Description
A synovial fluid substitute that restores the physiological and rheological properties of arthritic joints. This therapeutic effect is achieved by the specific characteristics of the hyaluronic acid used. The hyaluronic acid in SINOVIAL 16 2 ml, obtained through fermentation and not chemically modified, is excellently tolerable. 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 level of the area into which it is injected, without exerting any systemic action. The improvement is immediate: after the first injection, the overall WOMAC index decreases, and starting 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 surgery. SINOVIAL 16 2 ml is a medical device designed to supplement synovial fluid, restoring the physiological and rheological properties of arthritic joints and tendons. In the joint, SINOVIAL 16 2 ml reduces pain and promotes recovery of joint and tendon mobility, acting only in the synovial cavity into which it is injected, without exerting any systemic action. Furthermore, SINOVIAL 16 2 ml, thanks to its lubricating and viscoelastic properties, 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 the post-operative period.

How to use
Aspirate any joint effusion before injecting.
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 (needle diameter between 18 and 22G) and screw it firmly until you feel a slight pressure to ensure a watertight seal and prevent leakage during administration, holding the Luer Lock collar firmly between your fingers.
Inject SINOVIAL 16 2 ml at room temperature and under conditions of strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peritendinous area, depending on the identified medical need.

Components
0.8% hyaluronic acid, highly purified sodium salt (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 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 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 large 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 discarded after use.
Keep out of the reach and sight of children.
After intra-articular or tendon synovial injection, advise the patient to avoid all strenuous physical activity and to resume normal activities only after a few days.
The presence of an air bubble does not affect the characteristics of the product.
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 side effects. During the use of SINOVIAL 16 2 ml, symptoms such as pain, heat, redness, or swelling may appear at the injection site. These side effects can be alleviated by applying ice to the treated area. These usually disappear after a short time. Doctors should ensure that patients are informed of any side effects that occur after treatment.
SINOVIAL 16 2 ml must not be injected if the joint is infected or severely inflamed 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 if the joint is infected or severely inflamed or if the patient has a skin condition or infection at 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.

Conservation
Store at room temperature, below 25°C, 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 hyaluronic acid sodium salt in 2 ml of sodium chloride buffered saline solution).

Cod. 6000001294