Land: Zweden
Taal: Zweeds
Bron: Läkemedelsverket (Medical Products Agency)
fludarabinfosfat
Actavis Group PTC ehf.
L01BB05
fludarabine phosphate
25 mg/ml
Koncentrat till injektions-/infusionsvätska, lösning
fludarabinfosfat 25 mg Aktiv substans
Apotek
Receptbelagt
Fludarabin
Förpacknings: Injektionsflaska, 2 ml; Injektionsflaska, 5 x 2 ml
Godkänd
2013-06-27
1 _ _ PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUDARABIN ACTAVIS 25 MG/ML CONCENTRATE 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. See section 4. WHAT IS IN THIS LEAFLET 1. What /…/ is and what it is used for 2. What you need to know before you use /…/ 3. How to use /…/ 4. Possible side effects 5. How to store /…/ 6. Contents of the pack and other information 1. WHAT /…/ IS AND WHAT IT IS USED FOR /…/ is an anti-cancer drug. /…/ is used to treat chronic B-cell lymphocytic leukaemia (B-CLL) in patients with sufficient healthy blood cell production. This is a type of cancer of white blood cells (the cells are called lymphocytes). First treatment for chronic lymphocytic leukaemia with /…/ 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 USE /…/ DO NOT USE /…/: - 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 your kidney function is severely impaired. - If you have a low number of red blood cells, because of a certain type of anaemia (decompensated haemolytic anaemia). Your doctor will have told you if you have this condition. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Fludarabine Phosphate if: - Your liver does not work properly, as your doctor may give you this medicine with caution. - You have any form of kidney disease, as your kidney function should be checked regularly. If it is found that your kidneys do not work properly you may be given this medicine at a reduc Lees het volledige document
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fludarabin Actavis 25mg/ml concentrate for solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for injection/infusion contains 25 mg fludarabine phosphate. Each vial of 2 ml contains 50 mg fludarabine phosphate. Excipient with known effect: Contains sodium (from sodium hydroxide) at amounts up to 23 mg per ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for injection/infusion. Clear, colourless or almost colourless solution, pH 7.3-7.7. 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 /.../ 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 /.../ should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Posology _Adults _ The recommended dose is 25 mg fludarabine phosphate/m² body surface given daily for 5 consecutive days 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 diluted in 10 ml of 0.9 % sodium chloride. Alternatively, for infusion, the required dose may be diluted in 100 ml 0.9 % sodium chloride and infused over approximately 30 minutes (see also section 6.6). The optimal duration of treatment has not been clearly established. The duration of treatment depends on the treatment success and the tolerability of the drug. It is recommended that /.../ be administered up to the achievement of response (usually 6 cycles) and then the drug should be discontinued. _Hepatic impairment _ No data Lees het volledige document