Indication: Active immunization against hepatitis A infection in persons 12 years of age and older.
Use Cases:
Pre-exposure for travelers to hepatitis A endemic areas, individuals with chronic liver disease, people with hemophilia, users of illicit drugs, MSM, and those in close contact with adoptees from endemic areas.
Post-exposure immunization for household and close contacts of hepatitis A cases.
Outbreak control in community and institutional settings.
Contraindications
Hypersensitivity to any component of AVAXIM® or severe allergic reaction after previous administration of the vaccine or similar vaccines.
Warnings and Precautions
General: Inform recipients about the benefits and risks of immunization and assess their health status and immunization history.
Protection: Does not protect against hepatitis B, C, delta virus, E, or other liver pathogens.
Hematologic: Caution in individuals with bleeding disorders; intramuscular injections may cause hematoma.
Immune: Reduced efficacy in immunocompromised individuals.
Pregnant and Nursing Women: Limited data; use only if clearly needed.
Adverse Reactions
Clinical Trials: Mild and transient, mainly within the first few days post-vaccination. Common reactions include:
Rare: Mild transient elevation of serum transaminases, injection site nodule.
Post-Market: Includes vasovagal syncope, urticaria, rashes, and increased transaminases.
Drug Interactions
Vaccine-Drug: Immunosuppressive treatments may interfere with immune response.
Concomitant Vaccine Administration: Safe with immune globulin and other vaccines using separate injection sites.
Dosage and Administration
Recommended Dose: Single dose of 0.5 mL intramuscularly, with a booster 6-36 months later for long-term protection.
Administration: Preferred site is the deltoid muscle. Inspect for particulate matter and discoloration before use. Shake well before administration.
Overdose
Management: Contact regional Poison Control Centre.
Action and Clinical Pharmacology
Mechanism of Action: Induces production of specific anti-HAV antibodies.
Pharmacodynamics: Over 90% protected 14 days post-vaccination, 100% protected one month post-vaccination. Immunity persists for at least 36 months after initial dose.
Storage and Stability
Storage: Store at 2° to 8°C, do not freeze. Discard if exposed to freezing. Do not use after the expiration date.
Dosage Forms, Composition, and Packaging
Dosage Forms: Pre-filled syringes containing 0.5 mL of sterile, whitish, cloudy suspension.
Composition: Includes inactivated hepatitis A virus (GBM strain), aluminum hydroxide, formaldehyde, neomycin, 2-phenoxyethanol, and polysorbate 80.
