SYNOLIS V-A

SODIUM HYALURONATE & SORBITOL VISCO ANTALCIC

CE medical device, class III.
Synolis V-A is indicated for reducing pain and improving mobility of the knee joint and other synovial joints affected by degenerative and traumatic changes.
Synolis V-A is a sterile, pyrogen-free, isotonic viscoelastic solution based on sodium hyaluronate dissolved in a buffered physiological solution. The sodium hyaluronate contained in this injectable intra-articular 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 sterilised 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 joints and absorb shocks, simulating the rheological properties of synovial fluid, determine the effectiveness of this product in the treatment of osteoarthritis. Synolis V-A acts by restoring the physiological and rheological properties of osteoarthritic synovial fluid, reducing pain and discomfort as well as improving joint mobility.
Synolis V-A comes in a 2 ml pre-filled glass syringe. The syringe is contained in a single sterilised protective wrapper. Two types of packaging are available: a box of 1 or 3 syringes containing instructions for use and a leaflet.

Dosage and administration method
Synolis V-A must be injected into the joint by a doctor specialised in intra-articular injections.
Aspirate any effusions before injecting Synolis.
Synolis V-A must be injected at room temperature.
Perform strict asepsis of the injection site.
Use a needle of appropriate length and size (18 to 21 G, 2” is recommended).
Screw the needle firmly onto the syringe's luer lock.
Inject only into the joint cavity.
In cases of knee osteoarthritis, it is advisable to administer Synolis V-A according to a dosage schedule of 3 injections one week apart.

Contraindications
Synolis V-A 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 in the presence of infection or severe inflammation.
- Be injected into patients with skin conditions 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 for the patient or user.
- The solution must be administered following strict aseptic procedures (skin disinfection near the injection site is necessary before administering the product).
- The Synolis V-A syringe must not be reused for other patients and/or for repeated injections (single-use); the product must not be resterilised.
- Do not use beyond the expiry date.
- Check the integrity of the single protective wrapper.
- sterilised; otherwise, avoid use.
- Patients are advised to avoid any intense physical activity for at least 48 hours after injection.

Incompatibilities
A known incompatibility exists between sodium hyaluronate and quaternary ammonium salts such as benzalkonium chloride. Carefully avoid contact of Synolis V-A with such products (as in the case of some disinfectants), or with medical-surgical materials treated with this type of product. Currently, no other information is available on the compatibility of Synolis V-A with other products for intra-articular use.

Side effects
Intra-articular injections of Synolis V-A may cause temporary pain, oedema, and/or effusion. These reactions generally resolve within a few days. Contact your doctor if these symptoms persist for more than a week, or if any side effects occur. The doctor will advise on appropriate treatment.

Storage
Store at a temperature between 2°C and 25°C.
Protect from light and frost.

Format
Pack of 1 pre-filled 2 ml syringe.

CE marking registration number
0120