Rabies Immune Globulin (Human) — BayRab® (rabies immune globulin human solvent/detergent treated) treated with solvent/detergent is a sterile solution of antirabies immune globulin for intramuscular administration; it contains no preservative. BayRab (rabies immune globulin human solvent/detergent treated) is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solu-tion is adjusted to a final concentration of 0.3% tri-n-butyl phosphate ( TNBP) and 0.2% sodium cholate. After the addition of solvent ( TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. BayRab (rabies immune globulin human solvent/detergent treated) is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. BayRab (rabies immune globulin human solvent/detergent treated) is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the international unit (IU) for rabies antibody.