Description
SYNOLIS GOES
SODIUM HYALURONATE & SORBITOL VISCO ANTALCICCE Class III medical device.
Synolis VA is indicated to reduce pain and improve mobility of the knee joint and other synovial joints affected by degenerative and traumatic alterations.
Synolis VA is a sterile, apyrogenic and isotonic viscoelastic solution based on sodium hyaluronate dissolved in a buffered physiological 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 weight of 2,000,000 Daltons in the sterilized solution. The high concentration and high molecular weight of sodium hyaluronate, associated 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 efficacy of this product in the treatment of osteoarthritis. Synolis VA works by re-establishing the physiological and rheological properties of the synovial fluid affected by arthrosis, allowing for a reduction in pain and related discomfort as well as improving joint mobility.
Synolis VA comes in a 2 ml pre-filled glass syringe. The syringe is contained in a single sterilized protective wrapper. Two types of packaging are available: box of 1 or 3 syringes containing the indications for use and an information leaflet.
Dosage and method of administration
Synolis VA must be injected into the joint by a physician trained in intra-articular injections.
Aspirate any spills before injecting Synolis.
Synolis VA must 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”).
Screw the needle firmly onto the luer lock connector of the syringe.
Inject only into the joint cavity.
In cases of gonarthrosis it is advisable to administer Synolis VA following a dosage regimen of 3 injections spaced one week apart.
Contraindications
Synolis VA must not:
- Be used in patients with known hypersensitivity to sodium hyaluronate and/or sorbitol.
- Be used in patients with a history of autoimmune diseases or in the presence of an abnormal physiological state.
- Be injected into a joint in the presence of venous or lymphatic stasis in the affected limb.
- Be injected into a joint if there is infection or severe inflammation.
- Be injected into patients with skin disease or infection at the injection site.
- Be injected intravascularly.
- Be injected outside the intra-articular cavity or into the synovial membrane.
- Be injected in the presence of severe effusion in the joint.
- Be injected into pregnant women and subjects under 18 years of age.
Precautions for use
- Reuse of single-use devices carries the potential risk of infection in 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 must not be reused for other patients and/or for repeated injections (single use); the product must not be sterilized.
- Do not use beyond the expiration date.
- Check the integrity of the single 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. Carefully avoid contact of Synolis VA with such products (as in the case of some disinfectants), or with medical-surgical materials treated with this type of product. Currently, no further information is 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 usually resolve within a few days. Contact your doctor if these symptoms persist for more than a week, or if any 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
Pack of 1 pre-filled syringe of 2 ml.
CE mark registration number
0120
