Transfusion medicine handbook

5. Fractionated Products

5.4.5 TETAGAM P

Tetagam P is a human tetanus immunoglobulin for intramuscular use [7]. It should not be injected intravascularly because of the risk of shock. Tetagam P does not have full New Zealand registration and so consultation with a NZBS Transfusion Medicine Specialist/Medical Officer is required prior to release of this product. It is supplied by NZBS under Section 29, a provision in the Medicines Act 1981, whereby a medical practitioner can prescribe a medicine that is not registered with Medsafe.

1 mL of Tetagam P contains at least 250 IU of antibodies to tetanus toxin.

Indications for Use

Postexposure prophylaxis

Immediate prophylaxis after tetanus prone injuries in patients:

• not adequately vaccinated
• whose immunisation status is not known with certainty
• with severe deficiency in antibody production.

Therapy of clinically manifest tetanus

Tetanus immunoglobulin should always be administered in conjunction with an active tetanus vaccination unless there are contraindications or confirmation of adequate vaccination.

Dosage and Administration

Prophylaxis of tetanus prone wounds

250 IU unless the risk is thought to be extremely high.

The dose may be increased to 500 IU in case of:

• infected wounds where surgically appropriate treatment cannot be achieved within 24 hours
• deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign-body injury (e.g., bites, stings or shots)
• burns
• tissue necrosis
• septicaemic abortion
• adults weighing more than the average. [7]

In case of extensive burns it is advisable to administer a second injection of 250 IU Tetagam P after the exudative phase of the burn has subsided (about 36 hours after onset of the burn).

Therapy of clinically manifest tetanus

Single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures). Regarding frequency, interval of injection and duration of therapy repeated doses depend on the clinical picture.