ORTHOVISC
ORTHOVISC
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 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 interaction between adjacent tissues, additionally, it can act as a viscoelastic support maintaining separation between tissues. Various formulations based on sodium hyaluronate can have different molecular weights, but are always considered to have the same chemical structure.
Method of use
Store at a temperature between 2°C and 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 a fulcrum hypodermic needle, non-rigid and compliant with ISO/ANSI standards for appropriate diameter. The diameters used for knee injections are gauges 18-21. The final selection for any procedure must be determined by the physician. The volume varies depending on the size of the joint space, but must 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 that the joint is not overfilled. The recommended treatment regime is 3 injections at one-week intervals for each treatment cycle, with a maximum of one treatment cycle per 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 be relative or absolute contraindications for the use of the products:
– known sensitivity to any of the ingredients contained in both products;
– pre-existing infections in the skin region of the intended injection site;
– known joint infections;
– known systemic bleeding disorders.
Products may contain traces of gram-positive bacterial proteins and are contraindicated in patients with a history of similar allergies.
Warnings
Standard precautions for injections into joints are recommended. Only qualified medical personnel trained 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 closely monitor the patient. Do not overfill the joint space. If pain increases during injection, stop the injection and withdraw the needle. In case of abnormal outcomes during product administration, patients should immediately contact their doctor. Do not use if the inner packaging (bag) is open or damaged. For intra-articular injection. Not for intravenous injection. The sale and use of this medical device are limited to a doctor or under medical supervision. Single-use product. Do not re sterilize.
Storage
Store the 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
