Description
Pre-filled syringe.
Viscoelastic, pyrogen-free liquid containing hylan A and B polymers 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 solution (pH 7.2 ± 0.3).
Hylan GF 20 is biologically similar to hyaluronate. Hyaluronate is a component of synovial fluid and determines its viscoelasticity. The mechanical (viscoelastic) properties of Hylan GF 20 are, however, superior to those of hyaluronate-based solutions of similar concentrations.
The elasticity and viscosity of synovial fluid in subjects aged 18 to 27 years, measured with a superimposable technique, at 2.5 Hz are G'=117+13 Pa and G''=45+8 Pa, respectively. Hylans are physiologically metabolized through the same process as hyaluronates and the decomposition products are non-toxic.
It temporarily restores the viscoelasticity of synovial fluid, provides clinical benefits to patients at 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 through which the physiological state and rheological characteristics of the synovial fluid of the arthritic joint are replenished.
Viscosupplementation is indicated to relieve pain and functional limitations, allowing 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 package is opened or damaged.
The contents of the syringe must 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 by the body without touching the plunger rod.
Administer using strictly aseptic procedures, taking particular care when removing the nozzle.
Unscrew the spout before removing it to minimize product spillage.
Use appropriately sized needles:
- Synvisc from 18 gauge to 22 gauge.
Use the needle of the appropriate length for the joint to be treated:
- Synvisc-One 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 case of treatment of the hip and shoulder.
The contents of the syringe are for single use only. Recommended dosing guidelines indicate inserting the entire volume of the syringe (2 ml). Discard any unused Synvisc.
Do not reuse the syringe and/or needle. Reusing syringes, needles, and/or the product from a used syringe may result in loss of sterility, product contamination, and/or incomplete treatment.
Under fluoroscopic guidance, ionic or nonionic contrast media can be used. Do not use more than 1 ml of contrast media 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 2 ml injections into the knee, spaced one week apart. For 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
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.
Duration of effect
Treatment with Hylan GF 20 affects only 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, sodium dihydrogen phosphate hydrate 0.04 mg, water for injections q.b.

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 must not be used in the presence of infections or severe inflammation 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, complications in the injection area have been caused by extra-articular spread of Synvisc.
- Do not use disinfectants containing quaternary ammonium salts concomitantly for skin preparation, as in their presence the hyaluronate may precipitate.
- Hylan GF 20 must 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 avoids any excessive motor activity following the intra-articular injection, and resumes full activity within a few days.
- Hyaln GF 20 has not been tested in pregnant women or in 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 2°C to 30°C. Do not freeze.

Format
3 pre-filled syringes of 2 ml.

Cod. 002344