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SYNVISC HYLAN GF 20 Description Prefilled syringe. Viscoelastic, pyrogen-free liquid containing hylan polymers A and B, produced from a highly purified avian extract. Hylans are derived from hyaluronate (the sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium gluconate. Hylan GF 20 contains hylan A and B (8 mg ± 2 mg per ml) in sodium chloride buffered saline (pH 7.2 ± 0.3). Hylan GF 20 is biologically similar to hyaluronate. Hyaluronate is a component of synovial fluid and determines its viscoelasticity. However, the mechanical (viscoelastic) properties of Hylan GF 20 are superior to those of hyaluronate-based solutions with similar concentrations. The elasticity and viscosity of synovial fluid in subjects aged 18 to 27 years, measured with a superposition technique, at 2.5 Hz are G=117+13 Pa and G=45+8 Pa, respectively. Hylans are physiologically metabolized by the same process as hyaluronates, and the breakdown products are non-toxic. It temporarily restores the viscoelasticity of synovial fluid, provides clinical benefits to patients in all stages of joint osteoarthritis, and is most effective in patients who actively and regularly use the affected joint. It achieves its therapeutic effect through viscosupplementation, a process by which the physiological state and rheological characteristics of the synovial fluid of the arthritic joint are restored. Viscosupplementation is indicated for the relief of pain and functional limitations, allowing a greater range of motion of the joint. Indicated only for intra-articular use by a physician for the symptomatic treatment of pain associated with osteoarthritis of the knee, hip, ankle and shoulder. How to use Do not use if the packaging is open or damaged. The contents of the syringe should be used immediately after opening the package. Remove synovial fluid or effusion before each injection. Inject at room temperature. To remove the syringe from the blister (or container), hold it tightly to your body, without touching the plunger rod. Administer using strictly aseptic procedures, paying particular attention to removing the nozzle. Unscrew the spout before removing it to minimize product spillage. Use the appropriate size needles: - Synvisc from 18 gauge to 22 gauge. Use the needle of the appropriate length for the joint to be treated: - Synvisc-One from 18 gauge to 20 gauge. To ensure a perfect seal and avoid leakage during administration, make sure the needle is firmly attached to the syringe. Do not squeeze or apply excessive pressure when attaching the needle or removing the needle guard, as this may break the syringe tip. Inject only into the synovial space, performing the operation under instrumental guidance if necessary, for example fluoroscopy, especially in the case of hip and shoulder treatment. The contents of the syringe are for single use only. The recommended dosing instructions indicate that the entire volume of the syringe (2 ml) should be injected. Discard any unused Synvisc. Do not reuse the syringe and/or needle. Reuse of syringes, needles and/or product from a used syringe may result in loss of sterility, contamination of the product and/or incomplete treatment. Under fluoroscopic guidance, ionic or nonionic contrast agents may be used. Do not use more than 1 ml of contrast agent per 2 ml of Hylan GF 20. Do not resterilize Hylan GF 20. The dosage regimen of Hylan GF 20 depends on the joint being treated. Knee osteoarthritis The recommended treatment regimen is three injections of 2 ml into the knee, one week apart. For optimal effect, it is essential to administer all three injections. The maximum recommended dose is six injections over a period of six months, with a break of at least four weeks between treatment regimens. Osteoarthritis of the hip, ankle, and shoulder The recommended initial treatment regimen is a single 2 ml injection. However, a second 2 ml injection is recommended if adequate symptomatic pain relief is not achieved. Duration of effect Treatment with Hylan GF 20 only affects the injected joint and does not produce a general systemic effect. components Each ml contains: hylan 8 mg, sodium chloride 8.5 mg, disodium hydrogen phosphate 0.16 mg, disodium phosphate hydrate 0.04 mg, water for injections qb warnings Hylan GF 20 should not be injected into the joint in the presence of venous or lymphatic stasis in the affected limb. Hylan GF 20 should not be used in the presence of severe infections or inflammations or skin diseases or infections in the injection area. Hylan GF 20 should not be used in patients with known hypersensitivity (allergy) to hyaluronate preparations (sodium hyaluronate). - Do not inject intravascularly. - Do not inject extra-articularly or into synovial tissue or capsule. In general, injection site complications have been caused by extra-articular spread of Synvisc. Do not use disinfectants containing quaternary ammonium salts for skin preparation at the same time, as hyaluronate may precipitate in their presence. Hylan GF 20 should not be used if significant intra-articular effusion has occurred prior to injection. As with all invasive joint procedures, it is recommended that the patient avoid any excessive motor activity after the intra-articular injection and resume full activity within a few days. Hyaln GF 20 has not been tested in pregnant women or children/adolescents under 18 years of age. Hylan GF 20 contains small amounts of avian protein and should not be used in patients with hypersensitivity to this protein. Conservation Store at a temperature between 2°C and 30°C. Do not freeze. Format 2 ml pre-filled syringe. Code 010144
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