1 Syringe x 3ml per pack
DUROLANE® is an intra-articular injection used for the symptomatic treatment of mild to moderate osteoarthritis of the knee or hip. In addition, DUROLANE® is used in intra-articular injections for the symptomatic treatment of mild to moderate osteoarthritis of the indicated synovial joints and for pain relief following arthroscopic procedures in the presence of mild to moderate osteoarthritis. DUROLANE® is a sterile, clear viscoelastic gel supplied in a 3 mL glass syringe. The product is for single use only.
DUROLANE® contains 20 mg/mL of non-animal hyaluronic acid stabilized in a physiological buffer solution of sodium chloride of pH 7. Each box of DUROLANE® contains a 3mL pre-filled syringe and a patient implant card. The needle is not provided. DUROLANE® is not reimbursed by social security. Only on medical prescription. The product must be injected by a qualified physician.
Each mL of Durolane® contains: • Hyaluronic acid, stabilized 20 mg. • Physiological solution of sodium chloride, pH 7 qs • Contains ≤ 2 ppm of 1,4-butanediol diglycidyl ether (BDDE), used to stabilize the gel.
DUROLANE®, stabilized hyaluronic acid in single injection is a medical device intended to be used by your doctor in intra-articular injection for the symptomatic treatment of mild to moderate osteoarthritis of the knee or hip. DUROLANE® is also intended to be used for the symptomatic treatment associated with mild to moderate osteoarthritic pain of the ankle, shoulder, elbow, wrist, fingers and toes. DUROLANE® is also indicated to relieve pain following joint arthroscopy in the presence of osteoarthritis for three months following the procedure. This medical device is a regulated health product which bears, under this regulation, the CE marking (CE2797). Read the instructions carefully and seek advice from your doctor. DUROLANE® is not reimbursed by Social Security. Only on medical prescription. Manufacturer: Bioventus LLC. Distributor: medac SAS DUROLANE®, Bioventus® and the Bioventus® logo are registered trademarks of Bioventus LLC. Revision date: June 2024.
Summary of Indications for Use:
DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.
Do not inject DUROLANE in patients with knee joint infections, skin diseases, or other infections in the area of the injection site. Do not administer to patients with known hypersensitivity or allergy to sodium hyaluronate preparations. Risks can include transient pain or swelling at the injection site.
DUROLANE has not been tested in pregnant or lactating women, or children.
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