EASYSPRAY for Open Wound Surgery Quick Reference Guide Sept 2013

EASYSPRAY Quick Reference Guide CAUTION BOX Any application of pressurised gas may be associated with a potential risk of air or gas embolism, tissue rupture or air or gas entrapment with compression, which may be life threatening if the product is sprayed incorrectly

PRESCRIBING INFORMATION - TISSEEL

Precautions For TISSEEL Fibrin Sealant

Ready to use Solutions for Sealant

• In open surgery: when applying sprayable fibrin solutions for sealant using a pressure regulator device, the maximum pressure should be 2.0 bar (28.5 psi). The product should be sprayed at a distance at least 10 cm from the tissue surface. • 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. • Prior to applying sprayable fibrin solutions for sealant, the surface area of the wound should only be dried using standard techniques (eg, intermittent application of compresses, swabs, use of suction devices). • Blood pressure, pulse rate, oxygen saturation and end tidal CO2 should be monitored closely when spraying fibrin solutions for sealant using a pressure regulator device, because of the possibility of occurrence of air or gas embolism. • Regulators should be used in line with manufacturer recommendations and the SmPC and Instruction for Use

In order to ensure optimal safe use of TISSEEL by spray application the following recommendations should be followed: Recommended pressure, distance and devices for spray application of TISSEEL Surgery

Open wound

Spray set to be used

Applicator tips to be used

Pressure regulator to be used

TISSEEL / ARTISS Spray Set

n.a.

EASYSPRAY

TISSEEL / ARTISS Spray Set 10 pack

n.a.

EASYSPRAY

DUPLOJECT Spray Set

n.a.

TISSOMAT

TISSEEL/TISSUCOL Spray Set

n.a.

EASYSPRAY

Recommended distance from target tissue

Recommended spray pressure

10-15 cm

1.5-2.0 bar (21.5-28.5 psi).

When spraying the 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.

WARNINGS AND PRECAUTIONS Caution: Pressurized gas supply must be between 3.5 and 7 bar (50-100 psi). Caution: DO NOT connect to an oxygen source. Failure to follow these instructions can lead to explosion, which could result in serious injury or death. Prior to operation make sure that the pressure range of the device is adjusted to the range specified in the appropriate spray set instructions for use. Caution: Spraying into enclosed body cavities requires appropriate safety measures to make sure that the above mentioned risks will be avoided. NOTE: Do not use with rechargeable batteries. The use of accessories of other manufacturers is not permitted.

Baxter Healthcare Ltd Wallingford Road, Compton Newbury, RG20 7QW Surecall Tel: +44 (0) 1635 206345 Surecall Fax: +44 (0) 1635 206071 Email: [email protected]

Lyo Two-Component Fibrin Sealant

(Please consult the Summary of Product Characteristics before prescribing) Name and composition: TISSEEL Lyo - powders and solvents for fibrin sealant. 1) Sealer protein concentrate; after reconstitution 1 ml contains 96-125 mg total protein of which 72-110 mg is fibrinogen; 2) Aprotinin Solution, 3000 KIU per ml; 3) Thrombin Powder, 1 ml contains 500 IU of Thrombin in 45-55 mg total protein; 4) Calcium chloride solution, 40μmol per ml. 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 (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: 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. Side effects: See Summary of Product Characteristics for detail. Hypersensitivity / anaphylactic / anaphylactoid reactions may occur, especially in patients who have previously received aprotinin. Early symptoms of allergic reactions include flushing, urticaria, pruritus, nausea, hypotension, tachycardia or bradycardia, bronchospasm, tightness in chest and dsypnoea. Do not inject – risk of thromboembolic complications. 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. 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. 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. When applying by spray, follow the instructions provided with the spray device, with particular reference to gas pressure and distance from the tissue surface. 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. Contraindications: Do not apply intravascularly. Hypersensitivity to active substances or other components. Not for the treatment of active or spurting arterial or venous bleeding. Interactions: Avoid solutions containing alcohol, iodine and heavy metals. Overdose: Not reported. Legal category: POM Basic NHS price: TISSEEL Lyo 2 ml kit - £83.46; 4 ml kit - £166.92; 10 ml kit - £379.85. TISSEEL Ready to use 2ml - £97.50; 4ml - £195; 10ml - £443.75. Marketing Authorisation Number and Holder: TISSEEL Lyo - PL 00116/0321. TISSEEL Ready to use - PL 00116/0627 Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE Date of preparation: March 2013 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.Any adverse events relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on 01635 206360, or by email to vigilanceuk@ baxter.com

For detailed information please contact your local representative In some countries TISSEEL Fibrin Sealant is licensed under the trademark of TISSUCOL Fibrin Sealant. Baxter, Tisseel, Tissucol, and Easyspray are trademarks of Baxter International Inc., its subsidiaries or affiliates.. UK/90/14-0002 April 2014