ORTHOVISC
ORTHOVISC mini

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

Mode of use
Store at a temperature between 2° and 25°C. Let them reach the ambient temperature about 20-45 minutes before use. Not by intravenous injection. The required quantity is slowly melted into the selected joint space through a hypodermic fulcrum needle, not rigid in accordance with the appropriate diameter ISO/ANSI standards. The diameters used for knee injections are 18-21 calibers. The final selection for any procedure must be determined by the doctor. The volume varies depending on the size of the joint space, but should not exceed 2 ml for the knee and other large joints or 1 ml for the small joints. It is up to the doctor to determine the appropriate volume to ensure that the joint is not overfilled. The recommended therapeutic regime is 3 injections at intervals of one week each week for each treatment cycle, with a maximum treatment cycle for individual articulation in a period of 6 months. Remove any effusion of 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 products:
– note 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 abnormalities of bleeding.
Products can contain traces of gram-positive bacterial proteins and are contraindicated in patients with anamnesi of similar allergies.

Warnings
It is recommended to take normal precautions for injections of substances in joints. Only medical personnel competent in injection techniques accepted for administration of agents in the joints should inject sodium hyaluronate for this application. Do not use excessive amounts of sodium hyaluronate and keep the patient under close surveillance. Do not overfill space. If the pain increases during injection, stop the injection and withdraw the needle. In case of abnormal consequences to the administration of the products, patients should contact the doctor immediately. Do not use if the inner packaging (pack) is open or damaged. For intrarticular injection. Not by intravenous injection. The sale and use of this medical device are limited to a doctor or under the supervision of a doctor. Disposable product. Don't resterilize.

Conservation
Store 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