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

medtas pty ltd - fluorouracil, quantity: 2.5 g - 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.

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

medtas pty ltd - fluorouracil, quantity: 2.5 g - injection, solution - excipient ingredients: water for injections; sodium hydroxide - 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.

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

medtas pty ltd - fluorouracil, quantity: 500 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.

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

medtas pty ltd - fluorouracil, quantity: 1000 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.

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

medtas pty ltd - fluorouracil, quantity: 5 g - injection, solution - excipient ingredients: water for injections; sodium hydroxide - 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)

alembic pharmaceuticals 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 fluorouracil was administered by intraperitoneal in

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

alembic pharmaceuticals limited - 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 fluorouracil was administered by intraperitoneal in

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

sandoz pty ltd - fluorouracil, quantity: 500 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, 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.

Ireland - English - 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

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

accord-uk ltd - fluorouracil sodium - solution for infusion - 50mg/1ml