NORTH AMERICAN CORAL SNAKE ANTIVENIN (EQUINE) (coral snake (micrurus fulvius) immune globulin antivenin- equine injection, powde

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (UNII: Y605XBM2GL) (CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) - UNII:Y605XBM2GL)

Available from:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

CORAL SNAKE IMMUNE GLOBULIN ANTIVENIN IMMUNE GLOBULIN ANTIVENIN - UNII:Y605XBM2GL)

Composition:

CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 250 [arb'U] in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties). Risk Summary There are no available human data that establish developmental toxicity related to the use of North American Coral Snake Antivenin (Equine). There are no available animal data informing the North American Coral Snake Antivenin (Equine)-associated risk. North American Coral Snake Antivenin (Equine) should be given to a pregnant woman only if clearly required. In the US general population, the background risk of major birth defects is 2–4% and of miscarriage is 15–20% in clinically recognized pregnancies. Risk Summary Lactation studies have not been conducted with North American Coral Snake Antivenin (Equine). It is not known whether North American Coral Snake Antivenin (Equine) is excreted in human milk. North American Coral Snake Antivenin (Equine) should be administered to lactating women only if

Product summary:

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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NORTH AMERICAN CORAL SNAKE ANTIVENIN (EQUINE)- CORAL SNAKE (MICRURUS
FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) INJECTION, POWDER, FOR
SOLUTION
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORTH AMERICAN CORAL
SNAKE ANTIVENIN (EQUINE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR NORTH
AMERICAN CORAL SNAKE ANTIVENIN (EQUINE).
NORTH AMERICAN CORAL SNAKE ANTIVENIN (EQUINE)
LYOPHILIZED POWDER FOR SOLUTION FOR INTRAVENOUS INJECTION
INITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
North American Coral Snake Antivenin (Equine) is a horse-derived
antivenin indicated for the treatment of
envenomation caused by North American coral snakes_ - Micrurus_. (1)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
•
•
•
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DOSAGE FORMS AND STRENGTHS
Lyophilized powder in single use vial for reconstitution for
injection. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
Patients sensitive to North American Coral Snake Antivenin (Equine) or
horse serum may develop
anaphylaxis. Prior to intravenous North American Coral Snake Antivenin
(Equine) administration consider
performing a proper skin test and modify therapy if indicated. (5.1)
ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER, INC. AT
1-800-438-1985 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
In adults and adolescents, the dose may vary from 3 to 5 vials,
depending on the response to
treatment. (2.1)
In small children, the dose may be decreased, depending on the
response to treatment. (2.1)
Contents of each reconstituted vial can neutralize approximately 250
mouse (Lethal Dose) LD or
approximately 2 mg of _M. fulvius _venom. (2.1)
50
Infuse the first 1 or 2 mL over a 3- to 5-minute period, observing for
allergic reaction. If tolerated,
administer