METHOTREXATE Solution for Injection Ref.[6979] Active ingredients: Methotrexate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Product name and form

Methotrexate 2.5 mg/ml Injection.

Pharmaceutical Form

Solution for Injection.

Vials containing a clear yellow solution.

Qualitative and quantitative composition

Each ml of solution contains 2.5 mg methotrexate (sodium salt formed in situ).

Each vial of 2 ml of solution contains 5 mg methotrexate (sodium salt formed in situ).

For excipients, see 6.1.

Active Ingredient Description
Methotrexate

Methotrexate (4-amino-10-methylfolic acid) is a folic acid antagonist which inhibits the reduction of folic acid and increase of tissue cells. Methotrexate enters the cell through an active transport mechanism of reduced folates. As a result of polyglutamation of methotrexate caused by the folylpolyglutamylate enzyme, the duration of the cytotoxic effect of the drug substance in the cell increases.

List of Excipients

Sodium chloride
Sodium hydroxide
Water for Injections

Pack sizes and marketing

5 mg/2 ml: Conventional or Onco-Tain Type I glass vial with rubber stopper, aluminium seal and plastic ‘flip-off’ top. Packs containing 5 vials.

Not all presentations and pack sizes listed above may be marketed.

Marketing authorization holder

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Marketing authorization dates and numbers

PL 04515/0013

21st March 2003

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