BCG 10 ANTI-TUBERCULOSIS VACCINE 0.05mg / dose powder + solvent for injection suspension medication leaflet

J07AN01 BCG vaccine • Antiinfectives for systemic use | Bacterial vaccines | Tuberculosis vaccines

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.

General data about BCG 10 ANTI-TUBERCULOSIS VACCINE 0.05mg / dose

Substance: BCG vaccine

Date of last drug list: 01-05-2024

Commercial code: W68779001

Concentration: 0.05mg / dose

Pharmaceutical form: powder + solvent for injection suspension

Quantity: 5

Product type: generic

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: BIOMED-LUBLIN - POLONIA

Holder: ANISAPHARM DISTRIBUTION S.R.L. - ROMANIA

Number: 710/2022/01

Shelf life: 30 months

Concentrations available for BCG vaccine

0.05mg/dose, 100mg, 100mg/ml, 2-8X10^8 UFC BCG Tice, 5X10^8 UFC BCG Tice, 75mg/ml, 81mg