Tetanus Toxoid Vaccine (Adsorbed) I.P.

1. DESCRIPTION:
   Tetanus Vaccine (Adsorbed) I.P. is a preparation of Tetanus formol toxoid adsorbed on aluminium phosphate gel. Thiomersal is used as a preservative. The potency is not less than 40 International Units per single human dose.
2. COMPOSITION:
   Each single dose (0.5ml) contains:
       Tetanus Toxoid : 5 to 25 Lf.
       Aluminium : < or =1.25 mg
       Thiomersal : 0.01 %
3. STORAGE:
   2 - 8⁰C in dark and should not be allowed to freeze.
4. EXPIRY:
   36 months.
5. TREATMENT / INDICATIONS:
   Tetanus is a life-threatening bacterial disease that is caused by the toxin of a bacterium called Clostridium tetani which enter the body through an open wound. Although the tetanus infection is more common when there is a deep puncture wound such as a bite, cut, burn or an ulcer, it may well be caused by a tiny prick or scratch on the skin. Hence, it is advisable to actively immunize every person. Tetanus vaccine is used:
   • To protect infants against the risks of tetanus neonatorum by immunizing pregnant mothers.
   • To actively immunize civil population particularly those who are exposed to occupational risks such as road workers, athletes, agricultural workers, industrial workers etc.
   • To actively immunize civil and defence personnel, home guards and police personnel.
6. PRECAUTIONS :
   • Shake well, withdraw the contents aseptically from the vial
   • Do not freeze the contents of the vial
   • Protect the vaccine vial from light
   • Allergic reactions with component of product should be borne in mind
   • Separate sterile syringe should be used for each individual.
7. POSOLOGY AND ADMINISTRATION:
   • DOSE - 0.5ml by intramuscular route.
   • PROTECTION OF THE NEW BORN AGAINST TETANUS - The full basic course of immunization against tetanus toxoid consists of three primary doses of 0.5ml at least four weeks apart, followed by booster doses at 18 months, 5 years, 10 years and 16 years and then every 10 years.
   • VACCINATION OF INJURED PERSONS- If more than 5 years have elapsed, 0.5 ml of the adsorbed tetanus toxoid should be given immediately. A second 0.5ml dose of toxoid is recommended after 2 weeks and a third dose after one month.
8. PRESENTATION:
   5 ml vial containing 10 doses of Vaccine
9. CONTRAINDICATIONS:
   • A severe reaction to a previous dose of TT.
   • It should not be administered to infants or children with high fever, or other evidence of acute illness.
10. ADVERSE REACTIONS (IF ANY):
    Mild fever, joint pain, muscle aches, nausea, tiredness, or pain/itching/swelling/redness at the injection site may occur. Acetaminophen may be used to reduce these effects
11. VACCINE VIAL MONITORING (If APPLICABLE): VVM used
    VVM-30