Learn More About TACHOSIL® Patch

Efficacy Results in Hepatic Surgery, by Treatment, Intent-to-Treat Population

Bleeding controlled at 3 minutes in approximately 81% of patients treated with TachoSil® patch1

TachoSil® Patch (n=114) 95% Comparator* (n=110) 81% 76%

50% Proportion patients of who achieved hemostasis

(n=92) (n=55) (n=108) (n=84)

Hemostasis at 3 minutes Hemostasis at 5 minutes (p<0.001) (p<0.001)

* The comparator group was treated with hemostatic ﬂ eece material made of oxidized cellulose polymer.

The ability of TachoSil® patch to control bleeding in hepatic resection surgery was evaluated in a randomized, open label, parallel-group, multi-center trial to compare the efﬁ cacy and safety of TachoSil® versus a comparator treatment.* ITT population = 224 patients. The most common ARs in the TachoSil® (N=114) vs. comparator (N=109) groups, respectively, of the hepatic resection trial were nausea (30% vs. 27%) and anemia (23% vs. 21%).

Selected Important Risk Information Do not use TachoSil® Fibrin Sealant Patch in place of sutures, ligature, cautery or other primary modes for control of hemostasis. Do not use TachoSil® Fibrin Sealant Patch in individuals with known hypersensitivity to human blood products or horse proteins.

For detailed Important Risk Information, please see back page

and accompanying full Prescribing Information.

Prescribing Information. Prescribing Deerﬁ eld, Illinois 60015 Illinois eld, Deerﬁ USBS/421/14-0008(1)a(2) 12 / 2016 / 12 USBS/421/14-0008(1)a(2)

One Baxter Parkway Baxter One For detailed Important Risk Information, please see back page and accompanying full full accompanying and page back see please Information, Risk Important detailed For

and are used under license. under used are and

Baxter International Inc. International Baxter

TachoSil and the TachoSil logo are registered trademarks of Takeda AS, AS, Takeda of trademarks registered are logo TachoSil the and TachoSil

venous bleeding. Not for use in children under one month of age. of month one under children in use for Not bleeding. venous

Baxter is a registered trademark of Baxter International Inc. International Baxter of trademark registered a is Baxter

Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or or arterial major of treatment in ligation mechanical of forms other or sutures of place in use for Not

www.tachosilus.com

by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. or ineffective is cautery) or ligature suture, as (such techniques surgical standard by

For questions or ordering information, please call 888-229-0001. call please information, ordering or questions For patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding bleeding of control when surgery hepatic and cardiovascular in hemostasis to adjunct an as patients

TachoSil is a ﬁ brin sealant patch indicated for use with manual compression in adult and pediatric pediatric and adult in compression manual with use for indicated patch sealant brin ﬁ a is

Please see accompanying full Prescribing Information. Prescribing full accompanying see Please

TachoSil 1. 1. patch [package insert]. Baxter Healthcare Corporation. 07/2015. Corporation. Healthcare Baxter insert]. [package patch

Reference:

2 1144923 (4.8 cm x 4.8 cm) 4.8 x cm (4.8 in 1.9 x in 1.9

1144922 1 cm) 4.8 x cm (9.5 in 1.9 x in 3.7

Qty Size Number Reorder

leakage in hepatic surgery. hepatic in leakage

gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection and post-procedural bile bile post-procedural and infection tract urinary hypophosphatemia, infection, wound hemorrhage, gastrointestinal

vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial ﬁ brillation, pleural effusion, effusion, pleural brillation, ﬁ atrial itching, ascites, count, cell blood white increased pain, abdominal fever, vomiting,

The most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and and nausea anemia, were trials clinical during patients of >1% in reported reactions adverse common most The

reduce the risk of viral transmission. transmission. viral of risk the reduce

disease (vCJD) agent and the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to to designed steps manufacturing despite agents, (CJD) disease Creutzfeldt-Jakob the and agent (vCJD) disease

HEMOSTATIC CHOICE HEMOSTATIC

May carry a risk of transmitting infectious agents, such as viruses, and theoretically, the variant Creutzfeldt-Jakob Creutzfeldt-Jakob variant the theoretically, and viruses, as such agents, infectious transmitting of risk a carry May

TachoSil pieces of of pieces Fibrin Sealant Patch. Patch. Sealant Fibrin

LOGICAL Bio ®

Use the least number of patches required to cover the entire bleeding area. Do not pack. Remove any unattached unattached any Remove pack. not Do area. bleeding entire the cover to required patches of number least the Use

Avoid packing in cavities or closed spaces because this may cause compression of underlying tissue. underlying of compression cause may this because spaces closed or cavities in packing Avoid

TachoSil administration of of administration .

® TACHOSIL FIBRIN SEALANT PATCH A PATCH SEALANT FIBRIN

® adhesions at undesired sites, ensure tissue areas outside the application area are adequately cleansed before before cleansed adequately are area application the outside areas tissue ensure sites, undesired at adhesions

gastrointestinal obstruction in abdominal surgery due to tissue adhesions. To prevent the development of tissue tissue of development the prevent To adhesions. tissue to due surgery abdominal in obstruction gastrointestinal

TachoSil

Fibrin Sealant Patch contains collagen which may adhere to bleeding surfaces. May carry a risk of of risk a carry May surfaces. bleeding to adhere may which collagen contains Patch Sealant Fibrin

Avoid application to contaminated areas of the body or in the presence of active infection. infection. active of presence the in or body the of areas contaminated to application Avoid

Can cause hypersensitivity or allergic/anaphylactoid reactions with ﬁ rst-time or repetitive application. application. repetitive or rst-time ﬁ with reactions allergic/anaphylactoid or hypersensitivity cause Can

horse proteins. proteins. horse

TachoSil Do not use use not Do Fibrin Sealant Patch in individuals with known hypersensitivity to human blood products or or products blood human to hypersensitivity known with individuals in Patch Sealant Fibrin

TachoSil is applied to the surface of cardiac, vascular or hepatic tissue only. only. tissue hepatic or vascular cardiac, of surface the to applied is

TachoSil life-threatening thromboembolic events. Thrombosis can occur if if occur can Thrombosis events. thromboembolic life-threatening is exposed intravascularly. Ensure that that Ensure intravascularly. exposed is

TachoSil TachoSil Do not apply apply not Do can result in in result can of application Intravascular intravascularly. Patch Sealant Fibrin

® ®

Important Risk Information Risk Important

Not for use in children under one month of age. of month one under children in use for Not

Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. bleeding. venous or arterial major of treatment in ligation mechanical of forms other or sutures of place in use for Not

ineffective or impractical. or ineffective

and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is is cautery) or ligature suture, as (such techniques surgical standard by bleeding of control when surgery hepatic and

Indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular cardiovascular in hemostasis to adjunct an as patients pediatric and adult in compression manual with use for Indicated

Indications and Usage Usage and Indications

Fibrin Sealant Patch Sealant Fibrin TachoSil ® Adjunctive hemostasis to control mild-to-moderate intraoperative bleeding.1 Do not use for the treatment of major arterial or venous bleeding. Efficacy Results in Hepatic Surgery, ® TachoSil patch harnessesby Treatment, the effi cacy Intent-to-Treatof a fi brin sealant in the Population convenience of a surgical patch for targeted bleeding coverage. The coating of active biological ingredients fi brinogen and thrombin on one side Bleedingof the collagen controlled patch at promote 3 minutes hemostasis in approximately by triggering 81% the last stage of ® 1 the coagulation cascade to createof patients a fi brin treated clot. with TachoSil patch TachoSil® Patch (n=114) 95% Ready-to-use Comparator* (n=110) 81% No mixing 76% No thawing No refrigeration 50% No special apparatus

ConformableProportion patients of who achieved hemostasis Maintains ﬂ exibility that accommodates tissue and organ movement Can be cut to size(n=92) and shape of (n=55)wound (n=108) (n=84) Wet or dry ﬁ eld application Hemostasis at 3 minutes Hemostasis at 5 minutes (p<0.001) (p<0.001)

* The comparator group was treated with hemostatic ﬂ eece material made of oxidized cellulose polymer. Staying Power 1 The ability High adhesiveof TachoSil strength® patch shown to control to withstand bleeding pressures in hepatic up resectionto 61.4 hPa surgery (46.1 wasmmHg) evaluated in a randomized, Does not haveopen tolabel, be removed parallel-group, multi-center trial to compare the efﬁ cacy and safety of TachoSil® was applied to swine liver wounds and showed progressive degradation. TachoSil® versus a comparator treatment.* ITT population = 224 patients. Remnants of the patch may remain present up to 12 months* The most common ARs in the TachoSil® (N=114) vs. comparator (N=109) groups, respectively, of *Preclinicalthe hepatic resultsresection may trial not were correlate nausea with (30% results vs. in 27%) humans. and anemia (23% vs. 21%).

SelectedSelected Important Important Risk Risk Information Information ® Do Benot sure use TachoSilTachoSil® FibrinFibrin SealantSealant PatchPatch extendsin place 1of to sutures, 2 cm beyond ligature, the cautery margins or ofother the wound. primary Avoid modespacking for in control cavities of or hemostasis closed spaces.. ® Do Usenot onlyuse TachoSilthe minimum Fibrin amount Sealant of patches Patch in necessary individuals to with achieve known hemostasis. hypersensitivity to human blood Unattached products pieces or horse of TachoSilproteins. ® Fibrin Sealant Patch should be carefully removed.

ForFor detailed detailed Important Important Risk Risk Information, Information, please please see see back back page page andand accompanying accompanying full full Prescribing Prescribing Information. Information. The ﬁ brinogen-thrombin reaction initiates the last step in the coagulation cascade to form the ﬁ brin clot. Compress TachoSil® patch gently over the wound area for at least 3 minutes until coagulation is triggered.1

Hemostasis is achieved when the formed fibrin clot adheres the collagen patch to the wound surface, thus providing a physical barrier to bleeding.

The equine collagen is structured in a honeycomb-like, closed cell formation, and can serve as a mechanical carrier. Remains ﬂ exible1 Will not swell1

TachoSil® patch is coated with two active human coagulation factors: ﬁ brinogen and thrombin. Upon contact with a bleeding wound surface, the active substances become dissolved and partly diffuse into the wound surface.1

Microscopic side view of TachoSil® patch. The thrombin and fibrinogen is anchored to the honeycomb-like indentations of the collagen carrier.

Selected Important Risk Information Do not use TachoSil® Fibrin Sealant Patch in individuals known to have anaphylactic or severe systemic reaction to human blood products or horse proteins. Can cause hypersensitivity or allergic/anaphylactoid reactions with ﬁ rst-time or repetitive application. Avoid application to contaminated areas of the body or in the presence of active infection.

For detailed Important Risk Information, please see back page and accompanying full Prescribing Information. Efficacy Results in Hepatic Surgery, by Treatment, Intent-to-Treat Population

Bleeding controlled at 3 minutes in approximately 81% of patients treated with TachoSil® patch1

TachoSil® Patch (n=114) 95% Comparator* (n=110) 81% 76%

Efficacy Results in Cardiovascular Surgery, 50% by Treatment, Intent-to-Treat Population

Bleeding controlled at 3 minutes in approximately 75% of patients treated with TachoSil® patch1 Proportion patients of who achieved hemostasis 95%‡ TachoSil® Patch (n=59) Comparator* (n=60) (n=92) (n=55) (n=108) (n=84) 75%† 72%‡ Hemostasis at 3 minutes Hemostasis at 5 minutes (p<0.001) (p<0.001)

* The comparator group was treated with hemostatic ﬂ eece material made of oxidized cellulose polymer. 33%†

® Proportion patients of The ability of TachoSil patch to control bleeding in hepatic resection surgery was evaluated in who achieved hemostasis a randomized, open label, parallel-group, multi-center trial to compare the efﬁ cacy and safety of ® (n=44) (n=20) (n=56) (n=43) TachoSil versus a comparator treatment.* ITT population = 224 patients. The most common ARs in the TachoSil® (N=114) vs. comparator (N=109) groups, respectively, Hemostasis at 3 minutes Hemostasis at 6 minutes (p<0.0001) (p=0.0006) of the hepatic resection trial were nausea (30% vs. 27%) and anemia (23% vs. 21%).

* The comparator group was treated using hemostatic fl eece without additional active coagulation-stimulating compounds. † The 95% confi dence intervals at 3 minutes were 0.635 to 0.857 (TachoSil®) and 0.214 to 0.453 (comparator). Selected Important Risk Information ‡ The 95% confi dence intervals at 6 minutes were 0.893 to 1.000 (TachoSil®) and 0.603 to 0.831 (comparator). Do not use TachoSil® Fibrin Sealant Patch in place of sutures, ligature, cautery or other primary modes for control of hemostasis. The ability of ® patch to control bleeding in cardiovascular surgery was evaluated in an TachoSil Do not use TachoSil® Fibrin Sealant Patch in individuals with known hypersensitivity to human ® open-label, 1:1 randomized, parallel-group study comparing TachoSil patch with a comparator blood products or horse proteins. treatment.* ITT population = 119 patients.

The most common ARs in the TachoSil® (N=62) vs. comparator (N=57) groups, respectively, of the For detailed Important Risk Information, please see back page CV trial were atrial ﬁ brillation (29% vs. 25%), pleural effusion (23% vs. 19%) and pyrexia (6% vs. 5%). and accompanying full Prescribing Information. Efficacy Results in Hepatic Surgery, by Treatment, Intent-to-Treat Population

Bleeding controlled at 3 minutes in approximately 81% of patients treated with TachoSil® patch1

TachoSil® Patch (n=114) 95% Comparator* (n=110) 81% 76%

50% Proportion patients of who achieved hemostasis

(n=92) (n=55) (n=108) (n=84)

Hemostasis at 3 minutes Hemostasis at 5 minutes (p<0.001) (p<0.001)

* The comparator group was treated with hemostatic ﬂeece material made of oxidized cellulose polymer.

The ability of TachoSil® patch to control bleeding in hepatic resection surgery was evaluated in a randomized, open label, parallel-group, multi-center trial to compare the efﬁcacy and safety of TachoSil® versus a comparator treatment.* ITT population = 224 patients. The most common ARs in the TachoSil® (N=114) vs. comparator (N=109) groups, respectively, of the hepatic resection trial were nausea (30% vs. 27%) and anemia (23% vs. 21%).

For detailed Important Risk Information, please see back page

and accompanying full Prescribing Information.

Prescribing Information. Prescribing Deerﬁ eld, Illinois 60015 Illinois eld, Deerﬁ USBS/421/14-0008(1)a(2) 12 / 2016 / 12 USBS/421/14-0008(1)a(2)

One Baxter Parkway Baxter One For detailed Important Risk Information, please see back page and accompanying full full accompanying and page back see please Information, Risk Important detailed For

and are used under license. under used are and

Baxter International Inc. International Baxter

TachoSil and the TachoSil logo are registered trademarks of Takeda AS, AS, Takeda of trademarks registered are logo TachoSil the and TachoSil venous bleeding. Not for use in children under one month of age. of month one under children in use for Not bleeding. venous

Baxter is a registered trademark of Baxter International Inc. International Baxter of trademark registered a is Baxter

www.tachosilus.com by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. or ineffective is cautery) or ligature suture, as (such techniques surgical standard by

TachoSil is a ﬁbrin sealant patch indicated for use with manual compression in adult and pediatric pediatric and adult in compression manual with use for indicated patch sealant ﬁbrin a is

Please see accompanying full Prescribing Information. Prescribing full accompanying see Please

6. T il oS h c a axt B nsert]. i e packag [ patch 7/201 0 orporation. C ealthcare H er 1. 1.

Reference:

1144923 2 (4.8 cm x 4.8 cm) 4.8 x cm (4.8 in 1.9 x in 1.9

1144922 1 cm) 4.8 x cm (9.5 in 1.9 x in 3.7

Qty Size Number Reorder

leakage in hepatic surgery. hepatic in leakage

he most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and and nausea anemia, were trials clinical during patients of >1% in reported reactions adverse common most he T

reduce the risk of viral transmission. transmission. viral of risk the reduce

HEMOSTATIC CHOICE HEMOSTATIC

TachoSil pieces of of pieces Fibrin Sealant Patch. Patch. Sealant Fibrin

LOGICAL Bio ®

Avoid packing in cavities or closed spaces because this may cause compression of underlying tissue. underlying of compression cause may this because spaces closed or cavities in packing Avoid

TachoSil administration of of administration .

® TACHOSIL FIBRIN SEALANT PATCH A PATCH SEALANT FIBRIN

choSil Ta Fibrin Sealant Patch contains collagen which may adhere to bleeding surfaces. May carry a risk of of risk a carry May surfaces. bleeding to adhere may which collagen contains Patch Sealant Fibrin

Avoid application to contaminated areas of the body or in the presence of active infection. infection. active of presence the in or body the of areas contaminated to application Avoid

horse proteins. proteins. horse

TachoSil Fibrin Sealant Patch in individuals with known hypersensitivity to human blood products or or products blood human to hypersensitivity known with individuals in Patch Sealant Fibrin use not Do

TachoSil is applied to the surface of cardiac, vascular or hepatic tissue only. only. tissue hepatic or vascular cardiac, of surface the to applied is

TachoSil TachoSil Fibrin Sealant Patch intravascularly. Intravascular application of of application Intravascular intravascularly. Patch Sealant Fibrin apply not Do can result in in result can

® ®

Important Risk Information Risk Important

Not for use in children under one month of age. of month one under children in use for Not

ineffective or impractical. or ineffective

Indications and Usage Usage and Indications

Fibrin Sealant Patch Sealant Fibrin TachoSil ®