Description
Synolis VA 80/160 is a viscoelastic, sterile, pyrogen-free, isotonic, 2% sodium hyaluronate buffer solution. The sodium hyaluronate contained in Synolis VA 80/160 is obtained by bacterial fermentation and has a high average molecular weight of 2 MDalton. 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-absorbing 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 depleted during the development of osteoarthritis. Synolis VA 80/160 thus reduces local pain and discomfort caused by symptomatic osteoarthritis and improves the mobility of 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 not been successful.
Sterilization method: moist heat.

Directions for use
During the treatment of knee or hip osteoarthritis, Synolis VA 80/160 is administered as a single intra-articular injection. A further injection of Synolis VA 80/160 can be performed upon recurrence of osteoarthritis symptoms or for the maintenance of local pain management and joint function. However, the benefits of treatment are expected to last at least 6 months for responsive patients. The time before repeating the treatment regimen also depends on the physician's experience and/or the severity of the condition. Synolis VA 80/160 should be injected into the synovial cavity by a physician specialized in intra-articular injections. Before injecting Synolis VA 80/160, do 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 appropriate needle size (recommendation: 18G to 21G);
- securely attach the needle to the luer lock fitting 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 breastfeeding 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, depending on the nature of 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 injection. Check the integrity of the inner packaging before use and check the expiration date. Do not use the product beyond the expiration date or if the package has been opened or damaged. Do not transfer Synolis VA 80/160 to another container or add other ingredients to the product. Intra-articular injection should be performed carefully to avoid injecting into the 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. The Synolis VA 80/160 solution must be administered following strict aseptic procedures. Synolis VA 80/160 is a single-use product, which must not be used for different patients and/or sessions. It must not be re-sterilized. The reuse of single-use products can cause infections, as it would no longer be sterile. Only the gel is sterile, not the outside of the syringe. Advise patients to avoid any intense physical activity for at least 48 hours after intra-articular injection. Dispose of the syringe in accordance with accepted medical practice and national, local, and institutional requirements in force. 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 is 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 that side effects may occur which must be described to the patient before treatment. A slight hemorrhage may occur during the injection, but it will stop spontaneously upon completion of the injection. Occasionally, one or more of the following reactions may occur immediately or as a delayed reaction. These include temporary local pain, edema, 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 physician. The physician may prescribe appropriate treatment for these undesirable effects. Other typical possible side effects of viscosupplement injections include inflammation, redness, swelling, skin irritation, allergic and tissue reactions.

Storage
Store at a temperature between 2°C and 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 viscoanalgesic gel. Synolis VA 80/160 is available in packs of 1 syringe. Each box includes traceability labels and 1 instruction for use leaflet.

Code SYN400