Product Dossier
H-B-VAX II
Product Dossier for H-B-VAX II (Hepatitis B surface antigen recombinant, Merck Sharp & Dohme). ARTG record, PBS listing, PBAC outcomes — compiled by…
- Sponsor: Merck Sharp & Dohme
- Active ingredient: Hepatitis B surface antigen recombinant
- Therapeutic area: Infectious Disease
- Related brand: TWINRIX
- Related brand: ENGERIX-B
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
H-B-VAX II is a hepatitis B vaccine recombinant available in multiple formulations and strengths for intramuscular injection.
Approved indications
— Immunisation against hepatitis B in paediatric populations (5 microgram formulation) — Immunisation against hepatitis B in adult and adolescent populations (10 microgram and 40 microgram formulations)
Dosing overview
Dosing of H-B-VAX II varies by age group and formulation strength. Paediatric formulations contain 5 microgram per 0.5 mL dose , while adult formulations are available in 10 microgram per 1 mL and 40 microgram per 1 mL strengths .
Key safety warnings
H-B-VAX II formulations are preservative-free or thiomersal-free , which reduces exposure to antimicrobial preservatives during immunisation.
Regulatory history
H-B-VAX II was first registered on the ARTG on 1 February 2000 as a paediatric 5 microgram per 0.5 mL preservative-free injection vial . Adult formulations (10 microgram per 1 mL and 40 microgram per 1 mL thiomersal-free injection vials) were registered on 21 August 2002 . Pre-filled syringe presentations of both the paediatric 5 microgram per 0.5 mL preservative-free formulation and the 10 microgram per 1 mL thiomersal-free formulation were registered on 10 August 2006 .