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ORTHOFLEX® forte//Protect cartilage and greatly improve the joints mobility

Prefilled syringes|

 

Synovial fluid supplement

 

 

 

 

Sodium Hyaluronate 30 mg/2ml

Description

 

  • ORTHOFLEX forte® is a viscoelastic injectable prefilled syringe used intra articular for treating arthritis. It is similar to synovial fluid, a substance that occurs naturally in the joints, synovial fluid acts as a lubricant and shock absorber.

  • ORTHOFLEX forte® is 30mg/2ml solution of highly purified sodium hyaluronate with high molecular weight that guarantees its excellent efficiency and a strong therapeutic effect ( 2,0-2,9 million  daltons).
    Obtained by bio fermentative process, synthetic origin gives a complete safety eliminating any allergic reactions.

  • ORTHOFLEX forte® is a prefilled syringes having aluminum blister for sealing that assure 3 years guarantee of validity, sterilized by autoclaving.

Effects

 

  • ORTHOFLEX forte® has in the medium term, a double effect by restoring in the joints the levels of sodium hyaluronate, restoring also the mechanical properties of synovial fluid and having a long-lasting effect by stimulating naturally the body in secretion of hyaluronic acid. The therapeutic efficacy has been proved up to six months of relief, replaces natural joint fluid to cushion, protect and lubricate the knee, help restore mobility by treating knee pain at its source. 

Indications

 

  • ORTHOFLEX forte® is recommended for patients that have joints pain coupled with reduced mobility. These symptoms can occur as a result of degenerative disease or trauma.

  • ORTHOFLEX forte® greatly reduces pain, treating and restoring joint mobility and elasticity.

  • The treatment consists in administration of intra articular injections between 1 - 3 ORTHOFLEX forte®/1 at weekly intervals depending on the severity of the degenerative or traumatic change to the synovial joint.

  • Indications like Gonarthritis, Coxarthritis, Omarthritis, Arthritis of the elbow, Rhizarthritis and Ankle arthritis.

Physicochemical Properties:

 

  • Treatment  1-3 injection

  • 30mg/2ml (1.5%) sodium hyaluronate

  • Estimative molecular weight sized into 2.0÷2.9 million Daltons (viscometric data)

  • Average molecular weight 2.4 million Daltons( viscometric data)

  • Intrinsic viscosity 1.5 – 3.8m3/kg

  • Osmolarity300 - 370 mOsmol/kg

  • Endotoxin limit -less than 0.5 EU/mg sodium hyaluronate

  • PH 5.0- 8.5

  • Elasticity minimum 60 Pa (2.5Hz, maximum effort)

  • Viscosity minimum  45 Pa (2.5Hz, maximum effort)

                
Quality

  • ORTHOFLEX forte® is produced according to Good Manufacturing Practice (GMP) and ISO13485 being certified as a system with high quality ingredients, CE marked medical device being in accordance with the European Directive  93/42/EE.