Description
Sterile, apyrogenic solution based on lightly cross-linked sodium hyaluronate with a proprietary chemical binder. It contains 22 mg/ml of lightly cross-linked sodium hyaluronate (NaHA) dissolved in phosphate-buffered saline at physiologic osmolarity. 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 replacement for synovial fluid in human joints.
– It is suitable for the treatment of symptoms of human joint dysfunction such as osteoarthritis.
The actions performed by the product are: lubrication and mechanical support. Method of use
Inject the required amount of product through a sterile, disposable hypodermic needle of suitable diameter into the selected joint space. The sterile needle should be attached to the Monovisc syringe by medical personnel using an aseptic technique approved by the clinical center. The most commonly used diameters for injections into the knee are gauges 18-21. The final selection for any procedure must be determined by the physician. Before injecting the product, the physician must ensure that penetration into the synovial joint space is adequate.
Warnings
It is recommended that normal precautions be taken when 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 anatomy of the patient and should be determined by the physician performing the procedure. Do not use an excessive amount of sodium hyaluronate and keep the patient under close supervision. Do not overfill the synovial space. If pain increases during injection, stop the injection and withdraw the needle. For intrarticular use. Sterile contents. Disposable. Do not resterilize. Do not use if the inner packaging of the product is opened or damaged. After each injection, discard used needles or syringes. The sale and use of this device is restricted to a physician 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.
Fillers must be prescribed and administered by licensed physicians with specific professional expertise. Aesthetic medicine is a branch of medicine and, therefore, should be practiced only by professional and experienced physicians.
