ANTIVENIN® Principal Display Panel (micrurus fulvius) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

NDC 0008-0423-01

North American
Coral Snake
Antivenin
(Equine)
10 mL

Lyophilized Powder for Solution
for Intravenous Injection

Rx only

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

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

North American
Coral Snake
Antivenin
(Equine)
10 mL

Lyophilized Powder for Solution
for Intravenous Injection

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

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

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...

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2 DOSAGE AND ADMINISTRATION

For intravenous use only.

2.1 Dose

Contents of each reconstituted vial can neutralize...

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3 DOSAGE FORMS AND STRENGTHS

Each package contains one single use vial with lyophilized North American Coral Snake Antivenin (Equine) for dilution with 10 mL of diluent (Sterile Water for Injection, USP). Contents of each...

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4 CONTRAINDICATIONS

Do not administer North American Coral Snake Antivenin (Equine) prophylactically to asymptomatic patients.1
Do not administer North American Coral Snake Antivenin (...

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Patients sensitive to North American Coral Snake Antivenin (Equine) or horse serum may develop anaphylaxis....

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6 ADVERSE REACTIONS

The most common adverse reactions observed after treatment with North American Coral Snake Antivenin (Equine) were anaphylaxis and serum sickness, vomiting, and abdominal pain. Because these reactions...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available...

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11 DESCRIPTION

North American Coral Snake Antivenin (Equine) is a sterile lyophilized powder for solution for injection containing serum globulins obtained by fractionating blood from healthy horses that have been immunized...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

North American Coral Snake Antivenin (Equine) specifically binds to and neutralizes coral snake venom.

...

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14 CLINICAL STUDIES

There have been no well-controlled clinical studies of the use of North American Coral Snake Antivenin (Equine) in patients experiencing envenomation by the Eastern Coral Snake, however a retrospective...

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15 REFERENCES

Bowden, C and Krenzelok, E: Clinical applications of commonly used contemporary antidotes, a US perspective. Drug Safety 1997; 16(1):9-47.
Sasaki, J et al: Coral snake bites and envenomation in...

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16 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).

...

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17 PATIENT COUNSELING INFORMATION

Advise patients to contact the physician or emergency department immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness up to 14 days following...

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U.S. Govt. License No. 3

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

...

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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.