Companion Animal Product & Promotions Guide

CLEVOR® (ropinirole ophthalmic solution) 30 mg/mL For ophthalmic use in dogs only Single use dropper BRIEF SUMMARY: Before using CLEVOR® (ropinirole ophthalmic solution), please consult the product insert, a summary of which follows: CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. INDICATION: For induction of vomiting in dogs. DOSAGE AND ADMINISTRATION: This product should be administered by veterinary personnel. Dosing Instructions: Administer the appropriate number of eye drops topically according to Table 1. The number of eye drops administered corresponding to body weight results in a target dose of 3.75 mg/m 2 (dose band 2.7 - 5.4 mg/m 2 ). If the dog does not vomit within 20 minutes of the first dose, then a second dose may be administered. Table 1. Dose Administration Body weight in kilograms Body weight in pounds Total number of eye drops Example admini-stration 1.8 - 5 4 - 11.1 1 1 drop into either left or right eye 5.1 - 10 11.2 - 22.1 2 1 drop each eye 10.1 - 20 22.2 - 44.1 3 2 drops in one eye and 1 drop in the other eye 20.1 - 35 44.2 - 77.2 4 2 drops in each eye 35.1 - 60 77.3 - 132.3 6 An initial dose of 2 drops in each eye, followed 2 minutes later by 1 drop in each eye 60.1 - 100 132.4 - 220.5 8 An initial dose of 2 drops in each eye, followed 2 minutes later by 2 drops in each eye Dose Administration: • Wear gloves and protective eye wear when handling or administering this product to prevent accidental exposure. • Open the dropper by twisting off the tail. • Keep the dog's head steady in a slightly upright position. • Hold the dropper in an upright position without touching the eye. • Rest your finger on the forehead of your dog to maintain the distance between the dropper and the eye. • Squeeze the prescribed number of drops in to the eye(s). • CLEVOR is a single use dropper and is light sensitive. • After administration, with gloves on, return the dropper to the aluminum pouch and place in the carton. • If the dog does not vomit, a second dose can be given 20 minutes after administration of the first dose. • This second dose is the same number of drops as the first dose. • Thirty minutes after opening, with gloves on, dispose of dropper, aluminum pouch, and carton. Refer to the Animal Safety Warnings section for treatment of protracted vomiting. CONTRAINDICATIONS: Do not use in dogs with central nervous system depression or seizures. Do not use in cases of ingestion of sharp foreign objects, corrosive agents (acids or alkalis), volatile substances or organic solvents. Do not use in cases with corneal ulceration, ocular irritation, or ocular injury. Do not use when there is a known sensitivity to ropinirole or the inactive ingredients. WARNINGS: Human Safety Warnings: Not for use in humans. Keep out of reach of children. Wear gloves and protective eye wear when handling or administering this product to prevent accidental exposure. In case of accidental eye, oral or skin exposure, flush with water. If wearing contact lenses, eyes should be rinsed first, then remove contact lenses and continue rinsing. Remove contaminated clothing. Ropinirole is a dopamine agonist. Seek medical attention if accidental exposure occurs and show the package insert or label to the physician. Exposure to this drug may cause adverse reactions such as headache, nausea, vomiting, dizziness, orthostatic hypotension, and sleepiness. Avoid contact with the product if pregnant, planning to become pregnant, or breast- feeding, as exposure has been shown to have adverse effects on embryo-fetal development based on rodent studies. Animal Safety Warnings: This product should be administered by veterinary personnel. Dogs should be monitored for CLEVOR-associated clinical signs, including protracted vomiting, salivation, muscle tremors, evidence of abdominal discomfort, lethargy, transient tachycardia, transient decrease in blood pressure and signs of ocular irritation, including conjunctival hyperemia, mild blepharospasm, and protrusion of the third eyelid. These clinical signs are related to the pharmacological action of ropinirole. To stop protracted vomiting, administer metoclopramide (dopamine D2 antagonist) at a dose of 0.5 mg/kg intravenously (IV) or subcutaneously (SQ). Metoclopramide also decreases the prevalence of most CLEVOR-associated clinical signs. PRECAUTIONS: The safe use of CLEVOR has not been evaluated in dogs with cardiac disease or cardiovascular compromise. CLEVOR can cause transient tachycardia and transient decreased systolic blood pressure. The safe use of CLEVOR has not been evaluated in dogs with hepatic impairment. CLEVOR is metabolized by the liver. The safe use of CLEVOR has not been evaluated in dogs younger than 4.5 months of age and weight less than 4 pounds. The safe use of CLEVOR has not been evaluated in dogs that are pregnant, lactating, or intended for breeding. ADVERSE REACTIONS: Safety was evaluated during a field study that enrolled 132 dogs (100 in the CLEVOR group and 32 in the vehicle control group). CLEVOR was administered as drops into the eyes at the dose as directed by the dosing table (see DOSAGE AND ADMINISTRATION). The following table shows the number of dogs exhibiting ocular, systemic, and clinical pathology adverse reactions. Table 2: Adverse Reactions Reported During the Study (all dogs) Organ System Adverse Reaction CLEVOR (N=100) Vehicle control (N=32) Ocular Conjunctival hyperemia a 51 (51%) 6 (19%) Protrusion of the third eyelid a 38 (38%) 1 (3%) Conjunctival discharge a 30 (30%) 1 (3%) Blephar- ospasm a 19 (19%) 0 Conjunctival swelling a 3 (3%) 0 Scratching/rubbing of eyes a 4 (4%) 0 Corneal ulceration 1 (1%) 0 Corneal fluorescein uptake without corneal ulceration 1 (1%) 0 Systemic Lethargy 41 (41%) 0 Tachycardia (>160 beats per minute) a,b 14 (14%) 0 Vomiting duration longer than one hour 8 (8%) 0 Salivation 3 (3%) 1 (3%) Trembling 3 (3%) 0 Diarrhea or soft stool 2 (2%) 1 (3%) Anxious 1 (1%) 0 Borborygmi 1 (1%) 0 Clinical Pathology Crystalluria c 13 (20%) 3 (15%) Pyuria c 12 (18%) 3 (15%) Increased liver enzymes d 3 (3%) 0 Decreased blood glucose 2 (2%) 0 Increased prothrombin time 1 (1%) 0 a Assessment performed 30 minutes after dose administration b Tachycardia resolved for most dogs within 4 hours after dose administration c Urinalysis results were reported for only 86 dogs (66 administered CLEVOR and 20 control) d All three dogs had elevated alanine aminotransferase. Additionally, one of the dogs also had an elevated aspartate aminotransferase and another of the dogs also had an elevated alkaline phosphatase and total bilirubin. Note: If any animal experienced the event more than once, only the first occurrence was tabulated. To report suspected adverse events call 1(800) 835-9496, for technical assistance or to obtain a copy of the SDS, contact Vetoquinol USA, Inc. at 1 (800) 267-5707 or www.vetoquinolusa.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae. CLEVOR is a trademark of Orion Corporation Manufactured by: Orion Corporation Distributed by: Vetoquinol USA, Inc. Ft. Worth, TX (USA) 76137 1 (800) 267-5707 www.vetoquinolusa.com Issued 06/2020 Approved by FDA under NADA # 141-534

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