Synvisc hyaluronic acid syringe 3 syringes 2 ml

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 consist of disaccharide repeating 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 solution physiological buffered sodium chloride (pH 7.2 ± 0.3).

Characteristics
Hylan GF is biologically similar to hyaluronate. Hyaluronate is one of the components of synovial fluid and determines its viscoelasticity 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 are G'=117 ± 13 Pa and G''=45 ± 8 Pa respectively. 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 liquid synovial.
It brings clinical benefits to patients in all stages of joint arthrosis.
It is more effective in patients who actively and regularly use the joint affected by the pathology.
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 movement wider than 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 doctor for symptomatic treatment of pain associated with osteoarthritis of the knee, hip, ankle and shoulder.
Synvisc-One is intended only for intra-articular use by a physician in the treatment of pain associated with osteoarthritis of the knee .

Contraindications
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 skin infections in the injection area.

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

Precautions
Hylan GF 20 does not It should be used if a large intra-articular effusion has occurred before the injection. As with all invasive joint procedures, it is recommended that the patient avoids any excessive motor activity after the intra-articular injection. joint, and that it resumes 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 quantity of protein of avian origin and should not be used in patients with hypersensitivity to this protein.

Side Effects
Side effects that may affect the joint in where the injection was given are as follows: transient pain and/or swelling and/or effusion in the joint following intra-articular injection of Hylan GF 20. Post-marketing experience with Synvisc has shown that in some cases the effusion could be of considerable size and could cause pronounced pain; It is important to remove and analyze the fluid to exclude microcrystalline infections or arthropathies. These reactions generally subside after a few days. The clinical benefits of treatment may still be noticeable after such reactions. During the clinical trial on Synvisc, no intra-articular infections were recorded, which were rarely encountered during the clinical use of Synvisc.
The systemic effects related to the administration of Synvisc rarely emerged from the post-marketing experience were the following: rash, urticaria, pruritus, fever, nausea, headache, dizziness, chills, muscle cramps, paraesthesia, peripheral edema, malaise, breathing difficulties, hot flushes and facial edema. Controlled clinical studies with Synvisc showed no statistically significant differences in the number or types of systemic side 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 open or damaged.
The contents of the syringe must be used immediately after opening the package.
Remove the 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 when removing the nozzle.
Unscrew the gray nozzle before removing it, to minimize product leakage.
Use appropriately sized needles: Synvisc - from 18 gauge to 22 gauge.
Use the needle of a length suitable for the joint to be treated.
To ensure a perfect seal and avoid leakage during administration, make sure that the needle is firmly seated on the syringe.
Do not tighten or apply excessive pressure when attaching the needle or removing the needle guard, as this may break the tip of the syringe.
Inject only in the synovial space performing the operation if necessary under instrumental guidance, for example fluoroscopy, especially in case of treatment of the hip and shoulder. The contents of the syringe are disposable. Recommended dosing guidelines state to inject the entire volume (2 ml for Synvisc) of the syringe. Discard any unused Synvisc.
Do not reuse the syringe and/or needle. Reuse of syringes, needles and/or used syringe product may lead to loss of sterility, product contamination and/or incomplete processing. Under fluoroscopic guidance, an ionic or non-ionic contrast medium can 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.

Dosage
The scheme dosage of Hylan GF 20 depends on the joint to be treated.
Knee osteoarthritis:
Synvisc The recommended treatment regimen for Synvisc is three injections of 2 ml into the knee, one week apart on the other. To achieve the optimal effect it is essential to give all three injections. The maximum recommended dosage is 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 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
Generally, a maximum duration of effect for patients who respond well to treatment for up to 26 weeks, even if shorter or longer periods were observed. Data extrapolated from prospective clinical studies conducted in patients with knee osteoarthritis have demonstrated treatment benefits for up to 52 weeks, following a single treatment course of three injections of Synvisc.

Storage
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.

Format
Pack of 3 pre-filled 2 ml syringes .