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Vaccinia Immune Globulin
» Vaccinia Immune Globulin conforms to the regulations of the FDA concerning biologics (see Biologics 1041 ). It is a sterile, nonpyrogenic solution of globulins derived from the blood plasma of adult human donors who have been immunized with vaccinia virus (Smallpox Vaccine). It is standardized for viral neutralizing activity in eggs or tissue culture with the U.S. Reference Vaccinia Immune Globulin and a specified vaccinia virus. It contains not less than 15 g and not more than 18 g of protein per 100 mL, not less than 90.0 percent of which is gamma globulin. It contains 0.3 M glycine as a stabilizing agent, and contains a suitable antimicrobial agent.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date is not later than 3 years after date of issue.
Labeling— Label it to state that it is not intended for intravenous injection.
Auxiliary Information— Staff Liaison : Tina S. Morris, Ph.D., Senior Scientist
Expert Committee : (BBBBP05) Biologics and Biotechnology - Blood and Blood Products
USP29–NF24 Page 2234
Phone Number : 1-301-816-8397