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

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - fluorouracil 5%{relative};  ;   - topical cream - 5% w/w - active: fluorouracil 5%{relative}     excipient: methyl hydroxybenzoate polysorbate 60 propyl hydroxybenzoate propylene glycol purified water stearyl alcohol white soft paraffin - dp-fluorouracil is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenical forms, keratoa canthoma; bowen's disease; superficial basal-cell carcinoma.

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

fresenius kabi usa, llc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - fluorouracil is indicated for the treatment of patients with: •  adenocarcinoma of the colon and rectum •  adenocarcinoma of the breast •  gastric adenocarcinoma •  pancreatic 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)]. animal data malformations including cleft palate, skeletal

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

sagent pharmaceuticals - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - fluorouracil injection 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 by intraperitoneal

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

fresenius kabi usa, llc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - fluorouracil is indicated for the treatment of patients with: •  adenocarcinoma of the colon and rectum •  adenocarcinoma of the breast •  gastric adenocarcinoma •  pancreatic 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)]. animal data malformations including cleft palate, skeletal

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

accord healthcare, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - 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

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

mylan pharmaceuticals inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 5 mg in 1 g - fluorouracil 5% topical cream is recommended for the topical treatment of multiple actinic or solar keratoses. in the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. safety and efficacy in other indications have not been established. the diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. with isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. the success rate with fluorouracil 5% topical cream is approximately 93%, based on 113 lesions in 54 patients. twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures. fluorouracil 5% topical cream may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pr