What Trasylol is and what it is used for
Trasylol belongs to a group of drugs called fibrinolysis inhibitors, i.e. drugs that prevent blood loss.
Trasylol can help reduce the blood loss you have during and after heart surgery. It is also used to reduce the need for blood transfusion during and after heart surgery. The doctor/surgeon has decided that you would benefit from treatment with Trasylol because you run an increased risk of major blood loss, as you will undergo a bypass operation with blood circulation outside the body (heart-lung machine).
What you need to know before you receive Trasylol
You should not receive Trasylol
- if you are allergic to Trasylol or any of the other ingredients of this medicine (listed in section 6).
- if there is a positive aprotinin-specific IgG antibody test, which shows an increased risk of an allergic reaction to Trasylol.
- if it is not possible to carry out an aprotinin-specific IgG antibody test before treatment and you have been treated, or suspect you have been treated, with Trasylol in the last 12 months.
Warnings and precautions
Talk to your doctor before receiving Trasylol.
Talk to your doctor if any of the following apply to you, to help him/her decide if Trasylol is suitable for you:
- Your kidneys are not working normally. If you have kidney problems, Trasylol should only be used if the doctor/surgeon considers it beneficial.
- You have been treated, or suspect you have been treated, with aprotinin or aprotinin-containing fibrin glue in the last 12 months.
If any of these apply to you, your doctor will decide whether or not Trasylol is suitable for you.
Trasylol will only be given if your doctor has previously carried out blood tests to check if the treatment is appropriate (eg an appropriate aprotinin-specific IgG antibody test). Otherwise, other treatments may be a better option for you.
You will be closely monitored for allergic reactions to the medicine and the doctor/surgeon will treat any symptoms you may experience. Standard equipment for emergency treatment of severe allergic reactions must be available during treatment with Trasylol.
Children and young people
Other medicines and Trasylol
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, you should tell the doctor if you are taking:
- medicines used to dissolve blood clots, such as streptokinase, urokinase, alteplase (r-tPA)
- aminoglycosides ( antibiotics, medicines used to treat infections ).
It is recommended that the doctor/surgeon, in addition to Trasylol, give heparin (a medicine used to prevent blood clots) before and after surgery. Your doctor will determine the heparin dose based on blood test results.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. If you are pregnant or breastfeeding, Trasylol should only be used if the doctor/surgeon considers it beneficial. The doctor will discuss the risks and benefits of using this medicine with you.
How to use Trasylol
For adult patients, the following dosage is recommended:
Before the operation, you will be given a small amount of Trasylol (1 ml) to test if you are allergic to Trasylol. Medicines that prevent allergy symptoms (H 1 – antagonists or H 2 – antagonists ) can be given 15 minutes before the test dose with Trasylol.
If there are no signs of allergy, you will receive 100-200 ml of Trasylol over 20-30 minutes, followed by 25-50 ml per hour (maximum 5-10 ml/min) for the rest of the operation.
Usually, you will not receive more than 700 ml of Trasylol at one time.
There are no specific dosage recommendations for elderly patients or patients with impaired renal function.
Trasylol is usually given while you are lying down, by slow injection or infusion (by “drip”) through a catheter into a blood vessel in your body.
If you receive more Trasylol than the recommended dose
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Although allergic reactions are rare in patients treated with Trasylol for the first time, patients who receive Trasylol more than once are at an increased risk of an allergic reaction. The symptoms of an allergic reaction may include:
If any of these happen to you while receiving Trasylol, the doctor/surgeon will stop treatment with the medicine.
Other side effects are:
Uncommon: may affect up to 1 in 100 patients
- chest pain ( myocardial ischemia, coronary occlusion/thrombosis ), heart attack ( myocardial infarction )
- leakage of the heart’s fluid into surrounding body cavities ( pericardial effusion )
- blood clots ( thrombosis )
- kidney disease ( acute renal failure, renal tubular necrosis )
- decreased urine output
Rare: may affect up to 1 in 1,000 patients
- blood clots in blood vessels ( arteries )
- severe allergic reaction ( anaphylactic/anaphylactoid reaction )
Very rare: may affect up to 1 in 10,000 patients
- swelling at or around the injection site (injection/infusion site reactions, ( thrombo- ) phlebitis at the infusion site)
- blood clots in the lungs ( pulmonary embolism )
- severe blood clotting disorder that can result in tissue damage and bleeding ( disseminated intravascular coagulation )
- the inability of the blood to clot normally ( coagulopathy )
- severe allergic shock ( anaphylactic shock ), which can be life-threatening
If you experience side effects, talk to your doctor. This also applies to any side effects that are not mentioned in this information.
How Trasylol should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 ºC. Store in the original packaging. Light sensitive.
Use before the expiry date whated on the carton after Utg.dat/EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is aprotinin 10,000 KIE/ml.
- Other ingredients are sodium chloride and water for injections.
Appearance and package sizes of the medicine
Solution for injection/infusion.
The solution is clear and colorless.
Marketing Authorisation Holder
Nordic Group BV
2132 WT Hoofddorp
Nordic Drugs AB
Box 300 35
200 61 Limhamn
Fresenius Kabi Austria GmbH