Synvisc One Sir Ac Ialur 1S 6ml

COMPOSITION
Hylan G-F 20 is available as
- Synvisc-One, prefilled syringe 6 ml
Hylan G-F 20 is a sterile, apyrogenic, viscoelastic liquid containing hylan. The 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 about 6,000,000 daltons, and hylan B is a hydrogel. Hylan G-F 20 contains hylan A and B (8.0 mg ± 2.0 mg per ml) in buffered sodium chloride saline (pH 7.2 ± 0.3).

FEATURES
Hylan G-F 20 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 G-F 20 are, however, superior to those of synovial fluid and to those of hyaluronate solutions of similar concentration. Hylan G-F 20 has an elasticity (storage modulus G ') at 2.5 Hz of 111 ± 13 Pascal (Pa) and a viscosity (loss modulus G ') of 25 ± 2 Pa. The elasticity and viscosity of knee synovial fluid in subjects aged 18 to 27 years, measured by an overlapping technique, at 2.5 Hz are G ' = 117 ± 13 Pa and G'' = 45 ± 8 Pa, respectively. The hylans are metabolized physiologically through the same process as hyaluronates, and the decomposition products are nontoxic.

INDICATIONS AND USE
Hylan G-F 20
- Temporarily reconstitutes the viscoelasticity of synovial fluid.
- It brings clinical benefits to patients in all stages of joint osteoarthritis.
- is most effective in patients who actively and regularly use the joint affected by the disease.
- achieves its therapeutic effect through viscosupplementation, a process by which the physiological state and rheological characteristics of the synovial fluid of the arthritic joint are replenished.
Viscosupplementation with Hylan G-F 20 is indicated to relieve pain and functional limitations by allowing more extensive joint motion. In vitro studies have shown that Hylan G-F 20 protects cartilage cells from damage due to the action of physical and chemical agents.
Synvisc-One is indicated only for intra-articular use by a physician in the treatment of pain associated with knee osteoarthritis.

CONTRAINDICATIONS
- Hylan G-F 20 should not be injected into the joint if there is venous or lymphatic stasis in the affected limb.
- Hylan G-F 20 should not be used in the presence of infection or severe inflammation or dermopathy or skin infection in the area of the injection site.

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

PRECAUTIONS
- Hylan G-F 20 should 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 after intra-articular injection, and resume full activity within a few days.
- Hylan G-F 20 has not been tested in pregnant women or in children/youth under 18 years of age.
- Hylan G-F 20 contains small amounts of avian protein and should not be used in patients with hypersensitivity to this protein.

UNDESIRABLE EFFECTS
- Undesirable effects that may affect the joint into which the injection was given: transient pain and/or swelling and/or effusion in the injected joint may occur following intra-articular injections of Hylan G-F 20. Cases of acute inflammation characterized by joint pain, swelling, effusion, and sometimes sensation of heat and/or stiffness in the joint have been reported following intra-articular injection of Synvisc-One. Synovial fluid analysis reveals aseptic fluid without crystals. Often this reaction responds within a few days to treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), intra-articular steroids, and/or arthrocentesis. Clinical benefit from treatment may still be evident after such reactions.
- During the clinical trial on Synvisc-One Intra-articular infections have not been reported, and have rarely occurred during clinical use Synvisc.
- Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and angioedema have also been reported.
- In the controlled clinical trial with Synvisc-One, the frequency and type of side effects were similar among the group of patients treated with Synvisc-One and the group of patients who had received placebo treatments.

DOSING AND ADMINISTRATION
- Do not use Hylan G-F 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 G-F 20.
- Inject at room temperature.
- To take the syringe out of the blister (or container), hold it tightly by the body without touching the plunger stem.
- Administer using strictly aseptic procedures, taking special care when removing the nozzle.
- Unscrew the gray spout before pulling it out to minimize product spillage.
- Use appropriately sized needles:
- Synvisc-One - 18-gauge to 20-gauge
- To ensure a tight seal and prevent spillage during administration, make sure the needle is firmly inserted on the syringe.
- Do not tighten or apply excessive pressure when applying the needle or removing the needle guard, as this may break the syringe tip.
- Inject only into the synovial space by 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 disposable. Recommended dosing guidelines indicate to inject the entire volume (6 ml per Synvisc-One) of the syringe. Discard the Synvisc-One unused.
- Do not reuse the syringe and/or needle. Reuse of syringes, needles, and/or product from a used syringe may lead to loss of sterility, contamination of product, and/or incomplete treatment.
- Ionic or nonionic contrast agent may be used under fluoroscopic guidance. Do not use more than 1 ml of contrast medium per 2 ml of Hylan G-F 20.
- Do not resterilize Hylan G-F 20.

POSOLOGY
The dosage schedule of Hylan G-F 20 depends on the joint to be treated.
Arthrosis of the knee:
Synvisc-One
The recommended treatment regimen for Synvisc-One is one injection of 6 ml into the knee, which can be repeated after six months if warranted by the patient's symptoms.


DURATION OF EFFECT
Treatment with Hylan G-F 20 affects only the joint site of injection and does not produce a general systemic effect.
Synvisc-One
Data from a prospective clinical trial in patients with knee osteoarthritis showed a reduction in pain for up to 52 weeks after a single injection of Synvisc-One, as well as improvements related to joint stiffness and function.

Clinical data from a double-blind, randomized, controlled trial in patients with knee OA showed clinically significant and statistically significant reduction in pain compared with the placebo group. A total of 253 patients were treated (124 received Synvisc-One and 129 received placebo). Over the course of 26 weeks, in patients treated with Synvisc-One there was a mean percent change in pain from the initial figure of 36%, while patients in the placebo group showed a mean percent change in pain from the initial figure of 29%.

Additional prospective clinical data from two multicenter open-label studies in patients with knee OA showed statistically significant improvements in pain relief from baseline for up to 52 weeks after a single administration of Synvisc-One.

In the first study, 394 patients treated with Synvisc-One showed a statistically significant change in the WOMAC A1 walking pain subscale score (-28 ± 19.89 mm on a VAS of 100 mm) at Week 26 compared with the initial data. In addition, statistically significant changes from baseline were observed in the WOMAC A1 and WOMAC A, B and C scores for all six observation periods between Week 1 and Week 52, demonstrating improvement in walking pain and pain at rest (WOMAC A1 -32.7 ± 19.95 mm; WOMAC A -29.18 ± 19.158 mm), stiffness (WOMAC B -25.77 ± 22.047 mm) and joint function (WOMAC C -25.72 ± 19.449 mm) over the 52 weeks.

CONTENT PER ml (hylan G-F 20)
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 injectable preparations as needed.

PACKING
The contents of each syringe are sterile and apyrogenic. Store at a temperature between +2°C and +30°C. Do not freeze.
Synvisc-One comes in a 10-mL glass syringe prefilled with 6 mL of Hylan G-F 20.

Code.002420