Gel-One® Cross-linked Hyaluronate is a 100% cross-linked gel, allowing for better cushioning and greater product durability1 in a single 3mL injection, giving healthcare providers confidence in addressing mild to moderate OA of the knee with a safe, effective and complete treatment.
Procedures
Philosophies
Application
Effective Pain Relief: 100% cross-linked, high molecular weight gel, offering increased product durability, cushioning and resistance to diffusion1
Easy-to-Use: Single injection with only 3mL treatment volume
Proven Safety Profile: Safe for repeat use with no increased risk of side effects2,3,5,6
Gel-One is a sterile, transparent and viscoelastic hydrogel. It is a cross-linkedÌýhyaluronateÌý(also referred to asÌýhyaluronan, hyaluronic acid, or HA).Ìý
Each 3mL syringe contains 1% (10mg/mL)ÌýhyaluronanÌýsolutionÌýoriginated from an avian source (highly purified, from chicken combs). In processing, polysaccharide chains are part of the creation of the Gel-One cross-linked polymer.ÌýIn vitro testing has shown that theÌýviscoelastic properties ofÌýGel-OneÌýprovide cushioning and shock-absorption within the osteoarthritic joint.5
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Indications For Use
Gel-OneÌýHyaluronateÌýis indicatedÌýfor 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-OneÌýHyaluronate, ask your patients if they are allergic toÌýhyaluronanÌýproducts, cinnamon, or products from birds such as feathers, eggs, and poultry. Gel-OneÌýHyaluronateÌýis only for injection into the knee, performed by a doctor or other qualified health care professional. Gel-OneÌýHyaluronateÌýinjectionÌýshould not be usedÌýin the presence of a skin disease or infection around the area where the injection will be given. Gel-OneÌýHyaluronateÌýhas not been testedÌýto show pain relief in joints other than the knee and for conditions other than OA. Gel-OneÌýHyaluronateÌýhas not been testedÌýin patients who are pregnant, mothers who are nursing, or anyone under the age of 21. Strenuous or prolonged weight-bearing activities after treatmentÌýare not recommended. The effectiveness of repeat treatment cycles of Gel-OneÌýHyaluronateÌýhas not been established. The side effects most commonly seen after injection of Gel-OneÌýHyaluronateÌýin 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 materialÌýis intendedÌýfor US Health Care Professionals.
Gel-One is a registered trademark ofÌýSeikagakuÌýCorporation.
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All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to 911³Ô¹Ï or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of 911³Ô¹Ï.  Ìý
This material is intended for health care professionals. Distribution to any other recipient is prohibited.Ìý
For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see theÌýinstructions for use or contact your local representative; search this website for additional product information.ÌýTo obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please visit .ÌýFor product related questions, please call 1-800-348-2759.Ìý
