Indication: Active immunization against hepatitis A virus (HAV) infection.
Use: Approved for individuals 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to anticipated exposure to HAV.
Contraindications
Known hypersensitivity to any component of the vaccine or its container.
Severe febrile illness is a contraindication for vaccination, though minor infections are not.
Warnings and Precautions
General: Appropriate medication should be available in case of anaphylactic reactions. Supervise vaccinees for 30 minutes post-immunization.
Immune System: Reduced efficacy in immunocompromised individuals; may require additional doses.
Pregnant and Nursing Women: Use only if clearly needed; risks to the fetus are considered negligible.
Hematologic: Caution in individuals with thrombocytopenia or bleeding disorders due to risk of bleeding at injection site.
Adverse Reactions
Very Common (≥10%): Irritability, headache, pain, and redness at the injection site, fatigue.
Common (≥1% and <10%): Loss of appetite, drowsiness, gastrointestinal symptoms, injection site swelling, fever.
Can be administered with other inactivated vaccines and immune globulin (human) but should be given at separate sites.
No significant interactions with concomitantly administered recombinant hepatitis B vaccine (ENGERIX-B), typhoid, yellow fever, cholera, tetanus, MMR, or varicella vaccines.
Dosage and Administration
Primary Immunization:
Adults (19+ years): Single dose of HAVRIX 1440 (1 mL suspension).
Children and Adolescents (1-18 years): Single dose of HAVRIX 720 Junior (0.5 mL suspension).
Booster Dose: Recommended 6-12 months after the primary dose to ensure long-term protection.
Administration: Intramuscular injection in the deltoid region for adults and children, antero-lateral thigh for young children. Not for intravenous use.
Overdose Management
Contact regional Poison Control Centre. Adverse events reported following overdose are similar to those with normal administration.
Action and Clinical Pharmacology
Mechanism of Action: Induces production of specific anti-HAV antibodies.
Immune Response: High seroconversion rates observed in clinical studies, with over 99% of subjects developing antibodies within one month post-vaccination.
Storage and Stability
Store at 2-8°C, do not freeze. Discard if frozen. Stable at temperatures up to 25°C for 3 days.
Dosage Forms, Composition, and Packaging
HAVRIX 1440: 1440 ELISA Units/mL for adults.
HAVRIX 720 Junior: 720 ELISA Units/0.5 mL for children.
Components: Formaldehyde-inactivated hepatitis A virus adsorbed onto aluminium hydroxide. Contains amino acids, disodium phosphate, monopotassium phosphate, polysorbate 20, potassium chloride, sodium chloride, water for injection, and trace neomycin sulphate.
