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Fidelis Animal Health Company Headquarters
Address
Fidelis Animal Health
675 Highway One, Suite B113
North Brunswick, New Jersey 08902
Phone
Toll-free: 833-ETHIQAXR (833-384-4729)
Email
info@fidelisah.com
To report suspected adverse drug experiences, contact Fidelis at 833-384-4729. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-800-FDA-VETS or www.fda.gov/reportanimalae
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Boxed Warning
WARNING: ABUSE POTENTIAL and LIFE-THREATENING RESPIRATORY DEPRESSION and ACCIDENTAL EXPOSURE
Abuse Potential
Ethiqa XR 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 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 Ethiqa XR. 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 Ethiqa XR.
Life-Threatening Respiratory Depression
The concentration of buprenorphine in Ethiqa XR is 1.3 mg/mL. Respiratory depression, including fatal cases, may occur with abuse of Ethiqa XR. Ethiqa XR has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. Because of the potential for adverse reactions associated with accidental injection, Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids.
Important Safety Information
For Rats and Mice:
Only administer Ethiqa XR by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use on mice or rats with pre-existing respiratory deficiencies. Do not keep rats on wood chip-type bedding after administration of Ethiqa XR. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression.
For Humans:
Ethiqa XR should only be administered by a veterinarian or laboratory staff trained in the handling of potent opioids. Protective clothing is recommended to avoid direct contact with human skin or mucus membranes which could result in absorption of buprenorphine and adverse reactions. Not for use in humans.
For more information, consult the prescribing information including the boxed warning.