dcsimg

Ireland

Baxter

IMPORTANT SAFETY INFORMATION ON THE CORRECT USE OF TISSEEL Lyo, TISSEEL Ready to Use and ARTISS Solutions for Sealant WITH SPRAY APPLICATION

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. 
When applying TISSEEL/ ARTISS using a spray device, be sure to use a pressure within the pressure range recommended by the spray device manufacturer.

TISSEEL/ ARTISS 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.
TISSEEL/ ARTISS should only be reconstituted and administered according to the instructions and with the devices recommended for this product

When spraying TISSEEL/ ARTISS, 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.

Reporting of suspected adverse reactions

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. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. E-mail: medsafety@hpra.ie.

Any adverse events relating to Baxter products can also be reported direct to Baxter Pharmacovigilance on +44 (0) 1635 206360, or by email to vigilanceuk@baxter.com.

For detailed information on the correct use of TISSEEL/ARTISS, please see the links below:

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