2.2 Reconstitution
Reconstitute RETAVASE immediately before administration.
Reconstitute RETAVASE only with the supplied Sterile Water for Injection. Slight foaming upon reconstitution may occur; if necessary allow the vial to stand undisturbed for several minutes to allow dissipation of any large bubbles. Prior to administration, inspect the product for particulate matter and discoloration.
Use aseptic technique throughout.
Step 1: Open the package containing the reconstitution spike. Remove the protective cap from the luer lock port of the reconstitution spike and remove the protective cap on the end of the sterile 10 mL pre-filled syringe. Remove the protective flip-cap from one vial of RETAVASE.
Step 2: Clean the rubber closure with an alcohol wipe (not contained within kit).
Step 3: Connect the sterile pre-filled syringe to the reconstitution spike.
Step 4: Remove the protective cap from the spike end of the reconstitution spike and firmly insert the spike into the vial of RETAVASE.
Step 5: Connect the syringe plunger to the sterile 10 mL pre-filled syringe by screwing the plunger into the rubber stopper.
Step 6: Transfer the 10 mL of Sterile Water for Injection through the reconstitution spike into the vial of RETAVASE.
Step 7: With the reconstitution spike and empty pre-filled syringe still attached to the vial, swirl the vial gently until the contents are fully dissolved, may take up to 2 minutes. DO NOT SHAKE. Upon reconstitution, the solution should be clear and colorless. Discard if particulate matter or discoloration is observed. The resulting solution concentration is 1 unit/mL and delivers 10 mL (10 units reteplase).
Step 8: Disconnect the empty pre-filled syringe from the reconstitution spike and connect the plastic, graduated syringe to the reconstitution spike that is still attached to the vial.
Step 9: Withdraw 10 mL of RETAVASE reconstituted solution into the graduated syringe. A small amount of solution will remain in the vial due to overfill. Detach the graduated syringe from the reconstitution spike.
