Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
CYTARABINE
Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France
L01BC01
CYTARABINE 100 mg/ml
SOLUTION FOR INFUSION OR INJECTION
CYTARABINE 100 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2014-01-13
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER CYTARABINE MYLAN CYTARABINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Cytarabine Mylan is and what it is used for 2. Before you are given Cytarabine Mylan 3. How to use Cytarabine Mylan 4. Possible side effects 5. How to store Cytarabine Mylan 6. Further information 1. WHAT CYTARABINE MYLAN IS AND WHAT IT IS USED FOR Cytarabine Mylan is used in adults and children. The active ingredient is cytarabine. Cytarabine is one of a group of medicines known as cytotoxics, these medicines are used in the treatment of acute leukaemias (cancer of blood where you have too many white blood cells) including prophylaxis and treatment of CNS involvement (meningeal leukaemia).Cytarabine interferes with the growth of cancer cells, which are eventually destroyed. Remission induction is an intensive treatment to force leukaemia into retreat. When it works, the balance of cells in your blood becomes more normal and your health improves. This relatively healthy period is called a remission. Maintenance therapy is a milder treatment to make your remission last as long as possible. Quite low doses of cytarabine are used to keep the leukaemia under control and stop it flaring up again. 2. BEFORE YOU ARE GIVEN CYTARABINE DO NOT USE CYTARABINE MYLAN IF YOU: are allergic (hypersensitive) to cytarabine, or any of the other ingredients of cytarabine. If the cell count in your blood report is very low due to some cause other than cancer, or as decided by your doctor. If you are feeling increasing difficulties in body coordination after radiation treatment or treatment with another anticancer drug such as methotrexate. if you are pregnant. Lesen Sie das vollständige Dokument
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cytarabine Mylan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cytarabine Mylan 20 mg/ml: 1 ml solution contains 20 mg cytarabine. Each 5 ml vial contains 100 mg of cytarabine. Each 25 ml vial contains 500 mg of cytarabine Each 50 ml vial contains 1000 mg of cytarabine. Cytarabine Mylan 100 mg/ml: 1 ml solution contains 100 mg cytarabine. Each 20 ml vial contains 2000 mg of cytarabine. Excipients: Cytarabine Mylan 20 mg/ml: 1 ml solution contains 6,8 mg sodium chloride equivalent to 2,67 mg/ml sodium. To be taken into consideration by patients on a CONTROLLED SODIUM DIET. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection or Infusion. Clear, colourless solution. pH- 7.0 - 9.5 Osmolarity: 250 to 400 mOsm/L 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For induction of remission in acute myeloid leukaemia in adults and for other acute leukaemias of adults and children including prophylaxis and treatment of CNS involvement (meningeal leukaemia). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cytarabine Mylan 20 mg/ml, solution for injection/infusion is intended for intravenous, intramuscular, subcutaneous or intrathecal use. Page 2 of 16 Cytarabine Mylan 100 mg/ml, solution for injection/infusion is intended for intravenous use. Subcutaneous injection is generally well tolerated, and may be recommended when used in maintenance therapy. CYTARABINE 100 MG/ML SHOULD NOT BE ADMINISTERED BY THE INTRATHECAL ROUTE. Treatment with cytarabine should be initiated by, or be in consultation with, a doctor with extensive experience in treatment with cytostatics. Only general recommendations can be given, as acute leukaemia is almost exclusively treated with combinations of cytostatics. Dosage recommendations, may be made according to body weight (mg/kg) or according to BSA(mg/m 2 ). Dose recommendation may be converted from those in terms of bodyweight to those related to surface area by means of nomograms. 1) R Lesen Sie das vollständige Dokument