VISCOSEAL®

INSTRUCTIONS FOR USE

Sodium hyaluronate from fermentation 0.5 %. Synovial fluid substitute. 10 ml mono-use container in a sterile sachet. Sterile by moist heat.

Composition:
1 ml isotonic solution contains 5.0 mg sodium hyaluronate from fermentation, sodium chloride, sodium monohydrogenphosphate, sodium dihydrogenphosphate and water for injections.

Indication:
To relieve pain, improve mobility and promote joint recovery by flushing out irrigating solution and substituting the synovial fluid following arthroscopic procedures or joint lavage.

Directions for use:
The contents and outer surface of the VISCOSEAL® mono-use container are sterile as long as the sachet remains unbroken. VISCOSEAL® should be used at the end of the arthroscopy after completion of the normal irrigating procedure. Remove the container from the sachet. Twist off the cap and remove the air bubble by squeezing the container. Attach its Luer tip to a portal already placed in the joint. Introduce VISCOSEAL® into the joint cavity by squeezing the container. This will help to wash out the remaining irrigating solution.

Precautions:
The general precautions for arthroscopic procedures should be observed. VISCOSEAL® should be instilled accurately into the joint cavity. As VISCOSEAL® does not contain preservatives, any solution not used immediately after opening should be discarded. Do not use if the mono-use container or sterile sachet are damaged. Store between 2 °C and 25 °C! Do not use after the expiry date indicated on the box. Keep out of the reach of children.

Side effects:
No undesirable effects are expected with VISCOSEAL® when used in the approved indication and at the dosage prescribed. The contra-indications must be considered.

Contra-Indications:
Known hypersensitivity to any of the constituents of the product.

Interactions:
No information on the incompatibility of VISCOSEAL® with other solutions for intra-articular use is available to date.

Characteristics and mode of action:
Arthroscopy is a common procedure to visualise, diagnose and treat problems inside a joint. The joint is normally irrigated with solutions such as saline or Ringer lactate before and during arthroscopy in order to allow a clear view of the operation site and to rinse out debris. There is evidence that the presence of these solutions in the joint after irrigation may be detrimental to the cartilage. Furthermore, during the procedure the synovial fluid, which has particular viscoelastic and protective properties due to its hyaluronic acid content, is washed from the joint. Therefore, although the intervention may result in a long-term improvement of joint function, in the short-term patients may suffer from postarthroscopy complaints like pain, swelling and impaired mobility of the joint. VISCOSEAL® has been developed to relieve these symptoms and promote joint recovery. It contains a highly purified specific fraction of hyaluronic acid pro duced by fermentation and is devoid of animal protein. Flushing VISCOSEAL® through the joint cavity will help remove the remaining irrigating solution and efficiently coat all surfaces of the joint. The VISCOSEAL® left in the joint will act as a lubricant and a shock absorber and its macromolecular meshwork will prevent the free passage of inflammatory cells and molecules through the joint cavity. In addition, hyaluronic acid is able to promote wound healing.

Presentation and package size:
1 x 10 ml mono-use container of VISCOSEAL® in a sterile sachet.
To be used by a physician only.
Last revision date: November 2009