Trasylol 10,000 KIU/ml, solution for injection or infusion

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

APROTININ CONCENTRATED SOLUTION

Tersedia dari:

Nordic Group B.V.

Kode ATC:

B02AB; B02AB01

INN (Nama Internasional):

APROTININ CONCENTRATED SOLUTION

Dosis:

10,000 kallikrein inactivator unit/millilitre

Bentuk farmasi:

Solution for injection/infusion

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Area terapi:

Proteinase inhibitors; aprotinin

Status otorisasi:

Authorised

Tanggal Otorisasi:

2018-03-29

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Trasylol 10,000 KIU/ml solution for injection or infusion
Aprotinin
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. See section 4
WHAT IS IN THIS LEAFLET
1.
What Trasylol is and what it is used for
2.
What you need to know before you are given Trasylol
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 APROTININ
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
2
-
if no aprotinin specific IgG antibody test is possible prior to
treatment and you have
received or you suspect that you have received aprotinin-containing
medicinal products in
the last 12 months.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE RECEIVING TRA

Karakteristik produk

Health Products Regulatory Authority
24 March 2023
CRN00CXW9
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trasylol 10,000 KIU/ml, solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains: Aprotinin 10,000 KIU (Kallikrein Inhibitor Units)
For a full list ofexcipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection/infusion
The solution is clear and colourless
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aprotinin is indicated for prophylactic use to reduce blood loss and
blood transfusion in adult patients who are at high risk of
major blood loss undergoing isolated cardiopulmonary bypass graft
surgery (i.e. coronary artery bypass graft surgery that is
not combined with other cardiovascular surgery).
Aprotinin should only be used after careful consideration of the
benefits and risks, and the consideration that alternative
treatments are available (see section 4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
An appropriate aprotinin-specific IgG antibody test may be considered
before administration of aprotinin (see section 4.3).
Adult:
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 H
1
‑antagonist and a H
2
‑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).
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