Antivenin North American Coral Snake

Name: Antivenin North American Coral Snake

References

  1. Bowden, C and Krenzelok, E: Clinical applications of commonly used contemporary antidotes, a US perspective. Drug Safety 1997; 16(1):9-47.
  2. Sasaki, J et al: Coral snake bites and envenomation in children, A case series. Ped Emerg Care 2014; 30(4):262-5.
  3. Wood A, Schauben J, Thundiyil J, et al. Review of Eastern coral snake (Micrurus fulvius fulvius) exposures managed by the Florida Poison Information Center Network: 1998-2010. Clin Toxicol 2013; 51(8):783-8.

How Supplied/Storage and Handling

North American Coral Snake Antivenin (Equine) is supplied as a sterile lyophilized powder in single use vial (NDC 0008-0423-01) in a carton (NDC 0008-0423-03).

Store vials between 2 and 8°C (36 and 46° F). Do not freeze.

Use the reconstituted and diluted product within 4 hours.

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

NDC 0008-0423-03
Contains 1 of NDC 0008-0423-01

Antivenin
Micrurus fulvius
equine origin

North American
Coral Snake
Antivenin
10 mL

This package contains one vial of
lyophilized Antivenin (Micrurus fulvius)
with 0.25% phenol as a preservative
(before lyophilization).
Sealed under partial vacuum.

Pfizer Injectables

Rx only

NORTH AMERICAN CORAL SNAKE ANTIVENIN (EQUINE) 
coral snake (micrurus fulvius) immune globulin antivenin (equine) injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0008-0423
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE)) CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 250 [arb'U]  in 10 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL  
THIMEROSAL  
Packaging
# Item Code Package Description
1 NDC:0008-0423-03 1 VIAL in 1 CARTON
1 NDC:0008-0423-01 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101099 10/12/2016
Labeler - Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. (828831441)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company LLC 618054084 ANALYSIS(0008-0423), API MANUFACTURE(0008-0423), LABEL(0008-0423), MANUFACTURE(0008-0423), PACK(0008-0423)
Revised: 09/2017   Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
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