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

Havrix Monodose

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

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

Havrix Monodose is a hepatitis A vaccine containing inactivated hepatitis A virus adsorbed on aluminium hydroxide, supplied as a single‑dose injectable suspension for intramuscular use. It is marketed in the European Union and requires a prescription. The product is designed to stimulate active immunity against hepatitis A infection by prompting the body to produce specific antibodies.

Manufacturer / TM Owner

Glaxosmithkline (Ireland) Limited

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Indications & Clinical Uses

Havrix Monodose is indicated for the prevention of hepatitis A infection in individuals who are at risk of exposure. It is commonly used in the following situations:

  • Routine immunisation of children and adults living in or travelling to areas with high hepatitis A prevalence.
  • Protection of laboratory personnel handling hepatitis A virus specimens.
  • Pre‑exposure prophylaxis for travelers to endemic regions.
  • Outbreak control in community or institutional settings.
  • Immunisation of individuals with chronic liver disease to reduce disease severity.
  • Use in persons seeking protection before international travel.

Side Effects

Side effects of Havrix Monodose are generally mild and transient, reflecting the body’s immune response to the vaccine. Serious adverse events are rare but reported.

Common

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

Serious

  • Severe allergic reaction (anaphylaxis).
  • Guillain‑Barré syndrome (very rare).
  • High fever persisting more than 48 hours.
  • Neurological symptoms such as weakness or tingling.
  • Persistent joint pain.
  • Severe injection‑site reactions (e.g., cellulitis).

Precautions & Warnings

Before administering Havrix Monodose, healthcare providers should consider the following precautions:

  • Verify that the individual has no known severe allergy to any vaccine component, especially aluminium hydroxide.
  • Defer vaccination in persons with acute moderate or severe illness until recovery.
  • Use caution in individuals with a history of Guillain‑Barré syndrome.
  • Discuss potential risks and benefits with pregnant or breastfeeding women, as safety data are limited.
  • Monitor for signs of an allergic reaction for at least 15 minutes post‑injection.
  • Ensure proper storage and handling to maintain vaccine potency.

Avoid Interactions

Havrix Monodose may interact with other medications or vaccines, influencing safety or effectiveness.

Avoid

  • Simultaneous administration of live viral vaccines (e.g., measles, mumps, rubella) in the same injection site.
  • Use of immunosuppressive therapy that may diminish antibody response.

Use with caution

  • Concurrent administration of other inactivated vaccines (e.g., influenza) at a different site.
  • Antipyretics (acetaminophen, ibuprofen) taken prophylactically, which may modestly reduce immunogenicity.
  • Blood products or immunoglobulins given within 3 months before or after vaccination.
  • Chronic corticosteroid therapy, which may affect immune response.
  • Any medication that alters immune function, requiring clinical judgment.

Frequently Asked Questions

The active ingredient is an inactivated hepatitis A virus adsorbed onto aluminium hydroxide, which stimulates the immune system to produce protective antibodies.

Havrix Monodose is given as a single intramuscular injection, typically in the deltoid muscle.

Individuals at risk of hepatitis A exposure, such as travelers to endemic areas, laboratory workers, and people with chronic liver disease, are candidates for vaccination.

Safety data in pregnancy are limited; healthcare providers should evaluate the risk‑benefit profile before vaccinating pregnant individuals.

Common reactions include pain, redness, or swelling at the injection site, low‑grade fever, headache, fatigue, muscle aches, and mild nausea.

Yes, although rare, severe allergic reactions such as anaphylaxis can occur and require immediate medical attention.

Live viral vaccines should not be administered at the same site, while other inactivated vaccines can be given at a different site if needed.

Immunity typically persists for at least 10‑20 years, but booster doses may be recommended for continued protection in high‑risk individuals.

A mild fever is common; over‑the‑counter antipyretics can be used if needed, but prophylactic use before vaccination may slightly reduce antibody response.

Contraindications include a known severe allergy to any vaccine component, particularly aluminium hydroxide, and a history of severe reaction to a previous hepatitis A vaccine dose.

Yes, immunosuppressive drugs may reduce the vaccine’s ability to generate a strong antibody response, and timing of vaccination may need adjustment.

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

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GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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