EUTHANASIA SOLUTION CIII

Manufacturer
Vedco, Inc.
Effective date
2019-10-18
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:02:43

Label at a glance#

ProductEuthanasia
Active ingredientpentobarbital sodium, phenytoin sodium
Label structure11 sections

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 inject...

Label contents#

Full prescribing information#

GENERAL PRECAUTIONS SECTION

PRODUCT INFORMATION

FOR DOGS ONLY

CAUTION  Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

DESCRIPTION SECTION

A non-sterile solution containing pentobarbital sodium and phenytoin sodium as the active ingredients. Rhodamine B, a bluishred
fluorescent 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

MECHANISM OF ACTION SECTION

EUTHANASIA SOLUTION (pentobarbital sodium and phenytoin sodium) contains two active ingredients which are chemically compatible
but 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

PHARMACODYNAMICS SECTION

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

INDICATIONS & USAGE SECTION

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

WARNING

WARNINGS SECTION

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

ENVIRONMENTAL WARNING SECTION

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

USER SAFETY WARNINGS SECTION

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

PRECAUTIONS SECTION

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, an
unconscious 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 & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

EUTHANASIA SOLUTION is available in 100 mL multiple dose vials.

STORAGE

STORAGE AND HANDLING SECTION

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.

SPL UNCLASSIFIED SECTION

Manufactured for VEDCO, INC., St. Joseph, MO 64507
For Technical Service, contact (800) 338-3659.

09/17

PRINCIPAL DISPLAY PANEL - 100 mL Vial Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-Sterile Solution Multiple Dose Vial

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

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 reach of children. If eye contact, flush with water and seek medical advice/attention.
Store at controlled room temperature 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86° F).

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DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
pentobarbital sodiumACTIVE INGREDIENTNJJ0475N0S3
phenytoin sodiumACTIVE INGREDIENT4182431BJH3
PentobarbitalACTIVE MOIETYI4744080IR3
PhenytoinACTIVE MOIETY6158TKW0C53

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50989-30250989-302-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
pentobarbital sodiumNJJ0475N0SACTIB
phenytoin sodium4182431BJHACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentobarbital SodiumPENTOBARBITAL SODIUMHikma Pharmaceuticals USA Inc.d375b92a-baa1-4d63-9ad1-1467dcfde7d52024-03-08Warnings, Adverse reactionsName fallback
generic name: PENTOBARBITAL SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.