Integrilin solution for infusion

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

eptifibatide

זמין מ:

Glaxo Operations UK Ltd.

קוד ATC:

B01AC16

INN (שם בינלאומי):

eptifibatide

כמות:

0,75mg/ml

טופס פרצבטיות:

solution for infusion

יחידות באריזה:

(1) glass vial 100ml

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2020-01-09

עלון מידע

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

מאפייני מוצר

Reason for update: Excipients update
Market: UK
Agency Approval Date: 08/09/2020
Text Date: 11/09/2020
Issue No. 11 Draft 1
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
1
Reason for update: Excipients update
Market: UK
Agency Approval Date: 08/09/2020
Text Date: 11/09/2020
Issue No. 11 Draft 1
of