Expiration date: 07/2025
Composition and form of issue:
Powder lyophilized for the preparation of solution for injection of 1 FL.
cytarabine 100 mg
excipients: hydrochloric acid sodium hydroxide (to bring the pH)
solvent: benzyl alcohol-45 mg water for injection-q.s.
in bottles of 100 mg, complete with solvent in ampoules of 5 ml in a pack of cardboard 1 set.
Powder lyophilized for the preparation of solution for injection of 1 FL.
cytarabine 500 mg
excipients: hydrochloric acid sodium hydroxide (to bring the pH)
solvent: benzyl alcohol-90 mg water for injection-q.s.
in bottles of 500 mg, complete with solvent in bottles of 10 ml in a pack of cardboard 1 set.
Powder lyophilized for the preparation of solution for injection of 1 FL.
cytarabine 1000 mg
excipients: hydrochloric acid sodium hydroxide (to bring the pH)
in bottles of 1000 mg in a pack of cardboard 1 bottle.
Dosage and administration:
In / in jet or infusion, p / to or intrathecal. The scheme and method of application vary in different chemotherapy regimens. The average daily dose-100 mg / m2. Elderly patients or patients with reduced reserves of hematopoiesis appoint smaller doses — 50-70 mg/m2.
In acute non-lymphoblastic leukemias for the induction of remission in chemotherapy with conventional doses in combination with other antitumor drugs — 100 mg/m2/day in the form of continuous I/infusion for 7 days or 100 mg/m2 I/every 12 hours 7 days in a row. Just spend 4-7 treatment courses. The intervals between courses of 14 days or more.
In the treatment of leukemias with poor prognosis, as well as refractory and recurrent acute leukemias, it is possible to use high doses of Cytosar — 2-3 g/m2 in the form of 1-3-hour infusions every 12 hours for 2-6 days in combination with other anticancer drugs or without them.
Intrathecally, in acute leukemia-at a dose of 30 mg / m2 every 4 days before the normalization of the cerebrospinal fluid, and then another 1 additional administration. Dosage (from 5 to 75 mg/m2) and fractional application (from 1 time per day for 4 days to 1 time in 4 days) depends on the type and severity of neurological symptoms and the effectiveness of previous therapy.
Solution preparation.
To obtain a solution with a concentration of 20 mg/ml, 5 ml of solvent should be added to the contents of the 100 mg vial.
To obtain a solution with a concentration of 50 mg/ml, 10 ml of solvent should be added to the contents of the 500 mg vial.
To obtain a solution with a concentration of 100 mg/ml, 10 ml of solvent should be added to the contents of the 1000 mg vial.
The concentration of cytarabine should not exceed 100 mg/ml.
The attached solvent contains benzyl alcohol, so it can not be used for intrathecal administration.
Powder for injection can be dissolved in water for injection, 0, 9% sodium chloride solution or 5% dextrose solution with or without preservative.
As a solvent for intrathecal use 0, 9% sodium chloride solution is used. The solvent for intrathecal use and high-dose therapy should not contain preservatives (benzyl alcohol).
