IGANTET INJECTION 250 IU/ML [SIN12556P]

Product Info

IGANTET INJECTION 250 IU/ML

[SIN12556P]

Therapeutic indications

• Prophylaxis in persons with recent injuries that might be contaminated with tetanus spores and who did not receive vaccination in the previous 10 years or whose prior vaccination regimen was incomplete or is unknown.

• Treatment of clinically manifest tetanus.

Posology
Slow injection by the i.m. route.
In case of clotting disorders where intramuscular injections are contraindicated, human antitetanus immunoglobulin can be administered subcutaneously. Careful manual pressure with a compress should be applied therefore on the site after injection.
If large total doses (≥ 5 ml) are required, it is advisable to administer them in divided doses at different sites.
Antitetanus immunoglobulin and vaccine should be administered using different syringes, needles and injection sites.
Besides wound cleansing or debridement and intramuscular human antitetanus immunoglobulin injection, active immunisation with the tetanus vaccine must be started simultaneously in a separate site of the body according to the following instructions:

• Clean-minor wounds
  It is not recommended to administer neither a revaccination nor antitetanus immunoglobulin to patients who did receive the last booster dose in the previous 10 years and whose prior antitetanus vaccination regimen was complete.
  It is recommended to administer a vaccine dose to patients who did not receive the last booster dose in the previous 10 years and whose prior antitetanus vaccination regimen was incomplete or is unknown. Antitetanus immunoglobulin administration is not necessary.

• Dirty-major wounds
  It is not necessary to administer a revaccination to patients who did receive the last booster dose in the previous 5 years and whose prior antitetanus vaccination regimen was complete.
  However, if more than 5 years have passed since the last booster dose, a vaccine dose should be administered to the patient. In both cases, it is not necessary to administer antitetanus immunoglobulin.
  It is necessary to administer a vaccine dose together with antitetanus immunoglobulin to patients whose prior antitetanus vaccination regimen was incomplete or is unknown.

The antitetanus vaccine to be used may contain only tetanus toxoid or tetanus toxoid together with diphtheric toxoid (adults dT vaccine). The latter must not be administered to wounded immunodeficient patients.
It is recommended that the physician determines if a minor wound is “tetanus prone”, based on the likelihood that Clostridium tetani was present on the object which caused the wound.
Children and adults have to receive the same dose.

• Prophylaxis of tetanus
  250 international units by intramuscular route.
  This dosage should be doubled (i.e. 500 international units) in case of anfractuous (dirty deep wounds with tissue destruction) or infected wounds or if the injury has occurred more than 24 hours before, or in adults weighing more than the average.

• Therapy of clinically manifest tetanus
  Several studies suggest the value of human antitetanus immunoglobulin in the treatment of clinically manifest tetanus using single doses of 3000 to 6000 international units i.m. in combination with other appropriate clinical procedures.

Contraindications
The lethal risk associated with tetanus rules out any potential contraindication (see item corresponding to Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).