


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.
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.
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
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