Denmark Skift (land)
Fermathron™
Fermathron™ is a sodium hyaluronate viscosupplement for intra-articular injection into the synovial space of synovial joints in patients suffering from mild to moderate osteoarthritis or degenerative or traumatic changes to the synovial joint.
Features
- 1% /(w/v) sodium hyaluronate in a phosphate buffered saline for intra-articular injections
- for the relief of pain and stiffness of synovial joints, including the knee
- for patients with degenerative and traumatic changes to synovial joints
- for patients with mild to moderate osteoarthritis
- 3 up to 5 injections once a week
- 5 injections into the knee joint relieve symptoms for at least 6 months
- manufactured by a continuous bacterial fermentation process
- pseudoplastic behaviour: lubricant and shock absorber
- sterilised by filtration and the outer surface of the syringe has been sterilised by ethylene oxide
Osteoarthritis
Osteoarthritis is a non-inflammatory progressive disorder affecting moveable joints, in particular weight-bearing joints like the knee. The disease causes alterations in the composition of the synovial fluid and these changes result in reduction in several of the physiological protective functions of the synovial fluid. Intra-articular injection with the natural, viscoelastic material hyaluronan has been shown in clinical studies to be an effective therapy for reducing pain and increasing mobility in this debilitating condition.
These changes in rheological properties result in disruption of the collagen network and sensitisation of the pain receptors in the capsule.
Supplementation of the natural synovial fluid with hyaluronan restores and augments the rheological properties of the synovial compartment. Its use in humans was first described in 1971 and since then many studies have shown this to be an effective therapy for symptom relief.
Production
Fermathron™ is a solution of sodium hyaluronate for intra-articular injection. The sodium hyaluronate has a molecular weight of 1 million
The sodium hyaluronate is manufactured by continuous fermentation of the natural bacterium Streptococcus equi. The continuous fermentation provides a steady state environment in which the growth of the micro-organisms is balanced and cell-wall turnover and breakdown is minimised thus reducing the production of any toxic metabolites. The sodium hyaluronate is produced as a capsule around the outside of the bacterial cell so that the sodium hyaluronate can be extracted without disrupting the bacterial cell. This continuous bacterial fermentation process therefore allows a simple though rigorous purification process that results in a highly purified product.
Physical properties
One of the essential properties of hyaluronan and hyaluronan solutions is its pseudoplastic behaviour. Thus, solutions of hyaluronan can serve as effective lubricants when movements are slow and as shock absorbers when movements are fast. This behaviour is dependent on the fact that the molecule, which is highly folded at rest, begins to unfold as shear is applied and reaches a liquid state when completely unfolded. Fermathron™ consists of long-chain, highly folded molecules that exhibit the classical variation of viscosity with shear rate characteristic of pseudoplastic behaviour.
Presentation
Fermathron™ is presented as a clear solution of sterile 1% (w/v) sodium hyaluronate in a phosphate buffered saline. 2.0 ml Fermathron™ sterilised by filtration is enclosed within a disposable glass syringe, ready-to-use. The syringe is packed within a blister pack and an outer cardboard carton. The outer surface of the pre-filled syringe has been sterilised by ethylene oxide.
Administration
The recommended dosage regimen is injection into the affected synovial joint space once a week for 3 up to 5 injections, depending on the severity of the degenerative or traumatic change of the synovial joint. The recommended dosage regimen for patients with mild to moderate osteoarthritis of the knee joint is up to 5 weekly injections of 2.0 ml of Fermathron™ into the synovial space of the knee joint. This therapy regimen will relief of symptoms for at least 6 months.
Ensure that the area of the injection is free from infection or skin disease. Clean the skin around the injection site with antiseptic and allow to dry before the injection is given. If joint effusion is present, aspirate before the injection of Fermathron™ is given.
The contents of the syringe are sterile and should be injected using a sterile needle of an appropriate size (19 to 20 gauge is recommended). The syringe is fitted with a Luer lock (6%).
Current papers:
(1) Balazs EA, Denlinger JL. Viscosupplementation: A new concept in the treatment of osteoarthritis. Journal of Rheumatology 1993; 20(suppl 39): 3-9.
(2) Lequesne MG, Mery C, Samson M, Gerard P. Indexes of severity for osteoarthritis of the hip and knee. Scandinavian Journal of Rheumatology 1987; suppl 65: 85-89.
(3) McDonald C, Hantel S, Strohmeier M. A randomised controlled study to compare the performance and safety of two sources of sodium hyaluronate given as a viscosupplement by intra-articular injection to patients with osteoarthritis of the knee. Journal of Clinical Research 2000; 3: 41-50.
(4) Rydell N, Balazs EA. Effect of intra-articular injection of hyaluronic acid on the clinical symptoms of osteoarthritis and on granulation tissue formation. Clinical Orthopaedics 1971; 1(80): 25-32.
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