Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
cytarabin
Actavis Group PTC ehf.
L01BC01
cytarabine
100 mg/ml
Injektions-/infusionsvätska, lösning
cytarabin 100 mg Aktiv substans
Receptbelagt
Förpacknings: Injektionsflaska, 1 ml; Injektionsflaska, 5 ml; Injektionsflaska, 10 ml; Injektionsflaska, 20 ml
Avregistrerad
2016-12-08
1 PACKAGE LEAFLET: INFORMATION FOR THE USER 100 MG/ML SOLUTION FOR INJECTION/INFUSION cytarabine 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cytarabin Actavis is and what it is used for 2. What you need to know before you are given Cytarabin Actavis 3. How to use Cytarabin Actavis 4. Possible side effects 5. How to store Cytarabin Actavis 6. Contents of the pack and other information 1. WHAT CYTARABIN ACTAVIS IS AND WHAT IT IS USED FOR Cytarabin Actavis 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). 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 spell is called a remission. Maintenance therapy is a milder treatment to make your remission last as long as possible. Quite low doses of Cytarabin Actavis are used to keep the leukaemia under control and stop it flaring up again. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CYTARABIN ACTAVIS DO NOT USE CYTARABIN ACTAVIS: - If you are allergic to cytarabine, or any of the other ingredients of this medicine (listed in section 6). - 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 with ano Läs hela dokumentet
1 1. NAME OF THE MEDICINAL PRODUCTI Cytarabin Actavis 100 mg/ml solution for injection/infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 mg cytarabine. Each 1 ml vial contains 100 mg cytarabine. Each 5 ml vial contains 500 mg cytarabine. Each 10 ml vial contains 1000 mg cytarabine. Each 20 ml vial contains 2000 mg cytarabine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection/infusion The product is a clear, colourless to pale yellow solution. pH: 7.0 – 9.5 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 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 ). Dosage recommendations may be converted from those in terms of bodyweight to those related to surface area by means of nomograms. _1. Remission induction_ Induction therapy dosage and schedule vary depending on the regimen used. a) Continuous treatment The following dose regimens have been used for continuous treatment in remission induction. i) Rapid injection - 2 mg/kg/day is a judicious starting dose. Administer for 10 days. Obtain daily blood counts. If no antileukaemic effect is noted and there is no apparent toxicity, increase to 4 mg/kg/day and maintain until therapeutic response or toxicity is evident. Almost all patients can be carried to toxicity with these doses. 2 ii) 0.5 - 1.0 mg/kg/day may be given in an infusion of up to 24 hours duration. Results from one hour infusions have been satisfactory in the majority of patients. After 10 days this initial daily dose may be increased to 2 mg/kg/d Läs hela dokumentet