Mirel Dosage/Direction for Use

Reteplase is for intravenous administration only. Reteplase is administered as two bolus injections of 10 units each. Each bolus is administered over 2 minutes. The second bolus is given 30 minutes after the first bolus injection.
No other medication should be injected or infused in the same intravenous line. No other medication should be added to the injection solution containing Reteplase. There is no experience with patients receiving repeat courses of therapy with Reteplase.
If Reteplase is to be injected through an intravenous line containing heparin, a normal saline or 5% dextrose (D5W) solution should be flushed through the line prior to and following the Reteplase injection.
Although the value of anticoagulants and antiplatelet drugs during and following administration of Reteplase has not been studied, heparin has been administered concomitantly in most of the patients. Aspirin has been given either during and/or following heparin treatment.
Reconstitution: Each vial should be reconstituted with 10 mL of sterile water for injection (WFI) in the following manner: Step 1: Remove the protective flip-cap from one vial of Reteplase (MIREL).
Step 2: Withdraw 10 mL of sterile water for injection from the container into a sterile 10 mL syringe with sterile needle.
Step 3: Clean the rubber cap of Reteplase (MIREL) vial and pierce the rubber cap with the syringe needle containing WFI and allow the WFI to transfer into the vial. Ensure all the WFI is transferred into the vial.
Step 4: Remove the needle and syringe from the vial. Gently swirl the contents of the vial for dissolution. Do not shake or vortex. Repeat gentle swirling till all the contents are dissolved.
Step 5: Allow the vial to stand for few seconds for dissipation of air bubbles.
Step 6: Attach a fresh sterile needle to the syringe and withdraw the reconstituted solution into the syringe.
Step 7: The 10 mL bolus is now ready for administration.
Step 8: After 30 minutes the same steps to be followed for the second bolus injection.
When reconstituted as directed, Reteplase (MIREL) should be used within 4 hours. Prior to administration, the product should be visually inspected for particulate matter and discoloration.