Synvisc Hyaluronic Acid Syringe 1 syringe 2ml

SYNVISC

HYLAN GF 20

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

Features
Hylan GF È biologically similar to hyaluronate. Hyaluronate is one of the components of the synovial fluid and determines its viscoelastic characteristics. The properties mechanical (viscoelastic) 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 & amp; # 177 13 Pascal (Pa) and a viscosity À (loss modulus G '') of 25 & amp; # 177 2 Pa. The elasticity À and viscosity of the synovial fluid of the knee in subjects of age and agrave; between 18 and 27 years, measured with a superimposable technique, at 2.5 Hz they are respectively G '= 117 & amp; # 177 13 Pa and G' '= 45 & amp; # 177 8 Pa. The hylans are metabolized physiologically through the same process of hyaluronates and the decomposition products are not toxic.

Indications and use
Hylan GF 20:
Temporarily restores viscoelasticity À of the synovial fluid.
It brings clinical benefits to patients in all stages of arthrosis of the joints.
& amp; Egrave Pi Ù effective in patients who actively and regularly use the joint affected by the disease.
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 more movement; extended 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 È 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 affected limb.
Hylan GF 20 must not be used in the presence of infections or severe inflammation or skin diseases or infections skin in the injection site.

Posology
The dosage regimen of Hylan GF 20 depends on the joint to be treated.
Osteoarthritis of the knee :
Synvisc The recommended treatment regimen for Synvisc È of three injections of 2 ml in the knee, one week apart.
To achieve the optimal effect È It is essential to practice 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, a second injection of 2 ml is recommended if adequate symptomatic pain relief is not obtained. Clinical data have shown that patients benefit from this second injection if given one to three months after the first.

Duration of Effect
Treatment with Hylan GF 20 it affects only the injection site joint and does not produce a general systemic effect.
Synvisc
Generally È A maximum duration of effect was found for patients who respond well to treatment up to 26 weeks, although longer periods were observed. short or longer; long. Data extrapolated from prospective clinical trials in patients with knee osteoarthritis have demonstrated treatment benefits for up to 52 weeks after a single treatment course of three injections of

Conservation < br /> Store at a temperature between + 2 & deg; C and + 30 & deg; C. Do not freeze.

Content 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.
Cod. 010126/0110150/010144