Package leaflet: Information for the patient Trasylol

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask the doctor/surgeon giving you Trasylol.

-    If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Trasylol product is and what it is used for

2.    What you need to know before you are given Trasylol product

3.    How to use Trasylol

4.    Possible side effects

5.    How to store Trasylol

6.    Contents of the pack and other information

1.    What Trasylol is and what it is used for

Trasylol belongs to a group of medicines called anti-fibrinolytics, i.e. medicines to prevent blood loss.

Trasylol can help to reduce the amount of blood loss you have during and after heart surgery. It is also used to reduce the need for a blood transfusion during and after heart surgery. Your doctor/surgeon has decided that you would benefit from Trasylol treatment because you are at increased risk of major blood loss since you will undergo a heart bypass operation using a circulation outside your body (heart-lung machine).

Your doctor will administer Trasylol after careful consideration of the benefits and risks, and the availability of alternative treatments.

2.    What you need to know before you are given Trasylol You must not be given Trasylol

-    if you are allergic to Trasylol or any of the other ingredients of this medicine (listed in section 6).

-    if a positive aprotinin-specific IgG antibody test is available, showing an increased risk of an allergic reaction to Trasylol

-    if no aprotinin specific IgG antibody test is possible prior to treatment and you have received or you suspect that you have received Trasylol in the last 12 months.

Warnings and precautions

Talk to your doctor before receiving Trasylol

Tell your doctor if any of these apply to you, to help him or her decide if Trasylol is suitable for you:

-    Your kidneys do not work properly. If you have kidney problems Trasylol should only be used if your doctor/surgeon feels it will be of benefit.

-    You have or suspect you have received aprotinin or aprotinin containing fibrin sealants in the last 12 months.

If any of these apply to you, your doctor will decide whether Trasylol is suitable for you or not.

Trasylol will only be given if your doctor has done blood tests before to check you are suitable (e.g. an appropriate aprotinin-specific IgG antibody test), otherwise other medicines may be a better option for you.

You will be monitored carefully for any allergic reaction to the medicine and your doctor/surgeon will treat any symptoms you may experience. Standard emergency treatment for severe allergic reactions should be readily available during treatment with Trasylol.

Children and adolescents

The safety and efficacy of Trasylol in children below the age of 18 years have not been established. Other medicines and Trasylol

Tell your doctor if you are taking, have recently taken or might take any other medicines.

You should specifically tell your doctor if you take:

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

-    aminoglycosides (antibiotics, medicines used to treat infections)

It is recommended that your doctor/surgeon should, in addition to Trasylol, administer heparin (a medicine used to prevent blood clots) before and during the operation. Your doctor will evaluate the dose of heparin based from the results from tests of your blood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. If you are pregnant or breast-feeding Trasylol should only be used if your doctor/surgeon finds it will be of benefit. Your doctor will discuss with you the risks and benefits of using this medicine.

3. How to use Trasylol

For adult patients the following dose regimen is recommended:

You will receive a small amount of Trasylol (1 ml) before the operation begins, to test if you are allergic to the Trasylol . Medicines used to prevent the symptoms of allergy (Hi-antagonist and a H₂-antagonist) may be administered 15 minutes prior to the test dose of Trasylol

If there are no signs of allergy, you will be given 100-200 ml Trasylol over 20 to 30 minutes, followed by 25 - 50 ml per hour (max. 5 - 10 ml/min) until the end of the operation.

In general, you will not be given more than 700 ml of Trasylol at any one time.

There is no special dose recommendation for elderly patients or patients with poor kidney function.

Trasylol will usually be given to you lying down by slow injection or infusion (through ‘a drip’) through a catheter into a larger vein in your body.

If you are given more Trasylol than the recommended dose

There is no specific substance to counteract the effects of Trasylol.

4.    Possible side effects

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

Although allergic reactions are rare in patients receiving Trasylol for the first time, patients who are given Trasylol more than once may have an increased chance of an allergic reaction. The symptoms of an allergic reaction may include:

-    breathing difficulties

-    reduced blood pressure

-    itching, rash and hives

-    feeling sick

If any of these occur during administration of Trasylol your doctor/surgeon will stop treatment with the drug.

Other side effects are:

Uncommon: may affect up to 1 in 100 patients

-    chest pain (myocardial ischaemia, coronary occlusion / thrombosis), heart attack (myocardial infarction)

-    leakage of heart fluid into the surrounding body cavity (pericardial effusion)

-    blood clot (thrombosis)

-    kidney disease (acute renal failure, renal tubular necrosis)

-    passing less urine than is normal

Rare: may affect up to 1 in 1,000 patients

-    blood clot in blood vessels    (arteries)

-    severe allergic reaction (anaphylactic /anaphylactoid reaction)

Very rare: may affect up to 1 in 10,000 patients

-    swelling on or around the location of the injected skin (injection and infusion site reactions, infusion site (thrombo-) phlebitis)

-    blood clot in the lungs (pulmonary embolism)

-    severe blood clotting disorder that results in tissue damage and bleeding (disseminated intravascular coagulation)

-    inability of the blood to clot or coagulate normally (coagulopathy)

-    severe allergic shock (anaphylactic shock), which is potentially life threatening

If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet.

5.    How to store Trasylol

Your doctor/surgeon or hospital pharmacist (chemist) will store Trasylol appropriately. They will not store it above 25 ^oC.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Do not use Trasylol after the expiry date which is stated on the label of each vial and on the outer carton.

Medicines must not be disposed of via wastewater or household waste. Any unused Trasylol will be disposed of by the pharmacist. These measures will help to protect the environment.

6. Contents of the pack and other information

What Trasylol contains

Trasylol is a solution, which contains aprotinin. Three pack sizes are available - 50 ml, 100 ml or 200 ml.

•    Each 50 ml glass vial contains 500,000 Kallikrein Inactivator Units, equivalent to 277.8 Ph.Eur. units of aprotinin in 0.9% w/v sodium chloride (salt) solution in Water for Injections.

•    Each 100 ml glass vial contains 1,000,000 Kallikrein Inactivator Units, equivalent to 555.6 Ph.Eur. units of aprotinin in 0.9% w/v sodium chloride (salt) solution in Water for Injections.

•    Each 200 ml glass vial contains 2,000,000 Kallikrein Inactivator Units, equivalent to 1111.2 Ph.Eur. units of aprotinin in 0.9% w/v sodium chloride (salt) solution in Water for Injections.

This leaflet was last revised in September 2013.

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