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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 a prescription‑only hepatitis A vaccine that contains an inactivated hepatitis A virus adsorbed on aluminium hydroxide, supplied as an injectable solution. The product is manufactured for the European market and is administered intramuscularly to stimulate active immunity against hepatitis A infection. No specific strength is listed on the label, and the formulation is designed for use in adults and children as directed by a healthcare professional.

Manufacturer / TM Owner

Glaxosmithkline Biologicals S.A.

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Indications & Clinical Uses

Havrix is indicated for the prevention of hepatitis A infection in individuals who are at risk of exposure or who seek immunization against the virus.

  • Primary prophylaxis for adults and children aged 12 months and older.
  • Protection for travelers to regions where hepatitis A is endemic.
  • Immunization of laboratory personnel handling hepatitis A virus.
  • Use in outbreak settings to control spread of hepatitis A.
  • Administration as a two‑dose series, with the second dose given 6–12 months after the first.

Side Effects

Following intramuscular injection, Havrix may cause transient reactions; most are mild and resolve without intervention.

Common

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

Serious

  • Severe allergic reaction (anaphylaxis) with symptoms such as difficulty breathing, swelling of the face or throat, and rapid heartbeat.
  • Guillain‑Barré syndrome, a rare neurological disorder characterized by muscle weakness.
  • Persistent high fever or severe rash.
  • Severe joint pain.
  • Seizures.

Precautions & Warnings

Healthcare providers should assess individual risk factors and medical history before administering Havrix to ensure safe and effective immunization.

  • Defer vaccination in persons with known severe allergy to any vaccine component, including aluminium salts.
  • Postpone administration in individuals experiencing acute moderate or severe illness.
  • Use with caution in patients with compromised immune systems; vaccine may be less effective.
  • Discuss potential risks with pregnant or breastfeeding women, as safety data are limited.
  • Monitor for signs of anaphylaxis for at least 15 minutes after injection.
  • Avoid routine revaccination without documented loss of immunity.

Avoid Interactions

Havrix generally has a low potential for drug interactions, but certain medications and vaccines may influence its safety or effectiveness.

Avoid

  • Concurrent administration with live‑attenuated vaccines (e.g., measles, mumps, rubella) should be avoided; separate them by at least 4 weeks.
  • Simultaneous use of immunoglobulin products may reduce the immune response to Havrix.

Use with caution

  • Immunosuppressive therapy (e.g., corticosteroids, chemotherapy) may diminish antibody production; consider timing of vaccination.
  • Antipyretics such as acetaminophen or ibuprofen can be used to manage mild post‑vaccination symptoms, but routine prophylactic use may blunt the immune response.
  • Blood products or plasma containing hepatitis A antibodies may interfere with vaccine efficacy; schedule vaccination accordingly.

Frequently Asked Questions

The first dose of Havrix is approved for use in individuals aged 12 months and older, according to regional immunization guidelines.

Full protection is achieved with a two‑dose series; the second dose is typically administered 6 to 12 months after the first.

Safety data for Havrix use during pregnancy are limited; vaccination should be considered only if the potential benefit outweighs any potential risk.

Common reactions include pain, redness, swelling, and mild tenderness at the injection site, usually resolving within a few days.

Protective antibodies typically develop within 2 to 4 weeks after the first dose, with higher protection after the second dose.

There are no specific medications that must be avoided, but immunosuppressive drugs may reduce the vaccine’s effectiveness.

Havrix can be co‑administered with inactivated vaccines, but live‑attenuated vaccines should be spaced at least 4 weeks apart.

Seek immediate medical attention; severe reactions such as anaphylaxis require emergency care and treatment with epinephrine.

Havrix provides high levels of protection against hepatitis A, making it a recommended vaccine for travelers to endemic areas.

A booster may be considered for individuals at continued risk or if serologic testing shows waning immunity, based on clinical judgment.

Havrix should be stored in a refrigerator between 2°C and 8°C (36°F–46°F) and protected from freezing.

Havrix uses an inactivated hepatitis A virus adsorbed on aluminium hydroxide, similar to other licensed hepatitis A vaccines, but formulation and manufacturer may vary.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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