Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.

Do not inject Synvisc extra-articularly or into the synovial tissues and capsule. Local and systemic adverse events, generally in the area of the injection, have occurred following extra-articular injection of Synvisc.

Intravascular injections of Synvisc may cause systemic adverse events.

General

The effectiveness of a single treatment cycle of less than three injections of Synvisc has not been established.

The safety and effectiveness of Synvisc in locations other than the knee and for conditions other than osteoarthritis have not been established.

Do not inject anesthetics or other medications into the knee joint during Synvisc therapy. Such medications may dilute Synvisc and affect its safety and effectiveness.

Use caution when injecting Synvisc into patients who are allergic to avian proteins, feathers, and egg products.

The safety and effectiveness of Synvisc in severely inflamed knee joints have not been established.

Strict aseptic administration technique must be followed.

STERILE CONTENTS. The syringe is intended for single use. The contents of the syringe must be used immediately after its packaging is opened. Discard any unused Synvisc.

Do not use Synvisc if package is opened or damaged. Store in original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.

Remove synovial fluid or effusion before each Synvisc injection.

Synvisc should be used with caution when there is evidence of lymphatic or venous stasis in that leg.

Provide patients with a copy of the Patient Labeling prior to use.

Transient pain, swelling and/or effusion of the injected joint may occur after intra-articular injection of Synvisc. In some cases the effusion may be considerable and can cause pronounced pain; cases where swelling is extensive should be discussed with the physician.

As with any invasive joint procedure, it is recommended that the patient avoid any strenuous activities or prolonged weight-bearing activities such as jogging or tennis following the intra-articular injection.

Pregnancy: The safety and effectiveness of Synvisc have not been established in pregnant women.

Nursing mothers: It is not known if Synvisc is excreted in human milk. The safety and effectiveness of Synvisc have not been established in lactating women.

The safety and effectiveness of Synvisc have not been established in children.

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