BCG-MEDAC powder + solvent for intravesical suspension 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.

General data about BCG-MEDAC

Substance: BCG vaccine

Date of last drug list: 01-01-2019

Commercial code: W13958001

Pharmaceutical form: powder + solvent for intravesical suspension

Quantity: 1

Product type: original

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

Marketing authorisation

Manufacturer: MEDAC GESELLSCAFT FUR KLINISCHE SPEZIALPRÄPARATE - GERMANIA

Holder: MEDAC GESELLSCAFT FUR KLINISCHE SPEZIALPRÄPARATE - GERMANIA

Number: 3457/2011/01

Shelf life: 2 years

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