Nazione: Cipro
Lingua: greco
Fonte: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
CYTARABINE
PHARMACEUTICAL TRADING CO LTD (0000003066) 33 ARTEMIDOS AVENUE, METROPOLITAN COURT, LARNACA, 6025
L01BC01
CYTARABINE
100MG/ML
SOLUTION FOR INJECTION
CYTARABINE (0000147944) 100MG
INTRAVENOUS USE; ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ
Εθνική Διαδικασία
CYTARABINE
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 100MG (880049001) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 500MG (880049002) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 1G (880049003) 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 5 VIALS X 500MG (880049004) 5 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή; PACK WITH 5 VIALS X 100 MG (880049005) 5 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
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 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 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. 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 eviden Leggi il documento completo