INTRA-ARTICULAR SYRINGE MONOVISC HYALURONIC ACID 20MG/ML 4 ML

SINGLE VISC

CE medical device.
Sterile, pyrogenic 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 phosphate buffered saline at physiological osmolarity. It is composed of high molecular weight, ultrapure 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 dysfunction such as osteoarthritis.
The actions performed by the product are: lubrication and mechanical support.

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

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 for 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
It is recommended that you take the usual precautions for injecting substances into joints. Only medical personnel skilled in 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's anatomy and must be defined by the physician performing the procedure. Do not use excessive amounts of sodium hyaluronate and monitor the patient closely. 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. Do not resterilize. Do not use if the inner product package is open or damaged. After each injection, discard used needles or syringes. Sale and use of this device is restricted to or under the supervision of a physician.

storage
Store at a temperature between 2° - 25°C. Protect from freezing.

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

Code VRMV1