Tachosil
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
TachoSil Fibrin Sealant Patch is a sterile, bioabsorbable combination product comprised of two active substances (human plasma-derived fibrinogen and human plasma-derived thrombin) coated onto a collagen sponge of equine origin. The collagen sponge serves as a flexible and mechanically stable carrier for the active substances to facilitate application of the human fibrinogen and thrombin to the wound surface. 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 square inch of the patch contains approximately 35.5 mg of human fibrinogen and 12.9 units of human thrombin. Other inactive ingredients include equine collagen, human albumin, sodium chloride, sodium citrate, and L‑arginine hydrochloride.
TachoSil is sterilized by gamma irradiation after completion of inner and outer packaging, resulting in a sterile product in a sterile inner package.
Viral Clearance
The active biological substances of TachoSil (human fibrinogen and human thrombin) are manufactured from pooled human plasma collected in FDA-licensed facilities in the United States. Human plasma is tested by FDA-licensed Nucleic Acid Test (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus-1 (HIV-1). NAT testing for hepatitis A virus (HAV) and parvovirus B19 is also performed. Human plasma is also tested for the presence of hepatitis B surface antigen (HBsAg), and antibodies to hepatitis C virus (anti-HCV) and human immunodeficiency viruses types 1 and 2 (anti-HIV 1/2).
The manufacturing procedure for each TachoSil component and final product include processing steps designed to reduce the risk of viral transmission. In particular, the virus clearance steps in the manufacture of human fibrinogen and thrombin include pasteurization, precipitation and adsorption. The virus clearance step in the manufacture of the collagen sponge is the pH treatment.
The virus clearance capacity of these procedures in the manufacture of fibrinogen, thrombin and collagen sponge has been validated using viruses with a wide range of physicochemical characteristics. These in vitro validation studies were conducted using samples from manufacturing intermediates spiked with virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The cumulative virus reduction factors (expressed as log10) are shown in Table 5 for each virus tested.
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| Table 5. Cumulative Virus Reduction Factors for the Components of TachoSil |
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| Cumulative Reduction Factors for Virus Removal/Inactivation of Human Thrombin |
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| Reduction Factors [log10] of Virus* tested |
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| Enveloped Viruses |
Non-enveloped Viruses |
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| Manufacturing step |
HIV-1 |
HSV |
BVDV |
CPV |
HAV |
| Pasteurization, precipitation and adsorption steps |
≥19.6 |
≥21.4 |
≥13.4 |
6.6 |
8.7 |
| Cumulative Reduction Factors for Virus Removal/Inactivation of Human Fibrinogen |
|||||
| Reduction Factors [log10] of Virus* tested |
|||||
| Enveloped Viruses |
Non-enveloped Viruses |
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| Manufacturing step |
HIV-1 |
HSV† |
BVDV |
CPV |
HAV |
| Pasteurization, precipitation and adsorption steps |
≥9.6 |
≥9.1 |
≥11.2 |
4.4 |
≥6.7 |
| Reduction Factors for Virus Removal/Inactivation of the Collagen Sponge (equine) |
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| Reduction Factors [log10] of Virus* tested |
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| Enveloped Viruses |
Non-enveloped Viruses |
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| Manufacturing step |
PRV |
PI-3 |
PPV |
Reo3 |
|
| pH treatment |
≥5.7 |
≥5.9 |
--- |
--- |
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A validation study was also conducted to evaluate the capacity for gamma irradiation to inactivate and/or remove viruses in the final TachoSil product. The virus reduction factors (expressed as log10) are shown in Table 6 for each virus tested.
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| Table 6. Virus Reduction Factors for TachoSil Final Sterilization by Gamma Irradiation |
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| Reduction Factor of Gamma Irradiation (Final Sterilization of TachoSil) |
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| Reduction Factors [log10] of Virus* tested |
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| Enveloped Viruses |
Non-enveloped Viruses |
|||
| Manufacturing step |
PRV |
PI-3 |
PPV |
Reo3 |
| Gamma Irradiation |
≥4.7 |
≥4.0 |
3.0 |
≥6.2 |
All infections considered by a physician possibly to have been transmitted by this product should be reported to Baxter [see Warnings and Precautions (5.7)].
Sources
Tachosil Manufacturers
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Baxter Healthcare Corporation
![Tachosil (Thrombin Human And Fibrinogen) Patch [Baxter Healthcare Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tachosil | Baxter Healthcare Corporation
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 AppliedTachoSil 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 ApplicationTachoSil 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
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
A
B
C
Record patient name and TachoSil batch number every time that TachoSil is administered to a patient.
2.3 RetreatmentIf 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.
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