Tenivac

Tenivac

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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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.

History

There is currently no drug history available for this drug.

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.

Tenivac Manufacturers


  • Sanofi Pasteur Inc.
    Tenivac (Clostridium Tetani Toxoid Antigen (Formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (Formaldehyde Inactivated)) Injection, Suspension [Sanofi Pasteur Inc.]

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