50 mg/2.5 ml Hyaluronic acid sodium salt

Visco-supplementary device of the joints.
Sterile - Disposable

Directions
Pains or reduced mobility due to degenerative, post-traumatic or joint disorders.
Sinovial One 2.0% is a substitute for synovial fluid, which allows you to restore the physiological and rheological properties of arthritic joints. This therapeutic action is performed by the particular characteristics of the hyaluronic acid used. The hyaluronic acid contained in Sinovial One 2.0%, obtained by fermentation and not chemically modified, has excellent tolerability. By restoring the viscoelastic properties of the synovial fluid, Sinovial One 2.0% reduces pain and restores joint mobility.
Sinovial One 2.0% acts only on the joint where it is injected, without exerting any systemic action.
Sinovial One 2.0% is a single dose preparation and should be injected once per treatment cycle. If necessary, further injections can be performed. The opportunity and frequency with which the treatment cycle can be repeated must be evaluated by the doctor for each individual patient, considering in each case the risk/benefit ratio of the treatment.

Product Description
Sinovial One 2.0% consists of a buffered physiological solution of hyaluronic acid sodium salt with viscoelastic properties.
Sinovial One contains 2.0% highly purified hyaluronic acid sodium salt with a molecular weight between 800 and 1,200 kDalton.
The other ingredients of the product are: sodium chloride, sodium phosphate and water for injections. Hyaluronic acid sodium salt (hyaluronan*) is formed by repeated chains of disaccharide units of N-acetylglucosamine and sodium glucuronate, represents a fundamental component of the synovial fluid, to which it confers the particular viscoelastic properties. The sales sodium hyaluronic acid of Sinovial One 2.0% is obtained by fermentation and has not undergone chemical modification processes.
Sinovial One 2.0% comes in the form of a 3 ml glass syringe containing 2.5 ml of solution. The contents of the syringe are sterile and non-pyrogenic.
*Alternative names are often used.

Instructions for Use
- Aspirate any articular effusion before injecting Sinovial One 2.0%.
- Pull off the syringe cap paying particular attention to avoid contact with the opening.
- Insert the 21G diameter needle included in the package.
- Screw the needle tightly into the Luer-type locking collar of the syringe to ensure a watertight seal and prevent leakage during administration.
- Inject Sinovial One 2.0% at room temperature and under strict aseptic conditions. Inject Sinovial One 2.0% only into the synovial space.

Warnings
- The contents of the pre-filled syringe are sterile. The syringe is packed in a sealed container.
- The external surface of the syringe is not sterile.
- Do not use Sinovial One 2.0% after the expiry date stated on the package. Do not use Sinovial One 2.0% if the packaging is open or damaged.
- The injection site must be on healthy skin.
- Do not inject vascularly. Do not inject outside the joint cavity, into the synovial tissue or joint capsule.
- Do not administer Sinovial One 2.0% in the presence of abundant intra-articular effusion.
- Not sterilized