ORDERING

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Nationwide Distribution

Ethiqa XR® (buprenorphine extended-release injectable suspension) 1.3 mg/mL CIII is available through national distributors and is simple to order.  Please contact your distributor to determine whether a prescription is necessary for your application.

To place an order, kindly contact one of the following distributors: MWI Animal Health, Covetrus, Hanna Pharmaceutical Supply, Patterson Veterinary, or Midwest Veterinary Supply.

If you have any questions or need assistance ordering product, please contact us at info@fidelisah.com

800-824-3703
Product Number 86084-100-30
855-724-3461
Product Number 072117

800-MIDWEST
Product Number 267.10000.3

302-571-8761
Product Number 86084-0100-30

800-225-7911
Product Number 07-894-7617

As a controlled CIII drug substance, Ethiqa XR should be handled carefully to minimize the risk of 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 is indicated for the control of post-procedural pain in mice, rats, ferrets, and non-human primates.

Ethiqa XR® Dosing and Specifications

Packaging

5 mL multi-dose glass vial containing  3.0 mL of injectable suspension

Buprenorphine concentration
1.3 mg/mL
Dosing—Mice

Single subcutaneous injection of 3.25 mg/kg body weight

Dosing—Rats

Single subcutaneous injection of 0.65 mg/kg body weight

Dosing—Ferrets

Single subcutaneous injection of 0.6 mg/kg body weight

Dosing—Non-Human Primates

Single subcutaneous injection of 0.2 mg/kg body weight

Dose Repetition
If needed, a single repeat dose may be administered after the initial dose
Syringe/Needle Size
Use a 0.5- or 1.0-mL syringe fitted with a 20- to 23-gauge needle for injections
Stability

Approved for 36-month shelf life

Storage

Store vial at 15° to 25°C +/- 2°C (59° to 77°F ) or refrigerated. Do not freeze. Store in a locked, substantially constructed cabinet according to DEA and local controlled substance guidelines. Product could change physical properties if not stored within the specified storage conditions and original vial container.

Shelf life after broaching

90 Days

Administration

 

Ethiqa XR should only be handled and administered by a veterinarian, veterinary technician or laboratory staff trained in the handling of potent opioids. To prevent human adverse reactions or abuse, at least 2 trained administrators should be present during injection of Ethiqa XR.

LP.EthiqaXR.017.04.24

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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 Rats, Mice, Ferrets, 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.060.04.24