Human fibrinogen

VISTASEAL, a fibrin sealant (human), is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients. VISTASEAL™, a fibrin sealant, is indicated as an adjunct to hemostasis for mild to moderate bleeding in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

VISTASEAL contains human fibrinogen and human thrombin. When applied onto the wound site and mixed, these biological components generate a cross-linked fibrin clot in a process that recreates the last stage of the human blood coagulation system. Fibrinogen is converted into fibrin monomers and fibrinopeptides by thrombin. The fibrin monomers aggregate and form a fibrin clot which stops the bleeding. Factor XIIIa, which is activated from factor XIII by thrombin, crosslinks fibrin. Calcium ions are required for both the conversion of fibrinogen and the crosslinking of fibrin.

For topical use only. For topical use only. The recommended dose of VISTASEAL is based on the surface area coverage as described in Section Table 1. After thawing, use VISTASEAL within 7 days if stored at 2 ºC - 8 ºC [36 ºF - 46 ºF], or within 24 hours if stored at room temperature (20 °C ‑ 25 °C [68 ºF - 77 ºF]), if it remains sealed in the original packaging. Prior to applying VISTASEAL, use standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) to dry the surface area of the target bleeding site. Apply VISTASEAL by dripping or spraying. When applying VISTASEAL using a spray device, ensure that the distance from the tissue is within the recommended ranges for the applicator tip used. Apply a sufficient volume of VISTASEAL to entirely cover the intended application area with a thin layer.

Do not inject directly into the circulatory system. Do not use for the treatment of severe or brisk arterial bleeding. In these situations, blood flow will wash away VISTASEAL and prevent hemostasis. Do not use VISTASEAL in patients known to have anaphylactic or severe systemic hypersensitivity reactions to the administration of human blood products. Do not use VISTASEAL for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved. Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.

Thromboembolic events may occur if VISTASEAL is administered intravascularly. Hypersensitivity reactions can occur. May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reactions (reported in >1% of patients) were procedural pain, and nausea. or http://www.fda.gov/medwatch.

Storage Store the frozen kit (VISTASEAL fibrin sealant (human) with VISTASEAL Dual Applicator) in a freezer (at -18 °C [0 ºF] or colder) for up to 2 years. After thawing, VISTASEAL can be stored before use for not more than 7 days at 2 - 8 °C [36 - 46 °F] or 24 hours at room temperature (20 - 25 °C [68 - 77 °F]) if it remains sealed in the original packaging (blister). The cold storage condition must not be interrupted until use. Keep the sterilized blister in the outer carton to protect from light.