ARTHRUM 75 Description Sterile, non-pyrogenic, physiological viscoelastic solution based on non-crosslinked hyaluronic acid of non-animal origin. The solution is presented in a single-use pre-filled syringe. Each pack contains one syringe of ARTHRUM VISC 75, a leaflet and a set of labels to ensure traceability. Indicated for pain reduction and restoration of joint mobility by replacing and supplementing the elastoviscosity of synovial fluid in the arthritic joint. ARTHRUM VISC 75 exerts its therapeutic effect through viscosupplementation, a process that improves the physiological and rheological properties of synovial fluid in the arthritic knee. ARTHRUM VISC 75 is indicated for the symptomatic treatment of gonarthrosis by intra-articular injection. ARTHRUM VISC 75 should be administered exclusively intra-articularly by a physician for the relief of pain associated with osteoarthritis of the knee. How to use Intended for intra-articular injection by a licensed medical professional, in accordance with local laws in force. Technical skills are essential for successful treatment; this medical device should be used by physicians specialized in injection techniques. The medical device must be used in the original packaging as supplied. Any modification or use of the product, which is not in accordance with the conditions of use described in this leaflet, may compromise its sterility, efficacy and tolerability. The physician must inform the patient about the indications, contraindications, incompatibilities and potential adverse reactions of the medical device before starting treatment. - Before injection, thoroughly disinfect the area to be treated. - Check that the sterile protection is intact. - Take the syringe and remove the protective cap. - Holding the syringe body, insert the needle into the Luer Lock fitting. - Carefully turn the needle clockwise to secure it in the socket. - visually check if the needle is correctly attached. - Remove the needle cap. - Inject slowly. Failure to follow these instructions may result in needle disengagement and/or leakage of the medical device at the Luer Lock connection. The ARTHRUM VISC 75 administration regimen involves an intra-articular injection. components Sodium hyaluronate 75 mg. warnings It should not be administered to: - patients with hypersensitivity to hyaluronic acid; - patients suffering from autoimmune diseases, sarcoidosis, severe multiple allergies, cardiovascular diseases; with the administration of anticoagulants; - patients taking immunosuppressants or interferon; - pregnant or breastfeeding women; - children. Do not administer intravascularly. Do not inject outside the joint cavity, nor into the synovial tissue or capsule. Hyaluronic acid solution (sodium hyaluronate) is incompatible with quaternary ammonium salts, such as benzalkonium chloride. ARTHRUM VISC 75 should never come into contact with the above-mentioned products or surgical materials previously cleaned with them. The physician must inform the patient about potential immediate or delayed adverse reactions related to the administration of this medical device prior to injection. Potential side effects: - Immediate adverse reactions related to the injection: pain, redness, swelling at the injection site. - Adverse reactions of inflammatory origin: Pseudogout attack. Chondrocalcinosis. Pseudoseptic arthritis. - Other side effects: Poor efficacy or poor effect of treatment in a particularly advanced radiological stage of gonarthrosis. The patient should immediately report the appearance and/or persistence of side effects to the doctor, who will need to remedy them with appropriate treatment. Any other adverse reactions related to the administration of the medical device should be reported to the distributor and/or manufacturer. - Check the expiration date written on the label. - Do not reuse, sterility cannot be guaranteed. - Do not resterilize. - It is recommended to use sterile 21G (0.8 x 50 mm) needles with Luer tips and ensure their compatibility with Luer-Lock fittings before use. - Used needles and syringes must be disposed of in the appropriate containers, in accordance with current regulations. Conservation Keep away from frost, heat and light. Shelf life in intact packaging: 36 months. Format 3 ml syringe. Code: RVE 111-3100