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

Tisseel Valupak Kit 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. This medicine may also be used to prevent leaks from a wound left in stomach tissue after a colostomy is removed.

Tisseel Valupak Kit is sometimes used to help skin tissues stick together during skin graft procedures or cosmetic surgery.

Tisseel Valupak Kit may also be used for purposes not listed in this medication guide.

You should not be treated with Tisseel Valupak Kit if you are allergic to cows or products made from cows.

Tisseel Valupak Kit can be sprayed or dripped onto the affected skin or surgical area. Tisseel Valupak Kit is applied by a healthcare professional in a surgical or clinical setting.

Tisseel Valupak Kit is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some people develop symptoms of a viral infection after being treated with Tisseel Valupak Kit. Call your doctor if you have flu-like symptoms such as fever, chills, drowsiness, or a runny nose. You may also have joint pain and a skin rash about 2 weeks after the start of your flu symptoms.

You should not be treated with Tisseel Valupak Kit if you are allergic to cows or products made from cows.

It is not known whether Tisseel Valupak Kit will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether fibrin sealant topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Because you will receive Tisseel Valupak Kit in a clinical setting, you are not likely to miss a dose.

Since Tisseel Valupak Kit is applied by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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 of Tisseel Valupak Kit 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.