Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is indicated for active immunization of children 7 years of age or older, and adults, for prevention of tetanus.

For immunization of infants and children younger than 7 years of age against tetanus and diphtheria, refer to the manufacturers´ package inserts for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine absorbed (DTaP) and for Diphtheria and Tetanus Toxoids absorbed (For Pediatric Use) (DT).

Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is not to be used for the treatment of active tetanus disease. For use of this vaccine for tetanus prophylaxis in wound management, refer to DOSAGE AND ADMINISTRATION.

Persons who have had tetanus should still be immunized since this clinical infection does not always confer immunity.

As with any vaccine, vaccination with Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. may not protect 100% of individuals.

If passive protection against tetanus is required, Tetanus Immune Globulin (Human) (TIG) should be used (see DOSAGE AND ADMINISTRATION, TETANUS PROPHYLAXIS IN WOUND MANAGEMENT).

Parenteral drug products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. (See DESCRIPTION section.) If these conditions exist, the vaccine should not be administered.

SHAKE VIAL WELL before withdrawing each dose. Discard vial if vaccine cannot be resuspended.

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.

Inject intramuscularly in the area of the vastus lateralis (mid-thigh laterally) or deltoid. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

For persons 7 years of age and older who have not been immunized previously against tetanus, the primary immunization series of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. consists of three 0.5 mL doses. The intervals between doses recommended by the ACIP are 4 to 8 weeks between the first and second dose, and 6 to 12 months between the second and third dose.¹

Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. may be used to complete the primary immunization series for tetanus in children 7 years of age or older who have received one or two doses of whole-cell pertussis DTP, DTaP, and/or DT vaccine. However the safety and efficacy of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. in such children have not been evaluated.

Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. There is no need to start the series over again, regardless of the time elapsed between doses.

Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is approved for booster immunization in persons 7 years of age and older who have completed primary immunization against tetanus.

Booster immunization against tetanus is recommended by the ACIP in persons 11-12 years of age if at least 5 years have elapsed since the last dose of a tetanus and diphtheria toxoid-containing vaccine.⁴ Subsequent routine booster immunization against tetanus is recommended every 10 years.^4,11 If a dose of a tetanus toxoid-containing vaccine is given sooner than 10 years, as part of wound management or on exposure to diphtheria, the next booster is not needed for 10 years thereafter.¹ MORE FREQUENT BOOSTER IMMUNIZATION AGAINST TETANUS IS NOT RECOMMENDED AND MAY BE ASSOCIATED WITH INCREASED INCIDENCE AND SEVERITY OF ADVERSE REACTIONS.^1,3 (See WARNINGS section).

The need for active immunization with a tetanus toxoid-containing preparation, with or without passive immunization with TIG (Human) depends on both the condition of the wound and the patient´s vaccination history (TABLE 1).

A thorough attempt must be made to determine whether a patient has completed primary immunization. Persons who have completed primary immunization against tetanus, and who sustain wounds which are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation only if they have not received tetanus toxoid within the preceding 10 years. For tetanus prone wounds (eg, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years. If a booster dose is given sooner than 10 years as part of wound management, the next routine booster should not be given for 10 years thereafter.¹

Persons who have not completed primary immunization against tetanus, or whose immunization history is unknown or uncertain, should be immunized with a tetanus toxoid-containing product. Completion of primary immunization thereafter should be ensured. In addition, if these persons have sustained a tetanus-prone wound, the use of TIG (Human) is recommended. TIG (Human) should be administered at a separate site, with a separate needle and syringe, according to the manufacturer&180;s package insert. If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not completed a primary immunizing course of tetanus toxoid and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.¹

Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is approved for wound management in patients 7 years of age and older.

CONCOMITANT VACCINE ADMINISTRATION

No safety and immunogenicity data are available on the concomitant administration of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. with other US licensed vaccines.

Vial (latex-free), 1 Dose (10 per package) † Product No. 49281-820-10

Vial, 5 mL — Product No. 49281-800-83

CPTÒ Code: 90703

CPT is a registered trademark of the American Medical Association.

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

REFERENCES

1. Centers for Disease Control and Prevention (CDC). Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Morb Mortal Wkly Rep. 1991;40(RR-10):1-28.

3. CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR Morb Mortal Wkly Rep. 2002;51(RR-2):1-36.

4. CDC. Recommended childhood and adolescent immunization schedule—United States, 2005. MMWR Morb Mortal Wkly Rep. 2005;53(51):Q1-3.

11. CDC. Recommended adult immunization schedule—United States, October 2004-September 2005. MMWR Morb Mortal Wkly Rep. 2004;53(45):Q1-4.

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