GENERAL PROPERTIES

Sodium Hyaluronate

Osteoarthritis is a degenerative joint disease that causes pain and loss of mobility. It is the most common rheumatic disease and is second only to cardiovascular disease in producing chronic disability.

Osteoarthritis is not a passive ?wear and tear? phenomenon, as was believed until recently. It is an active disease with a complex underlying pathology.

Ostenil® is a novel agent that has been developed specifically for the treatment of osteoarthritis. It is a solution of hyaluronan (sodium hyaluronate) and is administered intra-articularly as a course of three to five weekly injections. The molecular weight of the hyaluronan in Ostenil® has been carefully selected to produce an optimal therapeutic profile. The beneficial effects of Ostenil® develop gradually during a course of injections and persist for several months. Following a course of five injections, symptomatic improvement can be expected to last for up to 6 months. BIOCOMPATIBILITY Results of acute, sub-acute and chronic toxicity studies together with the results of the foetal toxicity, fertility, peri-and post-natal toxicity studies show that sodium hyaluronate is well tolerated. INTERACTIONS No information on the incompatibility of OSTENIL® with other solutions for intra-articular use is available to date. STORAGE Store below 25°C in original sterile pack, away from heat sources and light. Do not freeze. SHELF-LIFE 3 years if stored in original unopened package at room temperature, below 25°C. PACKAGING Three pre-filled syringe of 20 mg/2.0ml OSTENIL® in a sterile pack To be sold under physician?s prescription For sale in pharmacies only. TRB CHEMEDICA S.A. Rue Michel-Servet,12 P.O.- Box 352 CH-1211 Geneva 12 Switzerland Tel : +41 (0) 227 03 49 00 Fax : +41 (0) 227 03 49 01 info@trbchemedica.com TRB CHEMEDICA A.G. D-85540 Haar/Munich Germany Tel. ++49 89 46 20 08 47 Fax. ++49 89 46 20 08 48