Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Cladribine
Lipomed GmbH
L01BB04
cladribine
Antineoplastic agents
Leukemia, Hairy Cell
Litak is indicated for the treatment of hairy-cell leukaemia.
Revision: 7
Authorised
2004-04-14
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER LITAK 2 MG/ML SOLUTION FOR INJECTION cladribine 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 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 LITAK is and what it is used for 2. What you need to know before you use LITAK 3. How to use LITAK 4. Possible side effects 5. How to store LITAK 6. Contents of the pack and other information 1. WHAT LITAK IS AND WHAT IT IS USED FOR LITAK contains the active substance cladribine. Cladribine is a cytostatic agent. It affects the growth of malignant (cancerous) white blood cells which play a role in hairy cell leukaemia. LITAK is used to treat this disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LITAK DO NOT USE LITAK - if you are allergic to cladribine or any of the other ingredients of LITAK (listed in section 6) - if you are pregnant or breast-feeding - if you are less than 18 years of age - if you have moderate to severe kidney or liver impairment - if you are using other medicines which affect the production of blood cells in the bone marrow (myelosuppression). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using LITAK. At any time during or after your treatment, TELL YOUR DOCTOR OR NURSE IMMEDIATELY if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a SERIOUS AND POTENTIALLY FATAL BRAIN CONDITION known as progressive multifocal leukoencephalopathy (PML) . If you had these symptoms prior to treatment with cladribine, TELL YOUR DOCTOR a Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT LITAK 2 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 2 mg of cladribine (2-CdA). Each vial contains 10 mg of cladribine in 5 ml of solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LITAK is indicated for the treatment of hairy cell leukaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy. Posology The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight for 5 consecutive days. Deviations from the posology indicated above are not advised. _Elderly _ Experience with patients older than 65 years is limited. Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function. The risk requires assessment on a case-by-case basis (see section 4.4). _Renal and hepatic impairment _ There are no data on the use of LITAK in patients with renal or hepatic impairment. LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or with moderate to severe hepatic impairment (Child-Pugh score > 6) (see sections 4.3, 4.4 and 5.2). _Paediatric population _ LITAK is contraindicated in patients less than 18 years of age (see section 4.3). Method of administration LITAK is supplied as a ready-to-use solution for injection. The recommended dose is directly withdrawn by a syringe and injected as a subcutaneous bolus injection without dilution. LITAK should be inspected visually for particulate matter and discoloration prior to administration. LITAK should warm up to room temperature prior to administration. 3 _Self-administration by the patient Przeczytaj cały dokument