Tubersol

DRUG DESCRIPTION

Tuberculin Purified Protein Derivative¹ (Mantoux) - TUBERSOL (tuberculin purified protein) ®
for intradermal (Mantoux) tuberculin testing is available in a stabilized solution
bio-equivalent to 5 U.S. units (TU) PPD-S per test dose (0.1 mL).

TUBERSOL (tuberculin purified protein) ® is prepared by Aventis Pasteur Limited from a large Master Batch,
Connaught Tuberculin (CT68) and is a cell-free purified protein fraction obtained
from a human strain of Mycobacterium tuberculosis grown on a protein-free
synthetic medium, and inactivated.²

TUBERSOL (tuberculin purified protein) ® is a sterile isotonic solution of Tuberculin in phosphate buffered
saline containing Tween 80 (0.0005%) as a stabilizer. Phenol 0.28% is added
as a preservative.^3,4,5

Prior to release, each successive lot is tested for potency in sensitized guinea
pigs in comparison with the U.S. Standard Tuberculin PPD-S.⁶