Hovid Entecavir Tablets 0.5mg

国: マレーシア

言語: 英語

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

有効成分:

ENTECAVIR MONOHYDRATE

から入手可能:

HOVID BERHAD

INN（国際名）:

ENTECAVIR MONOHYDRATE

パッケージ内のユニット:

30 Tablets

製:

Cohance Lifesciences Limited

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOVID ENTECAVIR TABLETS
Entecavir tablets 0.5mg (0.5mg), Entecavir tablets 1.0mg (1 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Hovid Entecavir is used for
2.
How Hovid Entecavir works
3.
Before you use Hovid Entecavir
4.
How to use Hovid Entecavir
5.
While
you
are
using
Hovid
Entecavir
6.
Side effects
7.
Storage
and
Disposal
of
Hovid
Entecavir
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT HOVID ENTECAVIR IS USED FOR
Hovid
Entecavir
is
indicated
for
the
treatment of chronic hepatitis B (HBV)
infection in adult:
•
whose liver is damaged but still
functions
properly
(compensated
liver disease)
•
whose liver is damaged and does
not
function
properly
(decompensated liver disease).
HOW HOVID ENTECAVIR WORKS
Infection by the hepatitis B virus can
lead
to
damage
to
the
liver.
Hovid
Entecavir reduces the amount of virus in
your body, and improves the condition
of the liver.
BEFORE YOU USE HOVID ENTECAVIR
_- When you must not use it _
Do not take this medicine if:
•
you are allergic (hypersensitive) to
entecavir
or
any
of
the
other
ingredients of this medicine
•
you
are
HIV/HBV
co-infected
patient
and
also
not
receiving
highly active antiretroviral therapy
(HAART).
•
you
are
pregnant
or planning
to
become
pregnant,
unless
considered
essential
by
the
physician.
It
has
not
been
demonstrated that Hovid Entecavir
is safe to use during pregnancy
•
you
are
breastfeeding.
Ask
your
doctor
or
pharmacist
for
advice
before taking any medicine. It is not
known whether entecavir, the active
ingredient in Hovid Entecavir, is
excreted in human breast milk.
Hovid Entecavir 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 ever had problems with
your kidneys
•
you have a transplanted liver
•
your
liver
does
not
function
properly
(decompensated
liver
disease)
•
you
have
any
other
allergies
or
health problem
•
you
have

製品の特徴

VIENT03-var1 (MY)
DESCRIPTION
HOVID ENTECAVIR TABLETS 0.5 MG
White triangular shaped film-coated tablets debossed ‘A’ on one
side and
‘88’ on the other side.
HOVID ENTECAVIR TABLETS 1 MG
Pink triangular shaped film-coated tablets debossed 'A' on one side
and
'89' on other side.
COMPOSITION
HOVID ENTECAVIR TABLETS 0.5 MG
Each tablet contains 0.5 mg Entecavir.
HOVID ENTECAVIR TABLETS 1 MG
Each tablet contains 1 mg Entecavir.
PHARMACODYNAMICS
Entecavir is a guanosine nucleoside analogue with activity against HBV
polymerase, is efficiently phosphorylated to the active triphosphate
(TP)
form, which has an intracellular half-life of 15 hours. By competing
with
the natural substrate deoxyguanosine TP, entecavir-TP functionally
inhibits the 3 activities of the viral polymerase: (1) priming of the
HBV
polymerase, (2) reverse transcription of the negative strand DNA from
the pregenomic messenger RNA, and (3) synthesis of the positive strand
HBV DNA. The entecavir-TP Ki for HBV DNA polymerase is 0.0012 μM.
Entecavir-TP is a weak inhibitor of cellular DNA polymerases α, β,
and δ
with K
i
values of 18 to 40 µM. In addition, high exposures of entecavir
had no relevant adverse effects on γ polymerase or mitochondrial DNA
synthesis in HepG2 cells (K i > 160 µM).
PHARMACOKINETICS
ABSORPTION
Entecavir is rapidly absorbed with peak plasma concentrations
occurring
between
0.5-1.5
hours. The
absolute
bioavailability
has
not
been
determined.
Based on urinary excretion of unchanged drug, the bioavailability has
been estimated to be at least 70%. There is a dose- proportionate
increase in C
max
and AUC values following multiple doses ranging from
0.1-1 mg. Steady-state is achieved between 6-10 days after once daily
dosing with approximately 2 times accumulation. C
max
and C
min
at
steady-state are 4.2 and 0.3 ng/ml, respectively, for a dose of 0.5
mg,
and 8.2 and 0.5 ng/ml, respectively, for 1 mg.
DISTRIBUTION
The estimated volume of distribution for entecavir is in excess of
total
body
water.
Protein
binding
to
human
ser