RECOTHROM™ Thrombin, Topical (Recombinant)
RECOTHROM™ is the first and only recombinant thrombin approved for use in surgical hemostasis. It was approved by the U.S. Food and Drug Administration (FDA) on January 17th 2008. RECOTHROM™ is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
Important Safety Information: For topical use only - do not inject directly into the ciruculatory system. Potential risk of thrombosis if absorbed systemically. Do not use for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM™, any components of RECOTHROM™ or hamster proteins. No specific adverse events have been established as adverse reactions causally related to RECOTHROM™ administration. In a clinical study comparing RECOTHROM™ to bovine thrombin, adverse events were reported with similar frequency in both treatment groups. The most common event was incision site complication. Limited data (n=6) are available on repeat exposure to RECOTHROM™.
Please see complete U.S. Prescribing Information for RECOTHROM™
For more information about RECOTHROM™, go to: www.RECOTHROM.com
|
Back
to top
