Evicel Fibrin Sealant

Generic name: fibrinogen human and thrombin human
Dosage form: topical kit
Drug class:Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Indications and Usage for Evicel Fibrin Sealant

EVICEL® fibrin sealant (human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Evicel Fibrin Sealant Dosage and Administration

For topical use only. Do not inject.

Thawing

Thaw the two components of EVICEL® (BAC2 and Thrombin) in one of the following ways:

• 2°C to 8°C (refrigerator): vials thaw within 1 day; or
• 20°C to 25°C (room temperature): vials thaw within 1 hour; or
• 37°C (warm water bath): vials thaw within 10 minutes and must not be left at this temperature for longer than 10 minutes. The temperature must not exceed 37°C.

Preparation Prior to Application

Once thawed, use the components of EVICEL® (BAC2 and Thrombin) within 30 days if refrigerated or within 24 hours if stored at room temperature.

Do not use after the expiration date stated on the box, or after 30 days if refrigerated after thawing. Do not re-freeze EVICEL® once it has been thawed. Do not refrigerate EVICEL® after storage at room temperature. Discard unused product after 24 hours at room temperature.

Discard if the packaging of EVICEL® is damaged.

While maintaining a sterile surgical field, prepare the product assembly as follows:

• Draw the BAC2 and Thrombin into the application device (see diagram enclosed in the application device package).
• Fill both syringes of the application device with equal volumes. The solutions should not contain air bubbles.
• Carefully remove the vial a...