Description
Thrombin, bovine topical solution is used to help control minor bleeding during surgery.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of thrombin, bovine topical solution in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of thrombin, bovine topical solution in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Active bleeding, severe or
- Bovine thrombin or factor V antibodies, known or suspected—Should not be used in patients with these conditions.
- Bleeding problems or
- Blood clotting problems—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is applied only to your skin or incision during surgery. This medicine should not be given as an injection.
Precautions
It is very important that your doctor check your progress closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue. or unusual tiredness or weakness.
Check with your doctor right away if you have tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area. These may be symptoms of blood clotting problems.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Cough or hoarseness
- difficulty breathing
- fast heartbeat
- fever or chills
- hives, itching, skin rash
- irritation
- joint pain, stiffness, or swelling
- lower back or side pain
- pain in the chest, groin, or legs, especially the calves
- painful or difficult urination
- redness of the skin
- severe, sudden headache
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in arm or leg
- swelling of the eyelids, face, lips, hands, or feet
- vision changes
Less common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- pale skin
- pinpoint red spots on the skin
- red, tender, or oozing skin at the incision
- sweating
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Bruising
- collection of blood under the skin
- coughing or vomiting blood
- chest tightness
- deep, dark purple bruise
- difficulty swallowing
- itching, pain, redness, or swelling
- persistent bleeding or oozing from puncture sites, mouth, or nose
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
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. Also, your health care professional may 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 or are bothersome or if you have any questions about them:
More common
- Constipation
- muscle spasms
- nausea
- trouble sleeping
- vomiting
Incidence not known
- Swelling
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.
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