Description
Visco-supplementary joint device.
The sodium salt of hyaluronic acid is formed by repeating chains of disaccharide units of N-acetylglucosamine and sodium glucuronate and represents a fundamental component of the synovial fluid, to which it gives its particular viscoelastic properties.
Consisting 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 through fermentation and has not undergone chemical modification. This results in excellent tolerability. Furthermore, the HA chains with 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 for the administration of higher concentrations of hyaluronic acid with 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 in cases of acute and chronic tendinopathies and/or those associated with joint disability and in the tendon repair process, even following surgery.
Designed to supplement synovial fluid, restoring the physical and rheological properties of arthritic joints and tendons. In the joint, SINOVIAL HL 64 2 ml reduces pain and promotes recovery of associated joint and tendon mobility, acting only in the synovial cavity into which it is injected, without exerting any systemic action.
Thanks to its lubricating and viscoelastic properties, it acts on the tendon sheath, improving tendon gliding and the physiological healing/repair processes, thus preventing the formation of adhesions in the post-operative period. Treatment may consist of up to three injections, depending on the severity of the joint and/or tendon degeneration. The appropriateness and frequency of repeat treatment must be assessed by the physician for each individual patient, 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” 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 (18 or 22G diameter needle included in the package) and screw it firmly until you feel a light pressure, so as to ensure a watertight seal and prevent the liquid from leaking during administration, keeping the “Luer Lock” closure collar firmly between your fingers.
Inject SINOVIAL HL 64 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
High molecular weight hyaluronic acid (H-HA) and low molecular weight hyaluronic acid (L-HA), sodium chloride, sodium phosphate and water for injections.

Warnings
- The contents of the pre-filled syringe are 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 large 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 discarded after use.
- Keep out of the reach and sight of children.
- After the injection, advise the patient to avoid all strenuous 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 the product with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
- The product 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.

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

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

Cod. 6000001389