For Vaccination of Adults (≥19 Years of Age) Against Hepatitis A1
A SINGLE 1-mL DOSE GIVEN AT 0 MONTHS, FOLLOWED BY A BOOSTER DOSE GIVEN BETWEEN 6 AND 12 MONTHS LATER
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX.
Prescribing Information for HAVRIX.
Indication for HAVRIX
HAVRIX is a vaccine indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.
Important Safety Information for HAVRIX
Severe allergic reaction (eg, anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX
The tip caps of the prefilled syringes for HAVRIX contain natural rubber latex, which may cause allergic reactions
Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to HAVRIX
In clinical trials with HAVRIX in children 11 to 25 months of age, the most common solicited adverse reactions were injection-site pain and redness, irritability, drowsiness, and loss of appetite
In clinical trials with HAVRIX in adults and children 2 years of age and older, the most common solicited adverse reactions were injection-site soreness and headache
Vaccination with HAVRIX may not result in protection in all vaccine recipients
To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967.
Trademarks are owned by or licensed to the GSK group of companies.