Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bausch health us, llc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 0.5 g in 10 ml - efudex 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 efudex 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. efudex 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 defect (cleft lip and palate) has been reported in the newborn of a patient using efudex as recommended. one birth defect (ventricular septal defect) and cases of miscarriage have been reported when efudex was applied to mucous membrane areas. multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil. animal reproduction studies have not been conducted with efudex. fluorouracil administered parenterally has been shown to be teratogenic in mice, rats, and hamsters when given at doses equivalent to the usual human intravenous dose; however, the amount of fluorouracil absorbed systemically after topical administration to actinic keratoses is minimal (see clinical pharmacology). fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on day 10 or 12 of gestation. similarly, intraperitoneal doses of 12 to 37 mg/kg given to rats between days 9 and 12 of gestation and intramuscular doses of 3 to 9 mg/kg given to hamsters between days 8 and 11 of gestation were teratogenic and/or embryotoxic (i.e., resulted in increased resorptions or embryolethality). in monkeys, divided doses of 40 mg/kg given between days 20 and 24 of gestation were not teratogenic. doses higher than 40 mg/kg resulted in abortion. efudex should not be used in patients with dihydropyrimidine dehydrogenase (dpd) enzyme deficiency. a large percentage of fluorouracil is catabolized by the dpd enzyme. dpd enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities. efudex is contraindicated in women who are or may become pregnant during therapy. if this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus. efudex is also contraindicated in patients with known hypersensitivity to any of its components.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mayne pharma inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - 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 defe

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

accord healthcare inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil cream usp 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 usp 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 bi

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil cream usp 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 usp 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 bi

Izraēla - angļu - Ministry of Health

megapharm ltd - fluorouracil - cream - fluorouracil 50 mg / 1 g - pyrimidine analogues - antineoplastic agent to treat actinic keratosis multiple and superfacial basel cell carcinoma.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

cvn pharma pty ltd - fluorouracil, quantity: 5 % w/w - cream - excipient ingredients: white soft paraffin; methyl hydroxybenzoate; propyl hydroxybenzoate; polysorbate 60; stearyl alcohol; purified water; propylene glycol - solar and senile keratoses, bowen's disease.

Izraēla - angļu - 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.

Malta - angļu - Malta Medicines Authority

meda pharmaceuticals limited - fluorouracil - cream - fluorouracil - antineoplastic agents

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

spear dermatology products - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 5 mg in 1 g

Kanāda - angļu - Health Canada

hill dermaceuticals inc - fluorouracil (fluorouracil sodium) - cream - 4% - fluorouracil (fluorouracil sodium) 4% - misc. skin and mucous membrane agents