Description
Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) , for intramuscular orsubcutaneous use, is a sterile solution of toxoid in isotonic sodium chloridesolution. The vaccine is clear or slightly turbid in appearance.
Clostridium tetani culture is grown in a peptone-based medium and detoxified with formaldehyde. The detoxified material is then purified by serial ammonium sulfate fractionation, followed by sterile filtration. The toxoid is then diluted with physiological saline solution (0.85%). Each dose contains the preservative thimerosal [(mercury derivative), 25 mg mercury/dose]. This product does not contain an aluminum-containing adjuvant.
Each 0.5 mL dose is formulated to contain 4 Lf (flocculation units) of tetanus toxoid (tetanus (tetanus toxoid) toxoid) and passes the guinea pig potency test. The residual formaldehyde content, by assay, is less than 0.02%.
