Synvisc One Hyaluronic Acid Syringe 1 X 6 ml

Hylan GF 20: Temporarily restores viscoelasticity. of synovial fluid. It brings clinical benefits to patients in all stages of joint osteoarthritis. &` more 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 replenished. 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-One is Intended only for intra-articular use by a physician in the treatment of pain associated with knee osteoarthritis. 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. Do not use disinfectants containing quaternary ammonium salts to prepare the skin at the same time, as the hyaluronate could precipitate in their presence.

Precautions

Hylan GF 20 must not be used if you have undergone a significant intra-articular effusion occurred. As with all invasive joint procedures, it is recommended that the patient avoids any physical activity. excessive motor activity after the intra-articular injection, and that full activity is resumed. within a few days. Hylan GF 20 is not been tested in pregnant women or in children/adolescents. under 18 years. Hylan GF 20 contains small quantities of of protein of avian origin and should not be used in patients with hypersensitivity to it. to this protein. Side Effects Side effects that may affect the joint in which it is 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. No intra-articular infections were recorded during the clinical trial on Synvisc-One. articular. In the controlled clinical trial with Synvisc-One, the frequency and types of side effects were similar between the group of patients treated with Synvisc-One and the group of patients who received placebo treatments.

Dosage and Administration

Do not use Hylan GF 20 if the package is open 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 when removing the nozzle. Unscrew the gray nozzle before removing it, to minimize product leakage. Use the needle of a length suitable for the joint to be treated. Synvisc-One - 18 gauge to 20 gauge. To ensure a perfect seal and avoid leakage during administration, ensure the needle is firmly inserted into the syringe. Do not tighten or apply excessive pressure when attaching the needle or removing the needle guard, as you may break the syringe tip. Inject only into the synovial space, carrying out 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 single use. Recommended dosing guidelines state to inject the entire volume (6 ml for Synvisc-One) of the syringe. Discard unused Synvisc-One. Do not reuse the syringe and/or needle. Reusing syringes, needles, and/or used syringe product may cause harm. lead to loss of sterility, product contamination and/or incomplete processing. Under fluoroscopic guidance you can an ionic or non-ionic contrast medium may be used. Do not use any more of 1 ml of contrast medium for 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. Knee Osteoarthritis: Synvisc-One The recommended treatment regimen for Synvisc-One is of a single injection of 6 ml into the knee, which can be repeated after six months if justified by the patient's symptoms.

Duration of Effect

Treatment with Hylan GF 20 only affects the joint where the injection was made and does not produce a general systemic effect. Data extrapolated from a prospective clinical study conducted on patients with knee osteoarthritis demonstrated treatment benefits for up to 26 weeks, after a single injection of Synvisc-One.

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 is sterile and non-pyrogenic. Synvisc-One is supplied in a 10 ml glass syringe pre-filled with 6 ml of Hylan GF 20.