Reconstitution and Administration

Video transcript

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Reconstitution and Administration

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Welcome, this video will walk you through the reconstitution and administration process for AREXVY.

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How Supplied; Preparation, Reconstitution and Administration

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Important information about how AREXVY is supplied will also be discussed.

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How Supplied

AREXVY 0.5 mL IM Injection

1. Adjuvant suspension component (liquid)

2. Lyophilized antigen component (powder)

Reconstitution and Administration

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AREXVY is supplied in 2 vials, an adjuvant suspension component (liquid) and a lyophilized antigen component (powder), that must be combined prior to administration. Use only the supplied adjuvant suspension component for reconstitution.

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How Supplied

Refrigerated

Between 2-8°C (36-46°F)

Protect From Light

Do Not Freeze

Reconstitution and Administration

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Prior to reconstitution, store both the adjuvant suspension component vials and the lyophilized antigen component vials refrigerated between 2 degrees Celsius and 8 degrees Celsius (36 to 46 degrees Fahrenheit). Store in the original package in order to protect vials from light. Do not freeze. Discard if the adjuvant suspension component or the antigen component have been frozen.

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Preparation

Reconstitution and Administration

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When you are ready to reconstitute the vaccine, follow these steps.

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Preparation

Step A: Withdraw the entire contents of the vial containing the adjuvant suspension component (liquid).

Step B: Slowly transfer the entire contents of the syringe into the lyophilized antigen component vial (powder).

Step C: Gently swirl the vial until the powder is completely dissolved. Do not shake vigorously.

Wash your hands or wear gloves. Preparation will also require needles, syringes, disinfecting swabs, and a bandage.

DO NOT SHAKE VIGOROUSLY

Reconstitution and Administration

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Check the expiration date of both vials. If expired, do not use. Cleanse both vial stoppers with a sterile alcohol swab. Using sterile needles and sterile syringes, withdraw the entire contents of the vial containing the adjuvant suspension component (liquid) by slightly tilting the vial.

Slowly transfer the entire contents of the syringe into the lyophilized antigen component vial (powder).

Gently swirl the vial until the powder is completely dissolved. Do not shake vigorously. The reconstituted vaccine should be an opalescent, colorless to pale brownish liquid.

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Preparation

Refrigerated

Between 2-8°C (36-46°F) or at Room Temperature up to 25°C (77°F)

Protect From Light

Discard Reconstituted Vaccine if Not Used Within 4 Hours

Do Not Freeze

Reconstitution and Administration

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After reconstitution, administer AREXVY immediately or store protected from light in the refrigerator between 2 degrees Celsius and 8 degrees Celsius (36 to 46 degrees Fahrenheit) or at room temperature up to 25 degrees Celsius (77 degrees Fahrenheit) and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours. Do not freeze. Discard if the vaccine has been frozen.

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Preparation

Prior to administration, inspect for particulate matter and discoloration

Questions about AREXVY?

Call 877-AREXVY1 (877-273-9891)

Reconstitution and Administration

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Immediately prior to administering, parenteral drug products should be inspected visually for particulate matter and discoloration immediately prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

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Preparation

STEP D: After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine and administer intramuscularly.

AREXVY is for intramuscular injection only

For illustrative purposes only.

Reconstitution and Administration

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After reconstitution, if stored, cleanse the vial stopper with a sterile alcohol swab prior to administration. Withdraw 0.5 mL from the vial containing the reconstituted vaccine. Disinfect the injection site prior to administration, and administer intramuscularly. AREXVY is for intramuscular injection only.

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©2023 GSK or licensor.

RSASTBD230013 June 2023

Produced USA.

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