The vaccine is indicated for active immunization of adults and children aged 12 months and above against infection caused by Hepatitis A virus.

This is a purified, sterile suspension of inactivated Hepatitis A vaccine derived from Hepatitis A virus grown in human diploid cells. It is processed through harvesting, purification, inactivation with formaldehyde, and adsorption onto aluminium hydroxide.

Hepatitis A virus belongs to the picornavirus family and is one of several viruses that cause liver disease. The incubation period is typically around 28 days (range: 15–50 days). The clinical presentation varies widely, ranging from asymptomatic infection to severe hepatitis and, rarely, death. The presence of antibodies against HAV provides protection against infection; however, the minimum antibody level required for protection has not been clearly established.

Hepatitis A vaccine should be administered intramuscularly only. It must not be given intravenously. The primary immunization schedule consists of two doses: the first dose on the selected date and the second dose after 6 months.

Children 12 months to 15 years: Recommended dose is 0.5 mL

• First dose: On the selected date
• Second dose: 6 months after the first dose

Children 16 years and above: Recommended dose is 1 mL

• First dose: On the selected date
• Second dose: 6 months after the first dose

Method of administration: Hepatitis A vaccine should be administered intramuscularly in the deltoid muscle in adults and older children, and in the anterolateral thigh in younger children. It should not be injected into the gluteal region or given subcutaneously/intradermally, as this may result in reduced immune response. The vaccine should be visually inspected before use; do not use if particulate matter or discoloration is observed. Shake well before use to obtain a slightly milky-white suspension. Use as supplied.

Co-administration: Hepatitis A vaccine is an inactivated vaccine and can generally be administered with other inactivated vaccines without affecting immune response. If given with other vaccines, use separate syringes and different injection sites. Co-administration with Hepatitis B, typhoid, yellow fever, cholera (injectable), or tetanus vaccines does not interfere with immune response. It may also be given with human immunoglobulin for individuals at risk of exposure, but both should be administered at separate sites.

Individuals with hypersensitivity to any component of the vaccine. Those suffering from serious illnesses, fever, or immune disorders should not receive the vaccine.

Injection-site reactions are common and usually resolve within 72 hours without treatment. Mild and temporary adverse effects may include pain and redness at the injection site, and fever following vaccination.

The vaccine should be administered during pregnancy only when clearly necessary and when the potential benefits justify the possible risks. Caution is advised when considering vaccination in breastfeeding women.

• Shake well before use
• Use with caution in individuals or families with a history of convulsions, epilepsy, chronic diseases, or allergies
• Do not use if the container is cracked, contains foreign particles, or is expired
• Use immediately after opening
• Emergency medicines such as adrenaline should be available at the vaccination site
• The patient should be observed under medical supervision for at least 30 minutes after vaccination
• Do not freeze the vaccine

Vaccines, Anti-sera & Immunoglobulin

Keep out of the sight and reach of children. Store and transport at 2°C to 8°C. Protect from light.