Trasylol

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Aprotinin 10000 kIU/mL equivalent to to 200 mg/ml.

Fáanlegur frá:

Link Pharmaceuticals Ltd

INN (Alþjóðlegt nafn):

Aprotinin 10000 kIU/mL (Equiv. to 200 mg/ml.)

Skammtar:

100000kIU/10mL

Lyfjaform:

Solution for injection

Samsetning:

Active: Aprotinin 10000 kIU/mL equivalent to to 200 mg/ml. Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Einingar í pakka:

Vial, glass, 1x50ml, 50 mL

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Bayer AG

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, - 50 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, - 100 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, - 200 mL - 36 months from date of manufacture stored at or below 25°C

Leyfisdagur:

1969-12-31

Upplýsingar fylgiseðill

TRASYLOL
®

Aprotinin 

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 

This leaflet answers some common questions 
about TRASYLOL.  It does not contain all 
available information. 
It does NOT take the place of talking to your 
doctor or pharmacist. 

All medicines have risks and benefits.  Your 
doctor has weighed the risks of you receiving 
TRASYLOL against the benefits they expect it 
will have for you. 

Please read this leaflet carefully.  If you have 
any concerns about being given this medicine, 
ask your doctor or your pharmacist. 

CONTENTS OF THIS LEAFLET 

•  WHAT TRASYLOL IS USED FOR 
•  BEFORE YOU ARE GIVEN TRASYLOL 
•  HOW TRASYLOL IS GIVEN 
•  WHILE YOU ARE RECEIVING TRASYLOL 
• SIDE 
EFFECTS 
•  AFTER YOU HAVE RECEIVED TRASYLOL 
• PRODUCT 
DESCRIPTION 

WHAT TRASYLOL IS USED FOR 

TRASYLOL is used to prevent and treat 
abnormal bleeding conditions during Coronary 
Artery Bypass Graft (CABG) surgery.   

TRASYLOL is a sterile intravenous medication.  
It contains the drug APROTININ which is a protein 
obtained and purified from cow’s lungs. 
Aprotinin is similar to a protein that naturally 
occurs in humans.  Being given TRASYLOL 
helps to supplement natural processes 
controlling bleeding while you are undergoing 
surgery.  TRASYLOL is only used in hospitals. 

Your doctor may have prescribed TRASYLOL 
for another reason.  Ask your doctor if you have 
any questions about why TRASYLOL is being 
prescribed. 

BEFORE YOU ARE GIVEN TRASYLOL 

WHEN YOU MUST NOT HAVE TRASYLOL 

You must not have TRASYLOL if: 
•  you are allergic to aprotinin 

•  you have been treated with aprotinin in the 
last 12 months 
•  you are sitting or standing up.  You must be 
lying down when you are given the drug 

You must not be given TRASYLOL that has 
passed the expiry date.  This date appears after 
the words “EXP” or “EXPIRY” printed o

Vara einkenni

DATASHEET 
1 
TRASYLOL
®

_APROTININ _

GENERAL INFORMATION 

_QUALITATIVE AND QUANTITATIVE COMPOSITION _

1 vial of 50 mL/100 mL/200 mL contains aprotinin concentrated
solution, corresponding to 
500,000 KIU (Kallikrein Inhibitor Units) /1,000,000
KIU/2,000,000 KIU in sterile isotonic 
sodium chloride solution.  

500,000 KIU (approx. 70 mg aprotinin) corresponds to 277.8
Eur.Ph.Units 
1,000,000 KIU (approx. 140 mg aprotinin) corresponds to 555.6
Eur.Ph.Units 
2,000,000 KIU (approx. 280 mg aprotinin) corresponds to 1111.1
Eur.Ph.Units 

_PHARMACEUTICAL FORM _

TRASYLOL is a colourless clear solution for infusion. 

_DESCRIPTION _
_ _
Aprotinin is a highly purified natural proteinase inhibitor
obtained from bovine lungs. It is 
made up of 58 amino acid residues that are arranged in
a single polypeptide chain, 
cross-linked by three disulfide bridges. It has a
molecular weight of 6512 Daltons and a 
chemical formula of C
284
H
432
N
84
O
79
S
7
. It is supplied as a clear, colourless, sterile isotonic 
solution for intravenous administration. Each millilitre contains
10,000 KIU (1.4 mg/mL) 
and 9 mg sodium chloride in water for injection. Hydrochloric acid
and/or sodium 
hydroxide is used to adjust the pH to 4.5-6.5. 

CLINICAL PARTICULARS 

_INDICATIONS _

TRASYLOL is used prophylactically to reduce perioperative blood
loss and to reduce the 
need for blood transfusion in adult patients undergoing
cardiopulmonary bypass in the 
course of isolated coronary artery bypass graft surgery, where
the risk of bleeding is 
high (impaired haemostasis, e.g. presence of aspirin), or
where transfusion is 
unavailable or unacceptable. 

_POSOLOGY AND METHOD OF ADMINISTRATION _

RECOMMENDED USUAL DOSE: 

The following dosage regimen is recommended for adult patients:  

Owing to the risk of allergic/anaphylactic reactions, a 1
mL (10,000 KIU) test dose 
should be