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SUPARTZSNREG

Joint Fluid Therapy


SUPARTZ Frequenty Asked Questions

  1. What is OA of the knee?

    • Osteoarthritis (ah-stee-oh-ar-THRY-tis) or OA of the knee can be caused by several factors one of which is due to a low level of a lubricating substance (hyaluronan) in the fluid that cushions your knee (synovial fluid). Without enough hyaluronan, the bones of your knee begin to rub against each other, causing erosion, bone spurs and pain. Common risk factors for OA of the knee are being overweight, joint injury, overuse of the joint, weak muscles, nerve injury, having other forms of arthritis, having family members with arthritis, and simply being over 55.

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    2. bdrArndTable What is OA of the knee? Osteoarthritis (ah-stee-oh-ar-THRY-tis) or OA of the knee can be caused by several factors one of which is due to a low level of a lubricating substance (hyaluronan) in the fluid that cushions your knee (synovial fluid). Without enough hyaluronan, the bones of your knee begin to rub against each other, causing erosion, bone spurs and pain. Common risk factors for OA of the knee are being overweight, joint injury, overuse of the joint, weak muscles, nerve injury, having other forms of arthritis, having family members with arthritis, and simply being over 55. 6373887327EE47E1A75EF56D6BAED6E8 15397
  2. What is SUPARTZ® Joint Fluid Therapy?

    • SUPARTZ® Joint Fluid Therapy is a solution made of highly purified, sodium hyaluronate (hyaluronan or HA). Hyaluronan is a natural chemical found in the body and in joint tissues and fluid (synovial fluid) that fills the joints. The body’s own hyaluronan acts like a lubricant and shock absorber in synovial fluid of a healthy joint.

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    3. bdrArndTable What is SUPARTZ® Joint Fluid Therapy? SUPARTZ® Joint Fluid Therapy is a solution made of highly purified, sodium hyaluronate (hyaluronan or HA). Hyaluronan is a natural chemical found in the body and in joint tissues and fluid (synovial fluid) that fills the joints. The body’s own hyaluronan acts like a lubricant and shock absorber in synovial fluid of a healthy joint. 85B7A049B7564AB7B0E9B710D2020ECE 15396
  3. How does SUPARTZ® Joint Fluid Therapy work?

    • Osteoarthritis negatively affects the quality of synovial fluid and therefore its ability to protect and lubricate your joint. The goal of SUPARTZ® Joint Fluid Therapy is to supplement the poor quality HA in your painful knee with additional highly purified HA.

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    4. bdrArndTable How does SUPARTZ® Joint Fluid Therapy work? Osteoarthritis negatively affects the quality of synovial fluid and therefore its ability to protect and lubricate your joint. The goal of SUPARTZ® Joint Fluid Therapy is to supplement the poor quality HA in your painful knee with additional highly purified HA.
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  4. Are you a candidate for SUPARTZ® Joint Fluid Therapy?

    • You could be if:
      1. Your knee pain is due to osteoarthritis
      2. You are not getting adequate OA knee pain relief from walking and/or physical therapy
      3. You are also not getting adequate OA knee pain relief from pain medications, including:
        • Ibuprofen (eg Advil®)
        • Acetaminophen (eg Tylenol®)
        • Naproxen sodium (eg Aleve®)
        • Cox-2s/NSAIDs: (Celebrex®, MOBIC®)

      If you meet the three criteria above, ask your doctor if SUPARTZ® Joint Fluid Therapy is right for you.

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    5. bdrArndTable Are you a candidate for SUPARTZ® Joint Fluid Therapy? You could be if:
    1. Your knee pain is due to osteoarthritis
    2. You are not getting adequate OA knee pain relief from walking and/or physical therapy
    3. You are also not getting adequate OA knee pain relief from pain medications, including:
      • Ibuprofen (eg Advil®)
      • Acetaminophen (eg Tylenol®)
      • Naproxen sodium (eg Aleve®)
      • Cox-2s/NSAIDs: (Celebrex®, MOBIC®)

    If you meet the three criteria above, ask your doctor if SUPARTZ® Joint Fluid Therapy is right for you.

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  5. You should not have SUPARTZ® Joint Fluid Therapy if:

      • You are allergic to products from birds such as feathers, eggs and poultry.
      • You have infections or skin diseases in the area the injection will be given.
      • You have had any previous allergic reactions to SUPARTZ or similar material, ie, hyaluronate products.

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    6. bdrArndTable You should not have SUPARTZ® Joint Fluid Therapy if:
    • You are allergic to products from birds such as feathers, eggs and poultry.
    • You have infections or skin diseases in the area the injection will be given.
    • You have had any previous allergic reactions to SUPARTZ or similar material, ie, hyaluronate products.
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  6. Can I use SUPARTZ® therapy if I am pregnant or nursing?

    • The safety and effectiveness of SUPARTZ® Joint Fluid Therapy have not been established in pregnant women or in lactating women.

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    7. bdrArndTable Can I use SUPARTZ® therapy if I am pregnant or nursing? The safety and effectiveness of SUPARTZ® Joint Fluid Therapy have not been established in pregnant women or in lactating women. 417FCBAFFF254410898DAD1955E08C86 15392
  7. Can SUPARTZ® be used in children?

    • The safety and effectiveness of SUPARTZ® Joint Fluid Therapy have not been established in children.

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    8. bdrArndTable Can SUPARTZ® be used in children? The safety and effectiveness of SUPARTZ® Joint Fluid Therapy have not been established in children. CE26034A5D944CE6A9243C67851908E0 15391
  8. What are the side effects of SUPARTZ®?

      • Pain and/or swelling of the injected joint may occur after injection of SUPARTZ® Joint Fluid Therapy.
      • The following were the most common adverse events occurring in SUPARTZ® Joint Fluid Therapy-treated patients: joint pain with no evidence of inflammation, joint pain with evidence of inflammation, back pain, pain (non-specific), injection site reaction, headache and injection-site pain. These adverse events also occurred at similar rates in the patients treated with saline.

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    9. bdrArndTable What are the side effects of SUPARTZ®?
    • Pain and/or swelling of the injected joint may occur after injection of SUPARTZ® Joint Fluid Therapy.
    • The following were the most common adverse events occurring in SUPARTZ® Joint Fluid Therapy-treated patients: joint pain with no evidence of inflammation, joint pain with evidence of inflammation, back pain, pain (non-specific), injection site reaction, headache and injection-site pain. These adverse events also occurred at similar rates in the patients treated with saline.
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  9. Other things you should know about SUPARTZ® Joint Fluid Therapy

      • SUPARTZ® Joint Fluid Therapy is only for injection into the knee, performed by a qualified physician.
      • The safety and effectiveness of repeat treatment cycles of SUPARTZ® Joint Fluid Therapy have not been established.
      • The effectiveness of a single treatment cycle of less than three injections has not been established.
      • The safety and effectiveness of the use of SUPARTZ® Joint Fluid Therapy in joints other than the knee have not been established.
      • The safety and effectiveness of the use of SUPARTZ® Joint Fluid Therapy given at the same time as other injectables have not been established.

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    10. bdrArndTable Other things you should know about SUPARTZ® Joint Fluid Therapy
    • SUPARTZ® Joint Fluid Therapy is only for injection into the knee, performed by a qualified physician.
    • The safety and effectiveness of repeat treatment cycles of SUPARTZ® Joint Fluid Therapy have not been established.
    • The effectiveness of a single treatment cycle of less than three injections has not been established.
    • The safety and effectiveness of the use of SUPARTZ® Joint Fluid Therapy in joints other than the knee have not been established.
    • The safety and effectiveness of the use of SUPARTZ® Joint Fluid Therapy given at the same time as other injectables have not been established.
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  10. How can I get more information about SUPARTZ Joint Fluid Therapy?

      • Ask your physician
      • Call Smith & Nephew Customer Service at 1-800-238-7538, option 2.

      The above is intended to be a summary only, please read the full IFU at http://global.smith-nephew.com/us/patients/images/PackageInsert.pdf.

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    11. bdrArndTable How can I get more information about SUPARTZ Joint Fluid Therapy?
    • Ask your physician
    • Call Smith & Nephew Customer Service at 1-800-238-7538, option 2.

    The above is intended to be a summary only, please read the full IFU at http://global.smith-nephew.com/us/patients/images/PackageInsert.pdf.

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