Страна: Малта
Език: английски
Източник: Medicines Authority
FLUDARABINE PHOSPHATE
Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
L01BB05
FLUDARABINE PHOSPHATE 50 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
FLUDARABINE PHOSPHATE 50 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2013-03-08
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUDARABINE PHOSPHATE 50 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION fludarabine phosphate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Fludarabine is and what it is used for 2. What you need to know before you use Fludarabine 3. How to use Fludarabine 4. Possible side effects 5. How to store Fludarabine 6. Contents of the pack and other information 1. WHAT FLUDARABINE IS AND WHAT IT IS USED FOR The name of your medicine is ‘Fludarabine phosphate 50 mg powder for solution for injection/infusion’ but in the rest of the leaflet it will be called ‘Fludarabine’. It contains the active ingredient fludarabine phosphate. This medicine is an anti-cancer medicine that inhibits the growth of cancer cells. It is used in the treatment of B-cell chronic lymphocytic leukaemia (B-CLL), a cancer of the lymphocytes (white blood cells), in patients who have a sufficient amount of healthy blood cells in their bone marrow. First treatment for chronic lymphocytic leukaemia with fludarabine should only be started in patients with advanced disease having disease related symptoms or evidence of disease progression. This medicine works by stopping the growth of new cancer cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUDARABINE DO NOT USE FLUDARABINE - if you are allergic to fludarabine or any of the other ingredients of this medicine (listed in section 6). - if your kidney function is severely reduced. Your doctor will decide, based on your kidney func Прочетете целия документ
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. Excipient with known effect: Each vial of fludarabine 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. Page 1 of 16 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 bo Прочетете целия документ