Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Accord Healthcare Limited, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Fluorouracil 50 mg/ml Solution for Injection or Infusion.
Pharmaceutical Form |
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Solution for Injection or Infusion. A clear colourless solution with a pH in the range of 8.6 to 9.4. |
1 ml of solution contains 50 mg of fluorouracil (as sodium salt formed in situ).
Each 5 ml vial contains 250 mg of fluorouracil.
Each 10 ml vial contains 500 mg of fluorouracil.
Each 20 ml vial contains 1000 mg of fluorouracil.
Each 50 ml vial contains 2500 mg of fluorouracil.
Each 100 ml vial contains 5000 mg of fluorouracil.
Excipients with known effect: 8.25 mg/ml (0.360 mmol/ml) sodium
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Fluorouracil |
Fluorouracil is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine – which become the building blocks of DNA. They prevent these substances from becoming incorporated into DNA during the “S” phase (of the cell cycle), stopping normal development and division. Fluorouracil blocks an enzyme which converts the cytosine nucleotide into the deoxy derivative. In addition, DNA synthesis is further inhibited because Fluorouracil blocks the incorporation of the thymidine nucleotide into the DNA strand. Fluorouracil is used 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. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid. |
List of Excipients |
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Sodium hydroxide (For pH adjustment) |
Fluorouracil Injection 50 mg/ml, 5 ml is filled in 5 ml Type I clear glass vials with rubber closure.
Fluorouracil Injection 50 mg/ml, 10 ml is filled in 10 ml Type I clear glass vials with rubber closure.
Fluorouracil Injection 50 mg/ml, 20 ml is filled in 20 ml Type I clear glass vials with rubber closure.
Fluorouracil Injection 50 mg/ml, 50 ml is filled in 50 ml Type I clear glass vials with rubber closure.
Fluorouracil Injection 50 mg/ml, 100ml is filled in 100 ml Type I clear glass vials with rubber closure.
Pack sizes:
Pack of 1X 5 ml vial
Pack of 1X 10 ml vial
Pack of 1X 20 ml vial
Pack of 1X 50 ml vial
Pack of 1X 100 ml vial
Not all pack sizes may be marketed.
Accord Healthcare Limited, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0078
10/06/2009 / 28/04/2014
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