CRUSIA 4000 IU (40 mg)0.4 ml Solution for Injection in Pre-filled Syringe

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
07-08-2022
Ciri produk Ciri produk (SPC)
07-08-2022
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
17-03-2021

Bahan aktif:

ENOXAPARIN SODIUM

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

ENOXAPARIN SODIUM

Unit dalam pakej:

10 Pre-Filled Syringes; 2 Pre-Filled Syringes

Dikeluarkan oleh:

Rovi Pharmaceutical Industrial Service

Risalah maklumat

                                CRUSIA
®
Enoxaparin Sodium Solution for Injection in Pre-filled Syringe
(20mg/0.2ml, 40mg/0.4ml, 60mg/0.6ml, 80mg/0.8ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What CRUSIA is used for.
2.
How CRUSIA works.
3.
Before you use CRUSIA.
4.
How to use CRUSIA.
5.
While you are using it.
6.
Side effects.
7.
Storage and Disposal of CRUSIA.
8.
Product Description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
11.
Serial Number.
WHAT _CRUSIA_
IS USED FOR.
CRUSIA contains enoxaparin sodium as
the active ingredient which belongs to a
group
of
a
medicine
called
Low
Molecular Weight Heparins (LMWH).
Your
doctor
may
have
prescribed
CRUSIA
to
PREVENT
the
following
conditions of:
•
Formation of blood clots in the veins
(thromboembolic
disorders),
including in orthopedic and general
surgery.
•
Formation of blood clots in the veins
of
bedridden
patients
admitted
because of a sudden illness, including
heart failure, acute respiratory failure,
severe
infections
or
rheumatic
diseases.
•
Blood
clotting
(coagulation)
in
the
extracorporeal
circulation
by
hemodialysis
(kidney
replacement
therapy).
Your
doctor
may
have
prescribed
CRUSIA
to
TREAT
the
following
conditions of:
•
Blood clots in the veins (deep vein
thrombosis)
with
or
without
pulmonary embolism (a blockage of
an artery by a blood clot).
•
A sudden painful feeling tightness in
the chest (unstable angina) and some
form of a heart attack (myocardial
infarction
without
Q-wave),
in
combination with acetylsalicylic acid
(aspirin).
•
An acute heart attack (STEMI: ST-
segment
Elevation
Myocardial
Infarction)
in
patient
not
for
subsequent
coronary
angioplasty-
Percutaneous
Coronary
Intervention
(PCI).
HOW _CRUSIA_ WORKS?
CRUSIA WORKS IN TWO WAYS;
i.
Stopping
existing
blood
clots
from
getting any bigger. This helps your
body to break them down and stop
them causing you harm.
ii.
Stopping blood clots forming in your
blood.
BEFORE YOU USE _CRUSIA_
•
_When you must not use it? _
Do not use CRUSIA if:
-
If you ar
                                
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Ciri produk

                                AIP002146A
AIP002146A
_ELDERLY_
For all indications except STEMI, no dose reduction is necessary in
the elderly patients, unless kidney function is
impaired (see below “renal impairment” and section Special
warnings and special precautions for use).
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with impaired kidney function, see below “renal impairment” and
section Special warnings and special
precautions for use.
_HEPATIC IMPAIRMENT _
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special precautions for use).
_RENAL IMPAIRMENT (SEE SECTIONS SPECIAL WARNINGS AND PRECAUTIONS FOR
USE AND PHARMACOKINETIC PROPERTIES)_
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during haemodialysis.
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The recommended dosage adjustments do not apply to the haemodialysis
indication.
• Moderate and mild renal impairment
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METHOD OF ADMINISTRATION
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be administered by the intramuscular route.
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