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Adsorbed Diphtheria Toxoid; Adsorbed Diphtheria Prophylactic

Category Active immunizing agent.

      Adsorbed Diphtheria Vaccine is a sterile suspension of suitable adjuvant(s), such as aluminium hydroxide, aluminium phosphate, onto which purified diphtheria toxoid is adsorbed. The diphtheria toxoid is prepared from diphtheria toxin produced by the growth in suitable media of Corynebacterium diphtheriae by treatment with formaldehyde. Each 0.5 ml contains not less than 30 IU of adsorbed diphtheria vaccine.

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

Strength available 30 IU of adsorbed diphtheria toxoid per 0.5 ml.

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

Dose Children under 6 years of age: Intramuscular or deep subcutaneous, 0.5 ml.

Contra-indication It is contra-indicated in individuals with serious diseases, fever, or with a history of severe systemic or allergic reactions to Adsorbed Diphtheria Vaccine.

Warning Low fever; fatigue; headache; erythema and swelling at the injection site may occur.

Additional information Adsorbed Diphtheria Vaccine should not be used in persons over 6 years of age.

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 adjuvant(s); (3) that it is not to be frozen.

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 a clear supernatant liquid is obtained. The clear supernatant liquid reacts with a suitable diphtheria antitoxin, producing a precipitate.

pH 6.0 to 7.0 (Appendix 4.11).

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

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 6 weeks of the injection, none of the animals shows signs or dies from diphtheria toxaemia. 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 Diphtheria Vaccine” (Appendix 15.3.1). The lower confidence limit (P = 0.95) of the estimated potency is not less than 30 IU per single human dose (0.5 ml).