{"product_id":"ostenil-plus-1-x-2-ml","title":"Ostenil Plus 1x 2.0 ml","description":"\u003cdiv class=\"page\" title=\"Page 1\"\u003e\n\u003cdiv class=\"section\"\u003e\n\u003cdiv class=\"layoutArea\"\u003e\n\u003cdiv class=\"column\"\u003e\n\u003cp\u003e\u003ca href=\"https:\/\/stakonmed.de\/collections\/ostenil\" title=\"Ostenil | Joint Injections | StakonMed\"\u003eOSTENIL\u003c\/a\u003e® PLUS\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSodium hyaluronate 2.0%. A viscoelastic solution for injection into the joint space to improve mobility and relieve pain in osteoarthritis. Transparent solution made from natural, highly purified sodium hyaluronate obtained by fermentation. Free from animal proteins. Sterilized with moist heat. The contents and the outer surface of the OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS prefilled syringe are sterile as long as the sterile barrier is intact. For single use only.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eComposition:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e1 ml isotonic solution (pH 7) contains 20.0 mg sodium hyaluronate, sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol, and water for injection purposes.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIndications:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003ePain and restricted mobility of the knee and other large synovial joints such as hip and shoulder.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eContraindications:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eOSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS must not be administered to patients with known hypersensitivity to any of the components of the product.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003ePrecautions:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eTreatment with OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS is not recommended for children, pregnant or breastfeeding women, or in inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis. If a joint effusion is present, it should be reduced first. National guidelines for intra-articular injections must be followed, including thorough disinfection of the injection site and other measures to prevent joint infections. OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS should be injected precisely into the joint space, if necessary under imaging guidance. Avoid injections into blood vessels or surrounding tissue. Do not use if the prefilled syringe or sterile packaging is damaged. Any solution not used immediately after opening must be discarded. Otherwise, sterility cannot be guaranteed, which may pose an infection risk. Do not resterilize, as this may damage the product. There is currently no information on impairment of diagnostic procedures such as MRI, clinical assessments, or therapeutic treatments by OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eInteractions: \u003c\/span\u003e\u003cspan\u003eThere is currently no information on incompatibility of OSTENIL® PLUS with other medical devices and drugs for intra-articular use or with oral analgesics or anti-inflammatory drugs.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSide effects:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn very rare cases (less than 1 in 10,000 patients), local reactions such as pain, warmth, redness, swelling\/joint effusion, itching, and other local intolerance reactions may occur during or after injection of OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS. As with all invasive joint treatments, infection may occur in very rare cases. It cannot be completely excluded that in very rare cases the intra-articular injection itself causes systemic side effects such as tachycardia, hypotension, hypertension, palpitations, nausea, and shortness of breath. These reactions may occur independently of the applied solution. Patients should be informed about contraindications and side effects before injection of OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eReporting of side effects:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAny serious incident related to the medical device must be reported to the manufacturer TRB Chemedica AG and the responsible local authority of the user.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDosage and administration:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eInject OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS a total of 1 to 3 times at weekly intervals into the affected joint. Multiple joints can be treated simultaneously. Depending on the severity of the joint disease, the positive effect can last at least six months. If necessary, the treatment cycle can be repeated. Remove the prefilled syringe from the sterile packaging, remove the Luer Lock cap from the syringe, attach a suitable needle with Luer connection (e.g., 18 to 25 G) and lock it by slight rotation. Remove any air bubbles from the syringe before injection.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDisposal:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDispose of the syringe immediately after use in an appropriate safety container. Do not dispose of the OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS prefilled syringe in household waste. Follow local regulations for proper disposal of the safety container.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eProperties and mode of action:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSynovial fluid, which behaves viscoelastically due to the presence of hyaluronic acid, is found in all synovial joints, where it ensures normal, pain-free movement due to its lubricating and cushioning properties. In degenerative joint diseases such as osteoarthritis, the viscoelasticity of synovial fluid is significantly reduced, impairing its lubricating and cushioning properties. This increases mechanical stress on the joint and cartilage destruction, ultimately leading to pain and restricted mobility of the affected joint. Supplementing this synovial fluid by intra-articular injections with highly purified hyaluronic acid can improve the viscoelastic properties of the synovial fluid. Lubricating and cushioning properties are enhanced, and mechanical overload of the joint is reduced. Clinical studies have shown pain relief and improved joint mobility for up to six months.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eOSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS additionally contains mannitol, a radical scavenger that helps stabilize the sodium hyaluronate chains.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eStorage:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eStore in a dry, light-protected place at 2°C to 25°C! Do not use after the expiration date indicated on the packaging. Keep out of reach of children.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDosage form:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e1 prefilled syringe containing 40 mg\/2.0 ml OSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS in sterile packaging.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAs long as the EUDAMED database is not fully operational, the report on safety and clinical performance (SSCP) is available to the public on the company website www.trbchemedica.de.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eOSTENIL\u003c\/span\u003e\u003cspan\u003e® \u003c\/span\u003e\u003cspan\u003ePLUS is a medical device. It may only be used by a physician experienced and trained in intra-articular injections.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDate of last revision: 2022-01\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"TRB Chemedica AG","offers":[{"title":"Default Title","offer_id":47355880014164,"sku":"128","price":57.85,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0786\/8756\/8212\/files\/ostenil-plus-trb-chemedica-ag-gelenkspritzen-stakonmed-821548.jpg?v=1772215064","url":"https:\/\/stakonmed.com\/products\/ostenil-plus-1-x-2-ml","provider":"StakonMed","version":"1.0","type":"link"}