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Sinovial

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					Sinovial
                           ®



(sodium hyaluronate for intra-articular injection)




DESCRIPTION

Hyaluronic acid (HA) is a very important component                 In pathological conditions, there is a reduction of
of the articular cartilage and has a significant role in           the HA synthesis by the synoviocytes and the
maintaining the articular homeostasis. The                         production of a form of HA which is not able to
concentration of HA in the synovial fluid of human                 guarantee      the     metabolic   balance      with
knee is about 2.5-4.0 mg/ml in normal conditions. In               consequent impact on the articulation.
patients suffering from rheumatoid arthritis (RA) or               The substitution of the damaged fluid with an
osteoarthritis (OA) its concentration is halved. HA                intra-articular injection of HA having the same
contributes to the lubrication of the articulation,                properties of the original synovial fluid is able to
shock absorption and nutrition for the articular tissue.           restore the physiological conditions of the joint.


                          Hyaluronan                            CH2OH
                                                                                        OH
                          Disaccharide    O HO                    O
                                                3
                                                                   O HO                  1
                                                                          4
                                                                                             O
                                                 HNCOCH3                            O
                                                                  Na OOC
                                                                     +-




                                          N-Acetyl-D-Glucosamine          Na-D-Glucuronate



PRODUCT CHARACTERISTICS

• Sinovial ® is a medical device constituted by a                  • The effects of Sinovial ® are already evident
physiological solution of sodium hyaluronate (NaHA) in             starting from the 1st injection (out of a cycle of 3 to 5)
sterile syringe for intra-articular injections ready to use.1      and last up to 6 months, suggesting a long-lasting
• Sodium hyaluronate is obtained by bio-fermentation               carry-over effect of the treatment.1-5
(Streptococcus of Lancefields group A and C)
throughout high purification processes which ensure a              Sinovial ® is available in the following ready-to-use
final product with a defined molecular weight (800-1200            formulations:
KDalton).1                                                         • Sinovial ® 0.8% (16mg HA in 2mL) for an effective
• Sinovial ® is totally free from the animal proteins              and well tolerated viscosupplementation in knee OA
occurring in the extractive materials.1                            and other conditions.1-5
• Sinovial ® is indicated in case of replacement                   • Sinovial ® 1.6% (32mg HA in 2mL) indicated
and/or complementing of synovial fluid damaged                     especially for those conditions when a major joint
following degenerative or traumatic origin diseases                lubrication and an attack therapy in OA are needed.
of the articulation.1-5                                            • Sinovial ® mini, a 0.8% physiological solution of
• The administration of Sinovial ® results in a                    sodium hyaluronate at a low volume (8mg HA in
marked pain reduction, improvement of the articular                1mL), in case of infiltration of little joints (e.g.
mobility, decreased use of rescue medication.1-5                   rhizarthrosis, tenosynovitis, trigger finger).1,6,7
MAIN DIFFERENTIATING POINTS FROM OTHER HA

A) Molecular weight

1) Low-to-mid molecular weight (MW) hyaluronic                                         more effective than high MW HAs in reducing
acids which consist in long unbranched chains of                                       synovial inflammation and for the restoration of
natural hyaluronan, not chemically modified.                                           the rheological properties of synovial fluid (the
Products belonging to this category are ie:                                            so-called viscosupplementation effect).8,9
Sinovial ® (MW=800-1200 kDa);                                                          2) High molecular weight hylans which consist in
Hyalgan ® (MW=500-730 kDa).                                                            chemically modified cross-linked hyaluronan
Evidences from large animal models of OA show                                          chains. A product belonging to this category is ie:
that HAs with MW between 500-1000 KDa are                                              Synvisc ® (MW=6000 kDa).


B) Viscoinduction

The long-lasting effect compared to the relatively                                     The viscoinduction effect of HA may by far exceed
short half-life of intra-articular hyaluronic acid may                                 that of the lubricant effect and represents a most
be explained by its CD44-mediated metabolic                                            advanced explanation of the mechanism of action
modulation.                                                                            of HA with low-to-mid MW.8


C) Source of hyaluronan

Sinovial ® is obtained by biofermentation, which                                       obtained by extraction from rooster combs with a
ensures that the product is pure and free of potentially                               potential increased risk of immunogenicity due to the
allergenic animal proteins. Other HAs/hylans are                                       presence of avian proteins.10,11


IN SUMMARY

Sinovial ® represents a modern approach which contributes to normalize the articular liquid with reduction
in pain and improvement in articular mobility.




Other IBSA’s hyaluronic acid trademarks: Yaral ®/Yaral ® Forte/Yaral ® Mini, Intragel ® 0,8%/Intragel ® 1,6%




REFERENCES                                                                             5.    Depont F. et al. Osteoporosis International 2004; 17 (1): S103 (abstract P363).
1. Gigante A. and Callegari L.. Rheumatology International 2010; DOI                   6.    Callegari L. et al. Topics di terapia intra-articolare 2009; 1 (1): 15-19.
   10.1007/s00296-010-1660-6                                                           7.    Roux C. et al. Joint Bone Spine 2007; 74: 368-372.
2. Pavelka K. et al. Osteoporosis International 2010; 21 (1): S387 (abstract P 902).   8.    Ghosh P. and Guidolin D. Semin. Arthritis Rheum. 2002; 32 (1): 10-37.
3. Theiler R. and Brühlmann P. Current Medical Research Opinion 2005; 21 (11):         9.    Vitanzo P.C. and Sennett B.J. Am. Journ. Orthop. 2006; 35 (9): 421-8.
   1727-1733.                                                                          10.   Hamburger M.I. et al. Semin. Arthritis Rheum. 2003; 32 (5): 296-309.
4. Castellacci E. and Polieri T. Drugs Exptl. Clin. Res. 2004; XXX (2): 67-73.         11.   Goldberg V.M. and Coutts R.D. Clin. Orthop. Relat. Res. 2004; (419): 130-7.




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