SYNVISC ONE

SYNVISC ONE is a sterile gel:
- Viscoelastic based on hylan G-F 20, a sodium hyaluronate derivative, for intra-articular injection.
- Clear, slightly yellow, viscous and transparent, with no visible particles.
- It relieves pain and improves mobility in joints.

- SANOFI
- NAME: SYNVISC ONE
- COMPOSITION: 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 q.b.
- PRESENTATION: 1 x 6 ml.
- NEEDLES: 18 gauge to 20 gauge.
- INDICATIONS: Indicated only for intra-articular use by a physician in the treatment of pain associated with osteoarthritis of the knee.
- INJECTION DEPTH: Intra-articular injections within the synovial cavity of the joint.
- DURATION: The recommended treatment regimen for Synvisc-One is a single injection of 6 ml into the knee, which can be repeated after six months if justified by the patient's symptoms.
- USE: Strict medical use.

- Syringe: 1 x 6 ml.

Knee.

Hylan 8.0 mg, sodium chloride 8.5 mg, disodium hydrogen phosphate 0.16 mg, sodium dihydrogen phosphate hydrate 0.04 mg, water for injection q.b.

- The efficacy of a course of treatment consisting of less than three injections (2 mL each) of SYNVISC ONE has not been established.
- The safety and efficacy of SYNVISC ONE at sites other than the knee and for conditions other than osteoarthritis have not been established.
- The safety and efficacy of using SYNVISC ONE concomitantly with other intra-articular injectables have not been established.
- Use caution when injecting SYNVISC ONE in patients allergic to proteins of avian origin, feathers or egg products.
- Strict adherence to an aseptic administration technique is required.
- Sterile content. The syringe is intended for single use only. The contents should be used immediately after opening the package. Discard any unused quantities of SYNVISC ONE.
- Do not use SYNVISC ONE if the packaging has been opened or damaged. Store in the original packaging (protected from light) at room temperature below 30 °C. DO NOT FREEZE.
- Remove any synovial fluid or effusion before each injection of SYNVISC ONE.
- SYNVISC ONE should be used with caution in patients with signs of lymphatic or venous stasis in the limb to be treated.

- Do not administer to patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.
- Do not inject SYNVISC ONE into the knees of patients with knee joint infections or skin diseases/infections in the area of the injection site.

Temporarily restores the viscoelasticity of synovial fluid. It provides clinical benefit to patients in all stages of joint arthrosis. It is most effective in patients who actively and regularly use the affected joint. It achieves its therapeutic effect through viscosupplementation, a process by which the physiological state and rheological characteristics of the synovial fluid in the arthritic joint are restored.