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Legend (hyaluronate) Multi Dose Injectable 10mg/ml, Vial(20ml)
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Product ID: *V**LEGEND20
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Product Summary
  • VETERINARY PRESCRIPTION REQUIRED
  • This drug is not approved for human use.

LEGEND® / LEGEND® MULTI DOSE

(hyaluronate sodium) Injectable Solution

For Intravenous Use in Horses Only. Not for Intra-Articular Use


CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.


DESCRIPTION:

Legend® (hyaluronate sodium) Injectable Solution and Legend® Multi Dose (hyaluronate sodium) Injectable Solution is a clear, colorless solution of low viscosity. Legend Injectable Solution is pyrogen free, sterile and does not contain a preservative. Legend Injectable Solution 2 mL is administered by intravenous or intra-articular injection. Legend 4 mL is for intravenous use only. Legend Multi Dose Injectable Solution is pyrogen free and sterile. It is administered by intravenous injection only.

Hyaluronic acid, the conjugate acid of hyaluronate sodium, is extracted from the capsule of Streptococcus spp. and purified, resulting in a form which is essentially free of protein and nucleic acids.

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.


INDICATIONS:

Legend® (hyaluronate sodium) Injectable Solution and Legend® Multi Dose (hyaluronate sodium) Injectable Solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.


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.


CONTRAINDICATIONS:

There are no known contraindications for the use of Legend® (hyaluronate sodium) Solution and Legend® Multi Dose (hyaluronate sodium) Injectable Solution in horses.


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.


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 (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.


ANIMAL SAFETY:

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 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- 2mL 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.


STORAGE:

Do not store above 40° C (104° F).

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