Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
CYTARABINE
Hospira UK Limited
L01BC01
CYTARABINE
20 Mg/Ml
Solution for Inj/Inf
Product subject to prescription which may not be renewed (A)
Pyrimidine analogues
Authorised
1989-11-20
15:05 S10820 S10328 Svus N/A 8 pt Ireland 02 Leaflet N/A SVI007-1 118 x 570 mm (20 panels) N/A PAR-2017-0012315 BLACK BARCODE Nº PHARMA CODE NEW COMPONENT Nº DATE: 26 DEC 2017 TIME: OLD COMPONENT Nº PACKAGING SITE SMALLEST BODY TEXT SIZE MARKET PROOF Nº COMPONENT DRAWING Nº DIMENSIONS NOTES PAR NUMBER COLOURS PRINTING NON-PRINTING 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. Y Lue koko asiakirja
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. Each 1 ml of solution contains 2.7 mg sodium 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 be infused daily in 1-24 hours for ten days, and then at a rate of 2 mg/kg/day until toxicity is observed. Continue to toxicity or until remission occurs. Results from one hour infusions have been satisfactory in the majority of patients. _Intermittent dosing_: Cytarabine may be given as intermittent IV doses of 3-5 mg/kg daily, for five consecutive days. This course of treatment can be repeated after an Lue koko asiakirja