Dear Health Care Professional Letter about the risk of fatal air or gas embolism due to inappropriate use of the spray applicator attached to a pressure regulator during administration of the sprayable fibrin sealant Tisseel Lyo
The company Agmar d.o.o., the marketing authorisation holder for the medicinal product Tisseel Lyo has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to health care professionals informing them about the risk of fatal air or gas embolism due to inappropriate use (exceeded recommended pressure, inadequate distance from the tissue surface) of the spray applicator attached to a pressure regulator during administration of the sprayable fibrin sealant Tisseel Lyo.
Here you may view the Dear Health Care Professional Letter in the continuation of this information (in Croatian).
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.