Human clostridium tetani toxoid immune globulin

Hyper TET is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain. It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus. A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.

Routine prophylactic dosage schedule: Adults and children 7 years and older: Hyper TET, 250 units should be given by deep intramuscular injection. At the same time, but in a different extremity and with a separate syringe, Tetanus and Diphtheria Toxoids Adsorbed (For Adult Use) (Td) should be administered according to the manufacturer's package insert. Adults with uncertain histories of a complete primary vaccination series should receive a primary series using the combined Td toxoid. To ensure continued protection, booster doses of Td should be given every 10 years. Children less than 7 years old: In small children the routine prophylactic dose of Hyper TET may be calculated by the body weight (4.0 units/kg).

None known.

HyperTET is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.

Slight soreness at the site of injection and slight temperature elevation may be noted at times. Sensitization to repeated injections of human immunoglobulin is extremely rare. In the course of routine injections of large numbers of persons with immunoglobulin there have been a few isolated occurrences of angioneurotic edema, nephrotic syndrome, and anaphylactic shock after injection.

Antibodies in immunoglobulin preparations may interfere with the response to live viral vaccines such as measles, mumps, polio, and rubella. Therefore, use of such vaccines should be deferred until approximately 3 months after Tetanus Immune Globulin (Human) — Hyper TET ® administration. No interactions with other products are known.

Store at 2–8°C (36–46°F).