מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
FLUDARABINE PHOSPHATE
Ebewe Pharma Ges.m.b.H Nfg. KG
FLUDARABINE PHOSPHATE
25 Micromol
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fludarabin phosphate "Ebewe" 25mg/ml concentrate for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vial of 2 ml contains 50 mg fludarabine phosphate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for injection or infusion. Clear, colourless or almost colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of B-cell chronic lymphocytic leukemia (CLL) in patients with sufficient bone marrow reserves. First line treatment with Fludarabin “Ebewe” should only be initiated in patients with advanced disease, Rai stages III/IV (Binet stages C), or Rai stages I/II (Binet stages A/B) where the patient has disease related symptoms or evidence of progressive disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fludarabin should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. It is strongly recommended that Fludarabin should be only administered intravenously. No cases have been reported in which paravenously administered Fludarabin led to severe local adverse reactions. However, unintentional paravenous administration of Fludarabin must be avoided. Adults The recommended dose of Fludarabin is 25 mg/m 2 body surface given daily for 5 consecutive days (= one cycle) every 28 days by the intravenous route. The required dose (calculated on the basis of the patient's body surface) is drawn up into a syringe. For intravenous bolus injection this dose is further diluted in10ml of sodium chloride 9 mg/ml (0.9%) solution for injection. Alternatively, for infusion, the required dose may be diluted in 100ml of sodium chloride 9 mg/ml (0.9%) solution for injection and קרא את המסמך השלם