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Havrix

Active Ingredient:
Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid
Origin:
EU

Havrix (Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid)

Havrix is an injectable hepatitis A vaccine containing inactivated hepatitis A virus adsorbed on aluminium hydroxide, produced on human diploid cells. It is supplied in a sterile liquid form for intramuscular administration and is marketed in the European Union. The product is prescription‑only and is classified as a prophylactic vaccine (ATC code J07BB01) that stimulates protective antibodies against hepatitis A virus and provides long‑term immunity.

Manufacturer / TM Owner

Glaxosmithkline Biologicals S.A.

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Indications & Clinical Uses

Havrix is indicated for the prevention of hepatitis A virus infection in individuals at risk.

  • Healthy adults and children aged 12 months and older who require protection against hepatitis A.
  • Travelers to regions where hepatitis A is endemic or where outbreaks have occurred.
  • Persons with occupational exposure to hepatitis A, such as laboratory workers handling the virus.
  • Individuals with chronic liver disease who need additional protection.
  • Close contacts of patients with confirmed hepatitis A infection.

Side Effects

The safety profile of Havrix includes both common, generally mild reactions and rare, serious events.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever.
  • Headache.
  • Fatigue or malaise.
  • Muscle aches.

Serious

  • Severe allergic reaction (anaphylaxis) with difficulty breathing or swelling of the face.
  • Guillain‑Barré syndrome (rare neurological condition).
  • Thrombocytopenia (low platelet count).
  • Seizures (rare).

Precautions & Warnings

Before administering Havrix, healthcare providers should consider several precautionary factors.

  • Known severe allergy to any component of the vaccine, including aluminium hydroxide.
  • History of anaphylaxis after a previous dose of Havrix or another hepatitis A vaccine.
  • Acute moderate or severe illness; vaccination should be postponed until recovery.
  • Pregnancy and breastfeeding status should be discussed with a clinician, as data are limited.
  • Immunocompromised individuals may have a reduced antibody response and may require additional dosing.
  • Children under 12 months are not approved for this vaccine.

Avoid Interactions

Havrix may interact with other medical products, influencing safety or immune response.

Avoid

  • Concurrent administration with other live vaccines (e.g., measles, mumps, rubella) without appropriate interval.
  • Use of immunoglobulin products that may neutralize the vaccine antigen if given shortly before or after vaccination.

Use with caution

  • Simultaneous receipt of other inactivated vaccines (e.g., influenza) – generally acceptable but monitor for increased local reactions.
  • Patients receiving immunosuppressive therapy may have diminished vaccine efficacy.
  • Antipyretic or analgesic medications (e.g., acetaminophen) taken prophylactically may mask mild systemic reactions.

Frequently Asked Questions

Havrix is approved for individuals aged 12 months and older.

The standard schedule consists of two doses given six months apart; a third dose may be recommended for certain high‑risk groups.

Pregnancy status should be discussed with a healthcare professional, as limited safety data are available.

Typical reactions include pain at the injection site, mild fever, headache, fatigue, and muscle aches.

Yes, it is recommended because hepatitis A infection can be more severe in those with existing liver conditions.

Live vaccines should be spaced apart; inactivated vaccines can generally be administered concurrently but may increase local reactions.

Protection typically persists for at least 10‑20 years, though long‑term studies continue to evaluate duration.

Yes, immunoglobulin given shortly before or after vaccination can neutralize the antigen and reduce the immune response.

Seek immediate medical attention; anaphylaxis requires emergency treatment with epinephrine and supportive care.

No, Havrix is a prescription‑only vaccine and must be administered by a qualified healthcare professional.

Adults who completed a primary series in childhood generally have lasting immunity, but booster doses may be advised for high‑risk exposure.

The vaccine should be stored in a refrigerator between 2°C and 8°C and protected from freezing.

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GNH India Pharmaceuticals Limited

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