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TETANUS VACCINE, ADSORBED

Adsorbed Tetanus Toxoid

Category Active immunizing agent.

       Adsorbed Tetanus Vaccine is a sterile suspension of suitable adjuvant(s), such as aluminium hydroxide, aluminium phosphate, onto which purified tetanus toxoid is adsorbed. The tetanus toxoid is prepared from tetanus toxin produced by the growth in suitable media of Clostridium tetani by treatment with formaldehyde. Each 0.5 ml contains not less than 40 IU of adsorbed tetanus vaccine.

      The vaccine complies with the requirements stated under Vaccines, with the following modifications.

Description Light colour suspension, free from evident clumps after shaking.

Strength available 40 IU of adsorbed tetanus toxoid per 0.5 ml.

Dose Intramuscular, 0.5 ml.

Contra-indication

1. It is contra-indicated in individuals who have a history of systemic hypersensitivity or neurologic reactions to the vaccine.

2. It is contra-indicated in individuals with thrombocytopenia or any coagulation disorder; in this situation, subcutaneous administration may be advisable.

Warning

1. It is not recommended for immunizing children under 7 years of age.

         2. If a contra-indication to using a tetanus vaccinecontaining preparation exists in an individual who has previously received less than 3 doses of tetanus vaccine or tetanus vaccine adsorbed, only passive immunization with tetanus immunoglobulin (TIG) should be considered when injury other than a clean, minor wound (not tetanus prone) is sustained.

3. Local reactions and mild systemic reactions may occur.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 2 years from the date of the last satisfactory test for potency.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition the label on the container states (1) the number of IU in each single human dose; (2) the name and the amount of the adjuvant(s); (3) that it is not to be frozen; (4) it is to be well-shaken before use.

Identification Dissolve in the vaccine to be examined sufficient sodium citrate dihydrate to give a 10 per cent w/v solution. Maintain at 37º for about 16 hours and centrifuge until the clear supernatant liquid is obtained. The clear supernatant liquid reacts with a suitable tetanus antitoxin, producing a precipitate.

pH 6.0 to 7.0 (Appendix 4.11).

Phenol Phenol should not be added to Adsorbed Tetanus Vaccine, since it has been shown to have deleterious effects on antigenic properties of the toxoid.

Specific toxicity Inject subcutaneously five times the single human dose stated on the label into each of five healthy guinea-pigs, each weighing 250 to 350 g, that have not previously been treated with any material that will interfere with the test. The vaccine complies with the test if within 3 weeks of the injection, none of the animals shows signs or dies from tetanus. If more than one animal dies from non-specific causes, repeat the test once. The vaccine complies with the test if not more than one animal dies in the second test.

Assay Carry out the “Biological Assay of Adsorbed Tetanus Vaccine” (Appendix 15.3.3). The lower confidence limit (P = 0.95) of the estimated potency is not less than 40 IU per single human dose (0.5 ml).

MONOGRAPHS • TETANUS VACCINE, ADSORBED
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หมายเหตุ / Note : TP II 2011 PAGE 273