Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - fluorouracil sodium - solution for injection/infusion - 25 milligram(s)/millilitre - pyrimidine analogues; fluorouracil

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

sandoz inc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil injection, usp 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.

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

accord healthcare, inc. - 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 fluorouraci

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

gland pharma limited - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - 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)].

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ebewe pharma - fluorouracil - concentrate for solution for injection - 50 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ebewe pharma - fluorouracil - concentrate for solution for injection - 50 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ebewe pharma, austria - fluorouracil - solution for injection - 50 mg/ml

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)]. 

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - fluorouracil - injection - 50 mg/ml - fluorouracil 50 mg/ml

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

pfizer australia pty ltd - fluorouracil, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections - fluorouracil is indicated 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.