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 tissue 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 believed to play an important role in modulating the interaction between adjacent tissues; furthermore, it can act as a viscoelastic support maintaining separation between tissues. Various sodium hyaluronate preparations may have different molecular weights but are believed to always have the same chemical structure.

Instructions for use
Store at a temperature between 2° and 25°C. Allow them 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 a non-rigid, full-bore hypodermic needle compliant with ISO/ANSI standards, of suitable diameter. Diameters used for knee injections are 18-21 gauge. The final selection for any procedure must be determined by the physician. 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 small joints. It is up to the physician to determine the appropriate volume to ensure the joint is not overfilled. The recommended treatment regimen is 3 injections at one-week intervals for each treatment cycle, with a maximum of one treatment cycle per individual joint in a 6-month period. Remove any joint effusion 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 area 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
It is recommended to take normal precautions for injecting substances into joints. Only medical personnel competent in accepted injection techniques for administering agents into joint spaces should inject sodium hyaluronate for this application. Do not use an excessive amount of sodium hyaluronate and keep the patient under close observation. Do not overfill the space. If pain increases during injection, stop the injection and withdraw the needle. In case of abnormal consequences from the administration of the products, patients should immediately contact their doctor. Do not use if the inner packaging (pouch) is open 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 re-sterilize.

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

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

Code. VROV1 / VROV3 / VR0M1 / VR0M3