d. After reconstitution each ml of suspension will contain 25 mg of azacitidine (100 mg/4 ml). The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates. The product should be discarded if it contains large particles or agglomerates. Do not filter the suspension after reconstitution since this could remove the active substance. It must be taken into account that filters are present in some adaptors, spikes and closed systems; therefore such systems should not be used for administration of the drug after reconstitution.
5. The rubber top should be cleaned and a new syringe with needle inserted. The vial should then be turned upside down, making sure the needle tip is below the level of the liquid. The plunger should then be pulled back to withdraw the amount of medicinal product required for the proper dose, making sure to purge any air trapped within the syringe. The syringe with needle should then be removed from the vial and the needle disposed of.
6. A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe. The needle should not be purged prior to injection, in order to reduce the incidence of local injection site reactions.
7. If needed (doses over 100 mg) all the above steps for preparation of the suspension should be repeated. For doses greater than 100 mg (4 ml), the dose should be equally divided into 2 syringes (e.g, dose 150 mg = 6 ml, 2 syringes with 3 ml in each syringe).
8. The contents of the dosing syringe must be re-suspended immediately prior to administration. The temperature of the suspension at the time of injection should be approximately 20°C-25°C. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved. The product should be discarded if it contains large particles or agglomerates.
Storage of the reconstituted product
For immediate use:
The Vidaza suspension may be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes. If elapsed time is greater than 45 minutes, the reconstituted suspension should be discarded appropriately and a new dose prepared.
For later use:
When reconstituting using water for injections that has not been refrigerated, the reconstituted suspension must be placed in a refrigerator (2°C to 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours. If the elapsed time in the refrigerator is greater than 8 hours, the suspension should be discarded appropriately and a new dose prepared.
When reconstituting using refrigerated (2°C to 8°C) water for injections, the reconstituted suspension must be placed in a refrigerator (2°C to 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 22 hours. If the elapsed time in the refrigerator is greater than 22 hours, the suspension should be discarded appropriately and a new dose prepared.
The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20°C-25°C. If the elapsed time is longer than 30 minutes, the suspension should be discarded appropriately and a new dose prepared.
Calculation of an individual dose
The total dose, according to the body surface area (BSA) can be calculated as follows:
Total dose (mg) = Dose (mg/m2) x BSA (m2)
The following table is provided only as an example of how to calculate individu |
