Horse tendons for production of Collagen Sponge are collected from slaughterhouses. ---(b)(4)-- (horse–(b)(4)) slaughterhouses are certified by authorities of the European Union. -----(b)(4)---- slaughterhouses possess an approval of the EU veterinary authorities and are listed on the FSIS (USDA) list as certified facilities. All slaughterhouses are regularly inspected and approved by the national veterinary authorities and are audited by Nycomed. Each batch of horse tendons supplied to Nycomed is accompanied by a veterinary certificate and by a QA certificate issued by a quality responsible person at the slaughterhouse.
Transmissible Spongiform Encephalopathy
TachoSil has an acceptable safety profile with regard to prions. TachoSil does not contain any bovine ingredients. According to current knowledge, horses do not develop prion disease. Measures to avoid cross contamination of the equine tendons are in place at the slaughterhouses. For the Active Substances - Human Fibrinogen and Human Thrombin - strict plasma donor selection criteria are employed by the manufacturer.........Full FDA document with IFU available below.....
