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

rebel distributors corp - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 g - fluorouracil 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 cream is approximately 93%, based on 113 lesions in 54 patients. eighty-eight lesions treated with the cream produced 7 failures. fluorouracil cream may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. one birth defec

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

physicians total care, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 g - fluorouracil 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 cream is approximately 93%, based on 113 lesions in 54 patients. eighty-eight lesions treated with the cream produced 7 failures. fluorouracil cream may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. one birth defec

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

taro pharmaceutical industries ltd. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 g - fluorouracil 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 cream and solution 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 may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies in pregnant women with either the topi

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

gland pharma limited - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - fluorouracil is indicated for the treatment of patients with: 1.1 adenocarcinoma of the colon and rectum 1.2 adenocarcinoma of the breast 1.3 gastric adenocarcinoma 1.4 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 defects and deformed appendages (paws and tails) were observed when fluorouracil was administered by intraperitoneal injection to mice at doses at or above 10 mg/kg (approximately 0.06 times a human dose of 12 mg/kg on a mg/m2 basis) for 4 days during the period of organogenesis. similar results were observed in hamsters administered fluorouracil intramuscularly at doses lower than those administered in commonly used clinical treatment regimens. in rats, administration of fluorouracil by intraperitoneal injection at doses greater than 15 mg/kg (approximately 0.2 times a human dose of 12 mg/kg on a mg/m2  basis) for a single day during organogenesis resulted in delays in growth and malformations including microanophthalmos. in monkeys, administration of fluorouracil during organogenesis at doses approximately equal to a human dose of 12 mg/kg on a mg/m2  basis resulted in abortion; at a 50% lower dose, resorptions and decreased fetal body weights were reported. it is not known whether fluorouracil or its metabolites are present in human milk. because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness in pediatric patients have not been established. reported clinical experience has not identified differences in safety or effectiveness between the elderly and younger patients. contraception females based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. advise females of reproductive potential to use effective contraception during treatment with fluorouracil and for up to 3 months following cessation of therapy [see use in specific populations (8.1)]. males fluorouracil may damage spermatozoa. advise males with female partners of reproductive potential to use effective contraception during and for 3 months following cessation of therapy with fluorouracil [see nonclinical toxicology (13.1)].   infertility females advise females of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil [see nonclinical toxicology (13.1)].   males advise males of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil [see nonclinical toxicology (13.1)].

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, skele

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

bluepoint laboratories - 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 (paws and tails) were observed when fluorouracil was administered by intraperitoneal injection

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)

sandoz inc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - fluorouracil is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas. fluorouracil therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function, those with potentially serious infections or those with a known hypersensitivity to fluorouracil.

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.