For the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non pharmacologic therapy and to simple analgesics. For the treatment to decrease pain and discomfort allowing more extensive movement of the Knee
Cartilaginous Defect Repair Agent
Joints contain a fluid, called synovial fluid, which acts as a lubricant and shock absorber. Patients with osteoarthritis have synovial fluid that is thinner than normal, and, therefore, it is less effective as a lubricant and shock-absorber. Hylan G-F 20 is an elastic fluid that is made from a substance called hyaluronan, that is found in normal joint fluid. Hyaluronan is the key substance in joint fluid that provides the shock-absorbing quality to the fluid, and it is essential for the proper functioning of joints. When Hylan G-F 20 is injected into the knee of a patient with osteoarthritis, the drug helps to restore the shock-absorbing effect of the fluid within the knee. This can reduce pain, resulting in a more active lifestyle.
It is administered as a single intra-articular injection. Remove synovial fluid or effusion before injecting hylan G-F 20.Strict aseptic administration technique must be followed. Inject into the synovial space only, using if necessary, appropriate guidance such as fluoroscopy especially in joints such as the hip and shoulder. The recommended treatment regimen is one injection in the knee.
It should not be used in patients with known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations. itshould not be injected into the joint if there is venous or lymphatic stasis in the limb to be injected. Synvisc-One should not be used in infected or severely inflamed joints or in patients having skin disease or infections in the area of the injection site.
Transient pain, Transient swelling and/or Effusion. Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and angioedema
The safety and effectiveness of ithas not been established in pregnant women. It is not known if SynviscOne is excreted in human milk. The safety and effectiveness of ithave not been established in lactating women.
Do not use Hylan G-F 20 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.
2.25 mL glass syringe containing one 2 mL (16 mg) dose of hylan G-F 20. The contents of the syringe are sterile and nonpyrogenic.
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