Description
MONO VISC
CE medical device.Sterile, non-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 a physiological osmolar phosphate buffered saline solution. It is composed of ultrapure, high molecular weight 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 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 hypodermic needle of appropriate 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 knee injections are 18-21 gauge. The final selection for any procedure should be determined by the physician. Before injecting the product, the physician should ensure that penetration into the synovial joint 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 at the intended injection site;
- known joint infection;
- known systemic bleeding abnormalities.
Warnings
It is recommended that the usual precautions for injecting substances into joints be taken. Only medical personnel competent in the accepted injection techniques for the administration of 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 defined by the physician performing the procedure. Do not use an excessive amount 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 internal packaging of the product 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.
Code VRMV1
