pharmachologic effect
Synvisc I is a biological analogue of hyaluronan, which is a component of synovial fluid that determines its viscoelastic properties. However, the mechanical (viscoelastic) properties of Synvisc I are superior to those of synovial fluid and hyaluronan solutions in comparable concentrations.
Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Synvisc I contains hylan A and hylan B (8 mg and 2 mg in 1 ml), diluted in physiological sodium chloride solution (pH 7.2±0.3). The average molecular weight of hylan A is about 6 million daltons. Gilan B is a hydrated gel. Hylans are excreted from the body in the same way as hyaluronan; its breakdown products are not toxic.
Synvisc I is effective in patients at any stage of knee joint pathology; most effective in patients with active and regular load on the affected knee joint.
The therapeutic effect is achieved by “restoring viscosity”, thereby restoring the rheological properties of the synovial fluid and the physiological properties of the tissues of the joint affected by osteoarthritis.
Viscosity restoration with Synvisc I is a treatment designed to reduce pain and discomfort, allowing for more extensive joint movement. In vitro studies have shown that Synvisc I protects cartilage cells from certain physical and chemical damage.
Effect duration
The effect of using Synvisc I applies only to the affected joint. Synvisc I has no general effect. Data from prospective clinical studies in patients with knee osteoarthritis demonstrated the effectiveness of Synvisc I for up to 52 weeks after 1 injection.
Description
Synvisc I/Synvisc One (Hylan G-F20) is a sterile, pyrogen-free, viscoelastic liquid containing hylans. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan G-F20 contains hylan A and hylan B (8.0 mg and 2.0 mg per 1 ml), diluted in physiological sodium chloride solution (pH 7.2 ± 0.3) The average molecular weight of hylan A is about 6 million Dalton Gilan B is a hydrated gel.
Directions for use and doses
Intra-articular. Synvisc I should be administered at room temperature.
Intra-articular administration of the drug can only be carried out by a specialist
Before each injection of Synvisc I, synovial fluid or intra-articular exudate should be removed.
Synvisc I should not be used if the packaging is opened or damaged.
The appropriate length and size (18-20) needle should be used.
- The recommended regimen for using Synvisc I is 1 injection into the knee joint.
A second injection, if necessary, can be given 6 months after the first.
Characteristics
Hylan G-F20 is a biological analogue of hyaluron, which is a component of synovial fluid that determines its viscoelastic properties. However, the mechanical (viscoelastic) properties of Hylan G-F20 are superior to those of synovial fluid and hyaluronan solutions at comparable concentrations. The elasticity of Hylan G-F20 (storage modulus G') at 2.5 Hz is 111±13 Pascal (Pa), and the viscosity (loss modulus G") is 25±2 Pa. The elasticity and viscosity of the synovial fluid of the knee joint in people aged 18-27 years, measured by the same method and at the same frequency, are respectively: G'=l 17±13 Pa and G”=45±8 Pa. Hylans are excreted from the body in the same way as hyaluronan, and its breakdown products are not toxic.
special instructions
Synvisc I should not be used if the packaging is opened or damaged.
Repeated sterilization of Synvisc I is not permitted.
Synvisc I should not be used for intravascular administration.
Do not use for extra-articular injection or injection into synovial tissue or joint capsule. As a result of extra-articular administration, adverse reactions may develop in the injection area.
Synvisc I should not be administered if significant intra-articular effusion is observed immediately before injection.
Synvisc I should not be used together with skin disinfectants containing quaternary ammonium salts, because in their presence, hyaluronan can form a sediment.
Synvisc I contains small amounts of chicken protein and should not be used in patients with hypersensitivity to chicken protein.
As with any invasive joint procedure, after an intra-articular injection the patient is advised to avoid strenuous physical activity and gradually resume normal activity over several days.
Side effects
After an intra-articular injection of Synvisc I/Synvisc One, the following side effects may be observed on the side of the knee into which the injection was made: short-term pain and/or swelling and/or joint effusion. Post-marketing experience with Synvisc I/Synvisc One has shown that in some cases joint effusion can be significant and cause more prolonged pain. In these cases, it is necessary to puncture the joint and remove the exudate with its subsequent analysis to exclude infection and microcrystalline arthropathy. Usually such reactions disappear without a trace within a few days. The presence of such reactions does not affect the effectiveness of treatment. Intra-articular infections were not observed in any of the clinical studies of Synvisc I/Synvisc One and Synvisc/Synvisc, and intra-articular infections were only rarely reported in clinical studies of Synvisc/Synvisc.
Post-marketing experience has revealed the following systemic reactions, which were rarely observed with the administration of Synvisc/Synvisc: rash, urticaria, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema (including on the face) , weakness, difficulty breathing, redness of the skin.
In a controlled clinical trial, the incidence and type of side effects were found to be similar between the Synvisc I/Synvisc One group and the placebo group.
Storage conditions
- The contents of the syringe are sterile and pyrogen-free.
- Store at temperatures from +2 °C to +30 °C. Do not freeze!
- Keep out of the reach of children.
- Do not use after expiration date.
Delivery of goods is carried out while maintaining the temperature regime. For some regions, the cost and delivery conditions may be changed.
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Synvisc synovial fluid prosthesis syringe 6 ml 1 pc Description Synvisc I/Synvisc One (Hylan G-F20) is a sterile, pyrogen-free, viscoelastic liquid containing hylans. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan G-F20 contains hylan A and hylan B (8.0 mg and 2.0 mg per 1 ml), diluted in physiological sodium chloride solution (pH 7.2 ± 0.3) The average molecular weight of hylan A is about 6 million Dalton Gilan B is a hydrated gel. Characteristics Hylan G-F20 is a biological analogue of hyaluron, which is a component of synovial fluid that determines its viscoelastic properties. However, the mechanical (viscoelastic) properties of Hylan G-F20 are superior to those of synovial fluid and hyaluronan solutions at comparable concentrations. The elasticity of Hylan G-F20 (storage modulus G') at 2.5 Hz is 111±13 Pascal (Pa), and the viscosity (loss modulus G") is 25±2 Pa. The elasticity and viscosity of the synovial fluid of the knee joint in people aged 18-27 years, measured by the same method and at the same frequency, are respectively: G'=l 17±13 Pa and G”=45±8 Pa. Hylans are excreted from the body in the same way as hyaluronan, and its breakdown products are not toxic. Indications for use Synvisc I/Synvisc One is intended only for intra-articular administration by a physician for the treatment of pain caused by osteoarthritis of the knee joint. Synvisc I/Synvisc One (Hylan G-F20): temporarily replaces and replenishes synovial fluid; effective in patients at all stages of development of knee joint pathology; most effective in patients with active and regular load on the affected knee joint; the therapeutic effect is achieved by “restoring viscosity”, due to which the rheological properties of the synovial fluid and the physiological and rheological properties of the tissues of the joint affected by osteoarthritis are restored. Viscosity restoration with Hylan G-F20 is a treatment designed to reduce pain and discomfort, allowing for more extensive joint movement. In vitro studies have shown that Hylan G-F20 protects cartilage cells from certain physical and chemical damage. Duration of effect The effect of using Synvisc I/Synvisc One applies only to the affected joint. Synvisc I/Synvisc One has no general effect. Data from prospective clinical studies in patients with knee osteoarthritis demonstrated the effectiveness of Synvisc I/Synvisc One for up to 52 weeks after a single injection. Contraindications Synvisc I/Synvisc One should not be injected into the knee joint if there is venous or lymphatic stasis of the limb. Synvisc I/Synvisc One should not be injected into an infected or severely inflamed knee joint or used in patients with skin lesions or infection in the immediate vicinity of the injection site. Precautions Synvisc I/Synvisc One should not be administered if significant intra-articular effusion is observed immediately before injection. As with any invasive joint procedure, after an intra-articular injection the patient is advised to avoid strenuous physical activity and gradually restore normal activity over several days. There have been no studies using Synvisc I/Synvisc One in pregnant women or children and adolescents under 18 years of age. Synvisc I/Synvisc One contains small amounts of chicken protein and should not be used in patients with hypersensitivity to chicken protein. Side effects After intra-articular injection of Synvisc I/Synvisc One, the following side effects may be observed on the side of the knee into which the injection was made: short-term pain and/or swelling and/or joint effusion. Post-marketing experience with Synvisc I/Synvisc One has shown that in some cases joint effusion can be significant and cause more prolonged pain. In these cases, it is necessary to puncture the joint and remove the exudate with its subsequent analysis to exclude infection and microcrystalline arthropathy. Usually such reactions disappear without a trace within a few days. The presence of such reactions does not affect the effectiveness of treatment. Intra-articular infections were not observed in any of the clinical studies of Synvisc I/Synvisc One and Synvisc/Synvisc, and intra-articular infections were only rarely reported in clinical studies of Synvisc/Synvisc. Post-marketing experience has revealed the following systemic reactions, which were rarely observed with the administration of Synvisc/Synvisc: rash, urticaria, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema (including on the face) , weakness, difficulty breathing, redness of the skin. In a controlled clinical trial, the incidence and type of side effects were found to be similar between the Synvisc I/Synvisc One group and the placebo group. Method of use The recommended regimen for using Synvisc I/Synvisc One is one injection into the knee joint. A second injection, if necessary, can be given 6 months after the first. Synovial fluid or exudate should be removed before injecting Synvisc I/Synvisc One. Synvisc I/Synvisc One should be administered at room temperature, in strict accordance with the rules of asepsis, especially when removing the protective cap from the syringe. Synvisc I / Synvisc-One should be injected strictly into the synovial space, using fluoroscopic direction of injection if necessary. When fluoroscopy is used, ionic or nonionic contrast agent may be used to determine the direction of injection. For every 2 ml of Synvisc I/ Synvisc One, no more than 1 ml of contrast agent should be used. The appropriate length and size (18-20) needle should be used. Special instructions Do not use for intravascular administration. Do not use for extra-articular injection or injection into synovial tissue or joint capsule. As a result of extra-articular administration, adverse reactions may develop in the injection area. Do not use together with skin disinfectants containing quaternary ammonium salts, as in their presence hyaluronan may form a precipitate. The contents of the syringe are for single use only. Synvisc I/Synvisc One should not be used if the packaging is opened or damaged. When removing the syringe from the blister, it should be held by the body without touching the piston rod. Before removing the cap, it should be turned to minimize leakage of the syringe contents. To prevent the contents of the syringe from leaking, keep the needle in close contact with the syringe during injection. Do not twist or apply excessive force when securing the needle or removing the cap, as this may cause the tip of the syringe to break. Repeated sterilization of Synvisc I/Synvisc One is not permitted. Composition Per 1 ml One milliliter contains: 8 mg Hylan GF 20, 8.5 mg sodium chloride, 0.16 mg sodium hydrogen phosphate, 0.04 mg sodium dihydrogen phosphate, water for injection - up to 1 ml. Release form: 6 ml of synovial fluid prosthesis in 10 ml glass syringes. 1 syringe is placed in a blister made of polymer material, hermetically sealed on top with a film. The blister along with instructions for use is placed in a cardboard box. Storage conditions The contents of the syringe are sterile and pyrogen-free. Store at temperatures from +2 °C to +30 °C. Do not freeze! Keep out of the reach of children. Do not use after expiration date. /upload/iblock/68b/68bbc586de049a3875195a91aa5bd4b6.jpg Synvisk-1