Antivenin (Micrurus Fulvius)
»Antivenin (Micrurus Fulvius)conforms to the regulations of the FDAconcerning biologics (see Biologics á1041ñ).It is the sterile,non-pyrogenic preparation derived by drying a frozen solution of specific venom-neutralizing globulins obtained from the serum of healthy horses immunized against venom of the Eastern Coral snake (Micrurus fulvius).It is standardized by biological assay on mice,in terms of one dose of antivenin neutralizing the venom of Micrurus fulviusin not less than 250mouse LD50.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 105
to constant weight (±1mg).
to 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).
,1year;or 0,2years).
Labeling—
Label it to indicate the species of snake against which the Antivenin is to be used,and to state that it was prepared in the horse.
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 173
Phone Number:1-301-816-8397