Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or solvents except those mentioned in Special Precautions for Disposal and Other Handling as follows.
Special Precautions for Disposal and Other Handling: ZALTRAP is a sterile, preservative-free and non-pyrogenic concentrate, therefore the solution for infusion should be prepared by a healthcare professional using safe-handling procedures and aseptic technique.
Caution should be exercised when handling ZALTRAP, taking into account the use of containment devices, personal protective equipment (e.g., gloves), and preparation procedures.
Preparation of the Infusion Solution: Inspect the ZALTRAP vial visually prior to use. The concentrate solution must be clear and without particles.
Based on the required dose for the patient, withdraw the necessary volume of ZALTRAP concentrate from the vial. More than one vial could be needed for the preparation of the infusion solution.
Dilute it to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution or 5% glucose solution for infusion. The concentration of the final ZALTRAP solution for intravenous infusion should be kept within the range of 0.6 mg/ml to 8 mg/ml of aflibercept.
PVC containing DEHP infusion bags or polyolefin infusion bags should be used.
The diluted solution should be inspected visually for particulate matter and discolouration prior to administration. If any discolouration or particulate matter is observed, the reconstituted solution should be discarded.
ZALTRAP is a single-use vial. Do not re-enter the vial after the initial puncture. Any unused concentrate should be discarded.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.