The Horse

FEB 2016

The Horse:Your Guide To Equine Health Care provides monthly equine health care information to horse owners, breeders, veterinarians, barn/farm managers, trainer/riding instructors, and others involved in the hands-on care of the horse.

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LEGEND® (hyaluronate sodium) Injectable Solution PURE LEGEND is the frst FDA-approved IV joint therapy. And it's backed by decades of experience deriving ultra-pure hyaluronic acid (HA) – so you can have confdence when it counts. IMPORTANT SAFETY INFORMATION: The safety of LEGEND has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares. The following adverse reactions have been reported following use of LEGEND Injectable Solution: Following intravenous use: occasional depression, lethargy, and fever. Following intra-articular (LEGEND Injectable Solution — 2 mL only) use: lameness, joint efusion, joint or injection site swelling, and joint pain. Now a Merial Equine brand. Made in the U.S.A. Legend ® Multi Dose (hyaluronate sodium) Injectable Solution, Legend (hyaluronate sodium) Injectable Solution, BRIEF SUMMARY: Prior to use 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. INDICATIONS: Legend ® Injectable Solution and Legend ® Multi Dose Injectable Solution are indicated in the treatment of equine joint dysfunction associated with equine osteoarthritis. CONTRAINDICATIONS: There are no known contraindications for the use of Legend ® Injectable Solution and Legend ® Multi Dose Injectable Solution in horses. RESIDUE WARNINGS: Do not use in horses intended for human consumption. HUMAN WARNINGS: Not for use in humans. Keep out of reach of children. ANIMAL SAFETY WARNING: For Legend Injectable Solution 4 mL and Legend Multi Dose Injectable Solution – Not for Intra-articular use. The Intra-articular safety of hyaluronate sodium with benzyl alcohol has not been evaluated. PRECAUTIONS: Complete lameness evaluation should be conducted by a veterinarian. Sterile procedure during the injection process must be followed. Intra-articular injections should not be made through skin that is infamed, infected or has had a topical product applied. The safety of Legend Injectable Solution and Legend Multi Dose has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares. ADVERSE REACTIONS: No side effects were observed in Legend Injectable Solution clinical feld trials. Side effects reported post-approval: Following intravenous use: Occasional depression, lethargy, and fever. Following intra-articular (Legend Injectable Solution – 2 mL only) use: joint or injection site swelling and joint pain. For medical emergencies or to report adverse reactions, call 1-800-422-9874. ANIMAL SAFETY SUMMARY: Animal safety studies utilizing Legend Multi Dose Injectable Solution were not performed. Legend Multi Dose Injectable Solution was approved based on the conclusion that the safety of Legend Multi Dose Injectable Solution will not differ from that demonstrated for the original formulation of Legend Injectable Solution. Legend Injectable Solution was administered to normal horses at one, three and fve times the recommended intra-articular dosage of 20 mg and the intravenous dose of 40 mg. Treatments were given weekly for nine consecutive weeks. No adverse clinical or clinical pathologic signs were observed. Injection site swelling of the joint capsule was similar to that seen in the saline treated control horses. No gross or histological lesions were observed in areas of the treated joint. For customer care or to obtain product information, including a Material Safety Data Sheet, call 1-888-637-4251 Option 2. ®LEGEND is a registered trademark of Merial. ©2015 Merial, Inc., Duluth, GA. All rights reserved. EQUIOLG1512-B (03/15)

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