Cross-linked Hyaluronate, 30.0 mg.
Sodium Chloride, 24.3 mg.
Dibasic Sodium Phosphate Dodecahydrate, 0.89 mg.
Sodium Dihydrogen Phosphate Dihydrate, 1.93 mg.
Water for Injection, q.s. to 3mL.
Gel-One Cross-linked Hyaluronate is an injectable hyaluronate gel approved for the treatment of pain in osteoarthritis (OA) of the knee. It is intended for patients that do not respond to other conservative treatments.
Gel-One is the first low-volume viscosupplement available in a single-injection formula. Unlike other viscosupplement treatments, Gel-One requires only 3mL of cross-linked hyaluronate for safe, effective and complete treatment with no reports of pseudosepsis.2-4
Procedures
Philosophies
Application
Gel-One is a sterile, transparent and viscoelastic hydrogel. It is a cross-linked hyaluronate (also referred to as hyaluronan, hyaluronic acid, or HA).
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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, ask your patients if they 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. Gel-One Hyaluronate injection should not be used in the presence of 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. Strenuous or prolonged weight-bearing activities after treatment are not recommended. 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 knee effusion.
These reactions are generally mild and do not last long. For complete instructions for use, see the package insert.
This material is intended for US Health Care Professionals.
Gel-One is a registered trademark of Seikagaku Corporation.
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This material is intended for health care professionals. Distribution to any other recipient is prohibited.
For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert or contact your local representative; search this website for additional product information. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.