{"product_id":"sinogel","title":"Sinogel 1x 3.0 ml      (EXP 31.07.2026)","description":"\u003ch2\u003eSINOGEL® 3 ml – Instructions for use\u003c\/h2\u003e\n\u003ch3\u003eDescription\u003c\/h3\u003e\n\u003cp\u003eOsteoarthritis (OA) is a chronic degenerative disease characterized by progressive damage to the articular cartilage, narrowing of the joint space, remodeling of the subchondral bone, formation of marginal joint osteophytes, and synovitis. Optimal OA therapy consists of an intra-articular injection of exogenous hyaluronic acid, which can relieve symptoms by restoring the viscoelastic properties of synovial fluid.\u003c\/p\u003e\n\u003cp\u003eHyaluronic acid sodium salt is formed from repetitive chains of disaccharide units of N-acetylglucosamine and sodium glucuronate and is an essential component of synovial fluid, where it acts as a joint lubricant under shear stress and as a shock absorber under compressive load.\u003c\/p\u003e\n\u003cp\u003eSINOGEL® 3 ml consists of a buffered saline solution of highly purified hyaluronic acid with high molecular weight and sodium chondroitin of biotechnological origin. The hyaluronic acid used in the medical device is obtained by fermentation and has not been chemically modified. This results in excellent tolerability.\u003c\/p\u003e\n\u003ch3\u003ePurpose\u003c\/h3\u003e\n\u003cp\u003eSINOGEL® 3 ml, with its special formula and high glycosaminoglycan concentration (GAG), belongs to the latest generation of intra-articular treatments and was specifically developed for viscosupplementation of large joints, where a large volume of solution with a high concentration of hyaluronic acid without high viscosity is recommended. Thanks to a special and patented treatment of the solution, the hyaluronic acid and sodium chondroitin chains present in the product interact with each other, giving the solution rheological properties so that the viscosity values are lower than those of pure hyaluronic acid at the same concentration.\u003c\/p\u003e\n\u003ch3\u003eIndications\u003c\/h3\u003e\n\u003cp\u003eSINOGEL® 3 ml is indicated for pain or movement restrictions due to degenerative diseases, post-traumatic disorders, or joint changes.\u003c\/p\u003e\n\u003cp\u003eSINOGEL® 3 ml is a medical device designed to restore the physiological and rheological properties of synovial fluid in joints affected by osteoarthritis.\u003c\/p\u003e\n\u003cp\u003eSINOGEL® 3 ml restores the viscoelastic properties of synovial fluid, relieves pain, and promotes the restoration of joint mobility.\u003c\/p\u003e\n\u003ch3\u003eTarget groups and users\u003c\/h3\u003e\n\u003cp\u003eSINOGEL® 3 ml is indicated for adults of both sexes and may only be administered by qualified personnel via intra-articular injection.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSINOGEL® 3 ml is prescription-only.\u003c\/strong\u003e\u003c\/p\u003e\n\u003ch3\u003eComposition\u003c\/h3\u003e\n\u003cp\u003eSINOGEL® 3 ml consists of a pre-filled syringe with 3 ml solution and contains the following ingredients:\u003c\/p\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003eFunctional ingredient\u003c\/th\u003e\n\u003cth\u003eQuantity\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eSodium hyaluronate\u003c\/td\u003e\n\u003ctd\u003e72 mg\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eSodium chondroitin\u003c\/td\u003e\n\u003ctd\u003e48 mg\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003eOther ingredients\u003c\/th\u003e\n\u003cth\u003eQuantity\u003c\/th\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eSodium chloride\u003c\/td\u003e\n\u003ctd\u003e21.000 mg\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eMonosodium phosphate\u003c\/td\u003e\n\u003ctd\u003e0.135 mg\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eDisodium phosphate\u003c\/td\u003e\n\u003ctd\u003e0.48 mg\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWater for injection purposes\u003c\/td\u003e\n\u003ctd\u003eq.s. 3.0 ml\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003ch3\u003eDosage\u003c\/h3\u003e\n\u003cp\u003eIt is recommended to perform 1 infiltration per treatment cycle. The appropriateness and frequency with which the treatment cycle can be repeated must be individually assessed by the physician, considering the risk-benefit ratio for each patient.\u003c\/p\u003e\n\u003ch3\u003eAvailable packages\u003c\/h3\u003e\n\u003cp\u003eSINOGEL® 3 ml is available in packs containing 1 pre-filled syringe (72.0 mg sodium hyaluronate and 48.0 mg sodium chondroitin in 3 ml sodium chloride buffered saline) and a 21G x 1½” (0.8 x 40 mm) needle.\u003c\/p\u003e\n\u003cp\u003eThe contents of the syringe are sterile and pyrogen-free.\u003c\/p\u003e\n\u003cp\u003ePre-filled syringe steam sterilized.\u003c\/p\u003e\n\u003cp\u003eNeedle sterilized with ethylene oxide.\u003c\/p\u003e\n\u003cp\u003eManufacturer: Terumo Europe N. V. – Interleuvenlaan 40 – 3001 Leuven, Belgium\u003c\/p\u003e\n\u003ch3\u003eInstructions for use\u003c\/h3\u003e\n\u003cp\u003eBefore injecting SINOGEL® 3 ml, joint effusions must be aspirated.\u003c\/p\u003e\n\u003cp\u003eCarefully unscrew the syringe cap, holding the Luer-Lock collar between your fingers and taking special care not to touch the opening.\u003c\/p\u003e\n\u003cp\u003eScrew the 21G needle (included in the package) firmly onto the Luer-Lock collar of the syringe until you feel slight resistance to ensure an airtight seal and prevent fluid leakage during administration.\u003c\/p\u003e\n\u003cp\u003eInject SINOGEL® 3 ml at room temperature and under strictly aseptic conditions. For viscosupplementation of hip osteoarthritis, it is recommended to perform the injection under ultrasound guidance.\u003c\/p\u003e\n\u003cp\u003eInject SINOGEL® 3 ml only into the synovial cavity.\u003c\/p\u003e\n\u003ch3\u003eAfter use\u003c\/h3\u003e\n\u003cp\u003eFill out the implant card and hand it over to the patient.\u003c\/p\u003e\n\u003cp\u003eNote: Fill out one implant card for each prefilled syringe used for treatment (i.e., 1 prefilled syringe = 1 completed implant card).\u003c\/p\u003e\n\u003cp\u003eThe implant card is inside the box; to remove it, proceed as follows:\u003c\/p\u003e\n\u003col\u003e\n\u003cli\u003eOpen the SINOGEL® 3 ml box.\u003c\/li\u003e\n\u003cli\u003eRemove all blister packs with prefilled syringes from the box.\u003c\/li\u003e\n\u003cli\u003eRemove the implant card from the box. Gently press down the blue-bordered area of the outer packaging (back) without breaking it.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003ch3\u003eInstructions for filling out the implant card\u003c\/h3\u003e\n\u003cp\u003eFill in the fields marked with the following symbols with the specified information:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003ePatient's name or patient ID\u003c\/li\u003e\n\u003cli\u003eDate of treatment\u003c\/li\u003e\n\u003cli\u003eName and address of the implanting healthcare facility\u003c\/li\u003e\n\u003cli\u003eDoctor's name\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003eWarnings\u003c\/h3\u003e\n\u003cul\u003e\n\u003cli\u003eThe contents of the prefilled syringe are sterile. The syringe is contained in a sealed blister pack.\u003c\/li\u003e\n\u003cli\u003eThe outer surface of the syringe is not sterile.\u003c\/li\u003e\n\u003cli\u003eDo not use the medical device after the expiration date printed on the package.\u003c\/li\u003e\n\u003cli\u003eDo not use the medical device if the packaging is opened or damaged, as the sterility of the product may be compromised.\u003c\/li\u003e\n\u003cli\u003eThe injection must be performed on healthy skin.\u003c\/li\u003e\n\u003cli\u003eDo not use in pregnant or breastfeeding women.\u003c\/li\u003e\n\u003cli\u003eDo not use in patients with autoimmune diseases.\u003c\/li\u003e\n\u003cli\u003eDo not inject intravascularly. Do not inject outside the joint cavity, into synovial tissue, or the joint capsule.\u003c\/li\u003e\n\u003cli\u003eDo not administer SINOGEL® 3 ml if there is a severe joint effusion.\u003c\/li\u003e\n\u003cli\u003eDo not resterilize. The medical device is intended for single use only.\u003c\/li\u003e\n\u003cli\u003eDo not reuse to avoid contamination risks.\u003c\/li\u003e\n\u003cli\u003eStore at room temperature below 25 °C and away from heat sources. Do not freeze.\u003c\/li\u003e\n\u003cli\u003eOnce opened, the medical device must be used immediately and disposed of after use.\u003c\/li\u003e\n\u003cli\u003eSINOGEL® 3 ml is indicated for adult patients. Keep out of reach of children.\u003c\/li\u003e\n\u003cli\u003eDo not use SINOGEL® 3 ml in case of known hypersensitivity or allergies to any of the product's components.\u003c\/li\u003e\n\u003cli\u003eAfter the injection, instruct the patient to avoid any intense physical activity and to resume normal activities only after a few days.\u003c\/li\u003e\n\u003cli\u003eProtect from sunlight.\u003c\/li\u003e\n\u003cli\u003eExisting air bubbles do not affect the product properties.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3\u003ePrecautions for use\u003c\/h3\u003e\n\u003cp\u003eDo not mix the medical device with disinfectants such as quaternary ammonium salts or chlorhexidine, as this may cause the product to precipitate.\u003c\/p\u003e\n\u003ch3\u003eInteractions\u003c\/h3\u003e\n\u003cp\u003eCurrently, no interactions between SINOGEL® 3 ml and drugs\/other treatments are known. However, if you are using medications or other therapeutic measures simultaneously, consult your doctor for more information.\u003c\/p\u003e\n\u003ch3\u003eSide effects\u003c\/h3\u003e\n\u003cp\u003eExtra-articular infiltration of SINOGEL® 3 ml can cause local adverse effects.\u003c\/p\u003e\n\u003cp\u003eDuring the use of SINOGEL® 3 ml, symptoms such as pain, warmth, redness, or swelling at the injection site may occur. These secondary complaints can be relieved by applying ice to the treated joint and usually subside after a short time. Doctors must ensure that patients inform them of any adverse effects that may occur after treatment.\u003c\/p\u003e\n\u003cp\u003eIn case of an adverse event, the manufacturer or the competent authority must be informed.\u003c\/p\u003e\n\u003ch3\u003eOverdose\u003c\/h3\u003e\n\u003cp\u003eAdhere to the specified dosage and contact your doctor or the nearest hospital if you notice side effects related to an overdose.\u003c\/p\u003e\n\u003ch3\u003eContraindications\u003c\/h3\u003e\n\u003cp\u003eSINOGEL® 3 ml must not be injected if there is an infected or severely inflamed joint or if the patient has a skin condition or infection at the injection site.\u003c\/p\u003e\n\u003ch3\u003eShelf life\u003c\/h3\u003e\n\u003cp\u003eShelf life: 36 months.\u003c\/p\u003e\n\u003cp\u003eThe expiration date indicates the maximum shelf life of the medical device.\u003c\/p\u003e\n\u003ch3\u003eDisposal\u003c\/h3\u003e\n\u003cp\u003eDo not dispose of the product in the environment after use. Follow local regulations for product disposal.\u003c\/p\u003e\n\u003ch3\u003eSummary of Safety and Clinical Performance\u003c\/h3\u003e\n\u003cp\u003eYou can download the Summary of Safety and Clinical Performance (SSCP) using the following link:\u003c\/p\u003e\n\u003cp\u003ehttps:\/\/www.ibsa.it\/en\/chi-siamo\/summary-of-safety-and-clinical-performance.html\u003cbr\u003ehttps:\/\/www.ibsa.it\/en\/chi-siamo\/sscp-area-riservata.html\u003c\/p\u003e\n\u003ch3\u003eDate of last revision of the package leaflet\u003c\/h3\u003e\n\u003cp\u003eFebruary 2023\u003c\/p\u003e","brand":"IBSA","offers":[{"title":"Default Title","offer_id":51849374204244,"sku":"136","price":109.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0786\/8756\/8212\/files\/sinogel-1x-30-ml-ibsa-gelenkspritzen-stakonmed-4474722.jpg?v=1772274022","url":"https:\/\/stakonmed.com\/products\/sinogel","provider":"StakonMed","version":"1.0","type":"link"}