Description
Synovial fluid substitute, which restores the physiological and rheological properties of arthritic joints. This therapeutic action is exerted 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, shows excellent tolerability. By restoring the viscoelastic properties of the synovial fluid, SINOVIAL 16 2 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 16 2 ml acts only in the area where it is injected, without exerting any systemic action. The improvement is immediate: already after the first injection, the overall WOMAC index decreases and from the third injection, the decrease becomes statistically significant.
Indicated in cases of acute and chronic tendinopathies and/or those associated with joint disability, and in the tendon repair process, even following surgical interventions. SINOVIAL 16 2 ml is a medical device designed to supplement synovial fluid, allowing the restoration of the physiological and rheological properties of arthritic joints and tendons. In the joint, SINOVIAL 16 2 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 properties, SINOVIAL 16 2 ml acts at the level of the tendon sheath, where it improves tendon gliding and physiological healing/repair processes, thus preventing the formation of adhesions in the post-operative period.

How to use
Aspirate any joint effusion before proceeding with the injection.
Carefully unscrew the cap of the syringe, holding the "Luer Lock" collar firmly 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 with a diameter between 18 and 22G) by screwing it firmly until a slight pressure is felt, to ensure a watertight seal and prevent fluid leakage during administration, 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-tendon area, depending on the identified medical need.

Components
0.8% highly purified sodium hyaluronate (molecular weight between 800 and 1,200 KDalton), 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 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 intended 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 quaternary ammonium salt or chlorhexidine disinfectants as precipitation may occur.
Extra-articular infiltration of SINOVIAL 16 2 ml may cause local side effects. During the use of SINOVIAL 16 2 ml, symptoms such as pain, a sensation of heat, 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 side effects that have 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 quaternary ammonium salt or chlorhexidine disinfectants as precipitation may occur.
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 and in any case below 25 °C and away from heat sources. Do not freeze.
Shelf life in intact packaging: 36 months.

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

Code 6000001294