6.5 Nature and contents of container Abrysvo powder and solvent for solution for injection Single dose vials Powder for 1 dose in a vial (type 1 glass or equivalent) with a stopper and a flip off cap. Solvent for 1 dose in a vial (type 1 glass or equivalent) with a stopper and a flip off cap. Pack sizes Carton containing 25 single dose vials of powder (antigens) and a separate carton containing 25 vials of solvent. Abrysvo powder and solvent for solution for injection in multidose container Multidose vials Powder for 3 doses in a vial (type 1 glass or equivalent) with a stopper and a flip off cap. Solvent for 3 doses in a vial (type 1 glass or equivalent) with a stopper and a flip off cap.
Pack sizes Carton containing 25 multidose vials of powder (antigens) and a separate carton containing 25 multidose vials of solvent (75 dose pack). 6.6 Special precautions for disposal and other handling Abrysvo powder and solvent for solution for injection Single dose vials The vial containing antigens for Abrysvo (powder) must be reconstituted only with the vial of solvent provided to form Abrysvo. Preparation for administration 1. Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the solvent and inject the entire contents of the syringe into the vial containing the powder. 2.
Gently swirl the vial in a circular motion until the powder is completely dissolved. Do not shake. 3. Withdraw 0.5 mL from the vial containing the reconstituted vaccine. Abrysvo powder and solvent for solution for injection in multidose container Multidose vials The multidose vial containing antigens for Abrysvo (powder) must be reconstituted only with the multidose vial of solvent provided to form Abrysvo. Abrysvo is administered as a single dose of 0.5 mL. The maximum number of doses per multidose vial is 3. 13