国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOFARABINE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
CLOFARABINE
1Units Units
PHARMACHEMIE B.V.
1 EVOLTRA ® 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Concentrate for solution for infusion QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine. Excipient with known effect: Each 20 ml vial contains 180 mg of sodium chloride. For the full list of excipients, see section _List of excipients_. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients (1 to 21 years old) who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis (see section _Pharmacodynamic _ _Properties_). POSOLOGY AND METHOD OF ADMINISTRATION Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias. Posology _Adults (including the elderly) _ There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients (see section _Pharmacokinetic Properties_). _Paediatric patients _ _Children and adolescents (≥ 1 year old) _ The recommended dose in monotherapy is 52 mg/m 2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days. Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle. Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75 × 10 9 /l) and return to baseline organ function. A 25% dose reduction may be warranted in patients experiencing significant toxicities (see below). There is currently limited experience of 完全なドキュメントを読む