Havrix Vaccination in India

Havrix – GSK

Indication and Usage –

• HAVRIX is 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.

Dosage and Administration –

• HAVRIX should be administered by intramuscular injection only. HAVRIX should not be administered in the gluteal region; such injections may result in suboptimal response.
• Do not administer this product intravenously, intradermally, or subcutaneously.
• Children and Adolescents (aged 12 months through 18 years)

Primary immunization for children and adolescents consists of a single 0.5-mL dose and a 0.5- mL booster dose administered anytime between 6 and 12 months later. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in young children or the deltoid muscle of the upper arm in older children.

• Adults (aged 19 years and older)

Primary immunization for adults consists of a single 1-mL dose and a 1-mL booster dose administered anytime between 6 and 12 months later. In adults, the injection should be given in the deltoid region.

Contraindications –

• Severe allergic reaction (e.g., 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.

Adverse reactions –

• Metabolism and Nutrition Disorders: Anorexia.
• Gastrointestinal Disorders: Nausea.
• General Disorders and Administration Site Conditions.
• Fatigue; fever >99.5°F (37.5°C); induration.
• Redness and swelling of the injection site; malaise.

Drug interactions and other interactions –

• Concomitant Administration with Vaccines and Immune Globulin

In clinical studies HAVRIX was administered concomitantly with the following

1. INFANRIX (DTaP)
2. Hib conjugate vaccine
3. Pneumococcal 7-valent conjugate vaccine
4. MMR vaccine
5. Varicella vaccine.

HAVRIX may be administered concomitantly with immune globulin.

When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. Do not mix HAVRIX with any other vaccine or product in the same syringe.

• Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids may reduce the immune response to HAVRIX.