Merck -Bacillus of Calmette and Guerin (BCG) Vaccine for Percutaneous Use
BCG VACCINE for percutaneous use is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bov/s.{1} The TICE® strain used in this BCG VACCINE preparation was developed at the University of Illinois from a strain originated at the Pasteur Institute.
The medium in which the TICE® 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 vials, each containing 1 to 8 x 108 colony forming units (CFU) of 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. Intradermal guinea pig testing is also used as an indirect measure of potency.
Reconstitution requires addition of Sterile Water for Injection, USP at 4-25°C (39-77T). For an adult dosage, 1 ml_ of Sterile Water for Injection, USP, should be added to one single-dose vial of vaccine. For a pediatric dosage, 2 ml_ of Sterile Water for Injection, USP, should be added to one single-dose vial of vaccine (see DOSAGE AND ADMINISTRATION).
No preservatives have been added.