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24-Hour Once-Daily* Surgical Pain Control

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24-Hour Once-Daily* Surgical Pain Control ONLY BUPRENORPHINE FDA APPROVED FOR CATS Once-daily* 24-hour surgical pain control *Administered subcutaneously for up to 3 days. IMPORTANT SAFETY INFORMATION: Due to serious human safety and abuse concerns, including physical or psychological dependence, life-threatening respiratory depression and additive CNS depressant effects, read the full prescribing information before using this drug, including the complete Boxed Warning. Not for use in humans. Hospital staff should be trained in the handling of potent opioids and should avoid accidental exposure. SIMBADOL has not been evaluated in breeding, pregnant, or lactating cats, in cats younger than 4 months of age or moribund cats. Do not use in cats with known hypersensitivity to buprenorphine hydrochloride or any of the components of SIMBADOL, or known intolerance to opioids. Use with caution in cats with impaired hepatic function. Adverse reactions may include hyperthermia, tachycardia, hypotension, hypertension, hypothermia, anorexia, and hyperactivity. For more safety information, refer to the full Prescribing Information, attached. Do you have an opioid that works through the night? • Opioids are the cornerstone of effective pain ONLY BUPRENORPHINE treatment in veterinary medicine1 FDA • According to a recent survey of 255 general APPROVED practice veterinarians, 100 percent state that the FOR CATS duration of pain experienced by cats after spays, neuters or dental extractions lasts at least 24 hours.2 SIMBADOL™ (buprenorphine injection) is a novel combination of dose and concentration. SIMBADOL provides once-daily, 24-hour surgical pain control. Efficacy Demonstrated efficacy in 2 large clinical studies in cats n = 198 • Treatment success defined as a cat not requiring rescue cats assessed analgesia during the 72-hour observation period3 • SIMBADOL administered subcutaneously once daily on days 1 (60 minutes before surgery), 2, and 33 Treatment success in Treatment success in feline soft tissue surgery 3 ,4 feline orthopedic surgery 3,5,† 100 (P = 0.005) 100 (P = 0.002) 90 90 80 % 80 (%) 71 (%) 70 70 61% 60 60 % Success 50 44 Success 50 % 40 40 32 30 30 n=33 Treatment 20 Treatment 20 10 10 SIMBADOL Placebo SIMBADOL Placebo (n = 93) (n = 102) (n = 105) (n = 102) †Orthopedic surgical procedures included onychectomy, onychectomy and castration, or onychectomy and ovariohysterectomy.3,5 In 2 randomized, double-blind, placebo-controlled, parallel group studies, in a total of 450 cats at 19 sites in the US, subjects received either a subcutaneous injection of 0.24 mg/kg of SIMBADOL or physiologic saline approximately 60 minutes prior to surgery, at the same time as preanesthetic medication. Subsequent once-daily doses were given at 24 hours and 48 hours after the initial treatment. Treatment success was defined as a cat that made it through an entire 72-hour period without rescue analgesia.4,5 Well tolerated Safety profile established 2 Large Clinical Studies: The majority of adverse events were mild in severity and similar to the placebo group in frequency4,5 Target Animal Safety Study:‡ Well tolerated at up to 5X the labeled dose for up to 9 days6 Surgical Blood Pressure Study:§ There were no differences in mean blood pressure between groups3 ‡In a 9-day target animal safety study, 4-month-old healthy cats (4/sex/ group; n=32) were administered SIMBADOLTM (buprenorphine injection) subcutaneously at 0X (saline), 1X (0.24 mg/kg), 3X (0.72 mg/kg), or 5X (1.2 mg/kg) once daily.3 §Arterial blood pressure was assessed in a study of 16 healthy 8.5 to 29.1 month-old cats (4/sex/group) who were subcutaneously administered SIMBADOL at 0.24 mg/kg (1X) or meloxicam (control), 1 hour prior to anesthetic induction for a 1-hour exploratory laparotomy. Arterial blood pressure was monitored following anesthetic induction and through laparotomy, with indirect blood pressure monitoring prior to anesthesia and for 8 hours following anesthetic recovery.3 Convenience Once-daily subcutaneous dosing,* 24-hour convenience *Once-daily for up to 3 days. 24-hour convenience Cat-friendly • 24-hour surgical pain control, day and night Practice-friendly • Multidose 10 mL vial for use up to 28 days after first puncture3 Give SIMBADOL today for 24-hour surgical pain control– even through the night The first and only buprenorphine FDA approved for cats Demonstrated safety and efficacy in more than 200 cats treated with SIMBADOL3 Up to 3 once-daily subcutaneous doses 3 for a total of 72 hours of pain control Convenient 10 mL multidose vial Dosing: 0.24 mg/kg Concentration: 1.8 mg/mL See attached Package Insert for full prescribing information, First dose is given including the complete Boxed Warning for human safety. approximately 1 hour before surgery References: 1. Grimm K, Tranquilli W, Lamont L, eds. Essentials of Small Animal Anesthesia and Analgesia; 2nd ed. Hoboken, NJ: Wiley-Blackwell, 2011:99. 2. Data from Fall 2015 Pain, Anesthesia and Sedation study of 255 companion animal veterinarians conducted by Encuity Research. 3. SIMBADOL [package insert]. Kalamazoo, MI: Zoetis Inc.; August 2015. 4. Data on file. Clinical Efficacy (Soft Tissue), 08-30-MC-D-CT-BP. Zoetis Inc. 5. Data on file. Clinical Efficacy (Orthopedic), 08-31-MC-D-CT-BP. Zoetis Inc. 6. Data on file. SIMBADOL Target Animal Safety Study, 09-06-WR-D-TS-BP. Zoetis Inc. All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted. © 2016 Zoetis Services LLC. All rights reserved. SIM-00001R For Use in Cats Only Abuse: Abuse of SIMBADOL poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances including other opioids and benzodiazepines. Buprenorphine has been diverted for non-medical use into illicit channels of distribution. All people handling opioids require careful monitoring for signs of abuse. Drug abuse is the intentional non-therapeutic use of 1.8 mg/mL a prescription drug for its rewarding psychological or physiological effects. Abuse of opioids can occur in the absence of true addiction. 1.8 mg/mL Storage and Discard: For subcutaneous use in cats SIMBADOL is a Class III opioid. Store in a locked, substantially constructed cabinet according to Opioid Analgesic DEA and local controlled substance guidelines. Discard broached vials after 28 days. Any unused or expired vials must be destroyed by a DEA registered reverse distributor; for further information, CAUTION: contact your local DEA field office or call Zoetis Inc. at 1-888-963-8471. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Information for physician: HUMAN SAFETY WARNING SIMBADOL injectable solution is a mu opioid partial agonist (1.8 mg buprenorphine/mL). In the case of an emergency, provide the physician with the package insert. Naloxone may not be effective Abuse Potential in reversing respiratory depression produced by buprenorphine. The onset of naloxone effect may SIMBADOL contains buprenorphine (1.8 mg/mL), an opioid agonist and Schedule III controlled be delayed by 30 minutes or more. Doxapram hydrochloride has also been used as a respiratory substance with an abuse potential similar to other Schedule III opioids. Buprenorphine has stimulant. certain opioid properties that in humans may lead to dependence of the morphine type. Abuse of buprenorphine may lead to physical dependence or psychological dependence. PRECAUTIONS: The risk of abuse by humans should be considered when storing, administering, and disposing Hyperactivity (opioid excitation) has been observed up to 8 hours after anesthetic recovery (see of SIMBADOL. Persons at increased risk for opioid abuse include those with a personal or ADVERSE REACTIONS). family history of substance abuse (including drug or alcohol abuse or addiction) or mental Safety has not been evaluated in moribund cats (i.e., those not expected to live more than 24 hours illness (suicidal depression). with or without surgery). Use in such cases should be based on the risk-benefit assessment of the Life-Threatening Respiratory Depression veterinarian. Respiratory depression, including fatal cases, may occur with abuse of SIMBADOL. Use with caution in cats with impaired hepatic function. The use of SIMBADOL has not been evaluated in breeding, pregnant, or lactating cats, or in cats Additive CNS Depressant Effects younger than 4 months of age. SIMBADOL has additive CNS depressant effects when used with alcohol, other opioids, or illicit drugs that cause central nervous system depression. ADVERSE REACTIONS: In two controlled field studies, a total of 450 male and female cats 4 months to 16 years old, weighing Accidental Exposure between 2.6 – 20.0 lb were included in the field safety analysis. In one study, cats underwent a Because of the potential for adverse reactions associated with accidental injection, SIMBADOL soft tissue surgical procedure (soft tissue). In the other study, cats underwent onychectomy, should only be administered by veterinarians or veterinary technicians who are trained in the onychectomy and castration, or onychectomy and ovariohysterectomy (orthopedic). The following handling of potent opioids. tables (one table for each study) show the number of cats exhibiting each observation. See Human Safety for detailed information. Adverse Reactions in the Soft Tissue Field Study DESCRIPTION: SIMBADOL (N = 109) Control (N = 112) SIMBADOL is a clear, colorless to slightly yellow, sterile, injectable solution intended for subcutaneous During During administration for use in cats. Each milliliter of SIMBADOL contains 1.8 mg buprenorphine (equivalent Adverse Reactiona Surgeryb After Surgery Surgeryb After Surgery to 1.94 mg buprenorphine hydrochloride), 50 mg anhydrous dextrose, 1.8 mg methylparaben, Hypotensionc 39 (35.8%) 29 (26.6%) 33 (29.5%) 24 (21.4%) 0.2 mg propylparaben, 0.2 mg sodium acetate trihydrate, 0.5 mg glacial acetic acid, 100.0 mg Tachycardiad 26 (23.9%) 29 (26.6%) 15 (13.4%) 20 (17.9%) anhydrous ethanol, water for injection, and hydrochloric acid and/or sodium hydroxide to adjust pH.
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