Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: For use of vial of antigens for Abrysvo (powder), pre-filled syringe of solvent and vial adaptor: Abrysvo must be reconstituted prior to administration by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder using the vial adaptor.
The vaccine must be reconstituted only with the solvent provided.
Preparation for administration: Step 1. Attach vial adaptor: Peel off the top cover from the vial adaptor packaging and remove the flip off cap from the vial.
While keeping the vial adaptor in its packaging, centre over the vial's stopper and connect with a straight downward push. Do not push the vial adaptor in at an angle as it may result in leaking. Remove the packaging.
Step 2. Reconstitute the powder component (antigens) to form Abrysvo: For all syringe assembly steps, hold the syringe only by the Luer lock adaptor. This will prevent the Luer lock adaptor from detaching during use.
Twist to remove the syringe cap, then twist to connect the syringe to the vial adaptor. Stop turning when you feel resistance.
Inject the entire contents of the syringe into the vial. Hold the plunger rod down and gently swirl the vial until the powder is completely dissolved (approximately 1-2 minutes). Do not shake.
Step 3. Withdraw reconstituted vaccine: Invert the vial completely and slowly withdraw the entire contents into the syringe to ensure a 0.5 mL dose of Abrysvo.
Twist to disconnect the syringe from the vial adaptor.
Attach a sterile needle suitable for intramuscular injection.
The prepared vaccine is a clear and colourless solution. Visually inspect the vaccine for large particulate matter and discolouration prior to administration. Do not use if large particulate matter or discolouration is found.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.