ABOUT RECOTHROM
RECOTHROM, Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.
Important Risk Information
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Contraindications: Do not inject directly into the circulatory system. Do not use for the treatment of massive or brisk arterial bleeding. Do not administer to patients with a history of hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.
Warnings and precautions: RECOTHROM may cause thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT. Hypersensitivity reactions, including anaphylaxis, may occur.
The most common adverse reaction (incidence 6%) was thromboembolic events. Antibody formation to RECOTHROM occurred in < 1% of patients. None of the antibodies detected neutralized native human thrombin.
Full prescribing information is available here.
ABOUT PREVELEAK
PreveLeak Surgical Sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Important Risk Information
Contraindications: PreveLeak is not for use in patients with known allergies to materials of bovine or shellfish origin. PreveLeak is not for intravascular use. PreveLeak is not for cerebrovascular repair or cerebrospinal leak repair.
Warnings: Do not use PreveLeak as a substitute for sutures or staples. Avoid exposure of PreveLeak to nerves. Do not use PreveLeak in the presence of obvious infection and use it with caution in contaminated areas of the body. Do not allow either the uncured or polymerized form of PreveLeak to contact circulating blood. PreveLeak contains a material of animal origin that may be capable of transmitting infectious agents. Repeated use of PreveLeak in subsequent surgeries has not been studied. Hypersensitivity reactions were not seen using PreveLeak, but hypersensitivity of bovine serum albumin has been reported.
Full instructions for use are available here.
ABOUT RAPLIXA
RAPLIXA is a fibrin sealant (human) indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP) and is applied directly or using the RAPLIXASpray device.
