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: EVICEL™ Core Sales Aid

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

name: EVICEL™ 510K Spray Device and Modular Device

http://www.ethicon360.com/sites/default/files/EVICEL_510K_Letter_Revised.pdf

name: EVICEL™ General Hemostasis Indication Press Release

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

name: EVICEL™ Burn Surgery Video

http://prod.360.ethicon.edgesuite.net/FLV/EVICEL_Burn_Skin_Graft_web.flv

name: EVICEL™ In-Service Video 2008

http://prod.360.ethicon.edgesuite.net/FLV/EVICEL_INSERVICE_050409.flv

name: EVICEL™ Knee Replacement Video

http://prod.360.ethicon.edgesuite.net/FLV/EVICEL_Ortho_Knee_Web.flv

name: EVICEL™ Liver Resection Video

http://prod.360.ethicon.edgesuite.net/FLV/Liver_Hemostasis_web.flv

name: EVICEL™ Hip Replacement Video

http://prod.360.ethicon.edgesuite.net/FLV/Orthopaedic_Hip_web.flv

name: EVICEL™ Plastics FLAP Video

http://prod.360.ethicon.edgesuite.net/FLV/Plastics_Porcine_FLAP_web.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

Product Monograph

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: EVICEL™ Core Sales Aid

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

name: EVICEL™ Customer In-Service Presentation

http://www.ethicon360.com/sites/default/files/Evicel Customer In-service Presentation 2008.pdf

name: EVICEL™ Product Tracking Letter

http://www.ethicon360.com/sites/default/files/Product Tracking Letter - Final 5-19-09_0.pdf

name: EVICEL™ Preparation Poster

http://www.ethicon360.com/sites/default/files/Prep Poster_0.pdf

name: EVICEL™ in Burn Surgery

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

name: EVICEL™ in Orthopedic Surgery

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

name: EVICEL™ in Plastic Surgery

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

name: EVICEL™ Applicator Tip Slim Jim

http://www.ethicon360.com/sites/default/files/EVICEL Updated Brochure_0.pdf

name: Customer Letter - Important Drug Warning

http://www.ethicon360.com/sites/default/files/EVC-0354_Ethicon_Letter1.pdf

name: EVICEL™ Burn Surgery Video

http://prod.360.ethicon.edgesuite.net/FLV/EVICEL_Burn_Skin_Graft_web.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