Entecavir STELLA 0.5 mg film-coated tablet

Country: Малезија

Језик: Енглески

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

Активни састојак:

Entecavir Monohydrate

Доступно од:

STADPHARM SDN. BHD.

INN (Међународно име):

Entecavir Monohydrate

Јединице у пакету:

30 Tablets

Произведен од:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Информативни летак

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ENTECAVIR STELLA 0.5MG FILM-COATED
TABLETS
Entecavir 0.5 mg as entecavir monohydrate
1
WHAT IS IN THIS LEAFLET
1.
What Entecavir STELLA 0.5 mg is
used for
2.
How Entecavir STELLA 0.5 mg
works
3.
Before you use Entecavir STELLA
0.5 mg
4.
How to use Entecavir STELLA 0.5
mg
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Entecavir
STELLA 0.5 mg
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ENTECAVIR STELLA
0.5 MG IS
USED FOR
Entecavir STELLA 0.5 mg is indicated
for the treatment of long term (chronic)
hepatitis B virus infection in adults.
Entecavir STELLA 0.5 mg can be used in
people whose liver is damaged but still
functions properly (compensated liver
disease) and in people whose liver is
damaged and does not function properly
(decompensated liver disease).
HOW ENTECAVIR STELLA 0.5 MG WORKS
Infection by the hepatitis B virus can lead
to damage to the liver. Entecavir
STELLA 0.5 mg reduces the amount of
virus in your body, and improves the
conditions of the liver.
BEFORE YOU USE ENTECAVIR STELLA
0.5
MG
_- When you must not use it _
Do not take Entecavir STELLA
0.5 mg if
you have hypersensitivity to entecavir or
any component of Entecavir STELLA 0.5
mg.
_- Before you start use it _
Talk to your doctor or pharmacist before
taking Entecavir STELLA 0.5 mg:
•
if you have ever had problems with
your kidneys, tell your doctor. This is
important because Entecavir STELLA
0.5 mg is eliminated from your body
through the kidneys and your dose or
dosing schedule may need to be
adjusted.
•
do not stop taking Entecavir STELLA
0.5 mg without your doctor’s advice
since your hepatitis may worsen after
stopping treatment. When your
treatment with Entecavir STELLA 0.5
mg is stopped, your doctor will continue
to monitor you and take blood tests for
several months.
•
discuss with your doctor whether your
liver functions properly and, if not,
what the possible effects on your
Entecavir STELLA 0.5 mg treatmen

Карактеристике производа

_RX PRESCRIPTION ONLY _
_ _
ENTECAVIR STELLA 0.5 MG FILM-COATED TABLET
1.
NAME OF THE MEDICINAL PRODUCT
ENTECAVIR STELLA 0.5 MG FILM-COATED TABLET
2.
THE SIGNS SHOULD BE NOTED AND RECOMMENDED
Keep out of reach of children
Read the package insert carefully before use
3.
COMPOSITION
_Each film-coated tablet contains: _
Entecavir (as entecavir monohydrate)
.................................................. 0.5 mg
Excipients q.s.
......................................................................................
1 tablet
4.
PHARMACEUTICAL FORM
Film-coated tablet.
White, triangle-shaped, film-coated tablet, engraved with “0.5” on
one side
and “E” on the other side.
5.
INDICATIONS
Entecavir STELLA 0.5 mg film-coated tablet 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
Entecavir STELLA 0.5 mg film-coated tablet:
˗
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
adults
with
HIV/HBV
co-infection
who have
received prior
lamivudine therapy.
6.
ADMINISTRATION AND DOSAGE
_ADMINISTRATION _
Entecavir STELLA 0.5 mg film-coated tablet should be taken orally.
_DOSAGE _
˗
_Compensated liver disease _
_Nucleoside naïve patients:_ The recommended dose of Entecavir STELLA
is
0.5 mg orally once daily with or without food.
_Lamivudine-refractory patients_ (i.e., history of hepatitis B viremia
while
receivi