Theracys

Drug Description

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BCG LIVE (INTRAVESICAL)

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).

DRUG 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 10⁸colony forming units (CFU) per vial when resuspended in the diluent provided.

Brand Name: Theracys
Generic Name: BCG Live (Intravesical)

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