site or in conjunction with an absorbable gelatin sponge, USP.
It can be stored at room temperature and is convenient for lengthy surgeries; it is stable at room temperature up to 24 hours after reconstitution.
The following package configurations are available:
■5,000 Unit RECOTHROM Kit (NDC 28400-105-41)
■20,000 Unit RECOTHROM Kit (NDC 28400-120-41)
■20,000 Unit RECOTHROM with Spray Device Kit (NDC 28400-120-50)
Important safety information includes:
■RECOTHROM® Thrombin, topical (Recombinant) from ZymoGenetics is for topical use only and should not be injected directly into the circulatory system.
■RECOTHROM should not be used for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.
■There is a potential risk of blood clots if the product is absorbed into the circulatory system.
In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction. The serious adverse event that occurred in ≥1% (n=6/583) of patients exposed to RECOTHROM in completed clinical trials was atrial fibrillation. The most common adverse events reported in these trials (N=583) were incision site pain (51%), procedural pain (30%), and nausea (28%). Adverse events reported in these trials were consistent with those commonly observed in surgical patients. |
