Human Fibrinogen + Human Thrombin + Aprotinin (Fibrin Sealant) topical

Indications

Human Fibrinogen + Human Thrombin + Aprotinin (Fibrin Sealant) topical is used for: Indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. Indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies.

Adult Dose

Adjunct to Hemostasis & Sealing Adult If maximum area to be sealsed is 8 cm² via cannula or 100 cm² using spray, use 2 mL If maximum area to be sealed is 16 cm² via cannula or 200 cm² using spray, use 4 mL If maximum area to be sealed 40 cm² via cannula or 500 cm² using spray, use 10 mL Apply as a thin layer by dripping or spraying using cannula or spray set Ensure that the amount to be applied is sufficient to entirely cover the intended application area

Child Dose

Adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies <1 month: Safety and efficacy not established >1 month If maximum area to be sealed is 8 cm² via cannula or 100 cm² using spray;, use 2 mL If maximum area to be sealed is 16 cm² via cannula or 200 cm² using spray, use 4 mL If maximum area to be sealed 40 cm² via cannula or 500 cm² using spray, use 10 mL

Renal Dose

Administration

Apply as a thin layer by dripping or spraying using a cannula or spray set. The treating physician will determine the amount to be applied based on the surface to be covered. Ensure that the amount applied is sufficient to entirely cover the intended application area. Avoid application beyond the intended area. Allow at least 2 minutes after application to achieve sufficient polymerization. If repeat application is needed, dry the site as much as possible before reapplying.

Contra Indications

Hypersensitivity

Precautions

For Topical Use Only. Do not inject directly into the circulatory system or into highly vascularized tissue. Intravascular application of can lead to intravascular coagulation, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients.

Pregnancy-Lactation

Interactions

Oxidized cellulose-containing preparations can reduce the efficacy.

Adverse Effects

Side effects of Human Fibrinogen + Human Thrombin + Aprotinin (Fibrin Sealant) topical : Hypersensitivity or allergic/anaphylactoid reactions have occurred. In isolated cases, these reactions have progressed to severe anaphylaxis.

Mechanism of Action

Upon mixing Sealer Protein (Human) and Thrombin (Human), soluble fibrinogen is transformed into fibrin, forming a rubber-like mass that adheres to the wound surface and achieves hemostasis and sealing or gluing of tissues. It mimics the final coagulation cascade step as it has all relevant components to form a clot. ItL is effective in heparinized patients and in patients medicated with anti-platelet drugs.