IFOSFAMIDE INJECTION Powder for concentrate for solution for infusion Ref.[9061] Active ingredients: Ifosfamide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Product name and form

Ifosfamide Injection 1g.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

White powder.

Qualitative and quantitative composition

Each vial contains 1g of ifosfamide.

When reconstituted as directed, each milliliter of concentrate contains 80 mg Ifosfamide.

Active Ingredient Description
Ifosfamide

Ifosfamide is an antineoplastic, a cytotoxic alkylating agent. It is a prodrug and shows no in vitro cytotoxic activity until activated by microsomal enzymes. The cytotoxic activity of ifosfamide (alkylation of the nucleophilic centres in the cells) is associated with the activated oxazaphosphorine ring hydroxylated at the C4 atom which interacts with DNA-DNA cross linking. This activity manifests itself by blocking the late S and early G2 phases of the cell cycle.

List of Excipients

None.

Pack sizes and marketing

Type I or Type III clear glass injection vial with bromobutyl rubber closure and beading cap. Vials are packed singly in a cardboard box.

Vials are packed with or without a protective plastic overwrap. Protective plastic overwrap does not come into contact with the medicinal product and provides additional transport protection, which increases the safety for the medical and pharmaceutical personnel.

Marketing authorization holder

Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Marketing authorization dates and numbers

PL 00116/0392

15 December 2003

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