Cerezyme Caution For Usage

Special Precautions for Disposal and Other Handling: Each vial of Cerezyme is for single use only.
The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Occasionally, small dosage adjustments may be made to avoid discarding partially used vials. Dosages may be rounded to the nearest full vial, as long as the monthly administered dosage remains substantially unaltered.
Use Aseptic Technique: Reconstitution: Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution. The reconstituted volume is 10.6 ml. The pH of the reconstituted solution is approximately 6.1.
After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted. Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discoloration. Do not use vials exhibiting foreign particles or discoloration. After reconstitution, promptly dilute vials and do not store for subsequent use.
Dilution: The reconstituted solution contains 40 units imiglucerase per ml. The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial. Withdraw 10.0 ml reconstituted solution from each vial and combine the withdrawn volumes. Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml. Mix the infusion solution gently.
It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 μm filter to remove any protein particles. This will not lead to any loss of imiglucerase activity. It is recommended that the diluted solution be administered within 3 hours. The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Cerezyme contains no preservatives. Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.