ONKOTRONE Concentrate for solution for infusion Ref.[27750] Active ingredients: Mitoxantrone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Product name and form

Onkotrone Injection.

2 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Sterile dark blue aqueous solution.

Qualitative and quantitative composition

Each 1 ml of solution contains 2 mg mitoxantrone (as hydrochloride).

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

Sodium chloride
Sodium acetate
Acetic acid
Water for injections
Carbon dioxide
Nitrogen

Pack sizes and marketing

Containers:

Clear glass type 1 injection vial with rubber stopper and aluminium flange cap.

Contents:

Onkotrone Injection is a sterile dark blue aqueous solution of mitoxantrone hydrochloride equivalent to 2 mg/ml. It is available in the following vial sizes:

  • 1 injection vial containing 20 mg mitoxantrone in 10 ml injection solution
  • 1 injection vial containing 25 mg mitoxantrone in 12.5 ml injection solution
  • 1 injection vial containing 30 mg mitoxantrone in 15 ml injection solution

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00116/0398

Date of first authorisation: 14 September 2004
Date of last renewal: 16 September 2010

Drugs

Drug Countries
ONKOTRONE Australia, Estonia, Lithuania, Malta, New Zealand, Romania, United Kingdom

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