GNH USA

Europe — EMA

Havrix

Havrix hepatitis A vaccine – EU‑approved inactivated vaccine details, indications, side effects, precautions, and interactions.

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

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What is Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?

Havrix is an injectable solution vaccine containing inactivated hepatitis A virus adsorbed on aluminium hydroxide, supplied in a standard dose for intramuscular administration. The product is a prescription‑only vaccine approved in the European Union for the prevention of hepatitis A infection. It presents the viral antigen to the immune system to stimulate protective antibodies. It is administered as a single dose or as part of a two‑dose series.

What is Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid used for?

Havrix is indicated for the active immunisation against hepatitis A virus infection.

- Provides primary prevention for travelers to endemic regions and individuals with occupational exposure. - Included in routine childhood vaccination schedules for children aged one year and older. - Can be used in outbreak control to quickly immunise at‑risk populations. - Recommended for persons with chronic liver disease to reduce severe hepatitis A outcomes. - May be administered to individuals with clotting factor disorders when intramuscular injection is appropriate. - Used as part of pre‑exposure prophylaxis for people living in areas with high hepatitis A incidence.

What are the side effects of Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?

Common and serious adverse reactions have been reported following Havrix administration, most of which are mild and self‑limiting.

Common: - Pain, redness, or swelling at the injection site lasting 1–3 days. - Mild fever or chills occurring within 24 hours after vaccination. - Headache, fatigue, or muscle aches that resolve spontaneously. - Nausea or loss of appetite for a short duration. - Transient joint pain or arthralgia reported in a small number of recipients.

Serious: - Severe allergic reaction (anaphylaxis) with difficulty breathing, hives, or swelling of the face. - High fever (>39°C) persisting beyond 48 hours. - Neurological events such as Guillain‑Barré syndrome, though extremely rare. - Severe rash or urticaria requiring medical attention. - Persistent vomiting or diarrhea lasting more than 48 hours.

What precautions apply to Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid ?

Before administering Havrix, healthcare providers should evaluate patient history and consider specific safety precautions.

- Do not vaccinate individuals with a known severe allergy to any vaccine component, including aluminium hydroxide. - Postpone vaccination in persons experiencing an acute febrile illness until recovery. - Use with caution in immunocompromised patients, as response may be reduced. - Pregnancy and lactation status should be assessed; benefits must outweigh potential risks. - Children under one year of age are not eligible for this vaccine. - Patients with clotting disorders should receive the injection using a subcutaneous route if intramuscular is contraindicated.

What does Hepatitis A Virus (Inactivated ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid interact with?

Havrix may interact with other vaccines or biologic products; certain combinations should be avoided or used with caution.

Avoid: - Live attenuated vaccines administered within 4 weeks before or after Havrix. - Immunoglobulin or blood products given within 2 weeks of vaccination. - Concurrent administration of other inactivated vaccines without proper spacing. - Administration of other hepatitis vaccines (e.g., hepatitis B) on the same day is not recommended.

Use with caution: - Immunosuppressive therapy, including corticosteroids, may diminish vaccine efficacy. - Pregnancy, as safety data are limited; risk‑benefit assessment required. - Chronic liver disease patients may need closer monitoring after vaccination. - Individuals with autoimmune disorders should be evaluated before immunisation.

Frequently asked questions

What is the active ingredient in Havrix?+
Havrix contains an inactivated hepatitis A virus that is adsorbed onto aluminium hydroxide as an adjuvant.
How is Havrix administered?+
Havrix is given as an intramuscular injection, typically in the deltoid muscle.
Who should receive Havrix?+
Anyone at risk of hepatitis A infection, including travelers to endemic areas, children over one year, and people with chronic liver disease, may be recommended to receive Havrix.
What is the recommended vaccination schedule for Havrix?+
The vaccine can be administered as a single dose or as a two‑dose series, with the second dose given 6 to 12 months after the first, depending on local guidelines.
Can Havrix be given to pregnant women?+
Safety data in pregnancy are limited; vaccination should be considered only if the potential benefits outweigh any potential risks.
What are the most common side effects of Havrix?+
Common reactions include pain, redness, or swelling at the injection site, mild fever, headache, fatigue, and occasional nausea.
Are there any serious adverse reactions associated with Havrix?+
Serious but rare events may include severe allergic reactions (anaphylaxis), high fever lasting more than 48 hours, and, very rarely, neurological conditions such as Guillain‑Barré syndrome.
Should Havrix be given together with other vaccines?+
Live attenuated vaccines should be spaced at least 4 weeks apart, and other inactivated vaccines should be administered with appropriate intervals.
Is Havrix safe for people with clotting disorders?+
Individuals with clotting factor deficiencies should discuss the route of administration with their healthcare provider; a subcutaneous injection may be considered if intramuscular injection is contraindicated.
What should I do if I experience a severe reaction after Havrix?+
Seek immediate medical attention if you develop symptoms such as difficulty breathing, swelling of the face or throat, high fever, or a severe rash.
Can immunoglobulin interfere with Havrix effectiveness?+
Yes, immunoglobulin or blood products given within 2 weeks of vaccination may reduce the immune response to Havrix.
Does Havrix provide lifelong immunity against hepatitis A?+
Havrix induces protective antibodies that can last many years, but booster doses may be recommended for certain high‑risk groups.
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 ) Adsorbed On Aluminium Hydroxide Hydrated Produced On Human Diploid
Route
Intramuscular Use
Manufacturer
Glaxosmithkline Biologicals S.A.
Origin
EU

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