DUPLOSPRAY Quick Reference Guide (laparoscopic procedures)

Position DUPLOSPRAY System so the foot pedal is placed next to the surgeon’s foot at time of application.

Instructions for Circulating Nurse | DUPLOSPRAY MIS Regulator

Attach gas supply hose, located at back of regulator, to source of medical grade CO2.

21

Instructions for Scrub Nurse | DUPLOSPRAY MIS Applicator

Attach patient vent line (red luer connector) to available female luer on trocar vent valve. Ensure vent valve is fully open.

6

Pass assembled double syringe and spray applicator to surgeon for spray application.

5

Attach gas supply line (clear luer connector) to sterile applicator. Turn white locking collar to secure connection.

4

Fasten the pull strap to the double syringe holder to assure the spray applicator is tightly secured.

3

Firmly attach the applicator to the nozzles of the double syringe.

2

Thread sterile replaceable tip onto applicator using tip alignment tool.

1

Instructions for Surgeon

While activating foot pedal dispense TISSEEL Fibrin Sealant through applicator tip by depressing double syringe plungers using very slow, steady pressure. To stop spray delivery release pressure on plung-ers while maintaining gas flow by hold-ing down foot pedal for an additional 3-5 seconds to clear applicator tip.

3

TIPS

• The patient vent line attached to the trocar cannula vent valve will only vent gas out when foot pedal is depressed. After connection to trocar cannula, ensure vent valve is fully open on trocar cannula prior to spray application.

• If tip becomes occluded during use, remove plugged tip by unscrewing it counterclockwise. Using a sterile cloth, wipe any clotted material off exposed tube ends. Screw on new tip and tighten with finger pressure.

• The twin-tube assembly can be easily separated as necessary to allow freedom of movement.

Please see the TISSEEL SmPC provided together with this material.

The use of TISSEEL Fibrin Sealant is restricted to experienced surgeons who have been trained in the use of TISSEEL.

In order to ensure optimal safe use of TISSEEL by spray application, apply a minimum spray distance of 2 cm and a maximum spray pressure of 1.5 bar to minimise the potential risk of air or gas embolism, tissue rupture, or air or gas entrapment with compression.

While depressing foot pedal, adjust gas flow rate to 1.0-2.0 litres per minute. Check gas flow by noting height of ball in flow gauge while stepping on foot pedal.

4

Attach spray set to regulator. Connect the blue vent line filter to the blue female luer and the clear gas line filter to the male luer on the regulator.

3

Depress foot pedal to start gas flow prior to applying TISSEEL Fibrin Sealant. Check gas flow gauge on regulator before inserting applicator. If flow level ball does not move when foot pedal is depressed, the applicator tip is occluded and should be replaced.

2

Confirm actual flow of max 2 litres/min with theatre personnel.

1

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DUPLOSPRAY Quick Reference Guide

Connect to regulated CO2 gas source only; maximum input pressure not to exceed 100 psi. To avoid possible air or gas embolism, do not directly spray into circulatory pathways.

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 Duplospray are trademarks of Baxter International Inc., its subsidiaries or affiliates..

ROI/MG24/13-0001f September 2013

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 Spray set to be used Applicator tips to be used Pressure regulator to be used Recommended distance from target tissue

Recommended spray pressure

Laparoscopic/ minimally invasive procedures n.a.

DUPLOSPRAY MIS Applicator 20cm

DUPLOSPRAY MIS Regulator

2 – 5 cm 1.2-1.5 bar (18-22 psi)

DUPLOSPRAY MIS Regulator NIST B11

DUPLOSPRAY MIS Applicator 30cm

DUPLOSPRAY MIS Regulator

DUPLOSPRAY MIS Regulator NIST B11

DUPLOSPRAY MIS Applicator 40cm

DUPLOSPRAY MIS Regulator

DUPLOSPRAY MIS Regulator NIST B11

Replaceable tipDUPLOSPRAY MIS Regulator

DUPLOSPRAY MIS Regulator NIST B11 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.

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

Precautions For TISSEEL Fibrin Sealant

• 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 laparoscopic procedures: Use CO2 only when using spray application. When applying the product as a spray using a CO2 pressure regulator device, the maximum pressure should be 1.5 bar (22 psi). The product should be sprayed at a distance at least 2cm (recommended range 2-5cm) from the tissue surface.

CAUTION BOX

PRESCRIBING INFORMATION - TISSEEL Lyo Two-Component Fibrin SealantReady to use Solutions for 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 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. 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 Factor XIII and 3000 KIU/ml Aprotinin. Thrombin Solution contains 500 IU/ml Human Thrombin and 40μmol/ml Calcium Chloride. Presenta-tions of 1, 2 or 5ml in each chamber resulting in total volume of 2ml, 4ml or 10ml of sealant.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: 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 tis-sue 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 pos-sible before application. Application can be repeated if necessary. Apply by drops or spray as needed depend-ing on indication. Side effects: See Summary of Product Characteristics for detail. Hypersensitivity / anaphy-lactic / 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 bradycar-dia, bronchospasm, tightness in chest and dsypnoea. Postoperative wound infection, fibrin D- dimer increase, sensory disturbance, pain, nausea, increase in body temperature, rash, pain in extremity and seroma have been reported. 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. 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, 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. 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. 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. Safety and efficacy in paediatric patients not 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. 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 Number and Holder: TISSEEL Lyo - PA 167/129/6. TISSEEL Ready to use - PA 167/129/005 Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE Date of preparation: October 2013 Further information is available on request.

Any adverse event relating to Baxter products should be reported to Baxter Healthcare directly by calling 01-206-5500 and asking for the Quality Department.

Baxter Healthcare encourages healthcare professionals to continue to be vigilant and to report suspected adverse reactions with TISSEEL to the Irish Medicines Board (online at www.imb.ie, telephone 01-6764971 or using the yellow card system).

Baxter Healthcare Ltd Unit 7 Deansgrange Business Park Blackrock Co. Dublin

Tel: 01 2065500 Fax: 01 2065555

www.baxterhealthcare.ie

Caution: 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. Be sure to take appropriate measures to address these risks by observing the recommended minimum spraying distance and the maximum pressure provided in the appropriate spray set instructions for use.

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