Integrilin 75mg100ml solution for infusion vials

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Eptifibatide

Fáanlegur frá:

GlaxoSmithKline UK Ltd

ATC númer:

B01AC16

INN (Alþjóðlegt nafn):

Eptifibatide

Skammtar:

750microgram/1ml

Lyfjaform:

Solution for infusion

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02090000; GTIN: 5000123312108

Upplýsingar fylgiseðill

1
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 clotting or a low
blo

Vara einkenni

OBJECT 1
INTEGRILIN 0.75 MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 22-Jun-2015 |
GlaxoSmithKline UK
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.
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
_Adults (≥ 18 years of age) presenting with unstable angina (UA) or
non-Q-wave myocard