Description
A synovial fluid substitute that restores the physiological and rheological properties of osteoarthritic joints. This therapeutic action is provided by the specific characteristics of the hyaluronic acid used. The hyaluronic acid contained in SINOVIAL 16 2 ml, obtained by fermentation and not chemically modified, exhibits excellent tolerability. By restoring the viscoelastic properties of synovial fluid, SINOVIAL 16 2 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 16 2 ml acts only at the injection site, without any systemic action. The improvement is immediate: the WOMAC global index decreases after the first injection, and the decrease becomes statistically significant from the third injection onwards.
Indicated for acute and chronic tendinopathies and/or those associated with joint disability, and in the tendon repair process, including following surgical procedures. SINOVIAL 16 2 ml is a medical device designed to supplement synovial fluid, restoring the physiological and rheological properties of osteoarthritic joints and tendons. In the joint, SINOVIAL 16 2 ml reduces pain and promotes the recovery of associated joint and tendon mobility, acting only within the synovial cavity where it is injected, without exerting any systemic action. Furthermore, thanks to its lubricating and viscoelastic properties, SINOVIAL 16 2 ml acts at the tendon sheath level, where it improves tendon gliding and the physiological healing/repair processes, thereby preventing the formation of adhesions in post-operative courses.

How to use
Aspirate any joint effusion before proceeding with the injection.
Carefully unscrew the syringe cap, holding the Luer Lock collar firmly between your fingers and taking particular care to avoid contact with the opening. Insert the needle into the Luer Lock collar of the syringe (a needle with a diameter between 18 and 22G), screwing it in firmly until a slight pressure is felt to ensure a watertight seal and prevent liquid leakage during administration, while holding the Luer Lock collar firmly between your fingers.
Inject SINOVIAL 16 2 ml at room temperature and under strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peri-tendinous area, depending on the identified medical need.

Components
0.8% highly purified sodium hyaluronate (molecular weight between 800 and 1,200 KDaltons), sodium chloride, sodium phosphate, water for injections.

Warnings
SINOVIAL 16 2 ml can only be injected by a doctor.
The content of the pre-filled syringe is sterile.
The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use after the expiry date indicated on the packaging.
Do not use if the packaging is open or damaged.
The injection site must be on healthy skin.
Do not inject intravascularly. Do not inject outside the joint cavity, into the synovial tissue or joint capsule. Do not administer in the presence of abundant intra-articular effusion.
Do not re-sterilize. The device is for single use only. Do not reuse to avoid any risk of contamination.
Once opened, it must be used immediately and disposed of after use.
Keep out of reach and sight of children.
After intra-articular or tendon sheath injection, advise the patient to avoid all intense physical activities and to resume normal activities only after a few days.
The possible presence of an air bubble does not affect the product's characteristics.
Do not mix SINOVIAL with disinfectants such as quaternary ammonium salts or chlorhexidine, as a precipitate may form.
Extra-articular infiltration of SINOVIAL 16 2 ml may cause local adverse effects. During the use of SINOVIAL 16 2 ml, symptoms such as pain, warmth, redness or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. They normally disappear after a short time. The doctor must ensure that patients inform them of any side effects that occurred after treatment.
SINOVIAL 16 2 ml should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the area of the injection site.
The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components.
To date, no interactions between SINOVIAL 16 2 ml and other drugs are known.
Do not mix with disinfectants such as quaternary ammonium salts or chlorhexidine, as a precipitate may form.
It should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the area of the injection site. The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components.
SINOVIAL 16 2 ml can only be injected by a doctor.

Storage
Store at room temperature, below 25°C, and away from heat sources. Do not freeze.
Shelf life unopened: 36 months.

Format
Pack of 1 pre-filled syringe (16.0 mg of sodium hyaluronate in 2 ml of buffered saline solution).

Code. 6000001294