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Typhim

Indications & Dosage
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INDICATIONS

Typhim Vi vaccine is indicated for active immunization against typhoid fever for persons two years of age or older.

Immunization with Typhim Vi vaccine should occur at least two weeks prior to expected exposure to S typhi.

Typhim Vi vaccine is not indicated for routine immunization of individuals in the United States (US).14

Selective immunization against typhoid fever is recommended under the following circumstances:1) travelers to areas where a recognized risk of exposure to typhoid exists, particularly ones who will have prolonged exposure to potentially contaminated food and water, 2) persons with intimate exposure (ie, continued household contact) to a documented typhoid carrier, and 3) workers in microbiology laboratories who frequently work with S typhi.14

Typhoid vaccination is not required for international travel, but is recommended for travelers to such areas as Africa, Asia, and Central and South America where there is a recognized risk of exposure to S typhi. Current CDC advisories should be consulted with regard to specific locales. Vaccination is particularly recommended for travelers who will have prolonged exposure to potentially contaminated food and water. However, even travelers who have been vaccinated should use caution in selecting food and water.15

There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disaster or in persons attending rural summer camps.14

An optimal reimmunization schedule has not been established. Reimmunization every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time.

Typhim Vi vaccine has efficacy against typhoid fever caused by S typhi infection but will not afford protection against species of Salmonella enterica serovar typhi other than S typhi or other bacteria that cause enteric disease.

For recommended primary immunization and reimmunization see DOSAGE AND ADMINISTRATION section.

Typhim Vi vaccine should not be used to treat a patient with typhoid fever or a chronic typhoid carrier.

DOSAGE AND ADMINISTRATION

Before administration, parenteral drug products should be checked visually for any deviation from normal appearance including container integrity. The syringe or vial and its packaging should also be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If evidence of such defects are observed, the syringe should not be used.

For intramuscular use only. Do NOT inject intravenously.

Typhim Vi vaccine is indicated for persons two years of age and older.

The immunizing dose for adults and children is a single injection of 0.5 mL. The dose for adults is given intramuscularly in the deltoid, and the dose for children is given IM either in the deltoid or the vastus lateralis. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk.

A reimmunizing dose is 0.5 mL. Reimmunization consisting of a single dose for US travelers every two years under conditions of repeated or continued exposure to the S typhi organism is recommended at this time.14

The syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.

The skin at the site of injection first should be cleansed and disinfected. Tear off upper seal of vial cap. Cleanse top of rubber stopper of the vial with a suitable antiseptic and wipe away all excess antiseptic before withdrawing vaccine.

HOW SUPPLIED

Syringe, without needle, 0.5 mL † Product No.49281-790-51

Vial, 20 Dose† Product No.49281-790-20

CPTÒCode:90691

CPT is a registered trademark of the American Medical Association.

STORAGE

Store between 2° - 8°C (35° - 46°F).DO NOT FREEZE.

REFERENCES

14. Recommendations of the Immunization Practices Advisory Committee (ACIP). Typhoid Immunization. MMWR 43:No. RR-14, 1994

15. CDC. Health Information for International Travel 1992. U.S.Department of Health and Human Services, Public Health Service

Manufactured by:
Aventis Pasteur SA
Lyon France
US Govt License #1279
Distributed by:
Aventis Pasteur Inc.
Swiftwater PA 18370 USA
1-800-VACCINE (1-800-822-2463)
Product Information as of August 2004
FDA revision date: 08/04

Brand Name: Typhim
Generic Name: Typhoid Vi Polysaccharide Vaccine

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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