Vaccinia Immune Globulin
»Vaccinia Immune Globulin conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).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 15g and not more than 18g of protein per 100mL,not less than 90.0percent of which is gamma globulin.It contains 0.3Mglycine as a stabilizing agent,and contains a suitable antimicrobial agent.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 3years after date of issue.
Labeling— Label it to state that it is not intended for intravenous injection.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 2008
Phone Number:1-301-816-8339