Europe — EMA
Havrix Adulto
Learn about Havrix Adulto hepatitis A vaccine: indications, safety profile, precautions, and FAQs for adults and adolescents in the EU.
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What is 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.
What is Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid used for?
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.
What are the side effects of Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?
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.
What precautions apply to Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?
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.
What does Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid interact with?
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
What age groups are eligible to receive Havrix Adulto?+
How many doses of Havrix Adulto are required for full protection?+
Can pregnant women receive Havrix Adulto?+
What are the most common side effects after Havrix Adulto vaccination?+
How long does immunity last after completing the Havrix Adulto series?+
Is Havrix Adulto safe for people with chronic liver disease?+
Can Havrix Adulto be given at the same time as the seasonal influenza vaccine?+
What should I do if I experience a severe allergic reaction after receiving Havrix Adulto?+
How soon before travel should I receive Havrix Adulto for protection?+
Is a booster dose of Havrix Adulto needed later in life?+
What are the storage requirements for Havrix Adulto?+
Can immunocompromised patients receive Havrix Adulto?+
Product details
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