Description
A synovial fluid substitute that restores the physiological and rheological properties of osteoarthritic joints. This therapeutic action is provided by the particular characteristics of the hyaluronic acid used. The hyaluronic acid contained in SINOVIAL 50 2.5 ml, obtained by fermentation and not chemically modified, shows excellent tolerability. By restoring the viscoelastic properties of the synovial fluid, SINOVIAL 50 2.5 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 50 2.5 ml acts only at the injection site, without exerting any systemic action. The improvement is immediate: 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 repair process of tendons, even after surgical interventions. SINOVIAL 50 2.5 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 50 2.5 ml reduces pain and promotes the recovery of associated joint and tendon mobility, acting only in the synovial cavity where it is injected, without exerting any systemic action. Furthermore, thanks to its lubricating and viscoelastic characteristics, SINOVIAL 50 2.5 ml acts at the tendon sheath, where it improves tendon gliding and physiological healing/repair processes, thereby preventing adhesion formation in the post-operative period.

Instructions for use
Aspirate any joint effusion before proceeding with the injection.
Carefully unscrew the syringe cap, firmly holding the Luer Lock collar between your fingers and paying particular attention to avoid contact with the opening. Insert the needle into the Luer Lock collar of the syringe (needle diameter between 18 and 22G) by screwing it firmly until slight pressure is felt, to ensure a watertight seal and prevent fluid leakage during administration, while still firmly holding the Luer Lock collar between your fingers.
Inject SINOVIAL 50 2.5 ml at room temperature and under strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peri-tendon area, depending on the identified medical need.

Components
2% hyaluronic acid, highly purified sodium salt (molecular weight between 800 and 1,200 KDalton), sodium chloride, sodium phosphate, water for injections.

Warnings
SINOVIAL 50 2.5 ml can only be injected by a physician.
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 shown 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 tendon sheath injection, advise the patient to avoid all intense physical activities and to resume normal activities only after a few days.
The eventual presence of an air bubble does not affect the product's characteristics.
Do not mix SINOVIAL 50 2.5 ml with disinfectants of the quaternary ammonium salt or chlorhexidine type, as precipitation may occur.
Extra-articular infiltration of SINOVIAL 50 2.5 ml may cause local side effects. During the use of SINOVIAL 50 2.5 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 physician must ensure that patients inform them of any side effects that occurred after treatment.
SINOVIAL 50 2.5 ml must not be injected into 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 50 2.5 ml and other drugs are known.
Do not mix with disinfectants of the quaternary ammonium salt or chlorhexidine type, as precipitation may occur.
It must not be injected into 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 must not be used in case of known hypersensitivity to sodium hyaluronate or other components.
SINOVIAL 50 2.5 ml can only be injected by a physician.

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

Format
Pack containing 1 pre-filled syringe (50.0 mg sodium hyaluronate in 2.5 ml of buffered sodium chloride physiological solution) and 1 21G x 1 ½ needle (0.8 x 40 mm).

Cod. 6000001307