TachoSil

TACHOSIL- human thrombin and fibrinogen human patch
Baxalta US Inc.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

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 Size and 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)

337.4

123.1

10

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

170.5

62.2

14

1.2 inch x 1.0 inch(3.0 cm x 2.5 cm)

55.5

20.3

42

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

FigureFigureFigureFigure

A

B

C

D

2.2 Method of Application

• Cleanse surgical instruments and gloves 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) or gloves covered with blood due to the affinity of collagen to blood.

• 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

FigureFigureFigure

A

B

C

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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.