SPL Set ID: c9b74876-e665-442b-87ad-b7333bc9a67a
1 drug(s) with this SPL Set ID
TICE ® BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. 1 The TICE strain was developed at the University of Illinois from a strain originated at the Pasteur Institute. The medium in which the BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. The final preparation prior to freeze drying also contains lactose. The freeze-dried BCG preparation is delivered in glass vials, each containing 1 to 8 × 10 8 colony forming units (CFU) of TICE BCG which is equivalent to approximately 50 mg wet weight. Determination of in vitro potency is achieved through colony counts derived from a serial dilution assay. A single dose consists of 1 reconstituted vial (see DOSAGE AND ADMINISTRATION ). For intravesical use the entire vial is reconstituted with sterile saline. TICE BCG is viable upon reconstitution. No preservatives have been added.