Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
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 |
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 | Description | |
|---|---|---|
| Mitoxantrone |
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 |
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
PL 04515/0127
19th September 2006
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