Tice

DRUG DESCRIPTION

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 (bacillus of calmette and guerin) ® 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 x 10⁸
colony forming units (CFU) of TICE® BCG (bacillus of calmette and guerin) 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 (bacillus of calmette and guerin) is viable upon reconstitution.

No preservatives have been added.