MITOXANTRONE Concentrate for solution for infusion

Active ingredients: Mitoxantrone

Product name and form

Mitoxantrone 2 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear, dark-blue aqueous solution with a pH of 3.0-4.5

Qualitative and quantitative composition

Each millilitre of concentrate contains 2 mg mitoxantrone (as hydrochloride). Each 10 ml vial contains 20 mg mitoxantrone (as hydrochloride).

Excipient(s) with known effect: This medicinal product contains 1.4 mmol sodium per 10 ml vial.

For the full list of excipients, see section 6.1.

Active Ingredient

Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA.

List of Excipients

Glacial acetic acid
Sodium acetate trihydrate
Sodium chloride
Sodium metabisulphite (E223)
Water for Injections

Pack sizes and marketing

Not all pack sizes may be marketed.

20 mg/10 ml in a clear Type I glass vial (with or without Onco-Tain shrink wrapping) with rubber closure, presented in packs of single vials.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 04515/0127

19th September 2006