Havrix Pediatric

Hepatitis A vaccine is used to prevent infection caused by the hepatitis A virus (HAV). The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Hepatitis A is a serious disease of the liver that can cause death. It is caused by the hepatitis A virus (HAV), and is spread most often through infected food or water. Hepatitis A may also be spread by close person-to-person contact with infected persons (such as between persons living in the same household). Although some infected persons do not appear to be sick, they are still able to spread the virus to others.

Hepatitis A is less common in the U.S. and other areas of the world that have a higher level of sanitation and good water and sewage (waste) systems. However, it is a significant health problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote (out-of-the-way) areas, hepatitis A vaccine will help protect you from hepatitis A disease.

It is recommended that adults and children 12 months of age and older to be vaccinated with hepatitis A vaccine when traveling to the following parts of the world:

• Africa.
• Asia (except Japan).
• Parts of the Caribbean.
• Central and South America.
• Eastern Europe.
• The Mediterranean basin.
• The Middle East.
• Mexico.

Immunization against hepatitis A disease is also recommended for adults and children 12 months of age and older who live in areas that have a high rate of hepatitis A disease or who may be at increased risk of infection from hepatitis A virus. These persons include:

• Military personnel.
• Persons living in or moving to areas that have a high rate of HAV infection.
• Persons who may be exposed to the hepatitis A virus repeatedly due to a high rate of hepatitis A disease, such as Alaskan Eskimos and Native Americans.
• Persons engaging in high-risk sexual activity, such as homosexual and bisexual males.
• Persons who use illegal injection drugs.
• Persons living in a community experiencing an outbreak of hepatitis A.
• Persons working in facilities for the mentally retarded.
• Employees of child day-care centers.
• Persons who work with hepatitis A virus in the laboratory.
• Persons who handle primate animals.
• Persons with hemophilia.
• Food handlers.
• Persons with chronic liver disease.

This vaccine is to be given only by or under the supervision of a doctor.

No adjustment recommended.

Hepatitis A vaccine is contraindicated in patients who have had signs of hypersensitivity after a previous dose of any hepatitis A vaccine, or who are allergic to trace substances (e.g., neomycin) which may be present in certain formulations. The cap and plunger of Havrix(R) prefilled syringes contain latex, which may cause allergic reactions in sensitive patients.

Hepatitis A has a long incubation period. This vaccine may not prevent infection in persons with unrecognized infection at time of vaccination.

Anaphylaxis may occur, even in patients with no previous hypersensitivity to the vaccine ingredients. Epinephrine and other medications and equipment should be readily available to treat anaphylactic or severe allergic reactions.

Delaying vaccination should be considered in patients with febrile illnesses.

Caution is recommended in patients with thrombocytopenia or coagulation disorders that would contraindicate intramuscular injection.

The expected immune response may not occur in immunosuppressed patients.

Hepatitis A vaccine is only intended for intramuscular administration. Injection into a blood vessel should be avoided.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).