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TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Limitations for Use TachoSil cannot safely or effectively be used in place of sutures or other form of mechanical ligation for the treatment of major arterial or venous bleeding. Not for use in children under one month of age. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. ( 1 ) Limitations for Use Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. ( 1 ) Not for use in children under one month of age. ( 8.4 )

Do not use TachoSil for: • Intravascular application. Bleeding from large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of TachoSil to blood flow during absorption of the product. This can result in life-threatening thromboembolic events [see Warnings and Precautions (5.1) ] . • Individuals known to have anaphylactic or severe systemic reaction to human blood products or horse proteins [see Warnings and Precautions (5.2) ] . Do not apply TachoSil intravascularly. Intravascular application of TachoSil may result in life-threatening thromboembolic events. ( 4 ) Do not use TachoSil in individuals with known hypersensitivity to human blood products or horse proteins. ( 4 )

• Thrombosis can occur if TachoSil is applied intravascularly. Ensure that TachoSil is applied to the surface of cardiac, vascular or hepatic tissue only. ( 5.1 ) • Can cause hypersensitivity or allergic/anaphylactoid reactions with first time or repetitive application. ( 5.2 ) • Avoid use in contaminated areas of the body or in the presence of an active infection. ( 5.3 ) • TachoSil contains collagen, which may adhere to bleeding surfaces. May carry a risk of gastrointestinal obstruction in abdominal surgery due to tissue adhesions. To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the application area are adequately cleansed before administration of TachoSil. ( 5.4 ) • Avoid packing in cavities or closed spaces, because this may cause compression of underlying tissue. ( 5.5 ) • Use the least number of patches required to cover the entire bleeding area. Do not pack. Remove any unattached pieces of TachoSil. ( 5.6 ) • May carry a risk of transmitting infectious agents, such as viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent, and the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission. ( 5.7 ) 5.1 Thrombosis Thrombosis can occur if TachoSil is applied intravascularly. Ensure that TachoSil is applied to the surface of cardiac, vascular, or hepatic tissue only. 5.2 Hypersensitivity Reactions Hypersensitivity or allergic/anaphylactoid …

8.1 Pregnancy Risk Summary A review of available data suggests that major birth defects occur in 2-4% of the U.S. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. Animal reproduction studies have not been conducted with TachoSil. There are no adequate and well-controlled studies in pregnant women. It is also not known whether TachoSil can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TachoSil should be administered to pregnant women only if clearly needed.