Wellstat Therapeutics Corporation - search results

United States - English - NLM (National Library of Medicine)

vistogard- uridine triacetate granule

wellstat therapeutics corporation - uridine triacetate (unii: 2wp61f175m) (uridine - unii:whi7hq7h85) - uridine triacetate 951 mg in 1 g - vistogard® is indicated for the emergency treatment of adult and pediatric patients: - following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or - who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. limitations of use - vistogard is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs. - the safety and efficacy of vistogard initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established. none. risk summary limited case reports of uridine triacetate use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. when adminis

United States - English - NLM (National Library of Medicine)

xuriden- uridine triacetate granule

wellstat therapeutics corporation - uridine triacetate (unii: 2wp61f175m) (uridine - unii:whi7hq7h85) - uridine triacetate 951 mg in 1 g - xuriden® is indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria. none risk summary there are no available data on xuriden use in pregnant women to inform a drug-associated risk. when administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses similar to the maximum recommended human dose (mrhd) of 120 mg/kg per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see data] . the background risk of major birth defects and miscarriage for the indicated population are 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. data animal data in an embryo-fetal development study, uridine triacetate was administered orally to pregnant rats during the period of organogenesis at doses up to 2000 mg/kg per day (about 2.7 times the maximum recommended human dose (mrhd) of 120

Canada - English - Health Canada

zovirax 400 tablet

glaxosmithkline inc - acyclovir - tablet - 400mg - acyclovir 400mg - nucleosides and nucleotides

Canada - English - Health Canada

zovirax 800 tablet

glaxosmithkline inc - acyclovir - tablet - 800mg - acyclovir 800mg - nucleosides and nucleotides

Israel - English - Ministry of Health

relestat

abbvie biopharmaceuticals ltd, israel - epinastine hydrochloride - ophthalmic solution - epinastine hydrochloride 0.05 %w/v - epinastine - epinastine - treatment of the symptoms of seasonal allergic conjunctivitis.