third trimester of pregnancy. in animal reproduction studies, ursodiol had no adverse effects on embryo-fetal development when administered at doses greater than human therapeutic doses (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or ot

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

impax generics - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mother. th

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

actavis pharma, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg -       ursodiol tablets, usp 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cirrhosis (pbc).       patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation.       reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.       it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol tablets, us

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

par pharmaceutical, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets, usp are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mothe

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

avera mckennan hospital - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 250 mg - ursodiol tablets, usp are indicated for the treatment of patients with primary biliary cirrhosis (pbc). patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation. pregnancy category b. reproduction studies have been performed in pregnant rats at oral doses up to 22 times the recommended maximum human dose (based on body surface area) and in pregnant rabbits at oral doses up to 7 times the recommended maximum human dose (based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ursodiol. there are no adequate or well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether ursodiol is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when ursodiol are administered to a nursing mothe