SOMNASOL- euthanasia solution injection, solution

SomnaSol by

Drug Labeling and Warnings

SomnaSol by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, Med-Pharmex, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

ANADA 200-280

FOR DOGS ONLY
CAUTION:  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 bluish-red 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), purified water q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

PHARMACODYNAMICS

ACTIONS:
EUTHANASIA-III SOLUTION 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:
The sequence of events leading to humane, painless, and rapid euthanasia following intravenous injection of EUTHANASIA-III solution is similar to that following intravenous injection of pentobarbital sodium or other barbituric 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 & USAGE

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

WARNINGS

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 wild life. 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 eyes with water and seek medical attention.

PRECAUTIONS

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, 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 & ADMINISTRATION

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 to needle/syringe separation.

HOW SUPPLIED

HOW SUPPLIED:  EUTHANASIA-III SOLUTION is available in 100 mL multiple-dose vials.

Manufactured by a non-sterilizing process.

STORAGE AND HANDLING

STORAGE:  Store between 15° and 30°C (59°F and 86°F).

Med-Pharmex, Inc.
Pomona, CA 91767
October 2004.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOMNASOL 
euthanasia solution injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-4829
Route of Administration	INTRAVENOUS, INTRACARDIAC	DEA Schedule	CIII

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PENTOBARBITAL SODIUM (UNII: NJJ0475N0S) (PENTOBARBITAL - UNII:I4744080IR)	PENTOBARBITAL SODIUM	390 mg  in 1 mL
PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)	PHENYTOIN SODIUM	50 mg  in 1 mL

Product Characteristics
Color	red (bluish-red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-4829-1	100 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200280	02/03/2005

Labeler - Henry Schein Animal Health (017880659)

Registrant - Med-Pharmex, Inc (025353699)

Establishment
Name	Address	ID/FEI	Business Operations
Med-Pharmex, Inc		025353699	manufacture