Synvisc-One (hylan g-f 20 single intra-articular injection) 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.
DOSAGE AND ADMINISTRATION
Directions For Use
Precaution: Do not use Synvisc-One (hylan g-f 20 single intra-articular injection) if the package has been opened or damaged. Store in the original packaging (protected from light) at room temperature below 86°F (30°C). DO NOT FREEZE.
Precaution: The syringe containing Synvisc-One (hylan g-f 20 single intra-articular injection) is intended for single use. The contents of the syringe must be used immediately after the syringe has been removed from its packaging.
Precaution: Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because hyaluronan can precipitate in their presence.
Synvisc-One (hylan g-f 20 single intra-articular injection) is administered as a single intra-articular injection. Strict aseptic administration technique must be followed.
- Using an 18- to 20-gauge needle, remove synovial fluid or effusion before injecting Synvisc-One (hylan g-f 20 single intra-articular injection) .
- Do not use the same syringe for removing synovial fluid and for injecting Synvisc-One (hylan g-f 20 single intra-articular injection) ; however, the same 18- to 20-gauge needle should be used.
- Twist the tip cap before pulling it off, as this will minimize product leakage.
- To ensure a tight seal and prevent leakage during administra tion, 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 syringe tip.
- Inject the full 6 mL in one knee only.
Synvisc-One is supplied in a 10-mL glass syringe containing 3 doses (48 mg) of hylan G-F 20. The contents of the syringe are sterile and non-pyrogenic.
MANUFACTURED AND DISTRIBUTED BY: Genzyme Biosurgery, a division of Genzyme Corporation, 1125 Pleasant View Terrace, Ridgefield, New Jersey 07657. Telephone: 1-888-3-SYNVISC (1-888-379-6847).
Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.
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