Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Fludarabine phosphate
Fresenius Kabi Oncology Plc
L01BB; L01BB05
Fludarabine phosphate
50 milligram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Purine analogues; fludarabine
Not marketed
2013-05-03
FLUDARABINE PHOSPHATE 50 MG - PACK INSERT - IRELAND+UK+MALTA (Travesh Sharma) D:\Europe\Fludarabine\Ireland+UK+Malta\Fludarabine phosphate 50 mg - Pack Insert - Ireland+UK+Malta.indd SIZE: 339 X 300 MM 5 APRIL 2013 9:18 AM VER. 04 TIMES NEW ROMAN 8.5 PTS. Black xxxxxx xxxxxxxxxx V001/BO The following information is intended for healthcare professionals only: Fludarabine as other potiential cytotoxic medicines must be prepared by qualified personnel in a designated area. Consideration must be given to handling and disposal according to guidelines used for cytotoxic drugs. FOR INTRAVENOUS USE ONLY. INCOMPATIBILITIES Must not be mixed with other drugs. INSTRUCTIONS FOR USE AND HANDLING RECONSTITUTION Fludarabine must be prepared for use by aseptically adding sterile water for injections. When reconstituted with 2 ml of sterile water for injections, the powder must fully dissolve in less than 60 seconds. Each ml of the resulting solution will contain 25 mg of fludarabine phosphate. The solution should be inspected visually. The reconstituted/ diluted solution must be clear, colorless and without particles. DILUTION The reconstituted solution draws up into a syringe. For intravenous bolus injection this dose is further diluted into 10 ml 0.9% sodium chloride. For intravenous infusion the solution is diluted into 100 ml 0.9% sodium chloride or 5% dextrose injection and infused over 30 minutes. In clinical studies, the product has been diluted in 100 ml or 125 ml of 5% dextrose (for injection) or 0.9 % sodium chloride solution. The dilution compatibility study has been carried out in polyolefin infusion bags. After first opening, the product should be used immediately. AFTER RECONSTITUTION: The physicochemical stability of the drug product after reconstitution in water for injections has been demonstrated for 24 hours at 25°C ± 2°C/ 60% ± 5%RH and for 7 days at 5°C ± 3°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in- use storage times and PACKAGE LEAFLE Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fludarabine Phosphate 50mg 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. Excipient with known effect: Each vial of fludarabine phosphate 50 mg powder for solution for injection /infusion contains less than 1 mmol sodium (23 mg), i.e. essentially 'sodium-free'. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection/ infusion. Sterile lyophilized white or almost white powder or cake. 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 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 should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Intravenous administration Fludarabine must be administered only intravenously. No cases have been reported in which paravenously administered fludarabine led to severe local adverse reactions. However, unintentional paravenous administration must be avoided. Adults The recommended dose of fludarabine is 25 mg/m2 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 injections. Each ml of the resulting solution for injection /infusion contains 25 mg fludarabine phosphate (see section 6.6). 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 into 10 ml of sodium chloride 9 mg/ml (0.9%). Altern Przeczytaj cały dokument