"The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are"...
Tuberculin Purified Protein Derivative (Mantoux)
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
1. Landi S.Preparation, purification, and stability of tuberculin. Appl Microbiol 1963;11:408-412.
2. Landi S. et al. Preparation and characterization of a large batch of tuberculin purified protein derivative (PPD-CT68). Ann Scalvo.1980;22:889-907.
3. Landi S, et al.Adsorption of tuberculin PPD to glass and plastic surfaces. Bull.WHO 1966;35:593-602.
4. Landi S, et al.Disparity of potency between stabilized and nonstabilized dilute tuberculin solutions. Am Rev Respir Dis 1971;104:385-393.
5. Landi S, et al.Stability of dilute solutions of tuberculin purified protein derivative. Tubercle 1978;59:121-133.
6. U.S.Code of Federal Regulations,Title 21, Part 650, Subpart B - tuberculin.
Last reviewed on RxList: 1/30/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Tubersol Information
Report Problems to the Food and Drug Administration
Find out what women really need.