“Composition of HYLAN GF 20
Hylan GF 20 is available as a 2 ml Synvisc® pre-filled syringe.
Hylan GF 20 is a sterile, non-pyrogenic, viscoelastic fluid containing hylan. Hylans are derivatives of hyaluronate (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 GF 20 contains hylan A and B (8.0 mg ± 2.0 mg per ml) in a sodium chloride buffer solution (pH 7.2 ± 0.3).
Indications and use
Hylan GF 20:
Temporarily restores the viscoelasticity of the synovial fluid.
It provides clinical benefits to patients at all stages of osteoarthritis of the joints.
It is most effective in patients who actively and regularly use the affected joint.
The therapeutic effect is achieved through viscous supplementation – a process by which the physiological state and rheological characteristics of the synovial fluid of the arthritic joint are restored.
Hylan GF 20 viscous supplement is indicated for the relief of pain and functional limitations, providing a greater range of joint motion. In vitro studies have shown that Hylan GF 20 protects cartilage cells from damage caused by 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 joints.
Synvisc-One is intended for intra-articular use only by a physician for the treatment of pain associated with osteoarthritis of the knee.
Dosage and Administration
Do not use Hylan GF 20 if the package is open or damaged.
The contents of the syringe must be used immediately after opening the package.
Avoid synovial fluid or effusion before each injection of Hylan GF 20.
Inject at room temperature.
To remove the syringe from the blister (or tablet), hold it firmly by the body, without touching the plunger rod.
Inject the product strictly under aseptic conditions, taking special care when removing the nozzle.
Before removing the gray nozzle, unscrew it to minimize spillage of the product.
Use the appropriate needle size: Synvisc – 18-22 gauge.
Use the needle of the appropriate length for the joint to be treated.
To ensure a perfect seal and to avoid leakage during injection, make sure the needle is securely attached to the syringe.
Do not apply pressure or apply excessive force when attaching the needle or removing the needle cap, as this may cause breakage of the syringe tip.
Inject into the synovial space only, if necessary under instrumental control, such as fluoroscopy, especially for hip and shoulder joints. The contents of the syringe are for single use only. The recommended dosing instructions indicate that the entire volume of the syringe (2 ml for Synvisc) should be injected. Discard any unused Synvisc.
Do not reuse the syringe and/or needle. Reuse of syringes, needles and/or products from used syringes may result in loss of sterility, contamination of the products and/or incomplete processing. Ionic or non-ionic contrast media may be used under fluoroscopy. Do not use more than 1 ml of contrast media per 2 ml of Hylan GF 20.
Do not re-sterilize Hylan GF 20.
Dosage
The dosage regimen for Hylan GF 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. All three injections must be administered for optimal effect. The maximum recommended dose is six injections over six months, with at least four weeks between treatments. Hip, ankle and shoulder osteoarthritis:
Synvisc 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. Clinical data have shown that patients benefit from a second injection when administered one to three months after the first.
Duration of effect
Hylan GF 20 treatment affects only the joint into which it is injected and has no systemic effect. Maximum duration of effect.”
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