BARACLUDE TABLET 0.5 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ENTECAVIR

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

ENTECAVIR

Unit dalam pakej:

30Tablet Tablets; 10Tablet Tablets

Dikeluarkan oleh:

PATHEON INC.

Risalah maklumat

BARACLUDE
®
TABLET
Entecavir (0.5mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What
_BARACLUDE_
_® _
is used for
2.
How
_BARACLUDE_
_® _
works
_3._
_ _
Before you use
_BARACLUDE_
_®_
_ _
_4._
_ _
How to use
_BARACLUDE_
_®_
_ _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_BARACLUDE_
_®_
_ _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _BARACLUDE_
_® _
IS USED FOR
_BARACLUDE_
_® _
is indicated for the
treatment of long term (chronic) hepatitis
B virus infection in adults with evidence
of active viral replication.
HOW _BARACLUDE_
_® _
WORKS
_BARACLUDE_
_® _
contains
an
active
ingredient, Entecavir, which has potent
and selective activity against hepatitis B
virus (HBV). By this way, it helps to
reduce the amount of hepatitis B virus in
your body.
BEFORE YOU USE _BARACLUDE_
_®_
_ _
-
_When you must not use it _
Do not take
_BARACLUDE_
_® _
if:

You
have
hypersensitivity
to
entecavir
or
any
component
of
_BARACLUDE_
_®_
_. _

You
are
HIV/HBV
co-infected
patient and also not receiving highly
active
antiretroviral
therapy
(HAART).
Do not take
_BARACLUDE_
_® _
if you are
pregnant, trying to get pregnant or think
you may be pregnant, unless considered
essential by the physician.
Do not take
_BARACLUDE_
_® _
if you are
breast-feeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
_BARACLUDE_
_® _
is not recommended for
children below the age of 16 years.
-
_Before you start use it _
Inform and discuss with your doctor or
pharmacist, if:

you have kidney problem

you have a transplanted liver

your
liver
does
not
function
properly
(decompensated
liver
disease)

you have any other allergies or
health problem
Your
doctor
will
decide
whether
Baraclude Tablet is suitable for you or
not.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy,
supermarket
or
heal

Ciri produk

1
BARACLUDE
®
(ENTECAVIR)
DESCRIPTION
BARACLUDE
®
(entecavir) is a guanosine nucleoside analogue with potent and
selective
activity against hepatitis B virus (HBV).
BARACLUDE
®
is available for oral administration as film-coated tablets in
strength of 0.5
mg of entecavir.
INDICATIONS
BARACLUDE
®
(entecavir) is indicated for the treatment of chronic hepatitis B
virus
infection in adults with evidence of active viral replication and
either evidence of persistent
elevations in serum aminotransferases (ALT or AST) or histologically
active disease.
The following points should be considered when initiating therapy with
BARACLUDE
®
:
•
This indication is based on histologic, virologic, biochemical, and
serologic
responses in nucleoside-treatment- naïve and lamivudine-resistant
adult patients
with
HBeAg-positive
or
HBeAg-negative
chronic
HBV
infection
with
compensated liver disease (see
CLINICAL TRIAL INFORMATION
).
•
Virologic, biochemical, serologic, and safety data are available from
a controlled
study
in adult subjects with chronic HBV infection and decompensated liver
disease
(see
UNDESIRABLE
EFFECTS
and
CLINICAL
TRIAL
INFORMATION
).
•
Virologic, biochemical, serologic, and safety data are available for a
limited
number of adult subjects with HIV/HBV co-infection who have received
prior
lamivudine therapy (see
WARNINGS AND PRECAUTIONS FOR USE
and
CLINICAL TRIAL INFORMATION
).
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSAGE
_Compensated liver disease _
2
Nucleoside-naïve patients: The recommended dose of BARACLUDE
®
is 0.5 mg orally
once daily with or without food.
Lamivudine-refractory
patients
(i.e.,
history
of
hepatitis
B
viremia
while
receiving
lamivudine therapy or known lamivudine resistance [LVDr, commonly
called YMDD]
mutations): The recommended dose is 1 mg once daily. BARACLUDE
®
should be taken
orally, on an empty stomach (empty means at least 2 hours before and
at least 2 hours after
a meal).
_Decompensated liver disease_
The recommended dose for patients with decompensated liver disease is
1