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DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, ADSORBED

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed; Adsorbed Diphtheria, Tetanus and Whooping-cough Prophylactic; DTP Vaccine; DTwP Vaccine 

Category Active immunizing agent.

       Adsorbed Diphtheria, Tetanus and Pertussis Vaccine is a sterile suspension of purified and adsorbed diphtheria and tetanus toxoids and killed Bordetella pertussis of one or more strains selected for high antigenic efficiency. The diphtheria toxoid and tetanus toxoid are prepared from toxins produced by the growth in suitable media of Corynebacterium diphtheriae and Clostridium tetani, respectively, by treatment with formaldehyde. Each 0.5 ml contains not less than 30 IU of adsorbed diphtheria toxoid, 40 IU of adsorbed tetanus toxoid and 4 IU of adsorbed pertussis vaccine.

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

Description Whitish turbid suspension, free from evident clumps after shaking.

Strength available 30 IU of adsorbed diphtheria toxoid, 40 IU of adsorbed tetanus toxoid and 4 IU of adsorbed pertussis vaccine per 0.5 ml.

Dose Intramuscular or deep subcutaneous, 0.5 ml.

Warning

1. It should not be used in persons over 6 years of age.

2. It should not be used in children who had convulsions or brain disorders (encephalopathy) within three days of a previous dose of vaccine.

3. High fever, persistent crying, collapse, or convulsions may occur.

4. It may cause prolonged seizures.

5. Risk-benefit should be considered if it is to be used in infants and children with underlying neurologic disorders.

Additional information

1. Children with a personal or close family history of epilepsy may also be at increased risk of seizures after vaccination.

2. Children experiencing a seizure during the course of immunization should be carefully assessed before deciding whether to continue immunization with the vaccine.

3. The first dose of the vaccine should be administered at 2 months of age.

          4. The decision about whether to give the vaccine to infants and children with underlying neurologic disorders can be difficult and must be made on an individual basis after careful and continuing consideration of the risks and benefits.

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 labelling described under the “General Information for Biological Products”, p. 177. In addition the label on the container states (1) the number of IU of each component per single human dose; (2) the name and the amount of the adjuvant(s); (3) that it is not to be frozen; (4) that it must be well shaken before use; (5) the vaccine is intended for vaccination of children under 6 years of age.

Identification Complies with the tests for Identification of Diphtheria VaccineAdsorbed, p. 245, of Tetanus Vaccine, Adsorbed, p. 273, and of Pertussis VaccineAdsorbed, p. 262.

pH 6.0 to 7.0 (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.

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

Specific toxicity Complies with the test for Specific toxicity described under Diphtheria VaccineAdsorbed, p. 245, Tetanus VaccineAdsorbed, p. 273, and of Pertussis VaccineAdsorbed, p. 262. For Diphtheria VaccineAdsorbed and Tetanus VaccineAdsorbed, the same animals are used and are observed for 6 weeks in order to cover the observation period specified for diphtheria.

Assay

       A. 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).

      B. Carry out one of the prescribed methods in the “Biological Assay of Adsorbed Tetanus Vaccine” (Appendix 15.3.3). If the test is carried out in guinea-pigs (Method A), the lower confidence limit (P = 0.95) of the estimated potency is not less than 40 IU per single human dose (0.5 ml). If the tests is carried out in mice (Method B), the lower confidence limit (P = 0.95) of the estimated potency is not less than 60 IU per single human dose (0.5 ml) due to whole-cell pertussis component.

       C. Carry out the “Biological Assay of Adsorbed Pertussis Vaccine” (Appendix 15.3.2). The estimated potency is not less than 4 IU per single human dose (0.5 ml) and the lower confidence limit (P = 0.95) of the estimated potency is not less than 2 IU per single human dose.

MONOGRAPHS • DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, ADSORBED
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หมายเหตุ / Note : TP II 2011 PAGE 275-276