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Havrix Adulto

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

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

Havrix Adulto is a prescription‑only hepatitis A vaccine containing inactivated hepatitis A virus adsorbed on aluminium hydroxide, supplied as an injectable solution. The product is marketed in the European Union and is used to stimulate active immunity against hepatitis A infection. It is given intramuscularly as a single dose or in a two‑dose schedule, per local guidelines, for adults and adolescents without prior immunisation routine.

Manufacturer / TM Owner

Smith Kline & French Portuguesa-Produtos Farmaceuticos Lda

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Indications & Clinical Uses

Havrix Adulto is indicated for the prevention of hepatitis A infection in individuals who have not previously received a hepatitis A vaccine.

  • Routine immunisation of adults traveling to hepatitis A endemic regions.
  • Protection of travelers to areas with poor sanitation or contaminated food and water.
  • Outbreak control in community or institutional settings.
  • Immunisation of individuals with chronic liver disease to reduce severe disease risk.
  • Use in pre‑exposure prophylaxis for laboratory personnel handling hepatitis A virus.

Side Effects

The safety profile of Havrix Adulto reflects typical vaccine reactions, with most events being mild and transient.

Common

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

Serious

  • Severe allergic reaction (anaphylaxis).
  • Guillain‑Barré syndrome (rare).
  • High fever with chills.

Precautions & Warnings

Precautions for Havrix Adulto focus on patient history, immune status, and potential adverse reactions. Healthcare providers should assess these factors before vaccination.

  • Do not vaccinate individuals with a known severe allergy to any vaccine component, especially aluminium salts.
  • Defer vaccination in persons with acute moderate or severe illness until recovery.
  • Use with caution in patients with weakened immune systems; vaccine may be less effective.
  • Pregnant or breastfeeding women should discuss potential benefits and risks with a clinician.
  • Post‑vaccination observation for at least 15 minutes is recommended to monitor immediate reactions.
  • Individuals with a history of Guillain‑Barré syndrome should be evaluated before immunisation.

Avoid Interactions

Havrix Adulto may interact with other vaccines or immunomodulating agents, influencing immune response or safety.

Avoid

  • Simultaneous administration with live attenuated vaccines (e.g., measles, mumps, rubella) without appropriate interval.
  • Concurrent use of immunosuppressive therapy that could diminish vaccine efficacy.

Use with caution

  • Administration with other inactivated vaccines (e.g., influenza) may increase local reactogenicity; spacing of 14 days is advised.
  • Patients receiving blood products or immunoglobulins should wait at least 3 months before vaccination.
  • Individuals on chronic corticosteroid therapy may have reduced antibody response; consider serologic testing.

Frequently Asked Questions

Havrix Adulto is approved for use in adolescents and adults who have not previously been immunised against hepatitis A, typically from age 12 years onward, depending on national guidelines.

A standard schedule consists of two doses given intramuscularly, with the second dose administered 6 to 12 months after the first to achieve long‑term immunity.

Pregnancy is not an absolute contraindication, but the decision should be made after weighing the benefits of protection against hepatitis A against any potential risks, in consultation with a healthcare professional.

The most frequently reported reactions are mild pain, redness, or swelling at the injection site, low‑grade fever, headache, fatigue, and occasional muscle aches.

Immunity is generally long‑lasting, with protective antibodies persisting for at least 10 to 20 years in most individuals; occasional booster doses may be considered for high‑risk groups.

Yes, vaccination is recommended for individuals with chronic liver conditions because hepatitis A infection can cause severe complications in this population.

Co‑administration with other inactivated vaccines is allowed, but spacing them by at least 14 days may reduce local reactogenicity and improve tolerability.

Seek immediate medical attention; anaphylaxis requires prompt treatment with epinephrine and supportive care. Report the reaction to your healthcare provider and the vaccine safety monitoring system.

Ideally, the first dose should be administered at least two weeks before departure, with the second dose given according to the recommended schedule for long‑term protection.

Routine boosters are not required for most people, but a booster may be advised for travelers returning to high‑risk areas after many years or for individuals with waning immunity.

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

Immunocompromised individuals can be vaccinated, but the immune response may be reduced; serologic testing after the series can confirm adequate protection.

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GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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