Europe — EMA
Havrix Monodose Vaccine
Learn about Havrix Monodose Vaccine – its uses, safety profile, precautions, and FAQs for hepatitis A prevention.
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What is Hepatitis A Virus (Inactivated), Algeldrate?
Havrix Monodose Vaccine is an injectable solution that contains inactivated hepatitis A virus as the active ingredient and algeldrate as an adjuvant. The product is supplied in a single‑dose vial, strength not specified, and is administered intramuscularly. It is a prescription vaccine marketed in the European Union for preventing hepatitis A infection and is classified under ATC code J07BC01 for individuals at risk of exposure to the virus.
What is Hepatitis A Virus (Inactivated), Algeldrate used for?
Havrix Monodose Vaccine is indicated for the active immunization against hepatitis A virus.
- Primary prevention of hepatitis A infection in adults and children aged one year and older. - Post‑exposure prophylaxis for persons who have had recent contact with a confirmed hepatitis A case. - Immunization of travelers heading to regions where hepatitis A is endemic or of intermediate prevalence. - Protection of individuals with chronic liver disease, clotting factor deficiencies, or other conditions that increase risk of severe hepatitis A. - Use in public health outbreak control measures to rapidly increase population immunity.
What are the side effects of Hepatitis A Virus (Inactivated), Algeldrate?
The safety profile of Havrix Monodose Vaccine includes a range of reactions that are typically mild and transient, as well as rare events that may require medical attention.
Common: - Pain, redness, or swelling at the injection site, usually mild and short‑lasting. - Low‑grade fever (up to 38.5 °C) within 24 hours, lasting 1–2 days. - Headache or fatigue that is transient and improves without treatment. - Mild muscle aches or joint discomfort occurring shortly after injection. - Nausea or mild stomach upset that resolves on its own.
Serious: - Severe allergic reaction (anaphylaxis) with hives, breathing difficulty, or shock; needs emergency care. - Guillain‑Barré syndrome, a rare autoimmune neuropathy reported in isolated cases after vaccination. - High fever with chills or persistent neurological symptoms that require prompt medical evaluation.
What precautions apply to Hepatitis A Virus (Inactivated), Algeldrate?
Precautions for Havrix Monodose Vaccine focus on patient history, immune status, and potential contraindications.
- Do not administer to individuals with known severe allergy to any vaccine component, including algeldrate. - Defer vaccination in persons with acute moderate or severe illness until recovery. - Use with caution in pregnant or breastfeeding women; discuss risk‑benefit with healthcare provider. - Evaluate immunocompromised patients, as response may be reduced; vaccination may still be recommended. - Post‑vaccination observation for at least 15 minutes is advised to monitor for immediate reactions.
What does Hepatitis A Virus (Inactivated), Algeldrate interact with?
Havrix Monodose Vaccine may interact with other agents that affect the immune system or increase the risk of hypersensitivity.
Avoid: - Live attenuated vaccines administered within 4 weeks before or after Havrix, as immune response may be altered. - Immunoglobulin or blood products given within 2 weeks of vaccination, which can reduce vaccine efficacy.
Use with caution: - Immunosuppressive therapy (e.g., corticosteroids, chemotherapy) may diminish antibody response; timing should be coordinated. - Antipyretics (acetaminophen, ibuprofen) taken prophylactically may mask mild fever; use only if needed. - Chronic liver disease or clotting disorders; monitor for bleeding at injection site.
Frequently asked questions
What is the mechanism of action of Havrix Monodose Vaccine?+
Who should receive Havrix Monodose Vaccine?+
How is Havrix Monodose Vaccine administered?+
Can Havrix Monodose Vaccine be given to pregnant women?+
What are common side effects after receiving Havrix Monodose Vaccine?+
How long does immunity last after a single dose of Havrix Monodose Vaccine?+
Is a booster dose required for Havrix Monodose Vaccine?+
Can Havrix Monodose Vaccine be used for post‑exposure prophylaxis?+
Are there any contraindications for Havrix Monodose Vaccine?+
How should Havrix Monodose Vaccine be stored before use?+
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