Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Cytarabine
Pfizer Healthcare Ireland
L01BC; L01BC01
Cytarabine
20 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Pyrimidine analogues; cytarabine
Marketed
1989-11-20
Page 1 of 9 2021-0073341 PACKAGE LEAFLET INFORMATION FOR THE USER CYTARABINE 20 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, ask your doctor or pharmacist. • This medicine has been prescribed for you only. 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cytarabine Solution for Injection or Infusion is and what it is used for 2. What you need to know before you use Cytarabine Solution for Injection or Infusion 3. How to use Cytarabine Solution for Injection or Infusion 4. Possible side effects 5. How to store Cytarabine Solution for Injection or Infusion 6. Contents of the pack and other information 1. WHAT CYTARABINE SOLUTION FOR INJECTION OR INFUSION IS USED FOR Cytarabine Solution for Injection or Infusion contains the active substance cytarabine which is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. Cytarabine Solution for Injection or Infusion is used to treat some types of leukaemia in adults and children (cancer affecting the blood), lymphomas (cancer of the lymph glands), leukaemic or lymphoma meningitis (inflammation of part of the spinal cord) and in some cancers of the covering of the spinal cord (meningeal cancers). It may be used in combination with other anti-cancer medicines. You must talk to a doctor if you do not feel better or if you feel worse 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE SOLUTION FOR INJECTION OR INFUSION DO NOT USE CYTARABINE SOLUTION FOR INJECTION OR INFUSION • if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in sectio Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 18 August 2021 CRN009ZMP Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cytarabine 20 mg/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 20 mg of cytarabine. Presentations 100 mg/5 ml 500 mg/25 ml 1 g/50 ml Amount cytarabine present 100 mg 500 mg 1 g Excipient with known effect Cytarabine 100 mg/5 ml (20 mg/ml) Injection contains 13.25 mg of sodium in each vial Cytarabine 500 mg/25 ml (20 mg/ml) Injection contains 66.75 mg of sodium in each vial. Cytarabine 1 g/50 ml (20 mg/ml) Injection contains 133.5 mg of sodium in each vial. For the full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alone or in combination for the induction of remission in leukaemia, particularly in acute myeloid leukaemia in adults and children. Also used in remission induction in acute lymphoblastic leukaemia, chronic myeloid leukaemia and acute myeloid leukaemia. Additionally, in the treatment and prophylaxis of leukaemic or lymphomatous meningitis. Also the treatment and maintenance of other meningeal neoplasms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following doses are given as a guide, but the clinician should consult relevant protocols for the appropriate dosage of cytarabine and other antineoplastic agents given in combination. Most doses are given in mg/kg but may be converted to doses related to surface area by the use of standard nomograms. REMISSION INDUCTION (ADULTS): _Continuous Dosing_: The usual dose in leukaemia, is 2 mg/kg by rapid intravenous injection daily for ten days. If after ten days neither therapeutic response nor toxicity has been observed, the dose may be increased to 4 mg/kg until a therapeutic response or toxicity is evident. Daily blood counts should be taken. Almost all patients can be carried to toxicity with these doses. Alternatively, 0.5 to 1 mg/kg may Կարդացեք ամբողջական փաստաթուղթը