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Tetanus

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Tetanus

Indications
Dosage
How Supplied

INDICATIONS

Tetanus (tetanus toxoid) Toxoid is indicated for booster injection only for persons 7 years of age or older against tetanus (tetanus toxoid) . This vaccine is NOT indicated for primary immunization.

Primary immunization schedule for children under 7 years of age (prior to seventh birthday) should consist of five doses of a vaccine containing tetanus toxoid (tetanus (tetanus toxoid) toxoid) . The initial three doses are given as Diphtheria and Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) s and Acellular Pertussis Vaccine Adsorbed (DTaP) vaccine, administered intramuscularly at intervals of 4 to 8 weeks. A fourth dose of DTaP is recommended at 15 to 20 months of age. The interval between the third and fourth dose should be at least 6 months. A fifth dose of DTaP is given before school entry (kindergarten or elementary school) at 4 to 6 years of age, unless the fourth dose was given after the fourth birthday.5,6 In instances where the pertussis vaccine component is contraindicated, Diphtheria and Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) s Adsorbed (For Pediatric Use) (DT) should be used for the remaining doses. For persons 7 years of age and older, Tetanus (tetanus toxoid) and Diphtheria Toxoids Adsorbed For Adult Use (Td) is preferred to tetanus toxoid alone.2,5

Tetanus Toxoid is interchangeable with Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) Adsorbed (contains aluminum adjuvant) as a booster, and would only be preferred if aluminum was to be avoided. Although the rate of seroconversion is essentially equivalent with either form, adsorbed toxoids induce more persistent antitoxin titers.2 Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) would be preferred over diphtheria-containing vaccines if there was a contraindication to the diphtheria component.

For the prevention of neonatal tetanus (tetanus toxoid) in unvaccinated pregnant women, see PREGNANCY section.2

This vaccine is NOT to be used for the treatment of tetanus (tetanus toxoid) infection.

As with any vaccine, vaccination with Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) may not protect 100% of susceptible individuals.

If passive immunization is required, Tetanus (tetanus toxoid) Immune Globulin (TIG) (Human) should be used (see DOSAGE AND ADMINISTRATION section).

DOSAGE AND ADMINISTRATION

2,5

Parenteral drug products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. The vaccine should not be used if particulate matter or discoloration is found.

FOR BOOSTER USE ONLY - NOT RECOMMENDED FOR PRIMARY IMMUNIZATION

SHAKE VIAL WELL before withdrawing each dose.

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

A needle length ≥one inch is preferred for these age groups because needles less than one inch might be of insufficient length to penetrate muscle tissue in certain adults and older children.10

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

After the initial immunization series is completed (see INDICATIONS AND USAGE section), a booster dose of 0.5 mL of Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) should be given intramuscularly every 10 years to maintain adequate immunity. This 10-year period is determined from the last dose administered irrespective of whether it was given earlier in routine childhood immunization or as part of wound management.5

Booster Injection After Injury:

A thorough attempt must be made to determine whether a patient has completed primary immunization. Patients with unknown or uncertain previous immunization histories should be considered to have no previous tetanus toxoid (tetanus (tetanus toxoid) toxoid) doses. Persons who had military service since 1941 can be considered to have received at least one dose. Although most people in the military since 1941 may have completed a primary series of tetanus toxoid (tetanus (tetanus toxoid) toxoid) , this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid (tetanus (tetanus toxoid) toxoid) and passive immunization (TIG Human) at the time of wound cleaning and debridement (Table 1).2

Available evidence indicates that complete primary vaccination with tetanus toxoid (tetanus (tetanus toxoid) toxoid) provides long-lasting protection ≥10 years for most recipients. Consequently,after complete primary tetanus (tetanus toxoid) vaccination, boosters, even for wound management, need to be given only every 10 years when wounds are minor and uncontaminated. For other wounds, a booster is appropriate if the patient has not received tetanus toxoid (tetanus (tetanus toxoid) toxoid) within the preceding five years. Persons who have received at least two doses of tetanus toxoid (tetanus (tetanus toxoid) toxoid) rapidly develop antitoxin antibodies.2

Tetanus (tetanus toxoid) and Diphtheria Toxoids Adsorbed for Adult Use (Td) is the preferred vaccine for active tetanus (tetanus toxoid) immunization in wound management of patients ≥7 years of age. Because a large proportion of adults are susceptible to diphtheria, this vaccine enhances diphtheria protection. Thus, by taking advantage of acute health-care visits, such as for wound management, some patients can be protected who otherwise would remain susceptible. For inadequately vaccinated patients of all ages, completion of primary vaccination at the time of discharge or at follow-up visits should be ensured.2

Tetanus Toxoid is interchangeable with Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) Adsorbed (contains aluminum adjuvant) as a booster, and would only be preferred if aluminum was to be avoided. Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) would be preferred over diphtheria-containing vaccines if there was a contraindication to the diphtheria component.

TABLE 12,5 Summary Guide to Tetanus (tetanus toxoid) Prophylaxis in Routine Wound Management*

History of Adsorbed Tetanus
Toxoid (Doses)
Clean, Minor Wounds
All Other Wounds**
Td
TIG
Td
TIG
Unknown or < three
≥ Three
Yes
No†
No
No
Yes
No§
Yes
No

* Important details are in the text of the insert.
** Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite.
† Yes, if >10 years since last dose.
§ Yes, if >5 years since last dose. (More frequent boosters are not needed and can accentuate side effects.)

If passive immunization for tetanus (tetanus toxoid) is needed, TIG (Human) is the product of choice. It provides longer protection than antitoxin of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG (Human) for wounds of average severity is 250 units intramuscularly. When tetanus toxoid (tetanus (tetanus toxoid) toxoid) and TIG (Human) are given concurrently, separate syringes and separate sites should be used. TIG should not be given with Tetanus Toxoid, but only with Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) Adsorbed.2

HOW SUPPLIED

Vial, 7.5 mL Product No. 49281-812-84

STORAGE

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

REFERENCES

2. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, Tetanus (tetanus toxoid) , and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40:No. RR-10, 1991

5. Report on the Committee of Infectious Diseases, ed 25. Elk Grove Village, IL. American Academy of Pediatrics, 2000

6. Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children, Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 46:No. RR-7, 14, 1997

10. ACIP. General recommendations on immunization. MMWR 43:No. RR-1, 1994

Manufactured by:
Aventis Pasteur Inc.
Swiftwater PA 18370 USA
Product information as of January 2002
FDA revision date: 01/02

Last reviewed on RxList: 6/6/2006
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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