Protet-IG

1. Prophylaxis of tetanus, following injury in patients whose immunization is incomplete or uncertain. 2. Therapeutically in the, treatment of tetanus. Tetanus immunoglobulin should always be administered in conjunction with an active tetanus vaccination unless there are contraindications or confirmations of adequate vaccination.

This vaccine should only be administered by intramuscular injection. Human tetanus immunoglobulin should not be administered by intravenously.

Intramuscular Post-exposure prophylaxis of tetanus: For adults single dose of 250 IU should be given. The dose may be increased to 500 IU in case of: 1. Infected wounds where surgically appropriate treatment cannot be achieved within 24 hours. 2. Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g., bites, stings or shots), 3. Burns, congelations, 4. Tissue necrosis, 5. Septicaemic abortion, 6. Adults weighing more than the average. In case of extensive burns, it is advisable to administer a second injection of 250 IU human tetanus immunoglobulin after the exsudative phase of the burn has subsided (about 36 hours after onset of the burn). At the same time, 0.5ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered. Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).

Intramuscular Post-exposure prophylaxis of tetanus: For children single dose of 250 IU should be given. The dose may be increased to 500 IU in case of: 1. Infected wounds where surgically appropriate treatment cannot be achieved within 24 hours. 2. Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g., bites, stings or shots), 3. Burns, congelations, 4. Tissue necrosis, 5. Septicaemic abortion, 6. Adults weighing more than the average. In case of extensive burns, it is advisable to administer a second injection of 250 IU human tetanus immunoglobulin after the exsudative phase of the burn has subsided (about 36 hours after onset of the burn). At the same time, 0.5ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered. Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).

Hypersensitivity homologous Ig-containing medicinal products particularly in patients w/ IgA deficiency & concurrent presence of Ab to IgA.

Tetanus immunoglobulin is used for passive immunisation against tetanus.

Caution when used in patients with coagulation disorders or thrombocytopenia. Not to be used for IV admin. Pregnancy, lactation. If adsorbed tetanus vaccine is to be used concurrently, the vaccine and immunoglobulin should be administered with separate syringes and into different inj sites with separate lymphatic drainage. Patients should be observed for at least 20 minutes after admin.

Inj-site reactions: Pain, soreness and tenderness. Increased temperature, angioneurotic oedema, nephritic syndrome, anaphylactic shock.

The safety for use of human tetanus immunoglobulin in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

May reduce the efficacy of live vaccines.