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

Havrix Junior Monodose

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

Havrix Junior Monodose (Hepatitis A Virus (Inactivated), Aluminium Hydroxide)

Havrix Junior Monodose is a monodose vaccine that contains inactivated hepatitis A virus and aluminium hydroxide as the active ingredients. It is formulated for intramuscular or subcutaneous administration and is marketed in the European Union as a prescription‑only product. Each vial provides a single dose intended for the pediatric hepatitis A immunisation schedule. The vaccine is approved for use in children aged 1 year and older, the recommended dosing interval.

Manufacturer / TM Owner

Glaxosmithkline (Ireland) Limited

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Indications & Clinical Uses

Havrix Junior Monodose is indicated for the prevention of hepatitis A infection in children according to national immunisation programs.

  • Active immunisation of children aged 1 year and older.
  • Primary vaccination series in regions with intermediate or high hepatitis A endemicity.
  • Administration before travel to areas where hepatitis A is common.
  • Use in outbreak control settings to protect susceptible pediatric populations.
  • Booster dose when recommended by health authorities after the primary series.
  • Co‑administration with other routine childhood vaccines when schedule permits.

Side Effects

The safety profile of Havrix Junior Monodose reflects typical vaccine reactions observed after intramuscular administration. Most reactions are mild and resolve without medical intervention.

Common

  • Mild pain, redness or swelling at the injection site.
  • Low‑grade fever lasting 24‑48 hours.
  • Headache or fatigue.
  • Muscle aches or joint stiffness.
  • Mild gastrointestinal discomfort such as nausea.

Serious

  • Allergic reactions such as urticaria, angioedema, or anaphylaxis.
  • Neurological events including Guillain‑Barré syndrome (very rare).
  • Seizures (rare).
  • Severe local reactions with extensive necrosis (extremely rare).

Precautions & Warnings

Precautions for Havrix Junior Monodose focus on patient history, immune status, and proper administration techniques.

  • Avoid vaccination in individuals with a known severe allergy to any vaccine component, such as aluminium hydroxide.
  • Postpone vaccination in children with moderate or severe acute illness until they recover.
  • Consider reduced antibody response in immunocompromised patients; effectiveness may be lower.
  • Administer only by the recommended intramuscular or subcutaneous route; do not use intradermal injection.
  • Observe the child for at least 15 minutes after injection for immediate reactions.
  • Safety in pregnancy and breastfeeding has not been established; discuss with a healthcare provider.

Avoid Interactions

Havrix Junior Monodose has limited known drug interactions, but certain substances may affect vaccine response or increase adverse‑event risk.

Avoid

  • Concurrent administration of immunoglobulins or blood products that may interfere with antibody formation.
  • Live viral vaccines given within 4 weeks before or after Havrix Junior Monodose.

Use with caution

  • Antipyretics (e.g., acetaminophen, ibuprofen) taken prophylactically may blunt the immune response; use only if needed for fever or pain.
  • Immunosuppressive therapies (e.g., corticosteroids, chemotherapy) may reduce vaccine efficacy; timing should be coordinated with the treating physician.
  • Chronic medical conditions such as liver disease may require individualized vaccination planning.

Frequently Asked Questions

Havrix Junior Monodose is approved for children aged 1 year and older, following the recommended pediatric immunisation schedule.

The vaccine is given as a single intramuscular or subcutaneous injection, using the monodose vial provided.

Its primary purpose is to prevent hepatitis A infection by inducing active immunity against the hepatitis A virus.

Yes, it can be co‑administered with other routine vaccines when the immunisation schedule permits, but timing should follow local guidelines.

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

Serious reactions are rare and may include allergic responses such as anaphylaxis, neurological events like Guillain‑Barré syndrome, seizures, or severe local tissue reactions.

Vaccination should be postponed if the child has a moderate or severe acute illness; mild illness does not usually contraindicate vaccination.

Safety data for use during pregnancy or breastfeeding are limited; a healthcare professional should evaluate the risks and benefits.

Concurrent administration of immunoglobulins or blood products may interfere with the vaccine’s ability to stimulate an immune response and should be avoided.

A booster dose is given according to national guidelines, typically several years after the primary series, depending on local health authority recommendations.

Prophylactic use of antipyretics may reduce the immune response; they should be used only if needed for fever or pain after vaccination.

Seek immediate medical attention; severe reactions such as anaphylaxis require prompt emergency treatment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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