WHO Model Prescribing Information: Drugs Used in Mycobacterial Diseases
(1991; 44 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoPreface
Cerrar esta carpetaTuberculosis
Ver el documentoIsoniazid
Ver el documentoPyridoxine
Ver el documentoRifampicin
Ver el documentoRifampicin/isoniazid
Ver el documentoPyrazinamide
Ver el documentoStreptomycin
Ver el documentoEthambutol
Ver el documentoThioacetazone/isoniazid
Ver el documentoBCG vaccine (dried)
Ver el documentoTuberculin (purified protein derivative)
Abrir esta carpeta y ver su contenidoLeprosy
Abrir esta carpeta y ver su contenidoNontuberculous mycobacterial diseases

BCG vaccine (dried)

Group: vaccine
Intradermal injection

General information

Bacille Calmette-Guérin (BCG) vaccines are lyophilized preparations of a live, attenuated strain of M. bovis. Various strains, all derived from the same original culture, but varying in their DNA structure, immunogenictiy and biochemical characteristics, are used for the manufacture of BCG vaccines. When administered shortly after birth they may provide substantial protection against severe forms of tuberculosis of childhood, including miliary tuberculosis and tuberculous meningitis. The response has been less consistent when they have been administered to older children.

Clinical information


To confer active immunity against tuberculosis. In countries where the risk of infection is high, it is recommended that all infants, including those born to HIV- positive mothers, should be vaccinated during the first year of life, provided that they have no clinical signs suggestive of AIDS.

Dosage and administration

It is important that the vaccine be administered intradermally (not subcutaneously) to avoid risk of abscesses.

It must be reconstituted with an appropriate diluent immediately before injection.

Neonates and infants: 0.05 ml by intradermal injection in the arm over the insertion of the deltoid muscle.

Children over 1 year old: 0.1 ml administered as above.


• Generalized eczema.

• Hypogammaglobulinaemia and immunodeficiency resulting from treatment with antimetabolites, irradiation or systemic corticosteroids.


If an infective dermatosis such as scabies is present, an injection site where there is no infection should be selected.

Adverse effects

Lymphadenitis, osteitis and localized necrotic ulceration may occur.

Very rarely, cases of disseminated BCG infection have been reported in immunodeficient patients. This condition is generally rapidly responsive to antituberculosis chemotherapy.


Lyophilized vaccines should be protected from light and the storage temperature should not be allowed to rise above 8 °C. BCG vaccine withstands prolonged freezing without deterioration. Unused portions of the reconstituted vaccine should be discarded at the end of the working day.

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