SYNOLIS VA SODIUM HYALURONATE AND SORBITOL VISCOREANTALCIQUE CE class III medical device. Synolis VA is indicated for reducing pain and improving mobility of the knee joint and other synovial joints affected by degenerative and traumatic changes. Synolis VA is a sterile, non-pyrogenic, isotonic viscoelastic solution based on sodium hyaluronate dissolved in a buffered saline solution. The sodium hyaluronate contained in this intra-articular injectable medical device is obtained by bacterial fermentation, has a high concentration (2%) and a high molecular weight, with an average molecular weight of 2,000,000 daltons in the sterilized solution. The high concentration and high molecular weight of sodium hyaluronate, combined with the presence of an excipient (sorbitol) that limits its degradation and the ability of the viscoelastic solution to lubricate the joints and absorb shocks, simulating the rheological properties of synovial fluid, determine the effectiveness of this product in the treatment of osteoarthritis. Synolis VA acts by restoring the physiological and rheological properties of the synovial fluid affected by osteoarthritis, allowing a reduction in pain and associated discomfort, as well as improving joint mobility. Synolis VA is packaged in a 2 ml pre-filled glass syringe. The syringe is contained in an individual sterile protective pouch. Two types of packaging are available: boxes of 1 or 3 syringes containing instructions for use and a package leaflet. Dosage and method of administration Synolis VA should be injected into the joint by a doctor who is specialized in intra-articular injections. Aspirate any leaks before injecting Synolis. Synolis VA should be injected at room temperature. Perform strict asepsis at the injection site. Use a needle of appropriate length and size (18 to 21 G, 2” recommended). Screw the needle firmly onto the Luer Lock fitting of the syringe. Inject only into the joint cavity. In cases of gonarthrosis, it is recommended to administer Synolis VA following a dosing schedule of 3 injections at one-week intervals. Contraindications Synolis VA should not: - Use in patients with known hypersensitivity to sodium hyaluronate and/or sorbitol. - It is used in patients with a history of autoimmune diseases or in the presence of an abnormal physiological state. - It is injected into a joint in the presence of venous or lymphatic stasis in the affected limb. - It is injected into a joint if there is an infection or severe inflammation. - To be injected into patients with skin conditions or infections at the injection site. - It is injected intravascularly. - It is injected outside the intra-articular cavity or into the synovial membrane. - To be injected in the presence of severe joint effusion. - To be injected into pregnant women and people under 18 years of age. Precautions for use Reuse of single-use devices poses a potential risk of infection to the patient or user. - The solution must be administered following strict aseptic procedures (disinfection of the skin near the injection site is necessary before administering the product). - The Synolis VA syringe should not be reused for other patients and/or for repeated injections (single use); the product should not be sterilized. - Do not use after the expiration date. - Check the integrity of the individual protective casing. - sterilized; otherwise, avoid using it. The patient is advised to avoid any strenuous physical activity for at least 48 hours after the injection. Incompatibility There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts such as benzalkonium chloride. Care should be taken to avoid contact of Synolis VA with such products (such as some disinfectants) or with medical and surgical materials treated with such products. No further information is currently available on the compatibility of Synolis VA with other products for intra-articular use. Side effects Intra-articular injections of Synolis VA may cause temporary pain, swelling and/or effusion. These reactions generally disappear within a few days. Contact your doctor if these symptoms persist for more than a week or if side effects occur. Your doctor will recommend appropriate treatment. Conservation Store at a temperature between 2°C and 25°C. Protect from light and frost. Format Box of 1 pre-filled syringe of 2 ml. CE marking registration number 0120