Special precautions for disposal and other handling: The diluted solution for infusion should be prepared by a healthcare professional using aseptic technique.
Preparation of solution for infusion: Two Tevimbra vials are required for each dose.
Remove the vials from the refrigerator, taking care not to shake them.
Inspect each vial visually for particulate matter and discolouration prior to administration. The concentrate is a clear to slightly opalescent, colourless to slightly yellowish solution. Do not use a vial if the solution is cloudy, or if visible particles or discolouration are observed.
Invert the vials gently without shaking. Withdraw the solution from the two vials (a total of 200 mg in 20 ml) into a syringe and transfer into an intravenous infusion bag containing sodium chloride 9 mg/ml (0.9%) solution for injection, to prepare a diluted solution with a final concentration ranging from 2 to 5 mg/ml. Mix diluted solution by gentle inversion to avoid foaming or excessive shearing of the solution.
Administration: Administer the diluted Tevimbra solution by infusion through an intravenous administration line with a sterile, non-pyrogenic, low-protein-binding 0.2 micron or 0.22 micron in-line or add-on filter with a surface area of approximately 10 cm2.
The first infusion should be delivered over 60 minutes. If well tolerated, subsequent infusions may be administered over 30 minutes.
Other medicinal products should not be co-administered through the same infusion line.
Tevimbra must not be administered as an intravenous push or single bolus injection.
The intravenous line must be flushed at the end of the infusion.
Discard any unused portion left in the vial.
Tevimbra vials are for single use only.
Disposal: Any unused medicinal product or waste material should be disposed of 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 previously mentioned in Special precautions for disposal and other handling.