Artiss Duploject

Fibrin sealant is made of two substances from human plasma that work together to help your blood clot.

Fibrin sealant topical is used to help control bleeding during surgery when other ways to close a wound or incision (such as stitches, bands, or heat) cannot be used. Fibrin sealant topical may also be used to prevent leaks from a wound left in stomach tissue after a colostomy is removed.

Fibrin sealant topical is sometimes used to help skin tissues stick together during skin graft procedures or cosmetic surgery.

Fibrin sealant topical may also be used for purposes not listed in this medication guide.

Because you will receive fibrin sealant topical in a clinical setting, you are not likely to miss a dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, warmth, redness, numbness, tingly feeling; nausea, vomiting, feeling light-headed, fast or slow heartbeats; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Fibrin sealant is sometimes applied with a spray device that uses gas pressure. High pressure may cause the release of air or gas under the skin tissues, where it can then travel throughout the body. This may be more likely when high pressure settings are improperly used by a healthcare provider during the spray application of fibrin sealant. Air or gas trapped within the body can cause serious or life-threatening effects. Talk with your doctor about this risk.

Tell your caregivers at once if you have:

• chest pain, cough, trouble breathing, gasping for breath;

• confusion, agitation, panic, extreme fear;

• sudden numbness or weakness (especially on one side of the body);

• sudden severe headache, slurred speech, problems with vision or balance;

• blue-colored appearance of your skin or lips;

• nausea, dizziness or spinning sensation;

• a light-headed feeling, like you might pass out; or

• redness, itching, irritation, or slow healing of the skin wound or treated area;

Common side effects may include:

• itching; or

• swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.