CONTRAINDICATIONS:
There are no known contraindications for the use of Legend® (hyaluronate sodium) Solution in horses.
RESIDUE WARNING:
Do not use in horses intended for human consumption.
HUMAN WARNINGS:
Not for use in humans. Keep this and all other drugs out of reach of children.
PRECAUTIONS:
Radiographic evaluation should be carried out in cases of acute lameness to ensure that the joint is free from serious fractures. As with any intra-articular treatment, special precautions must be followed as to injection technique and sterility for prevention of possible swelling or infection. Intra-articular injections should not be made through skin that has been recently fired or blistered, or that has excessive scurf and counterirritant on it.
The safety of Legend Injectable Solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.
ADVERSE REACTIONS:
No local or systemic side effects were observed in the clinical field trials with either intravenous or intra-articular injections.
Post-Approval Experience: While all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval reporting:
Following intravenous use: Occasional depression, lethargy, and fever.
Following intra-articular use: lameness, joint effusion, joint or injection site swelling, and joint pain.
For medical emergencies or to report adverse reactions, call 1-800-422-9874.
ANIMAL SAFETY:
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 dosage of 40 mg. Treatments were given once weekly for nine consecutive weeks (three times the maximum duration). No systemic clinical signs were observed nor were there any adverse effects upon hematology or clinical chemistry parameters. A transient, slight to mild post-injection swelling of the joint capsule occurred in some of the animals treated intra-articularly with Legend Injectable Solution as it did in the saline treated control horses. No gross or histological lesions were observed in the soft tissues or the surface areas of the treated joint.