Product image of Havrix Monodose (Hepatitis A Virus (Inactivated), Algeldrate) supplied by GNH India

Havrix Monodose

Active Ingredient:
Hepatitis A Virus (Inactivated), Algeldrate
Origin:
EU

Havrix Monodose (Hepatitis A Virus (Inactivated), Algeldrate)

Havrix Monodose is a hepatitis A vaccine containing inactivated hepatitis A virus (1440 ELU/0.5 mL) and algeldrate, supplied as a prefilled syringe for intramuscular or subcutaneous injection. Marketed in the EU, it stimulates active immunity against hepatitis A. The formulation allows a dose without reconstitution, suitable for travel use. It is intended for individuals who need hepatitis A prophylaxis before travel, during outbreaks, or as part of childhood immunization.

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 various populations.

  • Pre‑exposure prophylaxis for travelers to endemic areas.
  • Routine immunization of children as part of national vaccination programs.
  • Protection of individuals at occupational risk, such as laboratory workers.
  • Outbreak control in communities with ongoing hepatitis A transmission.
  • Post‑exposure prophylaxis for persons who have not previously been vaccinated, when administered promptly.
  • Immunization of people with chronic liver disease who are at higher risk of severe hepatitis A.

Side Effects

Adverse reactions reported after Havrix Monodose are generally mild and transient.

Common

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

Serious

  • Severe allergic reaction (anaphylaxis).
  • Guillain‑Barré syndrome (rare).
  • Thrombocytopenia.
  • High‑grade fever persisting more than 48 hours.
  • Neurologic symptoms such as weakness or paresthesia.
  • Seizures (very rare).

Precautions & Warnings

Before administering Havrix Monodose, healthcare providers should consider several precautionary measures.

  • Confirm no severe allergy to any vaccine component, especially gelatin or yeast proteins.
  • Defer vaccination in individuals with acute moderate or severe illness until recovery.
  • Use caution in persons with weakened immune systems; vaccine may be less effective.
  • Pregnancy status should be assessed; vaccine is generally avoided unless benefits outweigh potential risks.
  • Evaluate for history of thrombocytopenia or bleeding disorders before intramuscular injection.
  • Ensure proper storage and handling to maintain vaccine potency.

Avoid Interactions

Havrix Monodose has limited known drug interactions, but certain situations warrant attention.

Avoid

  • Concomitant administration of live viral vaccines (e.g., measles‑mumps‑rubella) within 4 weeks, as immune response may be reduced.

Use with caution

  • Immunosuppressive therapy (e.g., corticosteroids, chemotherapy) may diminish antibody response.
  • Antipyretics (acetaminophen, ibuprofen) taken prophylactically may mask fever, though they do not affect immunogenicity.
  • Blood products given within 2 weeks may interfere with vaccine efficacy.
  • Chronic liver disease medications may require timing adjustments.

Frequently Asked Questions

Havrix Monodose contains inactivated hepatitis A virus (1440 ELU per 0.5 mL) and the stabilizer algeldrate, presented as a sterile injectable solution in a prefilled syringe.

The vaccine is given by intramuscular or subcutaneous injection using the prefilled syringe; no reconstitution is required.

Travelers heading to regions where hepatitis A is endemic or where outbreaks are reported are advised to receive Havrix Monodose at least two weeks before departure.

Yes, the vaccine is approved for use in children as part of routine immunization schedules to protect against hepatitis A infection.

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

Serious but rare events may include severe allergic reactions (anaphylaxis), Guillain‑Barré syndrome, thrombocytopenia, prolonged high‑grade fever, neurologic symptoms, or seizures.

The safety of Havrix Monodose during pregnancy has not been fully established; it is generally avoided unless the potential benefit justifies the possible risk.

Havrix Monodose is a single‑dose, prefilled syringe formulation with a specific antigen content (1440 ELU/0.5 mL) and includes algeldrate as a stabilizer, whereas other products may use different dosing schedules or formulations.

Yes, the vaccine can be administered promptly after potential exposure to hepatitis A in individuals who have not been previously vaccinated.

The vaccine should be stored in a refrigerator between 2 °C and 8 °C (36 °F–46 °F) and protected from light; it must not be frozen.

A single dose provides protective antibodies for several years; a second dose is often recommended to achieve long‑term immunity lasting at least 15–20 years.

There are no major drug interactions, but immunosuppressive therapies may reduce the vaccine’s effectiveness, and live vaccines should be spaced appropriately.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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