The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the human fibrinogen/human thrombin product VeraSeal (Instituto Grifols SA) for use as a sealant during surgical procedures in adult patients.
VeraSeal will be available as solutions containing 80 mg/mL human fibrinogen and 500 IU/mL human thrombin. When the two active substances are mixed together, thrombin cuts fibrinogen into smaller fibrin units. The fibrin then aggregates and forms a fibrin clot that helps the wound to heal, preventing bleeding, the EMA explains in a statement.
VeraSeal is intended as supportive treatment for the improvement of hemostasis in surgery in which standard surgical techniques are insufficient and as suture support for hemostasis in vascular surgery.
The most common side effects are procedural pain, nausea, pruritus, and pyrexia. The CHMP recommends that use of VeraSeal be restricted to experienced surgeons who have been trained in the use of the product.
Detailed recommendations for the use of VeraSeal will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.
For more news, join us on Facebook and Twitter
Tidak ada komentar:
Posting Komentar