* Only use in presence of active bleeding
† EVICEL® Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.
▪ Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events.
▪ Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
▪ Do not use for the treatment of severe or brisk arterial bleeding.
▪ Do not use EVICEL® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip to the target site cannot be ensured.
Warnings and Precautions
▪ Life-threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer EVICEL®. This event appears to be related to the use of the spray device at pressures higher than recommended and/or at distances closer than recommended to the surface of the tissue.
▪ Monitor changes in blood pressure, pulse, oxygen saturation, and end-tidal CO2 when spraying EVICEL® because of the possibility of gas embolism.
▪ To reduce the risk of potentially life-threatening gas embolism, spray EVICEL® using only pressurized CO2 gas at the pressures and distances recommended for the specific tips.
▪ Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures.
▪ Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Prepare and administer EVICEL® according to the instructions and with only devices recommended for this product.
▪ May carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most common adverse reactions reported in clinical trials are peripheral edema, abdominal abscess, infection, hematoma, incision site hemorrhage, vascular graft occlusion, postoperative wound complication and decreased hemoglobin.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
1. Chalmers RT, Darling RC III, Wingard JT, et al. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010;97(12):1784–1789.
2. STRATAFIX™ Plus Knotless Tissue Control Device Consolidated Claims Matrix SFX 052362-160502
Full claim: With greater wound holding strength and security, STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices can close wounds substantially faster than using an interrupted technique.
3. DERMABOND® PRINEO® Skin Closure System Consolidated Claims Matrix 043320-151113
Full Claim: Combines the proven strength, flexibility, and antimicrobial protection of DERMABOND ADVANCED® Topical Skin Adhesive with the added support and security of a self-adhering mesh to further facilitate both wound-edge approximation and an optimal healing environment.
‡ For complete instructions for use, refer to the DERMABOND® PRINEO® Skin Closure System IFU