Device Dossier
Durolane - Synovial fluid supplementation substance
Device Dossier for Durolane - Synovial fluid supplementation substance (Synovial fluid supplementation substance, Class III, sponsor Emergo). ARTG…
- GMDN category: Synovial fluid supplementation substance
Intended purpose
DUROLANE is intended to be used for intra-articular injection for the symptomatic treatment of mild to moderate knee or hip osteoarthritis and mild to moderate osteoarthritis pain in the ankle, shoulder, elbow, wrist, fingers, and toes. DUROLANE is also indicated for pain following joint arthroscopy in the presence of osteoarthritis within three months of the procedure.
Functional description
DUROLANE is a sterile, transparent viscoelastic gel supplied in a 3 mL glass syringe and contains 20 mg/mL of stabilized hyaluronic acid. DUROLANE is a single injection, single dose preparation and should only be injected once per treatment course. Injections of hyaluronic acid in the joint, is intended to restore the viscosity and elasticity and may diminish pain and improve mobility of the joint.