Pharmaceutical particulars : מידע רוקחי

6.   PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Contains no excipients.

6.2 Incompatibilities
Benzyl alcohol increases the degradation rate of cyclophosphamide.
6.3 Shelf-life
The expiry date of the product is indicated on the packaging material.
The Product should be used immediately following reconstitution, or within 24 hours of reconstitution if kept in a refrigerator.
6.4 Special precautions for storage
Store below 25 °C.
Store in the original package.
Store the reconstituted solution in the refrigerator (at 2–8 °C). Do not store above 8 °C.

6.5 Nature and contents of container
Endoxan 500 mg / 1 g
Packs with 1 vial.
75 ml type I or type III glass vials with rubber stoppers and plastic and aluminium flip-off caps.



6.6 Special precautions for disposal and other handling
For intravenous administration
Prior to administration the contents of a vial should be dissolved in 50 ml physiological saline (0.9% w/v sodium chloride) by introducing the saline into the vial and shaking vigorously until the powder is completely dissolved.
Reconstitution results in a clear solution with a pH of between 4 and 6.

Cyclophosphamide Injection is compatible with the following infusion solutions: sodium chloride solution, glucose solution, sodium chloride and glucose solution, sodium chloride and potassium chloride solution, and potassium chloride and glucose solution.

General instructions
If vials are stored above the recommended temperature this can cause degradation of the active ingredient, identifiable by a yellow melted appearance to the vial contents. Vials containing melted material should not be used.

Cyclophosphamide is a cytotoxic agent. The handling and preparation of cyclophosphamide should always be in accordance with current guidelines on safe handling of cytotoxic agents.
The material should not be handled by women who are pregnant or who are breast-feeding.

Adequate care and precautions should be taken in the disposal of empty vials and items (syringes, needles, etc) used in reconstitution and administration.

7.   MARKETING AUTHORIZATION HOLDER
Baxter Oncology GmbH, Halle, Germany.