Synolis va 40-80 syringe 2ml

Product Description

Synolis V-A is a medical device indicated to reduce pain and improve mobility in synovial joints affected by degenerative and traumatic changes, based on sodium hyaluronate and sorbitol.

Indications

Synolis V-A is indicated to reduce pain and improve mobility in the knee joint and other synovial joints affected by degenerative and traumatic changes.
Synolis V-A is a sterile, non-pyrogenic, isotonic viscoelastic solution based on sodium hyaluronate dissolved in a buffered saline solution. The sodium hyaluronate contained in this medical device for intra-articular injection is Obtained by bacterial fermentation, it 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, combined with the presence of an excipient (sorbitol) that limits its degradation and the ability of the viscoelastic solution to lubricate the joints and absorb shock, simulating the rheological properties of synovial fluid, determine the effectiveness of this product in the treatment of arthrosis. Synolis V-A acts by restoring the physiological and rheological properties of the synovial fluid affected by arthrosis, allowing for the reduction of pain and related discomfort as well as improving mobility. Synolis V-A is presented in a 2 ml pre-filled glass syringe. The syringe is contained in a sterilized individual protective pouch. Two types of packaging are available: a box of 1 or 3 syringes containing the directions for use and a package leaflet.

Directions for use Instructions for use

Synolis V-A must be injected into the joint by a physician specialized in intra-articular injections.
Aspirate any effusions before injecting Synolis.
Synolis V-A must be injected at room temperature.
Perform strict aseptic conditions at the injection site.
Use a needle of appropriate length and size (18 to 21 G, 2" is recommended).
Firmly screw the needle onto the Luer lock connector of the syringe.
Inject only into the joint cavity.
In cases of gonarthrosis, it is advisable to use a syringe. It is advisable to administer Synolis V-A following a dosage regimen of 3 injections spaced one week apart.

Interactions

There is a known incompatibility 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 further information on compatibility is available. Synolis V-A with other products for intra-articular use.

Warnings

• Reuse of single-use devices carries a 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 required 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 sterilized.
• Do not use beyond the expiration date.
• Check the integrity of the single-use protective packaging.
• Sterilized; otherwise, avoid use.
• The patient is advised to avoid any activity strenuous physical activity for at least 48 hours after the injection.

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 disease or infection at the injection site.

Pregnancy and breastfeeding

Synolis V-A must not be injected in pregnant women.

Storage

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.