Package leaflet: Information for the patient

TRASYLOL
(Aprotininum)
277.8 Ph. Eur. units (500,000 KIU), solution for infusion
Please read all of this leaflet carefully before receiving this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor/surgeon.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Contents of the leaflet:

What Trasylol is and what it is used for
Important information before receiving Trasylol
How to use Trasylol
Possible side effects
How to store Trasylol
Contents of the pack and other information

1. What Trasylol is and what it is used for

Trasylol contains the active substance aprotinin. Trasylol belongs to a group of medicines called antifibrinolytics, i.e. medicines used to prevent blood loss.
Trasylol may help reduce blood loss during and after heart surgery. It may also be used to reduce the need for blood transfusions during and after heart surgery. Your doctor/surgeon will decide whether you may benefit from treatment with Trasylol if you are at increased risk of significant blood loss and are undergoing coronary artery bypass grafting using cardiopulmonary bypass (heart-lung machine).
Your doctor will administer aprotinin after carefully considering the benefits and risks, as well as the availability of alternative treatment options.

2. Important information before receiving Trasylol

When Trasylol must not be used

if the patient is allergic to aprotinin or to any of the other ingredients of this medicine (listed in section 6).
if the patient has had a positive test for specific aprotinin IgG antibodies, indicating an increased risk of an allergic reaction to Trasylol.
when it is not possible to perform a test for specific aprotinin IgG antibodies before starting treatment, and there is suspicion that the patient has been exposed to Trasylol within the past 12 months.

Warnings and precautions
Before receiving Trasylol, consult a doctor.
Tell the doctor if any of the following apply to the patient, to help the doctor
decide whether Trasylol is suitable:

if the patient’s kidneys are not functioning properly. If the patient has kidney problems, Trasylol should be used only if the doctor/surgeon considers it beneficial for the patient.
if the patient has received or suspects having received aprotinin or tissue adhesives containing aprotinin within the past 12 months.

If any of the above conditions apply to the patient, the doctor will decide whether Trasylol is
appropriate or not.
Trasylol will be administered only if the doctor first performs blood tests to confirm
that the patient can safely receive the medicine (e.g. an appropriate test for specific aprotinin IgG antibodies). Otherwise, alternative treatments may be more suitable for the patient.
The patient will be closely monitored for possible allergic reactions to the medicine, and the doctor/surgeon
will treat any symptoms that may occur. During treatment with Trasylol, emergency treatment must be readily available in case the patient experiences severe allergic reactions.

Children and adolescents
The safety and efficacy of Trasylol in children under 18 years of age have not been established.

Trasylol and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

medicines used to dissolve blood clots, such as streptokinase, urokinase, alteplase (r-tPA)
aminoglycosides (antibiotics used to treat infections)

It is recommended that the doctor/surgeon administer heparin (a medicine used to prevent blood clots) in addition to Trasylol, before and during surgery. The doctor will determine the heparin dose based on blood test results.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. Trasylol should be used during pregnancy or breastfeeding only if the doctor/surgeon considers it beneficial for the patient. The doctor will discuss the potential risks and benefits associated with using this medicine.

3. How to use Trasylol

The recommended dosage regimen for adult patients is as follows:
A small amount of Trasylol (1 ml) will be given before the start of surgery to determine whether the patient is allergic to Trasylol. Medications used to prevent allergic reactions (H\ and H\ antagonists) may be administered 15 minutes prior to the test dose of Trasylol.
If no allergic reactions occur, the patient will receive 100–200 ml of Trasylol over 20 to 30 minutes, followed by 25–50 ml per hour (max. 5–10 ml/min) until the end of surgery.
Typically, no more than 700 ml of Trasylol should be administered at any one time.
There are no specific dosage recommendations for elderly patients or patients with impaired renal function.
Trasylol is usually administered to patients lying down, as a slow intravenous injection or infusion (via intravenous drip) through a central venous catheter.
Administration of a higher than recommended dose of Trasylol
There is no specific agent available to counteract the effects of Trasylol.
If you have any further questions about the use of this medicine, please consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Although allergic reactions are rare in patients receiving Trasylol for the first time,
patients who are given Trasylol more than once may have a higher likelihood of
experiencing an allergic reaction. Symptoms of an allergic reaction may include:

difficulty breathing
low blood pressure
itching, rash, and hives
nausea

If any of these symptoms occur during administration of Trasylol, the doctor/surgeon will discontinue
treatment with this medicine.
Other side effects include:
Common: may occur in less than 1 in 10 patients

abnormal kidney function test results (increased creatinine levels)

Uncommon: may occur in less than 1 in 100 patients

chest pain [ myocardial ischaemia, blockage (thrombosis) of the coronary artery ], heart attack ( myocardial infarction )
accumulation of fluid around the heart ( pericardial effusion )
blood clot ( thrombosis )
reduced or interrupted blood flow to the brain ( stroke )
kidney disease ( acute kidney injury, renal tubular necrosis )
passing less urine than usual
severe allergic reaction ( anaphylactic or pseudoanaphylactic reaction )

Rare: may occur in less than 1 in 1,000 patients

blood clot in blood vessels ( arteries )
blood clot in the lungs ( pulmonary embolism )

Very rare: may occur in less than 1 in 10,000 patients

swelling at or around the injection site on the skin (reactions at infusion site), thrombophlebitis (infusion site )
severe blood clotting disorder leading to tissue damage and bleeding ( disseminated intravascular coagulation )
inability of the blood to clot properly ( coagulopathy )
severe life-threatening allergic shock ( anaphylactic shock )

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions,
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Trasylol

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Trasylol contains
50 ml of infusion solution contains:

The active substance is a concentrated solution of aprotinin with an activity of 277.8 Ph. Eur. units, equivalent to 500,000 KIU (kallikrein inactivating units).
Other components are: sodium chloride, water for injections.

What Trasylol looks like and contents of the pack
Trasylol is a clear, colourless infusion solution.
The pack contains 1 colourless glass bottle containing 50 ml of solution, closed with a siliconized chlorobutyl rubber stopper, sealed with an aluminium cap and a flip-off plastic seal, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Nordic Group B.V.
Siriusdreef 41
2132 WT Hoofddorp
The Netherlands
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
Manufacturer
Apotek Produktion & Laboratorier AB (APL)
Formvägen 5B
906 21 Umeå
Sweden
For further information, please contact the local representative of the Marketing Authorisation Holder:
AMRING FARMA SRL
Tel.: +40 31 620 1204
[email protected]