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Frequently asked questions for: Hyaluronidase in FertiCult™ Flushing medium

FAQ1: Which source are you using for the hyaluronidase ?
We are using pharmaceutical grade hyaluronidase that is sourced from bovine material.

FAQ2: What about the TSE/BSE threat in using materials from bovine sources ? Should we take extra precautions ?
FertiPro is following the guidelines mentionned in the European Directive 2004/C 24/3: "Note for the guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev 2 - October 2003) adopted by the Committee for Proprietary Medicinal Products (CPMP) and by the Committee for Veterinary Medicinal products (CVMP)".
The annex to this directive contains a list of tissues and their relative infectivity threat (based on WHO guidelines). Testis tissue (the source of our hyaluronidase) is listed in Category C: Tissue with no detected infectivity. This means that, as far as we know at this time, the hyaluroindase is not capable of transmitting the prion and our product is completely safe for use.
Our source hyaluronidase is pharmaceutical grade and comes with a veterinary health certificate.


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