Cross-linked Sodium Hyaluronate for Intra-Articular Injections
Therapeutic Class (Orthopedics):
A single intra-articular injection of cross-linked sodium hyaluronate designed to treat the symptoms of osteoarthritis
Sterile viscoelastic preparation
4 mL. Each mL of MONOVISC® contains 20 mg/mL of lightly cross-linked sodium hyaluronate (NaHA) dissolved in phosphate buffered saline.
Lightly cross-linked sodium hyaluronate (NaHA) dissolved in phosphate buffered saline.
Treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, e.g., acetaminophen.
Dosage and Directions for Use:
MONOVISC® is a single dose preparation. The recommended dose is 4 mL (one syringe) per knee joint.
The required amount of MONOVISC® is injected through a sterile, disposable, hypodermic needle of suitable gauge into the selected joint. The sterile needle should be attached to the MONOVISC® syringe by a health care professional using a health care facility-approved aseptic technique. Common needle gauges for injections into the knee are 18-21 gauge. The final needle selection for any procedure is determined by the physician. The health care provider should ensure proper penetration into joint synovial space prior to injecting MONOVISC®. The syringe is intended for single injection only.
The following pre-existing conditions may constitute relative or absolute contraindications to the use of MONOVISC®:
- Known sensitivity to hyaluronic acid based products
- Pre-existing infections of the skin region of the intended injection site
- Known infection of the index joint
- Known systemic bleeding disorders
- Known sensitivity to any of the materials contained in MONOVISC®
Warnings and Precautions:
This product is available under medical recommendation and the administration must be performed by a physician.
Precautions which are normally considered during injection of substances into joints are recommended. Only medical professionals trained in accepted injection techniques for delivering agents to joint spaces should inject sodium hyaluronate for this application. The amount of MONOVISC® necessary to be injected depends on specific site and patient anatomy. The synovial space should not be overfilled. If pain increases during the injection procedure, the injection should be stopped and the needle withdrawn. The safety and effectiveness of MONOVISC® concomitantly with other intra-articular injectables have not been tested. MONOVISC® has not been tested in pregnant or lactating women or in children. The effect of repeated injections of MONOVISC® has not been tested.
Mild to moderate episodes of transient swelling and discomfort have occasionally been observed following intra-articular injection of sodium hyaluronate preparations. General risks associated with the procedure of injecting substances into joints may include infections and bleeding.
STORE BETWEEN 2°C AND 25°C. PROTECT FROM FREEZING.
For more information, visit www.monovisc.ca.
MONOVISC® 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.
For additional information, contact us at 1-888-550-6060 or by email at firstname.lastname@example.org.