SYNVISC ONE HYALURONIC ACID INTRA-ARTICULAR SYRINGE 6 ML

Description
Sterile, non-pyrogenic, viscoelastic liquid containing hylan A and B polymers produced from a highly purified avian extract. 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 GF 20 contains hylan A and B (8.0 mg ± 2.0 mg per ml) in sodium chloride-buffered saline (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 synovial fluid and those of hyaluronate-based solutions of similar concentrations.
Hylan GF 20 has an elasticity (storage modulus G f) at 2.5 Hz of 111-13 Pascal (Pa) and a viscosity (loss modulus G h) of 25-2 Pa. The elasticity and viscosity of knee synovial fluid in subjects aged between 18 and 27 years, measured with a superimposable technique, at 2.5 Hz are GL = 117-13 Pa and G. = 45-8 Pa respectively. Hylans are physiologically metabolised through the same process as hyaluronates and the decomposition products are non-toxic.
Hylan GF 20:
- temporarily restores the viscoelasticity of the synovial fluid;
- provides clinical benefits to patients at all stages of joint osteoarthritis;
- it is more effective in patients who actively and regularly use the affected joint;
- 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 GF 20 is indicated for relieving pain and functional limitations, allowing for greater joint movement. 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.
Synvisc-One is indicated only for intra-articular use by a physician in the treatment of pain associated with osteoarthritis of the knee.

How to use
- Remove synovial fluid or effusion before each injection of Hylan GF 20. - Inject at room temperature. - To remove the syringe from the blister (or container), hold it by the body without touching the plunger rod. - Administer using strictly aseptic procedures, taking particular care when removing the nozzle. - Unscrew the nozzle before removing it, to minimize product spillage. - Use appropriately sized needles: • Synvisc – 18 gauge to 22 gauge (use the appropriate length needle for the joint being treated;
• Synvisc-One – 18 gauge to 20 gauge (to ensure a perfect seal and avoid leakage during administration, ensure 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 dosage guidelines indicate injecting the entire volume (2 ml for Synvisc and 6 ml for Synvisc-One) of the syringe. Discard any unused Synvisc/Synvisc-One.

Knee arthrosis
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.
Synvisc-One
The recommended treatment regimen for Synvisc-One is a single 6 ml injection into the knee, which may be repeated after six months if warranted by the patient's symptoms.
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.

Components
Each ml contains: hylan 8.0 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 should not be used if significant intra-articular effusion has occurred prior to the injection. - As with all invasive joint procedures, it is recommended that the patient avoid excessive motor activity following the intra-articular injection and resume full activity within a few days.
- Hylan 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.
- Do not use Hylan GF 20 if the package is open or damaged.
- 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, an ionic or nonionic contrast medium may be used. Do not use more than 1 ml of contrast medium per 2 ml of Hylan GF 20.
- Do not resterilize Hylan GF 20.

Conservation
The contents of the syringe must be used immediately after opening the package.
Store at 2°C to 30°C. Do not freeze.

Format
Synvisc is supplied in a 2.25 ml glass syringe pre-filled with 2 ml of Hylan GF 20.
Synvisc-One is supplied in a 10 ml glass syringe pre-filled with 6 ml of Hylan GF 20.

Cod. 002420