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DOSAGE AND ADMINISTRATION
Detailed Device Description
Synvisc-One combines the three doses of SYNVISC (hylan G-F 20) which consists of hylan A (average molecular weight 6,000,000 daltons) and hylan B hydrated gel in a buffered physiological sodium chloride solution, pH 7.2. Synvisc-One has an elasticity (storage modulus G') at 2.5 Hz of 111 ± 13 Pascals (Pa) and a viscosity (loss modulus G“) of 25 ± 2 Pa (elasticity and viscosity of knee synovial fluid of 18 to 27- year-old humans measured with a comparable method at 2.5 Hz: G' = 117 ± 13 Pa; G” = 45 ± 8 Pa.)
Each 10 mL syringe of Synvisc-One combines the three 2-mL doses (16 mg each) of a complete SYNVISC treatment regimen (48 mg). Each Synvisc-One 10-mL syringe contains:
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 nonpyrogenic.
Directions For Use
Precaution: Do not use Synvisc-One 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 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 is administered as a single intra-articular. Strict aseptic administration technique must be followed.
- Using an 18- to 20-gauge needle, remove synovial fluid or effusion before injecting Synvisc-One.
- Do not use the same syringe for removing synovial fluid and for injecting Synvisc-One; 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 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 syringe tip.
- Inject the full 6 mL in one knee only.
Genzyme Biosurgery a division of Genzyme Corporation, 1125 Pleasant View Terrace, Ridgefield, New Jersey 07657. Telephone: 1-888-3-SYNVISC (1-888-379-6847). Revised: Sep 2014.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/6/2016
Additional Synvisc-One Information
Synvisc-One - User Reviews
Synvisc-One User Reviews
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