A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tice Online, Description, Chemistry, Ingredients - Bacillus of Calmette and Guerin
Tice Online, Description, Chemistry, Ingredients - Bacillus of Calmette and Guerin
DESCRIPTION
|
WARNING
TICE® BCG contains live, attenuated mycobacteria. Because of the potential
risk for transmission, it should be prepared, handled, and disposed of
as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION
).
BCG infections have been reported in health care workers, primarily from
exposures resulting from accidental needle sticks or skin lacerations
during the preparation of BCG for administration. Nosocomial infections
have been reported in patients receiving parenteral drugs that were prepared
in areas in which BCG was reconstituted. BCG is capable of dissemination
when administered by the intravesical route, and serious infections, including
fatal infections, have been reported in patients receiving intravesical
BCG (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS ).
|
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® 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.
top
