Integrilin

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

eptifibatide

Tilgjengelig fra:

Glaxo Operations UK Ltd.

INN (International Name):

eptifibatide

Dosering :

2mg/ml

Legemiddelform:

solution for injection

Resept typen:

Prescription

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 clotting or a low
blood platelet count.
−
if you have or have had severe hypertension

Preparatomtale

SUMMARY OF PRODUCT CHARACHTERISTICS
INTEGRILIN 2MG SOLUTION FOR INJECTION, 0.75MG SOLUTION FOR INFUSION
1. NAME OF THE MEDICINAL PRODUCT
INTEGRILIN 0.75 mg/ml, solution for infusion
INTEGRILIN 2 mg/ml, solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
INTEGRILIN 0.75 mg/ml, solution for infusion: 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.
INTEGRILIN 2 mg/ml, solution for injection: Each ml of solution for
injection contains 2 mg eptifibatide. One
vial of 10 ml of solution for injection contains 20 mg of
eptifibatide.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for infusion and solution for injection
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 als