Angiox
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
14-09-2018
Vara einkenni
(SPC)
14-09-2018
Opinber matsskýrsla
(PAR)
14-09-2018
Virkt innihaldsefni:
Bivalirudin
Fáanlegur frá:
The Medicines Company UK Ltd
ATC númer:
B01AE06
INN (Alþjóðlegt nafn):
bivalirudin
Meðferðarhópur:
Antithrombotic agents
Lækningarsvæði:
Acute Coronary Syndrome
Ábendingar:
Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina / non-ST-segment-elevation myocardial infarction (UA / NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel.
Vörulýsing:
Revision: 22
Leyfisstaða:
Withdrawn
Leyfisdagur:
2004-09-20
Upplýsingar fylgiseðill
30
B. PACKAGE LEAFLET
Medicinal product no longer authorised
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANGIOX 250 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR
INFUSION
bivalirudin
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.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Angiox is and what it is used for
2.
What you need to know before you use Angiox
3.
How to use Angiox
4.
Possible side effects
5.
How to store Angiox
6.
Contents of the pack and other information
1.
WHAT ANGIOX IS AND WHAT IT IS USED FOR
Angiox contains a substance called bivalirudin which is an
antithrombotic medicine. Antithrombotics
are medicines which prevent the formation of blood clots (thrombosis).
Angiox is used to treat patients:
with chest pain due to heart disease (acute coronary syndromes - ACS)
who are having surgery to treat blockages in their blood vessels
(angioplasty and/or
percutaneous coronary intervention - PCI).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ANGIOX
DO NOT USE ANGIOX
-
if you are allergic to bivalirudin or any of the other ingredients of
this medicine (listed in section
6) or hirudins (other blood thinning medicines).
-
if you have, or have recently had, any bleeding from your stomach,
intestines, bladder or other
organs, for example, if you have noticed abnormal blood in your stools
or urine (except from
menstrual bleeding).
-
if you have, or have had, difficulty with your blood clotting (a low
platelet count).
-
if you have severe high blood pressure.
-
if you have an infection of the heart tissue.
-
if you have severe kidney problems or if you need kidney dialysis.
Check with the doctor if you are unsure.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Angiox.
if bleeding occurs (
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Angiox 250 mg powder for concentrate for solution for injection or
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg bivalirudin.
After reconstitution 1 ml contains 50 mg bivalirudin.
After dilution 1 ml contains 5 mg bivalirudin.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for injection or infusion (powder
for concentrate)._ _
_ _
White to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Angiox is indicated as an anticoagulant in adult patients undergoing
percutaneous coronary
intervention (PCI), including patients with ST-segment elevation
myocardial infarction (STEMI)
undergoing primary PCI.
Angiox is also indicated for the treatment of adult patients with
unstable angina/non-ST segment
elevation myocardial infarction (UA/NSTEMI) planned for urgent or
early intervention.
Angiox should be administered with acetylsalicylic acid and
clopidogrel.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Angiox should be administered by a physician experienced in either
acute coronary care or in coronary
intervention procedures.
Posology
_Patients undergoing PCI, including patients with ST-segment elevation
myocardial infarction _
_(STEMI) undergoing primary PCI _
_ _
The recommended dose of bivalirudin for patients undergoing PCI is an
intravenous bolus of
0.75 mg/kg body weight followed immediately by an intravenous infusion
at a rate of 1.75 mg/kg
body weight/hour for at least the duration of the procedure. The
infusion of 1.75 mg/kg body
weight/hour may be continued for up to 4 hours post-PCI and at a
reduced dose of 0.25 mg/kg body
weight/hour for an additional 4 – 12 hours as clinically necessary.
In STEMI patients the infusion of
1.75 mg/kg body weight/hour should be continued for up to 4 hours
post-PCI and continued at a
reduced dose of 0.25 mg/kg body weight/hour for an addition
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