Indications for use & important safety information
Indications for use
Gel-One Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen.
Important safety information
Before using Gel-One Hyaluronate, tell your doctor if you are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry. Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. You should not receive Gel-One Hyaluronate injection if you have a skin disease or infection around the area where the injection will be given. Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA. Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21. You should tell your doctor if you think you are pregnant or if you are nursing a child. Talk to your doctor before resuming strenuous or pro-longed weight-bearing activities after treatment. The effectiveness of repeat treatment cycles of Gel-One Hyaluronate has not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate in the clinical trial were knee pain, swelling, and/or fluid build-up around the knee. These reactions are generally mild and do not last long. If any of these symptoms or signs appear after you are given Gel-One Hyaluronate or if you have any other problems, you should call your doctor. Ask your surgeon if you are a candidate and discuss potential risks. For additional information, call 1-800-447-5633 , or visit www.zimmerbiomet.com.
This material is intended for U.S. patients.