decreased pregnancy rates, an increase in abnormal embryos and increased loss of embryos in mated females (see section 4.4).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol (E421)
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3 and 6.6.
6.3 Shelf life
Unopened powder vial:
4 years
After reconstitution:
When Vidaza is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25°C for 45 minutes and at 2°C to 8°C for 8 hours.
The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2°C to 8°C) water for injections. When Vidaza is reconstituted using refrigerated (2°C to 8°C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2°C to 8°C for 22 hours.
From a microbiological point of view, the reconstituted 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 must not be longer than 8 hours at 2°C to 8°C when reconstituted using water for injections that has not been refrigerated or not longer than 22 hours when reconstituted using refrigerated (2°C to 8°C) water for injections.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.5 Nature and contents of container
Colourless type I 30 ml glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene plastic button.
Pack size: 1 vial of 100 mg azacitidine.
6.6 Special precautions for disposal and other handling
Recommendations for safe handling
Vidaza is a cytotoxic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine suspensions. Procedures for proper handling and disposal of anticancer medicinal products should be applied.
If reconstituted azacitidine comes into contact with the skin, immediately and thoroughly wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.
Reconstitution procedure
Vidaza should be reconstituted with water for injections. The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2°C to 8°C) water for injections. Details on storage of the reconstituted product are provided below.
1. The following supplies should be assembled:
• Vial(s) of azacitidine; vial(s) of water for injections; nonsterile surgical gloves;
• Alcohol wipes; 5 ml injection syringe(s) with needle(s).
2. 4 ml of water for injections should be drawn into the syringe, making sure to purge any air trapped within the syringe.
3. The needle of the syringe containing the 4 ml of water for injections should be inserted through the rubber top of the azacitidine vial followed by injection of the water for injections into the vial.
4. Following removal of the syringe and needle, the vial should be vigorously shaken until a uniform cloudy suspension is achieve |
