TOMUDEX Powder for solution for infusion Ref.[9067] Active ingredients: Raltitrexed

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

Product name and form

Tomudex 2 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

White to cream coloured powder.

Qualitative and quantitative composition

One vial contains 2 mg raltitrexed.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Raltitrexed

Raltitrexed is a folate analogue belonging to the family of anti-metabolites and has potent inhibitory activity against the enzyme thymidylate synthase (TS). Compared to other antimetabolites such as 5-fluorouracil or methotrexate, raltitrexed acts as a direct and specific TS inhibitor. TS is a key enzyme in the de novo synthesis of thymidine triphosphate (TTP), a nucleotide required exclusively for deoxyribonucleic acid (DNA) synthesis. Inhibition of TS leads to DNA fragmentation and cell death.

List of Excipients

Mannitol
Dibasic sodium phosphate (heptahydrate or dodecahydrate)
Sodium hydroxide

Pack sizes and marketing

5 ml clear neutral type I glass vials, with a bromobutyl rubber closure and aluminium crimp seal with a plastic flip-off cover.

The vials are packed in individual cartons to protect the product from light.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 04515/0225

Date of first authorisation: 25 June 2000

Drugs

Drug Countries
TOMUDEX Austria, Australia, Canada, Spain, France, Malta, Turkey, United Kingdom

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