Synvisc is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e. g. , acetaminophen.

DIRECTIONS FOR USE

Synvisc is administered by intra-articular injection once a week (one week apart) for a total of three injections.

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

Precaution: Strict aseptic administration technique must be followed.

Precaution: Do not concomitantly use disinfectants containing qua-ternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.

Precaution: Remove synovial fluid or effusion before each Synvisc injection. Do not use the same syringe for removing synovial fluid and for injecting Synvisc, but the same needle should be used.

Take particular care to remove the tip cap of the syringe and needle aseptically.

Twist the gray tip cap before pulling it off, as this will minimize product leakage.

Inject Synvisc into the knee joint through an 18 to 22 gauge needle. To ensure a tight seal and prevent leakage during administration, secure the needle tightly while firmly holding the luer hub.

Precaution: 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 inject anesthetics or any other medications intra-articularly into the knee while administering Synvisc therapy. This may dilute Synvisc and affect its safety and effectiveness.

Precaution: The syringe containing Synvisc is intended for single use. The contents of the syringe must be used immediately after the syringe has been removed from its packaging. Inject the full 2 mL in one knee only. If treatment is bilateral, a separate syringe must be used for each knee. Discard any unused Synvisc.

DISTRIBUTED BY: Wyeth Pharmaceuticals Inc. Philadelphia, Pennsylvania 19101 Telephone: 1-800-99-WYETH

DEVELOPED AND MANUFACTURED BY: Genzyme Biosurgery a division of Genzyme Corporation 1125 Pleasant View Terrace Ridgefield, New Jersey 07657, Covered by U. S. patents #4, 636, 524, #4, 713, 448, #5, 099, 013, #5, 143, 724. SYNVISC and GENZYMEare registered trademarks of Genzyme Corporation.

Synvisc is supplied in a 2. 25 mL glass syringe containing 2 mL Synvisc. Product Number:0008-9149-02 ----- 3 disposable syringes

The contents of the syringe are sterile and nonpyrogenic.

Bookmark this page: