Description
Medical device.
Sodium hyaluronate for intra-articular injection.
Sodium hyaluronate is a high molecular weight polysaccharide composed of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is distributed throughout the body and is present in high concentrations in tissues such as the vitreous humor, synovial fluid, umbilical cord, and dermis. Sodium hyaluronate acts as a tissue lubricant and is thought to play an important role in modulating the interaction between adjacent tissues and may act as a viscoelastic support by maintaining tissue separation. Different sodium hyaluronate preparations may have different molecular weights but are thought to have the same chemical structure.

How to use
Store at 2° to 25°C. Allow to reach room temperature approximately 20-45 minutes before use. Not for intravenous injection. The required amount is slowly infused into the selected joint space through an ISO/ANSI compliant, non-rigid, fulcrum hypodermic needle of 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 will vary 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 small joints. The physician should determine the appropriate volume to ensure that the joint is not overfilled. The recommended regimen is 3 injections at 1 week intervals for each treatment course, with a maximum treatment course for an individual joint in any 6 month period. Any effusion from the joint should be removed prior to injecting the product. Don't 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 at 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
It is recommended that the usual precautions for injections of substances into joints be taken. Only medical personnel competent in accepted injection techniques for the administration of 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 observation. Do not overfill the space. If pain increases during the injection, stop the injection and withdraw the needle. In case of abnormal consequences to the administration of the products, patients should contact their physician immediately. Do not use if the inner package (pouch) is opened or damaged. For intra-articular injection. Not for intravenous injection. The sale and use of this medical device are restricted to a physician or under the supervision of a physician. Single use product. Do not resterilize.

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

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

Code VROV1 / VROV3 / VR0M1 / VR0M3