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DOSAGE AND ADMINISTRATION
Dosage And Schedule
DECAVAC vaccine may be used in persons 7 years of age and older who have not been immunized previously against tetanus and diphtheria or who have begun a primary immunization series but did not complete it. The primary immunization series consists of three 0.5 mL doses. The first two doses are administered at least 4 weeks apart and the third dose is administered at least 6 months after the second dose.
DECAVAC vaccine may be used to complete the primary immunization series for tetanus and diphtheria in persons 7 years of age or older who have received one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT). However, the safety and efficacy of DECAVAC vaccine in such regimens have not been evaluated.
Routine Booster Immunization
DECAVAC vaccine may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.1
Tetanus Prophylaxis in Wound Management
For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection.2 DECAVAC vaccine is approved for wound management of patients 7 years of age and older.
The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).
When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.2
Table 1: Guide to Use of Tetanus and Diphtheria
Toxoids Adsorbed (Td) and Tetanus Immune Globulin (TIG) (Human) for Tetanus
Prophylaxis in Routine Wound Management for Persons 7 Years of Age and Older
|History of Adsorbed Tetanus Toxoid (doses)||Clean, Minor Wounds||All Other Woundsa|
|Unknown or < three||Yes||No||Yes||Yes|
|aSuch 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.
bIf only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably, an adsorbed toxoid should be given.
cYes, if ≥ 10 years since the last tetanus toxoid-containing vaccine dose.
dYes, if ≥ 5 years since the last tetanus toxoid-containing vaccine dose. (More frequent boosters are not needed and can accentuate side effects.)
Diphtheria Prophylaxis for Case Contacts
DECAVAC vaccine may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years. Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis. (2)
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, DECAVAC vaccine should not be administered.
DECAVAC vaccine, after shaking, is a turbid liquid, whitish-gray in color.
For DECAVAC vaccine supplied in vials, shake the vial well before withdrawing the dose. Discard vial if DECAVAC vaccine cannot be resuspended.
For DECAVAC vaccine supplied in syringes, shake the syringe well before administering the dose. Discard syringe if DECAVAC vaccine cannot be resuspended.
Do not administer DECAVAC vaccine intravenously or subcutaneously.
DECAVAC vaccine should not be combined through reconstitution or mixed with any other vaccine.
Dosage Forms And Strengths
DECAVAC vaccine is a sterile suspension for injection available in 0.5 mL single-dose vials or syringes.
Vial, 1 Dose (10 per package) - NDC 49281-291-83. Contains no latex.
Syringe, 1 Dose (10 per package, without needle) - NDC 49281-291-10. The tip caps of the prefilled syringes may contain natural rubber latex. No other components contain latex.
Storage And Handling
Store at 2° to 8°C (35° to 46°F). Do not freeze.
Do not use vaccine after expiration date.
1 CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60(RR-02):1-60.
2 CDC. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991:40(No. RR-10):1-28.
Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA 5876-5877. Product information as of March 2011.
Last reviewed on RxList: 9/29/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Decavac Information
Report Problems to the Food and Drug Administration
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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