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|Vivotif Berna

TYPHOID VACCINE LIVE ORAL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Vivotif Berna

In Canada—

• Vivotif Berna

Category

• Immunizing agent, active

Description

Typhoid (TYE-foid) fever is a serious disease that can cause death. It is caused by a germ called Salmonella typhi , and is spread most often through infected food or water. Typhoid may also be spread by close person-to-person contact with infected persons (such as occurs with persons living in the same household). Some infected persons do not appear to be sick, but they can still spread the germ to others.

Typhoid fever is very rare in the U.S. and other areas of the world that have good water and sewage (waste) systems. However, it is a 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, typhoid vaccine will help protect you from typhoid fever. The U.S. Centers for Disease Control (CDC) currently recommend caution in the following areas of the world:

• Africa
• Asia
• Latin America

Typhoid vaccine taken by mouth helps prevent typhoid fever, but does not provide 100% protection. Therefore, it is very important to avoid infected persons and food and water that may be infected, even if you have taken the vaccine.

To get the best possible protection against typhoid, you should complete the vaccine dosing schedule (all 4 doses of the vaccine) at least 1 week before travel to areas where you may be exposed to typhoid.

If you will be traveling regularly to parts of the world where typhoid is a problem, you should get a booster (repeat) dose of the vaccine every 5 years.

Typhoid vaccine is available only from a health care professional, in the following dosage form:

• Oral
• Enteric-coated capsules (U.S. and Canada)

Before Using 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 typhoid vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to typhoid vaccine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. This vaccine contains sucrose and lactose, and the vaccine bacteria are grown in a mixture containing beef.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether typhoid vaccine passes into the breast milk. However, this vaccine has not been reported to cause problems in nursing babies.

Children—Typhoid vaccine is not recommended for infants and children up to 6 years of age. Although there is no specific information comparing use of typhoid vaccine in children 6 years of age and over with use in other age groups, this vaccine is not expected to cause different side effects or problems in these children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of typhoid vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.

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. When you are taking typhoid vaccine, it is especially important that your health care professional know if you are taking any of the following:

• Anti-infectives by mouth or by injection (medicine for infection) or
• Antimalarials (medicine for malaria)—These medicines may reduce the useful effect of the typhoid vaccine

• Treatment with x-rays, cancer medicines, or high doses of steroids—Treatment may increase the action of the vaccine, causing an increase in vaccine side effects, or treatment may block the useful effect of the vaccine

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

• Diarrhea or
• Fever or
• Other illness (severe) or
• Stomach or intestinal illness (severe) or
• Vomiting—The condition may reduce the useful effect of the vaccine

• Immune deficiency condition, including HIV or AIDS—The condition may increase the chance of side effects of the vaccine

Proper Use of This Vaccine

It is important that all 4 doses of the vaccine be taken exactly as directed . If all the doses are not taken or if doses are not taken at the correct times, the vaccine may not work properly.

The vaccine capsules are meant to dissolve in the intestines. Therefore, they should be inspected to make sure that they are not broken or cracked when you take them. If any are broken or cracked, you will need to replace them.

Typhoid vaccine must be stored in the refrigerator at a temperature between 2 and 8 °C (35.6 and 46.4 °F) at all times. If the vaccine is left at room temperature, it will lose its effectiveness. Therefore, remember to replace unused vaccine in the refrigerator between doses.

Each dose of the vaccine should be taken approximately 1 hour before a meal. Take with a cold or lukewarm drink that has a temperature that does not exceed body temperature, e.g., 37 °C (98.6 °F).

Swallow the capsule whole. Do not chew it before swallowing. Also swallow the capsule as soon as possible after you place it in your mouth.

Dosing—Follow your doctor"s orders or the directions on the label . The following information includes only the average dose of typhoid vaccine. If your dose is different, do not change it unless your doctor tells you to do so:

• Take 1 capsule by mouth every other day for a total of 4 doses.

Missed dose—If you miss a dose of this medicine and you remember it on the day it should be taken, take it as directed. However, if you do not remember the missed dose until the next day, take the missed dose at that time and reschedule your every-other-day doses from then. It is important that this vaccine be taken exactly as directed so it can give you the most protection against typhoid fever .

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator at all times . However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Vaccine

Tell your doctor that you have taken this vaccine:

• If you are to receive any other live vaccines within 1 month after taking this vaccine.

Side Effects of This Vaccine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. 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: 02/26/1997

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