Australie - anglais - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - fluorouracil, quantity: 0.5 g; salicylic acid, quantity: 10 g - solution - excipient ingredients: butyl methacrylate/methyl methacrylate copolymer (3:1); ethyl acetate; dimethyl sulfoxide; ethanol absolute; pyroxylin - actikerall is indicated for the topical treatment of solar (actinic) keratosis

Israël - anglais - Ministry of Health

neopharm ltd - fluorouracil; salicylic acid - solution - salicylic acid 10 g / 100 g; fluorouracil 0.5 g / 100 g - wart and anti-corn preparations - common warts ( special form : plantar warts, on areas of the sole of the foot that are subjected to pressure), plane juvenile warts of the extremities.

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

almirall ltd - fluorouracil; salicylic acid - cutaneous solution - 5mg/1gram ; 100mg/1gram

Israël - anglais - Ministry of Health

abic marketing ltd, israel - fluorouracil - solution for injection - fluorouracil 50 mg/ml - fluorouracil - fluorouracil - palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas, in selected patients considered incurable by surgery or other means.as leucovorin-fluorouracil chemotherapy combination for cancer treatment.

Israël - anglais - Ministry of Health

novartis israel ltd - fluorouracil - concentrate for solution for injection / infusion - fluorouracil 50 mg/ml - fluorouracil - fluorouracil - palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas, in selected patients considered incurable by surgery or other means.as leucovorin-fluorouracil chemotherapy combination for cancer treatment.

États-Unis - anglais - 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

États-Unis - anglais - 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

États-Unis - anglais - 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

États-Unis - anglais - 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

États-Unis - anglais - 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