(Respiratory Syncytial Virus Vaccine)

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ABRYSVO Act-O-Vial presentation is supplied in cartons of 1 and 10 Act-O-Vials, without syringes or needles. Each Act-O-Vial contains both the Lyophilized Antigen and Sterile Water Diluent (NDC 0069-2465-19).

Carton: 1 Act-O-Vial

NDC 0069-2465-01

Carton: 10 Act-O-Vials

NDC 0069-2465-10

ABRYSVO vial and prefilled syringe presentation is supplied in cartons of 1, 5, and 10 kits, without needles. Each kit includes a vial of Lyophilized Antigen Component (NDC 0069-0207-01), a prefilled syringe containing Sterile Water Diluent Component (NDC 0069-0250-01), and a vial adapter.

Carton: 1 kit

NDC 0069-0344-01

Carton: 5 kits

NDC 0069-0344-05

Carton: 10 kits

NDC 0069-0344-10

ABRYSVO vial and vial presentation is supplied in cartons of 5 and 10 doses packaged without syringes or needles. Each carton includes vials of Lyophilized Antigen Component (NDC 0069-0207-01) and vials of Sterile Water Diluent Component (NDC 0069-0651-01).

Carton: 5 doses

NDC 0069-1265-10

Carton: 10 doses

NDC 0069-1265-20

The Act-O-Vial stoppers, vial stoppers and the tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

16.2 Storage and Handling

Storage Before Reconstitution

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Discard if the carton has been frozen.

Storage After Reconstitution

After reconstitution, administer ABRYSVO immediately or store at room temperature [15ºC to 30ºC (59ºF to 86ºF)] and use within 4 hours. Do not freeze reconstituted vaccine.

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