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• Prior to dose preparation thaw at room temperature, between 15°C and 25°C (59°F and 77°F), for 15 to 30minutes in original carton, and verify thaw visually. Thawed vials may be held at room temperature forapproximately 1 hour prior to dosage preparation. Do not force thaw. Do not refreeze vial once thawed.
• Use aseptic technique for preparation of the ELZONRIS dose.
• A 2-step process is required for preparation of the final ELZONRIS dose:
- Step 1 - Prepare 10 mL of 100 mcg/mL ELZONRIS
- Using a sterile 10 mL syringe, transfer 9 mL of 0.9% Sodium Chloride Injection, USP to anempty sterile 10 mL vial.
- Gently swirl the ELZONRIS vial to mix the contents, remove the cap, and using a sterile 1 mLsyringe, withdraw 1 mL of thawed ELZONRIS from the product vial.
- Transfer the 1 mL of ELZONRIS into the 10 mL vial containing the 0.9% Sodium ChlorideInjection. Gently invert the vial at least 3 times to mix the contents. Do not shake vigorously.
- Following dilution the final concentration of ELZONRIS is 100 mcg/mL.
- Step 2 – Prepare the ELZONRIS infusion set.
- Calculate the required volume of diluted ELZONRIS (100 mcg/mL) according to patient’sweight.
- Draw up the required volume into a new syringe (if more than 10 mL of diluted ELZONRIS(100 mcg/mL) is required for the calculated patient dose, repeat step 1 with a second vial ofELZONRIS). Label the ELZONRIS syringe.
- Prepare a separate syringe with at least 3 mL of 0.9% Sodium Chloride Injection, USP (salineflush) to be used to flush the administration set once the ELZONRIS dose is delivered.
- Label the saline flush syringe.
- Connect the saline flush syringe to one arm of the Y-connector and ensure the clamp is closed.
- Connect the product syringe to the other arm of the Y-connector and ensure the clamp is closed.
- Connect the terminal end of the Y-connector to the microbore tubing.
- Remove the cap from the supply side of the 0.2 micron filter and attach it to the terminal end ofthe microbore tubing.
- Unclamp the arm of the Y-connector connected to the saline flush syringe. Prime the Yconnectorup to the intersection (do not prime the full infusion set with saline). Re-clamp the Yconnectorline on the saline flush arm.
- Remove the cap on the terminal end of the 0.2 micron filter and set it aside. Unclamp the arm ofthe Y-connector connected to the product syringe, and prime the entire infusion set, includingthe filter. Recap the filter, and re-clamp the Y-connector line on the product side. The infusionset is now ready for delivery for dose administration.
• Administer ELZONRIS within 4 hours. During this 4-hour window, the prepared dose should remain atroom temperature.
Do not reuse excess ELZONRIS. Any excess material should be thrown away immediately following
infusion.
2.4 Administration
• Establish venous access and maintain with sterile 0.9% Sodium Chloride Injection, USP.
• Administer the prepared ELZONRIS dose via infusion syringe pump over 15 minutes. The total infusiontime will be controlled using a syringe pump to deliver the entiredose and the saline flush over 15 minutes.
• Insert the ELZONRIS syringe into the syringe pump, open the clamp on the ELZONRIS side of the Yconnectorand deliver the prepared ELZONRIS dose.
• Once the ELZONRIS syringe has been emptied, remove it from the pump and place the saline flush syringein the syringe pump.
• Open the clamp on the saline flush side of the Y-connector and resume infusio |
