HYLAN G-F 20
Composition
Hylan G-F 20 is available as Synvisc®, a 2 ml pre-filled syringe.
Hylan G-F 20 is a sterile, non-pyrogenic, viscoelastic liquid containing hylan. Hylans are derivatives of hyaluronate (the sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of approximately 6,000,000 daltons and hylan B is a hydrogel.
Hylan G-F 20 contains hylan A and B (8.0 mg ± 2.0 mg per ml) in sodium chloride buffered saline (pH 7.2 ± 0.3).
Characteristics
Hylan G-F is biologically similar to hyaluronate. Hyaluronate is a component of synovial fluid and determines its viscoelastic characteristics. The mechanical (viscoelastic) properties of Hylan G-F 20 are, however, superior to those of hyaluronate-based solutions of similar concentration. Hylan G-F 20 has an elasticity (storage module G) at 2.5 Hz of 111 ± 13 Pascal (Pa) and a viscosity (loss modulus G'') of 25 ± 2 Pa. The elasticity and viscosity of the synovial fluid of the knee in subjects aged between 18 and 27 years, measured with a superimposable technique, at 2.5 Hz are respectively G'= 117 ± 13 Pa and G''=45 ± 8 Pa. Hylans are physiologically metabolized through the same process as hyaluronates and the decomposition products are non-toxic.
Indications and use
Hylan G-F 20:
Temporarily restores the viscoelasticity of the synovial fluid.
It provides clinical benefits to patients in all stages of joint osteoarthritis.
It is More effective in patients who actively and regularly use the affected joint.
It achieves its therapeutic effect through viscosupplementation, a process through which the physiological state and rheological characteristics of the synovial fluid of the arthritic joint are replenished.
Viscosupplementation with Hylan G-F 20 is indicated to relieve pain and functional limitations, allowing greater movement of the joint. In vitro studies have shown that Hylan G-F 20 protects cartilage cells from damage due to the action of physical and chemical agents.
Synvisc is 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.
Synvisc-One is intended only for intra-articular use by a physician in the treatment of pain associated with osteoarthritis of the knee.
Contraindications
Hylan G-F 20 must not be injected into the joint if there is venous or lymphatic stasis in the affected limb. Hylan G-F 20 must not be used in the presence of infections or severe inflammation or skin diseases or infections in the injection area.
Warnings
Do not inject intravascularly. Do not inject extra-articularly or into the synovial tissue or capsule. In general, complications in the injection area have been caused by extra-articular spread of Synvisc. Do not use concomitantly with disinfectants containing quaternary ammonium salts for skin preparation, as hyaluronate may precipitate in their presence.
Precautions
Hylan G-F 20 should not be used if significant intra-articular effusion has occurred prior to the injection.
As with all invasive procedures involving joints, it is recommended that the patient avoids any excessive motor activity after the intra-articular injection, and resumes full activity within a few days.
Hylan G-F 20 has not been tested in pregnant women or in children/adolescents under 18 years of age.
Hylan G-F 20 contains small amounts of avian protein and should not be used in patients with hypersensitivity to this protein.
Side Effects
Side effects that may affect The following adverse reactions may occur following intra-articular injection of Hylan G-F 20. Post-marketing experience with Synvisc has shown that in some cases the effusion may be significant and may cause severe pain; it is important to remove and analyze the fluid to exclude infection or crystal-induced arthropathy. These reactions generally subside after a few days. The clinical benefits of treatment may still be felt after such reactions. No intra-articular infections were recorded during clinical trials with Synvisc, which have been rarely observed during clinical use of Synvisc.
Systemic effects related to the administration of Synvisc that have rarely emerged from post-marketing experience have been the following: rash, urticaria, pruritus, fever, nausea, headache, dizziness, chills, muscle cramps, paraesthesia, peripheral edema, malaise, difficulty breathing, flushing, and facial edema. Controlled clinical studies with Synvisc have shown no statistically significant differences in the number or types of systemic side effects between the group of patients treated with Synvisc and the group of patients who received control treatments.
Dosage and Administration
Do not use Hylan G-F 20 if the package is opened or damaged.
The contents of the syringe must be used immediately after opening the package.
Remove any synovial fluid or effusion before each injection of Hylan G-F 20.
Inject at room temperature.
To remove the syringe from the blister (or tablet), hold it by the body without touching the plunger rod.
Administer using strictly aseptic procedures, paying particular attention when removing the nozzle.
Unscrew the grey nozzle before removing it, to minimize product spillage.
Use needles appropriately sized: Synvisc - 18 gauge to 22 gauge.
Use the appropriate length needle for the joint being treated.
To ensure a perfect seal and avoid leakage during administration, ensure that the needle is firmly attached to the syringe.
Do not tighten 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, using instrumental guidance if necessary, such as fluoroscopy, especially when treating the hip and shoulder. The contents of the syringe are for single use only. Recommended dosing guidelines recommend injecting the entire volume (2 ml for Synvisc) of the syringe. Discard any unused Synvisc.
Do not reuse the syringe and/or needle. Reusing syringes, needles, and/or product from a used syringe may result in serious injury. This may lead to loss of sterility, product contamination, and/or incomplete treatment. An ionic or non-ionic contrast medium may be used under fluoroscopic guidance. Do not use more than 1 ml of contrast medium per 2 ml of Hylan G-F 20.
Do not resterilize Hylan G-F 20.
Dosage
The dosage schedule for Hylan G-F 20 depends on the joint being treated.
Knee Osteoarthritis:
Synvisc The recommended treatment regimen for Synvisc is three 2 ml injections into the knee, one week apart. To achieve optimal effect, it is essential to administer all three injections. The maximum recommended dosage 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:
Synvisc The recommended initial treatment regimen is a single 2 ml injection. However, a second 2 ml injection is recommended if adequate symptomatic relief from pain is not achieved. Clinical data have shown that patients benefit from this second injection if administered one to three months after the first.
Duration of Effect
Treatment with Hylan G-F 20 affects only the injected joint and does not produce a general systemic effect.
Synvisc
A maximum duration of effect has generally been observed for patients who respond well to treatment of up to 26 weeks, although shorter or longer periods have been observed. Data from prospective clinical studies in patients with knee osteoarthritis have demonstrated treatment benefits for up to 52 weeks after a single treatment course of three Synvisc injections.
Storage
Store at +2°C to +30°C. Do not freeze.
Contents per ml (hylan G-F 20)
Hylan (A and B) 8.0 mg; sodium chloride 8.5 mg; disodium hydrogen phosphate 0.16 mg; sodium dihydrogen phosphate hydrate 0.04 mg; water for injections as required.
Packaging
The contents of each syringe are sterile and non-pyrogenic. Synvisc is supplied in a 2.25 ml glass syringe pre-filled with 2 ml of Hylan G-F 20.
Format
Pack of 3 pre-filled syringes of 2 ml.
Product Code:FRCM229535
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