Elzonris Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: General precautions: Procedures for proper handling, including personal protective equipment (e.g. gloves), and disposal of anticancer medicines should be followed.
The solution for infusion should be prepared by a healthcare professional using proper aseptic technique throughout the handling of this medicinal product.
Preparation and administration: Preparing the infusion: Ensure the following components required for dose preparation and administration are available prior to thawing ELZONRIS: One infusion syringe pump; One empty 10 mL sterile vial; Sodium chloride 9 mg/mL (0.9%) solution for injection; Three 10 mL sterile syringes; One 1 mL sterile syringe; One mini-bifuse Y-connector; Microbore tubing; One 0.2 µm low protein binding polyethersulfone in-line filter.
Use only if the solution is clear and colourless or with a few white to translucent particles.
Allow vials to thaw at 25 °C or below for up to 1 hour in the outer carton. Do not refreeze a vial once thawed.
Determining dosage amount: Calculation to determine the total ELZONRIS dose (mL) to be administered (see Dosage & Administration): See equation.

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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 sodium chloride 9 mg/mL (0.9%) solution for injection to an empty sterile 10 mL vial.
Gently swirl the ELZONRIS vial to mix the contents, remove the cap, and using a sterile 1 mL syringe, withdraw 1 mL of thawed ELZONRIS from the product vial.
Transfer the 1 mL of ELZONRIS into the 10 mL vial containing the 9 mL of sodium chloride 9 mg/mL (0.9%) solution for injection. 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's weight.
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 of ELZONRIS). Label the ELZONRIS syringe.
Prepare a separate syringe with at least 3 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to be used to flush the administration set once the ELZONRIS dose is delivered.
Label the sodium chloride 9 mg/mL (0.9%) solution for injection flush syringe.
Connect the sodium chloride 9 mg/mL (0.9%) solution for injection 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 µm filter and attach it to the terminal end of the microbore tubing.
Unclamp the arm of the Y-connector connected to the sodium chloride 9 mg/mL (0.9%) solution for injection flush syringe. Prime the Y-connector up to the intersection (do not prime the full infusion set with sodium chloride 9 mg/mL (0.9%) solution for injection). Re-clamp the Y-connector line on the sodium chloride 9 mg/mL (0.9%) solution for injection flush arm.
Remove the cap on the terminal end of the 0.2 µm filter and set it aside. Unclamp the arm of the Y-connector connected to the product syringe, and prime the entire infusion set, including the filter. Recap the filter, and re-clamp the Y-connector line on the product side. The infusion set is now ready for delivery for dose administration.
The diluted solution should be used immediately once prepared.
Administration: 1. Establish venous access and maintain with sterile sodium chloride 9 mg/mL (0.9%) solution for injection.
2. Administer the prepared ELZONRIS dose via infusion with an infusion syringe pump over 15 minutes. The total infusion time will be controlled using an infusion syringe pump to deliver the entire dose and the sodium chloride 9 mg/mL (0.9%) solution for injection flush over 15 minutes.
3. Insert the ELZONRIS syringe into the infusion syringe pump, open the clamp on the ELZONRIS side of the Y-connector and deliver the prepared ELZONRIS dose.
4. Once the ELZONRIS syringe has been emptied, remove it from the pump and place the sodium chloride 9 mg/mL (0.9%) solution for injection flush syringe in the infusion syringe pump.
5. Open the clamp on the sodium chloride 9 mg/mL (0.9%) solution for injection flush side of the Y-connector and resume infusion via the infusion syringe pump at the pre-specified flow to push the remaining ELZONRIS dose out of the infusion line to complete delivery.
Disposal: ELZONRIS is for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.