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

Havrix Za Otroke

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

Havrix Za Otroke (Hepatitis A Virus (Inactivated), Algeldrate)

Havrix Za Otroke is an injectable vaccine containing inactivated hepatitis A virus and algeldrate as excipient. It is supplied as an aqueous solution for intramuscular administration. The product is authorized in the European Union and is prescribed for immunization against hepatitis A infection. The formulation is intended for use in children and adolescents according to local immunization schedules. It stimulates the body to produce antibodies, providing immunity.

Manufacturer / TM Owner

Glaxosmithkline Biologicals S.A.

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Indications & Clinical Uses

Havrix Za Otroke is indicated for the prevention of hepatitis A infection in individuals for whom active immunization is appropriate.

  • Administration to children as part of routine childhood vaccination programs.
  • Use in travelers to regions where hepatitis A is endemic.
  • Immunization of individuals at increased risk due to occupational exposure (e.g., food handlers, healthcare workers).
  • Boosting immunity in persons who have previously received a hepatitis A vaccine series.
  • Providing protection for outbreak control in community settings.
  • Administration as a two-dose schedule, with the second dose given 6 to 12 months after the first to achieve long‑term immunity.

Side Effects

The safety profile of Havrix Za Otroke reflects typical reactions observed with inactivated viral vaccines.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever.
  • Headache.
  • Fatigue or mild malaise.
  • Mild nausea.
  • Transient joint pain.
  • Mild rash at the injection site.
  • Temporary loss of appetite.
  • Mild dizziness or light‑headedness.

Serious

  • Severe allergic reaction (anaphylaxis) characterized by difficulty breathing, rash, or swelling of the face and throat.
  • Guillain‑Barré syndrome, a rare neurological condition presenting with muscle weakness.
  • Thrombocytopenia with unexpected bruising or bleeding.
  • Seizures (rare) occurring within days after vaccination.
  • Autoimmune hepatitis, a rare inflammatory liver condition presenting with elevated liver enzymes.

Precautions & Warnings

Precautions for Havrix Za Otroke focus on patient history, immune status, and proper administration techniques.

  • Verify that the individual has not previously received a hepatitis A vaccine dose within the past 6 months.
  • Defer vaccination in persons with known severe allergic reaction to any component of the product, including algeldrate.
  • Postpone administration in individuals with acute moderate or severe illness until recovery.
  • Use with caution in immunocompromised patients, as response may be reduced.
  • Counsel pregnant or breastfeeding women that safety data are limited and vaccination should be considered based on risk assessment.
  • Ensure correct intramuscular injection technique to minimize local reactions.

Avoid Interactions

Havrix Za Otroke may interact with other agents that affect immune response or increase the risk of hypersensitivity.

Avoid

  • Concurrent administration with live viral vaccines (e.g., measles, mumps, rubella) should be avoided, as immune interference may reduce efficacy.
  • Simultaneous use of immunoglobulin products or blood products containing anti‑hepatitis A antibodies should be avoided because they can neutralize the vaccine antigen.

Use with caution

  • Administration with other inactivated vaccines (e.g., diphtheria‑tetanus‑pertussis) is permissible but monitor for increased local reactions.
  • Use in patients receiving immunosuppressive therapy (e.g., corticosteroids, biologics) may result in diminished antibody response; assess serologic protection.
  • Co‑administration with antipyretics (e.g., acetaminophen) may mask fever, a common post‑vaccination sign; consider timing.

Frequently Asked Questions

The vaccine contains inactivated hepatitis A virus as the antigen and algeldrate as an excipient.

It is given as an intramuscular injection, typically into the deltoid muscle.

The vaccine is intended for children and adolescents, following national immunization schedules.

A primary series of two doses is recommended, with the second dose administered 6 to 12 months after the first.

It may be co‑administered with other inactivated vaccines, but live viral vaccines should be given separately.

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

Rare serious events may include severe allergic reactions, Guillain‑Barré syndrome, thrombocytopenia, seizures, or autoimmune hepatitis.

Safety data in pregnancy are limited; vaccination should be considered only after evaluating the risk of hepatitis A exposure.

Routine serologic testing is not required unless the individual's vaccination history is unknown or incomplete.

Immediate medical attention is required; the reaction should be reported to local health authorities and the vaccine manufacturer.

Yes, passive antibodies from immunoglobulin can neutralize the vaccine antigen, reducing its efficacy.

Full immunization typically provides long‑term protection, often lasting many years, but exact duration may vary among individuals.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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