Description
Medical device designed to supplement synovial fluid, restoring the physiological and rheological properties of osteoarthritic joints and tendons.
The HA chains of different molecular weights present in SINOVIAL HL 32 1 ml, thanks to a specific and patented treatment of the solution, interact with each other, giving SINOVIAL HL 32 1 ml unique rheological characteristics that allow for higher concentrations of hyaluronic acid to be administered at the same solution viscosity. The HA chains of different molecular weights in SINOVIAL HL 32 1 ml provide greater resistance to hyaluronidase, as this enzyme is unable to recognize the conformation of these high and low molecular weight complexes. Therefore, SINOVIAL HL 32 1 ml is more suitable for in vivo applications in tissues. In vitro studies have been conducted to identify any incompatibilities and/or interactions between SINOVIAL HL 32 1 ml and platelet-rich plasma (PRP), used for intra-articular infiltrative treatment of osteoarthritis. The results show that PRP does not alter the rheological behavior of sodium hyaluronate, which therefore retains its viscosupplementation function; moreover, the results of studies conducted on human mesenchymal stem cell (MSC) cultures differentiated into chondrocytes demonstrate no cellular suffering, an indicator of toxicity: there is therefore no reason to believe that the biocompatibility of SINOVIAL HL 32 1 ml is altered by the concomitant administration of PRP.
SINOVIAL HL 32 1 ml, with its particular formula, belongs to the latest generation of osteoarthritis treatments and is indicated in cases of pain or reduced mobility due to degenerative conditions (osteoarthritis), post-traumatic conditions, and tendinopathies associated with joint disability.
SINOVIAL HL 32 1 ml is also indicated in cases of acute and chronic tendinopathies and/or associated with joint disability, and in the tendon repair process, even after surgical interventions.
It reduces pain and promotes the recovery of associated joint and tendon mobility, acting only in the synovial cavity where it is injected, without exercising any systemic action.
Furthermore, SINOVIAL HL 32 1 ml, thanks to its lubricating and viscoelastic characteristics, acts at the level of the tendon sheath where it improves tendon gliding and physiological healing/repair processes, thereby preventing the formation of adhesions in post-operative courses. The treatment can involve up to three injections depending on the severity of the joint and/or tendon degeneration. The advisability and frequency with which the treatment can be repeated must be evaluated by the physician for each individual patient, considering in each case the risk/benefit ratio of the treatment.

Instructions for use
Aspirate any joint effusion before proceeding with the injection of SINOVIAL HL 32 1 ml.
Carefully unscrew the syringe cap, holding the "Luer Lock" collar firmly between your fingers and paying particular attention to avoid contact with the opening. Insert the needle into the Luer Lock collar of the syringe (needle with diameter 22G or 29G included in the package) screwing it firmly until a slight pressure is felt, to ensure a watertight seal and prevent liquid leakage during administration, while holding the "Luer Lock" collar firmly between your fingers.
Inject SINOVIAL HL 32 1 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
SINOVIAL HL 32 1 ml can only be injected by a physician.
The contents of the pre-filled syringe are sterile. The syringe and needles are packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use SINOVIAL HL 32 1 ml after the expiry date indicated on the package.
Do not use SINOVIAL HL 32 1 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 32 1 ml in the presence of abundant 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, SINOVIAL HL 32 1 ml must be used immediately and disposed of after use.
Keep out of reach and sight of children.
After 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 product's characteristics.
Do not mix SINOVIAL HL 32 1 ml with disinfectants such as quaternary ammonium salts or chlorhexidine, as a precipitate may form.
HL 32 1 ml may cause local side effects. During the use of SINOVIAL HL 32 1 ml, symptoms such as pain, warmth, redness, or swelling may appear at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. Normally, they disappear after a short time. The physician must ensure that patients inform them of any side effects that occurred after treatment.
SINOVIAL HL 32 1 ml should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the area of the injection site.
To date, no interactions between SINOVIAL HL 32 1 ml and other drugs are known. Based on the in-vitro data available to date, no chemical-physical and biological interactions are known between SINOVIAL HL 32 1 ml and Platelet-Rich Plasma (PRP), used for intra-articular infiltrative treatment of osteoarthritis.

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 [16 mg (H-HA + 16 mg (L-HA) of hyaluronic acid sodium salt in 1 ml of buffered sodium chloride physiological solution];
- 1 needle 29 G x ½" TW (0.3 x 12 mm), for small joints;
- 1 needle 22 G x 1 ½" (0.7 x 40 mm), for large joints.

Code. 6000001359