Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sodium lactate solution, 60%
Lactic acid
Water for injection.


6.2   Incompatibilities
Cytarabine solutions for injection or infusion are incompatible with 5-fluorouracil, heparin, gentamicin, insulin, methotrexate, methylprednisolone, nafcillin, oxacillin and penicillin G. As further incompatibilities are possible, mixing with other pharmaceuticals should generally be avoided.

The medicinal product must not be mixed with medicinal products other than those listed in section 6.6.

6.3   Shelf life

Unopened package:
The expiry date of the product is indicated on the packaging materials 
After first opening:
Alexan is stable for 28 days after opening, stored at -20°C (with protection of light), 5°C+/-3°C (with protection of light), and at room temperature (20–25°C) with light protection and under influence of light.

After dilution:
A suitable infusion solution can be prepared by dilution of Alexan 50 mg/ml with 0.9% sodium chloride solution, 5% glucose solution and Ringer´s solution.
The maximum storage time for Alexan infusion solutions with a concentration of 20.0 mg/ml and of 0.1 mg/ml prepared in sodium chloride 0.9% is 28 days, stored in a refrigerator (2–8°C) with protection of light, and at room temperature (20–25°C) with or without light protection.
The maximum storage time for Alexan infusion solutions with a concentration of 20.0 mg/ml prepared in 5% glucose is 28 days, stored in a refrigerator (2–8°C) with protection of light, and at room temperature (20–25°C) with or without light protection.

The maximum storage time for Alexan infusion solutions with a concentration of 0.1 mg/ml prepared in 5% glucose is 28 days stored in a refrigerator (2–8°C) with protection of light, and 14 days stored at room temperature (20–25°C) with or without light protection.
The maximum storage time for Alexan infusion solutions with a concentration of 5.0 mg/ml prepared in Ringer´s solution in syringe of polypropylene is 2 days for all tested storage conditions (2–8°C with light protection, 20–25°C with or without light protection).
Stability studies results showed no influence from the container of the infusion vehicle (PVC bags, PP bags and glass bottles).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store below 25°C.
Keep in the original package in order to protect from light.
6.5   Nature and contents of container


For 50 mg/ml:
1 x 10 ml vials
1 x 20 ml vials
1 x 40 ml vials
Glass vials (type 1) with grey fluoropolymer coated rubber stoppers.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
For infusion, Alexan can be diluted with physiological saline solution, 5% glucose solution or Ringer's solution.

If Alexan comes into contact with the skin, the affected site should be rinsed with copious amounts of water and then thoroughly washed with water and soap. If the solution comes into contact with the eyes, the eyes should be carefully rinsed with copious amounts of water, and an ophthalmologist should be consulted immediately.

Pregnant personnel should not come into contact with this medicinal product.

Alexan should not be used after its expiration date.
After use, the bottle and the injection material (including gloves) should be disposed of according to the regulations for cytostatics. Any remaining medicine and the primary packaging must be disposed of as hazardous waste.