Fibrinogen/aprotinin and thrombin/calcium chloride (Topical application)

Aprotinin, calcium chloride, fibrinogen, and thrombin combination is used to help stop 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 grafts or cosmetic surgeries (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 receiving this medicine to ensure it is working properly.

This medicine may cause a severe allergic reaction, including anaphylaxis, which can be life-threatening and needs immediate medical help. Tell your doctor right away if you experience 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 passed on certain viruses to people who received them, although the risk is low. Both human donors and donated blood are tested for viruses to keep the transmission risk low. Discuss this risk with your doctor if you are concerned.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following points in mind:

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 about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any specific problems in children that would limit the usefulness of Artiss™ and Tisseel™.

Geriatric

Studies on how age affects the effects of Artiss™ have not been conducted in older adults. However, there have been no documented geriatric-specific problems so far.

Studies have not shown any geriatric-specific problems that would limit the usefulness of Tisseel™ in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or eating specific types of food due to possible interactions. Consuming 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 intended effects, a medicine may cause some unwanted effects. Not everyone will experience these side effects, but if they do occur, you may need medical attention.

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

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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue or 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 happen 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.