Tetanus Toxoid Absorbed
Tetanus Toxoid Absorbed
DRUG DESCRIPTION
Tetanus Toxoid Absorbed manufactured by Aventis Pasteur Inc., for intramuscular injection, 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.
Clostridium tetani culture is grown in a peptone-based medium containing an extract of bovine muscle tissue and detoxified with formaldehyde. The bovine muscle tissue used in this medium is US sourced. The detoxified material is then purified by serial ammonium sulfate fractionation and diafiltration, followed by sterile filtration. The toxoid is absorbed to aluminum potassium sulfate (alum). The absorbed toxoid is diluted with physiological saline solution (0.85%). Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is supplied in a unit dose 0.5 mL vial, which contains a trace amount of thimerosal [(mercury derivative), (≤0.3 mg mercury/dose)] from the manufacturing process. Tetanus Toxoid absorbed manufactured by Aventis Pasteur Inc. is also supplied in a 5 mL vial, which contains the preservative thimerosal [(mercury derivative), (25 mg mercury/dose)].
Each 0.5 mL dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and not more than 0.25 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%. The tetanus toxoid induces at least 2 units of antitoxin per mL in the guinea pig potency test.
Generic Name: Tetanus Toxoid Absorbed
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