Synvisc (Hylan G-F 20)

SYNVISC®

Biomatrix

Hylan G-F 20

Viscosupplementation

Description:

Synvisc (hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Hylans are derivatives of hyaluronan (sodium salt of hyaluronic acid) and consist of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate. Synvisc contains hylan fluid and hylan gel slurry (8 mg±2 mg/mL) in buffered physiological sodium chloride solution (pH 7.2±0.3).

Synvisc is biologically similar to hyaluronan. Hyaluronan is a component of synovial fluid which is responsible for its viscoelasticity. The mechanical (elastoviscous) properties of Synvisc are, however, superior to those of synovial fluid and hyaluronan solutions of comparable concentration. Hylans are degraded in the body by the same pathway as hyaluronan, and breakdown products are nontoxic.

Indications And Clinical Uses:

A temporary replacement and supplement for synovial fluid. Synvisc is intended only for intra-articular use to treat pain associated with osteoarthritis of the knee. Synvisc is most effective in patients who are actively and regularly using the affected joint. Synvisc is most beneficial in patients with early stage joint pathology.

Synvisc achieves its therapeutic effect through viscosupplementation, a process whereby the physiological and rheological states of the arthritic joint tissues are restored. Viscosupplementation with Synvisc is a treatment to decrease pain and discomfort, allowing more extensive movement of the joint. In vitro studies have shown that Synvisc protects cartilage cells against certain physical and chemical damage.

Contra-Indications:

If venous or lymphatic stasis is present in the leg, Synvisc should not be injected into the knee. Synvisc should not be used in infected or severely inflamed joints.WarningWarnings:

Warnings in Clinical States:

Do not inject intravascularly.

Precautions:

  • Transient pain and swelling may occur with intra-articular injections.
  • Synvisc should not be used if there is a large intra-articular effusion.
  • Synvisc has not been tested in pregnant women or children under 18 years of age.
  • Synvisc contains small amounts of avian protein and should not be used in patients with related hypersensitivities.

Dosage And Administration:

Do not use Synvisc if package is opened or damaged. Do not resterilize Synvisc. The syringe contents are for single use only. Administer using aseptic procedures, taking particular care in removing the tip cap. Use an appropriate size needle (e.g., 18 to 22 gauge). Remove effusion, if present, before injecting Synvisc. Inject into the synovial space only.

The recommended treatment regimen for Synvisc is 3 injections in the knee, 1 week apart. To achieve maximum effect, it is essential to administer all 3 injections. The maximum recommended dosage is 6 injections within 6 months, with a minimum of 4 weeks between treatment regimens. The duration of effect for those patients who respond to treatment is generally 12 to 26 weeks, although shorter and longer periods have also been observed. Synvisc does not produce a general systemic effect.

Availability And Storage:

Each mL contains: hylan 8 mg. Nonmedicinal ingredients: disodium hydrogen phosphate, sodium chloride, sodium dihydrogen phosphate hydrate and sterile water for injection. Glass syringes of 2.25 mL containing 2 mL Synvisc, packed aseptically in a blisterpack. The contents of the syringe are sterile and nonpyrogenic. Store at room temperature. Do not freeze.

SYNVISC® Biomatrix Hylan G-F 20 Viscosupplementation

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