TUBERCULIN Solution for injection Ref.[7657] Active ingredients: Tuberculin

Tuberculin PPD is indicated for the detection of a delayed hypersensitivity reaction to tuberculin as an aid in the detection of infection with Mycobacterium tuberculosis.

Clinically, a delayed hypersensitivity reaction to tuberculin is a manifestation of:

• Previous infection with M. tuberculosis or non-tuberculosis bacteria.
• Sensitization by previous vaccination with BCG Vaccine.

The reaction to intradermally injected tuberculin is a delayed (cellular) hypersensitivity reaction. The tuberculin reaction is characterized by the early predominance of mononuclear cells (small and medium sized lymphocytes and monocytes). Only a small proportion of these cells appear to be lymphocytes sensitized to tuberculin. Most cells are brought into the reaction through the release of biologically active substances by sensitized lymphocytes. An increase in vascular permeability leading to erythema and edema also occurs in tuberculin reactions. Characteristically, delayed hypersensitivity reactions to tuberculin begin at 5 to 6 hours, are maximal at 48 to 72 hours and subside over a period of days.

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.