Antivenin (Micrurus Fulvius)
» Antivenin (Micrurus Fulvius) conforms to the regulations of the FDA concerning biologics (see Biologics 1041). 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 fulvius in not less than 250 mouse LD50. It may contain a suitable preservative. When constituted as specified in the labeling, it is opalescent and contains not more than 20.0 percent of solids, determined by drying 1 mL at 105 to constant weight (±1 mg).
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 5 years after date of issue from manufacturer's cold storage (5, 1 year; or 0, 2 years).
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—Biologicals under Biological Reactivity Tests, In Vivo 88).
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Tina S. Morris, Ph.D.
Director,Biologics and Biotechnology
(BBVV05) Biologics and Biotechnology - Vaccines and Virology
USP32–NF27 Page 1572