Repeat Use

Important Safety Information for HYALGAN®

• HYALGAN® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpha-rmacologic therapy, and to simple analgesics, eg, acetaminophen
• HYALGAN® is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site
• The effectiveness of a single treatment cycle of less than 3 injections has not been established
• In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs placebo was injection-site pain
• Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the HYALGAN®-treated and placebo groups
• In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle

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