Tisseel (Topical application)

Aprotinin, calcium chloride, fibrinogen, and thrombin combination is used to help control bleeding during surgery when other methods to close a wound or incision, like stitches, bands, and heat cannot be used. It is also used to help skin tissues stick together during skin graft or cosmetic surgery (for example, burn treatment or facelift procedures). This medicine is a fibrin sealant.

Artiss™ and Tisseel™ contain man-made proteins (aprotinin, fibrinogen, and thrombin) that are used to stop bleeding by helping the blood to clot.

This medicine is to be given only by or under the supervision of your doctor.

It is very important that your doctor checks you or your child closely while you are receiving this medicine to ensure it is working properly.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

So far, studies have not shown any specific problems in children that would limit the use of Artiss™ and Tisseel™.

Geriatric

There have not been any studies on how age affects the use of Artiss™ in older adults. However, no specific problems for older adults have been reported so far.

Studies have also not shown any specific problems for older adults that would limit the use of Tisseel™.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the possible risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or non-prescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain kinds of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Less common

• Collection of blood or fluids under the skin
• deep, dark purple bruise
• itching, pain, redness, or swelling of the skin, wound, or treated area

Incidence not known

• Blurred vision
• chest pain, discomfort, or tightness
• confusion
• cough
• difficulty breathing
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, slow, pounding, or irregular heartbeat or pulse
• flushing, redness of the skin
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness, dizziness, or fainting
• numbness or tingling in the face, arms, or legs
• pain in the chest, groin, or legs, especially the calves
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe, sudden headache
• shortness of breath
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sweating
• trouble healing
• trouble speaking or walking
• unusual tiredness or weakness
• unusually warm skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Artiss
• Tisseel

Available Dosage Forms:

• Solution

A doctor or other trained health professional will give you this medicine. This medicine is applied only to your skin or incision during surgery. It may be used with a spray applicator.

This medicine should not be given as an injection.