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Uses
TENIVAC™ is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.
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Other Information
TENIVAC vaccine, Tetanus and Diphtheria Toxoids Adsorbed, is a sterile isotonic suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate.
Each 0.5 mL dose of TENIVAC vaccine contains the following active ingredients:
Tetanus Toxoid | 5 Lf |
Diphtheria Toxoid | 2 Lf |
Other ingredients per 0.5 mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 mcg of residual formaldehyde.
Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.
The adsorbed tetanus and diphtheria toxoids are combined with aluminum phosphate (as adjuvant), sodium chloride and water for injection. This product contains no preservative.
In the guinea pig potency test, the tetanus toxoid component induces at least 2 neutralizing units/mL of serum and the diphtheria toxoid component induces at least 0.5 neutralizing units/mL of serum.
The tip caps of the prefilled syringes may contain natural rubber latex. The vial stoppers do not contain latex.
Sources
Tenivac Manufacturers
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Sanofi Pasteur Inc.
Tenivac | Sanofi Pasteur Inc.
2.1 Primary ImmunizationIn persons who have not been immunized previously against tetanus and diphtheria, primary immunization with TENIVAC vaccine consists of three 0.5 mL doses. The first 2 doses are administered 2 months apart and the third dose is administered 6-8 months after the second dose.
TENIVAC vaccine may be used to complete the primary immunization series for tetanus and diphtheria, following 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 TENIVAC vaccine in such regimens have not been evaluated.
2.2 Routine Booster ImmunizationTENIVAC vaccine may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.
2.3 Diphtheria Prophylaxis for Case ContactsTENIVAC 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 recommendations of the Advisory Committee on Immunization Practices for additional interventions for diphtheria prophylaxis in close contacts of diphtheria patients. (1)
2.4 Tetanus Prophylaxis in Wound ManagementFor 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. (1) TENIVAC 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 passive immunization with Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history. (See Table 1.)
When indicated, TIG (Human) should be administered at a separate site, with a separate needle and syringe, according to the manufacturer'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)
Table 1: Guide for use of Tetanus and Diphtheria Toxoids Adsorbed (Td) for Tetanus Prophylaxis in Routine Wound Management in Persons 7 Years of Age and Older History of Adsorbed Tetanus Toxoid (Doses) Clean, Minor Wounds All Other Wounds* Td TIG Td TIG * Such as, but not limited to, wounds contaminated with dirt, puncture wounds and traumatic wounds. † If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably an adsorbed toxoid should be given. ‡ 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.) Unknown or <three Yes No Yes Yes ≥Three† No‡ No No§ No 2.5 AdministrationJust before use, shake the vial or syringe well until a uniform, white, cloudy suspension results. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, the product should not be administered.
When withdrawing a dose from a rubber-stoppered vial, do not remove either the rubber stopper or the metal seal holding it in place.
Each 0.5 mL dose of TENIVAC vaccine is to be administered intramuscularly. The preferred site is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously or subcutaneously.
TENIVAC vaccine should not be combined through reconstitution or mixed with any other vaccine.
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