Sodium Hyaluronate Gel (for Intra-Articular Injection)

Specifications

PRODUCT CHARACTERISTICS:
Is a medical device constituted by a physiological solution of sodium hyaluronate (NaHA) in sterile syringe for intra-articular injections ready to use.

Sodium hyaluronate is obtained by bio-fermentation (Streptococcus of Lancefields group A and C)
Throughout high purification processes which ensure a final product with a defined molecular weight (800-1200 KDalton).

Is totally free from the animal proteins occurring in the extractive materials.

Is indicated in case of replacement and/or complementing of synovial fluid damaged following degenerative or traumatic origin diseases of the articulation.

Results in a marked pain reduction, improvement of the articular mobility, decreased use of rescue medication.
* The effects Are already evident starting from the 1st injection (out of a cycle of 3 to 5) and last up to 6 months, suggesting a long-lasting carry-over effect of the treatment.

Is available in the following ready-to-use formulations:
* 0.8% (16mg HA in 2mL) for an effective
And well tolerated viscosupplementation in knee OA and other conditions.
* 1.6% (32mg HA in 2mL) indicated
Especially for those conditions when a major joint lubrication and an attack therapy in OA are needed.
* Mini, a 0.8% physiological solution of sodium hyaluronate at a low volume (8mg HA in
1mL), in case of infiltration of little joints (e. G. Rhizarthrosis, tenosynovitis, trigger finger).

MAIN DIFFERENTIATING POINTS FROM OTHER HA
A) Molecular weight
1) Low-to-MID molecular weight (MW) hyaluronic acids which consist in long unbranched chains of natural hyaluronan, not chemically modified. Products belonging to this category are ie:
(MW=800-1200 kDa); Hyalgan® (MW=500-730 kDa).

Evidences from large animal models of OA show that HAs with MW between 500-1000 KDa are more effective than high MW HAs in reducing synovial inflammation and for the restoration of the rheological properties of synovial fluid (the so-called viscosupplementation effect). 8, 9 2) High molecular weight hylans which consist in chemically modified cross-linked hyaluronan chains. A product belonging to this category is ie: Synvisc® (MW=6000 kDa).

B) Viscoinduction
The long-lasting effect compared to the relatively short half-life of intra-articular hyaluronic acid may be explained by its CD44-mediated metabolic modulation.

The viscoinduction effect of HA may by far exceed that of the lubricant effect and represents a most advanced explanation of the mechanism of action of HA with low-to-MID MW.

C) Source of hyaluronan
Is obtained by biofermentation, which ensures that the product is pure and free of potentially allergenic animal proteins. Other HAs/hylans are
Obtained by extraction from rooster combs with a potential increased risk of immunogenicity due to the presence of avian proteins.