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

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)

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

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

hi-tech pharmacal co., inc. - trifluridine (unii: rmw9v5rw38) (trifluridine - unii:rmw9v5rw38) - trifluridine 10 mg in 1 ml - trifluridine ophthalmic solution, 1% (trifluridine ophthalmic solution) is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2. trifluridine ophthalmic solution, 1% is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.

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

greenstone llc - trifluridine (unii: rmw9v5rw38) (trifluridine - unii:rmw9v5rw38) - trifluridine 1 g in 100 ml

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

sandoz inc - trifluridine (unii: rmw9v5rw38) (trifluridine - unii:rmw9v5rw38) - indications and usage: trifluridine ophthalmic solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2. contraindications: trifluridine ophthalmic solution is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.

Canada - English - Health Canada

apotex inc - trifluridine - solution - 1% - trifluridine 1% - antivirals

Canada - English - Health Canada

sandoz canada incorporated - trifluridine - solution - 1% - trifluridine 1% - antivirals

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

ax pharmaceutical corp - idoxuridine (unii: lgp81v5245) (idoxuridine - unii:lgp81v5245) - idoxuridine .99 g in 1 g

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - idoxuridine 0.5 g - topical powder - 0.5 g - active: idoxuridine 0.5 g

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

servier laboratories (aust) pty ltd - trifluridine, quantity: 20 mg; tipiracil hydrochloride, quantity: 9.42 mg - tablet, film coated - excipient ingredients: purified talc; stearic acid; macrogol 8000; titanium dioxide; hypromellose; indigo carmine aluminium lake; iron oxide yellow; carnauba wax; magnesium stearate; lactose monohydrate; iron oxide red; shellac; pregelatinised maize starch - colorectal cancer lonsurf is indicated for the treatment of adult patients with metastatic colorectal cancer (mcrc) who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti-egfr agents.,gastric cancer lonsurf is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, her2/neu-targeted therapy.