Avorix 0.5mg Film Coated Tablets

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

Entecavir Monohydrate

זמין מ:

NOVUGEN PHARMA SDN. BHD.

INN (שם בינלאומי):

Entecavir Monohydrate

יחידות באריזה:

1x10 Tablets; 3x10 Tablets; 6x10 Tablets; 10x10 Tablets; 50x10 Tablets; 100x10 Tablets

תוצרת:

NOVUGEN PHARMA SDN. BHD.

עלון מידע

_Consumer Medication Information Leaflet (RiMUP) _
AVORIX 0.5MG FILM COATED TABLETS
Entecavir 0.5mg
1
WHAT IS IN THIS LEAFLET
1.
What Avorix is used for
2.
How Avorix works
3.
Before you use Avorix
4.
How to use Avorix
5.
While you are using Avorix
6.
Side effects
7.
Storage and Disposal of Avorix
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT AVORIX IS USED FOR
Avorix
is
indicated
for
the
treatment
of
long
term
(chronic)
hepatitis B virus infection in adults
with
evidence
of
active
viral
replication.
HOW AVORIX WORKS
Avorix
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 AVORIX
−
_When you must not use it_
Do not take Avorix if:
•
You
have
hypersensitivity
to
entecavir
or
any
component
of
Avorix.
•
You
are
HIV/HBV
co-infected
patient
and
also
not
receiving
highly
active
antiretroviral
therapy (HAART).
Do
not
take
Avorix
if
you
are
pregnant, trying to get pregnant or
think you may be pregnant, unless
considered
essential
by
the
physician.
Do
not
take
Avorix
if
you
are
breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
Avorix
is
not
recommended
for
children below the age of 16 years.
−
_ Before you start to 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
Avorix 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
health food shop. Your doctor or
pharmacist
will
advise
whether
you should take Avorix together
with any other medicines.
HOW TO USE AVORIX
−
_How much to use_
Always tak

מאפייני מוצר

AVORIX 0.5MG
FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Avorix 0.5mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.532mg of Entecavir Monohydrate equivalent to
0.5mg Entecavir. For
the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film Coated Tablets.
White, round film-coated tablet debossed with “C21” on one side
and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
Entecavir:
-
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.
-
Virologic, biochemical, serologic, and safety data are available from
a controlled study in
adult subjects with chronic HBV infection and decompensated liver
disease.
-
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Compensated liver disease _
Nucleoside-naïve patients: The recommended dose of Entecavir 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. Entecavir 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 mg once daily,
which