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Tetanus Immune Globulin; Antitetanus Immunoglobulin Injection; Human Antitetanus Immunoglobulin Injection; TIG

Category Passive immunizing agent.

          Tetanus Immunoglobulin is a liquid or freezedried preparation containing immunoglobulins, mainly immunoglobulin G (IgG). It is obtained from plasma containing specific antibodies against the toxin of Clostridium tetani. Immunoglobulin may be added.

          Tetanus Immunoglobulin complies with the requirements stated under Immunoglobulin, p. 209, except for the minimum total protein content, and with those under this monograph.

Description The liquid Tetanus Immunoglobulin is clear or slightly opalescent and colourless or pale yellow to light brown.

          The freeze-dried Tetanus Immunoglobulin is a white or slightly yellow powder or solid friable mass.

Stability Liquid Tetanus Immunoglobulin should be discarded if it has been frozen. The reconstituted solution of freeze-dried Tetanus Immunoglobulin should be used immediately or as stated on the label.

Strength available 250 IU per single-dose container.

Dose For prophylaxis of tetanus----Adults and adolescents: Intramuscular, 250 to 500 IU.

          For treatment of tetanus: Intramuscular, 150 IU per kg of body weight into multiple sites, usual dose of 3000 to 6000 IU may be administered.

Contra-indication It is not for intravenous administration.

Warning

1. Local pain, tenderness, and erythema may occur at the injection site.

          2. It should be used with caution in individuals with thrombocytopenia or bleeding disorders, sincebleeding may occur following intramuscular administration of the drug.

          3. It should be administered cautiously to individuals with a specific IgA deficiency since anaphylaxis may occur.

          4. Low-grade fever, urticaria, angioedema and local inflammation may occur.

Additional information

          1. It should be administered at different sites when administering concomitantly with tetanus toxoid.

          2. The antibodies in tetanus immunoglobulin preparations may interfere with the immune responses to certain live virus vaccines such as measles, mumps, rubella including MMR, and oral polimyelitis vaccine (OPV). These vaccines should be administered at least 14 days before or 3 months after treatment with tetanus immunoglobulin. However, there appears to be no interference between tetanus immunoglobulin and yellow fever vaccine or oral typhoid (strain Ty 21a) vaccine.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 2 years from the date of manufacturing, or as indicated on the label.

Packaging and storage Liquid Tetanus Immunoglobulin shall be kept in a sealed colourless glass container, protected from light, and stored at a temperature of 2º to 8º; avoid freezing.

          Freeze-dried Tetanus Immunoglobulin shall be kept in a seal and colourless glass container, protected from light, and stored at a temperature not exceeding 25º, unless otherwise specified by manufacturers.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition, the label on the container states the number of IU per container.

          See also under Immunoglobulin, p. 209.

Assay Carry out the “Immunochemical Methods (Appendix 14.5). The potency is determined by comparing the antibody titre of the immunoglobulin to be examined with that of a reference preparation calibrated in International Units, using an immunoassay of suitable sensitivity and specificity.

          The stated potency is not less than 100 IU per ml. The estimated potency is not less than the stated potency. The confidence limits (P = 0.95) are not less than 80 per cent and not more than 125 per cent of the estimated potency.