Animal NDC 50989-302-12 Euthanasia

Pentobarbital Sodium And Phenytoin Sodium

Animal NDC Product Code 50989-302-12

Field Name Field Value
Animal NDC Code 50989-302-12
Proprietary Name Euthanasia What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pentobarbital Sodium And Phenytoin Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Vedco, Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Phenytoin Sodium
  • Pentobarbital Sodium
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200071 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Euthanasia Animal Product Label Images

Euthanasia Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

General Precautions

PRODUCT INFORMATIONFOR DOGS ONLYCAUTION  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

A non-sterile solution containing pentobarbital sodium and phenytoin sodium as the active ingredients. Rhodamine B, a bluishredfluorescent dye, is included in the formulation to help distinguish it from parenteral drugs intended for therapeutic use. Although the solution is not sterile, benzyl alcohol, a bacteriostat, is included to retard the growth of microorganisms.Each mL contains: Active ingredients: 390 mg pentobarbital sodium (barbituric acid derivative), 50 mg phenytoin sodium; Inactive ingredients: 10% ethyl alcohol, 18% propylene glycol, 0.003688 mg rhodamine B, 2% benzyl alcohol (preservative), water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

Actions

EUTHANASIA SOLUTION (pentobarbital sodium and phenytoin sodium) contains two active ingredients which are chemically compatiblebut pharmacologically different. Each ingredient acts in such a manner so as to cause humane, painless, and rapid euthanasia. Euthanasia is due to cerebral death in conjunction with respiratory arrest and circulatory collapse. Cerebral death occurs prior to cessation of cardiac activity.When administered intravenously, pentobarbital sodium produces rapid anesthetic action. There is a smooth and rapid onset of unconsciousness. At the lethal dose, there is depression of vital medullary respiratory and vasomotor centers.When administered intravenously, phenytoin sodium produces toxic signs of cardiovascular collapse and/or central nervous system depression.Hypotension occurs when the drug is administered rapidly.

Pharmacodynamic Activity

The sequence of events leading to humane, painless, and rapid euthanasia following intravenous injection of EUTHANASIA SOLUTION is similar to that following intravenous injection of pentobarbital sodium, or other barbituric acid derivatives. Within seconds, unconsciousness is induced with simultaneous collapse of the dog. This stage rapidly progresses to deep anesthesia with concomitant reduction in the blood pressure. A few seconds later, breathing stops, due to depression of the medullary respiratory center; encephalographic activity becomes isoelectric, indicating cerebral death; and then cardiac activity ceases.Phenytoin sodium exerts its effect during the deep anesthesia stage caused by the pentobarbital sodium. This ingredient, due to its cardiotoxic properties, hastens the stoppage of electrical activity in the heart.

Indications

For use in dogs for humane, painless, and rapid euthanasia.

Warning

For canine euthanasia only. Must not be used for therapeutic purposes. Do not use in animals intended for food.

Environmental Warning

ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with state and local laws, to prevent consumption of carcass material by scavenging wildlife.

Human Warning

Caution should be exercised to avoid contact of the drug with open wounds or accidental self-inflicted injections. Keep out of each of children. If eye contact, flush with water and seek medical advice/attention.

Precautions

Euthanasia may sometimes be delayed in dogs with severe cardiac or circulatory deficiencies. This may be explained by the impaired movement of the drug to its site of action. An occasional dog may elicit reflex responses manifested by motor movement; however, anunconscious animal does not experience pain, because the cerebral cortex is not functioning. When restraint may cause the dog pain, injury, or anxiety, or danger to the person making the injection, prior use of tranquilizing or immobilizing drugs may be necessary.

Dosage And Administration

Dosage: Dogs, 1 mL for each 10 pounds of body weight.Administration: Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog, or in a comatose dog with impaired vascular functions. Good injection skill is necessary for intracardiac injection. The calculated dose should be given in a single bolus injection. For intravenous injection, a needle of sufficient gauge to ensure intravenous placement of the entire dose should be used.The use of a Luer-Lok® syringe is recommended to prevent accidental exposure due to needle/syringe separation.

How Supplied

EUTHANASIA SOLUTION is available in 100 mL multiple dose vials.

Storage

Store at controlled room temperature of between 20˚ and 25˚C (68˚and 77˚F), with excursions permitted between 15° to 30°C (59° to 86°F). Manufactured by a nonsterilizing process.

Other

Manufactured for VEDCO, INC., St. Joseph, MO 64507For Technical Service, contact (800) 338-3659.09/17

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.