Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cytarabine
Accord-UK Ltd
L01BC01
Cytarabine
100mg/1ml
Solution for injection
Intravenous; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5060149312544
PACKAGE LEAFLET: INFORMATION FOR THE USER CYTARABINE 100 MG/ML SOLUTION FOR INJECTION OR 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, please ask your doctor or pharmacist or nurse This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet, See section 4 WHAT IS IN THIS LEAFLET 1. What Cytarabine injection is and what it is used for 2. What you need to know before you use Cytarabine injection 3. How to use Cytarabine injection 4. Possible side effects 5. How to store Cytarabine injection 6. Contents of the pack and other information 1. WHAT CYTARABINE INJECTION IS AND WHAT IT IS USED FOR Cytarabine injection is used in adults and children. The active ingredient is cytarabine. Cytarabine is one of a group of the 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 Cytarabine are used to keep the leukaemia under control and stop it flaring up again. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE INJECTION DO NOT USE CYTARABINE INJECTION If you are allergic (hypersensitive) to cytarabine, or any of the ingredients of Cytarabine Injection. If the cell co Lugege kogu dokumenti
OBJECT 1 CYTARABINE100MG/ML SOLUTION FOR INJECTION OR INFUSION. Summary of Product Characteristics Updated 13-Nov-2014 | Accord Healthcare Limited 1. Name of the medicinal product Cytarabine 100 mg/ml Solution for Injection or Infusion 2. Qualitative and quantitative composition 1 ml contains 100 mg Cytarabine. Each 1 ml vial contains 100 mg of Cytarabine. Each 5 ml vial contains 500 mg of Cytarabine. Each 10 ml vial contains 1 g of Cytarabine. Each 20 ml vial contains 2 g of cytarabine. Each 40 ml vial contains 4g of cytarabine. Each 50 ml vial contains 5g of cytarabine. For full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection or infusion. The product is a clear, colourless solution, which is practically free from particles. 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 accordingly 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 on 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 Lugege kogu dokumenti