Sinovial One Syringe 2% 2.5ml

Sinovial One 2.0%

CE medical device, Class III.
Visco-supplementary joint device.
Sterile and disposable.
Sinovial One 2.0% is a substitute for synovial fluid, which allows you to restore the properties of the synovial fluid. physiological and rheological aspects of arthritic joints. This therapeutic action is explained 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 properties viscoelastic properties of the synovial fluid, Sinovial One 2.0% reduces pain and restores mobility. joint.
Sinovial One 2.0% acts only at the level of the joint into which it is injected, without exerting any systemic action.
Sinovial One 2.0% is a single dose preparation and must be injected only 1 time per treatment cycle. If necessary, further injections may be performed. The opportunity and the frequency with which you can repeating the treatment cycle must be evaluated by the doctor for each individual patient, considering in each case the risk/benefit ratio of the treatment.

Indications
Pain or mobility reduced due to degenerative, post-traumatic conditions or joint alterations.

Available packs
Packs of 1 pre-filled syringe (50.0 mg of hyaluronic acid sodium salt in 2.5 ml of sodium chloride buffered saline) and 1 needle 21 G x 1 ½' (0.8 x 40 mm).
Vial-syringe sterilized by moist heat.
Needle sterilized with ethylene oxide.
Needle: CE 0197; Manufacturer: Terumo.

Product description
Sinovial One 2.0% is consisting of a buffered physiological solution of hyaluronic acid sodium salt with properties viscoelastic.
Sinovial One 2.0% contains 2.0% of highly purified hyaluronic acid sodium salt with a molecular weight between 800 and 1,200 kDalton.
The other components of the product are: sodium chloride, sodium phosphate and water for injections.
Hyaluronic acid sodium salt (hyaluronan*) is formed by repeating chains of units disaccharides of N-acetylglucosamine and sodium glucuronate, represents a fundamental component of the synovial fluid, to which it confers particular properties. viscoelastic.
The hyaluronic acid sodium salt 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.

Instructions for use
Aspirate any joint effusion before proceeding with the injection of Sinovial One 2.0%.
Extract the cap of the syringe, paying particular attention to avoid contact with the opening.
Insert the 21 G diameter needle included in the package.
Screw the needle firmly into the Luer-type closing collar of the syringe to ensure a watertight seal and prevent leakage of the liquid 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.
*Alternative names are often used.

Warnings
The contents of the pre-filled syringe are sterile. The syringe is packaged in a sealed container.
The external surface of the syringe is not sterile.
Do not use Sinovial One 2.0% after the expiry date shown on the package.
Do not use Sinovial One 2.0% if the packaging is sterile. open or damaged.
The injection site must be on healthy skin.
Do not inject vascularly. Do not inject outside the cavity. joint, in the synovial tissue or in the joint capsule.
Do not administer Sinovial One 2.0% in the presence of a large intra-articular effusion.
Do not sterilize again. The device is intended for single use only.
Do not reuse to avoid any risk of contamination.
Store at room temperature and in any case below 25°C and away from heat sources. Do not freeze.
Once opened Sinovial One 2.0% should be used immediately and discarded after use.
Keep out of reach of children.
After intra-articular injection, advise the patient to avoid all activities intense physical activity and to resume normal activities. only after a few days.
The possible presence of an air bubble does not affect the characteristics of the product.

Precaution for use
Do not mix Sinovial One 2.0% with disinfectants such as quaternary ammonium salts or chlorhexidine as they are can a precipitate may form.

Interactions
To date, there are no known interactions between Sinovial One 2.0% and other drugs.

Side effects< /b>
The extra-articular infiltration of Sinovial One 2.0% can cause side effects locally.
During the use of Sinovial One 2.0%, symptoms such as pain, sensation of heat, redness or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated joint.
Normally they disappear after a short time. The doctor must ensure that patients inform him of any side effects that may occur after treatment.

Contraindications
Sinovial One 2.0% must not be injected in the presence of a infected or severely inflamed joint or if the patient has a skin condition or infection in the area of the injection site.

TO BE SOLD ONLY ON MEDICAL PRESCRIPTION
INTRA-ARTICULAR INJECTION CAN ONLY BE CARRIED OUT BY A DOCTOR.

CE mark registration number of the pre-filled syringe: 0373
CE mark registration number of the 21G needle: 0197