Legend Multi 20mL, For Intravenous use only
The intra-articular safety of Legend Multi dose with benzyl alcohol has not been determined.
Legend Injectable Solution is supplied in 2 mL 20 mg and 4 mL 40 mg vials. Each mL contains 10 mg hyaluronate sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic, and 0.04 mg sodium phosphate monobasic. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid.
Legend Multi Dose Injectable Solution is supplied in 20 mL vials. Each mL contains 10 mg hyaluronate sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic, 0.04 mg sodium phosphate monobasic and 15.63 mg benzyl alcohol as a preservative. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid.
DOSAGE AND ADMINISTRATION:
Legend Multi Dose 20 mL and Legend 4 mL 40 mg injected intravenously only. Legend 2 mL 20 mg injected intravenously or intra-articularly in the carpus or fetlock.
Treatment may be repeated at weekly intervals for a total of three treatments.
Legend Injectable Solution 2 mL: Strict aseptic technique should be observed when administering by intra-articular injection. As with any intra-articular procedure, proper injection site disinfection and animal restraint are important. Excess joint fluid should be aseptically removed prior to injection. Care should be taken to avoid scratching the cartilage surface with the tip of the injection needle. Diffuse swelling lasting 24 to 48 hours may result from movement of the needle while in the joint space.
For intravenous administration, use aseptic technique and inject slowly into the jugular vein.
Horses should be given stall rest after treatment before gradually resuming normal activity.
Legend Injectable Solution 2 mL and 4 mL only: Discard any unused portion of the drug and the empty vial after opening.
There are no known contraindications for the use of Legend® hyaluronate sodium Solution and Legend® Multi Dose hyaluronate sodium Injectable Solution in horses.
Do not use in horses intended for human consumption.
Not for use in humans. Keep this and all other drugs out of reach of children.
ANIMAL SAFETY WARNING:
For 4 mL only - Not for Intra-articular use.
Multi Dose not for Intra-articular use. The Intra-articular safety of hyaluronate sodium with benzyl alcohol has not been evaluated.
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 Legend Injectable Solution - 2 mL only 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 and Legend Multi Dose Injectable Solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.
No local or systemic side effects were observed in the Legend Injectable Solution 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 for Legend Injectable Solution:
Following intravenous use: Occasional depression, lethargy, and fever.
Following intra-articular Legend Injectable Solution - 2 mL only 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.
Effectiveness studies utilizing Legend Multi Dose Injectable Solution were not performed. Legend Multi Dose Injectable Solution was approved based on the conclusion that the effectiveness of Legend Multi Dose Injectable Solution will not differ from that demonstrated for the original formulation of Legend Injectable Solution.
Forty-six horses with lameness in either the carpal or fetlock joints were treated intravenously or intra-articularly with Legend Injectable Solution in a well-controlled clinical study conducted at four locations. One, two or three injections were given based on clinical improvement. Overall clinical improvement was judged as excellent or good in 90% of the cases treated intravenously and 96% of those treated intra-articularly with Legend Injectable Solution.
We reference Bayer as the manufacturer and source for our information on Legend. For more information please click this website link: http://www.bayerdvm.com/Products/legend/legend.cfm