Sodium Hyaluronate for Intra-Articular Injection
Therapeutic Class (Orthopedics):
Intra-articular injection indicated for the symptomatic treatment of osteoarthritis of the knee.
Sterile viscoelastic preparation
ORTHOVISC® is a sterile viscoelastic preparation supplied in a disposable glass syringe delivering 2mL of sodium hyaluronate dissolved in physiological saline.
Each mL of ORTHOVISC® contains 15 mg of sodium hyaluronate adjusted to 20,000 – 70,000 centistokes, 9 mg of sodium chloride and q.s. Sterile Water for Injection USP.
Symptomatic treatment of osteoarthritis of the knee.
Dosage and Directions for Use:
ORTHOVISC® is administered by intra-articular injection one week apart for a total of three injections. Additional series of injections may be administered when clinically indicated.
The required amount of ORTHOVISC® is slowly infused through a sterile hypodermic needle of suitable gauge into the selected joint space. A plastic-hubbed needle is recommended. The volume will vary depending upon the size of the joint space, not to exceed 2mL for the knee.
At the present time there are no known contraindications to the use of ORTHOVISC® when used in the symptomatic treatment of joint disease.
ORTHOVISC® may contain trace quantities of gram positive bacterial proteins and is contraindicated for patients with a history of such allergies. Pre-existing infections of skin in the region of the intended injection or known systematic bleeding disorders may constitute relative or absolute contraindications.
Warnings and Precautions:
Precautions normally considered during injection of substances into joints are recommended. Only individuals familiar with accepted injection techniques for delivering agents to joint spaces should inject sodium hyaluronate for this application. An excess quantity of sodium hyaluronate is not to be used and the patient should be monitored closely. If pain increases during the injection procedure, the injection should be stopped and the needle withdrawn. The space should not be overfilled.
Adverse events reported in clinical trials have included mild or moderate reactions at the site of the injection.
STORE BETWEEN 2°C AND 25°C. PROTECT FROM FREEZING.
ORTHOVISC® is a registered trademark of Anika Therapeutics, Inc. used under license by Pharmascience Inc.
These products may not be suitable for everyone. Read the labels and follow the directions of use.
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