Description
Synovial fluid replacement, which restores the physiological and rheological properties of osteoarthritic joints. This therapeutic action is exerted by the specific characteristics of the hyaluronic acid used. The hyaluronic acid contained in SINOVIAL 32 2 ml, obtained by fermentation and not chemically modified, has excellent tolerability. By restoring the viscoelastic properties of the synovial fluid, SINOVIAL 32 2 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 32 2 ml acts only in the area where it is injected, without exerting any systemic action. The improvement is immediate: even after the first injection, the global WOMAC index decreases, and from the third injection, the decrease becomes statistically significant.
Indicated for acute and chronic tendinopathies and/or those associated with joint disability and in the tendon repair process, including following surgical interventions. SINOVIAL 32 2 ml is a medical device designed to supplement synovial fluid, allowing the physiological and rheological properties of osteoarthritic joints and tendons to be restored. In the joint, SINOVIAL 32 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 32 2 ml acts at the level of the tendon sheath, where it improves tendon gliding and the physiological healing/repair processes, thus preventing the formation of adhesions in post-operative courses.

Instructions for use
Aspirate any joint effusion before proceeding with the injection.
Carefully unscrew the syringe cap, firmly holding the "Luer Lock" closure collar between your fingers and paying particular attention to avoid contact with the opening. Insert the needle into the Luer Lock type closure collar of the syringe (needle diameter between 18 and 22G) by screwing it in firmly, until a slight pressure is felt, to ensure a watertight seal and prevent fluid leakage during administration, while firmly holding the "Luer Lock" closure collar between your fingers.
Inject SINOVI32 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
1.6% highly purified sodium hyaluronate (molecular weight between 800 and 1,200 KDaltons), sodium chloride, sodium phosphate, water for injection.

Warnings
SINOVIAL 32 2 ml can only be injected by a doctor.
The contents of the pre-filled syringe are 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 package.
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 into the 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 the reach and sight of children.
After intra-articular or intra-tendinous synovial 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 32 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
Extra-articular infiltration of SINOVIAL 32 2 ml may cause local undesirable effects. During the use of SINOVIAL 32 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. Normally, they disappear after a short time. The doctor must ensure that patients inform them of any undesirable effects occurring after treatment.
SINOVIAL 32 2 ml must 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 32 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 must 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 32 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 with intact packaging: 36 months.

Format
Pack of 1 pre-filled syringe (32.0 mg of sodium hyaluronate in 2 ml of buffered physiological sodium chloride solution).

Code 6000001304