Description
Substitute for synovial fluid, which allows to restore the physiological and rheological properties of arthritic joints. This therapeutic action is explained 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, has 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 level of the area in which it is injected, without exerting any systemic action. The improvement is immediate: already after the first injection, the global WOMAC index decreases and starting from the third injection the decrease becomes statistically significant.
Indicated in cases of acute and chronic tendinopathies and/or associated with joint disability and in the tendon repair process, even following surgery. SINOVIAL 50 2.5 ml is a medical device designed to integrate the synovial fluid, allowing the physiological and rheological properties of arthritic joints and tendons to be restored. 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 into which it is injected, without exerting any systemic action. SINOVIAL 50 2.5 ml also, thanks to its lubricating and viscoelastic characteristics, acts at the level of the tendon sheath, where it improves tendon gliding (“Tendon gliding”) and the physiological healing/repair processes, thus preventing the formation of adhesions in the post-operative course.

How to use
Aspirate any joint effusion before injecting.
Carefully unscrew the syringe cap, holding the "Luer Lock" closure collar firmly between your fingers and taking special care to avoid contact with the opening. Insert the needle into the Luer Lock closure collar of the syringe (needle diameter between 18 and 22G) screwing it firmly, until you feel a slight pressure in order to ensure a watertight seal and prevent the leakage of liquid during administration, holding the "Luer Lock" closure collar firmly between your fingers.
Inject SINOVIAL 50 2.5 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
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 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 vascularly. 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 intense physical activity and to resume normal activities only after a few days.
The possible presence of an air bubble does not affect the characteristics of the product.
Do not mix SINOVIAL 50 2.5 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
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, heat, redness or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. They usually disappear after a short time. The physician must ensure that patients inform him of any side effects that occur after treatment.
SINOVIAL 50 2.5 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 50 2.5 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 50 2.5 ml can only be injected by a doctor.

Conservation
Store at room temperature and in any case below 25 °C and away from heat sources. Do not freeze.
Validity with intact packaging: 36 months.

Format
Pack of 1 pre-filled syringe (50.0 mg hyaluronic acid sodium salt in 2.5 ml sodium chloride buffered saline) and 1 needle 21G x 1 ½" (0.8 x 40 mm).

Cod. 6000001307