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TISSEEL READY FOR USE is a brand name for Aprotinin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Supportive treatment where standard surgical techniques are insufficient - for improvement of haemostasis (see section 5.1) - as a tissue glue to promote adhesion/sealing or as suture support: - in gastrointestinal anastomoses - in neurosurgery where contact with cerebro-spinal fluid or dura mater may occur For mesh…
Verbatim from this product's MHRA label. Tap a section to expand.
, epilesional) use only, do not inject. 4). The use of TISSEEL is restricted to experienced surgeons who have been trained in the use of TISSEEL. Posology The amount of TISSEEL Ready to use to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications. 4). If used for tissue adherence, it is recommended that the initial application cover the entire intended application area.
Application of the product must be individualized by the treating physician. In clinical trials, the individual dosages have typically ranged from 4 to 20 ml. For some procedures, larger volumes may be required. The initial amount of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
The application can be repeated, if necessary. However, avoid reapplication of TISSEEL Ready to use to a pre-existing polymerized TISSEEL Ready to use layer as TISSEEL Ready to use will not adhere to a polymerized layer. e. 1 ml Sealer Protein Solution plus 1 ml Thrombin Solution) will be sufficient for an area of at least 10 cm2.
When TISSEEL Ready to use is applied by spraying, the same quantity will be sufficient to coat considerably larger areas, depending on the specific indication and the individual case. When TISSEEL Ready to use is used for mesh fixation it may be applied as drops and/or by a spray technique depending on the preference of the surgeon.
Usually the drops of TISSEEL are applied where surgeons routinely position staples and the layer of fibrin sealant achieved with spraying allows the entire mesh to be fixed in place without shrinking and folding. The quantity of TISSEEL Ready to use required for mesh fixation depends on the mesh size selected and the recommended amount is the same for different application techniques.
For example, 2-4 ml of reconstituted TISSEEL Ready to use applied as a thin layer is suitable to adequately fix a standard size mesh of approximately 10 x 15 cm. g. pubic tubercle in inguinal hernia repair) and at the margins of the mesh.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bradycardia, bronchospasm, chills, dyspnoea, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, pruritus, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants / haemostatics.
In isolated cases, these reactions have progressed to severe anaphylaxis. 4) or any other constituents of the product. Even if a second treatment with TISSEEL Ready to use was well tolerated, a subsequent administration of TISSEEL or systemic administration of aprotinin may result in severe anaphylactic reactions.
In the event of hypersensitivity reactions the administration has to be discontinued immediately. 4). Reactions to antibodies against components of fibrin sealant / haemostatic products may occur rarely. 4). 4. The following undesirable effects have been reported from clinical trials investigating the safety and efficacy of TISSEEL and from post-marketing experience with Baxter Fibrin Sealants.
In these trials, TISSEEL was administered for adjunct hemostasis in cardiac, vascular, total hip replacement and in liver and spleen surgeries. Other clinical trials included the sealing of lymphatic vessels in patients undergoing axillary lymph node dissection, sealing of colonic anastomosis and in durasealing in the posterior fossa.
In these studies a total of 1146 patients were administered Baxter Fibrin sealant. For the undesirable effects reported from post-marketing experience with Baxter Fibrin Sealants, the frequency cannot be estimated from the available data.
Very common (³ 1/10) Common (³ 1/100 to <1/10) Uncommon (³ 1/1,000 to <1/100) Rare (³ 1/10,000 to <1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Table 1: Adverse Reactions System organ class (SOC) Preferred MedDRA Term Frequency Infections and infestations Postoperative wound infection Common Blood and lymphatic system disorders Fibrin degradation products increased Uncommon Hypersensitivity reactions* Not known Anaphylactic reactions* Not known Anaphylactic shock* Not known Paresthesia Not known Bronchospasm Not known Wheezing Not known Pruritus Not known Immune system disorders Erythema Not known Nervous system disorders Sensory disturbance Common Bradycardia Not knownCardiac disorders Tachycardia Not known System organ class (SOC) Preferred MedDRA Term Frequency Axillary vein thrombosis ** Common Hypotension Rare Haematoma (NOS) Not known Embolism arterial Not known Air embolism*** Not known Cerebral artery embolism Not known Vascular disorders Cerebral infarction** Not known Respiratory, thoracic and mediastinal disorders Dyspnoea Not known Nausea UncommonGastrointestinal disorders Intestinal obstruction Not known Rash Common Urticaria Not known Skin and subcutaneous tissue disorders Impaired healing Not known Musculoskeletal and connective tissue disorders Pain in an extremity Common Procedural pain Uncommon Pain Common Increased body temperature Common Flushing Not known General disorders and administration site conditions Oedema Not known Seroma Very commonInjury, poisoning and procedural complications Angioedema Not known * anaphylactic reactions and anaphylactic shock have included fatal outcomes.
4. Warnings). TISSEEL Ready to use alone is not indicated for the treatment of active or spurting arterial or venous bleeding which is not controlled by conventional surgical techniques. TISSEEL Ready to use is not indicated to replace skin sutures intended to close surgical wounds.
4 Special warnings and precautions for use TISSEEL Ready to use alone is not indicated for the treatment of severe or brisk arterial or venous bleeding which is not controlled by conventional surgical techniques. For epilesional use only.
Do not apply intravascularly. Soft tissue injection of TISSEEL Ready to use carries the risk of an anaphylactoid reaction and / or local tissue damage. Caution must be used when applying fibrin sealant using pressurized air or gas. 8).
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly. Intravascular application can lead to intravascular coagulation and may result in life-threatening thromboembolic events and might increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients.
TISSEEL must be applied with caution to minimize any risk of intravascular application, for example in coronary bypass surgery. Because of the risk of intravascular injection, the product also must not be injected into highly vascularized tissue, such as nasal mucosa.
In two retrospective, non-randomized studies in Coronary Artery Bypass Graft (CABG) surgery, patients that received fibrin sealant showed a statistically significant increased risk of mortality. While these studies could not provide a determination of a causal relationship the increased risk associated with the use of TISSEEL Ready to use in these patients cannot be excluded.
Therefore, additional care should be taken to avoid inadvertent intravascular administration of this product. Injection of Sealer Protein and/or Thrombin Solution carries a risk of anaphylactoid reactions. Intravascular and intraventricular administration carries the additional risk of a thromboembolic complication.
TISSEEL
Ready to use must not be applied intravascularly. Intravascular application of TISSEEL Ready to use may result in life-threatening thromboembolic events. Known hypersensitivity to any constituents of the product, including aprotinin (see also section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aprotinin in United Kingdom.
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Application by spray, either alone or in combination with drops, should cover the mesh uniformly with a thin layer. In inguinal hernia repair the mesh covering vascular structures and nerves can be fixed with TISSEEL Ready to use alone using drops and/or spray.
Paediatric population Safety and efficacy of the product in paediatric patients have not been established. e. epilesional) use only, do not inject. Prior to application, TISSEEL must be warmed to 33-37°C. Tisseel must not be exposed to temperatures above 37°C and must not be microwaved.
0 psi) should be used. 5 bar (22 psi) and uses carbon dioxide gas only should be used. g. intermittent application of compresses, swabs, use of suction devices). Do not use pressurized air or gas for drying the site. TISSEEL must be sprayed only onto application sites that are visible.
6). 6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tips. Application beyond the intended area should be avoided. 4). After TISSEEL Ready to use has been applied, allow at least 2 minutes to achieve sufficient polymerization.
Depending on type of use, the sealed parts may have to be fixed or held in the desired position for this time. 2). It is strongly recommended that every time TISSEEL Ready to use is applied to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
6 for more detailed instructions.
** as a result of intravascular application into the superior petrosal sinus. g. at higher than recommended pressure and in close proximity to the tissue surface. Class Reactions Other adverse reactions associated with the fibrin sealant/hemostatic class include: Air or gas embolism when using devices with pressurized air or gas; this event appears to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface.
Manifestations of hypersensitivity include application site irritation, chest discomfort, chills, headache, lethargy, restlessness, and vomiting. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Both complications may be life-threatening. Therefore, care should be taken to ensure that Sealer Protein and/or Thrombin Solution are only applied topically. Caution must be used when applying fibrin sealant using pressurized air or gas 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-threatening or fatal.
Apply TISSEEL as a thin layer. Excessive clot thickness may negatively interfere with the product’s efficacy and the wound healing process. Life-threatening/fatal air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants.
This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface. The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with TISSEEL when sprayed in open wound surgery.
6 for pressures and distances). TISSEEL spray application should only be used if it is possible to accurately judge the spray distance as recommended by the manufacturer. Do not spray closer than the recommended distances. 2). TISSEEL Ready to use must not be used with the EasySpray/Spray set system in enclosed body areas.
Before the administration of TISSEEL Ready to use, care is to be taken that parts of the body outside the designated application area are sufficiently protected/covered to prevent tissue adhesion at undesired sites. g. the brain or the spinal cord, the risk of compressive complications should be taken into account.
As with any protein containing product, allergic type hypersensitivity reactions are possible. Signs of hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, the administration has to be discontinued immediately.
Intravascular application might increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients. Manifestations of hypersensitivity reactions to TISSEEL observed include: bradycardia, tachycardia, hypotension, flushing, bronchospasm, wheezing, dyspnoea, nausea, urticaria, angioedema, pruritus, erythema, paresthesia.
8). At the first sign or symptom of a hypersensitivity reaction, TISSEEL application must be stopped and medical care initiated. Remaining product must be removed from the site of application. Injection into the nasal mucosa must be avoided, as thromboembolic complications may occur in the area of the arteria ophthalmica.
Injecting TISSEEL Ready to use into tissue carries the risk of local tissue damage. TISSEEL Ready to use contains synthetic aprotinin, a monomeric polypeptide known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin there is a risk of anaphylactic reaction, particularly in the case of previous exposure.
Aprotinin is included in TISSEEL for its antifibrinolytic properties. As with other aprotinin-containing products, the use of TISSEEL should be documented in the patient’s records, pointing out that TISSEEL contains aprotinin. As synthetic aprotinin is structurally identical to bovine aprotinin the use of TISSEEL in patients with […]