{"product_id":"synvisc-one-1-x-6-ml","title":"Synvisc One 1x 6.0 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\u003eDescription for \u003ca href=\"https:\/\/stakonmed.de\/collections\/synvisc\" title=\"Synvisc | Joint injections | StakonMed\"\u003eSynvisc\u003c\/a\u003e One\u003cbr\u003e\u003c\/p\u003e\n\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\u003cspan\u003eHylan G-F 20 is available as\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cp\u003e\u003cspan\u003e• \u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003e, 2-ml pack.\u003cbr\u003e• \u003c\/span\u003e\u003cspan\u003eSynvisc-One\u003c\/span\u003e\u003cspan\u003e®\u003c\/span\u003e\u003cspan\u003e, 6-ml pack.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cbr\u003eHylan G-F 20 is a sterile, pyrogen-free, elastoviscous fluid containing Hylan A and Hylan B polymers derived from a highly purified avian extract. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. The average molecular weight of Hylan A is approximately 6,000,000 Daltons, and Hylan B is a hydrated gel. Hylan G-F 20 contains Hylan A and Hylan B (8.0 mg ± 2.0 mg per ml) in a buffered physiological sodium chloride solution (pH 7.2 ± 0.3).\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003ePROPERTIES\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eHylan G-F 20 is biologically similar to hyaluronan. Hyaluronan is a component of synovial fluid and is responsible for its viscoelasticity. However, the mechanical (elasto-viscous) properties of Hylan G-F 20 exceed those of synovial fluid and hyaluronan solutions of comparable concentration. At a frequency of 2.5 Hertz, Hylan G-F 20 has an elasticity (G’: shock absorption factor) of 111 ± 13 Pascal (Pa) and a viscosity (G’’: shock dissipation factor) of 25 ± 2 Pa. At a frequency of 2.5 Hertz, the elasticity and viscosity of knee synovial fluid measured by a comparable method in 18- to 27-year-olds were G’ = 117 ± 13 Pa and G’’ = 45 ± 8 Pa. Hylans are broken down in the body in the same way as hyaluronan; the breakdown products are non-toxic.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eINDICATIONS\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eHylan G-F 20\u003cbr\u003e• serves as a temporary replacement or supplement to synovial fluid. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• is indicated for patients at all stages of joint disease.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• shows the most effective results in patients who actively and regularly move the affected joints. \u003c\/span\u003e\u003cspan\u003emove regularly.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• The therapeutic effect of Hylan G-F 20 is based on viscosupplementation, \u003c\/span\u003e\u003cspan\u003ea process in which the physiological and rheological conditions of the \u003c\/span\u003e\u003cspan\u003earthritic joint tissue to be restored.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eViscosupplementation with Hylan G-F 20 is a therapy to relieve pain and physical discomfort, enabling improved joint mobility. \u003c\/span\u003e\u003cspan\u003eIn vitro\u003c\/span\u003e\u003cspan\u003e-Studies have shown that Hylan G-F 20 protects cartilage cells from certain physical and chemical damage.\u003cbr\u003e\u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003eis intended only for intra-articular use by the physician to treat pain associated with degenerative joint disease of the knee, hip, ankle, or shoulder.\u003cbr\u003e\u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eis intended only for intra-articular use by a physician to treat pain associated with degenerative joint disease of the knee.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCONTRAINDICATIONS\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• If venous or lymphatic congestion occurs in the affected limb, Hylan G-F 20 should not be injected into the joint.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Hylan G-F 20 must not be used in infected or severely inflamed joints or in patients with skin diseases or infections in the injection area. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Hylan G-F-20 must not be used in patients with known hypersensitivity (allergy) \u003c\/span\u003e\u003cspan\u003eused against hyaluronan (sodium hyaluronate).\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eWARNINGS\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Do not inject intravascularly.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Do not inject extra-articularly and not into the synovial tissue or capsule. \u003c\/span\u003e\u003cspan\u003eSide effects at the injection site may especially occur if the \u003c\/span\u003e\u003cspan\u003eInjection of \u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003enot strictly intra-articular.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Disinfectants containing quaternary ammonium salts can cause flocculation \u003c\/span\u003e\u003cspan\u003efavor hyaluronan. Therefore, they should not be used simultaneously, for example, to prepare the skin for the procedure.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003ePRECAUTIONS\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• If there is a large intra-articular effusion before injection, Hylan G-F 20 should not be used.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• As with any invasive procedure in the joint, patients are advised to avoid strenuous activities for a few days after the injection.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Hylan G-F 20 has not been tested in pregnant women and children under 18 years of age.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Hylan G-F 20 contains small amounts of bird protein and should be avoided in patients who \u003c\/span\u003e\u003cspan\u003eshould not be used in patients who react hypersensitively to this.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSIDE EFFECTS\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Side effects affecting the joint injected: After injection of Hylan G-F 20 into the joint, temporary pain and\/or swelling and\/or effusions in the injection area may occur. Cases of acute inflammation characterized by joint pain, swelling, effusion, and occasionally warming or stiffness of the joint have been reported after intra-articular injection of \u003c\/span\u003e\u003cspan\u003eSynvisc or Synvisc-One \u003c\/span\u003e\u003cspan\u003eobserved. Examination of the synovial fluid shows an aseptic fluid without crystals. This reaction often responds within a few days to treatment with a nonsteroidal anti-inflammatory drug (NSAID), intra-articular steroids, and\/or arthrocentesis, whereby a clinical benefit of the treatment may still be present even after the reactions have occurred.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Joint infections did not occur in any clinical study with \u003c\/span\u003e\u003cspan\u003eSynvisc\/Synvisc-One \u003c\/span\u003e\u003cspan\u003eand were rarely used in therapeutic applications with \u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003ereported.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Hypersensitivity reactions including anaphylactic reaction, \u003c\/span\u003e\u003cspan\u003eanaphylactoid reaction, anaphylactic shock, and angioedema have also been \u003c\/span\u003e\u003cspan\u003eobserved.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Since market introduction, the following systemic events have been reported, which are rare \u003c\/span\u003e\u003cspan\u003eafter administration of \u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003emay occur: rash, urticaria, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia (abnormal sensations such as tingling), peripheral edema, malaise, breathing difficulties, flushing, and facial swelling.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Controlled clinical studies showed no statistically significant differences in the number or type of systemic side effects between the patient group that \u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003ereceived, and the control group.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• The controlled clinical study with \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eshowed a comparable number and type of side effects between the patient group that \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003ereceived, and the control group that received a placebo.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDOSAGE AND ADMINISTRATION\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Do not use Hylan G-F 20 if the package has already been opened or damaged.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• The contents of the syringe must be used immediately after opening the package. \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Remove synovial fluid and effusions before injecting Hylan G-F 20.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Inject at room temperature.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Avoid touching the plunger when removing the syringe from the blister (or \u003c\/span\u003e\u003cspan\u003efrom the tray) want to take. Only touch the syringe body.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Use strictly aseptic techniques during administration and \u003c\/span\u003e\u003cspan\u003ebe especially careful when removing the protective cap.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Twist the protective cap before removing it. This minimizes \u003c\/span\u003e\u003cspan\u003eProduct leakage.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Use an appropriate needle size:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• \u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003e– 18 to 22 Gauge\u003cbr\u003eUse an appropriate needle length according to the joint to be treated.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003e– 18 to 20 Gauge\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• To achieve the best possible seal of the needle and thus prevent leakage during administration, hold the Luer-lock connection of the syringe vial firmly while screwing in the needle tightly.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Avoid excessive twisting or applying leverage when attaching the needle to the syringe or removing the needle shield, as this could cause the needle tip to break.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Inject strictly intra-articularly and, if necessary, perform under imaging guidance, especially for joints such as the hip and shoulder.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• The contents of a syringe are intended for single use only. The recommended dosage corresponds to the injection of the full contents (2 ml for \u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003eand 6 ml for \u003c\/span\u003e\u003cspan\u003eSynvisc-One\u003c\/span\u003e\u003cspan\u003e) of a syringe. Unused \u003c\/span\u003e\u003cspan\u003eSynvisc\/Synvisc-One \u003c\/span\u003e\u003cspan\u003eis to be disposed of.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Syringes and\/or needles must not be reused. Reuse of syringes, needles, and\/or product residues from already used syringes leads to loss of sterility. This can result in product contamination and\/or incomplete treatment.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• When using fluoroscopy, ionic and non-ionic contrast agents may be used. A maximum of 1 ml contrast agent may be used per 2 ml of Hylan G-F 20.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e• Do not re-sterilize Hylan G-F 20.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDOSAGE INSTRUCTIONS\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe dosage of Hylan G-F 20 depends on the joint to be treated.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eOsteoarthritis of the knee joint:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSynvisc\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe recommended treatment consists of 3 weekly intra-articular injections of 2 ml each. To achieve maximum effect, it is necessary to complete all 3 injections. The recommended maximum dosage is 6 injections within six months, with at least four weeks between treatment series.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSynvisc-One\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe recommended treatment consists of a 6 ml intra-articular injection. The injection can be repeated six months after the first injection if the patient's symptoms justify it.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cbr\u003e\u003c\/span\u003e\u003cspan\u003eOsteoarthritis of the hip joint\/upper ankle joint\/ \u003c\/span\u003e\u003cspan\u003eShoulder joint:\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSynvisc\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAn initial treatment with a single 2 ml injection is recommended. However, if adequate relief of symptoms is not achieved after this injection, administration of a second 2 ml injection is recommended. Clinical data have shown that patients benefit from a second injection if it is given within one to three months after the first injection.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDURATION OF EFFECT\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eTreatment with Hylan G-F 20 acts only locally in the joint; it does not produce a general systemic effect.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSynvisc\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIt is reported that the effect in patients who respond to treatment generally lasts up to 26 weeks, but both shorter and longer durations of effect have been observed. Furthermore, prospective clinical data in patients with knee osteoarthritis have shown a treatment benefit of up to 52 weeks after a single treatment cycle with three \u003c\/span\u003e\u003cspan\u003eSynvisc\u003c\/span\u003e\u003cspan\u003e-injections were shown.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eSynvisc-One\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eProspective clinical study data in patients with gonarthrosis after a single injection of \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003ea reduction in pain for up to 52 weeks as well as associated improvements in mobility and function.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eClinical data from a double-blind, randomized, controlled study in patients with gonarthrosis showed a statistically significant and clinically meaningful reduction in pain compared to placebo. A total of 253 patients were treated (124 received \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eand 129 received placebo). Over 26 weeks, patients under \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eshowed an average percentage change in pain from baseline of 36%, while patients in the placebo group showed an average percentage change in pain from baseline of 29%.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eAdditional prospective clinical data from two multicenter, open-label studies in patients with gonarthrosis after a single injection of \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eshowed a statistically significant improvement in pain relief for up to 52 weeks compared to baseline.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn the first study, 394 patients who \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eshowed a statistically significant change in the WOMAC A1 - walking pain subscore (-28 ± 19.89 mm on a 100 mm VAS, Visual Analog Scale) from baseline to week 26. Additionally, statistically significant changes from baseline were observed in WOMAC A1 and WOMAC A, B, and C scores across all six observation periods between week 1 and week 52, demonstrating improvements in walking pain and pain (WOMAC A1 -32.7 ± 19.95 mm; WOMAC A -29.18 ± 19.158 mm), mobility (WOMAC B -25.77 ± 22.047 mm), and function (WOMAC C -25.72 ± 19.449 mm) over 52 weeks.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIn the second study, 571 patients who \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eshowed a statistically significant improvement in pain over 26 weeks, measured by the Verbal Pain Questionnaire (VPQ). The average pain score improved from 3.20 at the start of treatment to 2.24 at the week 26 visit, with 64.6% of patients achieving pain relief. Secondary endpoints showed a statistically significant improvement in VPQ scores at all observation points from week 1 to week 52, with average VPQ scores decreasing from 3.20 at baseline to 2.26 at the week 52 visit, and 61.5% of patients achieving pain relief.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eCONTENT PER ml \u003c\/span\u003e\u003cspan\u003e(Hylan G-F 20)\u003cbr\u003e1 ml contains: 8.0 mg Hylan, 8.5 mg sodium chloride, 0.16 mg disodium hydrogen phosphate, 0.04 mg sodium dihydrogen phosphate, water for injection q.s.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eDOSAGE FORM\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eThe contents of the syringes are sterile and pyrogen-free. Store between +2 °C and +30 °C.\u003cbr\u003eDo not freeze.\u003cbr\u003e\u003c\/span\u003e\u003cspan\u003eSynvisc \u003c\/span\u003e\u003cspan\u003eis supplied in a 2.25 ml glass syringe vial containing 2 ml of Hylan G-F 20. \u003c\/span\u003e\u003cspan\u003eSynvisc-One \u003c\/span\u003e\u003cspan\u003eis supplied in a 10 ml glass syringe vial containing 6 ml of Hylan G-F 20.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eINFORMATION FOR PATIENTS\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eInform the patient before the injection that Synvisc and Synvisc-One are made from highly purified avian-derived hyaluronic acid.\u003c\/span\u003e\u003c\/p\u003e","brand":"Sanofi-Aventis GmbH","offers":[{"title":"Default Title","offer_id":47355873657172,"sku":"146","price":189.95,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0786\/8756\/8212\/files\/synvisc-one-sanofi-aventis-deutschland-gmbh-gelenkspritzen-stakonmed-927488.jpg?v=1772216110","url":"https:\/\/stakonmed.com\/products\/synvisc-one-1-x-6-ml","provider":"StakonMed","version":"1.0","type":"link"}