Apexib 5mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

APIXABAN

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

APIXABAN

Unit dalam pakej:

3x10 Tablets; 6x10 Tablets; 10x10 Tablets; 1x10 Tablets; 2x10 Tablets

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
APEXIB FILM COATED TABLETS
Apixaban (2.5mg, 5mg)
1
WHAT IS IN THIS LEAFLET
1.
What Apexib is used for
2.
How Apexib works
3.
Before you use Apexib
4.
How to use Apexib
5.
While you are using Apexib
6.
Side effects
7.
Storage and Disposal of Apexib
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT APEXIB IS USED FOR
Apexib is used to
•
prevent
blood
clots
in
veins
(venous
thromboembolic
events
(VTE))
after
a
hip
or
knee
replacement surgery.
•
prevent stroke and blood clots in
adult
patients
with
a
condition
called
non-valvular
atrial
fibrillation,
which
is
a
type
of
irregular heart rhythm with one or
more risk factors, such as:
o
previous
stroke
condition
or
transient ischaemic attack (TIA)
(mini stroke);
o
age ≥75 years
o
high
blood
pressure
(hypertension)
o
high
blood
sugar
levels
(diabetes mellitus)
o
symptomatic
heart
failure
(NYHA Class ≥II).
•
treat blood clots occurring in deep
veins
(Deep
Vein
Thrombosis
[DVT])
and
clots
in
your
lungs
(Pulmonary
Embolism
[PE])
and
also
to
prevent
these
from
recurring.
HOW APEXIB WORKS
The
active
substance
in
Apexib
is
apixaban. It helps to prevent blood clot
formation
by
inhibiting
Factor
Xa,
which is an important component of
blood clotting.
BEFORE YOU USE APEXIB
−
_When you must not use it _
Do not take Apexib if:
•
you are allergic to Apixaban or to
any of the other ingredients listed at
the end of this leaflet
•
you have an injury to a body organ
or any internal bleeding
•
you have liver disease associated
with
a
bleeding
disorder
called
coagulopathy and an increased risk
of bleeding
•
you have any condition or injury to
a
body
organ
that
could
lead
to
significant bleeding (such as ulcers
in
stomach;
cancerous
growth;
recent brain or spinal injury; recent
brain,
spinal
or
eye
surgery;
bleeding
in
the
brain;
abnormal,
enlarged
veins
in
the
tube
that
connects
the
throat
and
stomach
(esophagus);
an
abnormal
connection
between
arteries
and

Ciri produk

APEXIB 2.5MG FILM COATED TABLETS
APEXIB 5MG FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Apexib 2.5mg Film Coated Tablets
Apexib 5 mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
APEXIB 2.5MG FILM COATED TABLETS
: Each tablet contains 2.5mg Apixaban.
APEXIB 5MG FILM COATED TABLETS
: Each tablet contains 5mg Apixaban.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
APEXIB 2.5MG FILM COATED TABLETS
: Yellow, round shaped film-coated tablet, debossed with “E2”
on one side and plain on other side.
APEXIB 5MG FILM COATED TABLETS
: Pink, oval shaped, biconvex film-coated tablet with bevelled
edges, debossed with “E1” on one side and plain on other side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
FOR 2.5MG
Prevention of venous thromboembolic events (VTE) in adult patients who
have undergone elective
hip or knee replacement surgery.
FOR 2.5MG AND 5MG
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation
(NVAF), with one or more risk factors, such as prior stroke or
transient ischaemic attack (TIA); age
≥75 years; hypertension; diabetes mellitus; symptomatic heart
failure (NYHA Class ≥II).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent
DVT and PE in adults for haemodynamically unstable PE patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prevention of VTE _
(
_VTEp_
)
_: elective hip or knee replacement surgery _
_ _
The recommended dose of Apexib is 2.5mg taken orally twice daily. The
initial dose should be taken
12 to 24 hours after surgery.
Physicians may consider the potential benefits of earlier
anticoagulation for VTE prophylaxis as well
as the risks of post-surgical bleeding in deciding on the time of
administration within this time
window.
_In patients undergoing hip replacement surgery _
_ _
The recommended duration of treatment is 32 to 38 days.
_In patients undergoing knee replacement surgery _
_ _
The recommended du