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HYMOVIS Description Sterile hydrogel made with Hyadd4 (natural, highly purified sodium hexadecylamide hyaluronate, obtained from bacterial fermentation) in a buffered isotonic solution. Due to the high viscosity and elasticity provided by sodium hexadecylamide hyaluronate, HYMOVIS improves the lubricating and shock-absorbing function of the synovial fluid, protecting cartilage and soft tissue from mechanical damage. These properties, combined with its prolonged permanence in the joints, allow HYMOVIS to relieve pain and improve joint function for up to six months in mild to moderate osteoarthritis of the hip and knee. Indicated for the treatment of patients with mild to moderate osteoarthritis of the knee and hip. The device is indicated for the treatment of osteoarthritis of any nature. HYMOVIS is administered exclusively by intra-articular injection. The product must be administered exclusively by specialized medical personnel (e.g. orthopedic surgeon, rheumatologist, physiologist, radiologist, sports doctor, etc.). Remove any joint effusion, if present, before administration. Inject intra-articularly only. Intra-articular injection should be performed according to standard technique, with precise anatomical location. Ultrasound or radiographic guidance for the hip is recommended. Strictly follow all instructions for aseptic administration. Given its viscosity, inject HYMOVIS slowly into the joint using an appropriate sterile needle (18 or 20 G). The treatment consists of a single injection. No clinical data are available on the administration of more than one injection of HYMOVIS. components Main component: Hyadd4 (sodium hexadecylamide hyaluronate), 32 mg/4 ml. Other ingredients: sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate, water for injections. warnings If there is venous or lymphatic stasis in the affected limb, HYMOVIS should not be injected into the joint. It is not administered to patients with known individual hypersensitivity to the product components or in case of infections or skin conditions in the injection area. Treatment should be avoided if the joint shows signs of acute inflammation. The safety and efficacy of using HYMOVIS in conjunction with other intra-articular treatments have not been established. During the first 48 hours after the injection, the patient can perform all normal daily activities, but it is recommended not to overuse the treated joint. The syringe is for single use; inject the contents into a single joint. The assembled syringe should be discarded immediately after use, regardless of whether the hydrogel has been completely administered or not. If the product is reprocessed and/or reused, Fidia Farmaceutici cannot guarantee its performance, functionality, material structure, cleanliness or sterility. Reuse may result in illness, infection and/or serious injury to the patient or user. Do not use HYMOVIS after the expiry date which is stated on the carton. The expiry date refers to the product when properly stored in the original packaging. Do not use HYMOVIS if the packaging is open or damaged. Keep out of reach of children. Conservation Store in the original packaging between 2°C and 25°C. Do not freeze. Format Box containing 1 pre-filled syringe with Luer Lock system. Code 10001310
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