Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Hydrochloric Acid conc.

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       Sodium Hydroxide (disks)
Nitrogen
Water for injections
6.2    Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in sections 4.2 and 6.3 .

6.3    Shelf-life

The expiry date of the product is indicated on the packaging materials 
Stability in Infusion Solutions
Chemical and physical stability studies of cytarabine have demonstrated that cytarabine is stable for seven days at room temperature when admixed at 0.5 mg/ml in glass IV bottles and plastic IV bags with: water for injection; 5% Dextrose injection; and 0.9% Sodium Chloride injection solutions. Also when similarly admixed at 8-32 mg/ml in glass IV bottles and plastic IV bags, cytarabine is stable for seven days at room temperature, -20 degrees C, and 4 degrees C in 5% Dextrose Injection; 5% Dextrose in 0.2% Sodium Chloride Injection; and, in 0.9% Sodium Chloride Injection Solutions.
Cytarabine is stable at room temperature at a concentration of 2 mg/ml in the presence of KCl equivalent to 50 meg/500 ml in Dextrose 5% in water and 0.9% Sodium Chloride for up to eight days.
Cytarabine is also stable at room temperature and at refrigerated temperature (8 degrees C) at a concentration of 0.2-1.0 mg/ml in the presence of Sodium Bicarbonate equivalent to 50 meq/L in Dextrose 5% in Water or Dextrose 5% in 0.2% Sodium Chloride for seven days in Travenol glass bottles or Viaflex bags.
Cytarabine injection, and the infused solutions prepared therefrom, contain(s) no antimicrobial agents. Therefore, it is recommended that further dilution be effected immediately prior to use and infusion be commenced as soon as practicable after preparation of the admixture. Infusion should be completed within 24 hours of preparation and the residue discarded.

6.4    Special precautions for storage

Powder freeze dried for solution for injection: Store below 25°C
RECONSTITUTION
Cytarabine 1g vial is to be used for preparation of a solution for single dose administration.
Cytarabine sterile powder can be dissolved in water for injection, 0.9% sodium chloride or 5% glucose in water with or without preservative.
The maximum concentration that can be obtained after reconstitution with Cytarabine is 100mg/ml. In order to have a solution of exact 100mg/ml the following volume should be added:
 ml to add      cytarabine
9.4 ml            1g

6.5    Nature and contents of container

Vial glass type I, box of 1 vial

6.6    Special precautions for disposal and other handling
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IMPORTANT
No ampoule file is needed to open the ampoules. The neck of the ampoule is prescored at the point of constriction. A coloured dot on the ampoule head helps to orientate the ampoule. Take the ampoule and face the coloured dot. The ampoule opens easily by placing the thumb on the coloured dot and gently pressing downwards.

Cytarabine 1g vial is to be used for preparation of a solution for single dose administration