Synolis is an isotonic viscoelastic injectable solution in a pre-filled syringe with sodium hyaluronate 80mg and sorbitol 160mg, syringe capacity 4ml, monoshot 1 piece

Description
Synolis VA 80/160 is a sterile, apyrogenic, isotonic, buffered, viscoelastic solution of 2% sodium hyaluronate. The sodium hyaluronate contained in Synolis VA 80/160 is obtained by bacterial fermentation and has a high average molecular weight of 2 MDaltons. Synolis VA 80/160 has a neutral pH of 6.8 - 7.4 similar to that of synovial fluid. The high concentration and molecular weight of sodium hyaluronate, combined with a polyol (sorbitol) that limits its degradation, give this viscoelastic solution the ability to restore joint lubrication and shock absorption properties similar to those of healthy synovial fluid. Synolis VA 80/160 works by restoring the physiological and viscoelastic properties of synovial fluid that has gradually been depleted during the development of osteoarthritis. Synolis VA 80/160 therefore reduces local pain and discomfort caused by symptomatic osteoarthritis and improves the mobility of the synovial joints.
Synolis VA 80/160 is indicated for the treatment of symptomatic osteoarthritis, to reduce pain and improve mobility following degenerative changes in the synovial joints of the knee and hip. This treatment is suitable for patients in whom conservative non-pharmacological therapy and simple analgesics have failed.
Sterilization method: moist heat.

How to use
During the treatment of osteoarthritis of the knee or hip, Synolis VA 80/160 is administered as a single intra-articular injection. A further injection of Synolis VA 80/160 may be given when the symptoms of osteoarthritis return or to maintain local pain management and joint function. However, the benefits of treatment are expected to last at least 6 months for responsive patients. The length of time before repeating the treatment regimen also depends on the experience of the physician and/or the severity of the condition. Synolis VA 80/160 should be injected into the synovial cavity by a physician experienced in intra-articular injections. Before injecting Synolis VA 80/160, perform the following:
- aspirate any joint effusion before injecting the viscoelastic gel;
- at the time of intra-articular injection, Synolis VA 80/160 must be at room temperature;
- thoroughly disinfect the injection site;
- use an appropriately sized needle (recommended: 18G to 21G);
- securely attach the needle to the luer lock connection of the syringe;
- inject only into the joint cavity.

Components
Sodium hyaluronate, sorbitol, phosphate buffer.

Warnings
Synolis VA 80/160 must not be injected in patients with known hypersensitivity to sodium hyaluronate and/or sorbitol preparations, in pregnant or breast-feeding women, in patients under 18 years of age, intravascularly, in patients with a skin disorder or infection at the injection site.
Before treatment, inform patients about the device, its contraindications and possible side effects. Do not use Synolis VA 80/160 for any indication other than symptomatic osteoarthritis. In the absence of available clinical data on intolerance to Synolis VA 80/160 injection in patients with previous or active autoimmune diseases, the physician must decide whether to inject Synolis VA 80/160 on a case-by-case basis, based on the nature of the concomitant diseases and associated concomitant treatments. It is recommended to offer these patients a preliminary test and not to perform the injection if the disease is evolving. It is also recommended to carefully monitor these patients after the injection. Check the integrity of the internal packaging before use and check the expiry date. Do not use the product beyond the expiry date or if the package has been opened or damaged. Do not transfer Synolis VA 80/160 to another container and do not add other ingredients to the product. Intra-articular injection should be performed with caution to avoid injecting into a joint of a limb with venous or lymphatic stasis, injecting into an infected and inflamed joint, injecting in the presence of severe joint effusion, injecting outside the intra-articular cavity or into the synovial membrane; viscoelastic gels injected into the perisynovial area may be painful due to compression on other surrounding tissues. Synolis VA 80/160 solution must be administered following strict aseptic procedures. Synolis VA 80/160 is a single-use product, which should not be used for different patients and/or sessions. It should not be resterilized. Reusing single-use products may cause infections, as they would no longer be sterile. Only the gel is sterile, not the outside of the syringe. Advise patients to avoid any strenuous physical activity for at least 48 hours after intra-articular injection. Dispose of the syringe in accordance with accepted medical practice and applicable national, local and institutional requirements. There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts such as benzalkonium chloride. Avoid contact of Synolis VA 80/160 with such products (e.g. some disinfectants) or with medical or surgical instruments treated with these types of products. To date, there are no data available on the compatibility of Synolis VA 80/160 with other products for use as an intra-articular injection. There is a possibility of side effects that should be described to the patient prior to treatment. A slight hemorrhage may occur during the injection, but will stop spontaneously once the injection is completed. Occasionally one or more of the following reactions may occur immediately or as a delayed reaction. These are temporary local pain, swelling and/or joint effusion. These reactions usually resolve within a few days. If symptoms persist for more than a week or if other side effects occur, the patient should inform the doctor. The doctor can prescribe appropriate treatment for these side effects. Other typical possible side effects of viscosupplement injections include inflammation, redness, swelling, skin irritation, allergic reaction and tissue reaction.

Conservation
Store at 2°C to 25°C. Protect from light and frost. Do not freeze the product.
Validity with intact packaging: 24 months

Format
Synolis VA 80/160 is available as a 5 ml pre-filled glass syringe containing 4 ml of viscoantalgic gel. Synolis VA 80/160 is available in packs of 1 syringe. Each box includes traceability labels and 1 instruction sheet for use.

Code SYN400