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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What is the NDC number for Ethiqa XR?
The NDC number is 86084-100-30.
How long is analgesia shown to last?
In the pharmacokinetic studies, therapeutic drug concentrations of Ethiqa XR were maintained for up to 72 hours post-injection in captive rodents, ferrets, laboratory rabbits, and non-human primates.
Does Ethiqa XR require refrigeration?
Ethiqa XR does not require refrigeration and should be stored at room temperature, specifically between 15° to 25°C +/- 2°C (59°F to 77°F). If Ethiqa XR has been refrigerated, it should be allowed to reach room temperature before use. Do not heat Ethiqa XR. Heating the product or not storing the product in its original container or within the specified storage conditions could cause the product to change its physical properties.
For what species is Ethiqa XR indicated?
Ethiqa XR is indicated for control of post-procedural pain in captive rodents, ferrets, laboratory rabbits, and non-human primates. See the Package Insert, including Boxed Warning, for additional details.
What is the return policy?
Ethiqa XR is a controlled drug substance (CIII) and is generally not returnable; however, the return policy is determined by the distributor. For additional information, please contact your distributor.
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ETH.LP.201.01.D.ALL.AL
Boxed Warning
Abuse Potential
ETHIQA XR contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical 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 drugs or alcohol) or mental illness (e.g., depression).
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ETHIQA XR. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.
Accidental Exposure
Because of the potential for adverse reactions associated with accidental exposure, ETHIQA XR should only be administered by veterinarians, veterinary technicians, or laboratory staff who are trained in the handling of potent opioids. Accidental exposure to ETHIQA XR, especially in children, can result in a fatal overdose of buprenorphine.
Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants
Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
See HUMAN SAFETY WARNINGS for detailed information.
Important Safety Information
For Captive Rodents, Ferrets, Laboratory Rabbits, and Non-Human Primates:
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 in animals with pre-existing respiratory compromise.
Death has been reported when non-steroidal anti-inflammatory drugs (NSAIDs such as meloxicam and carprofen) and Ethiqa XR have been administered concomitantly in mice.
Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Pica involving wood chip type bedding can be lethal.
Ethiqa XR may cause sedation, decreased blood pressure, decreased heart rate, decreased gastrointestinal mobility, and respiratory depression. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. Animals should be monitored for signs of decreased cardiovascular and respiratory function when receiving Ethiqa XR.
The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune-compromised animals.
For Humans:
Not for use in humans. Keep out of reach of children and pets.
Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids, which may lead to overdose and death.
Ethiqa XR should be handled appropriately to minimize the risk of misuse, abuse, addiction, and criminal diversion, including restriction of access, the use of accounting procedures, and proper disposal methods as appropriate to the laboratory setting and as required by law.
Ethiqa XR should only be handled and administered by a veterinarian, veterinarian technician, or laboratory staff trained in the handling of potent opioids. Wear protective clothing when administering Ethiqa XR to avoid direct contact with human skin, eyes, oral, or other mucus membranes which could result in absorption of buprenorphine and adverse reactions.
For more information, consult the Prescribing Information including the Boxed Warning.
SA.EthiqaXR.060.05.2024