SYNVISC ONE®

The recommended treatment regimen is one injection in the knee. The injection may be repeated 6 months after the first dose, if justified by the patient’s symptoms. Hylan G-F 20 treatment affects only the injected knee; it does not produce a general systemic effect. Prospective clinical data in knee osteoarthritis patients have shown benefit of treatment up to 26 weeks, following a single Synvisc One injec-tion.

• Synvisc One®:
  • is a temporary replacement and supplement for synovial fluid.
  • is beneficial for patients in all stages of knee pathology.
  • is most effective in patients who are actively and regularly using the affected knee.
  • achieves its therapeutic effect through visco-supplementation, a process whereby the physiological and rheological states of the arthritic knee tissues are restored.

Visco-supplementation with Synvisc One® is a treatment to decrease pain and discomfort, allowing more extensive movement of the knee. Synvisc One® is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee.

Synvisc One® (hylan G-F 20) is a sterile, non-pyrogenic, elastoviscous fluid containing hylans. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating 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 hydrated gel. Hylan G-F 20 products contain hylan A and hylan B (8.0 mg ± 2.0 mg per ml) in buffered physiological sodium chloride solution (pH 7.2 ± 0.3).

• Do not inject intra-vascularly.
• Do not inject extra-articularly or into the synovial tissues and capsule. Adverse events, generally in the area of application, have occurred following extra-articular injection of Synvisc*.
• Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence, upon contact.
• Remove synovial fluid or effusion before injecting Synvisc One®.
• Inject at room temperature.
• To remove the syringe from the blister (or tray), take hold of it by the body, without making con-tact with the plunger rod.
• Administer using strict aseptic procedures, taking particular caution when removing the tip cap.
• Twist the grey tip cap before pulling it off, as this will minimize product leakage.
• Use an 18 - 20 gauge needle.
• To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the Luer hub.
• Do not over tighten or apply excessive leverage when attaching the needle or removing the needle guard, as this may break the tip of the syringe.
• Do not re-sterilize Synvisc One®.
• Inject into the synovial space only.
• The syringe contents are for single use only.

Contraindications

• If venous or lymphatic stasis is present, Synvisc One® should not be injected into the knee.
• Synvisc One® should not be used in infected or severely inflamed knees or in patients having skin diseases or infections in the area of the injection site.

After-care

As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities following the intra-articular injection, and resume full activities within a few days.