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: The powder and the suspension must be reconstituted prior to administration.
The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the vaccine.
How to prepare Arexvy: Arexvy must be reconstituted prior to administration.
1. Withdraw the entire contents of the vial containing the suspension into a syringe.
2. Add the entire contents of the syringe into the vial containing the powder.
3. Gently swirl until the powder is completely dissolved.
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine.
Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C - 8°C or at room temperature up to 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 4 hours.
Before administration: 1. Withdraw 0.5 mL of the reconstituted vaccine into the syringe.
2. Change the needle so that a new needle is being used.
Administer the vaccine intramuscularly.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.