{"product_id":"synolis-va-40-80","title":"Synolis VA 40\/80 1x 2.0 ml","description":"\u003ch2\u003eInstructions for use SYNOLIS VA\u003c\/h2\u003e\n\n\u003ch3\u003eDescription\u003c\/h3\u003e\n\u003cp\u003eSYNOLIS VA is a viscoelastic, sterile, apyrogenic, isotonic, buffered 2% sodium hyaluronate solution. The sodium hyaluronate used in SYNOLIS VA is obtained by bacterial fermentation and has a high average molecular weight (MW) of 2 MDa. SYNOLIS VA has a neutral pH of 6.8–7.4, similar to synovial fluid.\u003c\/p\u003e\n\n\u003cp\u003eA high concentration and high molecular weight of sodium hyaluronate combined with a polyol (sorbitol), which limits degradation, give this viscoelastic solution the ability to restore joint lubrication and shock absorption properties similar to those of healthy synovial fluid. SYNOLIS VA works by restoring the physiological and viscoelastic properties of synovial fluid, which are progressively lost during the development of osteoarthritis (OA). SYNOLIS VA thus relieves local pain and discomfort caused by symptomatic OA and improves the mobility of synovial joints.\u003c\/p\u003e\n\n\u003ch3\u003eIntroduction\u003c\/h3\u003e\n\u003cp\u003eSYNOLIS VA is available in two package sizes. Each box contains 1 syringe, traceability labels, and instructions for use. Each product includes an implant card for the patient to be completed by the physician.\u003c\/p\u003e\n\n\u003ctable\u003e\n  \u003ctbody\u003e\n    \u003ctr\u003e\n      \u003cth\u003eSYNOLIS VA 40\/80\u003c\/th\u003e\n      \u003cth\u003eSYNOLIS VA 80\/160\u003c\/th\u003e\n    \u003c\/tr\u003e\n    \u003ctr\u003e\n      \u003ctd\u003ePrefilled glass syringe with 2 ml viscous pain-relieving gel.\u003c\/td\u003e\n      \u003ctd\u003ePrefilled glass syringe with 4 ml viscous pain-relieving gel.\u003c\/td\u003e\n    \u003c\/tr\u003e\n  \u003c\/tbody\u003e\n\u003c\/table\u003e\n\n\u003ch3\u003eComposition\u003c\/h3\u003e\n\u003cp\u003ePer 1 ml:\u003c\/p\u003e\n\n\u003ctable\u003e\n  \u003ctbody\u003e\n    \u003ctr\u003e\n      \u003ctd\u003eSodium Hyaluronate\u003c\/td\u003e\n      \u003ctd\u003e20 mg\u003c\/td\u003e\n    \u003c\/tr\u003e\n    \u003ctr\u003e\n      \u003ctd\u003eSorbitol\u003c\/td\u003e\n      \u003ctd\u003e40 mg\u003c\/td\u003e\n    \u003c\/tr\u003e\n    \u003ctr\u003e\n      \u003ctd\u003eBuffered saline q.s.p.\u003c\/td\u003e\n      \u003ctd\u003e1 ml\u003c\/td\u003e\n    \u003c\/tr\u003e\n  \u003c\/tbody\u003e\n\u003c\/table\u003e\n\n\u003cp\u003eSterilization method: Moist heat.\u003c\/p\u003e\n\n\u003ch3\u003eIndications\u003c\/h3\u003e\n\u003cp\u003eSYNOLIS VA is indicated for the treatment of symptomatic osteoarthritis (OA) to relieve pain and improve mobility after degenerative changes in synovial joints:\u003c\/p\u003e\n\n\u003ctable\u003e\n  \u003ctbody\u003e\n    \u003ctr\u003e\n      \u003cth\u003eSYNOLIS VA 40\/80\u003c\/th\u003e\n      \u003cth\u003eSYNOLIS VA 80\/160\u003c\/th\u003e\n    \u003c\/tr\u003e\n    \u003ctr\u003e\n      \u003ctd\u003eKnee joint\u003c\/td\u003e\n      \u003ctd\u003eKnee and hip joint\u003c\/td\u003e\n    \u003c\/tr\u003e\n  \u003c\/tbody\u003e\n\u003c\/table\u003e\n\n\u003cp\u003eThis treatment is intended for patients who have not responded to conservative, non-pharmacological therapy and simple analgesics and\/or NSAIDs, or who have intolerance to simple analgesics and\/or NSAIDs.\u003c\/p\u003e\n\n\u003ch3\u003eDosage, type, and duration of use\u003c\/h3\u003e\n\u003cp\u003eTreatment must be adjusted according to the patient's radiological and physical condition (Kellgren-Lawrence score, pain, and mobility). Existing clinical data have demonstrated efficacy for different injection schedules depending on the severity of osteoarthritis:\u003c\/p\u003e\n\n\u003ctable\u003e\n  \u003ctbody\u003e\n    \u003ctr\u003e\n      \u003cth\u003eInjection schedule \/ Severity of the disease\u003c\/th\u003e\n      \u003cth\u003eMild to moderate\u003c\/th\u003e\n      \u003cth\u003eModerate to severe\u003c\/th\u003e\n    \u003c\/tr\u003e\n    \u003ctr\u003e\n      \u003ctd\u003e1 injection of SYNOLIS VA 40\/80\u003c\/td\u003e\n      \u003ctd\u003e✓\u003c\/td\u003e\n      \u003ctd\u003e\u003c\/td\u003e\n    \u003c\/tr\u003e\n    \u003ctr\u003e\n      \u003ctd\u003e1 injection of SYNOLIS VA 80\/160\u003c\/td\u003e\n      \u003ctd\u003e✓\u003c\/td\u003e\n      \u003ctd\u003e✓\u003c\/td\u003e\n    \u003c\/tr\u003e\n    \u003ctr\u003e\n      \u003ctd\u003e3 injections of SYNOLIS VA 40\/80 at intervals of 1 week each\u003c\/td\u003e\n      \u003ctd\u003e\u003c\/td\u003e\n      \u003ctd\u003e✓\u003c\/td\u003e\n    \u003c\/tr\u003e\n  \u003c\/tbody\u003e\n\u003c\/table\u003e\n\n\u003cp\u003eAn additional injection of SYNOLIS VA can be given if OA symptoms reoccur or to maintain local pain treatment and joint function. However, in patients who respond to the treatment, the benefit is expected to last at least six months.\u003c\/p\u003e\n\n\u003cp\u003eThe interval before repeating the treatment regimen also depends on the physician's experience and\/or the severity of the disease.\u003c\/p\u003e\n\n\u003cp\u003eSYNOLIS VA should be injected into the synovial cavity by a physician trained in intra-articular (i.a.) injections. Several measures must be taken before injecting SYNOLIS VA:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eSYNOLIS VA should be at room temperature at the time of intra-articular injection.\u003c\/li\u003e\n  \u003cli\u003eThe injection site must be carefully disinfected.\u003c\/li\u003e\n  \u003cli\u003eThe physician is responsible for selecting an appropriate needle size (recommended size for knee joint injections: 18 to 21 G).\u003c\/li\u003e\n  \u003cli\u003eThe needle must be firmly attached to the Luer-lock connection of the syringe.\u003c\/li\u003e\n  \u003cli\u003eInject precisely only into the joint cavity.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eContraindications\u003c\/h3\u003e\n\u003cp\u003eSYNOLIS VA must not:\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003eshould not be injected into patients with known hypersensitivity or allergy to sodium hyaluronate and\/or sorbitol preparations;\u003c\/li\u003e\n  \u003cli\u003eshould not be injected into patients with a skin disease or infection at the injection site;\u003c\/li\u003e\n  \u003cli\u003eshould not be injected intravascularly;\u003c\/li\u003e\n  \u003cli\u003eshould not be injected into pregnant or breastfeeding women;\u003c\/li\u003e\n  \u003cli\u003eshould not be injected into adolescents under 18 years of age.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eSpecial precautions for use\u003c\/h3\u003e\n\u003cul\u003e\n  \u003cli\u003eBefore treatment, the patient must be informed about the product, its contraindications, and possible side effects.\u003c\/li\u003e\n  \u003cli\u003eUse SYNOLIS VA only for symptomatic osteoarthritis (OA).\u003c\/li\u003e\n  \u003cli\u003eDue to the lack of available clinical data on the tolerability and efficacy of SYNOLIS VA in patients with a history of autoimmune disease, active autoimmune disease, or abnormal physiological conditions, the physician must decide on a case-by-case basis, depending on the type of disease and associated treatments, whether SYNOLIS VA can be injected. It is recommended to advise these patients to undergo a preliminary test and to avoid injection if the disease is active. Careful monitoring of these patients after injection is also recommended.\u003c\/li\u003e\n  \u003cli\u003eBefore use, check the integrity of the inner packaging and the expiration date. Do not use the product if the expiration date has passed or if the packaging has been opened or damaged.\u003c\/li\u003e\n  \u003cli\u003eDo not transfer SYNOLIS VA to another container or add any other components to the product.\u003c\/li\u003e\n  \u003cli\u003eExercise caution when performing the intra-articular injection to avoid injecting outside the intra-articular joint cavity or into the synovial membrane. Viscosupplementation gels injected into the perisynovial area can be painful due to compression of the surrounding tissues.\u003c\/li\u003e\n  \u003cli\u003eInjection into an arm or leg joint with significant venous or lymphatic stasis is not recommended.\u003c\/li\u003e\n  \u003cli\u003eInjection into an infected or severely inflamed joint is not recommended.\u003c\/li\u003e\n  \u003cli\u003eIn cases of severe joint effusions, the doctor must decide on a case-by-case basis whether SYNOLIS VA can be injected. The effusion must be aspirated before injecting SYNOLIS VA.\u003c\/li\u003e\n  \u003cli\u003eSynolis VA is a single-use product and must not be used for multiple patients and\/or multiple treatment sessions.\u003c\/li\u003e\n  \u003cli\u003eThe product must not be resterilized.\u003c\/li\u003e\n  \u003cli\u003eReusing single-use products can lead to infections as sterility is compromised. Only the gel is sterile, not the outside of the syringe.\u003c\/li\u003e\n  \u003cli\u003eSynolis VA must be administered under strict aseptic conditions.\u003c\/li\u003e\n  \u003cli\u003ePatients are advised to avoid strenuous physical activity for at least 48 hours after the injection.\u003c\/li\u003e\n  \u003cli\u003eThe product must be stored under the recommended storage conditions.\u003c\/li\u003e\n  \u003cli\u003eDispose of the syringe (and the needle selected by the doctor) according to recognized medical standards and in compliance with applicable national, local, and institutional requirements.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch3\u003eInteractions with other medicinal products\u003c\/h3\u003e\n\u003cp\u003eThere is a known incompatibility between sodium hyaluronate and quaternary ammonium salts such as benzalkonium chloride. Therefore, SYNOLIS VA must never come into contact with such products (e.g., certain disinfectants) or with medical or surgical devices treated with such products. So far, no data are available on the compatibility of SYNOLIS VA with other products for intra-articular use.\u003c\/p\u003e\n\n\u003ch3\u003eSide effects\u003c\/h3\u003e\n\u003cp\u003eSide effects may occur and must be explained to the patient before treatment. Injection may cause slight bleeding, which stops spontaneously once the injection is completed. Occasionally, one or more of the following reactions may occur immediately or with delay. Temporary local pain, swelling, and\/or joint effusions may occur. These reactions usually heal within a few days. If these symptoms last longer than a week or if other side effects occur, the patient must inform the doctor. The doctor may prescribe appropriate treatment for these adverse effects. Other possible typical side effects of visco-supplementation injections include inflammation, redness, swelling, skin irritation, allergic reactions, and tissue reactions.\u003c\/p\u003e\n\n\u003cp\u003eAny serious incident related to the product must be reported to the manufacturer and the competent authority of the member state where the user and\/or patient is established.\u003c\/p\u003e\n\n\u003ch3\u003eStorage\u003c\/h3\u003e\n\u003cp\u003eStore at 2 °C to 25 °C. Protect from light and extreme cold. Do not freeze the product.\u003c\/p\u003e","brand":"Aptissen GmbH","offers":[{"title":"Default Title","offer_id":51849555050836,"sku":"143-1","price":83.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0786\/8756\/8212\/files\/synolis-va-4080-1x-20-ml-aptissen-gmbh-gelenkspritzen-stakonmed-2877413.jpg?v=1772274020","url":"https:\/\/stakonmed.com\/products\/synolis-va-40-80","provider":"StakonMed","version":"1.0","type":"link"}