ADVANCED SURGERY Product Preparation Support
Welcome to the Baxter Advanced Surgery product preparation webpage. Here you will find support for our range of Haemostat, Sealant, Adhesion Reduction and Orthobiologics products. Please click on the product logo to be taken to the preparation resources.
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Reviewing these animations does not replace the training given to you by your healthcare provider, nor does it replace your responsibility to read and understand the full text of the Operator’s manual prior to operating the machine.
If there are any deviations between actions shown in the videos and the instructions within the operator’s manual, then the operators manual takes precedence.
If you have any questions about the content or require an operator manual, please contact your local Advanced Surgery representative for further information.
Adverse Events and any drug or medical device product quality complaints (including suspected defective medicines or medical device adverse incidents) should be reported.
For the UK reporting forms and information can be found at www.mhra.gov.uk/yellowcard. For Ireland report to the Health Products Regulatory Authority (HPRA) using a Yellow Card obtained from the HPRA, via the online system (www.hpra.ie) or by telephone on +353 (0)1-6764971.
Adverse Events relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on +44 (0)1635 206360, or by email to [email protected] Drug or medical device product quality complaints relating to Baxter products can be reported directly to Baxter Healthcare Ltd:
In the UK +44 (0)1604 704603, or by email to [email protected]. In Ireland on +353 (0)1 2065500 or by email to [email protected].
Alternatively please report directly to your Baxter Representative, who will take the details and forward to the Baxter Country Quality Assurance Team.
TISSEEL PRESCRIBING INFORMATION:
PRESCRIBING INFORMATION - TISSEEL Ready to use Solutions for Sealant (UK)
(Please consult the Summary of Product Characteristics before prescribing)
Composition: prefilled double chamber syringe containing deep frozen Sealer Protein Solution (with aprotinin) and Thrombin Solution (with Calcium Chloride Dihydrate). Sealer Protein Solution contains 91mg/ml human fibrinogen (clottable protein) and 3000 KIU/ml aprotinin. Thrombin Solution contains 500 IU/ml human thrombin and 40μmol per ml calcium chloride. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of sealant. Indications: Supportive treatment where standard surgical techniques are insufficient, for improvement of haemostasis, as a tissue glue to promote adhesion, sealing or as suture support, in gastrointestinal anastomoses, in neurosurgery where contact with cerebrospinal fluid or dura mater may occur and for mesh fixation in hernia repair, as an alternative or adjunct to sutures or staples. Dosage and Route: For epilesional (topical) use only. Use of TISSEEL is restricted to experienced surgeons who have been trained in the use of TISSEEL. A thin layer is applied under direct vision to the tissue surface where required. Dose depends on the indication, application method and number of applications. For tissue adherence, it is recommended that the initial application cover the entire intended application area. As a guideline for the gluing of surfaces, 1 pack of TISSEEL 2 ml will be sufficient for an area of at least 10 cm2. Tissue surface should be as dry as possible before application. Do not use pressurized air or gas for drying the site. Application can be repeated if necessary but avoid reapplication of TISSEEL to pre-existing polymerized TISSEEL. Apply by drops or spray as needed depending on indication. Side effects: See Summary of Product Characteristics for detail. Postoperative wound infections. Fibrin degradation products increased. Hypersensitivity/anaphylactic reactions, anaphylactic shock, paresthesia, bronchospasm, wheezing, pruritus, erythema. Sensory disturbance. Bradycardia, tachycardia. Axillary vein thrombosis, hypotension, haematoma, embolism arterial, air embolism, cerebral artery embolism, cerebral infarction. Dyspnoea. Nausea, Intestinal obstruction. Rash, urticaria, impaired healing. Pain in an extremity. Procedural pain, pain, increased body temperature, flushing, oedema. Seroma, angioedema. Class reaction: Air or gas embolism, see Precautions. Precautions: Life threatening thromboembolic complications may occur if unintentionally applied intravascularly. Apply with care in coronary artery bypass surgery due to increased risk of inadvertent intravascular application. Must not be injected into highly vascularized tissue, such as nasal mucosa. When spraying TISSEEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism. Air or gas embolism, tissue rupture, or gas entrapment with compression, which may be life-threatening, have occurred with the use of spray devices employing a pressure regulator to administer fibrin sealant at higher than recommended pressures and in close proximity to the tissue surface. When applying by spray, follow the instructions provided with the spray device, with particular reference to gas pressure and distance from the tissue surface. Do not administer with spray devices in enclosed body areas. Take risk of compressive complications into account when applying in confined spaces. Use with caution in patients with prior exposure to aprotinin. Caution in patients with bovine protein allergies. Infectious diseases due to the transmission of infective agents cannot be totally excluded. Use of Tisseel and batch number should be recorded in patient's notes. Excessive clot thickness may negatively interfere with product efficacy and the healing process. Oxidised cellulose-containing preparations should not be used with TISSEEL. Contraindications: Do not apply intravascularly. Hypersensitivity to active substances or other components. Not for the treatment of active or spurting arterial or venous bleeding. Not for replacement of skin sutures intended to close surgical wounds. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. Overdose: Not reported. Legal category: POM. Basic NHS price: 2ml - £97.50; 4ml - £195.00; 10ml - £443.75. Marketing Authorisation Number and Holder:PL 00116/0627 Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK. Date of preparation: Jan 2019
PRESCRIBING INFORMATION TISSEEL Ready to use Solutions for Sealant / Lyo Powder and Solvent for Sealant (IRELAND)
(Please consult the Summary of Product Characteristics before prescribing)
Name and composition: Tisseel Ready to use – prefilled double chamber syringe containing Sealer Protein Solution (with aprotinin) deep frozen in one chamber and Thrombin Solution (with Calcium Chloride) deep frozen in the other chamber. Sealer Protein Solution contains 91mg/ml Human Fibrinogen (as clottable protein), 0.6-5 IU/ml Human Factor XIII and 3000 KIU/ml Aprotinin. Thrombin Solution contains 500 IU/ml Human Thrombin and 40μmol/ml Calcium Chloride. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of sealant. Tisseel Lyo - powders and solvents for fibrin sealant. 1) Sealer protein concentrate, after reconstitution 1 ml contains 91 mg Human Fibrinogen (as clottable protein); 0.6-5 IU Human Factor XIII and 3000 KIU Aprotinin; 2) Thrombin solution, after reconstitution, 1 ml contains 500 IU of Human Thrombin and 40μmol Calcium Chloride. Indications: As a coagulant producer for use as a tissue sealant and haemostatic, for surgical incisions, plastic surgical repairs, orthopaedic, traumatic, and dental surgery. Dosage and Route: For epilesional (topical) use only. The use of TISSEEL is restricted to experienced surgeons who have been trained in the use of TISSEEL. A thin layer is applied to the tissue surface where required. Dose depends on the indication, application method and number of applications. As a guideline for the gluing of surfaces, 1 pack of TISSEEL 2 ml (i.e. 1 ml Sealer Protein Solution plus 1 ml Thrombin Solution) will be sufficient for an area of at least 10 cm2. Apply topically – tissue surface should be as dry as possible before application. Application can be repeated if necessary. Apply by drops or spray as needed depending on indication. Safety and efficacy in paediatric population not established. Side effects: See Summary of Product Characteristics for detail. Postoperative wound infections. Fibrin degradation products increased. Hypersensitivity/anaphylactic reactions, anaphylactic shock, paresthesia, bronchospasm, wheezing, pruritus, erythema. Sensory disturbance. Bradycardia, tachycardia. Axillary vein thrombosis, hypotension, haematoma, embolism arterial, air embolism, cerebral artery embolism, cerebral infarction. Dyspnoea. Nausea, Intestinal obstruction. Rash, urticaria, impaired healing. Pain in an extremity. Procedural pain, pain, increased body temperature, flushing, oedema. Seroma, angioedema. Class reaction: Air or gas embolism, see Precautions. Precautions: Apply with care in coronary artery bypass surgery due to increased risk of inadvertent intravascular application. TISSEEL and/or Thrombin Solution should only be applied topically. Do not inject in soft tissue – risk of local tissue damage. When spraying TISSEEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism. See SmPC for further details. Air or gas embolism, tissue rupture, or gas entrapment with compression, which may be life-threatening or fatal, have occurred with the use of spray devices with air or gas employing a pressure regulator to administer fibrin sealant. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. Must not be used with Easyspray/spray set in enclosed areas. When applying by spray, follow the instructions provided with the spray device, with particular reference to gas pressure and distance from the tissue surface. After TISSEEL has been applied, allow at least 2 minutes to achieve sufficient polymerization. Do not use pressurized air or gas for drying the site. TISSEEL must be sprayed only onto application sites that are visible. TISSEEL must not be applied intravascularly. Use with caution in patients with prior exposure to aprotinin. Caution in patients with bovine protein allergies. Infectious diseases due to the transmission of infective agents cannot be totally excluded. Use of Tisseel and batch number should be recorded in patient's notes. Excessive clot thickness may negatively interfere with product efficacy and the healing process. Oxidised cellulose-containing preparations should not be used with Tisseel. The effect of Tisseel on fertility has not been established. Contraindications: Do not apply intravascularly – can be life threatening. Hypersensitivity to active substances or other components. Not for the treatment of massive and brisk arterial or venous bleeding. Do not use to replace skin sutures intended to close surgical wounds. Interactions: No formal interaction studies have been performed. Thrombin component may be denatured by alcohol, iodine or heavy metals (e.g. antiseptic solutions). Overdose: Not reported. Legal category: POM. Marketing Authorisation Holder and Number: Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands. Tisseel Ready to use PA2299/025/001. Tisseel Lyo PA2299/025/002. Date of preparation: April 2019
ARTISS PRESCRIBING INFORMATION:
PRESCRIBING INFORMATION – ARTISS (UK)
(Please consult the Summary of Product Characteristics before prescribing)
Name and composition: ARTISS Solutions for Sealant – one prefilled double chamber syringe containing Sealer Protein Solution (with aprotinin) deep frozen in one chamber and Thrombin Solution (with calcium chloride) deep frozen in the other chamber. Sealer Protein Solution contains 91mg/ml human fibrinogen (clottable protein) and 3000 KIU/ml aprotinin. Thrombin Solution contains 4 IU/ml human thrombin and 40μmol/ml calcium chloride dihydrate. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of total volume of product ready for use. Contains human factor XIII co-purified with human fibrinogen in a range of 0.6 – 5 IU/ml. Indication: Hospital use only. A tissue glue to adhere / seal subcutaneous tissue in plastic, reconstructive and burn surgery, replacement or adjunct to sutures or staples. Adjunct to haemostasis on subcutaneous tissue surfaces. Dosage and Route: The use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. For epilesional use. Dose individualised and governed by indication, application methods and number of applications. Guide – 1 pack ARTISS 2ml sufficient for an area at least 10 cm2. Avoid excess granulation by applying only a thin layer. Surface of the wound should be as dry as possible. Side effects: See summary of product characteristics for detail. Risk of anaphylactic reaction. Intravascular injection may lead to life-threatening thromboembolic events. Hypersensitivity or allergic reactions. In isolated cases these reactions have progressed to severe anaphylaxis. Pruritus and skin graft failure. Precautions: Caution applying ARTISS using pressurised air or gas, not to be used with Easy Spray / Spray Set system in enclosed body areas. Any application of pressurised 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. Use spray device pressure within manufacturers recommended range, not exceeding 2.0 bars. Do not spray closer than 10-15 cm from tissue surface. Monitor blood pressure, pulse, oxygen saturation, end tidal CO2 for possibility of occurrence of air or gas embolism. Not indicated for use where a fast clotting sealant is required, especially in cardiovascular surgery. Not for use in neurosurgery or gastrointestinal or vascular anastomoses. Excessive clot thickness may interfere with efficacy and wound healing. Care to prevent adhesion at undesired sites. Signs of hypersensitivity include hives, urticaria, tightness of chest, wheezing, hypotension, anaphylaxis. Risk of anaphylaxis increased if previous exposure to aprotinin. In event of hypersensitivity or anaphylaxis discontinue use and remove polymerised product from surgical site. Oxycellulose containing preparations may reduce ARTISS efficacy. Infectious diseases due to transmission of infective agents cannot be totally excluded. Use of ARTISS and batch number should be recorded in patient’s notes. Carefully evaluate in patients with allergies to bovine proteins. Contra-indications: Not indicated to replace sutures intended to close surgical wound. Not for treatment of massive and brisk arterial or venous bleeding. Not for intravascular use. Hypersensitivity to active substances or excipients. Spray application should not be used in endoscopic procedures. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. The effects of ARTISS on fertility have not been established. Overdose: No cases of overdose have been reported. Legal Category: POM Basic NHS price: 2ml kit - £97.50; 4ml kit £195.00; 10ml kit £443.75 Marketing Authorisation Number and Holder: ARTISS – PL 00116/0634, Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk. IP24 3SE. Date of Preparation: May 2021.
PRESCRIBING INFORMATION – ARTISS (IRELAND)
Please consult the Summary of Product Characteristics before prescribing
Name and composition: ARTISS Solutions for Sealant – one prefilled double chamber syringe containing Sealer Protein Solution (with aprotinin) deep frozen in one chamber and Thrombin Solution (with calcium chloride dihydrate) deep frozen in the other chamber. Sealer Protein Solution contains 91mg/ml human fibrinogen (clottable protein) and 3000 KIU/ml aprotinin. Thrombin Solution contains 4 IU/ml human thrombin and 40μmol/ml calcium chloride dihydrate. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of total volume of product ready for use. Contains human factor XIII co-purified with human fibrinogen in a range of 0.6 – 5 IU/ml. Indication: Hospital use only. A tissue glue to adhere / seal subcutaneous tissue in plastic, reconstructive and burn surgery, replacement or adjunct to sutures or staples. Adjunct to haemostasis on subcutaneous tissue surfaces. Dosage and Route: The use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. For epilesional use, do not inject. Subcutaneous use only, not recommended for laparoscopic surgery. Dose individualised and governed by indication, application methods and number of applications. Guide – 1 pack ARTISS 2ml sufficient for an area at least 10 cm2. Avoid excess granulation by applying only a thin layer. Surface of the wound should be as dry as possible. Side effects: See summary of product characteristics for detail. Risk of anaphylactic reaction. Intravascular injection may lead to life-threatening thromboembolic events and DIC. Hypersensitivity or allergic reactions in isolated cases these reactions have progressed to severe anaphylaxis. Other known adverse reactions include dermal cyst, pruritus, skin graft failure, air or gas embolism when applied using pressurised air or gas, bradycardia, tachycardia, hypotension, haematoma, dyspnoea, nausea, urticarial, flushing, impaired healing, oedema, pyrexia and seroma. Precautions: Caution applying ARTISS using pressurised gas, not to be used with Easy Spray / Spray Set system in enclosed body areas. Any application of pressurised 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. Use spray device pressure within manufacturers recommended range, not exceeding 2.0 bars. Do not spray closer than 10-15 cm from tissue surface. Monitor blood pressure, pulse, oxygen saturation, end tidal CO2 for possibility of occurrence of air or gas embolism. Not indicated for use where a fast clotting sealant is required, especially in cardiovascular surgery. Not for use in neurosurgery and as a suture support for gastrointestinal or vascular anastomoses. Excessive clot thickness may interfere with efficacy and wound healing. Care to prevent adhesion at undesired sites. Signs of hypersensitivity include hives, urticaria, tightness of chest, wheezing, hypotension, anaphylaxis. Risk of anaphylaxis increased if previous exposure to aprotinin. In event of hypersensitivity or anaphylaxis discontinue use and remove polymerised product from surgical site. Oxycellulose containing preparations may reduce ARTISS efficacy. Infectious diseases due to transmission of infective agents cannot be totally excluded. Use of ARTISS and batch number should be recorded in patients’ notes. Carefully evaluate in patients with allergies to bovine proteins. The effects of ARTISS on fertility have not been established. Contra-indications: Not indicated to replace sutures intended to close surgical wound. Not for treatment of massive and brisk arterial or venous bleeding. Not for intravascular use. Hypersensitivity to active substances or excipients. Spray application should not be used in endoscopic procedures. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. Overdose: No cases of overdose have been reported. Legal Category: POM. Marketing Authorisation Number and Holder: PA2299/026/001, Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands. Date of Preparation: July 2021
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Reviewing these animations does not replace the training given to you by your healthcare provider, nor does it replace your responsibility to read and understand the full text of the Operator’s manual prior to operating the machine.
If there are any deviations between actions shown in the videos and the instructions within the operator’s manual, then the operators manual takes precedence.
If you have any questions about the content or require an operator manual, please contact your local Advanced Surgery representative for further information.
Adverse Events and any drug or medical device product quality complaints (including suspected defective medicines or medical device adverse incidents) should be reported.
For the UK reporting forms and information can be found at www.mhra.gov.uk/yellowcard. For Ireland report to the Health Products Regulatory Authority (HPRA) using a Yellow Card obtained from the HPRA, via the online system (www.hpra.ie) or by telephone on +353 (0)1-6764971.
Adverse Events relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on +44 (0)1635 206360, or by email to [email protected] Drug or medical device product quality complaints relating to Baxter products can be reported directly to Baxter Healthcare Ltd:
In the UK +44 (0)1604 704603, or by email to [email protected]. In Ireland on +353 (0)1 2065500 or by email to [email protected].
Alternatively please report directly to your Baxter Representative, who will take the details and forward to the Baxter Country Quality Assurance Team.
TISSEEL PRESCRIBING INFORMATION:
PRESCRIBING INFORMATION - TISSEEL Ready to use Solutions for Sealant (UK)
(Please consult the Summary of Product Characteristics before prescribing)
Composition: prefilled double chamber syringe containing deep frozen Sealer Protein Solution (with aprotinin) and Thrombin Solution (with Calcium Chloride Dihydrate). Sealer Protein Solution contains 91mg/ml human fibrinogen (clottable protein) and 3000 KIU/ml aprotinin. Thrombin Solution contains 500 IU/ml human thrombin and 40μmol per ml calcium chloride. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of sealant. Indications: Supportive treatment where standard surgical techniques are insufficient, for improvement of haemostasis, as a tissue glue to promote adhesion, sealing or as suture support, in gastrointestinal anastomoses, in neurosurgery where contact with cerebrospinal fluid or dura mater may occur and for mesh fixation in hernia repair, as an alternative or adjunct to sutures or staples. Dosage and Route: For epilesional (topical) use only. Use of TISSEEL is restricted to experienced surgeons who have been trained in the use of TISSEEL. A thin layer is applied under direct vision to the tissue surface where required. Dose depends on the indication, application method and number of applications. For tissue adherence, it is recommended that the initial application cover the entire intended application area. As a guideline for the gluing of surfaces, 1 pack of TISSEEL 2 ml will be sufficient for an area of at least 10 cm2. Tissue surface should be as dry as possible before application. Do not use pressurized air or gas for drying the site. Application can be repeated if necessary but avoid reapplication of TISSEEL to pre-existing polymerized TISSEEL. Apply by drops or spray as needed depending on indication. Side effects: See Summary of Product Characteristics for detail. Postoperative wound infections. Fibrin degradation products increased. Hypersensitivity/anaphylactic reactions, anaphylactic shock, paresthesia, bronchospasm, wheezing, pruritus, erythema. Sensory disturbance. Bradycardia, tachycardia. Axillary vein thrombosis, hypotension, haematoma, embolism arterial, air embolism, cerebral artery embolism, cerebral infarction. Dyspnoea. Nausea, Intestinal obstruction. Rash, urticaria, impaired healing. Pain in an extremity. Procedural pain, pain, increased body temperature, flushing, oedema. Seroma, angioedema. Class reaction: Air or gas embolism, see Precautions. Precautions: Life threatening thromboembolic complications may occur if unintentionally applied intravascularly. Apply with care in coronary artery bypass surgery due to increased risk of inadvertent intravascular application. Must not be injected into highly vascularized tissue, such as nasal mucosa. When spraying TISSEEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism. Air or gas embolism, tissue rupture, or gas entrapment with compression, which may be life-threatening, have occurred with the use of spray devices employing a pressure regulator to administer fibrin sealant at higher than recommended pressures and in close proximity to the tissue surface. When applying by spray, follow the instructions provided with the spray device, with particular reference to gas pressure and distance from the tissue surface. Do not administer with spray devices in enclosed body areas. Take risk of compressive complications into account when applying in confined spaces. Use with caution in patients with prior exposure to aprotinin. Caution in patients with bovine protein allergies. Infectious diseases due to the transmission of infective agents cannot be totally excluded. Use of Tisseel and batch number should be recorded in patient's notes. Excessive clot thickness may negatively interfere with product efficacy and the healing process. Oxidised cellulose-containing preparations should not be used with TISSEEL. Contraindications: Do not apply intravascularly. Hypersensitivity to active substances or other components. Not for the treatment of active or spurting arterial or venous bleeding. Not for replacement of skin sutures intended to close surgical wounds. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. Overdose: Not reported. Legal category: POM. Basic NHS price: 2ml - £97.50; 4ml - £195.00; 10ml - £443.75. Marketing Authorisation Number and Holder:PL 00116/0627 Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK. Date of preparation: Jan 2019
PRESCRIBING INFORMATION TISSEEL Ready to use Solutions for Sealant / Lyo Powder and Solvent for Sealant (IRELAND)
(Please consult the Summary of Product Characteristics before prescribing)
Name and composition: Tisseel Ready to use – prefilled double chamber syringe containing Sealer Protein Solution (with aprotinin) deep frozen in one chamber and Thrombin Solution (with Calcium Chloride) deep frozen in the other chamber. Sealer Protein Solution contains 91mg/ml Human Fibrinogen (as clottable protein), 0.6-5 IU/ml Human Factor XIII and 3000 KIU/ml Aprotinin. Thrombin Solution contains 500 IU/ml Human Thrombin and 40μmol/ml Calcium Chloride. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of sealant. Tisseel Lyo - powders and solvents for fibrin sealant. 1) Sealer protein concentrate, after reconstitution 1 ml contains 91 mg Human Fibrinogen (as clottable protein); 0.6-5 IU Human Factor XIII and 3000 KIU Aprotinin; 2) Thrombin solution, after reconstitution, 1 ml contains 500 IU of Human Thrombin and 40μmol Calcium Chloride. Indications: As a coagulant producer for use as a tissue sealant and haemostatic, for surgical incisions, plastic surgical repairs, orthopaedic, traumatic, and dental surgery. Dosage and Route: For epilesional (topical) use only. The use of TISSEEL is restricted to experienced surgeons who have been trained in the use of TISSEEL. A thin layer is applied to the tissue surface where required. Dose depends on the indication, application method and number of applications. As a guideline for the gluing of surfaces, 1 pack of TISSEEL 2 ml (i.e. 1 ml Sealer Protein Solution plus 1 ml Thrombin Solution) will be sufficient for an area of at least 10 cm2. Apply topically – tissue surface should be as dry as possible before application. Application can be repeated if necessary. Apply by drops or spray as needed depending on indication. Safety and efficacy in paediatric population not established. Side effects: See Summary of Product Characteristics for detail. Postoperative wound infections. Fibrin degradation products increased. Hypersensitivity/anaphylactic reactions, anaphylactic shock, paresthesia, bronchospasm, wheezing, pruritus, erythema. Sensory disturbance. Bradycardia, tachycardia. Axillary vein thrombosis, hypotension, haematoma, embolism arterial, air embolism, cerebral artery embolism, cerebral infarction. Dyspnoea. Nausea, Intestinal obstruction. Rash, urticaria, impaired healing. Pain in an extremity. Procedural pain, pain, increased body temperature, flushing, oedema. Seroma, angioedema. Class reaction: Air or gas embolism, see Precautions. Precautions: Apply with care in coronary artery bypass surgery due to increased risk of inadvertent intravascular application. TISSEEL and/or Thrombin Solution should only be applied topically. Do not inject in soft tissue – risk of local tissue damage. When spraying TISSEEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism. See SmPC for further details. Air or gas embolism, tissue rupture, or gas entrapment with compression, which may be life-threatening or fatal, have occurred with the use of spray devices with air or gas employing a pressure regulator to administer fibrin sealant. These events appear to be related to the use of the spray device at higher than recommended pressures and in close proximity to the tissue surface. Must not be used with Easyspray/spray set in enclosed areas. When applying by spray, follow the instructions provided with the spray device, with particular reference to gas pressure and distance from the tissue surface. After TISSEEL has been applied, allow at least 2 minutes to achieve sufficient polymerization. Do not use pressurized air or gas for drying the site. TISSEEL must be sprayed only onto application sites that are visible. TISSEEL must not be applied intravascularly. Use with caution in patients with prior exposure to aprotinin. Caution in patients with bovine protein allergies. Infectious diseases due to the transmission of infective agents cannot be totally excluded. Use of Tisseel and batch number should be recorded in patient's notes. Excessive clot thickness may negatively interfere with product efficacy and the healing process. Oxidised cellulose-containing preparations should not be used with Tisseel. The effect of Tisseel on fertility has not been established. Contraindications: Do not apply intravascularly – can be life threatening. Hypersensitivity to active substances or other components. Not for the treatment of massive and brisk arterial or venous bleeding. Do not use to replace skin sutures intended to close surgical wounds. Interactions: No formal interaction studies have been performed. Thrombin component may be denatured by alcohol, iodine or heavy metals (e.g. antiseptic solutions). Overdose: Not reported. Legal category: POM. Marketing Authorisation Holder and Number: Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands. Tisseel Ready to use PA2299/025/001. Tisseel Lyo PA2299/025/002. Date of preparation: April 2019
ARTISS PRESCRIBING INFORMATION:
PRESCRIBING INFORMATION – ARTISS (UK)
(Please consult the Summary of Product Characteristics before prescribing)
Name and composition: ARTISS Solutions for Sealant – one prefilled double chamber syringe containing Sealer Protein Solution (with aprotinin) deep frozen in one chamber and Thrombin Solution (with calcium chloride) deep frozen in the other chamber. Sealer Protein Solution contains 91mg/ml human fibrinogen (clottable protein) and 3000 KIU/ml aprotinin. Thrombin Solution contains 4 IU/ml human thrombin and 40μmol/ml calcium chloride dihydrate. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of total volume of product ready for use. Contains human factor XIII co-purified with human fibrinogen in a range of 0.6 – 5 IU/ml. Indication: Hospital use only. A tissue glue to adhere / seal subcutaneous tissue in plastic, reconstructive and burn surgery, replacement or adjunct to sutures or staples. Adjunct to haemostasis on subcutaneous tissue surfaces. Dosage and Route: The use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. For epilesional use. Dose individualised and governed by indication, application methods and number of applications. Guide – 1 pack ARTISS 2ml sufficient for an area at least 10 cm2. Avoid excess granulation by applying only a thin layer. Surface of the wound should be as dry as possible. Side effects: See summary of product characteristics for detail. Risk of anaphylactic reaction. Intravascular injection may lead to life-threatening thromboembolic events. Hypersensitivity or allergic reactions. In isolated cases these reactions have progressed to severe anaphylaxis. Pruritus and skin graft failure. Precautions: Caution applying ARTISS using pressurised air or gas, not to be used with Easy Spray / Spray Set system in enclosed body areas. Any application of pressurised 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. Use spray device pressure within manufacturers recommended range, not exceeding 2.0 bars. Do not spray closer than 10-15 cm from tissue surface. Monitor blood pressure, pulse, oxygen saturation, end tidal CO2 for possibility of occurrence of air or gas embolism. Not indicated for use where a fast clotting sealant is required, especially in cardiovascular surgery. Not for use in neurosurgery or gastrointestinal or vascular anastomoses. Excessive clot thickness may interfere with efficacy and wound healing. Care to prevent adhesion at undesired sites. Signs of hypersensitivity include hives, urticaria, tightness of chest, wheezing, hypotension, anaphylaxis. Risk of anaphylaxis increased if previous exposure to aprotinin. In event of hypersensitivity or anaphylaxis discontinue use and remove polymerised product from surgical site. Oxycellulose containing preparations may reduce ARTISS efficacy. Infectious diseases due to transmission of infective agents cannot be totally excluded. Use of ARTISS and batch number should be recorded in patient’s notes. Carefully evaluate in patients with allergies to bovine proteins. Contra-indications: Not indicated to replace sutures intended to close surgical wound. Not for treatment of massive and brisk arterial or venous bleeding. Not for intravascular use. Hypersensitivity to active substances or excipients. Spray application should not be used in endoscopic procedures. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. The effects of ARTISS on fertility have not been established. Overdose: No cases of overdose have been reported. Legal Category: POM Basic NHS price: 2ml kit - £97.50; 4ml kit £195.00; 10ml kit £443.75 Marketing Authorisation Number and Holder: ARTISS – PL 00116/0634, Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk. IP24 3SE. Date of Preparation: May 2021.
PRESCRIBING INFORMATION – ARTISS (IRELAND)
Please consult the Summary of Product Characteristics before prescribing
Name and composition: ARTISS Solutions for Sealant – one prefilled double chamber syringe containing Sealer Protein Solution (with aprotinin) deep frozen in one chamber and Thrombin Solution (with calcium chloride dihydrate) deep frozen in the other chamber. Sealer Protein Solution contains 91mg/ml human fibrinogen (clottable protein) and 3000 KIU/ml aprotinin. Thrombin Solution contains 4 IU/ml human thrombin and 40μmol/ml calcium chloride dihydrate. Presentations of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of total volume of product ready for use. Contains human factor XIII co-purified with human fibrinogen in a range of 0.6 – 5 IU/ml. Indication: Hospital use only. A tissue glue to adhere / seal subcutaneous tissue in plastic, reconstructive and burn surgery, replacement or adjunct to sutures or staples. Adjunct to haemostasis on subcutaneous tissue surfaces. Dosage and Route: The use of ARTISS is restricted to experienced surgeons who have been trained in the use of ARTISS. For epilesional use, do not inject. Subcutaneous use only, not recommended for laparoscopic surgery. Dose individualised and governed by indication, application methods and number of applications. Guide – 1 pack ARTISS 2ml sufficient for an area at least 10 cm2. Avoid excess granulation by applying only a thin layer. Surface of the wound should be as dry as possible. Side effects: See summary of product characteristics for detail. Risk of anaphylactic reaction. Intravascular injection may lead to life-threatening thromboembolic events and DIC. Hypersensitivity or allergic reactions in isolated cases these reactions have progressed to severe anaphylaxis. Other known adverse reactions include dermal cyst, pruritus, skin graft failure, air or gas embolism when applied using pressurised air or gas, bradycardia, tachycardia, hypotension, haematoma, dyspnoea, nausea, urticarial, flushing, impaired healing, oedema, pyrexia and seroma. Precautions: Caution applying ARTISS using pressurised gas, not to be used with Easy Spray / Spray Set system in enclosed body areas. Any application of pressurised 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. Use spray device pressure within manufacturers recommended range, not exceeding 2.0 bars. Do not spray closer than 10-15 cm from tissue surface. Monitor blood pressure, pulse, oxygen saturation, end tidal CO2 for possibility of occurrence of air or gas embolism. Not indicated for use where a fast clotting sealant is required, especially in cardiovascular surgery. Not for use in neurosurgery and as a suture support for gastrointestinal or vascular anastomoses. Excessive clot thickness may interfere with efficacy and wound healing. Care to prevent adhesion at undesired sites. Signs of hypersensitivity include hives, urticaria, tightness of chest, wheezing, hypotension, anaphylaxis. Risk of anaphylaxis increased if previous exposure to aprotinin. In event of hypersensitivity or anaphylaxis discontinue use and remove polymerised product from surgical site. Oxycellulose containing preparations may reduce ARTISS efficacy. Infectious diseases due to transmission of infective agents cannot be totally excluded. Use of ARTISS and batch number should be recorded in patients’ notes. Carefully evaluate in patients with allergies to bovine proteins. The effects of ARTISS on fertility have not been established. Contra-indications: Not indicated to replace sutures intended to close surgical wound. Not for treatment of massive and brisk arterial or venous bleeding. Not for intravascular use. Hypersensitivity to active substances or excipients. Spray application should not be used in endoscopic procedures. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. Overdose: No cases of overdose have been reported. Legal Category: POM. Marketing Authorisation Number and Holder: PA2299/026/001, Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands. Date of Preparation: July 2021
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