Tetanus is an acute, often-fatal disease of the nervous system that is caused by nerve toxins produced by the bacterium Clostridium tetani. This bacterium is found throughout the world in the soil and in animal and human intestines.
Diphtheria and Tetanus
Toxoids Adsorbed USP
(For Pediatric Use)
Caution: Federal (USA) law prohibits dispensing without prescription.
Diphtheria and Tetanus Toxoids Adsorbed USP (For Pediatric Use) (DT), for intramuscular use, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.
Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.1 Clostridium tetani cultures are grown in a peptone-based medium containing bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration. The 1 dose vial of vaccine is formulated without preservatives but contains a trace amount of thimerosal (a mercury [Hg] containing compound) from the manufacturing process (≤0.3 mg Hg/0.5 mL dose).The multidose (5 mL) vial of vaccine contains the preservative thimerosal (25 mg Hg/0.5 mL dose).
Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid,5 Lf of tetanus toxoid, and not more than 0.17 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%.Both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test.
REFERENCES
1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:21-32,1941
Getting diphtheria or tetanus disease is much riskier than getting the DT vaccines. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of DT vaccine causing serious harm, or death, is extremely small.
Seek emergency medical attention or contact your doctor immediately if any of the following rare but serious side effects from DT vaccine are experienced:
Read All Potential Side Effects and See Pictures of Diphtheria and Tetanus »
Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.
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