ANIMALGESICS FOR MICE AND RATS- buprenorphine hydrochloride injection, suspension, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)

Available from:

ANIMALGESIC LABORATORIES, INC.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Abuse Potential Animalgesics for Mice & Rats contains buprenorphine, a high concentration (1.3 mg/mL) opioid agonist and Schedule III controlled substance with an abuse potential similar to other Schedule III opioids. The high concentration of Animalgesics for Mice & Rats may be a particular target for human abuse. Buprenorphine has opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to low or moderate physical dependence or high psychological dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of Animalgesics for Mice & Rats. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (suicidal depression). Because of human safety risks, this drug should be used only with veterinary supervision. Do not dispense Animalgesics for Mice & Rats. Life-Threatening Respiratory Depression The

Product summary:

Animalgesics for Mice & Rats is supplied in a multi-use glass vial containing 3.0 mL or 1.6 mL of injectable drug suspension.

Authorization status:

Legally Marketed Unapproved New Animal Drugs for Minor Species

Summary of Product characteristics

ANIMALGESICS FOR MICE AND RATS- BUPRENORPHINE HYDROCHLORIDE INJECTION,
SUSPENSION,
EXTENDED RELEASE
ANIMALGESIC LABORATORIES, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ANIMALGESICS FOR MICE & RATS
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
NOT APPROVED BY FDA – Legally Marketed as an FDA Indexed Product
under MIF 900-014.
Extra-label Use is Prohibited.
Note – In order to be legally marketed, an animal drug product
intended for a minor species must be
Approved, Conditionally Approved, or Indexed by the FDA. THIS PRODUCT
IS INDEXED.
For subcutaneous use in mice and rats only.
This product is not to be used in animals intended for use as food for
humans or food-producing
animals.
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION,
AND ACCIDENTAL EXPOSURE
ABUSE POTENTIAL
ANIMALGESICS FOR MICE & RATS CONTAINS BUPRENORPHINE, A HIGH
CONCENTRATION (1.3 MG/ML) OPIOID
AGONIST AND SCHEDULE III CONTROLLED SUBSTANCE WITH AN ABUSE POTENTIAL
SIMILAR TO OTHER SCHEDULE
III OPIOIDS. THE HIGH CONCENTRATION OF ANIMALGESICS FOR MICE & RATS
MAY BE A PARTICULAR TARGET
FOR HUMAN ABUSE. BUPRENORPHINE HAS OPIOID PROPERTIES THAT IN HUMANS
MAY LEAD TO DEPENDENCE
OF THE MORPHINE TYPE. ABUSE OF BUPRENORPHINE MAY LEAD TO LOW OR
MODERATE PHYSICAL DEPENDENCE
OR HIGH PSYCHOLOGICAL DEPENDENCE. THE RISK OF ABUSE BY HUMANS SHOULD
BE CONSIDERED WHEN
STORING, ADMINISTERING, AND DISPOSING OF ANIMALGESICS FOR MICE & RATS.
PERSONS AT INCREASED
RISK FOR OPIOID ABUSE INCLUDE THOSE WITH A PERSONAL OR FAMILY HISTORY
OF SUBSTANCE ABUSE
(INCLUDING DRUG OR ALCOHOL ABUSE OR ADDICTION) OR MENTAL ILLNESS
(SUICIDAL DEPRESSION).
BECAUSE OF HUMAN SAFETY RISKS, THIS DRUG SHOULD BE USED ONLY WITH
VETERINARY SUPERVISION. DO
NOT DISPENSE ANIMALGESICS FOR MICE & RATS.
LIFE-THREATENING RESPIRATORY DEPRESSION
THE CONCENTRATION OF BUPRENORPHINE IN