ORTHOVISC
ORTHOVISC mini

CE medical devices, class III.
Sterile, pyrogenic solutions of sodium hyaluronate (15 mg / ml) dissolved in a physiological solution. They are indicated as viscoelastic supplements or substitutes for synovial fluid in human joints; are suitable for the treatment of symptoms of human synovial joint dysfunction such as osteoarthritis. The actions of both products are lubrication and mechanical support.

How to use
Store at a temperature between 2 ° and 25 ° C. Allow to reach room temperature approximately 20-45 minutes before use. Not by intravenous injection. The required amount is slowly infused into the selected joint space through a non-rigid, non-rigid fulcrum hypodermic needle conforming to ISO / ANSI standards of suitable diameter. The diameters used for knee injections are 18-21 calibers. The final selection for any procedure must be determined by the physician. The volume varies according to the size of the joint space, but should not exceed 2ml for the knee and other large joints or 1ml for the small joints. It is up to the doctor to determine the appropriate volume to make sure the joint is not overfilled. The recommended regimen is 3 injections at one week intervals for each treatment course, with a maximum treatment course for an individual joint over a 6 month period. Remove any effusion in the joint before injecting the product. Do not overfill the joint space.

Contraindications
The following pre-existing conditions may constitute relative or absolute contraindications for 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 infections of the joint;
- 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
It is recommended that normal precautions be taken for injecting the substances into the joints. Only medical personnel skilled in injection techniques accepted for administering agents into the joint spaces should inject sodium hyaluronate for this application. Do not use an excessive amount of sodium diyaluronate and keep the patient under close surveillance. Do not overfill the space. If the pain increases during the injection, stop the injection and withdraw the needle. In case of abnormal consequences when administering the products, patients should contact their doctor immediately. Do not use if the inner package (pouch) is opened or damaged. Intra-articular perinjection. Not for intravenous injection. The sale and use of this medical device is restricted to or under the supervision of a physician. Disposable product. Do not resterilize.

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

Format
Orthosivisc: pack of 1 and 3 syringes of 2 ml.
Orthosivisc mini (quantity for small joints): pack of 1 and 3 syringes of 1 ml.

Cod. VROV1 / VROV3 / VR0M1 / VR0M3