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

xiromed llc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil is indicated for the treatment of patients with: none. pregnancy category d risk summary  there are no adequate and well-controlled studies with fluorouracil in pregnant women. based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. malformations included cleft palate and skeletal defects. in monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see clinical pharmacology (12.1)].  animal data  malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouracil was administered b

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

bluepoint laboratories - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil is indicated for the treatment of patients with: 1.1adenocarcinoma of the colon and rectum 1.2adenocarcinoma of the breast 1.3gastric adenocarcinoma 1.4pancreatic adenocarcinoma  none. pregnancy category d risk summary  there are no adequate and well-controlled studies with fluorouracil in pregnant women. based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. malformations included cleft palate and skeletal defects. in monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see clinical pharmacology (12.1)]. 

Malta - English - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare limited - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - fluorouracil - solution for infusion or injection - fluorouracil 50 mg/ml - antineoplastic agents