Synvisc Prefilled Intraarticular Syringe Hyaluronic Acid 2ml

SYNVISC HYLAN GF 20

Composition
Hylan GF 20 is available as Synvisc® , 2ml 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 consist of repetitive 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 buffered saline sodium chloride (pH 7.2 ± 0.3).

Features
Hylan GF is biologically similar to hyaluronate. Hyaluronate is one of the components of the synovial fluid and determines its viscoelastic characteristics. The 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 ± 13 Pascal (Pa) and a viscosity (loss modulus G '') of 25 ± 2 Pa. The elasticity and viscosity of the liquid synovial of the knee in subjects aged between 18 and 27 years, measured with a superimposable technique, at 2.5 Hz they are respectively G '= 117 ± 13 Pa and G' '= 45 ± 8 Pa. The hylans are metabolized physiologically through the same process as hyaluronates and the decomposition products are non-toxic.

Indications and use
Hylan GF 20:
Temporarily restores the viscoelasticity of the synovial fluid.
It brings clinical benefits to patients in all stages of joint osteoarthritis.
It 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 reintegrated.
Viscosupplementation with Hylan GF 20 is indicated to relieve pain and functional limitations, allowing for more extensive movement 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 only indicated for intra-articular use by a physician for the symptomatic treatment of pain associated with osteoarthritis of the knee, hip, ankle and shoulder.
Contraindications
Hylan GF 20 should not be injected into the joint if there is 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 skin infections in the area of the injection.

Warnings
Do not inject intravascularly.
Do not inject extra - articularly or into tissues or synovial capsule. In general, complications in the area of the injection were caused by an extra-articular spread of Synvisc .
Do not use concomitantly disinfectants containing quaternary ammonium salts for skin preparation, as hyaluronate could precipitate in their presence.

Precautions
Hylan GF 20 must not be used if significant intra-articular effusion has occurred prior to injection.
As with all invasive joint-related procedures, it is recommended that the patient avoid any 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 the age of 18.
Hylan GF 20 contains small amounts of avian protein and should not be used in patients with hypersensitivity to this protein.

Side effects
The side effects that may affect the joint where the injection was given are the following: transient pain and / or swelling and / or effusion in the joint following the intra-articular injection of Hylan GF 20. The experience post-marketing with Synvisc has shown that in some cases the effusion could be significant and could cause pronounced pain; it is important to remove and analyze the liquid to rule out microcrystalline infections or arthropathies. These reactions generally subside after a few days. The clinical benefits of treatment may still be felt after such reactions. No intra - articular infections were recorded during the clinical trial on Synvisc , which were rarely encountered during clinical use of Synvisc .
Systemic effects related to Synvisc administration rarely emerged from post-marketing experience were the following: rash, urticaria, pruritus, fever, nausea, headache, dizziness, chills, muscle cramps, paraesthesia, peripheral edema, malaise, breathing difficulties, hot flashes and facial edema.
Controlled clinical trials with Synvisc revealed no statistically relevant differences in the number or types of systemic undesirable effects between the group of patients treated with Synvisc and the group of patients who received control treatments.

Dosage and Administration
Do not use Hylan GF 20 if the package is opened or damaged.
The contents of the syringe should be used immediately after opening the package.
Remove synovial fluid or effusion before each injection of Hylan GF 20.
Inject at room temperature.
To remove the syringe from the blister (or tablet), hold it tightly by the body without touching the plunger rod.
Administer using strictly aseptic procedures, paying particular attention to removing the spout.
Unscrew the gray spout before removing it, to minimize product spillage.
Use needles of the appropriate size: Synvisc - 18 gauge to 22 gauge.
Use the needle of suitable length for the joint to be treated. To ensure a tight seal and to avoid spillage during administration, make sure the needle is firmly seated on the syringe.
Do not tighten or exert excessive pressure when applying the needle or removing the needle guard, as this could break the tip of the syringe.
Inject into the synovial space only, performing the operation if necessary under instrumental guidance, e.g. fluoroscopy, especially in the case of hip and shoulder treatment.
The contents of the syringe are for single use only. Guidelines for recommended dosing are to inject the full volume (2ml for Synvisc ) of the syringe.
Discard the unused Synvisc .
Do not reuse the syringe and / or needle. Reuse of syringes, needles and / or the product of a used syringe can lead to loss of sterility, product contamination and / or incomplete handling.
An ionic or non-ionic contrast medium can be used under fluoroscopic guidance. Do not use more than 1 ml of contrast medium per 2 ml of Hylan GF 20.
Do not resterilize Hylan GF 20.

Dosage
The dosage schedule of Hylan GF 20 depends on the joint to be treated.
Osteoarthritis of the knee:
Synvisc The recommended treatment regimen for Synvisc is three 2ml injections into the knee, one week apart.
To achieve the optimal effect it is essential to practice all three injections. The maximum recommended dosage is six injections over a six month period, 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 a single 2 ml injection. 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 when given one to three months after the first.

Duration of the Effect
Treatment with Hylan GF 20 affects only the injection site joint and does not produce a general systemic effect.
Synvisc
A maximum duration of effect has generally been found for patients responding well to treatment of up to 26 weeks, although shorter or longer periods have been observed. Data extrapolated from prospective clinical studies in patients with osteoarthritis of the knee have shown treatment benefits for up to 52 weeks after a single treatment course of three injections of

storage
Store at a temperature between + 2 ° C and + 30 ° 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