Reconstitution and Dilution Using Aseptic Technique

1. Determine the number of Cerezyme vials to be reconstituted based on the individual patient's dosage regimen and remove vial(s) from the refrigerator.
2. Reconstitute each 400 unit vial of Cerezyme by slowly injecting 10.2 mL of Sterile Water for Injection, USP, down the inside wall of each vial.
3. Roll and tilt the vial to allow the powder to dissolve completely. Each vial will yield a concentration of Cerezyme after reconstitution of 40 units/mL. Visually inspect the solution after reconstitution for particulate matter and discoloration. Discard if opaque particles or discoloration are observed.
4. Withdraw up to 10 mL per vial. Discard unused portion.
5. Dilute the Cerezyme solution promptly with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 to 200 mL. For patients weighing less than 18 kg, dilute Cerezyme to a final volume of 100 mL. Gently invert infusion bag to mix the solution, avoiding vigorous shaking and agitation.
   Visually inspect the solution prior to administration of the final product for particulate matter and discoloration. Slight flocculation of protein particles (described as thin translucent fibers) may occur after dilution and does not affect the quality of the product.
6. For patients weighing 18 kg and greater, infuse the diluted Cerezyme solution over 1 to 2 hours. For patients weighing less than 18 kg, infuse the diluted Cerezyme solution over 2 hours.
7. The diluted solution may be filtered through an in-line low protein-binding 0.2 µm filter during administration.

Storage and Handling

• If the reconstituted Cerezyme vial is not used immediately, store at room temperature at 68°F to 77°F (20°C to 25°C) or refrigerated at 36°F to 46°F (2°C to 8°C) for up to 12 hours.
• After dilution, Cerezyme is stable for up to 24 hours when stored refrigerated at 36°F to 46°F (2°C to 8°C).