ORTHOVISC
ORTHOVISC mini

CE medical devices, class III.
Sterile, pyrogen-free solutions of sodium hyaluronate (15 mg/ml) dissolved in saline. They are indicated as viscoelastic supplements or synovial fluid substitutes in human joints; they are suitable for treating symptoms of human synovial joint dysfunction, such as osteoarthritis. Both products act as lubricants and mechanical support.

How to use
Store at 2°C to 25°C. Allow to reach room temperature for approximately 20-45 minutes before use. Not for intravenous injection. The required amount is slowly injected into the selected joint space using a non-rigid, ISO/ANSI standard pivot-type hypodermic needle of the appropriate diameter. Diameters used for knee injections are 18-21 gauge. The final selection for any procedure should be determined by the physician. The volume varies depending on the size of the joint space, but should not exceed 2 ml for knees and other large joints or 1 ml for small joints. It is the physician’s responsibility to determine the appropriate volume to ensure that the joint is not overfilled. The recommended treatment regimen is 3 injections at 1-week intervals for each treatment course, with a maximum treatment course for an individual joint in a 6-month period. Remove any effusion from the joint before injecting the product. Do not overfill the joint space.

Contraindications
The following pre-existing conditions may constitute relative or absolute contraindications to the use of the products:
– known sensitivity to any of the ingredients contained in the two products;
– pre-existing infections of the skin region of the intended injection site;
– known joint infections;
– known systemic bleeding abnormalities.
The products may contain traces of gram-positive bacterial proteins and are contraindicated in patients with a history of similar allergies.

warnings
Normal precautions for joint injections are recommended. Only healthcare professionals familiar with accepted injection techniques for administering agents into joint spaces should inject sodium hyaluronate for this application. Do not use excessive amounts of sodium hyaluronate and keep the patient under close supervision. Do not overfill the space. If pain increases during injection, stop the injection and remove the needle. If abnormalities occur after administration of the products, patients should contact their physician immediately. Do not use if the inner packaging (pouch) is opened or damaged. For intra-articular injection. Not intended for intravenous injection. Sale and use of this medical device is restricted to or under the supervision of a physician. For single use only. Do not resterilize.

Conservation
Store products at a temperature between 2°C and 25°C. Avoid freezing.

Format
Orthosivisc: package with 1 and 3 syringes of 2 ml each.
Orthosivisc mini (small joint quantity): package with 1 and 3 syringes of 1 ml each.

Code VROV1 / VROV3 / VR0M1 / VR0M3