Australia - English - 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

Israel - English - 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Israel - English - 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.

Israel - English - 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.

Canada - English - Health Canada

cipher pharmaceuticals inc - fluorouracil; salicylic acid - solution - 0.5%; 10% - fluorouracil 0.5%; salicylic acid 10% - antineoplastic agents

Israel - English - Ministry of Health

salomon,levin & elstein ltd - fluorouracil - solution for injection - fluorouracil 50 mg/ml - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - fluorouracil 50 mg/ml - solution for injection - 50 mg/ml - active: fluorouracil 50 mg/ml excipient: nitrogen sodium hydroxide water for injection - alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas. fluorouracil should only be used when other proven measures have failed or are considered impractical.

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

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

sandoz pty ltd - fluorouracil, quantity: 5000 mg - injection, solution - excipient ingredients: sodium hydroxide; water for injections - alone or in combination, for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas. fluorouracil should only be used when other proven measures have failed or are considered impractical.