ONCOTICE 5X10^8 UFC BCG Tice lyophilized powder for suspension of intravesical administration medication leaflet

L03AX03 • BCG vaccine • Antineoplastic and immunomodulating agents | Immunostimulants | Other immunostimulants

The BCG vaccine (Bacillus Calmette-Guérin) is a vaccine used to prevent tuberculosis (TB), particularly severe forms such as tuberculous meningitis and miliary tuberculosis in children. It is derived from an attenuated strain of Mycobacterium bovis, a close relative of the bacterium that causes TB.

The BCG vaccine is typically administered intradermally within the first days or months of life, especially in countries where tuberculosis is endemic. While it does not provide complete protection against all forms of TB, it is effective in reducing the risk of severe complications in children.

Side effects are generally mild and include redness, swelling, or a small lesion at the injection site, which heals within a few weeks. Rarely, local lymphadenopathy or more severe infections may occur, particularly in individuals with immunodeficiencies.

The BCG vaccine is not recommended for individuals with severe immunodeficiencies (such as those caused by HIV) or those undergoing immunosuppressive treatments. Administration should be performed by qualified medical personnel in accordance with national vaccination guidelines.