Description

MONOVISC is a sterile, non-pyrogenic, sodium hyaluronate solution, lightly cross-linked with a proprietary chemical cross-linker.

  • Contains lightly cross-linked sodium hyaluronate (NaHA) dissolved in phosphate-buffered saline at physiological osmolality
  • Manufactured from ultra-pure, high molecular weight sodium hyaluronate produced by bacterial fermentation

Application

MONOVISC Cross-Linked Sodium Hyaluronate Injection is a single, intra-articular injection of cross-linked sodium hyaluronate designed to treat the symptoms of osteoarthritis.



Indication

MONOVISC is indicated as a viscoelastic supplement or a replacement for synovial fluid in human joints.

  • Well suited for treatment of the symptoms of human joint dysfunctions such as osteoarthritis
  • The actions of MONOVISC are lubrication and mechanical support

Directions for use

The required amount of MONOVISC is injected through a sterile, disposable hypodermic needle of suitable gauge into the selected joint space.



Adverse reactions

Hyaluronic acid is a natural component of the tissues of the body. MONOVISC is thoroughly tested to determine that each batch conforms to the product quality attributes. Since sodium hyaluronate molecules are non-inflammatory, any phlogistic response is considered to be caused by the invasive procedure. 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.



How supplied

MONOVISC is a sterile viscoelastic preparation supplied in a disposable glass syringe delivering 4.0 mL. Each syringe contains lightly cross-linked sodium hyaluronate dissolved in phosphate-buffered saline.

 

Please refer to the Instructions for Use for complete product information.