EVICEL^® Fibrin Sealant (Human)

Complex Problem. Simple Solution.

EVICEL® Fibrin Sealant (Human), once thawed, is ready on-demand to meet your critical bleeding challenges by working independently of your patient’s clotting factors.

• The first and only fibrin sealant approved for general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical.
• Ready-to-use in less than 1 minute after thawing*¹^,²
• All-Human formulation – EVICEL® does not contain aprotinin or bovine derivatives¹ and does not expose patients to the risks associated with aprotinin³
• Multiple, clog-resistant tip options – Standard 6 cm tip or 35 cm Rigid or 45 cm Flexible tip
• Spray or drip application with all tips

* Thaws within 10 minutes at 37°C (and must not be kept at this temperature for longer than 10 minutes); within 1 hour at 20°C to 25°C (room temperature); or within 1 day at 2°C to 8°C (refrigerator). Once thawed, EVICEL® must not be refrozen. Once at room temperature, EVICEL® must not be refrigerated.

name: Core Brochure, EVICEL®

http://www.ethicon360.com/sites/default/files/Core_Slim_Jim_Evicel.pdf

name: General Hemostasis Indication Press Release, EVICEL®

http://www.ethicon360.com/sites/default/files/Gen_Hemostasis_PR.pdf

name: Prep/Use Card, EVICEL®

http://www.ethicon360.com/sites/default/files/Prep_Use_Card_Evicel_0.pdf

name: Ethicon Biosurgery Portfolio Video

http://prod.360.ethicon.edgesuite.net/ethicon360/biosurgery/Videos/ETH435%20-%20Portfolio%20External%20-%20012710.flv

name: Fact Sheet, EVICEL®

http://www.ethicon360.com/sites/default/files/EVICEL_fact_sheet_wPI.PDF

name: Ethicon™ Biosurgery Portfolio Pocket Guide

http://www.ethicon360.com/sites/default/files/Biosurgery_portalRev-new-wPIs.pdf

name: THR: Femoral Neck, Spray, EVICEL®

http://prod.360.ethicon.edgesuite.net/ethicon360/biosurgery/Videos/THR_Fem_Neck_Evicel.flv

name: THR: Post-Implant, Drip, EVICEL®

http://prod.360.ethicon.edgesuite.net/ethicon360/biosurgery/Videos/THR_Post_Implant_Drip_Evicel.flv

Indication:

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.

Important Safety Information:

For topical use only. Do not inject directly into the circulatory system.

Not indicated for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of air or gas embolism.

Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Anaphylactic reactions may occur.

Most common adverse events reported in clinical trials (≥5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, oedema peripheral, constipation.

See sales representative for Full Prescribing Information

name: Latex Free Letter, EVICEL®

http://www.ethicon360.com/sites/default/files/Latex_Free_Evicel.pdf

name: Plasma Suppliers Letter, EVICEL®

http://www.ethicon360.com/sites/default/files/Plasma_Suppliers_Evicel.pdf

name: Platelet Rich or Hemostasis Product Coding, EVICEL®

http://www.ethicon360.com/sites/default/files/Platelet_Rich_Plasma_Evicel.pdf

name: 2007 Annual Meeting of the Society for the Advancement of Blood Management (SABM), EVICEL®

http://www.ethicon360.com/sites/default/files/Vascular_SABM_Evicel.pdf

name: EVICEL Product Monograph

http://www.ethicon360.com/sites/default/files/FINAL EVICEL_mono.pdf

Indication:

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.

Important Safety Information:

For topical use only. Do not inject directly into the circulatory system.

Not indicated for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of air or gas embolism.

Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Anaphylactic reactions may occur.

Most common adverse events reported in clinical trials (≥5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, oedema peripheral, constipation.

See sales representative for Full Prescribing Information

Additional Professional information about EVICEL® Fibrin Sealant (Human) can be found below.

name: 510K Approval, EVICEL® Application Device

http://www.ethicon360.com/sites/default/files/App_Device_510k_Approval_Evicel.pdf

name: Biologics FDA Approval Letter, EVICEL®

http://www.ethicon360.com/sites/default/files/Biologics_FDA_Approval_Evicel.pdf

name: Fact Sheet, EVICEL®

http://www.ethicon360.com/sites/default/files/EVICEL_fact_sheet_wPI.PDF

name: Ethicon™ Biosurgery Portfolio Pocket Guide

http://www.ethicon360.com/sites/default/files/Biosurgery_portalRev-new-wPIs.pdf

name: EVICEL® in Orthopedics

http://www.ethicon360.com/sites/default/files/Slim_Jim_Ortho_Evicel_0.pdf

name: EVICEL® in Vascular Surgery

http://www.ethicon360.com/sites/default/files/Slim_Jim_Vascular_Evicel_0.pdf

name: EVICEL® in Burn Surgery

http://www.ethicon360.com/sites/default/files/EvicelBurnSlimJim wPI.PDF

name: EVICEL® in Plastic Surgery

http://www.ethicon360.com/sites/default/files/EvicelPlasticSlimJim wPI.PDF

name: Tips Brochure, EVICEL®

http://www.ethicon360.com/sites/default/files/Tips_Brochure_Evicel_0.pdf

name: Product Tracking Letter, EVICEL®

http://www.ethicon360.com/sites/default/files/Tracking_Requirements_Evicel.pdf

Indication:

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.

Important Safety Information:

For topical use only. Do not inject directly into the circulatory system.

Not indicated for the treatment of severe or brisk arterial bleeding.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.

Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of air or gas embolism.

Because this product is made from human plasma it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Anaphylactic reactions may occur.

Most common adverse events reported in clinical trials (≥5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, oedema peripheral, constipation.

See sales representative for Full Prescribing Information

EVICEL® Fibrin Sealant (Human)