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Adsorbed Diphtheria and Tetanus Vaccine for Adults and Aldolescents; Tetanus and Diphtheria Toxoids Adsorbed for Adults Use; dT Vaccine; Td Vaccine 

Category Active immunizing agent.

      Adsorbed Tetanus and Diphtheria Vaccine for Adult Use is a sterile suspension of suitable adjuvant(s) such as aluminium hydroxide, 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 2 IU of adsorbed diphtheria toxoid and 20 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.

Strength available 20 IU of adsorbed tetanus toxoid and 2 IU of adsorbed diphtheria 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.

Warning

      1. Patients who experienced severe Arthus-type hypersensitivity reaction following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given even emergency doses of Adsorbed Tetanus and Diphtheria Vaccine for Adult Use more frequently than every 10 years, even if they have a wound that is neither clean nor minor.

      2. 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.

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

      4. 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.

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

      6. 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. The concentration of diphtheria toxoid in Adsorbed Tetanus and Diphtheria Vaccine for Adult Use, which is intended for use in patients 7 years of age and older, is lower than that of the concentration of diphtheria toxoid in Adsorbed Diphtheria and Tetanus Vaccine.

      2. It is recommended that adults and children 7 years of age and older receive Adsorbed Tetanus and Diphtheria Vaccine for Adult Use rather than the singleentity tetanus toxoid for the primary immunizing series, all booster doses, and active tetanus immunization in wound management. This is to help ensure protection against diphtheria infection, since a large proportion of adults is susceptible to diphtheria infection.

      3. The primary immunizing series of Adsorbed Tetanus and Diphtheria Vaccine for Adult Use consists of 3 doses (2 initial and reinforcing) for adults and children 7 years of age and older.

      4. More frequent administration of Adsorbed Tetanus and Diphtheria Vaccine for Adult Use is not recommended except under circumstances of wound management or diphtheria prophylaxis since it may be associated with increased incidence and severity of adverse reactions.

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 the adjuvant(s); (3) that it is not to be frozen; (4) that it must be well shaken before use.

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

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 Tetanus and Diphtheria Vaccine for Adult Use, 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 2 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 20 IU per single human dose (0.5 ml).