Label: HYVISC- hyaluronate sodium injection
- NDC Code(s): 0010-4130-01
- Packager: Boehringer Ingelheim Animal Health USA Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated April 26, 2022
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- SPL UNCLASSIFIED SECTION
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.
Dosage and Administration:
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.
- Carefully diagnose each case using routine methods. The origin of lameness should be pinpointed to be within a specific joint or joints (e.g., lameness is localized to a specific joint using intra-articular anesthesia). Radiographs or other diagnostic aids should not reveal recent fractures or other serious abnormalities which would suggest a poor prognosis.
- Aseptically remove as much synovial fluid from the afflicted joint as can be easily withdrawn.
- Remove tip cap from the Hyvisc syringe and inject through a sterile needle, 20 gauge or larger.
- Inject a single 2 mL dose (one syringe) of Hyvisc into each joint to be treated; if the joint being treated is the hock joint, inject 4 mL (two syringes). Since Hyvisc is a viscous fluid, care should be exercised on injection so as not to dislodge the needle from the syringe.
- Two or four days of rest or light exercise is recommended before resumption of normal activity. Improvement of joint function should be seen within one to two weeks after Hyvisc Injection.
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.
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.
Safety Margin in Horses:
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.
- How Supplied:
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).
SPL UNCLASSIFIED SECTION
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
- Principal Display Panel – 2 mL syringe label
- Principal Display Panel – 2 mL display carton
INGREDIENTS AND APPEARANCE
hyaluronate sodium injection
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-4130 Route of Administration INTRA-ARTICULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM 11 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0010-4130-01 1 in 1 CARTON 1 2 mL in 1 SYRINGE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA122578 04/12/2022 Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)