Varicella-Zoster Immune Globulin
»Varicella-Zoster Immune Globulin conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile 15percent to 18percent solution of pH7.0containing the globulin fraction of human plasma consisting of not less than 99percent of immunoglobulin Gwith traces of immunoglobulin Aand immunoglobulin M,in 0.3Mglycine as a stabilizer and 1:10,000thimerosal as a preservative.It is derived from adult human plasma selected for high titers of varicella-zoster antibodies.Each unit of blood or plasma has been found nonreactive for hepatitis Bsurface antigen by a suitable method.The proteins of the plasma pools are fractionated by the cold ethanol precipitation method.The content of specific antibody is not less than 125units,deliverable from a vial containing not more than 2.5mLsolution.The unit is defined as equivalent to 0.01mLof a Varicella-Zoster Immune Globulin lot found effective in clinical trials and used as a reference for potency determinations,based on a fluorescent-antibody membrane antigen (FAMA)method for antibody titration.
Packaging and storage— Preserve at a temperature between 2and 8.
Expiration date— The expiration date is not later than 2years after date of issue from manufacturer's cold storage.
Labeling— Label it to state that it is to be administered by intramuscular injection,in the recommended dose based on body weight.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 2016
Phone Number:1-301-816-8339