• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
    / Baxter

    Active Ingredient *
    Aprotinin (acetate) 3000 KIU / 1 ml
    Human Fibrinogen 91 mg / 1 ml
    Human Thrombin 500 IU / 1 ml

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe

    2 ml

    not in the basket chart

    Pre-filled Syringe

    4 ml

    not in the basket chart

    Pre-filled Syringe

    10 ml

    not in the basket chart


    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 lifethreatening gas embolism, spray TISSEEL using only the appropriate pressurized gas within the pressure range and distance recommended in the device Instructions For Use. 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.
    See prescribing information for full details.


    Supportive treatment in adults and children from 1 month of age where standard surgical techniques appear insufficient: For improvement of Hemostasis. As a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastrointestinal anastomoses. For tissue sealing, to improve adhesion of the separated tissue (e.g. tissue flaps, grafts, split skin grafts [mesh grafts]). Efficacy in fully heparinized patients has been proven.


    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.
    Aprotinin Hypersensitivity: Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.
    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.
    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.

    Special Precautions

    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.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. 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.
    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 Table 4 at the attached doctor’s leaflet.
    Monitor changes in blood pressure, pulse, oxygen saturation and end tidal 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.
    For Minimally Invasive Surgery Procedures in 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 vent line to reduce the risk of gas embolization.
    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.
    Use in Surgery: To minimize the risk of intravascular application, exercise caution when using TISSEEL in surgery.
    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.
    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.
    See prescribing information for full details.

    Side Effects

    See prescribing information for full details.

    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.

    Pregnancy and Lactation

    Pregnancy: Pregnancy Category C. Animal reproduction studies have not 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 at this time.
    Parvovirus B19 most seriously affects pregnant women (fetal infection). TISSEEL should be given to a pregnant woman only if clearly needed.
    Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TISSEEL is administered to nursing mothers.

    Baxter AG, Austria