Arexvy Powder and suspension for suspension for injection

Manufacturer
GLAXOSMITHKLINE BIOLOGICALS S.A(BELGIUM)

Registraction Number
MAL24086007ARZ

Contents:

• Active Ingredient: Recombinant Respiratory Syncytial Virus pre-fusion F protein (RSVPreF3)
• Adjuvant: AS01E, which contains Quillaja saponaria Molina (QS-21) and 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota
• Form: Powder and suspension for suspension for injection

• Active immunization of individuals aged 60 years and older
• Active immunization of adults aged 50 through 59 years who are at increased risk for RSV disease

1. Reconstitution:
   • Withdraw the entire contents of the vial containing the suspension into a syringe.
   • Add the entire contents of the syringe into the vial containing the powder.
   • Gently swirl until the powder is completely dissolved.
2. Administration:
   • Administer the reconstituted solution via intramuscular injection in the deltoid muscle.
   • Use a 0.2-0.22 micron in-line filter.
3. Timing:
   • The reconstituted vaccine should be used promptly.
   • If not used within 4 hours, it should be discarded.
4. Storage:
   • Store the reconstituted vaccine in the refrigerator (2°C – 8°C) or at room temperature up to 25°C.