Vyepti Caution For Usage

Special precautions for disposal and other handling: The medicinal product requires dilution prior to administration. The dilution should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution for infusion.
The medicinal product contains no preservative and is intended for single use only and any unused medicinal product should be disposed.
Prior to dilution, the medicinal product (concentrate in the vials) should be inspected visually; do not use if the concentrate contains visible particulate matter or is cloudy or discoloured (other than clear to slightly opalescent, colourless to brownish-yellow).
For both the 100 mg and the 300 mg dose, a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prepare the VYEPTI solution for infusion as described below. No other intravenous diluents or volume may be used to prepare the VYEPTI solution for infusion.
Gently invert the VYEPTI solution for infusion to mix completely. Do not shake.
Following dilution, VYEPTI solution for infusion must be infused within 8 hours. During this time, VYEPTI solution for infusion may be stored at room temperature (below 25°C) or refrigerated at 2°C - 8°C. If stored at 2°C - 8°C, allow the VYEPTI solution for infusion to warm to room temperature prior to infusion. DO NOT FREEZE.
VYEPTI 100 mg dose: To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from one single-use vial using a sterile needle and syringe. Inject the 1.0 mL (100 mg) content into a 100 mL bag of 0.9% sodium chloride for injection
VYEPTI 300 mg dose: To prepare the VYEPTI solution for infusion, withdraw 1.0 mL of VYEPTI from 3 single-use vials using a sterile needle and syringe. Inject the resulting 3.0 mL (300 mg) content into a 100 mL bag of 0.9% sodium chloride for injection.
Infusion administration instructions: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particulate matter or is cloudy or discolored.
Infuse VYEPTI 100 mg dose or VYEPTI 300 mg dose as prescribed, following dilution of the vial content in a 100 mL bag of 0.9% sodium chloride for injection, over approximately 30 minutes. Use an intravenous infusion set with a 0.2 or 0.22 μm in-line or add-on filter. After the infusion is complete, flush the line with 20 mL of 0.9% sodium chloride for injection.
Do not administer VYEPTI as a bolus injection.
No other medications should be administered through the infusion set or mixed with VYEPTI.
Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in Special precautions for disposal and other handling.