Label: TACHOSIL- thrombin human and fibrinogen human patch 

  • Label RSS
  • NDC Code(s): 0944-8701-01, 0944-8702-02, 0944-8703-01, 0944-8703-05
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated 09/13

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TACHOSIL safely and effectively. See full prescribing information for TACHOSIL.
     
    TACHOSIL ® Fibrin Sealant Patch
    Absorbable Patch for Topical Use
    Initial U.S. Approval: [2010]

    INDICATIONS AND USAGE

    TachoSil is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis for use in cardiovascular surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. (1)

     

    Limitations for TachoSil Use

    Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. (1)

    DOSAGE AND ADMINISTRATION

    Apply on the surface of cardiovascular tissue only.
    Determine the number of TachoSil patches to be applied by the size of the bleeding area. (2)
    Apply the yellow, active side of the patch to the bleeding surface. (2)

    DOSAGE FORMS AND STRENGTHS

    TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
    Each absorbable patch contains, per square inches (inch 2): human fibrinogen 23.2-47.7 mg (35.5 mg); human thrombin 8.4-17.4 Units (12.9 U), per cm 2: human fibrinogen 3.6-7.4 mg (5.5 mg); human thrombin 1.3-2.7 Units (2.0 U) (3)

    CONTRAINDICATIONS

    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)

    WARNINGS AND PRECAUTIONS

    Thrombosis can occur if TachoSil is exposed intravascularly. Apply topically to soft tissue bleeding 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. (5.4)
    Avoid over-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)

    ADVERSE REACTIONS

    The most common adverse reactions >5% were: atrial fibrillation, pleural effusion, and pyrexia. (6.1)

     

    To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: No human or animal data. Use only if clearly needed. (8.1)

     

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 9/2013

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  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    TachoSil is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis for use in cardiovascular 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.
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  • 2 DOSAGE AND ADMINISTRATION

    For topical use on cardiovascular 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 Patches to be Applied

    TachoSil Patch Size

    Amount of Human Fibrinogen/ Total Patch Size (mg)

    Amount of Human Thrombin/Total Patch Size (Units)

    Maximum Number of TachoSil Patches to be Applied

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

    337.4

    123.1

    7

    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 premoistening 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 - 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 1 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

    Figure Figure Figure Figure

    A

    B

    C

    D

    2.2 Method of Application

    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 3 minutes (Fig. 2B).
    Pre-moisten surgical instruments and gloves with saline solution to reduce the adherence. 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.
    Hold TachoSil to the bleeding area for at least 3 minutes, then remove the gloved hand or moistened pad carefully from the patch. To avoid pulling the patch loose, first place a pre-moistened surgical instrument at one end of the patch before relieving the pressure (Fig. 2C). Gentle irrigation may also aid in removing the premoistened pad or glove hand without removing TachoSil from the bleeding area.
    Leave TachoSil in place once it adheres to organ tissue. 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

    Figure Figure Figure

    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, then repeat application procedure above, however without removing already applied TachoSil.
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  • 3 DOSAGE FORMS AND STRENGTHS

    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.

    Strength:

    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)

    Each absorbable TachoSil patch contains, 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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  • 4 CONTRAINDICATIONS

    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)].
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  • 5 WARNINGS AND PRECAUTIONS

    5.1 Thrombosis

    Thrombosis can occur if TachoSil is exposed intravascularly. Ensure that TachoSil is applied to the surface of cardiac and vascular tissue only.

    5.2 Hypersensitivity Reactions

    Hypersensitivity or allergic/anaphylactoid reactions may occur with TachoSil. Symptoms associated with allergic anaphylactic reactions include: flush, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnea, severe hypotension and anaphylactic shock. These reactions may occur in patients receiving TachoSil for the first time or may increase with repetitive applications of TachoSil.

    5.3 Infection

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

    5.4 Adhesions

    TachoSil contains collagen, which may adhere to bleeding surfaces.

    5.5 Compression

    When placing TachoSil into cavities or closed spaces, avoid over-packing because this may cause compression of underlying tissue.

    5.6 Dislodged Material

    Use only minimum amount of TachoSil patches necessary to achieve hemostasis. Do not pack. Theoretically, excess patch material can become dislodged and migrate to other areas of the body. Remove unattached pieces of TachoSil, if medically necessary [see Dosage and Administration (2.2)].

    5.7 Transmissible Infectious Agents

    Because the biological components of this product are made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent and the Creutzfeldt-Jakob disease (CJD) agent. The risk that TachoSil will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain virus infections, and by inactivating and removing certain viruses [see Description (11)]. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may present in such products.

    All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation, at telephone number 1-800-423-2862. The physician should discuss the risks and benefits of this product with the patient.

    Some viruses, such as parvovirus B19, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women (fetal infection), immune-compromised individuals or individuals with an increased erythropoiesis (e.g. hemolytic anemia).

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  • 6 ADVERSE REACTIONS

    The most common adverse reactions reported in > 5% of patients were atrial fibrillation and pyrexia. Atrial fibrillation was reported in 6% of TachoSil cases (and 6% of controls) and pyrexia in 6% of TachoSil cases (5% of controls).

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    In a randomized, open label, parallel-group multi-centre trial TachoSil was used as an adjunct to hemostasis in cardiovascular surgery when control of bleeding by standard surgical techniques was ineffective. The planned elective surgery was on the heart, the ascending aorta or arch, requiring a cardiopulmonary bypass procedure.

    A total of 62 subjects were treated with TachoSil and 57 with comparator. In the TachoSil group 76% were male, 24% female with mean (range) age 65 (23-82) years and with mean use of 1.2 TachoSil sponge (1-4) per surgical procedure.

    In the cardiovascular trial the most frequently reported adverse reactions were atrial fibrillation (18 patients [29%] in the TachoSil group and 14 patients [25%] in the comparator group) and pleural effusion (14 patients [23%] in the TachoSil group and 11 patients [19%] in the comparator group), see Table 2.

    *
    As treated population (safety data set).
    Comparator: Hemostatic fleece material without additional active coagulation stimulating compounds.

    Table 2

    Clinically Relevant Adverse Reactions Reported in at Least
    5% of Patients in Either Treatment Group (Cardiovascular Trial)

    Adverse Reaction
    (Preferred Term)

    TachoSil
    N = 62
    *
    n (%)

    Comparator
    N = 57
    *
    n (%)

    At least 1 adverse reaction

    46 (74%)

    43 (75%)

     
    Atrial fibrillation

    18 (29%)

    14 (25%)

     
    Pleural effusion

    14 (23%)

    11 (19%)

     
    Pyrexia

    4 (7%)

    3 (5%)

    6.2 Post Marketing Experience

    The following adverse reactions have been identified during post approval use of TachoSil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

    The following adverse reactions have been reported in post marketing experience with TachoSil in the EU and could reasonably be expected to occur with TachoSil in the US:

    General disorders and administration site conditions: drug ineffective, inflammation, granuloma, catheter related complication, multiorgan failure

    Injury, poisoning and procedural complications: foreign body trauma, post procedural pulmonary embolism

    Vascular disorders: thrombosis

    Infections and infestations: hepatitis C

    Respiratory, thoracic and mediastinal disorders: respiratory distress, laryngeal edema, hemothorax

    Blood and lymphatic system disorders: splenic hemorrhage, eosinophilia

    Renal and urinary disorders: renal artery thrombosis, renal failure

    Endocrine disorders: parathyroid disorder

    Eye disorders: mydriasis

    Nervous system disorders: nerve compression

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  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Pregnancy Category C

    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 [see Patient Counseling Information (17)].

    8.3 Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TachoSil is administered to nursing mothers.

    8.4 Pediatric Use

    The safety and effectiveness of TachoSil in pediatric patients undergoing cardiovascular surgery have not been established.

    8.5 Geriatric Use

    Clinical trials included 219 patients older than 65 years of age receiving TachoSil. No overall differences in safety or effectiveness were observed between the elderly and younger patients. However, greater susceptibility of some older patients to adverse reactions cannot be ruled out.

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  • 11 DESCRIPTION

    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-HIV1/2).

    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 3 for each virus tested.

    *
    HIV-1:     Human Immunodeficiency Virus 1
    HSV:        Herpes Simplex Virus
    BVDV:     Bovine Viral Diarrhoea Virus
    HAV:        Hepatitis A Virus
    PRV:         Pseudorabies Virus
    PI-3:          Parainfluenza Virus type 3
    PPV:         Porcine Parvovirus
    Reo 3:       Reo Virus type 3
    Additional reduction factor [log 10] of 1.6 for PRV not included in cumulative reduction factor for HSV

    Table 3

    Cumulative Virus Reduction Factors for the Components of TachoSil

    Cumulative Reduction Factors for Virus Removal/Inactivation of Human Thrombin

    Reduction Factors [log10] of Virus* tested

    Enveloped Viruses

    Non-enveloped Viruses

    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

    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)

    Reduction Factors [log10] of Virus* tested

    Enveloped Viruses

    Non-enveloped Viruses

    Manufacturing step

    PRV

    PI-3

    PPV

    Reo3

    pH treatment

    ≥ 5.7

    ≥ 5.9

    ---

    ---

    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 4 for each virus tested.

    *
    PRV:       Pseudorabies Virus
    PI-3:        Parainfluenza Virus type 3
    PPV:       Porcine Parvovirus
    Reo 3:     Reo Virus type 3

    Table 4

    Virus Reduction Factors for TachoSil Final Sterilization by Gamma Irradiation

    Reduction Factor of Gamma Irradiation (Final Sterilization of TachoSil)

    Reduction Factors [log10] of Virus* tested

    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)].

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  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    The mechanism of action of TachoSil is based on the interaction between the active biological substances (human fibrinogen and human thrombin) and the physiology of the fibrin clot formation (Fig. 3A). Upon contact with a bleeding wound surface, the active substances coated onto the equine collagen patch become dissolved and partly diffuse into the wound surface. The subsequent fibrinogen-thrombin reaction initiates the last step in the cascade of biochemical reactions-conversion of fibrinogen into fibrin monomers that further polymerize to form the fibrin clot.

    Hemostasis is achieved when the formed fibrin clot adheres the collagen patch to the wound surface, thus providing a physical barrier to bleeding (Fig 3B). TachoSil exhibits flexibility to accommodate for the physiological movements of tissues and organs and can withstand pressures up to 61.4 hPa (46.1 mm Hg).

    Figure 3: Scanning Electron Microscopy photos of TachoSil

    Figure Figure

    A. The side view of the TachoSil patch shows the coating of the human plasma components anchored to the indentations of the collagen carrier.

    B. The deposition of a fibrin clot formed from fibrinogen and thrombin of the coating results in hemostasis and conglutination of the TachoSil patch to the wound surface.

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  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term animal studies to evaluate the carcinogenic potential of TachoSil or studies to determine the genotoxicity or the effect of TachoSil on fertility have not been performed. An assessment of the carcinogenic potential of TachoSil was completed to demonstrate minimal carcinogenic risk from product use.

    13.2 Animal Toxicology and/or Pharmacology

    In a study conducted in swine, TachoSil was applied to liver wounds and showed progressive degradation. However, remnants of the TachoSil patch may remain present for more than 12 months. Histologic examination at 26 and 52 weeks revealed that granulation tissue encapsulates TachoSil remnants and forms a firm capsule around them. Remnants were found in all treated animals after 26 weeks (12/12) and in most animals (6/8) after 52 weeks. No other local reactivity or toxicities were noted.

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  • 14 CLINICAL STUDIES

    An open-label, multicenter, 1:1 randomized, parallel-group study comparing TachoSil with comparator (hemostatic fleece without additional active coagulation stimulating compounds) treatment was conducted to evaluate TachoSil for control of bleeding in 119 patients undergoing cardiovascular surgery requiring cardiopulmonary bypass procedure.

    In the Intent- to- Treat (ITT) population (119 patients), 59 patients were treated with TachoSil and 60 patients were treated with the comparator. A larger proportion of patients in the TachoSil treatment group (44/59; 74.6%) than in the comparator treatment group (20/60; 33.3%) achieved hemostasis within 3 minutes, which was a statistically significant difference (p<0.0001, Cochran-Mantel-Haenszel (CMH) test controlling for center). Fifty-six out of 59 (94.9%) patients in the TachoSil treatment group achieved hemostasis at 6 minutes compared to 43 out of 60 (71.7%) in the comparator treatment group, which was statistically significant (p=0.0006, CMH test controlling for center), see Table 5.

    *
    Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals
    Cochran-Mantel-Haenszel test controlling for center
    Hemostatic fleece material without additional active coagulation stimulating compounds

    Table 5

    Efficacy Results in Cardiovascular Surgery, by Treatment,
    ITT Population (n = 119)

    Treatment

    Total number
    of patients who
    achieved hemostasis

    Proportion of
    patients who
    achieved hemostasis

    95% CI for
    proportion
    *

    p-value

    Hemostasis at 3 min

      TachoSil (n =59)

    44

    0.746

    [0.635; 0.857]

    < 0.0001

      Comparator (n=60)

    20

    0.333

    [0.214; 0.453]

    Hemostasis at 6 min

      TachoSil (n =59)

    56

    0.949

    [0.893;1.000]

    < 0.0006

      Comparator (n=60)

    43

    0.717

    [0.603; 0.831]

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  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Each TachoSil patch is packaged in an appropriately sized blister pack of polystyrene formed foil and grid varnish coated medicinal paper and overwrapped with an aluminum laminate foil pack with a desiccant bag. Each patch is packaged individually.

    Each TachoSil patch is supplied in the following pack sizes:

    Package with 1 patch of 3.7 inch x 1.9 inch
    (9.5 cm x 4.8 cm)

    (NDC 0944-8701-01)

    Package with 2 patches of 1.9 inch x 1.9 inch
    (4.8 cm x 4.8 cm)

    (NDC 0944-8702-02)

    Package with 1 patch of 1.2 inch x 1.0 inch
    (3.0 cm x 2.5 cm)

    (NDC 0944-8703-01)

    Package with 5 patches of 1.2 inch x 1.0 inch
    (3.0 cm x 2.5 cm)

    (NDC 0944-8703-05)

    Storage

    Use TachoSil before expiration date indicated on the package.
    Store unopened packages of TachoSil between 2ºC and 25ºC. TachoSil does not require refrigeration. Do not freeze.
    Do not use if package is opened or damaged.
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  • 17 PATIENT COUNSELING INFORMATION

    Advise patients that, because TachoSil is made from human blood, it may carry a risk of transmitting infections agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob (CJD) agent.
    Because TachoSil may cause the formation of clots in blood vessels if exposed intravascularly, advise patients to consult their physician if they experience chest pain, shortness of breath or difficulty speaking or swallowing, or leg tenderness or swelling.
    Instruct patients to consult their physician if symptoms of B19 virus infection appear (fever, drowsiness and chills) followed about two weeks later by a rash and joint pain. Parvovirus B19 most seriously affects pregnant women (fetal infection), immune-compromised individuals or individuals with an increased erythropoisis (e.g. hemolytic anemia).
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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Baxter Healthcare Corporation
    Westlake Village, CA 91362 USA

    Manufactured by:
    Takeda Austria GmbH
    St. Peter Strasse 25
    A-4020 Linz
    Austria

    U.S. License No. 1894
    Issued August 1, 2013
    1US Trademark
    Registration No. 2,951,400


    1
    TachoSil is a registered trademark of Takeda Nycomed AS.
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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 3.7 inch x 1.9 inch Patch Carton

    NDC 0944-8701-01

    Absorbable Fibrin
    Sealant Patch
    TachoSil®

    1 patch of 3.7 inch x 1.9 inch
    (9.5 cm × 4.8 cm)

    Single use only

    Topical use only
    Do not use intravascularly

    Store at 2°C to 25°C (36°F to 77°F)
    Do not freeze

    Directions for use: See package insert

    Use immediately once the foil pouch is opened
    Do not resterilize

    Dispose of any unused product or waste material
    in accordance with local requirements

    Rx Only

    Product Code 1144922

    Baxter

    8701.jpg
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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 1.9 inch x 1.9 inch Patch Carton

    NDC 0944-8702-02

    Absorbable Fibrin
    Sealant Patch
    TachoSil®

    2 patches of 1.9 inch x 1.9 inch
    (4.8 cm × 4.8 cm)

    Single use only

    Topical use only
    Do not use intravascularly

    Store at 2°C to 25°C (36°F to 77°F)
    Do not freeze

    Directions for use: See package insert

    Use immediately once the foil pouch is opened
    Do not resterilize

    Dispose of any unused product or waste material
    in accordance with local requirements

    Rx Only

    Product Code 1144923

    Baxter

    8702.jpg
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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – 1.2 inch x 1.0 inch Patch Carton

    NDC 0944-8703-01

    Absorbable Fibrin
    Sealant Patch
    TachoSil®

    1 patch of 1.2 inch x 1.0 inch
    (3.0 cm × 2.5 cm

    Single use only

    Topical use only
    Do not use intravascularly

    Store at 2°C to 25°C (36°F to 77°F)
    Do not freeze

    Directions for use: See package insert

    Use immediately once the foil pouch is opened
    Do not resterilize

    Dispose of any unused product or waste material
    in accordance with local requirements

    Rx Only

    Product Code 0000000

    Baxter

    8703.jpg
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  • INGREDIENTS AND APPEARANCE
    TACHOSIL 
    thrombin human and fibrinogen patch
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-8701
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 5.5 mg
    FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 2.0 [USP'U]
    Inactive Ingredients
    Ingredient Name Strength
    EQUINE COLLAGEN  
    ALBUMIN HUMAN  
    RIBOFLAVIN  
    SODIUM CHLORIDE  
    SODIUM CITRATE  
    ARGININE HYDROCHLORIDE  
    Product Characteristics
    Color YELLOW (active side) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0944-8701-01 1 in 1 CARTON
    1 1 in 1 POUCH
    1 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    BLA BLA125351 04/05/2010
    TACHOSIL 
    thrombin human and fibrinogen patch
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-8702
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 5.5 mg
    FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 2.0 [USP'U]
    Inactive Ingredients
    Ingredient Name Strength
    EQUINE COLLAGEN  
    ALBUMIN HUMAN  
    RIBOFLAVIN  
    SODIUM CHLORIDE  
    SODIUM CITRATE  
    ARGININE HYDROCHLORIDE  
    Product Characteristics
    Color YELLOW (active side) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0944-8702-02 2 in 1 CARTON
    1 1 in 1 POUCH
    1 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    BLA BLA125351 04/05/2010
    TACHOSIL 
    thrombin human and fibrinogen patch
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0944-8703
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THROMBIN HUMAN (THROMBIN HUMAN) THROMBIN HUMAN 5.5 mg
    FIBRINOGEN HUMAN (FIBRINOGEN HUMAN) FIBRINOGEN HUMAN 2.0 [USP'U]
    Inactive Ingredients
    Ingredient Name Strength
    EQUINE COLLAGEN  
    ALBUMIN HUMAN  
    RIBOFLAVIN  
    SODIUM CHLORIDE  
    SODIUM CITRATE  
    ARGININE HYDROCHLORIDE  
    Product Characteristics
    Color YELLOW (active side) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0944-8703-01 1 in 1 CARTON
    1 1 in 1 POUCH
    1 1 in 1 BLISTER PACK
    2 NDC:0944-8703-05 5 in 1 CARTON
    2 1 in 1 POUCH
    2 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    BLA BLA125351 04/05/2010
    Labeler - Baxter Healthcare Corporation (039121363)
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