Product Insert

INDICATIONS AND USAGE:

Indicated for the management of patients with minimal to severe North American Crotalidae envenomation. The term Crotalidae is used to describe the Crotalinae subfamily of venomous snakes which includes rattlesnakes, copperheads and cottonmouths/water moccasins. Early use of VenomVet™ (within 6 hours of snakebite) is advised to prevent clinical deterioration and the occurrence of systemic cytotoxicity, neurotoxicity, myotoxicity and hemotoxicity.


DESCRIPTION:

VenomVet™ is an Equine derived Crotalidae Polyvalent Immune F(ab)2 antivenin. It is a sterile, nonpyrogenic, purified preparation of polyvalent equine immunoglobulin obtained from the blood of healthy horses immunized with three of the following snake venoms: Bothrops alternatus or Bothrops dirorus (previous name: Bothrops neuwiedi) (fer-de-lance), Lachesis muta (lancehead), Crotalus durissus terrificus or Crotalus simus (previous name: Crotalus durissus durissus) (South American rattlesnake). This product also contains Sodium Chloride and Phenol.

DOSAGE AND ADMINISTRATION:

VenomVet™ is restricted to use by or under the direction of a veterinarian.


It is recommended to mix each vial of antivenin with 100ml – 150mls of a crystalloid fluid and administer IV slowly while taking into consideration the patient’s weight and overall fluid load. Completed infusions can be reached at 30 minutes – 1 hour.


As with other equine derived antivenins, monitor the patient closely over the first 10 minutes for signs of hypersensitivity reactions. If one occurs then stop the infusion and when safe to resume, administer at a slower rate.


The number of 10ml vials used on each patient will vary and will be based upon the severity classification of each case, your clinical judgment, the snakebite severity score and coagulation times.

Discontinuation of treatment depends upon the normalization of the state of the patient and resolution of all symptoms, which indicates neutralized venom activity.


The product must not be injected at the site of the bite or perifocal area.


ADVERSE REACTIONS:

As with any equine derived antivenin, adverse reactions may occur, including life threatening anaphylactic and anaphylactoid reactions. Medical veterinary care must be available during and after the administration of VenomVet™. Anaphylactic (Type 1 Hypersensitivity) and anaphylactoid reactions may be characterized by hypotension, respiratory distress, vomiting, diarrhea, angioedema, urticaria and wheals, pruritis and fever. Delayed hypersensitivity reactions can also occur requiring patient monitoring post-treatment.


CONTRAINDICATIONS / WARNINGS AND PRECAUTIONS:

VenomVet™ should not be administered to patients known to be sensitive to equine derived antivenins/equine serum. Only administer VenomVet™ if the potential benefits outweigh the risks and medical management is immediately available. Severe, immediate allergic reactions (anaphylaxis and anaphylactoid) may be seen.


KEEP OUT OF THE REACH OF CHILDREN.


CONSIDER ADDITIONAL TREATMENT:

Appropriate antibacterial/tetanus prophylaxis is indicated for patients suspected of having puncture wounds.


CLINICAL PHARMACOLOGY / MECHANISM OF ACTION:

VenomVet™ is a F(ab)2 fragment created by a pepsin digestion of purified IgG that works by binding and neutralizing venom toxins, facilitating their redistribution away from target tissues and their elimination from the body.

ADDITIONAL INFORMATION:

Each box contains one 10ml dose.


Keep this medication refrigerated between 36°-46°F (2°-8°C).


Unused antivenin should be autoclaved or incinerated before disposal.


Restricted to use by or under the direction of a veterinarian.


This package is not returnable for credit or exchange.


U.S. Permit No. 444A