Description
Pre-filled syringe.
Viscoelastic, pyrogen-free fluid containing hylan A and B polymers produced from a highly purified avian-derived extract. Hylans are derived from hyaluronate (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium gluconate.
Hylan G-F 20 contains hylan A and B (8 mg ± 2 mg per ml) in buffered physiological sodium chloride solution (pH 7.2 ± 0.3).
Hylan G-F 20 is biologically similar to hyaluronate. Hyaluronate is one of the components of synovial fluid and determines its viscoelastic properties. The mechanical (viscoelastic) properties of Hylan G-F 20 are, however, superior to those of hyaluronate-based solutions of similar concentration.
The elasticity and viscosity of synovial fluid in subjects aged between 18 and 27, measured using a comparable 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, providing clinical benefits to patients at all stages of joint osteoarthritis, and is more 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 in the osteoarthritic joint are restored.
Viscosupplementation is indicated to relieve pain and functional limitations, allowing for greater joint movement.
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.

Directions for use
Do not use if the package is open 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 firmly by the barrel without touching the plunger rod.
Administer using strictly aseptic procedures, taking particular care when removing the cap.
Unscrew the cap before pulling it off, to minimize product leakage.
Use appropriate needle sizes:
- Synvisc 18 gauge to 22 gauge.
Use a needle of suitable length for the joint to be treated:
- Synvisc-One 18 gauge to 20 gauge.
To ensure a perfect seal and prevent leakage during administration, make sure the needle is securely attached to the syringe.
Do not overtighten or exert excessive pressure when attaching the needle or removing the needle guard, as this could break the tip of the syringe.
Inject only into the synovial space, performing the operation under instrumental guidance if necessary, for example, fluoroscopy, especially when treating the hip and shoulder.
The contents of the syringe are for single use only. Recommended dosage guidelines indicate inserting the entire volume of the syringe (2 ml). Discard unused Synvisc.
Do not reuse the syringe and/or needle. Reuse of syringes, needles, and/or the product from a used syringe may lead to loss of sterility, product contamination, and/or incomplete treatment.
Under fluoroscopic guidance, an ionic or non-ionic contrast medium may be used. Do not use more than 1 ml of contrast medium per 2 ml of Hylan G-F 20.
Do not re-sterilize Hylan G-F 20.
The dosage regimen for Hylan G-F 20 depends on the joint to be treated.
Knee osteoarthritis
The recommended treatment regimen 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 six-month period, with at least a four-week break between treatment regimens.
Hip, ankle, and shoulder osteoarthritis
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 G-F 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.s.

Warnings
- Hylan G-F 20 should not be injected into the joint in the presence of venous or lymphatic stasis in the affected limb.
- Hylan G-F 20 should not be used in the presence of infection or severe inflammation, or skin diseases or skin infections in the injection area.
- Hylan G-F 20 should not be used in patients with known hypersensitivity (allergy) to hyaluronate (sodium hyaluronate) preparations.
- Do not inject intravascularly.
- Do not inject extra-articularly or into tissues or the synovial capsule. In general, complications in the injection area have been caused by extra-articular diffusion of Synvisc.
- Do not use disinfectants containing quaternary ammonium salts for skin preparation concurrently, as hyaluronate may precipitate in their presence.
- Hylan G-F 20 should not be used if a significant intra-articular effusion has occurred before injection.
- As with all invasive procedures related to joints, it is recommended that the patient avoid any excessive motor activity after intra-articular injection, and resume 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.

Storage
Store at a temperature between 2 °C and 30 °C. Do not freeze.

Format
3 pre-filled syringes of 2 ml.

Code. 002344