Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Fludarabine phosphate
Genzyme Europe B.V.
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
Marketed
1994-12-12
PACKAGE LEAFLET: INFORMATION FOR THE USER powder for solution for injection or infusion Fludarabine phosphate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fludara is and what it is used for 2. What you need to know before you are given Fludara 3. How to use Fludara 4. Possible side effects 5. How to store Fludara 6. Contents of the pack and other information 1. WHAT FLUDARA IS AND WHAT IT IS USED FOR Fludara contains the active substance fludarabine phosphate which stops the growth of new cancer cells. All cells of the body produce new cells like themselves by dividing. Fludara is taken up by the cancer cells and stops them dividing. In cancers of the white blood cells _(such as chronic _ _lymphocytic leukaemia),_ the body produces many abnormal white blood cells _(lymphocytes)_ and lymph nodes start to grow in various parts of the body. The abnormal white blood cells cannot carry out the normal disease fighting functions and may push aside healthy blood cells. This can result in infections, a decrease in number of red blood cells _(anaemia)_, bruising, severe bleeding or even organ failure. Fludara is used in the treatment of B-cell chronic lymphocytic leukaemia (B-CLL) in patients with sufficient healthy blood cell production. First treatment for chronic lymphocytic leukaemia with Fludara should only be started in patients with advanced disease having disease-related symptoms or evidence of disease progression. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FLUDARA DO NOT USE FLUDARA: if you are allergic to fludarabine phosphate or any of the other ingredients of this medicine (listed in section 6). if you are breast-feeding. if you Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 11 November 2019 CRN009FZ0 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fludara 50 mg powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg fludarabine phosphate. One ml of reconstituted solution contains 25 mg fludarabine phosphate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. White lyophilisate for reconstitution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult patients with sufficient bone marrow reserves. First line treatment with Fludara should only be initiated in adult 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 Posology The recommended dose is 25 mg fludarabine phosphate/m² body surface area given daily for 5 consecutive days every 28 days by 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 (see section 6.6). The required dose (calculated on the basis of the patient's body surface area) of the reconstituted solution is drawn up into a syringe. For intravenous bolus injection this dose is further diluted in 10 ml sodium chloride 9 mg/ml (0.9%). Alternatively, for infusion, the required dose drawn up in a syringe may be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) and infused over approximately 30 minutes. The duration of treatment depends on the treatment success and the tolerability of the drug. In CLL patients, Fludara should be administered up to the achievement of best response (complete or partial remission, usually 6 cycles) and then the drug should be discontinued. _Patients with renal impairment_ Doses should be adjusted for patients with reduce Կարդացեք ամբողջական փաստաթուղթը