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PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE, ADSORBED

Category Active immunizing agent.

      Adsorbed Pneumococcal Polysaccharide Conjugate Vaccine is a sterile solution of purified capsular polysaccharide antigens obtained from suitable pathogenic strains of Streptococcus pneumoniae individually conjugated to a carrier protein. The vaccine may be adsorbed on a suitable adjuvant or adsorbant. The choice of polysaccharide depends on the frequency of the serotypes responsible for acute diseases and their geographical distribution. It contains immunochemically different capsular polysaccharides.

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

Description White suspension.

Strengths available 2 μg of each polysaccharide for S. pneumoniae serotypes 4, 9V, 14, 18C, 19F, and 23F, 4 μg of polysaccharide for serotype 6B (16 μg total polysaccharide) and approximately 20 μg of CRM 197 protein per 0.5 ml.

Dose Children younger than 10 years of age and infants 6 weeks of age and over: Intramuscular, 0.5 ml.

Warning

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

2. Fever, diarrhea, vomiting, decreased appetite, drowsiness, restless sleep, and irritability may occur. 

Expiration date When stored under the prescribed conditions, the expiration date is not later than 3 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 single human dose; (2) the number of micrograms of carrier protein per single human dose.

Identification Each polysaccharide present in the vaccine is identified by a suitable immunochemical method (Appendix 14.5).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains less than 12.5 Endotoxin Units per single human dose, unless otherwise justified and authorized. 

Assay

      POLYSACCHARIDE CONTENT The polysaccharide content for each serotype is determined by a suitable immunochemical method (for example, nephelometry assay) (Appendix 14.5).

      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.

MONOGRAPHS • PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE, ADSORBED
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หมายเหตุ / Note : TP II 2011 PAGE 265-266