Artiss Easyspray Hızlı Referans Kılavuzu - Sayfa 2

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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

Precautions

For ARTISS Solutions for Sealant

• In open-wound: 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 CO

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.

• ARTISS is recommended for subcutaneous use only. ARTISS is not recommended for laparoscopic use.

When applying ARTISS using a spray device be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer as follows:

Recommended pressure, distance and devices for spray application of ARTISS

Surgery

Spray set to be used

Tisseel / ArTiss spray set

Open wound of subcutaneous tissue

Tisseel / ArTiss spray set 10 pack

When spraying the ARTISS, changes in blood pressure, pulse, oxygen saturation and end tidal CO

WARNINGS AND PRECAUTIONS

Caution: Pressurised gas supply must be between 3.5 and 7 bar (51-100 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]

should be monitored closely when spraying fibrin solutions for sealant using a pressure

Applicator tips

Recommended distance

Pressure regulator to be used

to be used

from target tissue

n.a.

eAsysprAy

10 – 15 cm

n.a.

eAsysprAy

should be monitored because of the possibility of occurrence of air or gas embolism.

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. Pre-

sentations 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, re-

placement 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 cm

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. Pruritus, skin graft failure. Precautions: Caution applying ARTISS using pres-

surised gas, not to be used with Easy Spray / Spray Set system in enclosed body areas - risk of air or gas embo-

lism, tissue rupture or gas entrapment. 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 CO

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, hypo-

tension, 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 prepa-

rations 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. Hypersensitiv-

ity 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 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

Recommended spray pressure

Healthcare Limited, Caxton Way, Thetford, Norfolk. IP24 3SE. Date of Preparation: March 2013.

1.5-2.0 bar

(21.5-28.5 psi)

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 Pharmaco-

vigilance on 01635 206360, or by email to [email protected]

For detailed information please contact your local representative.

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

UK/MG24/13-0003e September 2013

. Avoid excess granulation by applying only a thin

for possibility of occurrence of air or gas embolism. Not indicated for use where a fast