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Adsorbed Diphtheria and Tetanus Toxoids; DT Vaccine

Category Active immunizing agent.

      Adsorbed Diphtheria and Tetanus Vaccine is a sterile suspension of suitable adjuvant(s), such as aluminium hydroxide or aluminium phosphate, onto which purified diphtheria toxoid and tetanus toxoid are adsorbed. The diphtheria toxoid and tetanus toxoid are prepared from diphtheria toxin and tetanus toxin 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 and 40 IU of adsorbed tetanus toxoid.

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

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

Strengths available 30 IU of adsorbed diphtheria toxoid and 40 IU of adsorbed tetanus toxoid per 0.5 ml.

Dose Intramuscular, preferably into the deltoid or the midlateral muscles of the thigh, 0.5 ml.

Contra-indication

1. It is contra-indicated in individuals hypersensitive to any ingredient in the formulations.

2. It is contra-indicated in individuals who have had immediate anaphylactic reaction to a previous dose.

3. It is not for subcutaneous or intravenous administration.

4. It is not given for adults and children 7 years of age and older. 

Warning

          1. It should be used with caution to individuals with thrombocytopenia or any coagulation disorder that would contra-indicate intramuscular injection unless the potential benefits outweigh the risk of administration.

2. It may cause mild to moderate local reactions at the injection site, including tenderness, erythema, and induration, which may persist for several days.

         3. Fever, chills, malaise, fatigue, arthralgias or generalized aches and pains, nausea and vomiting, erythema multiforme or other rash, flushing, generalized urticaria or pruritus, tachycardia, dizziness, and hypotension may occur.

         4. Children receiving immunosuppresive therapy, including radiation, corticosteroids, antimetabolites,alkylating agents, and cytotoxic drugs, or with other immunodeficiencies may have diminished antibody response to active immunization.

         5. It may be administered simultaneously at a separate site with H. influenzae type b (Hib) conjugate vaccines, hepatitis B vaccine, poliovirus vaccine inactivated (IPV), measles virus vaccine live, mumps virus vaccine live, and/or rubella virus vaccine live.

Additional information

          1. Before additional dose of Adsorbed Diphtheria and Tetanus Vaccine, the health status of the patient should be assessed. In addition, information should be obtained regarding any symptom and/or sign of an adverse reaction that occurred after the previous dose.

          2. Routine immunization of children should be deferred during an outbreak of poliomyelitis in the community, unless there is also an outbreak of diphtheria. In either case, emergency tetanus prophylaxis for wounds should be administered as usual.

          3. Children with impaired immune response may be immunized, but may have reduced antibody response to Adsorbed Diphtheria and Tetanus Vaccine. Children infected with human immunodeficiency virus (HIV) including those who are immunosuppressed in association with acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of HIV infection may receive Adsorbed Diphtheria and Tetanus Vaccine whether they have asymptomatic or symptomatic HIV infection.

         4. Diphtheria infection may not (and tetanus infection does not) confer immunity; therefore, initiation or completion of active immunization with Adsorbed Diphtheria and Tetanus Vaccine is indicated at the time of recovery from either of these infections.

         5. Interruption of the recommended schedule for the primary immunizing series of Adsorbed Diphtheria and Tetanus Vaccine by a delay between doses does not interfere with the final immunity achieved and does not necessitate starting the series over again, regardless of the length of time that elapsed between doses.

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) where applicable, that the vaccine is intended for primary vaccination of children; (3) the name and the amount of the adjuvant(s); (4) that it is not to be frozen; (5) that it must be well shaken before use. 

Identification Complies with the test for Identification of Diphtheria Vaccine, Adsorbed, p. 245, and of Tetanus Vaccine, Adsorbed, p. 273.

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 and Tetanus Vaccine, since it has been shown to have deleterious effects on antigenic properties of the toxoids.

Specific toxicity Complies with the test for Specific toxicity described under Diphtheria Vaccine, Adsorbed, p. 245, and under Tetanus Vaccine, Adsorbed, p. 273. For these two tests, 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 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).