Aptissen

Synolis VA 40/80 Syringe 2ml

SODIUM HYALURONATE & SORBITOL VISCO ANTALCIC

CE class III medical device.

Description

Synolis VA is indicated to reduce pain and improve mobility of the knee joint and other synovial joints affected by degenerative and traumatic changes.
Synolis VA is a sterile, pyrogenic 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 Dalton in the sterilized solution. The strong concentration and high molecular weight of sodium hyaluronate, associated with the presence of an excipient (sorbitol) which limits its degradation and the ability of the viscoelastic solution to lubricate the joints and absorb shocks, simulating the rheological properties of the synovial fluid, determine the efficacy of this product in the treatment of osteoarthritis. Synolis V-A works by restoring the physiological and rheological properties of the synovial fluid affected by osteoarthritis, allowing to reduce pain and related sense of discomfort as well as to improve joint mobility.
Synolis VA comes in a 2 ml pre-filled glass syringe. The syringe is contained in a single sterilized protective pouch. Two types of packs are available: box of 1 or 3 syringes containing indications for use and a package leaflet.

Posology and method of administration

Synolis VA must be injected into the joint by a doctor who specializes in intra-articular injections.
Aspirate any spills before injecting Synolis.
Synolis VA must be injected at room temperature.
Perform rigorous asepsis of the injection site.
Use a needle of suitable length and size (18 to 21G, 2 ”recommended).
Firmly screw the needle into the syringe luer lock port.
Inject only into the joint cavity.
In cases of gonarthrosis it is advisable to administer Synolis VA following a dosage schedule of 3 injections one week apart.

Contraindications

Synolis VA must not:

• For use in patients with known hypersensitivity to disodium hyaluronate and / or sorbitol.
• To be used in patients with a history of autoimmune diseases or in the presence of an abnormal physiological state.
• Be injected into a joint if there is venous or lymphatic stasis in the affected limb.
• Being injected into a joint if there is infection or severe inflammation.
• To be injected into patients with skin disease or injection site infection.
• Be injected intra-vascularly.
• Be injected outside the intra-articular cavity or into the sinnovial membrane.
• Be injected if there is a severe effusion in the joint.
• To be injected into pregnant women and people under the age of 18.

Precautions for use

• The reuse of disposable 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 necessary before administering the product).
• The Synolis VA syringe should not be reused for other patients and / or for repeated (single use) injections; 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 proven incompatibility between sodium hyaluronate and quaternary diammonium 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. No further information is currently available regarding the compatibility of Synolis VA with other products for intra-articular use.

Side effects

Intra-articular injections of Synolis VA can cause pain, edema and / or transient 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 arise. Your doctor will recommend appropriate treatment.

storage

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

Format

Pack size of 1 pre-filled syringe of 2 ml.

CE mark registration number

0120