Description
Medical device designed to integrate synovial fluid, allowing the physiological and rheological properties of arthritic joints and tendons to be restored.
The HA chains of different molecular weights present in SINOVIAL HL 32 1 ml, thanks to a specific and patented solution treatment, interact with each other, giving SINOVIAL HL 32 1 ml unique rheological characteristics that allow the administration of higher concentrations of hyaluronic acid at the same solution viscosity. The HA chains of different molecular weights in SINOVIAL HL 32 1 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 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 the intra-articular infiltrative treatment of osteoarthritis. The results obtained demonstrate that PRP does not alter the rheological behavior of sodium hyaluronate, which therefore retains its viscosupplementation function. Furthermore, the results of studies conducted on cultures of human mesenchymal stem cells (MSCs) differentiated into chondrocytes demonstrate that there is no cellular damage, 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 treatments for osteoarthritis and is indicated in cases of pain or reduced mobility due to degenerative conditions (arthrosis), 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 those associated with joint disability and in the tendon repair process, even following surgical interventions.
It 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.
Furthermore, thanks to its lubricating and viscoelastic properties, SINOVIAL HL 32 1 ml acts on the tendon sheath, improving tendon gliding and the physiological healing and repair processes, thus preventing the formation of adhesions in the post-operative period. Treatment may require up to three injections depending on the severity of the joint and/or tendon degeneration. The appropriateness and frequency with which treatment can be repeated must be assessed by the physician for each individual patient, considering in each case the risk/benefit ratio of the treatment.

How to use
Aspirate any joint effusion before injecting SINOVIAL HL 32 1 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 collar of the syringe (22G or 29G needle included in the package) and screw it firmly until you feel a slight pressure, ensuring a watertight seal and preventing leakage during administration, while holding the Luer Lock collar firmly between your fingers.
Inject SINOVIAL HL 32 1 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
SINOVIAL HL 32 1 ml can only be injected by a doctor.
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 shown 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 via a vascular route. 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 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 SINOVIAL HL 32 1 ml 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 presence of an air bubble does not affect the characteristics of the product.
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. Symptoms such as pain, heat, redness, or swelling may appear at the injection site when using SINOVIAL HL 32 1 ml. These side effects can be alleviated by applying ice to the treated area. They usually disappear after a short time. Physicians should ensure that patients are informed of any side effects that occur after treatment.
SINOVIAL HL 32 1 ml must not be injected if the joint is infected or severely inflamed or if the patient has a skin condition or infection in the area of ​​the injection site.
To date, no interactions are known between SINOVIAL HL 32 1 ml and other drugs. Based on in vitro data available to date, no chemical, physical, or biological interactions are known between SINOVIAL HL 32 1 ml and Platelet-Rich Plasma (PRP), used for the intra-articular infiltrative treatment of osteoarthritis.

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 [16 mg (H-HA + 16 mg (L-HA) hyaluronic acid sodium salt in 1 ml of sodium chloride buffered saline 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.

Cod. 6000001359