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APROTININ 10 000 KIU/ML INJECTION BP

Active substance(s): APROTININ

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NORDIC Aprotinin 10,000 KIU/ml Injection BP PIL V2
Created by VICTOR DESIGN - 09.04.14
Now Version 2- created 11.05.14
Size: Overall trim size 160 x 365 mm (includes perforation ‘tear off’)
Font: Minimum size 8pt (VAG Rounded Light & Bold) Minimum Line spacing 3.4mm

2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aprotinin 10,000 KIU/ml Injection BP
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 Aprotinin 10,000 KIU/ml
Injection (called Aprotinin Injection in the rest of this leaflet)
• 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 Aprotinin Injection is and what it is used for
2. What you need to know before you are given Aprotinin Injection
3. How to use Aprotinin Injection
4. Possible side effects
5. How to store Aprotinin Injection
6. Contents of the pack and other information

1. What Aprotinin Injection is and what it is used for
Aprotinin Injection belongs to a group of medicines called
anti-fibrinolytics, i.e. medicines to prevent blood loss.
Aprotinin Injection 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 Aprotinin Injection
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 aprotinin after careful
consideration of the benefits and risks, and the
availability of alternative treatments.

2 What you need to know before you are given
Aprotinin Injection
You must not be given Aprotinin Injection
• if you are allergic to Aprotinin Injection 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 Aprotinin Injection
• if no aprotinin specific IgG antibody test is possible
prior to treatment and you have received or you
suspect that you have received an Aprotinin-containing
medicinal product in the last 12 months.
Warnings and precautions
Talk to your doctor before receiving Aprotinin Injection.
Tell your doctor if any of these apply to you, to help him
or her decide if Aprotinin Injection is suitable for you:
• Your kidneys do not work properly. If you have kidney
problems Aprotinin Injection 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.

Aprotinin Injection 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 Aprotinin Injection
Children and adolescents
The safety and efficacy of Aprotinin Injection in children
below the age of 18 years have not been established.
Other medicines and Aprotinin Injection
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 Aprotinin Injection 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 Aprotinin Injection
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.

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

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Name of the Medicinal Product
Aprotinin 10,000 KIU/ml Injection BP
Qualitative and Quantitative Composition
Each 50ml vial contains aprotinin solution corresponding
to 500,000 Kallikrein Inactivator Units, KIU (= 277.8
European Pharmacopoeia, E.P. units) aprotinin in 0.9%
sodium chloride solution.
Pharmaceutical Form
Solution for Injection
Posology and Method of Administration
An appropriate aprotinin-specific IgG antibody test may
be considered before administration of aprotinin
(see section 4.3 of the Summary of Product Characteristics).

Owing to the risk of allergic/anaphylactic reactions, a 1 ml
(10,000 KIU) test dose should be administered to all patients
at least 10 minutes prior to the remainder of the dose. After
the uneventful administration of the 1 ml test dose, the
therapeutic dose may be given. A H1 antagonist and a H2
antagonist may be administered 15 minutes prior to the test
dose of aprotinin. In any case standard emergency treatments
for anaphylactic and allergic reactions should be readily available
(see section 4.4 of the Summary of Product Characteristics).
A loading dose of 1 - 2 million KIU is administered as a
slow intravenous injection or infusion over 20 - 30 minutes
after induction of anaesthesia and prior to sternotomy. A
further 1 - 2 million KIU should be added to the pump
prime of the heart-lung machine. To avoid physical
incompatibility of aprotinin and heparin when adding to
the pump prime solution, each agent must be added
during recirculation of the pump prime to assure
adequate dilution prior to admixture with the other
component.

3. How to use Aprotinin Injection
For adult patients the following dose regimen is
recommended:
You will receive a small amount of Aprotinin Injection
(1 ml) before the operation begins, to test if you are
allergic to the Aprotinin Injection. Medicines used to
prevent the symptoms of allergy (H1 antagonist and a H2
antagonist) may be administered 15 minutes prior to the
test dose of Aprotinin Injection
If there are no signs of allergy, you will be given 100-200 ml
Aprotinin Injection 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
Aprotinin Injection at any one time.
There is no special dose recommendation for elderly
patients or patients with poor kidney function
Aprotinin Injection 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 Aprotinin Injection than the
recommended dose
There is no specific substance to counteract the effects of
Aprotinin Injection

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
an Aprotinin-containing medicinal product for the first
time, patients who are given Aprotinin Injection 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 Aprotinin
Injection 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
Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any side effects not listed in this leaflet.
You can also report side effects directly via the national
reporting system in UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine

5. How to store Aprotinin Injection
Aprotinin Injection should be stored at room temperature
not exceeding 25°C, protected from light. Do NOT use
Aprotinin Injection if it is past the expiry date on the
packaging.
Keep out of the reach and sight of children.

6. Contents of the pack and other information
What Aprotinin Injection contains
Aprotinin Injection contains the active ingredient aprotinin
in water for injection.
One 50ml vial contains 500,000 Kallikrein Inactivator
Units (equal to 277.8 E.P. Units) of aprotinin.
Aprotinin Injection also contains the inactive ingredient
sodium chloride.
What Aprotinin Injection looks like and contents of the
pack
Aprotinin Injection is a sterile, clear colourless solution. It
is supplied in single glass vials of 50ml.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is
Nordic Pharma Ltd.,
Abbey House,
1650 Arlington Business Park,
Theale, Reading, RG7 4SA. (UK).
The manufacturer is
Fresenius Kabi Austria GmbH (FKA),
Hafnerstrasse 36,
A-8055 Graz, Austria.
This leaflet was last revised in 04/2014 (April 2014)

In general, the total amount of aprotinin administered per
treatment course should not exceed 7 million KIU.
Method of administration
Aprotinin should be infused using a central venous
catheter. The same lumen should not be used for the
administration of any other medicinal product.
When using a multi-lumen central catheter a separate
catheter is not required.
Aprotinin must be given only to patients in the supine
position and must be given slowly (maximum 5 - 10
ml/min) as an intravenous injection or a short infusion.

Incompatibilities
Aprotinin is incompatible with antibiotics such as
tetracyclines which react with proteins, corticosteroids,
heparin and nutrient solutions containing amino acids or
fat emulsions. The addition of aprotinin to mixed infusions
(particularly with beta-lactam antibiotics) should be
avoided. Electrolyte and sugar solutions are compatible
with aprotinin.
Shelf Life
3 years
Special Precautions for Storage
Store at room temperature (not more than 25°C); protect
from light.
Special precautions for disposal and other handling
Parenteral drug products should be inspected visually for
particulate matter and colour change prior to administration.
Any residual solution should not be kept for later use.
Any unused medicinal product or waste material should
be disposed of in accordance with local requirements.

00000000.000

The initial bolus infusion is followed by the administration
of a continuous infusion of 250,000 - 500,000 KIU per hour
until the end of the operation.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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