SYNOLIS V-A

SODIUM HYALURONATE AND SORBITOL

Class III CE medical device.
Synolis V-A is indicated to reduce pain and improve the mobility of knee joints and other synovial joints with degenerative and traumatic alterations.
Synolis V-A is a sterile, apirogenous and isotonic viscoelastic solution based on dissolved sodium hyaluronate in a buffered physiological solution. 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 average weight 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) that limits the degradation and capacity of the viscoelastic solution to lubricate joints and absorb shocks, simulating the rheological properties of the synovial liquid, determine the effectiveness of this product in the treatment of arthrosis. Synolis V-A acts by re-establishing the physiological and reological properties of the synovial fluid affected by arthrosis, allowing to reduce pain and its sense of discomfort as well as improve joint mobility.
Synolis V-A comes in 2 ml pre-filled glass syringe. The syringe is contained in a single sterilized enclosure. Two types of packages are available: box of 1 or 3 syringes containing indications for use and an illustration sheet.

Posology and methods of administration
Synolis V-A must be injected into the joint by a doctor specializing in intra-arthic injections.
Aspirate any deposits before injecting Synolis.
Synolis V-A must be injected at room temperature.
Perform a rigorous asepsis of the injection site.
Use a suitable length and size needle (we recommend 18 to 21 G, 2”).
Screw the needle firmly on the luer lock attack of the syringe.
Inject only within the joint cavity.
In case of gonartrosis it is advisable to administer Synolis V-A following a posological scheme of 3 injections a week away from each other.

Contraindications
Synolis V-A should not:
- To be used in patients with proven hypersensitivity to sodium hyaluronate and/or sorbitol.
- To be used in patients with autoimmune diseases or in the presence of abnormal physiological status.
- To be injected into a joint in the presence of venous or lymphatic stasis in the affected limb.
- To be injected into a joint in the presence of infection or severe inflammation.
- To be injected into patients with skin affection or infection at the injection site level.
- Being injected intravascularly.
- To be injected outside the intra-articular cavity or into the synovial membrane.
- To be injected in the presence of severe spill in the joint.
- To be injected into pregnant women and under 18.

Precautions of use
- Reuse of disposable devices involves the potential risk of infection in the patient or user.
- The solution must be administered in strict asepse modes (skin disinfection near the injection site necessary before product administration).
- Synolis V-A syringe should not be reused for other patients and/or repeated injections (monouse); the product should not be sterilized.
- Do not use it beyond the expiry date.
- Verify the integrity of the single protection enclosure.
- sterilized; otherwise avoid use.
- It is recommended for the patient to avoid any intense physical activity for at least 48 hours after injection.

Incompatibility
There is an incompatibility between sodium hyaluronate and quaternary ammonium salts such as benzalconium chloride. Carefully avoid Synolis V-A contact with such products (as in the case of some disinfectants), or with medical-surgical use materials treated with this type of product. There are currently no additional information on Synolis V-A compatibility with other intra-articular products.

Secondary effects
Synolis V-A intra-arctic injections can cause pain, edema and/or passenger deposit. Such reactions generally 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.

Conservation
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.

CE mark registration number
0120