สารบัญ

Category Active immunizing agent.

      Pneumococcal Polysaccharide Vaccine consists of a mixture of equal parts of purified capsular polysaccharide antigens prepared from suitable pathogenic strains of Streptococcus pneumoniae whose capsules have been shown to be made up of polysaccharides that are capable of inducing satisfactory levels of specific antibodies in man. It contains 23 immunochemically different capsular polysaccharides of S. pneumoniae serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17A or 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.

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

Description Clear, colourless liquid.

Strength available 25 μg of polysaccharide for each of the 23 serotypes per 0.5 ml.

Dose Adults and children 2 years of age and over: Intramuscular or subcutaneous, 0.5 ml.

Warning

1. It may cause pain, redness, induration and swelling at the injection site.

2. Headache, paresthesia, radiculoneuropathy, Guillain-Barré syndrome, rash, urticaria, nausea, and vomiting may occur.

3. It is not recommended for children younger than 2 years of age because they may not have a satisfactory antibody response.

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

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition, the label on the container states (1) the number of micrograms of each polysaccharide per human dose; (2) the total amount of polysaccharide in the container.

Identification The assay may serve as an identification test.

pH 4.5 to 7.4 (Appendix 4.11).

Antimicrobial preservative Where applicable, determine the amount of antimicrobial preservative by a suitable chemical method. The content is not less than the minimum amount shown to be effective and is not more than 115 per cent of the quantity stated on the label.

Abnormal toxicity Complies with the “Abnormal Toxicity Test” (Appendix 8.1), modified as follows for the test in guinea-pigs: inject intraperitoneally 10 human doses into each guinea-pig and observe for 12 days.

Pyrogens Complies with the “Pyrogen Test” (Appendix 8.2), using 2.5 μg per ml of each polysaccharide, per kg of the rabbit’s weight.

Assay Determine the content of each polysaccharide by a suitable immunochemical method (Appendix 14.5), using antisera specific for each polysaccharide contained in the vaccine, including factor sera for types within groups, and purified polysaccharides of each type as standards.

      The estimated amount of polysaccharide per dose is not less than 70 per cent and not more than 130 per cent of the content stated on the label. The confidence limits (P = 0.95) of the estimated amount of polysaccharide are not less than 80 per cent and not more than 120 per cent.