Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
FLUDARABINE PHOSPHATE
HOSPIRA UK Ltd
50 Milligram
Pdr for Soln Inj/Inf
2008-08-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fludarabine Phosphate 50 mg Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg of fludarabine phosphate. 1 ml of reconstituted solutions contains 25 mg of fludarabine phosphate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white plug. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves. First line treatment with Fludarabine Phosphate 50 mg Powder for Solution for Injection or Infusion should only be initiated in patients with advanced disease, Rai stages III/IV (binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fludarabine Phosphate 50 mg Powder for Solution for Injection or Infusion should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Intravenous administration Fludarabine Phosphate 50 mg Powder for Solution for Injection or Infusion is for intravenous use only. No cases have been reported in which paravenously administered fludarabine phosphate led to severe local adverse reactions. However, paravenous administration must be avoided. Adults The recommended dose of fludarabine phosphate is 25 mg/m 2 body surface area given daily for 5 consecutive days, every 28 days by the intravenous route. Each vial is to be made up in 2 ml water for injection. Each ml of the resulting solution will contain 25 mg fludarabine phosphate. IRISH MEDICINES BOARD ________________________________________________ Les hele dokumentet