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Hemostasis News

Raplixa Approved to Control Surgical Bleeding

Posted 10 May 2015 by

FRIDAY, May 1, 2015 – Raplixa (human fibrin sealant) has been approved by the U.S. Food and Drug Administration to help control bleeding during surgery, the agency said in a news release. Raplixa's use is sanctioned when standard surgical techniques – including sutures – are "ineffective or impractical," the FDA said. The spray-dried product is dissolved in the blood and triggers a reaction that promotes clotting to help stop bleeding. The product contains fibrinogen and thrombin, two proteins derived from human plasma. Its manufacturing process includes purification designed to render blood-borne viruses inactive, the agency said. Raplixa, designed to be used with an absorbable gelatin sponge, was clinically evaluated among more than 700 people over 11 months. The most common side effects included surgical pain, nausea, constipation, fever and lower blood pressure. The product is ... Read more

Related support groups: Hemostasis, Raplixa

FDA Approves Raplixa (fibrin sealant [human]) to Control Bleeding During Surgery

Posted 30 Apr 2015 by

April 30, 2015 – The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. Raplixa contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the ... Read more

Related support groups: Bleeding, Surgery, Hemostasis, Fibrin Sealant (Human, Raplixa

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thrombin, Artiss, Thrombi-Gel, Surgiflo, TachoSil, Evicel, Tisseel, Gelfoam Plus, Floseal Hemostatic Matrix, view more... fibrin sealant (human, Recothrom, Evithrom, Thrombin-JMI, Thrombostat, Thrombogen, Thrombinar, fibrinogen / thrombin, Thrombi-Pad