מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cytarabine
Pfizer Ltd
L01BC01
Cytarabine
100mg/1ml
Solution for injection
Subcutaneous; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010300; GTIN: 5015997195658
Page 1 of 7 PACKAGE LEAFLET INFORMATION FOR THE USER CYTARABINE 100 MG/ML INJECTION 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. 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. 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 INJECTION DO NOT USE CYTARABINE INJECTION • 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 (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 קרא את המסמך השלם
OBJECT 1 CYTARABINE INJECTION SOLUTION 100 MG/ML Summary of Product Characteristics Updated 22-Feb-2018 | Hospira UK Ltd 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 the full list of 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 Posology 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. 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 day קרא את המסמך השלם