Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
CYTARABINE
Hospira UK Limited
L01BC01
CYTARABINE
SOLUTION FOR INJECTION
CYTARABINE 100 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2014-03-21
Page 1 of 7 2017-0027232 PACKAGE LEAFLET: INFORMATION FOR THE USER CYTARABINE 100 MG/ML INJECTION 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. • If you get any side effects, talk to your doctor. 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 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 have had severe effects on your brain (encephalopathy) after radiation treatment or treatment with another anticancer medicine such as methotrexate • if you are pregnant (Unless your doctor considers the benefits to the mother outweigh the risks to the unborn child) Tell your doctor if you think any of the above applies to you before this medicine is used. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH CYTARABINE INJECTION • if your blood cell count is Baca dokumen lengkap
Cytarabine 100mg/mL Sept 2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cytarabine 100 mg/ml Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 100 mg of cytarabine Presentations 100 mg/1 ml 500 mg/5 ml 1 g/10 ml 2 g/20 ml Amount cytarabine Present 100 mg 500 mg 1 g 2 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 maintenance 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 100 mg/ml Injection is a ready to use injection and can be administered by the intravenous and subcutaneous routes. CYTARABINE 100 MG/ML INJECTION SHOULD NOT BE ADMINISTERED BY THE INTRATHECAL ROUTE DUE TO THE SLIGHT HYPERTONICITY OF THIS FORMULATION. (SEE SECTION 4.8 UNDESIRABLE EFFECTS). Cytarabine Injection can be diluted with Sterile 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. Cytarabine 100mg/mL Sept 2017 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 Baca dokumen lengkap