Angiox 250mg powder for concentrate for solution for infusion vials

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Bivalirudin

Доступно од:

The Medicines Company UK Ltd

АТЦ код:

B01AE06

INN (Међународно име):

Bivalirudin

Дозирање:

250mg

Фармацеутски облик:

Powder for solution for infusion

Пут администрације:

Intravenous

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 02080100

Информативни летак

1
B. PACKAGE LEAFLET
2
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 (if this happens, treatment with Angiox w

Карактеристике производа

OBJECT 1
ANGIOX 250MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INJECTION OR INFUSION
Summary of Product Characteristics Updated 03-Nov-2016 | The Medicines
Company UK Ltd
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 c