EVITHROM^® Thrombin, Topical (Human)

Experience the Human Alternative EVITHROM® Thrombin, Topical (Human) the only ready to use1 all human thrombin Time to hemostasis equivalent to bovine thrombin at 3, 6, and 10 minutes, as demonstrated in a randomized clinical trial2 Contains no bovine proteins No boxed warning Ready in less than 1 minute, after thawing,with no needles or reconstitution required3 Stable at room temperature for 24 hrs1

name: Product Exchange Request Form

http://www.ethicon360.com/sites/default/files/Product Exchange Request Form.pdf

name: Biosurgery Portfolio Pocket Brochure

http://www.ethicon360.com/sites/default/files/JJWM_332_12_wPI.pdf

Indication

EVITHROM^® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM^® may be used in conjunction with an Absorbable Gelatin Sponge, USP.²

Important Safety Information

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

Do not use 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.

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.

There is a potential risk of thrombosis if absorbed systemically.²

Anaphylactic reactions may occur.

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM^®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM^® or bovine thrombin group) ²

References:
1. Doria CM, Fischer CP, Wood CG, et al. Plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing cardiovascular, neurologic, and general surgery. Poster. Presented at: 2007 Annual Meeting of the Society for the Advancement of Blood Management (SABM), September 7-9, 2007, Hollywood, CA.
2. Evithrom Thrombin, Topical (Human) Full Prescribing Information.
3. Data on file.

Indication

EVITHROM^® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM^® may be used in conjunction with an Absorbable Gelatin Sponge, USP.¹

Important Safety Information

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

Do not use 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.

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.

There is a potential risk of thrombosis if absorbed systemically.¹

Anaphylactic reactions may occur.

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM^®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM^® or bovine thrombin group) ¹

References:
1. EVITHROM^® Thrombin, Topical (Human) Full Prescribing Information.

name: Biosurgery Portfolio Pocket Brochure

http://www.ethicon360.com/sites/default/files/JJWM_332_12_wPI.pdf

Indication

EVITHROM^® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM^® may be used in conjunction with an Absorbable Gelatin Sponge, USP.¹

Important Safety Information

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

Do not use 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.

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.

There is a potential risk of thrombosis if absorbed systemically.¹

Anaphylactic reactions may occur.

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM^®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM^® or bovine thrombin group) ¹

References:
1. EVITHROM^® Thrombin, Topical (Human) Full Prescribing Information.

EVITHROM® Thrombin, Topical (Human)