Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Cytarabine
Fresenius Kabi Deutschland GmbH
L01BC; L01BC01
Cytarabine
100 milligram(s)/millilitre
Solution for injection/infusion
Pyrimidine analogues; cytarabine
Marketed
2012-11-23
Ver 004, July 2020 PACKAGE LEAFLET: INFORMATION FOR THE USER CYTARABINE AND ASSOCIATED NAMES 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, 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 Cytarabine is and what it is used for 2. What you need to know before you are given Cytarabine 3. How Cytarabine is given to you 4. Possible side effects 5. How to store Cytarabine 6. Contents of the pack and other information 1. WHAT CYTARABINE IS AND WHAT IT IS USED FOR Cytarabine is used in adults and children. This medicine contains cytarabine, which 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. Cytarabine is also used for the induction and maintenance of remission of leukaemia. 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. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CYTARABINE DO NOT USE CYTARABINE IF YOU: are allergic to cytarabine, or any of the other ingredients of this medicine (listed in section 6). if your blood cell count (number of cells in your blood) is very low due to some cause other than cancer. Yo Lugege kogu dokumenti
Health Products Regulatory Authority 22 April 2021 CRN009VNN Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cytarabine 100 mg/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 100 mg of 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. Excipients: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION By intravenous infusion or injection or subcutaneous injection. Only general recommendations can be given, as acute leukaemia is almost exclusively treated with combinations of cytostatics. Dosage recommendation may be converted from those in terms of bodyweight to those related to surface area by means of nomograms. 1) REMISSION INDUCTION: ADULT a) Continuous treatment: 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. 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/DAY subject to toxicity. Continue to toxicity or until remission occurs. Health Products Regulatory Authority 22 April 2021 CRN0 Lugege kogu dokumenti