The stopper of the multi-dose vial contains dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

Except under circumstances of wound management (see DOSAGE AND ADMINISTRATION), booster doses of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. should not be administered more frequently than as recommended for Td vaccines (ie, at 11-12 years of age if at least 5 years have elapsed since the last dose of tetanus and diphtheria toxoid-containing vaccine, and every 10 years thereafter).⁴ More frequent booster doses may be associated with increased incidence and severity of adverse reactions.¹

Persons who experienced severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid usually have very high serum tetanus antitoxin levels and should not be given even emergency doses of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. more frequently than every 10 years, even ifthey have a wound that is neither clean nor minor.⁵

Because intramuscular injection can cause injection site hematoma, Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. should not be given to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. in such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.

If Guillain-Barré Syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.³

The Advisory Committee on Immunization Practices (ACIP) has published guidelines for vaccination of persons with recent or acute illness.³

GENERAL

Care is to be taken by the health-care provider for the safe and effective use of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc.

EPINEPHRINE INJECTION (1:1000) AND OTHER APPROPRIATE AGENTS AND EQUIPMENT MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE.

Prior to administration of any dose of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc., the vaccine recipient´s current health status and personal health history should be reviewed. This should include a review of the patient´s immunization history, any adverse events after previous immunizations and history concerning possible sensitivity to the vaccine and to dry natural latex rubber (contained in the stopper of the multidose vial only), in order to determine the existence of any contraindications to administration of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. and to allow an assessment of the benefits and risks of vaccination.

Special care should be taken to ensure that the injection does not enter a blood vessel.

Immunocompromised persons (whether from disease or treatment) may not obtain the expected immune response to Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc.

Administration of Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is not contraindicated in immunocompromised persons.^3,6

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of blood borne infectious agents. Needles should not be recapped and should be disposed ofaccording to biohazard waste guidelines.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No studies have been performed with Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. It is also not known whether Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. should be given to a pregnant woman only if clearly needed.

The ACIP has published recommendations for immunizing pregnant women against tetanus.³

NURSING MOTHERS

It is not known whether Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is administered to a nursing woman.

PEDIATRIC USE

Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is not indicated for infants and children younger than 7 years of age. For immunization of infants and children younger than 7 years of age against tetanus, 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).

GERIATRIC USE

The clinical study of Tetanus and Diphtheria Toxoids absorbed For Adult Use manufactured by Aventis Pasteur Inc. did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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.

5. CDC. Update on adult immunization recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 1991;40(RR-12):1-52.

6. CDC. Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR Morb Mortal Wkly Rep. 1993;42(RR-4):18.

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