Hyalovet

Name: Hyalovet

Hyalovet® (hyaluronate sodium) Veterinary Injection

NADA 140-806, Approved by FDA

For intra-articular administration in horses only

Caution

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

Adverse Reactions

As with any intra-articular injection a mild inflammatory response (tenderness, heat and swelling) may be seen in the joint following Hyalovet injection. The 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.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance call 1-866-638-2226.

Clinical Pharmacology

Results of gel chromatography studies demonstrate that Hyalovet (hyaluronate sodium) induces aggregation of cartilage proteoglycans sub-units as previously described for other fractions of hyaluronic acid2. In equine model studies of acute synovitis of the carpal joint, a single intra-articular injection of Hyalovet resulted in statistically significant (p<0.05) functional improvement with regard to lameness, swelling, pain, heat and joint flexion in a dosage dependent fashion. In chronic osteoarthritis secondary to carpal fracture in horses, a single intra-articular injection of 20 mg Hyalovet resulted in statistically significant (p<0.05) reduction in radiopharmaceutical uptake in subchondral bone, as compared to saline injected controls, a finding consistent with reduced inflammation. In controlled clinical trials in horses with lameness due to arthroses of the carpal or fetlock joints, intra-articular injection of 20 mg Hyalovet resulted in marked reduction in clinical lameness, pain on palpation, pain on flexion and facilitated return to training. A measurable and statistically significant (p<0.005) decrease in joint circumference was detected in the horses.

References

  1. Swann, D.A. et al: Role of hyaluronic acid in joint lubrication. Annals of the Rheumatic Diseases, 33 (1974): 318-326.
  2. Hascall, V.C. and Heinegard, D.: Aggregation of cartilage proteoglycans. I. The role of hyaluronic acid. Journal of Biological Chemistry, 249 (1974): 423-433.
  3. Gingerich, D.A. et al: Effect of exogenous hyaluronic acid on joint functions in experimentally-induced equine osteoarthritis: dosage titration studies. Research in Veterinary Science, 30 (1981): 192-197.

Hyalovet is a registered trademark of TRB Chemedica International S.A., Geneva, Switzerland.

© 2010 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

Product of Italy

12360

D4450C

680370/3

Manufactured for:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

Syringe Carton

Hyalovet 
hyaluronate sodium liquid
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:0010-4705
Route of Administration INTRA-ARTICULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYALURONATE SODIUM (HYALURONIC ACID) HYALURONIC ACID 20 mg  in 2 mL
Packaging
# Item Code Package Description
1 NDC:0010-4705-01 1 SYRINGE (SYRINGE) in 1 CARTON
1 2 mL in 1 SYRINGE
2 NDC:0010-4705-02 1 VIAL (VIAL) in 1 CARTON
2 2 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA140806 05/31/1988
Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)
Revised: 12/2010   Boehringer Ingelheim Vetmedica, Inc.
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