Active ingredients: Mitoxantrone
Mitoxantrone 2 mg/ml concentrate for solution for infusion.
Concentrate for solution for infusion.
Clear, dark-blue aqueous solution with a pH of 3.0-4.5
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.
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.
Glacial acetic acid
Sodium acetate trihydrate
Sodium metabisulphite (E223)
Water for Injections
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.
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
19th September 2006