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CAUTION
Federal Law restricts this drug to use by or on the order of a licensed veterinarian.
LEGEND® Multi (hyaluronate sodium) Dose
For Intravenous Use in Horses Only Not for Intra-Articular Use and
(hyaluronate sodium) LEGEND®
Injectable Solution 4 mL For Intravenous Use In Horses Only
2 mL For Intravenous or Intra-Articular Use In Horses Only
BRIEF SUMMARY
Prior to use please consult the product insert, a summary of which follows:
Injectable Solution and LEGEND® Multi Dose Injectable Solution are indicated in the treatment of equine joint dysfunction associated with equine osteoarthritis.
INDICATIONS LEGEND®
CONTRAINDICATIONS
There are no known contraindications for the use of LEGEND® LEGEND® 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.
ADVERSE REACTIONS
No side effects were observed in LEGEND Injectable Solution clinical field 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.
Injectable Solution and Multi Dose Injectable Solution in
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 inflamed, 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.
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 five 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, and ™ the Horse Logo is a trademark, of Merial. ©2016 Merial, Inc., Duluth, GA. All rights reserved.
© 2015 EVJ Ltd
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