Synvisc Hyaluronic Acid Syringe 1 syringe 2ml

SYNVISC

HYLAN GF 20

Composition
Hylan GF 20 is available as Synvisc®, 2 ml pre-filled syringe.
Hylan GF 20 is a sterile, non-pyrogenic, viscoelastic liquid containing hylan. Hylans are derivatives of hyaluronate (sodium salt of hyaluronic acid) and are made up of repetitive disaccharides of N-acetylglucosamine and sodium glucuronate. Hylan A has an average molecular weight of about 6,000,000 daltons and hylan B is a hydrogel. Hylan GF 20 contains hylan A and B (8.0 mg &#177 2.0 mg per ml) in sodium chloride buffered saline solution (pH 7.2 &#177 0.3).

Features
Hylan GF is biologically similar to hyaluronate. Hyaluronate is one of the components of the synovial fluid and determines its viscoelasticity characteristics. The properties mechanical (viscoelastic) properties of Hylan GF 20 are, however, superior to those of hyaluronate-based solutions of similar concentration. Hylan GF 20 has an elasticity (storage module G) at 2.5 Hz equal to 111 &#177 13 Pascal (Pa) and a viscosity of (loss modulus G'') of 25 &#177 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 they are respectively G'= 117 &#177 13 Pa and G''=45 &#177 8 Pa. The hylans are physiologically metabolised through the same process as hyaluronates and the decomposition products are not toxic.

Indications and use
Hylan GF 20:
Temporarily reconstitutes the viscoelasticity of the body. of synovial fluid.
It brings clinical benefits to patients in all stages of joint osteoarthritis.
&Egrave Più effective in patients who actively and regularly use the joint affected by the pathology.
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 reintegrated.
Viscosupplementation with Hylan GF 20 is indicated to relieve pain and functional limitations, allowing greater movement. extended of the joint. In vitro studies have shown that Hylan GF 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.
Contraindications< br /> Hylan GF 20 must not be injected into the joint in the presence of venous or lymphatic stasis in the limb affected by the pathology.
Hylan GF 20 must not be used in the presence of infections or severe inflammation or dermopathies or infections skin in the injection area.

Dosage
The dosage schedule of Hylan GF 20 depends on the joint to be treated.
Knee osteoarthritis :
Synvisc The recommended treatment regimen for Synvisc is of three injections of 2 ml into the knee, one week apart.
To achieve the optimal effect it is necessary to It is essential to give all three injections. The maximum recommended dosage is of six injections over 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 of a single injection of 2 ml. However, it is recommended to give a second injection of 2 ml if adequate symptomatic pain relief is not obtained. Clinical data have shown that patients benefit from this second injection if administered one to three months after the first.

Duration of Effect
The treatment with Hylan GF 20 it only affects the joint where the injection is injected and does not produce a general systemic effect.
Synvisc
It is generally A maximum duration of effect was found for patients responding well to treatment of up to 26 weeks, although longer periods were observed. short or longer long. Data extrapolated from prospective clinical studies conducted on patients with knee osteoarthritis have demonstrated treatment benefits for up to 52 weeks, after a single treatment cycle of three injections of

Preservation< br /> Store at a temperature between +2°C and +30°C. Do not freeze.

Contents per ml (hylan GF 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 GF 20.
Code. 010126 / 0110150 / 010144