MITOXANTRONE Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Mitoxantrone 2 mg/ml concentrate for solution for infusion.
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 ...
Pharmaceutical form
Concentrate for solution for infusion. Clear, dark-blue aqueous solution with a pH of 3.0-4.5
Therapeutic indications
Mitoxantrone is indicated in the treatment of metastatic breast cancer. Mitoxantrone is indicated in the treatment of non-Hodgkins lymphoma. Mitoxantrone is indicated for the treatment of acute myeloid ...
Posology and method of administration
Posology Mitoxantrone should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapy agents. Metastatic breast cancer and Non-Hodgkins lymphoma Single Agent ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including sulphites that may be produced during the manufacturing of mitoxantrone. Mitoxantrone is contraindicated ...
Special warnings and precautions for use
Precautions to be taken before handling or administering the medicinal product Mitoxantrone should be given slowly into a freely flowing intravenous infusion. Mitoxantrone must not be given subcutaneously, ...
Interaction with other medicinal products and other forms of interaction
Combining mitoxantrone with potentially cardiotoxic active substances (e.g. anthracyclines) increases the risk of cardiac toxicity. Topoisomerase II inhibitors, including mitoxantrone, when used concomitantly ...
Fertility, pregnancy and lactation
Contraception in males and females Mitoxantrone is genotoxic and is considered a potential human teratogen. Therefore men under therapy must be advised not to father a child and to use contraceptive measures ...
Effects on ability to drive and use machines
Mitoxantrone has minor influence on the ability to drive and use machines. Confusion and fatigue may occur following administration of mitoxantrone (see section 4.8).
Undesirable effects
Summary of the safety profile The most serious side effects with mitoxantrone are myocardial toxicity and myelosuppression. The most common side effects with mitoxantrone (seen in more than 1 patient in ...
Overdose
There is no known specific antidote for mitoxantrone. Accidental overdoses have been reported. Four patients receiving 140 to 180 mg/m2 as a single bolus injection died as a result of severe leukopenia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, Anthracyclines and related substances ATC Code: L01DB07 Mechanism of action Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic ...
Pharmacokinetic properties
Absorption The pharmacokinetics of mitoxantrone in patients following single-dose intravenous administration can be characterised by a three-compartment model. In patients administered 15-90 mg/m², there ...
Preclinical safety data
Single and repeat toxicity studies were conducted in mouse, rat, dog, rabbits, and monkey. The haematopoietic system was the primary target organ of toxicity showing myelosuppression. Heart, kidney, gastrointestinal ...
List of excipients
Glacial acetic acid Sodium acetate trihydrate Sodium chloride Sodium metabisulphite (E223) Water for Injections
Incompatibilities
Mitoxantrone Sterile Concentrate must not be mixed in the same infusion as heparin since a precipitate may form. It is recommended that Mitoxantrone Sterile Concentrate not be mixed in the same infusion ...
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Mitoxantrone Sterile Concentrate does not contain an antimicrobial preservative. Chemical and physical stability of the diluted product has been demonstrated ...
Nature and contents of container
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.
Special precautions for disposal and other handling
Single use only. Discard any unused contents. Any unused medicinal product or waste materials should be disposed of in accordance with local requirements. Mitoxantrone, in common with other potentially ...
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Marketing authorization number(s)
PL 04515/0127
Date of first authorization / renewal of the authorization
19th September 2006
Date of revision of the text
12/2019
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