Stability of reconstituted freeze-dried Bacille Calmette-Guérin used for intravesical immunotherapy for bladder cancer.

The product monographs for the commercially available products of Bacille Calmette-Guérin (BCG) state they must be used immediately following reconstitution. We hypothesized that the viability of the reconstituted preparations of BCG would not be altered for a period of up to 4 hours thus allowing a longer time interval between full preparation and its intravesical administration. Vials of freeze-dried ImmuCysttrade mark (Connaught Laboratories) and TICEtrade mark BCG (Organon-Teknika) were fully reconstituted in approximately 50 ml of saline and aliquots of the fully reconstituted product were serially diluted and inoculated onto freshly prepared Lowenstein-Jensen slants and colony counts were conducted at 0, 2, and 4 hours.