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Prescribing Information   |  OAKneePainRelief.com
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A well-documented safety profile

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In clinical studies, adverse events common to intra-articular treatment were comparable between SUPARTZ FX and saline-treated patients16,22,38,39

  • In these studies, more people discontinued treatment with saline placebo than those who received SUPARTZ FX therapy38
  • Pseudoseptic (acute inflammatory) reactions have NOT been reported in 20 prospective randomized controlled trials of
    SUPARTZ FX therapy41
  • The FDA reviewed data on more than 8,000 patients prior to approving SUPARTZ FX in the United States37

SUPARTZ FX offers a safety profile similar to saline placebo

Adverse events occurred at similar rates in patients treated with SUPARTZ FX and those treated with a saline placebo in an integrated analyses of multiple clinical studies. No serious injection site adverse events were reported and no allergic reactions due to SUPARTZ FX were reported.38

  • Results of integrated analysis of 5 clinical trials with 1,155 patients showed SUPARTZ FX had adverse events and discontinuation rates similar to saline placebo
  • Comparable incidence of adverse events following SUPARTZ FX versus saline placebo16,38

Safety Chart

  • Discontinuation rates due to adverse events were 1.8% for SUPARTZ and 3.2% for placebo38

Safety Chart

  • No reports of pseudoseptic reactions in the scientific literature‡41

‡Does not include current prescribing experience.

SUPARTZ FX contains virtually no detectable impurities

  • A study of impurities in hyaluronic acid (HA) products found that SUPARTZ FX has less protein content than other HA products42

Safety Chart

  • SUPARTZ FX also had significantly less bacteria endotoxin content and significantly less nucleic acids/DNA content compared with other HA products42

See additional SUPARTZ FX Resources

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DUROLANE, GELSYN-3 and SUPARTZ FX are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g., acetaminophen. Risks include general knee pain and pain at the injection site.

View Use and Important Safety Information at: DUROLANE.com, GELSYN3.com, and SUPARTZFX.COM

Summary of Indications for Use:
DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.

Do not inject DUROLANE in patients with knee joint infections, skin diseases, or other infections in the area of the injection site. Do not administer to patients with known hypersensitivity or allergy to sodium hyaluronate preparations. Risks can include transient pain or swelling at the injection site.

DUROLANE has not been tested in pregnant or lactating women, or children.

Full prescribing information can be found in product labeling, or by contacting Bioventus Customer Service at 800-836-4080.

Summary of Indications for Use:
GELSYN-3 is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). Do not administer to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations. Do not inject GELSYN-3 into the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site.

GELSYN-3 is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site.

Full prescribing information can be found in product labeling, or by contacting Bioventus Customer Service at 800-836-4080.

Summary of Indications for Use:
SUPARTZ FX is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. You should not use SUPARTZ FX if you have infections or skin diseases at the injection site or allergies to poultry products. SUPARTZ FX is not approved for pregnant or nursing women, or children. Risks can include general knee pain, warmth and redness or pain at the injection site.

Full prescribing information can be found in product labeling, or by contacting Bioventus Customer Service at 800-836-4080.

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