HYVISC- hyaluronate sodium injection
Boehringer Ingelheim Animal Health USA Inc.
Hyvisc® (hyaluronate sodium) Injection is a clear, colorless, viscous fluid contained in a 5 mL disposable syringe, as a single 2 mL dose. Chemically, hyaluronic acid is a high molecular weight mucopolysaccharide composed of repeating disaccharide units, each unit consisting of D-glucuronic acid and N-acetyl-D-glucosamine. Each mL of Hyvisc Injection contains 11 mg of hyaluronate sodium and 8.47 mg of sodium chloride, USP, in sterile water for injection, USP, q.s.
Hyaluronate sodium is a natural constituent of connective tissue and synovial fluid in both man and animals. In synovial fluid, hyaluronate sodium confers viscoelastic as well as lubricating properties1,2. In connective tissue, hyaluronate sodium specifically interacts with cartilage proteoglycans to form stable aggregates3,4,5. The mechanism of action by which exogenous hyaluronate sodium exerts its therapeutic effect in arthritic joints is not known at this time.
Hyvisc (hyaluronate sodium) Injection is recommended for the treatment of joint dysfunction in horses due to non-infectious synovitis associated with equine osteoarthritis.
The recommended dose of Hyvisc (hyaluronate sodium) Injection is 2 mL (22 mg) given to horses intra-articularly in small and medium-sized joints (carpal, fetlock). In larger joints (hock), the dosage is 4 mL (44 mg). Treatment may be repeated at weekly intervals for a total of three treatments. As with any intra-articular injection, aseptic technique is used. The following are suggested use directions regardless of the type of joint to be treated.
As with any intra-articular injection, a mild inflammatory response (tenderness, heat and swelling) may be seen in the joint following the Hyvisc Injection. This response is self-limiting, but may last from two to five days after treatment.
If inflammation is excessive or severe, the possibility of infection should be considered and appropriate antibiotic therapy instituted.
There are no known contraindications to the use of Hyvisc (hyaluronate sodium) Injection.
Do not use in horses intended for human consumption. Hyvisc (hyaluronate sodium) Injection must not be administered intravascularly.
Used or partially used syringes should be crushed and disposed of in an appropriate landfill.
Do not use if numerous small air bubbles are present throughout the solution.
In the clinical trial with Hyvisc (hyaluronate sodium) Injection, a mild, transient post-injection inflammatory response in the joint was reported in 12% of the cases treated. There were no other side effects.
To report suspected adverse drug experience or for technical service questions, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS (1-888-332-8387) or www.fda.gov/reportanimalae.
In toxicity studies of Hyvisc (hyaluronate sodium) Injection in horses, intra-articular doses at one, three, and five times the recommended dose once weekly for three consecutive weeks did not result in any drug related local or systemic toxic effects. The mild, transient post-injection inflammatory response observed within the joints of some horses was qualitatively and quantitatively similar to that detected in the physiologic saline injected controls. In a reproductive study in mares, 16 mL of Hyvisc (10 mg/mL) injected intramuscularly or subcutaneously once or twice during the second or third stage of pregnancy resulted in no adverse effects on the mares or newborn foals.
Store under refrigerated conditions, 2° - 8°C (36° - 46°F). Protect from freezing and avoid excessive heat.
Hyvisc (hyaluronate sodium) Injection, 11 mg/mL, is available in 2 mL prefilled, disposable syringes individually packaged.
1. Radin, E.L. et al: Annals of the Rheumatic Diseases, 30: 322-325, (1971).
2. Swann, D.A. et al: Annals of the Rheumatic Diseases, 33: 318-326, (1974).
3. Hardingham, T.E. and H. Muir: Biochemical et Biophysica Acta, 279: 401-405, (1972).
4. Hascall, V.C. and D. Heingard: Journal of Biological Chemistry, 249: 423-433, (1974).
5. Brandt, K.D. et al: Arthritis and Rheumatism, 19: 1308-1314, (1976).
Approved by FDA under NADA #122-578
Hyvisc® is a registered trademark of Anika Therapeutics, Inc.
Anika Therapeutics, Inc.
Bedford, MA 01730 U.S.A.
Boehringer Ingelheim Animal Health USA Inc.
Duluth, GA 30096
413003-07 AML 520-202/D
Revised 03/2021 © Anika Therapeutics, Inc. 2021
hyaluronate sodium injection
|Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)|