Product image of Havrix (Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ) supplied by GNH India

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 a hepatitis A vaccine whose active ingredient is an inactivated hepatitis A virus adsorbed on aluminium hydroxide hydrate and produced on human diploid cells. The product is supplied for intramuscular administration; specific strength and dosage form are not disclosed in the available data. It is marketed in the European Union and is used to induce immunity against hepatitis A infection through a standard immunization schedule.

Manufacturer / TM Owner

Glaxosmithkline Single Member A.E.B.E.

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Indications & Clinical Uses

Havrix is indicated for the prevention of hepatitis A virus infection in individuals who have not been previously immunized.

  • 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 at increased risk due to occupational exposure, such as laboratory workers handling hepatitis A virus.
  • Individuals with chronic liver disease who need additional protection against hepatitis A complications.
  • Outbreak control situations where rapid immunization of a population is recommended.

Side Effects

The safety profile of Havrix reflects the typical reactions observed with inactivated viral vaccines. These reactions are generally self‑limiting and do not require medical intervention.

Common

  • Mild pain, redness, or swelling at the injection site.
  • Low‑grade fever occurring within 24–48 hours after vaccination.
  • Headache or fatigue that resolves spontaneously.
  • Mild muscle aches or joint discomfort.
  • Transient nausea or gastrointestinal discomfort.
  • Mild rash or itching away from the injection site.
  • Temporary dizziness or light‑headedness.
  • Mild lymphadenopathy near the injection site.

Serious

  • Allergic reactions such as urticaria, angioedema, or anaphylaxis.
  • Neurologic events including Guillain‑Barré syndrome, though reported rarely.
  • Severe local reactions with extensive necrosis (extremely rare).
  • Severe allergic reaction with respiratory compromise (rare).

Precautions & Warnings

Before receiving Havrix, certain health considerations should be reviewed to ensure safe administration.

  • Confirm that the individual has not previously received a hepatitis A vaccine or documented immunity.
  • Defer vaccination in persons with a known severe allergy to any vaccine component, including aluminium salts.
  • Postpone administration in individuals experiencing an acute moderate or severe illness.
  • Discuss pregnancy or breastfeeding status with a healthcare professional, as safety data are limited.
  • Evaluate the presence of immunocompromising conditions that may affect vaccine response.
  • Consider the timing of other vaccinations to avoid simultaneous administration unless advised.

Avoid Interactions

Havrix may interact with other agents; awareness of potential interactions helps optimize vaccination timing.

Avoid

  • Concurrent administration with live attenuated vaccines is generally avoided to prevent immune interference.
  • Simultaneous receipt of immunoglobulin products that contain anti‑hepatitis A antibodies may reduce vaccine efficacy.

Use with caution

  • Co‑administration with other inactivated vaccines (e.g., influenza, tetanus) is permissible but monitor for increased local reactions.
  • Patients receiving immunosuppressive therapy may have a diminished immune response; timing of vaccination should be coordinated with the treating physician.
  • Use caution when vaccinating individuals on high‑dose corticosteroids, as antibody production may be suboptimal.

Frequently Asked Questions

The active ingredient is an inactivated hepatitis A virus adsorbed onto aluminium hydroxide hydrate and produced on human diploid cells.

Havrix is given by intramuscular injection, typically in the deltoid muscle, according to the recommended immunization schedule.

Havrix is recommended for individuals who have not been previously immunized against hepatitis A, including children aged 12 months and older, travelers to endemic areas, and persons at increased risk due to occupational exposure or chronic liver disease.

Pregnancy and breastfeeding status should be discussed with a healthcare professional, as specific safety data for Havrix in these populations are limited.

Common side effects include mild pain, redness, or swelling at the injection site, low‑grade fever, headache, fatigue, muscle aches, and transient gastrointestinal discomfort.

Serious reactions are rare but may include allergic responses such as urticaria, angioedema, anaphylaxis, and very rare neurologic events like Guillain‑Barré syndrome.

Vaccination should be deferred in individuals with a known severe allergy to any component of the vaccine, including aluminium salts.

Co‑administration with other inactivated vaccines is generally permissible, but healthcare providers may monitor for increased local reactions.

Immunosuppressive therapy can reduce the immune response to Havrix; timing of vaccination should be coordinated with the treating physician.

Vaccination should be postponed until the acute moderate or severe illness has resolved.

Yes, simultaneous receipt of such immunoglobulin may reduce the vaccine’s effectiveness and is generally avoided.

Official product information is available from the marketing authorization holder or national regulatory agencies in the European Union.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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