Natural origin, from bacterial fermentation Single dose, high dose (88mg) - high molecular weight (2 million Dalton) Lite cross-linking, to increase the time spent in the injection site and ensure a longer duration of action
Monovisc is a CE medical device. Sterile, pyrogen-free solution based on sodium hyaluronate slightly cross-linked with a proprietary chemical binder. Contains 22 mg / ml of lightly cross-linked sodium hyaluronate (NaHA) dissolved in physiologically osmolar phosphate buffered saline. It is composed of high molecular weight, ultrapure sodium hyaluronate, produced by bacterial fermentation. Hyaluronic acid is a complex natural polysaccharide of the glycosaminoglycan family. - It is indicated as a viscoelastic supplement or substitute for synovial fluid in human joints. - It is suitable for the treatment of symptoms of human joint dysfunctions such as osteoarthritis. The actions performed by the product are: lubrication and mechanical support.
Inject the required amount of product through a sterile, disposable hypodermic needle of suitable diameter into the selected joint space.
The sterile needle must be fixed to the Monovisc syringe by medical personnel, using an aseptic technique approved by the clinical center. The most 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 the penetration into the joint synovial space is adequate.
Warnings It is recommended to take the normal precautions for injecting substances into the joints. Sodium hyaluronate should be injected for this application only by medical personnel proficient in injection techniques accepted for administering agents into the joint spaces. The amount of product to be injected depends on the specific site and the patient's anatomy and must be defined by the doctor performing the procedure. Do not use an excessive amount of sodium hyaluronate and keep the patient under close surveillance. Do not overfill the synovial space. If the pain increases during the injection, stop the injection and withdraw the needle. For intra-articular use. Sterile content. Single use. Do not resterilize. Do not use if the internal package of the product is open or damaged. After each injection, discard used needles or syringes. The sale and use of this device are limited to a physician or under the supervision of a physician.
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.
Storage Store at a temperature between 2 ° - 25 ° C. Protect from freezing.