Description
Visco-supplementation device for joints.
Sodium hyaluronate is formed by repeating disaccharide units of N-acetylglucosamine and sodium glucuronate and is a fundamental component of synovial fluid, to which it confers particular viscoelastic properties.
Consists of a buffered physiological solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high and low molecular weight hyaluronic acid used in the device is obtained by fermentation and has not undergone chemical modification processes. This results in excellent tolerability. Furthermore, the HA chains of different molecular weights present in SINOVIAL HL 64 2 ml, thanks to a specific and patented treatment of the solution, interact with each other, giving SINOVIAL HL 64 2 ml unique rheological characteristics that allow higher concentrations of hyaluronic acid to be administered at the same solution viscosity. The HA chains of different molecular weights in SINOVIAL HL 64 2 ml provide greater resistance to hyaluronidase since this enzyme is unable to recognize the conformation of these high and low molecular weight complexes; therefore, SINOVIAL HL 64 2 ml is more suitable for in vivo applications in tissues.
Indicated for acute and chronic tendinopathies and/or those associated with joint disability and in the tendon repair process, including after surgery.
Designed to supplement synovial fluid, allowing the physical and rheological properties of osteoarthritic joints and tendons to be restored. In the joint, SINOVIAL HL 64 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.
Thanks to its lubricating and viscoelastic characteristics, it acts at the level of the tendon sheath where it improves tendon gliding and the physiological processes of scarring/repair, thus preventing the formation of adhesions in post-operative courses. The treatment can be up to three injections depending on the severity of the joint and/or tendon degeneration. The opportunity and frequency with which the treatment can be repeated must be evaluated by the physician for each individual patient, always considering the risk/benefit ratio of the treatment.

How to use
Aspirate any joint effusion before injecting SINOVIAL HL 64 2 ml.
Carefully unscrew the syringe cap, holding the “Luer Lock” closing collar firmly between your fingers and paying particular attention to avoid contact with the opening.
Insert the needle into the Luer Lock type closing collar of the syringe (needle with a diameter of 18 or 22G included in the package) screwing it on tightly, until a slight pressure is felt, in order to ensure a watertight seal and prevent liquid leakage during administration, holding the “Luer Lock” closing collar firmly between your fingers.
Inject SINOVIAL HL 64 2 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.

Components
High molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid, sodium chloride, sodium phosphate and water for injections.

Warnings
- The content of the pre-filled syringe is sterile. The syringe and needle are packaged in a sealed blister.
The outer surface of the syringe is not sterile.
- Do not use SINOVIAL HL 64 2 ml after the expiry date.
- Do not use SINOVIAL HL 64 2 ml 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 SINOVIAL HL 64 2 ml in the presence of abundant intra-articular effusion.
- Do not re-sterilize. The device is 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 the reach and sight of children.
- After the 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 characteristics of the product.
- Do not mix the product with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
- The product should not be injected into an infected or severely inflamed joint or if the patient has a skin condition or infection in the area of the injection site.

Storage
Store at room temperature and in any case below 25 °C and away from heat sources. Do not freeze.
Shelf life unopened: 36 months.

Format
Pack of 1 pre-filled syringe of 2 ml [32 mg (H-HA) + 32 mg (L-HA) of sodium hyaluronate in 2 ml of buffered physiological sodium chloride solution] and 1 needle 21G x 1 ½ (0.8 x 40 mm).

Code. 6000001389