EASYSPRAY and DUPLOSPRAY Pressure Regulator Reference Guide May 2014

EASYSPRAY and DUPLOSPRAY

EASYSPRAY Pressure Regulator Operation (open surgery) 1 Insert 9V battery into the EASYSPRAY Pressure Regulator device

4 Connect Spray Set filters to EASYSPRAY device. Connect the blue filter (pressure line) to the blue female luer connector and the clear filter (sensor line) to the male luer connector

2 Connect EASYSPRAY device to IV pole or cart rail using the clamps on the back of the device

5 Turn the on/off switch on the front side of the EASYSPRAY to the ON (I) position

3 Use suitable connection tube to connect the EASYSPRAY device to medical air (ranging 3.5 – 7 bar / 50 – 100 psi)

6 Check the gauge on the EASYSPRAY device for the appropriate pressure range of 1.5-2.0 bars (21.5-28.5 psi). Adjust pressure setting by turning the black pressure control knob

DUPLOSPRAY MIS Pressure Regulator Operation (laparoscopic procedures) 1 Position DUPLOSPRAY System so the foot pedal is placed next to the surgeon’s foot at time of application

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

3 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

4 While depressing foot pedal, adjust gas flow rate to 1.0-2.0 liters per minute. Check gas flow by noting height of ball in flow gauge while stepping on foot pedal 5 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

MIS Pressure Regulator Instructions for correct usage 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 Precautions For TISSEEL Fibrin Sealant and ARTISS Solutions for Sealant b 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. b In open-wound 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. b 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. b 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). b 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. b Regulators should be used in line with manufacturer recommendations and the SmPC and Instruction for Use. For TISSEEL Fibrin Sealant only b 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. b The only device designed for the application of TISSEEL in enclosed thoracic and abdominal spaces is the DuploSpray MIS applicator and regulator system. For ARTISS Solutions for Sealant only b ARTISS is recommended for subcutaneous use only. ARTISS is not recommended for laparoscopic use.

Fibrin Sealant

Surgery

Open wound

Spray set to be used

Applicator tips to be used

TISSEEL/ARTISS Spray Set

n.a.

TISSEEL/ARTISS Spray Set 10 Pack

n.a. DUPLOSPRAY MIS Applicator 20cm DUPLOSPRAY MIS Applicator 30cm

TISSEEL Laparoscopic/ minimally invasive procedures

n.a. DUPLOSPRAY MIS Applicator 40cm Replaceable Tip TISSEEL/ARTISS Spray Set

n.a.

TISSEEL/ARTISS Spray Set 10 Pack

n.a.

n.a

n.a

Open wound ARTISS Laparoscopic/ minimally invasive procedures

CAUTION: Any application of pressurized gas may be associated with a potential risk of air or gas embolism, tis appropriate measures to address these risks by observing the recommended minimum spraying distance and th

Recommended Pressure and Distance | Overview

Pressure regulator to be used EASYSPRAY EASYSPRAY

Recommended distance from target tissue

Recommended spray pressure/flow rate

10-15 cm

1.5-2.0 bar (21.5-28.5 psi).

2-5 cm

1.0-2.0 L/min (1.2-1.5 bar/ 18-22 psi)

10-15 cm

1.5-2.0 bar (21.5-28.5 psi)

n.a

n.a

DUPLOSPRAY MIS Regulator DUPLOSPRAY MIS Regulator NIST B11 DUPLOSPRAY MIS Regulator DUPLOSPRAY MIS Regulator NIST B11 DUPLOSPRAY MIS Regulator DUPLOSPRAY MIS Regulator NIST B11 DUPLOSPRAY MIS Regulator DUPLOSPRAY MIS Regulator NIST B11 EASYSPRAY EASYSPRAY n.a

ssue rupture or air or gas entrapment with compression, which may be life threatening. Be sure to take he maximum pressure provided in the appropriate spray set instructions for use and in the table above.

Notes

PRESCRIBING INFORMATION - TISSEEL Lyo Two-Component Fibrin Sealant Ready 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. Presentations 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 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. 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. Postoperative wound infection, fibrin degradation products increased, paresthesia, wheezing, erythema, bradycardia, tachycardia, auxillary vein thrombosis, hypotension, haematoma, cerebral artery embolism, cerebral infarction, intestinal obstruction, impaired healing, procedural pain, flushing, oedema, angioedema, sensory disturbance, pain, nausea, increase in body temperature, rash, pain in extremity and seroma have been reported. Do not inject – risk of thromboembolic complications. Risk of arterial embolism. 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. 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 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: May 2014 Further information is available on request.

PRESCRIBING INFORMATION – ARTISS (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. 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 laproscopic 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. 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: ARTISS – PA 167/131/001, Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE. Date of Preparation: May 2014

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin: Tel:+353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie E-mail: [email protected] . Adverse events should also be reported to Baxter Healthcare at +353 (0) 1 2065500, or by contacting your local Baxter representative.

b

For detailed information please contact your local representative

Baxter Healthcare Ltd. Unit 7 Deansgrange Business Park Blackrock Co. Dublin Tel: +353 1 2065500 Fax: +353 1 2065555 www.baxterhealthcare.ie

Baxter, Tisseel, Tissucol, Artiss, Duplospray, and Easyspray are trademarks of Baxter International Inc., its subsidiaries or affiliates

July 2015

ROI/128/15-0002