Integrilin

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

eptifibatide

Διαθέσιμο από:

GlaxoSmithKline (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

B01AC16

INN (Διεθνής Όνομα):

eptifibatide

Θεραπευτική ομάδα:

Antithrombotic agents

Θεραπευτική περιοχή:

Angina, Unstable; Myocardial Infarction

Θεραπευτικές ενδείξεις:

Integrilin is intended for use with acetylsalicylic acid and unfractionated heparin.Integrilin is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 24 hours and with ECG changes and / or elevated cardiac enzymes.Patients most likely to benefit from Integrilin 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 transluminal coronary angioplasty (PTCA).

Περίληψη προϊόντος:

Revision: 26

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1999-07-01

Φύλλο οδηγιών χρήσης

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INTEGRILIN 0.75 MG/ML SOLUTION FOR INFUSION
eptifibatide
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 hospital
pharmacist or nurse.
−
If you get any side effects talk to your doctor or hospital pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Integrilin is and what it is used for
2.
What you need to know before you are given Integrilin
3.
How to use Integrilin
4.
Possible side effects
5.
How to store Integrilin
6.
Contents of the pack and other information
1.
WHAT INTEGRILIN IS AND WHAT IT IS USED FOR
Integrilin is an inhibitor of platelet aggregation. This means that it
helps to prevent blood clots from
forming.
It is used in adults with manifestation of severe coronary
insufficiency defined as spontaneous and recent
chest pain with electrocardiographic abnormalities or biological
changes. It is usually given with aspirin
and unfractionated heparin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN INTEGRILIN
YOU MUST NOT BE GIVEN INTEGRILIN:
−
if you are allergic to eptifibatide or any of the other ingredients of
this medicine (listed in section
6).
−
if you have recently had bleeding from your stomach, intestines,
bladder or other organs, for
example if you have seen abnormal blood in your stool or urine (except
from menstrual bleeding)
in the past 30 days.
−
if you have had a stroke within the past 30 days or any haemorrhagic
stroke (also, be sure your
doctor knows if you ever had a stroke).
−
if you have had a brain tumour or a condition that affects the blood
vessels around the brain.
−
if you had a major operation or severe injury during the past 6 weeks.
−
if you have or have had bleeding problems.
−
if you have or have had difficulty with your blood

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
INTEGRILIN 0.75 mg/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 0.75 mg of eptifibatide.
One vial of 100 ml of solution for infusion contains 75 mg of
eptifibatide.
Excipients with known effect
Contains 161 mg of sodium per 100 ml vial
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INTEGRILIN is intended for use with acetylsalicylic acid and
unfractionated heparin.
INTEGRILIN is indicated for the prevention of early myocardial
infarction in adults presenting
with unstable angina or non-Q-wave myocardial infarction, with the
last episode of chest pain
occurring within 24 hours and with electrocardiogram (ECG) changes
and/or elevated cardiac
enzymes.
Patients most likely to benefit from INTEGRILIN 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 PTCA (Percutaneous
Transluminal Coronary
Angioplasty) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This product is for hospital use only. It should be administered by
specialist physicians experienced
in the management of acute coronary syndromes.
INTEGRILIN solution for infusion must be used in conjunction with
INTEGRILIN solution for
injection.
Concurrent administration of heparin is recommended unless this is
contraindicated for reasons
such as a history of thrombocytopenia associated with use of heparin
(see ‘Heparin administration’,
section 4.4). INTEGRILIN is also intended for concurrent use with
acetylsalicylic acid, as it is part
of standard management of patients with acute coronary syndromes,
unless its use is
contraindicated.
_ _
Posology
_ _
3
_Adults (_
≥
_ 18 years of age) presenting with unstable angina (UA) or non-Q-wave