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



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