Sinovial 32 - visco-supplementary joint device

Product Description

Synovial fluid substitute, which allows for the restoration of the physiological and rheological properties of arthritic joints.

Indications

This therapeutic action is explained by the particular characteristics of the hyaluronic acid used.
The hyaluronic acid contained in Sinovial 32 2.0 ml, obtained by fermentation and not chemically modified, has excellent tolerability.
By restoring the viscoelastic properties of the synovial fluid, Sinovial 32 2.0 ml reduces pain and restores joint and tendon mobility.
Sinovial 32 2.0 ml acts only at the level of the area into which it is injected, without exerting any systemic action.
The improvement is immediate: already 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 32 2.0 ml is a medical device designed to integrate synovial fluid, allowing the physiological and rheological properties of arthritic joints and tendons to be restored. In the joint, Sinovial 32 2.0 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 32 2.0 ml also, thanks to its lubricating and viscoelastic characteristics, 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.

Composition

1.6% hyaluronic acid, highly purified sodium salt (molecular weight between 800 and 1,200 kDalton), sodium chloride, sodium phosphate, water for injections.

Directions for use and Dosage

Aspirate any joint effusion before injecting.
Carefully unscrew the syringe cap, holding the "Luer Lock" closure collar firmly between your fingers and taking particular 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) and screw it firmly until you feel a slight pressure to ensure a watertight seal and prevent liquid leakage during administration, keeping the "Luer Lock" closure collar firmly between your fingers.
Inject Sinovial 32 2.0 ml at room temperature and under strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peritendinous area, depending on the identified medical need.

Warnings

Sinovial 32 2.0 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 external surface of the syringe is not sterile.
Do not use after the expiry date printed on the package.
Do not use if the package is opened or damaged.
The injection site must be on healthy skin.
Do not inject vascularly.
Do not inject outside the joint cavity, into 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 synovial tendon 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 32 2.0 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
Extra-articular infiltration of Sinovial 32 2.0 ml may cause local side effects.
During the use of Sinovial 32 2.0 ml, symptoms such as pain, a sensation of heat, redness or swelling may appear at the injection site.
These side effects 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 adverse effects that occur after treatment.
Sinovial 32 2.0 ml must not be injected if an infected or severely inflamed joint is present or if the patient has a skin condition or infection in the area of ​​the injection site.
The product must not be used in cases of known hypersensitivity to sodium hyaluronate or other components.
To date, no interactions between Sinovial 32 2.0 ml and other drugs are known.
Do not mix with disinfectants such as quaternary ammonium salts or chlorhexidine as it may cause irritation. a precipitate may form.
It must not be injected if an infected or severely inflamed joint is present 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 ingredients.
Sinovial 32 2.0 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:

3 pre-filled syringes (32.0 mg of hyaluronic acid sodium salt in 2 ml of buffered saline sodium chloride solution).
3 needles.