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

Havrix

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

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

Havrix is an injectable hepatitis A vaccine containing 720 ELU/0.5 mL of algeldrate combined with inactivated hepatitis A virus antigen, supplied as a sterile solution for intramuscular administration. It is marketed in the European Union as a prescription‑only product and belongs to the vaccine class used for active immunization against hepatitis A infection. The formulation is designed to stimulate protective antibody production in healthy individuals and those at risk.

Manufacturer / TM Owner

Glaxosmithkline Pharma Gmbh.

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Indications & Clinical Uses

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

  • Primary prophylaxis for hepatitis A in adults and children aged 12 months and older.
  • Pre‑travel vaccination for persons traveling to regions with intermediate or high hepatitis A endemicity.
  • Immunization of laboratory personnel handling hepatitis A specimens.
  • Protection of individuals with chronic liver disease or clotting‑factor disorders.
  • Use in outbreak settings to quickly establish herd immunity.

Side Effects

Following intramuscular injection, Havrix may cause transient reactions at the injection site and systemic symptoms that are generally mild and self‑limiting.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever (≤38 °C) within 24 hours.
  • Headache or mild fatigue.
  • Nausea or mild gastrointestinal discomfort.
  • Muscle aches or joint pain.
  • Transient swelling of lymph nodes near injection site.
  • Temporary dizziness or feeling of light‑headedness.

Serious

  • Severe allergic reaction (anaphylaxis) with difficulty breathing, hives, or swelling of the face.
  • Guillain‑Barré syndrome reported rarely after vaccination.
  • Persistent high fever or neurologic symptoms requiring medical evaluation.
  • Seizures or loss of consciousness (very rare).

Precautions & Warnings

Healthcare providers should assess individual health status before administering Havrix and observe recommended safety measures to minimize risk.

  • Defer vaccination in persons with known severe allergic reaction to any component of the product.
  • Postpone administration in individuals experiencing acute moderate or severe illness until recovery.
  • Use with caution in pregnant or breastfeeding women; benefits should outweigh potential risks.
  • Monitor for signs of anaphylaxis for at least 15 minutes after injection.
  • Consider alternative hepatitis A prophylaxis for immunocompromised patients with impaired antibody response.
  • Do not administer intravascularly; ensure proper intramuscular technique.
  • Record batch number and expiration date for traceability.

Avoid Interactions

Havrix does not contain pharmacologically active drugs, but certain substances may affect vaccine response or safety.

Avoid

  • Concomitant administration of other live vaccines (e.g., measles, mumps, rubella) at the same anatomical site.
  • Use of immunoglobulin products within 2 weeks before or after vaccination, which may reduce immunogenicity.
  • Simultaneous receipt of blood products that could interfere with antibody formation.

Use with caution

  • Immunosuppressive therapies (e.g., corticosteroids, chemotherapy) that may diminish antibody response.
  • Antipyretic or analgesic medications (e.g., acetaminophen, ibuprofen) taken prophylactically, which could mask mild systemic reactions.
  • Chronic alcohol consumption, which may impair immune function.

Frequently Asked Questions

Havrix is approved for individuals aged 12 months and older, including children, adolescents, and adults.

The standard schedule consists of two intramuscular doses, administered six months apart, to achieve long‑term immunity.

Pregnancy is not a contraindication, but vaccination should be considered after evaluating the potential benefits and risks with a healthcare professional.

Mild pain is common; however, if pain is severe, persistent, or accompanied by swelling, redness, or fever, seek medical advice promptly.

Havrix can be co‑administered with most non‑live vaccines, but live vaccines should be given at a different site or spaced apart according to local guidelines.

Immunity is expected to persist for at least 20 years in most individuals, with evidence of long‑term protection beyond that period.

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

People with immunosuppression may have a reduced antibody response; vaccination should be discussed with a clinician to weigh benefits and alternatives.

Signs include hives, swelling of the face or throat, difficulty breathing, and rapid heartbeat. Immediate medical attention is required if these occur.

Antipyretics can be used to relieve mild fever or discomfort, but they are not required and should not be taken prophylactically without advice.

Yes, vaccination is recommended for people with chronic liver conditions because they are at higher risk for severe hepatitis A infection.

Provide information about any previous allergic reactions, current illnesses, pregnancy status, immunosuppressive treatments, and recent receipt of blood products or immunoglobulins.

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GNH India Pharmaceuticals Limited

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Last updated:

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