TACHOSIL- human thrombin and fibrinogen human patch
Baxter Healthcare Corporation


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.


For topical use on cardiovascular or hepatic tissue only

Determine the number of patches to be applied by the size of the bleeding area.
Apply the yellow, active side of the patch to the bleeding area.
When applying TachoSil, do not exceed the maximum number of patches shown in Table 1 [see Warnings and Precautions (5.6)].

Table 1. Amount of Fibrinogen and Thrombin per Total Patch Sizeand Maximum Number of TachoSil Patches to be Applied

TachoSil Patch Size

Human Fibrinogen (mg)

Human Thrombin (Units)

Maximum Number of Patches to be Applied

3.7 inch x 1.9 inch(9.5 cm x 4.8 cm)




1.9 inch x 1.9 inch(4.8 cm x 4.8 cm)




2.1 Preparation for Application

TachoSil comes ready to use in sterile packages and must be handled using sterile technique in aseptic conditions. Discard damaged packages as resterilization is not possible.

When in the operating room, the outer aluminum foil pouch may be opened in a non-sterile environment (Fig. 1A). The inner sterile blister must be opened in a sterile environment (Fig. 1B).
Remove the TachoSil patch from the blister (Fig. 1C) , which can be used as a container for pre-moistening of the patch, if needed.
Determine the size of patch(es) to be applied to the bleeding surface. Select the appropriate TachoSil patch so that it extends 1 to 2 cm beyond the margins of the wound. The patch can be cut to the correct size and shape if desired (Fig. 1D). If more than one patch is used, overlap patches by at least 1 cm.
Prior to application, cleanse the area to be treated to remove disinfectants and other fluids. The fibrinogen and thrombin proteins can be denatured by alcohol, iodine or heavy metal ions. If any of these substances have been used to clean the wound area, thoroughly irrigate the area before the application of TachoSil.
Apply TachoSil directly to the bleeding area either wet or dry. If applied wet, pre-moisten TachoSil in 0.9% saline solution for no more than one minute and then apply immediately. In the case of a wet tissue surface (e.g., oozing bleeding) TachoSil may be applied without pre-moistening.

Figure 1: Pictures illustrating steps for preparation for application of TachoSil






2.2 Method of Application

Cleanse surgical instruments, gloves and adjacent tissues with saline solution to reduce the adherence to the TachoSil patch. The white, inactive side of TachoSil may also adhere to surgical instruments (e.g., forceps), gloves or adjacent tissues covered with blood due to the affinity of collagen to blood. It is important to note that failure to adequately clean adjacent tissues may cause adhesions [see Warnings and Precautions (5.4)].
Apply the yellow, active side of the patch to the bleeding area (Fig. 2A) and hold in place with gentle pressure applied through moistened gloves or a moist pad for at least three minutes (Fig. 2B).
To avoid pulling the patch loose, first place a clean surgical instrument at one end of the patch before relieving the pressure (Fig. 2C). Gentle irrigation may also aid in removing the pre-moistened pad or gloved hand without removing TachoSil from the bleeding area.
Leave TachoSil in place once it adheres to organ tissue. Only remove unattached TachoSil patches (or part of) and replace with new patches.
TachoSil cannot be resterilized once removed from inner pouch. Discard unused, opened packages of TachoSil at the end of the procedure.

Figure 2: Pictures illustrating steps for method of application of TachoSil





Record patient name and TachoSil batch number every time that TachoSil is administered to a patient.

2.3 Retreatment

If not satisfied with the placement of the patch, or if bleeding still occurs during or after the specified duration of compression, repeat application procedure above. Do not remove already applied TachoSil.


TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. The active side of the patch is yellow in color due to the presence of a colorant riboflavin (E101); and the non-active side is off-white in color.


Each absorbable TachoSil patch contains:

Per square inch:

Human fibrinogen

23.2 – 47.7 mg (35.5 mg)

Human thrombin

8.4 – 17.4 Units (12.9 U)

Per square centimeter:

Human fibrinogen

3.6 – 7.4 mg (5.5 mg)

Human thrombin

1.3 – 2.7 Units (2.0 U)

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