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Summary of Product Characteristics Amsidine - …

Summary of Product Characteristics Amsidine SPC/ Amsidine -september 2004 page 1 of 8 1. NAME OF THE MEDICINAL Product Amsidine , concentrate for solution for intravenous infusion 75 mg/ 1,5 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 75 mg amsacrine per 1,5 ml concentrate for solution for intravenous infusion. For excipients, see 3. PHARMACEUTICAL FORM Concentrate for solution for intravenous infusion. Description: Active ingredient in glass ampoule with orange-red liquid. Solvent in glass vial with colourless liquid. 4. CLINICAL PARTICULARS Therapeutic indications Acute non-lymphatic leukemia refractory to other treatments. Posology and method of administration Dosage and administration The usual doseage of amsacrine in the induction phase is 90 mg/ m2 during 5 succesive days at an infusion rate/day of 30-90 minutes. The total dose per course is 450 mg/ m2.

Summary of Product Characteristics Amsidine Any unused product, any items that come into contact with the product and waste material must be ...

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