ABRYSVO® Dosage and Administration

(Respiratory Syncytial Virus Vaccine)

2 DOSAGE AND ADMINISTRATION

2.1 Dose and Schedule

After reconstitution, a single dose of ABRYSVO is either approximately 0.5 mL (vial and prefilled syringe presentation) or 0.5 mL (vial and vial presentation) [see Dosage and Administration (2.2)].

2.2 Presentations and Reconstitution

ABRYSVO is supplied in 2 presentations as follows:

Vial and Prefilled Syringe Presentation

The vial and prefilled syringe presentation is supplied in a kit that includes a vial of Lyophilized Antigen Component (a sterile white powder), a prefilled syringe containing the Sterile Water Diluent Component, and a vial adapter.

Vial and Vial Presentation

The vial and vial presentation is supplied in cartons that include vials of Lyophilized Antigen Component (a sterile white powder) and vials containing the Sterile Water Diluent Component.

For both presentations, reconstitute the Lyophilized Antigen Component with the accompanying Sterile Water Diluent Component to form ABRYSVO, as described in the instructions below.

Reconstitution Instructions for Vial and Prefilled Syringe Presentation

Step 1-VPStep 2-VPStep 3-VPStep 4-VP

Step 1. Attachment of the vial adapter to the vial

Remove the flip top cap from the vial of Lyophilized Antigen Component.

Peel off the top cover from the vial adapter packaging.

While keeping the vial adapter in its packaging, center the adapter over the vial’s stopper and attach to the vial with a straight downward push.

Remove the packaging.

Step 2. Connection of the syringe to the vial adapter

Hold the syringe of Sterile Water Diluent Component by the Luer lock adapter.

Twist to remove the syringe cap.

Connect the syringe to the vial adapter by turning the Luer lock.

Step 3. Reconstitution of the Lyophilized Antigen Component with the Sterile Water Diluent Component to form ABRYSVO

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 (less than 1 minute).

Do not shake.

Step 4. Withdrawal of ABRYSVO

Invert the vial completely and slowly withdraw the entire contents into the syringe for an approximately 0.5 mL dose of ABRYSVO.

Twist to disconnect the syringe from the vial adapter.

Attach a sterile needle suitable for intramuscular injection.

Reconstitution Instructions for the Vial and Vial Presentation

Step 1-VVStep 2a-VVStep 2b-VVStep 3-VV

Step 1. Withdrawal of the Sterile Water Diluent

Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the Sterile Water Diluent Component.

Step 2. Reconstitution of the Lyophilized Antigen Component with the Sterile Water Diluent Component to form ABRYSVO

Inject the entire contents into the vial containing the Lyophilized Antigen Component (white powder). Gently swirl the vial in a circular motion until the powder is completely dissolved. Do not shake.

Step 3. Withdrawal of ABRYSVO

Withdraw 0.5 mL from the vial containing the reconstituted vaccine.

2.3 Administration

For intramuscular injection

After reconstitution, ABRYSVO is a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.

Administer ABRYSVO immediately or store at room temperature [15°C to 30°C (59°F to 86°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Dose and Schedule

After reconstitution, a single dose of ABRYSVO is either approximately 0.5 mL (vial and prefilled syringe presentation) or 0.5 mL (vial and vial presentation) [see Dosage and Administration (2.2)].

2.2 Presentations and Reconstitution

ABRYSVO is supplied in 2 presentations as follows:

Vial and Prefilled Syringe Presentation

The vial and prefilled syringe presentation is supplied in a kit that includes a vial of Lyophilized Antigen Component (a sterile white powder), a prefilled syringe containing the Sterile Water Diluent Component, and a vial adapter.

Vial and Vial Presentation

The vial and vial presentation is supplied in cartons that include vials of Lyophilized Antigen Component (a sterile white powder) and vials containing the Sterile Water Diluent Component.

For both presentations, reconstitute the Lyophilized Antigen Component with the accompanying Sterile Water Diluent Component to form ABRYSVO, as described in the instructions below.

Reconstitution Instructions for Vial and Prefilled Syringe Presentation

Step 1-VPStep 2-VPStep 3-VPStep 4-VP

Step 1. Attachment of the vial adapter to the vial

Remove the flip top cap from the vial of Lyophilized Antigen Component.

Peel off the top cover from the vial adapter packaging.

While keeping the vial adapter in its packaging, center the adapter over the vial’s stopper and attach to the vial with a straight downward push.

Remove the packaging.

Step 2. Connection of the syringe to the vial adapter

Hold the syringe of Sterile Water Diluent Component by the Luer lock adapter.

Twist to remove the syringe cap.

Connect the syringe to the vial adapter by turning the Luer lock.

Step 3. Reconstitution of the Lyophilized Antigen Component with the Sterile Water Diluent Component to form ABRYSVO

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 (less than 1 minute).

Do not shake.

Step 4. Withdrawal of ABRYSVO

Invert the vial completely and slowly withdraw the entire contents into the syringe for an approximately 0.5 mL dose of ABRYSVO.

Twist to disconnect the syringe from the vial adapter.

Attach a sterile needle suitable for intramuscular injection.

Reconstitution Instructions for the Vial and Vial Presentation

Step 1-VVStep 2a-VVStep 2b-VVStep 3-VV

Step 1. Withdrawal of the Sterile Water Diluent

Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the Sterile Water Diluent Component.

Step 2. Reconstitution of the Lyophilized Antigen Component with the Sterile Water Diluent Component to form ABRYSVO

Inject the entire contents into the vial containing the Lyophilized Antigen Component (white powder). Gently swirl the vial in a circular motion until the powder is completely dissolved. Do not shake.

Step 3. Withdrawal of ABRYSVO

Withdraw 0.5 mL from the vial containing the reconstituted vaccine.

2.3 Administration

For intramuscular injection

After reconstitution, ABRYSVO is a clear and colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.

Administer ABRYSVO immediately or store at room temperature [15°C to 30°C (59°F to 86°F)] and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.
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