CYTARABINE 100MG/ML SOLUTION FOR INJECTION

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

CYTARABINE

Διαθέσιμο από:

PHARMACEUTICAL TRADING CO LTD (0000003066) 33 ARTEMIDOS AVENUE, METROPOLITAN COURT, LARNACA, 6025

Φαρμακολογική κατηγορία (ATC):

L01BC01

INN (Διεθνής Όνομα):

CYTARABINE

Δοσολογία:

100MG/ML

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

CYTARABINE (0000147944) 100MG

Οδός χορήγησης:

INTRAVENOUS USE; ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

CYTARABINE

Περίληψη προϊόντος:

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

Αρχείο Π.Χ.Π.

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