Device Dossier
Euflexxa 1% sodium hyaluronate - Synovial fluid supplementation substance
Device Dossier for Euflexxa 1% sodium hyaluronate - Synovial fluid supplementation substance (Synovial fluid supplementation substance, Class III,…
- GMDN category: Synovial fluid supplementation substance
- Sponsor: Ferring Pharmaceuticals
Intended purpose
EUFLEXXA is indicated for the treatment of pain caused by osteoarthritis of the knee joint or other synovial joints. EUFLEXXA aids in lubrication of the joint, allows for greater mobility and flexibility of the treated joint, and reduces pain in the affected joint.
Functional description
A very highly purified viscoelastic, sterile solution of highly purified, high molecular weight (2.4-3.6 million daltons) hyaluronan (also known as sodium hyaluronate) in phosphate-buffered saline; extracted from bacterial cells. A polysaccharide consisting of a repeating disaccharide of N-acetylglucosamine and sodium glucuronate, linked by alternating b? 1,3 and b? 1,4 glycosidic bonds.