Patient Leaflet Updated 22-Nov-2024 | Nordic Pharma Limited
Aprotinin 10,000 KIU/ml Injection BP
Aprotinin 10,000 KIU/ml Injection BP
Aprotinin
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
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.
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:
If any of these apply to you, your doctor will decide whether Aprotinin Injection is suitable for you or not.
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
The safety and efficacy of Aprotinin Injection in children below the age of 18 years have not been established.
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:
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 on the results from tests of your blood.
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 breastfeeding 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.
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.
There is no specific substance to counteract the effects of Aprotinin Injection
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:
Other side effects are:
Common: many affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Rare: may affect up to 1 in 1,000 patients
Very rare: may affect up to 1 in 10,000 patients
If any of these occur during administration of Aprotinin Injection your doctor/surgeon will stop treatment with the drug.
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
or search for MHRA Yellow Card in the Google Play or Apple store.
By reporting side effects you can help provide more information on the safety of this medicine
Aprotinin Injection should be stored below 25°C, protected from light. Do NOT use Aprotinin Injection if it is past the expiry date on the packaging.
Keep out of the sight and reach of children.
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.
Aprotinin Injection is a sterile, clear colourless solution. It is supplied in single glass vials of 50ml.
The marketing authorisation holder is
The manufacturer is
This leaflet was last revised in November 2024
Version 2023/10
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