GNH USA

Europe — EMA

Havrix Monodose

Learn about Havrix Monodose hepatitis A vaccine—its uses, safety profile, precautions, and FAQs for travelers and healthcare providers.

Hepatitis A Virus (Inactivated), Algeldrate

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What is Hepatitis A Virus (Inactivated), Algeldrate?

Havrix Monodose is a hepatitis A vaccine containing inactivated hepatitis A virus (1440 ELU/0.5 mL) and algeldrate, supplied as a prefilled syringe for intramuscular or subcutaneous injection. Marketed in the EU, it stimulates active immunity against hepatitis A. The formulation allows a dose without reconstitution, suitable for travel use. It is intended for individuals who need hepatitis A prophylaxis before travel, during outbreaks, or as part of childhood immunization.

What is Hepatitis A Virus (Inactivated), Algeldrate used for?

Havrix Monodose is indicated for the prevention of hepatitis A infection in various populations.

- Pre‑exposure prophylaxis for travelers to endemic areas. - Routine immunization of children as part of national vaccination programs. - Protection of individuals at occupational risk, such as laboratory workers. - Outbreak control in communities with ongoing hepatitis A transmission. - Post‑exposure prophylaxis for persons who have not previously been vaccinated, when administered promptly. - Immunization of people with chronic liver disease who are at higher risk of severe hepatitis A.

What are the side effects of Hepatitis A Virus (Inactivated), Algeldrate?

Adverse reactions reported after Havrix Monodose are generally mild and transient.

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

Serious: - Severe allergic reaction (anaphylaxis). - Guillain‑Barré syndrome (rare). - Thrombocytopenia. - High‑grade fever persisting more than 48 hours. - Neurologic symptoms such as weakness or paresthesia. - Seizures (very rare).

What precautions apply to Hepatitis A Virus (Inactivated), Algeldrate?

Before administering Havrix Monodose, healthcare providers should consider several precautionary measures.

- Confirm no severe allergy to any vaccine component, especially gelatin or yeast proteins. - Defer vaccination in individuals with acute moderate or severe illness until recovery. - Use caution in persons with weakened immune systems; vaccine may be less effective. - Pregnancy status should be assessed; vaccine is generally avoided unless benefits outweigh potential risks. - Evaluate for history of thrombocytopenia or bleeding disorders before intramuscular injection. - Ensure proper storage and handling to maintain vaccine potency.

What does Hepatitis A Virus (Inactivated), Algeldrate interact with?

Havrix Monodose has limited known drug interactions, but certain situations warrant attention.

Avoid: - Concomitant administration of live viral vaccines (e.g., measles‑mumps‑rubella) within 4 weeks, as immune response may be reduced.

Use with caution: - Immunosuppressive therapy (e.g., corticosteroids, chemotherapy) may diminish antibody response. - Antipyretics (acetaminophen, ibuprofen) taken prophylactically may mask fever, though they do not affect immunogenicity. - Blood products given within 2 weeks may interfere with vaccine efficacy. - Chronic liver disease medications may require timing adjustments.

Frequently asked questions

What is the composition of Havrix Monodose?+
Havrix Monodose contains inactivated hepatitis A virus (1440 ELU per 0.5 mL) and the stabilizer algeldrate, presented as a sterile injectable solution in a prefilled syringe.
How is Havrix Monodose administered?+
The vaccine is given by intramuscular or subcutaneous injection using the prefilled syringe; no reconstitution is required.
Who should receive Havrix Monodose before traveling?+
Travelers heading to regions where hepatitis A is endemic or where outbreaks are reported are advised to receive Havrix Monodose at least two weeks before departure.
Can Havrix Monodose be given to children?+
Yes, the vaccine is approved for use in children as part of routine immunization schedules to protect against hepatitis A infection.
What are the common side effects after a Havrix Monodose injection?+
Typical reactions include pain, redness, or swelling at the injection site, low‑grade fever, headache, fatigue, nausea, and mild muscle aches.
Are there any serious adverse reactions associated with Havrix Monodose?+
Serious but rare events may include severe allergic reactions (anaphylaxis), Guillain‑Barré syndrome, thrombocytopenia, prolonged high‑grade fever, neurologic symptoms, or seizures.
Is Havrix Monodose safe for pregnant women?+
The safety of Havrix Monodose during pregnancy has not been fully established; it is generally avoided unless the potential benefit justifies the possible risk.
How does Havrix Monodose differ from other hepatitis A vaccines?+
Havrix Monodose is a single‑dose, prefilled syringe formulation with a specific antigen content (1440 ELU/0.5 mL) and includes algeldrate as a stabilizer, whereas other products may use different dosing schedules or formulations.
Can Havrix Monodose be used for post‑exposure prophylaxis?+
Yes, the vaccine can be administered promptly after potential exposure to hepatitis A in individuals who have not been previously vaccinated.
What storage conditions are required for Havrix Monodose?+
The vaccine should be stored in a refrigerator between 2 °C and 8 °C (36 °F–46 °F) and protected from light; it must not be frozen.
How long does immunity last after a single dose of Havrix Monodose?+
A single dose provides protective antibodies for several years; a second dose is often recommended to achieve long‑term immunity lasting at least 15–20 years.
Are there any drug interactions with Havrix Monodose?+
There are no major drug interactions, but immunosuppressive therapies may reduce the vaccine’s effectiveness, and live vaccines should be spaced appropriately.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Hepatitis A Virus (Inactivated), Algeldrate
Route
Intramuscular Use , Subcutaneous Use
Manufacturer
Glaxosmithkline (Ireland) Limited
Origin
EU

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