地西他滨decitabine说明书欧盟.pdf

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section .8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Dacogen 50 mg powder for concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 50 mg decitabine. After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine. Excipients with known effect: Each vial contains 0.5 mmol potassium (E340) and 0.29 mmol sodium (E524). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for infusion). White to almost white lyophilized powder. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Dacogen is indicated for the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy. 4.2 Posology and method of administration Dacogen administration must be initiated under the supervision of physicians experienced in the use of chemotherapeutic agents. Posology 2 In a treatment cycle, Dacogen is administered at a dose of 20 mg/m body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle). The total daily dose must not exceed 20 mg/m2 and the total dose per treatment cycle must not exceed 2 100 mg/m . If a dose is missed, treatment should be resume