Antivenin (Latrodectus mactans)
»Antivenin (Latrodectus mactans)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 black widow spiders (Latrodectus mactans).It is standardized by biological assay on mice,in terms of one dose of antivenin neutralizing the venom of Latrodectus mactansin not less than 6000mouse LD50.Thimerosal 1:10,000is added as a preservative.When constituted as specified in the labeling,it is opalescent and contains not more than 20.0percent of solids.
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;0,2years).
Labeling— Label it to indicate the species of spider against which the Antivenin is to be used,that it is not intended to protect against bites from other spider species,and to state that it was prepared in the horse.
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