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Percut. BCG Vaccine

Category Active immunizing agent.

      Percutaneous Bacillus Calmette-Guérin Vaccine is a suspension of living cells of an authentic strain of the bacillus of Calmette and Guérin with a higher viable bacterial count than Bacillus Calmette-Guérin Vaccine. It is prepared immediately before use by reconstitution from the dried vaccine with an appropriate volume of a suitable sterile liquid.

      The vaccine, reconstituted as stated on the label, complies with the requirements stated under Vaccines, with the following modifications.

Strengths available 1 × 10⁸ to 8 × 10⁸ CFU of Bacillus Calmette-Guérin per ml.

Dose Percutaneous, 0.2 to 0.3 ml, using the multiple puncture device.

      Neonates: the dosage should be decreased by 50 per cent by reconstituting the vaccine with 2 ml instead of 1 ml of sterile water for injection without preservatives. 

Contra-indication; Warning See under Bacillus Calmette-Guérin Vaccine, Freeze-Dried, p. 240.

Additional information

      1. It has been administered concurrently with yellow fever vaccine without interference with the immune response to either vaccine.

      2. It may not be effective if administered during therapy with some antituberculosis agents.

      3. If acute overdosage of BCG vaccine occurs and there is reason to suspect that a generalized BCG infection may develop, isoniazid or other appropriated antituberculosis agent therapy should be initiated.

      4. Healthy neonates and infants younger than 2 months of age who have not been exposed to tuberculosis may receive BCG vaccine without prior tuberculin skin testing.

      5. Individuals with chronic diseases of the skin (e.g., eczema) should receive immunization with BCG vaccine in a healthy area of skin.

Expiration date The expiration date is not later than 6 months from the date of the last satisfactory test for potency, or not later than 1 year after the date of the last satisfactory test for potency, if stored at a temperature less than 5º.

Packaging and storage Percutaneous Bacillus Calmette-Guérin Vaccine shall be kept in tightly closed containers, preferably of Type I glass, protected from light, and stored at a temperature between 2º and 8º; avoid freezing.

Labelling Complies with the “General Information for Biological Products”, p 177. In addition, the label on the container stated (1) that the vaccine is a living culture of the bacillus of Calmette and Guérin; (2) that any portion of the reconstituted vaccine not used at once should be discarded; (3) that the vaccine is for percutaneous administration and must not be given by the intracutaneous (intradermal) route.

Identification

1. When examined microscopically in stained smears, the bacilli exhibit the characteristics of an authentic strain of the bacillus of Calmette and Guérin.

2. Colonies grown on a suitable solid culture medium have a characteristic appearance.

Virulent mycobacteria Prepare a fivefold dilution of the vaccine using an appropriate sterile liquid. Inject 1 ml intramuscularly into each of six guinea-pigs weighing 250 to 400 g. None of the animals dies within 6 weeks or if one dies, a post-mortem examination establishes that it is free from tuberculosis. If two of the animals die within this period and a post-mortem examination establishes that both are free from tuberculosis, repeat the test on six further guinea-pigs. None of the second group of animals dies within 6 weeks or, if one dies, a post mortem examination establishes that it is free from tuberculosis.

Test of skin reaction (Excessive dermal reactivity) Inject intracutaneously into each of two guinea-pigs a volume of 0.1 ml of 1, 0.1, 0.01 and 0.001 doses of the vaccine being examined and of the comparison vaccine. Use an appropriate sterile liquid as diluent. The vaccine passes the test if the skin reactions produced within 3 weeks do not differ markedly from those produced by the comparison vaccine.

Skin-sensitizing potency Prepare a 25-fold dilution of the vaccine using an appropriate sterile liquid. Inject 0.5 ml subcutaneously or intramuscularly into each of two guinea-pigs. Within 4 weeks of injection, inject intracutaneously into each guinea-pig 10 IU of Old Tuberculin, or of Tuberculin Purified Protein Derivative, in a volume of 0.1 ml. An inflammatory area of induration and edema not less than 5 mm in diameter, irrespective of the area of erythema, is induced within 24 hours.