Indication: Active immunization against hepatitis A virus (HAV) infection.
Use: Recommended for individuals 12 months of age and older for pre-exposure prophylaxis against HAV.
Contraindications
Known hypersensitivity to any component of the vaccine, including amorphous aluminum hydroxyphosphate sulfate, neomycin (trace amounts), and latex in the vial stopper.
Severe allergic reactions to any ingredient in the formulation or component of the container.
Warnings and Precautions
Immunocompromised Individuals: May not achieve the expected immune response.
Latex Allergy: Contains dry natural latex rubber.
General: Adequate medical treatment should be available for immediate use in case of anaphylactic reactions.
Pregnancy and Breastfeeding: Use only if clearly needed as safety data are limited.
Special Populations: Not recommended for infants younger than 12 months due to lack of data.
Clinical Trials: No serious, vaccine-related adverse events identified. Most reactions were mild and transient.
Post-Marketing: Rare reports of Guillain-Barré syndrome, cerebellar ataxia, encephalitis, thrombocytopenia.
Drug Interactions
Concomitant Use: Can be administered with yellow fever, typhoid, measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, oral/inactivated polio, diphtheria, tetanus, acellular pertussis, and Haemophilus influenzae type b vaccines using separate sites and syringes.
Immune Globulin (IG): May be administered concomitantly using separate sites and syringes.
Dosage and Administration
Primary Immunization:
Children/Adolescents (12 months to 17 years): Single 0.5 mL (~25 U) dose, followed by a 0.5 mL booster 6-18 months later.
Adults (18 years and older): Single 1.0 mL (~50 U) dose, followed by a 1.0 mL booster 6-18 months later.
HIV-Infected Adults: 1.0 mL (~50 U) dose, followed by a booster 6 months later.
Administration: Intramuscular injection in the deltoid muscle (for adults, adolescents, and children older than 2 years) or the anterolateral area of the thigh (for children 12-23 months). Do not inject intravascularly, intradermally, or subcutaneously.
Missed Dose: Physician will decide on the schedule for the missed dose.
Overdose
Management: Contact regional Poison Control Centre.
Storage and Stability
Storage: Refrigerate at 2°C to 8°C. Do not freeze. VAQTA® can be administered if total time out of refrigeration does not exceed 72 hours.
Dosage Forms, Composition, and Packaging
Pediatric/Adolescent Presentation: 0.5 mL dose (25 U of hepatitis A virus protein).
Adult Presentation: 1.0 mL dose (50 U of hepatitis A virus protein).
Composition: Contains aluminum as an adjuvant, sodium borate, sodium chloride, and trace amounts of neomycin. No preservatives.
