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
Theracys Online, Description, Chemistry, Ingredients - BCG Live (Intravesical)
Theracys Online, Description, Chemistry, Ingredients - BCG Live (Intravesical)
BCG LIVE (INTRAVESICAL)
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WARNING
TheraCysÒ [BCG Live
(Intravesical)] 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 immunosuppressed patients receiving parenteral
drugs which were prepared in areas in which BCG was prepared. 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).
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DESCRIPTION
TheraCysÒ - BCG Live (Intravesical)
is a freeze-dried preparation made from the Connaught strain of Bacillus Calmette
and Guerin, which is an attenuated strain of Mycobacterium bovis.
The BCG organisms in the product are grown on media containing
potatoes, glycerine, asparagine, citric acid, potassium phosphate, magnesium
sulfate, ferric ammonium citrate, calcium chloride, copper sulfate and zinc
sulfate. Monosodium glutamate is added to the BCG organisms prior to freeze-drying.
Each vial of TheraCysÒ
contains 81 mg of freeze-dried BCG. Prior to use, each vial is reconstituted
with the accompanying diluent (3 mL), which contains sodium chloride, sodium
phosphate and Tween 80. Neither the freeze-dried BCG nor the diluent contain
preservative.
One dose of TheraCysÒ
consists ofone 81 mg vial ofreconstituted material further diluted in
50 mL sterile, preservative-free saline. The BCG organisms are viable upon reconstitution.
In vitro potency is determined by an assay of the number of colonies grown on
solid medium. The reconstituted product contains 10.5 ± 8.7 x 108 colony
forming units (CFU) per vial when resuspended in the diluent provided.
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