Direct healthcare professional communication on the new recommendations to minimise the risk of intestinal obstruction related to use of TachoSil (human fibrinogen/human thrombin)
01.02.2016
Takeda Pharmaceuticals Croatia d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the risk of adhesions to gastrointestinal tissues, leading to intestinal obstruction, associated with TachoSil.
Summary
- Cases of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use of TachoSil in abdominal surgery carried out in proximity to the bowel.
- To prevent tissue adhesions at undesired sites, it should be ensured that tissue areas outside the desired application area are adequately cleansed of residual blood before administration of TachoSil.
- For appropriate application of TachoSil, the enclosed updated product information and "Instructions for Use” should be examined.
Further information
TachoSil is a medicinal product that contains the active substances human fibrinogen and human thrombin coated onto a collagen patch, and is indicated in surgery to improve haemostasis, promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient.
Due to the strong affinity of collagen to blood, TachoSil may stick to adjacent tissues covered with blood if the surgical site is inadequately prepared and/or not cleansed of residual blood or if TachoSil is applied inappropriately.
Here you may view the direct healthcare professional communication.
The healthcare professionals are being reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends the patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
