MONO VISC

CE medical device.
Sterile, pyrogen-free solution based on slightly cross-linked sodium hyaluronate with a proprietary chemical binder. Contains 22 mg/ml of slightly cross-linked sodium hyaluronate (NaHA) dissolved in a phosphate-buffered saline solution at physiological osmolarity. It is composed of ultrapure, high molecular weight sodium hyaluronate produced by bacterial fermentation. Hyaluronic acid is a complex natural polysaccharide from the glycosaminoglycan family.
– It is indicated as a viscoelastic supplement or substitute for synovial fluid in human joints.
– It is suitable for treating the symptoms of human joint disorders such as osteoarthritis.
The actions performed by the product are: lubrication and mechanical support.

How to use
Inject the required amount of product into the selected joint space using a sterile, disposable hypodermic needle of the appropriate diameter. The sterile needle must be attached to the Monovisc syringe by medical personnel, using aseptic technique approved by the clinical center. The most commonly used diameters for knee injections are 18-21 gauge. The final selection for any procedure must be determined by the physician. Before injecting the product, the physician must ensure adequate penetration into the synovial joint space.

Contraindications
The product is composed of cross-linked sodium hyaluronate and may contain traces of gram-positive bacterial proteins. The following pre-existing conditions may constitute relative or absolute contraindications to the use of the product:
– known sensitivity to any of the materials contained in the product;
– pre-existing infections of the skin region of the intended injection site;
– known joint infection;
– known systemic bleeding abnormalities.

Warnings
Normal precautions for injecting substances into joints are recommended. Only medical personnel familiar with accepted injection techniques for administering agents into joint spaces should inject sodium hyaluronate for this application. The amount of product to be injected depends on the specific site and patient anatomy and must be determined by the physician performing the procedure. Do not use excessive amounts of sodium hyaluronate and keep the patient under close observation. Do not overfill the synovial space. If pain increases during the injection, stop the injection and withdraw the needle. For intra-articular use. Sterile contents. Single use only. Do not resterilize. Do not use if the product's internal packaging is opened or damaged. Discard used needles or syringes after each injection. The sale and use of this device are restricted to a physician or under the supervision of a physician.

Conservation
Store at 2° - 25°C. Protect from freezing.

Format
Sterile viscoelastic preparation supplied in a 4.0 ml disposable glass syringe.

Cod. VRMV1