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|Havrix

HEPATITIS A VACCINE INACTIVATED (Systemic)

Some commonly used brand names are:

In the U.S.—

• Havrix
• Vaqta

In Canada—

• Havrix
• Vaqta

Category

• Immunizing agent, active

Description

Hepatitis (hep-ah-TY-tiss) 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 persons 12 months of age or 2 years of age and older (depending on which brand of the vaccine is given) 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

Hepatitis A vaccine is also recommended for all persons 12 months or 2 years of age and older (depending on which brand of the vaccine is given) who live in areas that have frequent outbreaks 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 injectable 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

Hepatitis A vaccine is to be used only by or under the supervision of a doctor. It is available in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

Before Receiving This Vaccine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For hepatitis A vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to hepatitis A vaccine. Also tell your health care professional if you are allergic to any other substances, such as preservatives.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. However, since the vaccine does not contain contagious particles, it is not expected to cause problems during pregnancy. Before receiving this vaccine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—This vaccine has not been reported to cause problems in nursing babies. Be sure you have discussed the risks and benefits of the vaccine with your doctor.

Children—Havrix brand hepatitis A vaccine is not recommended for infants and children younger than 2 years of age. For children 2 years of age and older, this vaccine is not expected to cause different side effects or problems than it does in adults.

Vaqta brand hepatitis A vaccine is not recommended for infants and children younger than 12 months of age. For infants 12 months of age and older, this vaccine is not expected to cause different side effects or problems than it does in adults.

Older adults—This vaccine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. Elderly people may be more sensitive than younger adults to the effects of hepatitis A vaccine.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of hepatitis A vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems such as hemophilia or abnormal bleeding—Hepatitis A vaccine injection should be given with caution to avoid increased risks.

• Illness with fever or
• Severe infection—May need to delay receiving vaccine until patient is feeling better

• Patients with unsatisfactory immune response—May cause the vaccine to not work as well

Proper Use of This Vaccine

Dosing—The dose of hepatitis A vaccine will be different for different patients. Follow your doctor"s orders . The following information includes only the average doses of hepatitis A vaccine.

• For injection dosage form:
  • For prevention of hepatitis A disease:
    • Adults—One adult dose injected into a muscle. A booster (repeat) dose may be needed six to eighteen months after the first dose.
    • Havrix brand:
    • Children 2 to 18 years of age—One or two pediatric doses injected into a muscle. A booster (repeat) dose may be needed six to twelve months after the first dose.
    • Children up to 2 years of age—Use is not recommended.
    • Vaqta brand:
    • Children 12 months to 18 years of age—One or two pediatric doses injected into a muscle. A booster (repeat) dose may be needed six to eighteen months after the first dose.
    • Infants up to 12 months of age—Use is not recommended.

Side Effects of This Vaccine

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effects that occur after a dose of hepatitis A vaccine , even though the side effect may have gone away without treatment. Some types of side effects may mean that you should not receive any more doses of hepatitis A vaccine.

Get emergency help immediately if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 09/14/2005

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