Synovial Intra-Articular Syringe 1.6% 32Mg

Description
Substitute for synovial fluid, which allows restoring 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 32 2 ml, obtained through fermentation and not chemically modified, shows excellent tolerability. By restoring the viscoelastic properties of synovial fluid, SINOVIAL 32 2 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 32 2 ml acts only at the level of the area where it is injected, without exerting any systemic action. 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 associated with joint disability and in the tendon repair process, also following surgical procedures. SINOVIAL 32 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 32 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 characteristics, it acts at the level of the tendon sheath, where it improves the tendon's gliding (“Tendon gliding”) and the physiological processes of healing / repair, thus preventing the formation of adhesions during the post-operative course.

Method of use
Aspirate any joint effusion before proceeding with the injection.
Carefully unscrew the cap of the syringe, keeping firmly between your fingers the “Luer Lock” closure and paying particular attention to avoid contact with the opening. Insert the needle into the Luer Lock cap of the syringe (needle diameter between 18 and 22G) screwing it firmly until you feel slight pressure to ensure a watertight seal and prevent liquid from leaking during administration, maintaining the “Luer Lock” closure tightly between your fingers.
Inject SINOVIAL 32 2 ml at room temperature and under strict aseptic conditions, into the joint synovial space or into the tendon sheath / peri-tendinous zone, depending on the identified medical necessity.

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

Warnings
SINOVIAL 32 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 external surface of the syringe is not sterile.
Do not use after the expiry date printed on the packaging.
Do not use if the packaging is open or damaged.
The injection point must be on healthy skin.
Do not inject vascularly. Do not inject outside the joint cavity, into the synovial tissue or the joint capsule. Do not administer in the presence of abundant intra-articular effusion.
Do not sterilize again. 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 reach and sight of children.
After intra-articular or intrasynovial injection, advise the patient to avoid all intense physical activities and to resume normal activities only after a few days.
Any presence of an air bubble does not compromise the product's characteristics.
Do not mix SINOVIAL 32 2 ml with disinfectants such as quaternary ammonium salts or chlorhexidine, as a precipitate may form.
The extrarticular infiltration of SINOVIAL 32 2 ml may cause local side effects. During use of SINOVIAL 32 2 ml, symptoms such as pain, warmth, redness, or swelling may appear at the injection site. These secondary manifestations can be alleviated with ice application to the treated area. Usually, they disappear after a short time. The doctor must ensure that patients inform him of any adverse effects occurring after treatment.
SINOVIAL 32 2 ml must not be injected into an infected or severely inflamed joint or if the patient has a skin condition or infection in the injection area.
The product must not be used if there is a known hypersensitivity to sodium hyaluronate or other components.
Up to now, no interactions between SINOVIAL 32 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 must not be injected into an infected or severely inflamed joint or if the patient has a skin condition or infection in the injection area. The product must not be used if there is a known hypersensitivity to sodium hyaluronate or other components.
SINOVIAL 32 2 ml can only be injected by a doctor.

Storage
Store at room temperature and below 25 °C, away from heat sources. Do not freeze.
Shelf life with intact packaging: 36 months.

Format
Pack of 1 pre-filled syringe (32.0 mg of hyaluronic acid sodium salt in 2 ml of buffered saline solution of sodium chloride).

Code 6000001304