Ethiqa XR is packaged in a 5 mL glass vial containing 3.0 mL of injectable drug suspension.
Ethiqa XR currently has a 12-month expiration date. The expiration date is located on the vial label and carton.
Multi-use vials should be discarded 28-days after broaching. Fidelis does not have data to support beyond 28-days after the vial has been broached. Please discard after 28-days.
No, Ethiqa XR should be stored at room temperature (15° to 25°C or 59° to 77°F). If Ethiqa XR is refrigerated, bring to room temperature before use.
A 0.5 or 1.0 mL syringe fitted with a 20 or 23-gauge needle for injections can be used with aseptic technique to withdraw the dose.
Ethiqa XR is currently available through MWI Animal Health (phone 800.824.3703) (www.mwiah.com), Covetrus (phone 855-724-3461) (www.northamerica.covetrus.com) or Midwest Veterinary Supply (phone 800-MIDWEST) (www.midwestvetsupply.com/products). We are continuing to work with other distributors to expand availability. A purchasing account must be opened by a licensed veterinarian with a valid DEA license number before placing orders.
No, a prescription is not required. Ethiqa XR is NOT compounded or available from any pharmacy. It is available through animal health distributors, and accessible in the same manner your institution sources other controlled pharmaceutical products.
Ethiqa XR is indicated for use in mice and rats. See the Package Insert, including Boxed Warning, for additional details.
Ethiqa XR should only be administered by subcutaneous injection. It is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. See the Package Insert for full injection instructions.
Ethiqa XR is indicated for the control of post-operative procedural pain in mice and rats. In the clinical trials, Ethiqa XR was administered post-procedurally.
In the clinical trials, therapeutic drug concentrations of Ethiqa XR were maintained for 72 hours post-injection in both mice and rats.
Ethiqa XR has been used in clinical trials that evaluated safety, efficacy, tolerability and other measures in both mice and rats. Virtually all of this data has been published in peer-reviewed journals, and is available for review on our website, www.ethiqaxr.com. This data was reviewed by the FDA and used to support the granting of the FDA-Index Drug for use for post-procedural pain in mice and rats.
In Mice and Rats: The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune-compromised mice and rats. As with other opioids, buprenorphine 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. The use of paper or soft bedding for up to 3 days following administration of Ethiqa XR should be considered.
Normal mice may exhibit an obtunded response to stimuli up to 4 hours after receiving Ethiqa XR. Weight loss has been observed in mice treated post-procedurally with Ethiqa XR.
Rats may exhibit signs of nausea including pica up to 3 days post-treatment. Rats should be maintained on paper or soft bedding to avoid ingestion of wood chip-type bedding after administration of Ethiqa XR. Please note: Pica involving wood chip-type bedding can be lethal in rats.
Risks related to human exposure: Because of the potential for adverse reactions associated with exposure or accidental injection, Ethiqa XR should only be administered by trained personnel.
Protective clothing is recommended when handling the suspension.
Direct contact of Ethiqa XR to the eyes, mouth, skin, or other mucous membranes could result in the absorption of buprenorphine and the potential for adverse reactions, including respiratory depression which can be fatal in some cases. If contact is made to the eye, oral or other mucous membranes, flush the area with water and contact a physician. If contact with the skin, wash the exposed area with soap and water and contact physician. See Boxed Warning
Please report product defects to Fidelis Pharmaceuticals at 833-384-4729.
Concerns or adverse events can be reported by calling Fidelis Pharmaceuticals at (833) 384-4729.
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.
No drug-drug interaction studies have been performed with Ethiqa XR.
Important Safety Information for Rats and Mice, Not for use in humans
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.
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.