July 26, 2016
Recommended Topic Related To:

Synvisc-One

"The US Food and Drug Administration's (FDA's) Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee voted yesterday to recommend premarket approval of the Cartiva Synthetic Cartilage Implant for use in pati"...

A A A

Synvisc-One




Indications
Dosage
How Supplied

INDICATIONS

Synvisc-One 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

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:

  • Hylan polymers (hylan A + hylan B) 48 mg
  • Sodium chloride 51 mg
  • Disodium hydrogen phosphate 0.96 mg
  • Sodium dihydrogen phosphate monohydrate 0.24 mg
  • Water for injection q.s. to 6.0 mL

HOW SUPPLIED

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

Indications
Dosage
How Supplied

Synvisc-One - User Reviews

Synvisc-One User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Synvisc-One sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Arthritis

Get the latest treatment options