Label: TISSEEL FIBRIN SEALANT- fibrinogen human, human thrombin kit
TISSEEL FIBRIN SEALANT- fibrinogen human, human thrombin solution

  • NDC Code(s): 0338-4210-02, 0338-4211-04, 0338-4212-10, 0338-4301-02, view more
    0338-4302-04, 0338-4303-10, 0338-7112-01, 0338-7112-02, 0338-7112-05, 0338-7201-01, 0338-7201-02, 0338-7201-05, 0338-7332-01, 0338-7332-02, 0338-7332-05, 0338-7401-01, 0338-7401-02, 0338-7401-05, 0338-8402-01, 0338-8402-02, 0338-8402-03, 0338-8402-04, 0338-8402-09, 0338-8402-10, 0338-9560-01, 0338-9564-01, 0338-9568-01
  • Packager: Baxter Healthcare Corporation
  • Category: PLASMA DERIVATIVE

Drug Label Information

Updated December 26, 2019

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL.
    TISSEEL [Fibrin Sealant] For Topical Use Only
    Frozen solution and lyophilized powder for solution for topical use only

    Initial U.S. Approval: 1998

    INDICATIONS AND USAGE

    Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. (1)

    Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. (1)

    DOSAGE AND ADMINISTRATION

    For Topical Use Only. Do Not Inject (2)

    •
    Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. (2.3, 5.2)
    •
    Ensure that the amount of TISSEEL to be applied is sufficient to entirely cover the intended application area. (2.3)

    DOSAGE FORMS AND STRENGTHS

    TISSEEL Kit (Freeze-Dried) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with and without the DUPLOJECT Fibrin Sealant Preparation and Application System. (3)

    TISSEEL Pre-filled Syringe (Frozen) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with DUO Set (AST syringe) or DUPLOJECT COMBI (PRIMA syringe). (3)

    CONTRAINDICATIONS

    •
    Do not inject directly into the circulatory system or into highly vascularized tissue. (4.1, 5.3)
    •
    Do not use in individuals with a known hypersensitivity to aprotinin. (4.2, 5.1, 6)
    •
    Do not use for the treatment of severe or brisk arterial or venous bleeding. (4.3)
    •
    Do not spray where the minimum recommended distance from the applicator tip to the target site cannot be assured. (4.4).

    WARNINGS AND PRECAUTIONS

    •
    TISSEEL contains aprotinin, a protein known to be associated with anaphylactic reactions. (4.2, 5.1, 6)
    •
    To reduce the risk of potential life-threatening gas embolism, spray using only the appropriate pressurized gas at the recommended pressure and distance. For Open Surgical procedures, use the EASYSPRAY device connected to CO2, Medical Air or Nitrogen. For Minimally Invasive Surgery procedures use the DUPLOSPRAY MIS device connected only to CO2.(5.2)
    •
    TISSEEL is denatured when exposed to solutions containing alcohol, iodine or heavy metals. (5.2)
    •
    Apply only as a thin layer as excess clot thickness can negatively interfere with wound healing. (2, 5.2)
    •
    When using TISSEEL in surgery do not inject intravascularly. (4.1, 5.3, 6.2).
    •
    Safety has not been evaluated in neurosurgical procedures. (5.4)
    •
    TISSEEL is made from pooled human plasma which can contain infectious agents. (5.5)

    ADVERSE REACTIONS

    Hypersensitivity or allergic/anaphylactoid reactions have occurred. (6)

    To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-888-229-0001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    Oxidized cellulose-containing preparations can reduce the efficacy of TISSEEL and should not be used as carrier materials. (7)

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 12/2019

  • Table of Contents

    FULL PRESCRIBING INFORMATION: CONTENTS*

    1 INDICATIONS AND USAGE

    2 DOSAGE AND ADMINISTRATION

    2.1 Preparation of TISSEEL Kit (Freeze-Dried)

    2.2 Preparation of TISSEEL Pre-Filled Syringe (Frozen)

    2.3 Method of Application

    3 DOSAGE FORMS AND STRENGTHS

    4 CONTRAINDICATIONS

    4.1 Intravascular Application

    4.2 Aprotinin Hypersensitivity

    4.3 Severe or Brisk Bleeding

    4.4 Application below minimum recommended distance from target site

    5 WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity Reactions

    5.2 Application Precautions

    5.3 Use in Surgery

    5.4 Use in Neurosurgical Procedures

    5.5 Infection Risk from Human Plasma

    6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    6.2 Post-Marketing Experience

    7 DRUG INTERACTIONS

    8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    8.2 Lactation

    8.4 Pediatric Use

    8.5 Geriatric Use

    11 DESCRIPTION

    12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    12.2 Pharmacodynamics

    12.3 Pharmacokinetics

    13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    14 CLINICAL STUDIES

    14.1 Vascular Surgery

    14.2 Cardiac Surgery

    14.3 Cardiac Reoperations

    14.4 Splenectomy

    14.5 Colostomy Closure

    16 HOW SUPPLIED/STORAGE AND HANDLING

    17 PATIENT COUNSELING INFORMATION

    *
    Sections or subsections omitted from the full prescribing information are not listed.
  • 1 INDICATIONS AND USAGE

    Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients.

    Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

  • 2 DOSAGE AND ADMINISTRATION

    FOR TOPICAL USE ONLY – DO NOT INJECT

    Vials and pre-filled syringes are for single-patient use only. Discard any unused product.

    2.1 Preparation of TISSEEL Kit (Freeze-Dried)

    Do not expose to temperature above 37ºC
    Do not microwave
    Do not refrigerate or freeze after reconstitution

    Do not use iodine or heavy metal containing preparations such as betadine for disinfection of vial stoppers. Allow alcohol-based disinfectants to evaporate before puncturing stopper.

    Use separate syringes and transfer devices for reconstituting Sealer Protein and Thrombin solutions and for application to prevent clotting.

    The product must be used within 4 hours after reconstitution.

    Freeze-dried Sealer Protein Concentrate and Thrombin are reconstituted in Fibrinolysis Inhibitor Solution and Calcium Chloride Solution, respectively. The Sealer Protein Solution and Thrombin Solution are then combined using the DUPLOJECT Preparation and Application System, or an equivalent delivery device cleared by FDA for use with TISSEEL, to form the Fibrin Sealant.

    Pre-warming TISSEEL Kit with FIBRINOTHERM device
    See FIBRINOTHERM device manual for complete operating instructions. If a FIBRINOTHERM device is not available, contact Baxter (1-800-229-0001) for assistance.

    1.
    Place all four vials from the TISSEEL Kit into the pre-warmed wells of the FIBRINOTHERM device, using the appropriately sized adapter ring(s), and allow the vials to warm for up to 5 minutes (room temperature product will take less time).

    Preparation of Sealer Protein Solution with FIBRINOTHERM device

    1.
    Remove the caps from the Sealer Protein Concentrate and the Fibrinolysis Inhibitor Solution vials.
    2.
    Transfer the Aprotinin (Fibrinolysis Inhibitor Solution) into the vial containing the freeze-dried Sealer Protein Concentrate using the sterile reconstitution components (see directions provided with the device system for specific reconstitution instructions). Gently swirl the vial to ensure that the product is completely soaked.
    3.
    Place the vial into the largest opening of the FIBRINOTHERM device with the appropriate adapter ring. Switch on the stirrer and allow the vial contents to stir until all Sealer Protein Concentrate is dissolved. Reconstitution is complete when no undissolved particles are visible.

    Notes:

    -
    If the Sealer Protein Concentrate has not fully dissolved within 20 minutes discard the vial and prepare a fresh kit.
    -
    Keep the Sealer Protein Solution at 37°C without stirring. Stir shortly before drawing up the solution to ensure homogeneity.

    Preparation of Thrombin Solution with FIBRINOTHERM device

    To reconstitute the Thrombin (Human) with the Calcium Chloride Solution; follow steps 1-3 under Preparation of Sealer Protein with FIBRINOTHERM deviceutilizing the Thrombin and Calcium Chloride vials.

    Transferring to the Sterile Field

    For transfer of the Sealer Protein and Thrombin Solutions to the sterile field, the circulating nurse should disinfect the tops of the vials with a germicidal solution and allow to dry. The scrub nurse should withdraw the sterile solutions while the circulating nurse holds the non-sterile vials. Slowly withdraw the solution, by firm constant aspiration, to reduce the risk of large air bubbles.

    2.2 Preparation of TISSEEL Pre-Filled Syringe (Frozen)

    Do not expose to temperature above 37ËšC Do not microwave.
    Do not refrigerate or re-freeze after thawing.
    Do not use TISSEEL (frozen) until it is completely thawed and warmed (liquid consistency) to 33-37oC. Do not remove the protective syringe cap until use.

    AST Syringe – The plunger rod must be inserted into the syringe barrel (see ).
    PRIMA Syringe – The plunger is already assembled with the syringe barrel (see Figure 2).

    Sterile Water Bath (Quick Thawing): Transfer inner pouch to the sterile field, remove pre-filled syringe from inner pouch and place directly into sterile water bath ensuring the syringe is completely immersed in the water. Maintain the product at 33-37°C until use. Once the package is opened or the product is warmed to 33-37°C, it must be used within 4 hours.

    Non-Sterile Water Bath: Maintain the pre-filled syringe in pouches and place into a water bath outside the sterile field ensuring the pouches remain submerged. Remove from the water bath after thawing and warming, dry the external pouch and transfer inner pouch with pre-filled syringe onto the sterile field. Maintain the product at 33-37°C until use. Once the package is opened or the product is warmed to 33-37°C, it must be used within 4 hours.

    Incubator: Maintain the pre-filled syringe in pouches and place into an incubator. Remove from the incubator after thawing and warming. Transfer inner pouch with pre-filled syringe onto the sterile field. Maintain the product at 33-37°C until use. Once the package is opened or the product is warmed to 33-37°C, it must be used within 4 hours.

    Table 1: Approximate Water Bath or Incubator Thawing and Warming Times

    Pack Size

    Sterile Water Bath

    (Pouches Removed)

    33 - 37°C

    Non-Sterile Water Bath

    (In Pouches)

    33 - 37°C

    Incubator

    (In Pouches)

    33 - 37°C

    PRIMA Syringe

    AST Syringe

    PRIMA Syringe

    AST Syringe

    PRIMA Syringe

    AST Syringe

    2 mL

    5 minutes

    5 minutes

    15 minutes

    30 minutes

    40 minutes

    40 minutes

    4 mL

    5 minutes

    5 minutes

    20 minutes

    40 minutes

    50 minutes

    85 minutes

    10 mL

    10 minutes

    12 minutes

    35 minutes

    80 minutes

    90 minutes

    105 minutes

    Room Temperature Thawing: Unopened pouches can be stored for up to 48 hours at room temperature (15-25°C). Before use, warm the product to 33-37°C and apply immediately. The total thawing and warming time cannot exceed 48 hours.

    Table 2: Approximate Room Temperature Thawing Times

    Pack Size

    Room Temperature

    (In Pouches)

    15 – 25oC

    PRIMA Syringe

    AST Syringe

    2 mL

    80 minutes

    60 minutes

    4 mL

    90 minutes

    110 minutes

    10 mL

    160 minutes

    160 minutes

    Table 3: Approximate Water Bath or Incubator Warming Times for Thawed Product

    Pack Size

    Sterile Water Bath

    (Pouches Removed)

    33 – 37°C

    Non-Sterile Water Bath

    (In Pouches)

    33 – 37°C

    Incubator

    (In Pouches)

    33 – 37°C

    PRIMA Syringe

    AST Syringe

    PRIMA Syringe

    AST Syringe

    PRIMA Syringe

    AST Syringe

    2 mL

    2 minutes

    2 minutes

    5 minutes

    16 minutes

    16 minutes

    20 minutes

    4 mL

    2 minutes

    2 minutes

    8 minutes

    21 minutes

    21 minutes

    43 minutes

    10 mL

    4 minutes

    6 minutes

    12 minutes

    43 minutes

    35 minutes

    52 minutes

    2.3 Method of Application

    TISSEEL Kit (Freeze-Dried)

    Apply TISSEEL using the DUPLOJECT Fibrin Sealant Preparation and Application System or an equivalent delivery system (including open and minimally invasive spray devices) cleared by FDA for use with TISSEEL. Specific instructions for the use of TISSEEL in conjunction with each cleared delivery device are provided with the device.

    TISSEEL Pre-filled Syringe Frozen

    Apply pre-filled TISSEEL using the joining piece and application cannula accessory devices provided with the product or an equivalent delivery device (including open and minimally invasive spray devices) cleared by the FDA for use with TISSEEL.

    DUO Set (AST Syringe) Instructions (see ):

    1.
    Insert plunger into syringe barrel.
    2.
    Remove all air from the double chamber syringe.
    3.
    Firmly connect the two syringe nozzles to the joining piece (Y-connector) and secure it by fastening the tether strap to the syringe.
    4.
    Fit an application cannula to the joining piece. Apply by depressing plunger.

    DUPLOJECT COMBI (PRIMA Syringe) Instructions (see )

    1.
    The plunger is attached to the syringe barrel and does not need to be inserted.
    2.
    Remove all air from the double chamber syringe.
    3.
    Firmly connect the two syringe nozzles to the joining piece (Y-connector) and secure it by fastening the tether strap to the syringe.
    4.
    Fit an application cannula to the joining piece. Apply by depressing plunger.
     
    Note: Interruption of TISSEEL application causes clogging in the cannula. Replace the cannula immediately prior to resuming application. If the opening of the joining piece (Y-connector) facing the cannula is clogged, use the spare joining piece provided in the package.
    Figure 1 DUO SET (AST Syringe)

    Figure 1 DUO SET - AST Syringe
    Figure 2 DUPLOJECT COMBI - PRIMA Syringe

    Figure 2: DUPLOJECT COMBI - PRIMA Syringe

    TISSEEL must be sprayed only onto application sites that are visible. Dry the site of application as much as possible. The surface area of the wound needs to be dried using standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Do not use pressurized air or gas to dry the site.

    When applying TISSEEL using a spray device, utilize the recommended gas, pressure and distance from tissue within the ranges recommended by the manufacturer as follows:

    Table 4: Recommended Application Equipment, Gas and Parameters
    *
    Medical grade CO2 is the preferred gas for application, however compressed Air or Nitrogen are acceptable gasses for administration of TISSEEL in open surgery.

    Surgery

    Spray set / Applicator tips to use

    Pressure regulator to use

    Gas

    Distance

    Spray Pressure

    Open surgery

    TISSEEL /ARTISS

    Spray Set

    EASY SPRAY

    Pressure Regulator

    Medical grade CO2*, Compressed

    Air or Nitrogen

    10-15 cm

    1.5-2.0 bar

    (21.8-29.0 psi)

    Laparoscopic/ minimally invasive procedures

    DUPLOSPRAY MIS Applicator 20 cm

    DUPLOSPRAY

    MIS Regulator

    CO2 Only

    Range 2-5 cm

    3 cm recommended

    1.18-1.50 bar

    (17-22 psi)

    DUPLOSPRAY MIS Applicator 30 cm

    DUPLOSPRAY MIS Applicator 40 cm

    360º Flexible

    Applicator 40 cm

    Replaceable tip

    Apply TISSEEL as a thin layer by dripping or spraying using a cannula or spray set approved for use with TISSEEL. To reduce the risk of potentially life-threatening gas embolism, spray TISSEEL using only the appropriate pressurized gas within the pressure range and distance recommended in the device Instructions For Use (see Warnings and Precautions (5.2)). The treating physician will determine the amount of TISSEEL to be applied based on the surface to be covered. Ensure that the amount applied is sufficient to entirely cover the intended application area. The approximate surface areas covered by each package size of TISSEEL are listed in Table 5:

    Table 5: Surface Area Coverage

    Required package size of

    TISSEEL

    Maximum coverage using spray

    Maximum coverage using cannula

    2 mL
    4 mL
    10 mL

    100 cm2
    200 cm2
    500 cm2

    8 cm2
    16 cm2
    40 cm2

    Avoid application beyond the intended area. Allow at least 2 minutes after application to achieve sufficient polymerization. If repeat application is needed, dry the site as much as possible before reapplying. Reapply after removing residues from the prior application or before polymerization takes place since TISSEEL may not adhere firmly to a polymerized layer.

    In cases where very small volumes (1-2 drops) are required, expel and discard the first several drops from the application cannula immediately before application to ensure administration of adequately mixed TISSEEL.

  • 3 DOSAGE FORMS AND STRENGTHS

    TISSEEL Kit (Freeze-Dried) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with and without the DUPLOJECT Fibrin Sealant Preparation and Application System. TISSEEL Pre-Filled Syringe (Frozen) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with the DUO Set (AST Syringe) or DUPLOJECT COMBI (PRIMA Syringe).

  • 4 CONTRAINDICATIONS

    4.1 Intravascular Application

    Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients (see Warnings and Precautions (5.3) and Adverse Reactions (6.2)).

    4.2 Aprotinin Hypersensitivity

    Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin (see Warnings and Precautions (5.1) and Adverse Reactions (6)).

    4.3 Severe or Brisk Bleeding

    Do not use TISSEEL for treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.

    4.4 Application below minimum recommended distance from target site

    Do not spray TISSEEL where the minimum recommended distance from the applicator tip to the target site cannot be assured.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity Reactions

    Hypersensitivity reactions including allergic/and anaphylactoid reactions can occur with the use of TISSEEL. Cases have been reported in post marketing experience with Baxter’s fibrin sealant (see Adverse Reactions (6.2)). In specific cases, these reactions have progressed to severe anaphylaxis. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously. Even if the first treatment was well tolerated, this may not exclude the occurrence of an allergic reaction after a subsequent administration of TISSEEL or systemic aprotinin. Observed symptoms of allergic anaphylactic reactions to TISSEEL have included: bradycardia, tachycardia, hypotension, flushing, bronchospasm, wheezing, dyspnea, nausea, urticaria, angioedema, pruritus, erythema and paresthesia. Such reactions can also occur in patients receiving TISSEEL for the first time.

    Aprotinin is included in TISSEEL for its antifibrinolytic properties. Aprotinin, a protein, is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure (see Contraindications (4.2)). TISSEEL does not contain any substances of bovine origin.

    Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Mild reactions can be managed with antihistamines. Severe hypotensive reactions require immediate intervention using current principles of shock therapy. Remove remaining product from the application site.

    5.2 Application Precautions

    Any application of pressurized air or gas is associated with a potential risk of air or gas embolism, tissue rupture, or gas entrapment with compression, which may be life a threatening or fatal.

    Life threatening/fatal air or gas embolism has occurred when Fibrin Sealants were administered using pressurized gas with open regulator spray devices. This can occur if a spray device is used at higher than recommended pressures and in closer than recommended proximity to the tissue surface. The solubility of compressed CO2 is greater than either compressed N2 or Air thereby reducing the potential effect of embolization.

    Regardless of the type of gas used, to reduce the incidence of embolization, spray TISSEEL using only the recommended regulator, set within the recommended pressure range, with the appropriate applicator positioned at the recommended distance in .

    Monitor changes in blood pressure, pulse, oxygen saturation and endtidal CO2 due to the possibility of air or gas embolism.

    Use only spray catheters or applicators approved for use with TISSEEL.

    TISSEEL must not be sprayed in enclosed body areas using the EASYSPRAY device and must be sprayed onto only visible application sites.

    For Open Surgical procedures, use the EASYSPRAY Pressure Regulator connected to medical grade CO2, compressed Air or a Nitrogen compressed gas source along with the TISSEEL/ARTISS spray set, (see Method of Application (2.3)).

    For Minimally Invasive Surgery proceduresin enclosed body areas use of the DUPLOSPRAY MIS device connected only to compressed CO2, along with DUPLOSPRAY applicator is recommended. The DUPLOSPRAY MIS device is specifically designed to prevent over pressurization of the body cavity through a dedicated ventline to reduce the risk of gas embolization, (see Method of Application (2.3)).

    The sealer protein and thrombin solutions are denatured by alcohol, iodine or heavy metal ions. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.

    Apply TISSEEL as a thin layer as excess clot thickness can negatively interfere with wound healing.

    5.3 Use in Surgery

    When using TISSEEL in surgery, do not inject intravascularly (see Contraindications (4.1) and Adverse Reactions (6.2)).

    5.4 Use in Neurosurgical Procedures

    The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated, and its use in this setting is not approved by FDA (see Adverse Reactions (6.2) and Drug Interactions (7)).

    5.5 Infection Risk from Human Plasma

    TISSEEL is made from human plasma. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically the Creutzfeldt-Jakob disease (CJD) agent.

    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 1-888-229-0001.

  • 6 ADVERSE REACTIONS

    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.

    Increased D-Dimer levels have been observed during a clinical study in cardiovascular surgery (see Clinical Studies (14)), but did not exceed values reported in the literature occurring after this type of surgery. Postoperatively increased D-Dimers can result at least partly from the degradation of Fibrin Sealant.

    There were no reports of serious, associated adverse reactions reported above 1% in clinical studies.

    6.2 Post-Marketing Experience

    Because adverse reactions are reported voluntarily and the population is of uncertain size, it is not always possible to reliably estimate the frequency of these reactions.

    The following adverse reactions have been reported in the post-marketing experience.

    Immune System Disorders: Hypersensitivity, including anaphylactic reaction and anaphylactic shock. Anaphylactic reactions and anaphylactic shock have included fatal outcomes.
    Vascular Disorders:Hypotension, flushing, embolism, including cerebral artery embolism, cerebral infarction*, air embolism**
    Skin and subcutaneous Tissue Disorders:Angioedema, erythema, impaired healing, pruritus, urticaria
    Cardiac Disorders:Bradycardia, tachycardia
    Respiratory Disorders: Bronchospasm, dyspnea, wheezing
    Gastrointestinal Disorders:Nausea
    Nervous System Disorders:Paresthesia
    * as a result of intravascular application into the superior petrosal sinus
    ** As with other fibrin sealants life-threatening/fatal air or gas embolism when using devices with pressurized air or gas occurred; this event appears to be related to an inappropriate use of the spray device (e.g. at higher than recommended pressure and in close proximity to the tissue surface),

    Class effect: Manifestations of hypersensitivity or allergic reactions associated with the class of fibrin sealant/hemostatic products include: application site irritation, chest discomfort, chills, headache, lethargy, restlessness and vomiting.

    There have been reports of serious adverse events such as paralysis and other compressive complications possibly related to the use of fibrin sealants in combination with resorbable hemostatic agents. There have also been reports of fatalities following the misadministration of topical thrombin (see Warnings and Precautions (5.4)).

  • 7 DRUG INTERACTIONS

    Oxidized cellulose-containing preparations can reduce the efficacy of TISSEEL and should not be used as carrier materials. No interaction studies have been performed.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no direct or controlled studies of TISSEEL in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with TISSEEL. It is also not known whether TISSEEL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Some viruses, such as parvovirus B19, are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women (fetal infection). In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

    8.2 Lactation

    Risk Summary

    There is no information regarding the presence of TISSEEL in human milk, the effects on the breastfed infant, or the effects on milk production.  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TISSEEL and any potential adverse effects on the breastfed infant from TISSEEL or from underlying maternal condition.

    8.4 Pediatric Use

    Limited clinical study data are available with regard to the use of TISSEEL in children. Of 365 patients undergoing repeated cardiac surgery or emergency resternotomy in a clinical trial of TISSEEL, 27 pediatric patients aged 16 years or younger were treated with TISSEEL. Of these, 2 patients were less than 6 months, 2 patients were between the ages of 6 months and 2 years, 15 patients were between 3-11 years of age, and 8 patients were between 12-16 years of age. There were no differences in safety observed between these subjects and the overall population. (seeClinical Studies (14)).

    8.5 Geriatric Use

    Clinical studies included 218 patients aged 65 years of age or older treated with TISSEEL (159 undergoing cardiac surgery and 59 undergoing vascular surgery) (see Clinical Studies (14)). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

  • 11 DESCRIPTION

    TISSEEL [Fibrin Sealant] is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein and Thrombin mimic the final stage of the blood coagulation cascade.

    Sealer Protein (Human)
    Sealer Protein (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Sealer Protein (Human) is provided either as a freeze-dried powder for reconstitution with Aprotinin or as a finished frozen solution pre-filled into one side of a dual-chambered syringe. The active ingredient in Sealer Protein (Human) is fibrinogen. Sealer Protein (Human) solution contains fibrinolysis inhibitor, synthetic Aprotinin, that delays fibrinolysis. Aprotinin (Synthetic) is manufactured by solid phase synthesis from materials completely of non-human/non-animal origin.

    Thrombin (Human)
    Thrombin (Human) is a sterile, non-pyrogenic, vapor heated and solvent/detergent treated preparation made from pooled human plasma. Thrombin (Human) is also provided either as a freeze-dried powder for reconstitution with Calcium Chloride Solution or as a finished frozen solution pre-filled into one side of a dual-chambered syringe.

     
    The reconstituted solution or pre-filled syringe contains:
    Sealer Protein Solution
     
    Total protein: 96 – 125 mg/mL
    Fibrinogen: 67 – 106 mg/mL
    Aprotinin (Synthetic): 2250 – 3750 KIU/mL
    Other ingredients include: human albumin, tri-sodium citrate, histidine, niacinamide, polysorbate 80 and water for injection.
     
    Thrombin Solution
     
    Thrombin (Human): 400 – 625 units/mL*
    Calcium Chloride: 36 – 44 µmol/mL
    Other ingredients include: human albumin, sodium chloride and water for injection.
     
    * The potency expressed in units is determined with a clotting assay using an in-house internal standard that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).

    Viral Clearance
    TISSEEL is made from pooled human plasma collected at US licensed collection centers. The vapor heat and solvent/detergent treatment steps used in the manufacturing process have been shown to be capable of significant viral reduction. No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma (see Warnings and Precautions (5.5)). Validation studies were conducted using samples drawn from manufacturing intermediates for each of the two human plasma derived components. These samples were spiked with stock virus suspensions of known titers followed by further processing under conditions representative of respective manufacturing steps.

    The virus reduction factors (expressed as log10) of manufacturing steps for each of the viruses tested are shown in .

    Table 6: Reduction Factors for Virus Removal and/or Inactivation

    Sealer Protein Component

    Manufacturing Step

    Mean Reduction Factors [log10] of Virus Tested

    HIV-1

    HAV

    BVDV

    PRV

    MMV

    Early Manufacturing Steps

    n.d.

    n.d.

    n.d.

    n.d.

    2.7

    Solvent/Detergent Treatment

    >5.3

    n.d.

    >5.7

    >5.9

    n.d.

    Vapor Heat Treatment

    >5.5

    >5.6

    >5.7

    >6.7

    1.2

    Overall Reduction Factor (ORF)

    >10.8

    >5.6

    >11.4

    >12.6

    3.9

    Thrombin Component

    Manufacturing Step

    Mean Reduction Factors [log10] of Virus Tested

    HIV-1

    HAV

    BVDV

    PRV

    MMV

    Thrombin Precursor Mass Capture

    3.2

    1.5

    1.8

    2.5

    1.2

    Vapor Heat Treatment

    >5.5

    >4.9

    >5.3

    >6.7

    1.0

    Solvent/Detergent Treatment

    >5.3

    n.d.

    >5.5

    >6.4

    n.d.

    Ion Exchange Chromatography

    n.d.

    n.d.

    n.d.

    n.d.

    3.6

    Overall Reduction Factor (ORF)

    >14.0

    >6.4

    >12.6

    >15.6

    5.8

    n.d. = not determined

    HIV-1: Human Immunodeficiency Virus 1; HAV: Hepatitis A Virus; BVDV: Bovine Viral Diarrhea Virus, a model for Hepatitis C Virus; PRV: Pseudorabies Virus, a model for lipid enveloped DNA viruses, among those is Hepatitis B Virus; MMV: Mouse Minute Virus, a model for B19V.

    In addition, Human Parvovirus B19 (B19V) was used to investigate the upstream Thrombin precursor mass capture step, the Sealer Protein early manufacturing steps and the Thrombin and Sealer Protein vapor heating steps. Using quantitative PCR assays, the estimated B19V log reduction factors were: (a) 1.7 for the Thrombin precursor mass capture step, (b) 3.4 for Sealer Protein early manufacturing steps, (c) >4 for Thrombin vapor heat treatment and (d) 1.0 for Sealer Protein vapor heat treatment.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Upon mixing Sealer Protein (Human) and Thrombin (Human), soluble fibrinogen is transformed into fibrin, forming a rubber-like mass that adheres to the wound surface and achieves hemostasis and sealing or gluing of tissues. TISSEEL mimics the final coagulation cascade step as it has all relevant components to form a clot. TISSEEL is effective in heparinized patients and in patients medicated with anti-platelet drugs.

    12.2 Pharmacodynamics

    Thrombin is a highly specific protease that transforms the fibrinogen contained in Sealer Protein (Human) into fibrin. Fibrinolysis inhibitor, Aprotinin (Synthetic), is a polyvalent protease inhibitor that prevents premature degradation of fibrin. Preclinical studies with different fibrin sealant preparations simulating the fibrinolytic activity generated by extracorporeal circulation in patients during cardiovascular surgery have shown that incorporation of aprotinin in the product formulation increases resistance of the fibrin sealant clot to degradation in a fibrinolytic environment.

    12.3 Pharmacokinetics

    Unincorporated Aprotinin and its metabolites have a half-life of 30 to 60 minutes and are eliminated by the kidney. Pharmacokinetic studies were not conducted. TISSEEL is expected to be completely resorbed in 10 to14 days

    Because TISSEEL is applied only topically, systemic exposure or distribution to other organs or tissues is not expected.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term animal studies to evaluate the carcinogenic potential of TISSEEL or studies to determine the effect of TISSEEL on fertility have not been performed.

  • 14 CLINICAL STUDIES

    14.1 Vascular Surgery

    TISSEEL was evaluated in a prospective, controlled, randomized, single-blind, multicenter clinical study against manual compression with gauze pads in 140 subjects undergoing vascular surgery with expanded polytetrafluoroethylene (ePFTE) graft placement (arterio-arterial bypasses and AV shunts for dialysis access in the upper and lower extremity). Subjects received standardized dosages of heparin. Protamine was administered after the primary endpoint had been assessed. Long-term antiplatelet treatments were continued perioperatively at the surgeon’s discretion.

    Subjects were randomly assigned to TISSEEL or control when persistent bleeding at the study suture line was present after surgical hemostasis, i.e., sutures. Eligible bleedings before clamping and treatment application were defined as a minimum of 25% of the suture line bleeds or at least 5 suture line bleedings or any pulsatile or spurting needle hole bleeding. For the primary endpoint, hemostasis achieved at the study suture line at 4 minutes and maintained until surgical closure, a single application of TISSEEL was statistically significantly superior to control (p<0.0001; likelihood ratio chi-square test; 2.5% one sided) [ITT].

    Table 7: Vascular Surgery

    Hemostasis at the study suture line within 4 minutes and maintained until surgical closure

    TISSEEL

    Manual Compression

    Intent to Treat Analysis

    44/70 (62.9%)

    22/70 (31.4%)

    14.2 Cardiac Surgery

    TISSEEL was evaluated in a prospective, parallel design, randomized (1:1), double-blind, multicenter clinical study against an earlier formulation of the product, TISSEEL VH, in 317 subjects undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) and median sternotomy. Patients were treated with TISSEEL or the control product only when hemostasis was not achieved by conventional surgical methods. For the endpoint, hemostasis achieved at the primary treatment site within 5 minutes of treatment and maintained until closure of the surgical wound, TISSEEL was non-inferior to the earlier formulation of the product using a one-sided 97.5% confidence interval on the difference in the proportion of subjects successfully treated.

    Table 8: Cardiac Surgery

    Hemostasis within 5 minutes and maintained until surgical closure

    TISSEEL

    TISSEEL VH

    Intent to Treat Analysis

    127/144 (88.2%)

    129/144 (89.6%)

    14.3 Cardiac Reoperations

    An earlier formulation of TISSEEL was evaluated in an open-label crossover study against control topical hemostatic agents in 489 patients undergoing cardiovascular reoperation or resternotomy at 11 institutions. Patients were randomized to TISSEEL or control hemostatic agents when a topical hemostatic was needed at the conclusion of surgery and after all attempts at surgical hemostasis. Patients were crossed to the alternative therapy if bleeding continued after the 5 minute endpoint. At 10 centers, TISSEEL was used after administration of protamine sulfate. At one site, TISSEEL could be used before administration of protamine sulfate. 365 of the 489 patients developed bleeding episodes requiring treatment. For the endpoint (successful hemostasis at 5 minutes), TISSEEL was statistically significantly superior to control topical hemostatic agents in these patients. Similarly, absolute time to cessation of bleeding was statistically significantly shorter for TISSEEL than for control topical hemostatic agents (p<0.0001, Gehan- Wilcoxon test, two sided).

    Table 9: Cardiac Reoperations

    Hemostasis within 5 minutes

    TISSEEL

    Control Topical Hemostatic Agent

    82.4% (159/193)

    44.5% (76/172)

    Pearson χ2 two sided; p <0.0001; intent-to-treat analysis

    14.4 Splenectomy

    In a single center, open label trial, an earlier formulation of TISSEEL was compared to historical controls in patients undergoing laparotomy for blunt or penetrating traumatic injury to the spleen and/or liver. Use of TISSEEL resulted in the need for statistically significantly fewer splenectomies than control hemostatic maneuvers (Refer to Table 9). TISSEEL did not result in significantly reduced mortality in patients with blunt or penetrating trauma to the liver alone or to the liver and spleen (p=0.067, χ2, one sided).

    Table 10: Splenectomy

    Splenectomy Rate

    Injury to:

    TISSEEL

    Historic Controls

    Spleen

    0/19

    14/22

    p <0.001

    Spleen and liver

    1/26

    19/34

    p <0.001

    14.5 Colostomy Closure

    In a single center, prospective open label study of 118 patients randomized to standard of care (58 patients) or standard of care plus fibrin sealant (60 patients) for elective colostomy closure after temporary colostomy placement for treatment of traumatic injury to the colon, the earlier version of TISSEEL plus standard of care was also shown to be significantly superior to standard of care alone (p=0.0406, Jonckheere-Terpstra test for ordinal data, two sided) with regard to anastomotic complications (leakage, intra-abdominal abscess formation, re-operation, septic shock, and death).

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    How Supplied

    TISSEEL is supplied in the following pack sizes and presentations:

    Table 11: NDC Numbers

    Pack Size

     
    TISSEEL Kit (Freeze-Dried)

    TISSEEL Kit (Freeze-Dried)

    with DUPLOJECT System

    TISSEEL Pre-Filled AST Syringe

    (Frozen) with

    DUO Set

    TISSEEL Pre-Filled PRIMA Syringe (Frozen) with DUPLOJECT COMBI

    2 mL
     
    0338-4210-02

    0338-4301-02

    0338-8402-02

    0338-9560-01

    4 mL
     
    0338-4211-04

    0338-4302-04

    0338-8402-04

    0338-9564-01

    10 mL
     
    0338-4212-10

    0338-4303-10

    0338-8402-10

    0338-9568-01

    TISSEEL Kit contains one vial each of:

    1.
    Sealer Protein Concentrate (Human), Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile
    2.
    Fibrinolysis Inhibitor Solution, (Synthetic) Liquid, Sterile
    3.
    Thrombin (Human), Vapor Heated, Solvent/Detergent Treated, Freeze-Dried, Sterile
    4.
    Calcium Chloride Solution, Liquid, Sterile

    TISSEEL Pre-Filled Dual-Chambered Syringe contains:

    1.
    Sealer Protein Solution, Vapor Heated, Solvent/Detergent Treated, Frozen Solution, Sterile
    2.
    Thrombin Solution, Vapor Heated, Solvent/Detergent Treated, Frozen Solution, Sterile
    3.
    Sterile accessory devices (DUO Set and Plunger or DUPLOJECT COMBI)

    Storage and Handling
    TISSEEL Kit (Freeze-Dried)
    Store at 2-25°C. Avoid freezing. Do not freeze or refrigerate reconstituted solutions.

    TISSEEL Pre-filled Syringe (Frozen)
    Store at ≤ -20°C. Do not refrigerate or re-freeze after thawing. Once removed from the freezer, TISSEEL must be used within 48 hours. Prior to application, TISSEEL must be warmed to 33 - 37˚C.
    Once the pouches are opened or warmed to 33-37°C, they must be used within 4 hours.
    Do not use after the expiration date. Discard if packaging of any components is damaged.

  • 17 PATIENT COUNSELING INFORMATION

    Discuss the risks and benefits of this product with the patient since it is made from human plasma.

    Instruct patients to consult their physician if symptoms of B19 virus infection appear (fever, drowsiness, chills and runny nose) followed about two weeks later by a rash and joint pain (see Use in Specific Populations (8.1)).

    Manufactured For Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
    US License No. 140

    Baxter, Artiss, Duo, Duploject, Duploject Combi, Duplospray, Easyspray, Fibrinotherm and Tisseel are trademarks of Baxter International Inc.

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Tisseel Frozen 2mL Representative Pouch Label - NDC 0338-8402-01

    Tiseel Frozen 2 mL AST Pouch Label

    Fibrin Sealant
    TISSEEL 2 mL

    NDC 0338-8402-01

    Vapor Heated, Solvent/Detergent Treated, Frozen

    Baxter Logo

    Temperature sensitive – Do NOT expose above 37°C (99°F).

    TOPICAL USE ONLY DO NOT INJECT

    Read directions for thawing and application before use.

    Store at –20°C (–4°F) or colder. Unopened pouches may be
    stored for up to 48 hours at room temperature (15 – 25°C).

    Do not refrigerate or re-freeze.

    Rx Only

    Contents:

    Pre-filled syringe containing:

    – Sealer Protein Solution (1): 1 mL, sterile
    – Sealer Protein (Human)
    – Fibrinolysis Inhibitor (Aprotinin,
    Synthetic), 3000 KIU/mL

    – Thrombin Solution (2): 1 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 μmol/mL

    DMC

    Manufactured for
    Baxter Healthcare
    Corporation
    Deerfield, IL 60015 USA

    U.S. License No. 140
    0736623

    Lot No.:

    Exp. Date:

    P

    Tisseel Frozen 2mL Representative Carton Label 1 of 2 NDC 0338-8402-02
    Tisseel Frozen 2mL Representative Carton Label 2 of 2 NDC 0338-8402-02

    Tisseel Frozen 2 mL AST Carton Label

    0736624

    Fibrin Sealant
    TISSEEL

    Vapor Heated, Solvent/Detergent Treated, Frozen

    TOPICAL USE ONLY

    2 mL

    N3 0338-8402-02 3

    Fibrin Sealant
    TISSEEL

    TOPICAL USE ONLY

    2 mL

    Fibrin Sealant
    TISSEEL

    Vapor Heated, Solvent/Detergent Treated, Frozen

    NDC 0338-8402-02

    Prefilled Syringe

    2 mL

    TOPICAL USE ONLY

    Contents:
    Pre-filled syringe containing:

    Sealer Protein Solution: 1 mL, sterile
    – Sealer Protein (Human)
    – Fibrinolysis Inhibitor (Aprotinin, Synthetic), 3000 KIU/mL

    Thrombin Solution: 1 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 μmol/mL

    The risks and benefits of this product should be discussed with the patient.

    Rx Only

    DO NOT INJECT

    Store at –20°C (–4°F) or colder.

    Read enclosed directions for thawing and application before use.

    Unopened pouches may be stored for up to 48 hours at room
    temperature (15 – 25°C).

    Do not refrigerate or re-freeze.

    Not made with natural rubber latex

    For Single Use Only.

    Baxter Logo

    Fibrin Sealant
    TISSEEL

    TOPICAL USE ONLY

    2 mL

    Fibrin Sealant
    TISSEEL

    TOPICAL USE ONLY

    2 mL

    Baxter Logo

    736624

    Fibrin Sealant
    TISSEEL

    Vapor Heated, Solvent/Detergent Treated, Frozen

    Pre-filled Syringe

    2 mL

    TOPICAL USE ONLY
    DO NOT INJECT

    U.S. Pat. No.: 5,962,405

    Manufactured for Baxter Healthcare Corporation
    Deerfield IL, 60015 USA
    1-888-229-0001
    U.S. License No. 140
    Made in Austria

    Reorder Number: 1501261

    Baxter and Tisseel are trademarks of
    Baxter International Inc.

    Baxter Logo

    Tisseel Lyo 2mL Representative Carton Label 1 of 2 NDC 0338-4210-02
    Tisseel Lyo 2mL Representative Carton Label 2 of 2 NDC 0338-4210-02

    Tissel Lyo 2 mL Vial Carton Label

    NDC 0338-4210-02

    Fibrin Sealant
    TISSEEL     2 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    GTIN (01)
    LOT (10)
    EXPIRY (17)
    SERIAL (21)

    Baxter Logo

    NDC 0338-4210-02

    Barcode

    Fibrin Sealant
    TISSEEL     2 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Contents:

    Sealer Protein Concentrate (Human), Vapor Heated,
    Solvent/Detergent Treated, freeze dried, sterile, for
    1 mL of Sealer Protein Solution 86.5 mg/mL

    Fibrinolysis Inhibitor Solution (Synthetic), sterile,
    3000 KIU of Aprotinin /mL

    Thrombin (Human), Vapor Heated, Solvent/Detergent
    Treated, freeze dried, sterile, for 1 mL of Thrombin
    Solution 500 units/mL

    Calcium Chloride Solution, sterile, 40 μmol /mL

    The risks and benefits of this product should be discussed
    with the patient.
    Read enclosed directions for reconstitution and application
    before use.
    Use within four hours of reconstitution.

    NOT FOR INJECTION. For single use only.

    Not made with natural rubber latex

    Rx only

    Manufactured for Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    U.S. License No. 140

    Made in Austria

    U.S. Pat. No.: 5,962,405

    Baxter and Tisseel are trademarks of Baxter International Inc.

    0752668

    Fibrin Sealant
    TISSEEL     2 mL
    Vapor Heated, Solvent/
    Detergent Treated, Kit

    2 mL

    Store at 2°C to 25°C (36°F to 77°F).
    Avoid freezing.

    Tisseel Lyo 2mL Representative Sleeve Label 1 of 4 NDC 0338-4301-02
    Tisseel Lyo 2mL Representative Sleeve Label 2 of 4 NDC 0338-4301-02
    Tisseel Lyo 2mL Representative Sleeve Label 3 of 4 NDC 0338-4301-02
    Tisseel Lyo 2mL Representative Sleeve Label 4 of 4 NDC 0338-4301-02

    Tisseel Lyo 2mL Sleeve Carton Label

    Baxter Logo

    NDC 0338-4301-02

    Fibrin Sealant
    TISSEEL 2 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Manufactured for Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    U.S. License No. 140

    Made in Austria

    Reorder Number: 1504514

    Baxter, Duploject and Tisseel are trademarks of Baxter International Inc.

    U.S. Pat. No.: 5,962,405

    Baxter Logo

    NDC 0338-4301-02

    Fibrin Sealant
    TISSEEL 2 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    TOPICAL USE ONLY
    DO NOT INJECT

    Baxter Logo

    NDC 0338-4301-02

    Barcode

    Fibrin Sealant
    TISSEEL 2 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Contents:

    Sealer Protein Concentrate (Human), Vapor Heated,
    Solvent/Detergent Treated, freeze dried, sterile, for
    1 mL of Sealer Protein Solution 86.5 mg/mL

    Fibrinolysis Inhibitor Solution (Synthetic), sterile,
    3000 KIU of Aprotinin /mL

    Thrombin (Human), Vapor Heated, Solvent /Detergent
    Treated, freeze dried, sterile, for 1 mL of Thrombin Solution
    500 units/mL

    Calcium Chloride Solution, sterile, 40 μmol /mL

    The risks and benefits of this product should be discussed
    with the patient. Read enclosed directions for
    reconstitution and application before use. Use within four
    hours of reconstitution.

    NOT FOR INJECTION. For single use only.

    Not made with natural rubber latex
    Rx only

    Also includes: DUPLOJECT Fibrin Sealant Preparation and Application System 2 mL / 4 mL

    0752670

    Barcode

    Barcode
    N3 0338-4301-02 3

    Representative DUO Set A 2 mL 4 mL Label

    Tisseel Frozen 2 mL – 4 mL DUO Set Label

    Baxter Label

    DUO Set 2 ml / 4ml

    Indications for Use:

    For the application of TISSEEL Fibrin Sealant

    For single use only. Not made with natural rubber latex.

    Do not reuse or resterilize. Sterilized by gamma radiation.

    Sterile and non-pyrogenic in unopened and undamaged package.

    Rx only.

    Lot No:

    Exp. Date:

    REF

    BE-90-01-040

    Manufactured for:
    Baxter Healthcare Corporation,
    One Baxter Parkway
    Deerfield, IL 60015 USA

    Made in Belgium

    Tisseel Lyo 2 mL - 4 mL DUPLOJET Repesentative Label 1 of 4
    Tisseel Lyo 2 mL - 4 mL DUPLOJET Repesentative Label 2 of 4
    Tisseel Lyo 2 mL - 4 mL DUPLOJET Repesentative Label 3 of 4
    Tisseel Lyo 2 mL - 4 mL DUPLOJET Repesentative Label 4 of 4

    Tisseel Lyo 2 mL - 4 mL DUPLOJET Label

    Baxter Logo

    DUPLOJET 2 mL / 4 mL

    Fibrin Sealant Preparation and
    Application System

    Baxter Logo

    DUPLOJET 2 mL / 4 mL

    Fibrin Sealant Preparation and
    Application System

    BAXTER, DUPLOJET and TISSEEL are trademarks of
    Baxter International Inc., registered in the U.S. Patent and
    Trademark office.

    Manufactured for:
    Baxter Healthcare Corporation
    One Baxter Parkway
    Deerfield, IL 60015 USA

    DUPLOJET 2 mL / 4 mL
    Fibrin Sealant Preparation and
    Application System

    For Fibrin Sealant
    2 mL or 4 mL Kit

    2 mL
    4 mL

    Indications for Use:
    For the preparation and application of TISSEEL
    [Fibrin Sealant] 2 mL / 4 mL Kit.

    STERILE – SINGLE PATIENT USE ONLY – DO NOT RESTERILIZE

    Use separate devices for reconstruction of Sealer Protein Concentrate
    and Thrombin.

    Rx only

    Made in Belgium

    Barcode

    BE8001137

    BE-80-01-137

    DUPLOJET 2 mL / 4 mL
    Fibrin Sealant Preparation and
    Application System

    For Fibrin Sealant
    2 mL or 4 mL Kit

    2 mL
    4 mL

    DUPLOJET IFU Representative Label 1 of 4
    DUPLOJET IFU Representative Label 2 of 4
    DUPLOJET IFU Representative Label 3 of 4
    DUPLOJET IFU Representative Label 4 of 4

    DUPLOJET IFU Label

    Baxter Logo
    BE_30-02-680

    DUPLOJECT
    Fibrin Sealant Preparation and Application System

    Indications for Use:

    For the preparation and application of TISSEEL [Fibrin Sealant] kit.

    Note: See TISSEEL Fibrin Sealant package insert for additional preparation and
    application instructions.

    1.0 Reconstitution Instructions for the Circulating Nurse (Using the FIBRINO-
    THERM Heating and Stirring Device)

    1.1 Turn on the warming unit of the FIBRINOTHERM device (amber switch).

    1.2 Open TISSEEL [Fibrin Sealant] kit and place all vials into the appropriately sized
    heating wells of the FIBRINOTHERM device.

    1.3 Place the Sealer Protein vial into the large magnetic stirring well fitted with
    the appropriately sized adapter ring (if necessary). Do not activate the stirring
    mechanism at this time. The indicator light will remain lit until a temperature of
    37°C (98.6°F) is reached. Allow several minutes for proper warming.

    1.4 Open Pack A of the DUPLOJECT Preparation and Application System and
    assemble the blue-scaled and black-scaled syringes with the needles provided.

    1.5 Remove the flip-off caps from the blue-capped Sealer Protein Concentrate
    and Fibrinolysis Inhibitor Solution vials and wipe with a non-iodine based dis-
    infectant.

    1.6 Using the blue-scaled syringe, withdraw the Fibrinolysis Inhibitor Solution from
    the vial, tilting the vial slightly to facilitate removal of all solution. Inject the
    Fibrinolysis Inhibitor Solution into the Sealer Protein Concentrate vial. Gently
    swirl the vial to ensure that the freeze-dried material is fully soaked. Note: Do not
    invert or inject air into vials.

    1.7 Place the Sealer Protein Concentrate vial in the stirring well and activate the
    stirring mechanism of the FIBRINOTHERM device (green switch). Reconstitution
    is complete when no undissolved particles are visible. If Sealer Protein is not fully
    dissolved after 20 minutes, discard and prepare a fresh kit. Continue with steps 8
    through 11.

    1.8 Remove the flip-off caps from the black-capped Thrombin and Calcium Chloride
    Solution vials and wipe with a non-iodine based disinfectant.

    1.9 Using the black-scaled syringe, withdraw the Calcium Chloride Solution from the
    vial, tilting the vial slightly to facilitate removal of all solution. Inject the Calcium
    Chloride Solution into the Thrombin vial. Note: Do not invert or inject air into vials.

    1.10 Swirl contents of the Thrombin vial briefly and return it to an appropriately sized
    heating well in the FIBRINOTHERM device.

    1.11 Leave the Sealer Protein and Thrombin vials in the FIBRINOTHERM device until
    the solutions are ready to be passed into the sterile field.

    2.0 Preparation Instructions for the Scrub Nurse

    2.1 Open Pack B of the DUPLOJECT Preparation and Application System into the
    sterile field.

    2.2 Open Packs 1, 2, and 3.

    2.3 Assemble the blue-scaled and black-scaled syringes with the needles provided.
    Note: For 5 mL DUPLOJECT systems, attach the larger needle to the blue-scaled
    syringe.

    2.4 While the Circulating Nurse holds the vial slightly tilted, insert needle into
    vial (bevel side down) and withdraw all of the Sealer Protein Solution into the
    blue-scaled syringe using slow, constant aspiration. Discard needle in sharps
    container.

    2.5 While the Circulating Nurse holds the vial slightly tilted, insert needle into vial
    (bevel side down) and withdraw all of the Thrombin Solution into the black-scaled
    syringe using slow, constant aspiration. Discard needle in sharps container.

    2.6 Remove any air bubbles from the syringes and ensure both syringes contain the
    same volume.

    2.7 Snap the filled syringes into the two-syringe clip with the flanges in an up/down
    position, as illustrated below.

    2.8 Attach the joining piece to the syringe nozzles, ensuring that both are firmly
    seated. Secure the joining piece by fastening the retaining strap to the double
    syringe clip. Note: Align the syringe nozzles toward the middle for proper
    attachment.

    2.9 Fit one of the application needles onto the joining piece. A second application
    needle is provided in Pack 3 as a spare.

    2.10 DUPLOJECT Applicator is ready for use.

    2.11 If application of TISSEEL [Fibrin Sealant] is interrupted, replace the needle
    immediately before application is resumed. Note: If the apertures of the joining
    piece become clogged, Pack 4 contains one spare joining piece and two
    additional application needles.

    Rx Only
    DO NOT REUSE OR RESTERILIZE.
    NOT MADE WITH NATURAL RUBBER LATEX.

    STERILE AND NON-PYROGENIC IN UNOPENED AND UNDAMAGED PACKAGE.

    DISPOSE OF CONTAMINATED AND SHARP COMPONENTS PROPERLY.

    Baxter, Duploject, Fibrinotherm and Tisseel are registered trademarks of Baxter International Inc.

    Manufactured for:
    Baxter Healthcare Corporation
    One Baxter Parkway
    Deerfield, IL 60015 USA
    1-888-229-0001

    Made in Belgium

    Rev. Date: 2017-05-17

    Representative Pouch Label NDC 0338-9560-01

    2 mL PRIMA Pouch Label

    Fibrin Sealant
    TISSEEL 2 mL

    NDC 0338-9560-01

    Vapor Heated, Solvent/Detergent Treated, Frozen

    Baxter Logo

    Temperature sensitive – Do NOT expose above 37°C (99°F).

    TOPICAL USE ONLY DO NOT INJECT

    Read directions for thawing and application before use.
    Store at –20°C (–4°F) or colder. Unopened pouches
    may be stored for up to 48 hours at room temperature
    (15 – 25°C).

    Do not refrigerate or re-freeze.

    Rx Only

    Contents:
    Pre-filled syringe containing:
    – Sealer Protein Solution (1):     1 mL, sterile
    – Fibrinogen (Human), 86.5 mg/mL
    – Fibrinolysis Inhibitor (Aprotinin,
    Synthetic), 3000 KIU/mL

    – Thrombin Solution (2): 1 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 ìmol/mL

    Manufactured for
    Baxter Healthcare
    Corporation
    Deerfield, IL 60015 USA
    U.S. License No. 140
    0752652

    Barcode

    Lot No.:
    Exp. Date:


    Representative Carton Label NDC 0338-9560-01 1 of 2
    Representative Carton Label NDC 0338-9560-01 2 of 2

    2 mL PRIMA Carton Label

    0752653

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY

    NDC 0338-9560-01
    Barcode

    Barcode
    3 03389 56001 2

    2 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/Detergent Treated, Frozen
    with Pre-filled PRIMA Syringe

    TOPICAL USE ONLY

    Contents:
    Pre-filled syringe containing:
    Sealer Protein Solution: 1 mL, sterile

    – Fibrinogen (Human), 86.5 mg/mL
    – Fibrinolysis Inhibitor (Aprotinin, Synthetic),
    3000 KIU/mL

    Thrombin Solution: 1 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 μmol /mL

    The risks and benefits of this product should
    be discussed with the patient.

    Rx Only

    DO NOT INJECT

    Store at –20°C (–4°F) or colder.

    Read enclosed directions for thawing and
    application before use.

    Unopened pouches may be stored for up to
    48 hours at room temperature (15 – 25°C).

    Do not refrigerate or re-freeze.

    Not made with natural rubber latex
    For Single Patient Use Only.

    NDC 0338-9560-01

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/Detergent Treated, Frozen
    TOPICAL USE ONLY
    2 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY
    2 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY
    2 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/Detergent Treated, Frozen
    with Pre-filled PRIMA Syringe

    TOPICAL USE ONLY

    DO NOT INJECT

    U.S. Pat. No.: 5,962,405

    Manufactured for
    Baxter Healthcare Corporation

    Deerfield IL, 60015 USA

    1-888-229-0001

    U.S. License No. 140

    Made in Austria

    Reorder Number: 1506078

    Baxter and Tisseel are trademarks of
    Baxter International Inc.

    2 mL

    GTIN (01) 00303389560012

    EXPIRY (17)
    LOT (10)
    SERIAL (21)

    Baxter Logo

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY
    2 mL

    Representative Pouch Label NDC 0338-9564-01

    4 mL PRIMA Pouch Label

    Fibrin Sealant
    TISSEEL 4 mL

    NDC 0338-9564-01
    Barcode

    Vapor Heated, Solvent/Detergent Treated, Frozen

    Baxter Logo

    Temperature sensitive – Do NOT expose above 37°C (99°F).

    TOPICAL USE ONLY DO NOT INJECT

    Read directions for thawing and application before use.
    Store at –20°C (–4°F) or colder. Unopened pouches
    may be stored for up to 48 hours at room temperature
    (15 – 25°C).

    Do not refrigerate or re-freeze.

    Rx Only

    Contents:
    Pre-filled syringe containing:
    – Sealer Protein Solution (1):     2 mL, sterile
    – Fibrinogen (Human), 86.5 mg/mL
    – Fibrinolysis Inhibitor (Aprotinin,
    Synthetic), 3000 KIU/mL

    – Thrombin Solution (2): 2 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 µmol/mL

    Barcode

    Manufactured for
    Baxter Healthcare
    Corporation
    Deerfield, IL 60015 USA
    U.S. License No. 140

    0752656

    Barcode

    Lot No.:
    Exp. Date:

    Representative Carton Label NDC 0338-9564-01 1 of 2
    Representative Carton Label NDC 0338-9564-01 2 of 2

    4 mL PRIMA Carton Label

    0752657

    Barcode
    3 03389 56401 0

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/Detergent Treated, Frozen
    TOPICAL USE ONLY
    with Pre-filled PRIMA Syringe

    NDC 0338-9564-01

    TOPICAL USE ONLY

    Contents:
    Pre-filled syringe containing:
    Sealer Protein Solution: 2 mL, sterile
    – Fibrinogen (Human), 86.5 mg/mL
    – Fibrinolysis Inhibitor (Aprotinin, Synthetic),
    3000 KIU/mL

    Thrombin Solution: 2 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 μmol /mL

    The risks and benefits of this product should
    be discussed with the patient.

    Rx Only

    DO NOT INJECT

    Store at –20°C (–4°F) or colder.

    Read enclosed directions for thawing and
    application before use.

    Unopened pouches may be stored for up to
    48 hours at room temperature (15 – 25°C).

    Do not refrigerate or re-freeze.

    Not made with natural rubber latex
    For Single Patient Use Only.

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY
    4 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY
    4 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY
    4 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/Detergent Treated, Frozen
    with Pre-filled PRIMA Syringe

    TOPICAL USE ONLY

    DO NOT INJECT

    U.S. Pat. No.: 5,962,405

    Manufactured for
    Baxter Healthcare Corporation

    Deerfield IL, 60015 USA

    1-888-229-0001

    U.S. License No. 140

    Made in Austria

    Reorder Number: 1506079

    Baxter and Tisseel are trademarks of
    Baxter International Inc.

    4 mL

    Baxter Logo

    GTIN (01) 00303389564010
    LOT (10)
    EXPIRY (17)
    SERIAL (21)

    Representative Pouch Label NDC 0338-9568-01

    10 mL PRIMA Pouch Label

    Fibrin Sealant
    TISSEEL 10 mL

    NDC 0338-9568-01

    Vapor Heated, Solvent/Detergent Treated, Frozen

    Baxter Logo

    Temperature sensitive – Do NOT expose above 37°C (99°F).

    TOPICAL USE ONLY DO NOT INJECT

    Read directions for thawing and application before use.

    Store at –20°C (–4°F) or colder. Unopened pouches
    may be stored for up to 48 hours at room temperature
    (15 – 25°C).

    Do not refrigerate or re-freeze.

    Rx Only

    Contents:

    Pre-filled syringe containing:
    – Sealer Protein Solution (1): 5 mL, sterile
    – Fibrinogen (Human), 86.5 mg/mL
    – Fibrinolysis Inhibitor (Aprotinin,
    Synthetic), 3000 KIU/mL

    – Thrombin Solution (2): 5 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 ìmol/mL

    Manufactured for
    Baxter Healthcare
    Corporation
    Deerfield, IL 60015 USA
    U.S. License No. 140

    0752660

    Barcode

    Barcode

    Lot No.:
    Exp. Date:

    Representative Carton Label NDC 0338-9568-01 1 of 2
    Representative Carton Label NDC 0338-9568-01 2 of 2

    10mL PRIMA Carton Label

    0752661

    Barcode
    3 03389 56801 8

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY

    NDC 0338-9568-01
    Barcode

    10 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY

    10 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/Detergent Treated, Frozen
    with Pre-filled PRIMA Syringe

    TOPICAL USE ONLY

    Contents:
    Pre-filled syringe containing:
    Sealer Protein Solution: 5 mL, sterile
    – Fibrinogen (Human), 86.5 mg/mL
    – Fibrinolysis Inhibitor (Aprotinin, Synthetic),
    3000 KIU/mL

    Thrombin Solution: 5 mL, sterile
    – Thrombin (Human), 500 units/mL
    – Calcium Chloride, 40 μmol /mL

    The risks and benefits of this product should
    be discussed with the patient.

    Rx Only

    DO NOT INJECT

    Store at –20°C (–4°F) or colder.

    Read enclosed directions for thawing and
    application before use.

    Unopened pouches may be stored for up to
    48 hours at room temperature (15 – 25°C).

    Do not refrigerate or re-freeze.

    Not made with natural rubber latex

    For Single Patient Use Only

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY

    10 mL

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/
    Detergent Treated, Frozen
    TOPICAL USE ONLY
    10 mL

    Barcode

    Fibrin Sealant
    TISSEEL
    Vapor Heated, Solvent/Detergent Treated, Frozen
    with Pre-filled PRIMA Syringe

    TOPICAL USE ONLY

    DO NOT INJECT

    U.S. Pat. No.: 5,962,405

    Manufactured for
    Baxter Healthcare Corporation

    Deerfield IL, 60015 USA

    1-888-229-0001

    U.S. License No. 140

    Made in Austria

    Reorder Number: 1506080

    Baxter and Tisseel are trademarks of
    Baxter International Inc.

    10 mL

    Baxter Logo

    GTIN (01) 00303389568018
    EXPIRY (17)
    LOT (10)
    SERIAL (21)

    Tisseel Lyo 4mL Vial Carton Label 0338-4211-04 1 of 2
    Tisseel Lyo 4mL Vial Carton Label 0338-4211-04 2 of 2

    Lyo 4mL Vial Carton Label

    GTIN (01)
    LOT (10)
    EXPIRY (17)

    SERIAL (21)

    NDC 0338-4211-04

    Fibrin Sealant
    TISSEEL 4 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Baxter logo

    NDC 0338-4211-04
    barcode

    Fibrin Sealant
    TISSEEL 4 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Contents:
    Sealer Protein Concentrate (Human), Vapor Heated,
    Solvent /Detergent Treated, freeze dried, sterile, for
    2 mL of Sealer Protein Solution
    Fibrinolysis Inhibitor Solution (Synthetic), sterile,
    3000 KIU of Aprotinin /mL
    Thrombin (Human), Vapor Heated, Solvent /Detergent
    Treated, freeze dried, sterile, for 2 mL of Thrombin
    Solution 500 units/mL
    Calcium Chloride Solution, sterile, 40 μmol /mL

    The risks and benefits of this product should be discussed
    with the patient.
    Read enclosed directions for reconstitution and application
    before use.
    Use within four hours of reconstitution.
    NOT FOR INJECTION. For single use only.
    Not made with natural rubber latex
    Rx only

    Manufactured for Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    U.S. License No. 140

    Made in Austria

    Baxter and Tisseel are trademarks of Baxter International Inc.

    U.S. Pat. No.: 5,962,405

    Barcode
    0752678

    Fibrin Sealant
    TISSEEL 4 mL
    Vapor Heated, Solvent/
    Detergent Treated, Kit

    4 mL

    Store at 2°C to 25°C (36°F to 77°F).
    Avoid freezing.

    Tisseel Lyo 10mL Vial Carton Label 0338-4212-10 1 of 2
    Tisseel Lyo 10mL Vial Carton Label 0338-4212-10 2 of 2

    Lyo 10mL Vial Carton Label

    GTIN (01)
    LOT (10)
    EXPIRY (17)

    SERIAL (21)

    NDC 0338-4212-10

    Fibrin Sealant
    TISSEEL 10 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Baxter Logo

    NDC 0338-4212-10
    barcode

    Fibrin Sealant
    TISSEEL 10 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Contents:
    Sealer Protein Concentrate (Human), Vapor Heated,
    Solvent /Detergent Treated, freeze dried, sterile, for
    5 mL of Sealer Protein Solution 86.5 mg/mL

    Fibrinolysis Inhibitor Solution (Synthetic), sterile,
    3000 KIU of Aprotinin /mL

    Thrombin (Human), Vapor Heated, Solvent /Detergent
    Treated, freeze dried, sterile, for 5 mL of Thrombin
    Solution 500 units/mL

    Calcium Chloride Solution, sterile, 40 µmol /mL

    The risks and benefits of this product should be discussed
    with the patient.
    Read enclosed directions for reconstitution and application
    before use.
    Use within four hours of reconstitution.

    NOT FOR INJECTION. For single use only.

    Not made with natural rubber latex

    Rx only

    Manufactured for Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    U.S. License No. 140

    Made in Austria

    Baxter and Tisseel are trademarks of Baxter International Inc.

    U.S. Pat. No.: 5,962,405

    Barcode

    0752688

    Fibrin Sealant
    TISSEEL 10 mL
    Vapor Heated, Solvent/
    Detergent Treated, Kit

    10 mL

    Store at 2°C to 25°C (36°F to 77°F).
    Avoid freezing.

    Tisseel Lyo 4mL Sleeve Carton Label 0338-4302-04 1 of 2
    Tisseel Lyo 4mL Sleeve Carton Label 0338-4302-04 2 of 2

    Lyo 4mL Sleeve Carton Label

    Baxter Logo

    NDC 0338-4302-04

    Fibrin Sealant
    TISSEEL 4 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Manufactured for Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    U.S. License No. 140

    Made in Austria

    Reorder Number: 1504515

    Baxter, Duploject and Tisseel are trademarks of Baxter International Inc.

    U.S. Pat. No.: 5,962,405

    Baxter Logo

    NDC 0338-4302-04

    Fibrin Sealant
    TISSEEL 4 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    TOPICAL USE ONLY
    DO NOT INJECT

    Baxter Logo

    NDC 0338-4302-04
    barcode

    Fibrin Sealant
    TISSEEL 4 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Contents:
    Sealer Protein Concentrate     (Human), Vapor Heated,
    Solvent /Detergent Treated, freeze dried, sterile, for
    2 mL of Sealer Protein Solution 86.5 mg/mL

    Fibrinolysis Inhibitor Solution (Synthetic), sterile,
    3000 KIU of Aprotinin /mL

    Thrombin (Human), Vapor Heated, Solvent /Detergent
    Treated, freeze dried, sterile, for 2 mL of Thrombin Solution
    500 units/mL

    Calcium Chloride Solution, sterile, 40 μmol /mL

    The risks and benefits of this product should be discussed
    with the patient. Read enclosed directions for
    reconstitution and application before use. Use within four
    hours of reconstitution.

    NOT FOR INJECTION. For single use only.

    Not made with natural rubber latex

    Rx only

    Also includes: DUPLOJECT Fibrin Sealant Preparation and Application System 2 mL / 4 mL

    0752680

    Barcode

    Barcode
    N3 0338-4302-04 4

    Tiseel Lyo 10mL Sleeve Carton Label 0338-4303-10 1 of 2
    Tiseel Lyo 10mL Sleeve Carton Label 0338-4303-10 2 of 2

    Lyo 10mL Sleeve Carton Label

    Baxter Logo

    NDC 0338-4303-10

    Fibrin Sealant
    TISSEEL 10 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Manufactured for Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    U.S. License No. 140

    Made in Austria

    Reorder Number: 1504516

    Baxter, Duploject and Tisseel are trademarks of Baxter International Inc.

    U.S. Pat. No.: 5,962,405

    Baxter Logo

    NDC 0338-4303-10

    Fibrin Sealant
    TISSEEL 10 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    TOPICAL USE ONLY
    DO NOT INJECT

    Baxter Logo

    NDC 0338-4303-10

    Barcode

    Fibrin Sealant
    TISSEEL 10 mL
    Vapor Heated, Solvent/Detergent Treated, Kit

    Contents:
    Sealer Protein Concentrate     (Human), Vapor Heated,
    Solvent /Detergent Treated, freeze dried, sterile, for
    5 mL of Sealer Protein Solution 86.5 mg/mL

    Fibrinolysis Inhibitor Solution (Synthetic), sterile,
    3000 KIU of Aprotinin /mL

    Thrombin (Human), Vapor Heated, Solvent /Detergent
    Treated, freeze dried, sterile, for 5 mL of Thrombin Solution
    500 units/mL

    Calcium Chloride Solution, sterile, 40 μmol /mL

    The risks and benefits of this product should be discussed
    with the patient. Read enclosed directions for
    reconstitution and application before use. Use within four
    hours of reconstitution.
    NOT FOR INJECTION. For single use only.
    Not made with natural rubber latex
    Rx only

    Also includes: DUPLOJECT Fibrin Sealant Preparation and Application System 10 mL

    0752690

    Barcode

    Barcode
    N3 0338-4303-10 2

    Tisseel Duploject Combi Label

    Duploject Combi Label

    Baxter Logo

    DuploJect Combi
    Indication for Use:
    For the application of TISSEEL Fibrin Sealant.

    REF
    Batch code
    Use-by date

    For single use only. Not made with natural rubber latex.
    Do not reuse or resterilize. Sterilized using ethylene oxide.
    Sterile and non-pyrogenic in unopened and undamaged package. Rx Only.

    Manufactured for:
    Baxter Healthcare Corporation
    One Baxter Parkway
    Deerfield, IL 60015 USA
    1-888-229-0001

    Made in Belgium

    BE-90-01-044

  • INGREDIENTS AND APPEARANCE
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin kit
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-4210
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-4210-021 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, GLASS 1 mL
    Part 21 VIAL, GLASS 1 mL
    Part 31 VIAL, GLASS 1 mL
    Part 41 VIAL, GLASS 1 mL
    Part 1 of 4
    SEALER PROTEIN CONCENTRATE HUMAN 
    fibrinogen human powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7112-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 2 of 4
    HUMAN THROMBIN 
    human thrombin powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7332-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 3 of 4
    FIBRINOLYSIS INHIBITOR SOLUTION 
    aprotinin liquid
    Product Information
    Item Code (Source)NDC:0338-7201
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL) 3000 [iU]  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7201-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 4 of 4
    CALCIUM CHLORIDE SOLUTION 
    calcium chloride liquid
    Product Information
    Item Code (Source)NDC:0338-7401
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 40 umol  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7401-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin kit
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-4211
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-4211-041 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, GLASS 2 mL
    Part 21 VIAL, GLASS 2 mL
    Part 31 VIAL, GLASS 2 mL
    Part 41 VIAL, GLASS 2 mL
    Part 1 of 4
    SEALER PROTEIN CONCENTRATE HUMAN 
    fibrinogen human powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7112-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 2 of 4
    HUMAN THROMBIN 
    human thrombin powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7332-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 3 of 4
    FIBRINOLYSIS INHIBITOR SOLUTION 
    aprotinin liquid
    Product Information
    Item Code (Source)NDC:0338-7201
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL) 3000 [iU]  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7201-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 4 of 4
    CALCIUM CHLORIDE SOLUTION 
    calcium chloride liquid
    Product Information
    Item Code (Source)NDC:0338-7401
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 40 umol  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7401-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin kit
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-4212
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-4212-101 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, GLASS 5 mL
    Part 21 VIAL, GLASS 5 mL
    Part 31 VIAL, GLASS 5 mL
    Part 41 VIAL, GLASS 5 mL
    Part 1 of 4
    SEALER PROTEIN CONCENTRATE HUMAN 
    fibrinogen human powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7112-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 2 of 4
    HUMAN THROMBIN 
    human thrombin powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7332-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 3 of 4
    FIBRINOLYSIS INHIBITOR SOLUTION 
    aprotinin liquid
    Product Information
    Item Code (Source)NDC:0338-7201
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL) 3000 [iU]  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7201-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 4 of 4
    CALCIUM CHLORIDE SOLUTION 
    calcium chloride liquid
    Product Information
    Item Code (Source)NDC:0338-7401
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 40 umol  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7401-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin kit
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-4301
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-4301-021 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, GLASS 1 mL
    Part 21 VIAL, GLASS 1 mL
    Part 31 VIAL, GLASS 1 mL
    Part 41 VIAL, GLASS 1 mL
    Part 1 of 4
    SEALER PROTEIN CONCENTRATE HUMAN 
    fibrinogen human powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7112-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 2 of 4
    HUMAN THROMBIN 
    human thrombin powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7332-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 3 of 4
    FIBRINOLYSIS INHIBITOR SOLUTION 
    aprotinin liquid
    Product Information
    Item Code (Source)NDC:0338-7201
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL) 3000 [iU]  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7201-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 4 of 4
    CALCIUM CHLORIDE SOLUTION 
    calcium chloride liquid
    Product Information
    Item Code (Source)NDC:0338-7401
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 40 umol  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7401-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin kit
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-4302
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-4302-041 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, GLASS 2 mL
    Part 21 VIAL, GLASS 2 mL
    Part 31 VIAL, GLASS 2 mL
    Part 41 VIAL, GLASS 2 mL
    Part 1 of 4
    SEALER PROTEIN CONCENTRATE HUMAN 
    fibrinogen human powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7112-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 2 of 4
    HUMAN THROMBIN 
    human thrombin powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7332-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 3 of 4
    FIBRINOLYSIS INHIBITOR SOLUTION 
    aprotinin liquid
    Product Information
    Item Code (Source)NDC:0338-7201
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL) 3000 [iU]  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7201-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 4 of 4
    CALCIUM CHLORIDE SOLUTION 
    calcium chloride liquid
    Product Information
    Item Code (Source)NDC:0338-7401
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 40 umol  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7401-022 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin kit
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-4303
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-4303-101 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, GLASS 5 mL
    Part 21 VIAL, GLASS 5 mL
    Part 31 VIAL, GLASS 5 mL
    Part 41 VIAL, GLASS 5 mL
    Part 1 of 4
    SEALER PROTEIN CONCENTRATE HUMAN 
    fibrinogen human powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7112-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 2 of 4
    HUMAN THROMBIN 
    human thrombin powder, for solution
    Product Information
    Item Code (Source)NDC:0338-7332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7332-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 3 of 4
    FIBRINOLYSIS INHIBITOR SOLUTION 
    aprotinin liquid
    Product Information
    Item Code (Source)NDC:0338-7201
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL) 3000 [iU]  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7201-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Part 4 of 4
    CALCIUM CHLORIDE SOLUTION 
    calcium chloride liquid
    Product Information
    Item Code (Source)NDC:0338-7401
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 40 umol  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-7401-055 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin solution
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-8402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN90 mg  in 1 mL
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL)  
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-8402-021 in 1 CARTON
    1NDC:0338-8402-012 mL in 1 SYRINGE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:0338-8402-041 in 1 CARTON
    2NDC:0338-8402-034 mL in 1 SYRINGE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3NDC:0338-8402-101 in 1 CARTON
    3NDC:0338-8402-0910 mL in 1 SYRINGE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin solution
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-9560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL)  
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9560-012 mL in 1 SYRINGE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin solution
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-9564
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL)  
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9564-014 mL in 1 SYRINGE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    TISSEEL  FIBRIN SEALANT
    fibrinogen human, human thrombin solution
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC:0338-9568
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K) FIBRINOGEN HUMAN86.5 mg  in 1 mL
    HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G) HUMAN THROMBIN500 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    APROTININ (UNII: 04XPW8C0FL)  
    ALBUMIN HUMAN (UNII: ZIF514RVZR)  
    HISTIDINE (UNII: 4QD397987E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9568-0110 mL in 1 SYRINGE, PLASTIC; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10398005/01/1998
    Labeler - Baxter Healthcare Corporation (005083209)
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