Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
cytarabine
Pacira Limited
L01BC01
cytarabine
Antineoplastic agents,
Meningeal Neoplasms
Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Revision: 15
Authorised
2001-07-10
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER DEPOCYTE 50 MG SUSPENSION FOR INJECTION Cytarabine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have further questions, ask your doctor. − If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.. WHAT IS IN THIS LEAFLET: 1. What DepoCyte is and what it is given for 2. Wh at you need to know before you are given DepoCyte 3. How DepoCyte is given 4. Possible side effects 5. How to store DepoCyte 6. Contents of the pack and other information 1. WHAT DEPOCYTE IS AND WHAT IT IS GIVEN FOR DepoCyte is used to treat lymphomatous meningitis. Lymphomatous meningitis is a condition in which tumour cells have invaded the fluid or membranes that surround the brain and spinal cord. DepoCyte is used in adults to kill lymphoma tumour cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DEPOCYTE DEPOCYTE S HOULD NO T BE GIVEN − if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in section 6). − if you have a meningeal infection. WARNINGS AND PRECAUTIONS Severe neurological side effects have been reported with the use of DepoCyte. Symptoms have included effects on the nervous system (e.g. convulsions, pain, numbness or tingling, blindness or visual disturbances). Your doctor will check for these symptoms regularly. Make sure you take as directed any dexamethasone tablets that you may have been prescribed, as they reduce the risk of unwanted effects caused by DepoCyte. If your side effects get worse or you notice any new side effects, tell your doctor. OTHER MEDICINES AND DEPOCYTE Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 22 PREGNANCY, BREAST-FEEDING AND FERTILITY DepoCyte should not be given to pregnant women as Прочетете целия документ
1 ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT DepoCyte 50 mg suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 10 mg cytarabine. Each 5 ml vial contains 50 mg cytarabine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White to off-white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease. 4.2 P OSOLOGY AND METHO D OF ADMINISTRATION DepoCyte should be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Posology _Paediatric population_ Safety and efficacy in children aged under 18 years have not been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made. DepoCyte is not recommended for use in children and adolescents until further data become available. _Adults and the elderly_ For the treatment of lymphomatous meningitis, the dose for adults is 50 mg (one vial) administered intrathecally (lumbar puncture or intraventricularly via an Ommaya reservoir). The following r egimen of induction, consolidation and maintenance therapy is recommended: Induction therapy: 50 mg administered every 14 days for 2 doses (weeks 1 and 3). Consolidation therapy: 50 mg administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose of 50 mg at week 13. Maintenance therapy: 50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29). Method of administration DepoCyte is to be administered by slow injection over a period of 1-5 minutes directly into the cerebrospinal fluid (CSF) via either an intraventricular reservoir or by direct injection into the lumbar 3 sac. Following administration by lumbar puncture, it is recommended that the patient should be instructed to lie flat for one hour. All Прочетете целия документ