Antivenin (Crotalidae)Polyvalent
»Antivenin (Crotalidae)Polyvalent conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is a sterile,non-pyrogenic preparation derived by drying a frozen solution of specific venom-neutralizing globulins obtained from the serum of healthy horses immunized against venoms of four species of pit vipers,Crotalus atrox,Crotalus adamanteus,Crotalus durissus terrificus,and Bothrops atrox(Fam.Crotalidae).It is standardized by biological assay on mice,in terms of one dose of antivenin neutralizing the venoms in not less than the number of mouse LD50stated,of Crotalus atrox(Western diamondback),180;Crotalus durissus terrificus(South American rattlesnake),1320;and Bothrops atrox(South American fer-de-lance),780.It may contain a suitable preservative.When constituted as specified in the labeling,it is opalescent and contains not more than 20.0percent of solids,determined by drying 1mLat 105to constant weight (±1mg).
Packaging and storage— Preserve in single-dose containers,and avoid exposure to excessive heat.
Expiration date— The expiration date for Antivenin containing a 10%excess of potency is not more than 5years after date of issue from manufacturer's cold storage (5,1year;or 0,2years).
Labeling— Label it to indicate the species of snakes against which the Antivenin is to be used,and to state that it was prepared from horse serum.
Safety— It meets the requirements for general safety (see Safety Tests—Biologicalsunder Biological Reactivity Tests,In Vivo á88ñ).
Auxiliary Information— Staff Liaison:Tina S.Morris,Ph.D.,Senior Scientist
Expert Committee:(VVI)Vaccines,Virology,and Immunology
USP28–NF23Page 172
Pharmacopeial Forum:Volume No.28(4)Page 1068
Phone Number:1-301-816-8397