Pertussis Immune Globulin
»Pertussis 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 pertussis vaccine such that each 1.25mLcontains not less than the amount of immune globulin to be equivalent to 25mLof human hyperimmune serum.It may contain 0.3Mglycine as a stabilizing agent,and it contains a suitable preservative.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 3years after date of issue from manufacturer's cold storage (5,3years).
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 1523
Phone Number:1-301-816-8339