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ORTHOFLEX® gel//Intra articular injection for the treatment of osteoarthritis

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Prefilled syringes|

A new generation of viscosupplement

 

 

 

 

Viscoelastic solution consisting of highly purified cross linked biopolymers

 

  • Sodium hyaluronate =36 mg/ 2,25 ml 

  • Chondroitin sulfate = 67,5 mg/2,25 ml

  • N-acetylgucosmine = 67,5 mg.2,25 ml


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Description

 

  • ORTHOFLEX gel is a bio- matrix in the form of a sterile ,viscoelastic solution consisting of highly purified cross linked biopolymers ,sodium hyaluronate and chondroitin sulfate and n-acetylglucosamine.

  • ORTHOFLEX gel , administered as a single injection , restores good lubrication and shock absorption in the joint , and well provide significant improvement of symptoms.

Effects

 

Sodium hyaluronate, chondroitin sulfate and N-acetylgucosmine with ORTHOFLEX gel® in the treatment of degenerative diseases of synovial joints.

 

  • The unique combination between Glucosamine, Chondroitin sulfate with hyaluronic acid can  provide a complete product   for maintaining healthy joints.

  • It provides not only special protective properties between the joints but also movement of the joints fluid itself, transport nutrients and help reduce inflammation within the joints .

  • Hyaluronic acid is major component of the synovial fluid and cartilage and thanks to its viscoelastic and rheological properties is responsible of the lubrication and cushioning in joints.it decreases friction between joint surface and protects soft tissue from trauma by acting as a shock absorber.

  • Chondroitin sulfate ,a sulfate glycosaminoglycan, is an important structural component of the extracellular cartilage matrix .The role of chondroitin sulfate is to optimize the rheological behavior of hyaluronic acid , due to specific interactions.

  • N - acetylglucosamine which has stimulatory effect on hyaluronic acid synthesis in human articular chondrocytes and synovial fibroblast inhibs nitric oxide which in  turn reduce apoptosis  in cultured human chondrocytes.

Indications

 

The treatment consists in administration of intra-articular single treatment : 

 

  • ORTHOFLEX  gel is indicated as a viscoelastic supplement or a replacement for synovial fluid in human joints .

  • Orthoflex gel is product for viscosupplementation which is safe ,effective and well established treatment in osteoarthritis consisting in injecting a hyaluronic acid based solution into the affected synovial joint.

  • ORTHOFLEX gel is indicated for symptomatic treatment of non-inflammatory degenerative diseases of synovial joints , such as knee osteoarthritis.

  • The actions of ORTHOFLEX gel are lubrication and mechanic support.

  • Any joint in the body may  be affected (hand ,hip, knees, lower back, shoulder )

Physicochemical Properties:

 

Must be administered strictly intra-articular, 2 treatment per year  every 6 month according to the doctors recommendations. : 

 

  • Composition:  Sodium hyaluronate + Chondroitin sulphate + Nacetylglucosamine

  • Molecular weight:  3 Mio Dalton

  • Indication:  Osteoarthritis

  • Effect:  Pain relief, improve the movement of joints, protects the cartilage

  • Administration:  Intra-articular, 2 treatment per year  every 6 month

  • Packaging    2,25 ml prefilled syringe medical blister

  • 36 mg/2, 25 ml sodium hyaluronate

  • 67,5 mg/ 2,25 ml chondroitin sulfate

  • 67,5 MG/2,25ml N- acetylglucosamine

  • Storage    15 -25 °C

Quality:

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ORTHOFLEX gel® 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.

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