Kraj: Malta
Język: angielski
Źródło: Medicines Authority
CYTARABINE
Hospira UK Limited
L01BC01
CYTARABINE
SOLUTION FOR INJECTION
CYTARABINE 100 mg/5ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2007-05-07
PAGE 1 OF 7 2016-0017891 & 2016-0017897 PACKAGE LEAFLET: INFORMATION FOR THE USER CYTARABINE 20 MG/ML INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 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 an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. Cytarabine Injection is used to treat some types of leukaemia (cancer affecting the blood) and lymphomas (cancer of the lymph glands). It may be used in combination with other anti-cancer medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE INJECTION DO NOT USE CYTARABINE INJECTION • if you have shown signs of hypersensitivity (severe allergy) to cytarabine in the past, 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 (unless your doctor decides the benefits of treatment outweigh the risks) • if you are feeling increasing difficulties in body coordination after radiation treatment or treatment with another anticancer medicine such as methotrexate • if you are pregnant Tell your doctor if you think any of the above applies to you before this medicine is used. TAKE SPECIAL CARE WITH CYTARABINE INJECTION • if your blood cell count is low • if you have any problems with your liver including jaundice (causes yellowing of the skin) • if you have recently received cancer medicine treatment or radiot Przeczytaj cały dokument
Cytarabine 20mg/ml – Jul 2017 PAGE 1 OF 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cytarabine 20 mg/ml Injection 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 For excipients see 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cytarabine may be used alone or in combination with other antineoplastic agents. It is indicated alone or in combination for induction of remission and/or maintainance in patients with acute myeloid leukaemia, acute non-lymphoblastic leukaemias, acute lymphoblastic leukaemias, acute lymphocytic leukaemia, erythroleukaemia, blast crises of chronic myeloid leukaemia, diffuse histiocytic lymphomas (non-hodgkin's lymphomas of high malignancy), meningeal leukaemia and meningeal neoplasms. Clinicians should refer to the current literature on combination therapy before initiating treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cytarabine 20 mg/ml Injection is a ready to use solution and is suitable for intravenous, subcutaneous and intrathecal use. Cytarabine 20 mg/ml Injection can be diluted with Sterilised Water for Injections BP, Glucose Intravenous Infusion BP or Sodium Chloride Intravenous Infusion BP. Prepared infusions, in the recommended diluents should be used immediately. Alternatively, the diluted infusion fluids may be stored at 2-8°C, protected from light, but portions remaining unused after 24 hours must be discarded. REMISSION INDUCTION: ADULTS Cytarabine 20mg/ml – Jul 2017 PAGE 2 OF 12 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 not 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 to Przeczytaj cały dokument