Europe — EMA
Havrix
Learn about Havrix hepatitis A vaccine—its uses, safety profile, precautions, and FAQs for travelers and at‑risk individuals in the EU.
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What is Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?
Havrix is an injectable hepatitis A vaccine containing inactivated hepatitis A virus adsorbed on aluminium hydroxide, produced on human diploid cells. It is supplied in a sterile liquid form for intramuscular administration and is marketed in the European Union. The product is prescription‑only and is classified as a prophylactic vaccine (ATC code J07BB01) that stimulates protective antibodies against hepatitis A virus and provides long‑term immunity.
What is Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid used for?
Havrix is indicated for the prevention of hepatitis A virus infection in individuals at risk.
- Healthy adults and children aged 12 months and older who require protection against hepatitis A. - Travelers to regions where hepatitis A is endemic or where outbreaks have occurred. - Persons with occupational exposure to hepatitis A, such as laboratory workers handling the virus. - Individuals with chronic liver disease who need additional protection. - Close contacts of patients with confirmed hepatitis A infection.
What are the side effects of Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?
The safety profile of Havrix includes both common, generally mild reactions and rare, serious events.
Common: - Pain, redness, or swelling at the injection site. - Low‑grade fever. - Headache. - Fatigue or malaise. - Muscle aches.
Serious: - Severe allergic reaction (anaphylaxis) with difficulty breathing or swelling of the face. - Guillain‑Barré syndrome (rare neurological condition). - Thrombocytopenia (low platelet count). - Seizures (rare).
What precautions apply to Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?
Before administering Havrix, healthcare providers should consider several precautionary factors.
- Known severe allergy to any component of the vaccine, including aluminium hydroxide. - History of anaphylaxis after a previous dose of Havrix or another hepatitis A vaccine. - Acute moderate or severe illness; vaccination should be postponed until recovery. - Pregnancy and breastfeeding status should be discussed with a clinician, as data are limited. - Immunocompromised individuals may have a reduced antibody response and may require additional dosing. - Children under 12 months are not approved for this vaccine.
What does Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid interact with?
Havrix may interact with other medical products, influencing safety or immune response.
Avoid: - Concurrent administration with other live vaccines (e.g., measles, mumps, rubella) without appropriate interval. - Use of immunoglobulin products that may neutralize the vaccine antigen if given shortly before or after vaccination.
Use with caution: - Simultaneous receipt of other inactivated vaccines (e.g., influenza) – generally acceptable but monitor for increased local reactions. - Patients receiving immunosuppressive therapy may have diminished vaccine efficacy. - Antipyretic or analgesic medications (e.g., acetaminophen) taken prophylactically may mask mild systemic reactions.
Frequently asked questions
What is the recommended age for receiving Havrix?+
How many doses of Havrix are needed for full protection?+
Can Havrix be given to pregnant women?+
What are common side effects after Havrix injection?+
Is Havrix safe for people with chronic liver disease?+
Should I avoid other vaccines when receiving Havrix?+
How long does immunity last after completing the Havrix series?+
Can immunoglobulin interfere with Havrix effectiveness?+
What should I do if I experience a severe allergic reaction after Havrix?+
Is Havrix available over the counter?+
Can adults who were vaccinated as children still benefit from Havrix?+
What storage conditions are required for Havrix?+
Product details
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