1. NAME OF THE MEDICINAL PRODUCT
SHOULD READ AS FOLLOWS:
Mitoxantrone 2 mg/ml Concentrate for Solution for Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SHOULD READ AS FOLLOWS:
Each millilitre of concentrate contains 2 mg mitoxantrone (as hydrochloride). Each 10 ml vial contains 20 mg mitoxantrone (as hydrochloride).
This medicinal product contains 1.4 mmol sodium per 10 ml vial.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
SHOULD READ AS FOLLOWS:
Concentrate for Solution for Infusion.
Clear, dark-blue aqueous solution with a pH of 3.0-4.5
4.2 Posology and method of administration
SHOULD READ AS FOLLOWS:
Method of administration
4.3 Contraindications
SHOULD READ AS FOLLOWS:
FOR INTRAVENOUS USE ONLY.
4.4 Special warnings and special precautions for use
SHOULD READ AS FOLLOWS:
Cardiac monitoring should also be performed in patients without identifiable risk factors during therapy exceeding 160 mg/m2 of mitoxantrone, or during extended treatment.
6.1 List of excipients
SHOULD READ AS FOLLOWS:
Glacial acetic acid
Sodium acetate trihydrate
Sodium chloride
Sodium metabisulphite (E223)
6.3
SHOULD READ AS FOLLOWS:
Shelf life
2 years
6.6 Special precautions for disposal
SHOULD READ AS FOLLOWS:
Single use only. Discard any unused contents. Any unused product or waste materials should be disposed of in accordance with local requirements.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
SHOULD READ AS FOLLOWS:
19TH September 2006
10. DATE OF REVISION OF THE TEXT
SHOULD READ AS FOLLOWS:
15th March 2007
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