Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

xiromed llc - 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 pa

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

bluepoint laboratories - 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

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - . . . . 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.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

alembic pharmaceuticals limited - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - . . . . 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.

Iirimaa - inglise - HPRA (Health Products Regulatory Authority)

generics (uk) limited - fluorouracil - solution for inj/inf - 50 mg/ml - pyrimidine analogues - pyrimidine analogues - it is indicated in the treatment of the following malignancies and disease settings: in the treatment of metastatic colorectal cancer; as adjuvant treatment in colon and rectal cancer; in the treatment of advanced gastric cancer; in the treatment of advanced pancreatic cancer; in the treatment of advanced oesophageal cancer; in the treatment of advanced or metastatic breast cancer; as adjuvant treatment in patients with operable primary invasive breast cancer; in the treatment of inoperable locally advanced squamous cell carcinoma of the head and neck in previously untreated patients; in the treatment of locally recurrent or metastatic squamous cell carcinoma of the head and neck

Iirimaa - inglise - HPRA (Health Products Regulatory Authority)

hospira uk limited - fluorouracil sodium - solution for inj/inf - 25 mg/ml - pyrimidine analogues

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

pierre fabre pharmaceuticals, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 40 mg in 1 g - tolak (fluorouracil) cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. tolak cream is contraindicated: - during pregnancy [see warnings and precautions (5.5, 8.1)] - in patients with dihydropyrimidine dehydrogenase (dpd) deficiency [see warnings and precautions (5.6)] tolak cream may cause fetal harm when administered during pregnancy and is contraindicated in women who are pregnant. 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. tolak cream is contraindicated in patients with dihydropyrimidine dehydrogenase (dpd) deficiency. teratogenic effects: pregnancy category x [see contraindications (4.1)] . cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported wh

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

teva parenteral medicines, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 50 mg in 1 ml - adrucil (fluorouracil injection) is indicated for the treatment of patients with: none. teratogenic effects 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 wa

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

hill dermaceuticals, inc. - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 0.04 g in 1 g - tolak (fluorouracil) cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. tolak cream is contraindicated: - during pregnancy [see warnings and precautions (5.5, 8.1)] - in patients with dihydropyrimidine dehydrogenase (dpd) deficiency [see warnings and precautions (5.6)] tolak cream may cause fetal harm when administered during pregnancy and is contraindicated in women who are pregnant. 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. tolak cream is contraindicated in patients with dihydropyrimidine dehydrogenase (dpd) deficiency. teratogenic effects: pregnancy category x [see contraindications (4.1)] . cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported when pregnant women were exposed to a topical or parenteral fluorouracil product. in addition, ventricular septal defect and cases of miscarriage

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

almirall, llc - fluorouracil (unii: u3p01618rt) (fluorouracil - unii:u3p01618rt) - fluorouracil 10 mg in 1 g - fluoroplex cream is indicated for the topical treatment of multiple actinic (solar) keratoses. fluorouracil is contraindicated in women who are or may become pregnant. this product should not be used by patients who are allergic to any of its components.