Aggrastat (250mcg/ml) concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIROFIBAN

Available from:

Correvio (UK) Limited

ATC code:

B01AC17

INN (International Name):

TIROFIBAN

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

TIROFIBAN 4 µg/ml

Prescription type:

POM

Therapeutic area:

ANTITHROMBOTIC AGENTS

Authorization status:

Authorised

Authorization date:

2006-05-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER  

AGGRASTAT (250 MICROGRAMS/ML) CONCENTRATE FOR SOLUTION FOR INFUSION  
TIROFIBAN  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 your doctor or pharmacist.  

This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, 
even if  their signs of illness are the same as yours.  
• 
If you get any side effects, talk to
your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet.  

WHAT IS IN THIS LEAFLET:  
1.  What Aggrastat is and what it is used for  
2.  What you need to know before you use Aggrastat  
3.  How to use Aggrastat  
4.  Possible side effects  
5.  How to store Aggrastat  
6.  Contents of the pack and other information  

1. WHAT AGGRASTAT IS AND WHAT IT IS USED FOR 
Aggrastat is used to help assist the blood flow to
your heart and to help prevent chest pain and heart 
attacks. It works by preventing platelets, cells found in the
blood, from forming blood clots.  
This medicine may also be used in patients whose heart vessels
are dilated with a balloon (percutaneous 
coronary intervention or PCI). This is a procedure,
possibly with implantation of a small tube (stent), to 
improve the blood flow to the heart.  
Aggrastat is intended for use with aspirin and
unfractionated heparin.  

2. WHAT YOU NEED TO KNOW BEFORE YOU USE AGGRASTAT 

DO NOT USE AGGRASTAT 

• 
if you are allergic (hypersensitive) to tirofiban
or any of the other ingredients of Aggrastat (listed in 
Section 6 “WHAT AGGRASTAT CONTAINS”).  
• 
if you are bleeding int

Summary of Product characteristics

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AGGRASTAT
®*
(50 micrograms/ml) solution for infusion
AGGRASTAT
®*
(250 micrograms/ml) concentrate for solution for infusion

in the following document the abbreviated terms detailed below are
used.

Aggrastat means Aggrastat solution for infusion or Aggrastat
concentrate for
solution for infusion.

Aggrastat Solution will be used when referring to Aggrastat solution
for infusion
i.e. the 250 ml bag.

Aggrastat Concentrate will be used when referring to Aggrastat
concentrate for
solution for infusion i.e. the 50 ml vial.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aggrastat Solution:
1 ml of solution for infusion contains 56 micrograms of tirofiban
hydrochloride
monohydrate which is equivalent to 50 micrograms tirofiban.
Aggrastat Concentrate:
1 ml of concentrate for solution for infusion contains 281 micrograms
of tirofiban
hydrochloride monohydrate which is equivalent to 250 micrograms
tirofiban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Aggrastat Solution: solution for infusion (250 ml bag).
A clear, colourless solution.
Aggrastat Concentrate: concentrate for solution for infusion (50 ml
vial).
A clear, colourless concentrated solution.
Page 2 of 24
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aggrastat is indicated for the prevention of early myocardial
infarction in adult
patients presenting with acute coronary syndromes without ST elevation
(NSTE-ACS)
with the last episode of chest pain occurring within 12 hours and with
ECG changes
and/or elevated cardiac enzymes.
Patients most likely to benefit from Aggrastat treatment are those at
high risk of
developing myocardial infarction within the first 3-4 days after onset
of acute angina
symptoms
including
for
instance
those
that
are
likely
to
undergo
an
early
percutaneous coronary intervention (PCI). Aggrastat is also indicated
for the reduction
of atherothombotic events in patients with acute myocardial infarction
intended for
pri