Tecavir 0.5 (Entecavir Tablets 0.5 mg)

Country: Малезија

Језик: Енглески

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

Активни састојак:

ENTECAVIR MONOHYDRATE

Доступно од:

CAMBER LABORATORIES SDN. BHD.

INN (Међународно име):

ENTECAVIR MONOHYDRATE

Јединице у пакету:

10x10'stablet Tablets; 10 x 10'stablet Tablets

Произведен од:

Hetero Labs Limited

Информативни летак

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TECAVIR 0.5 (ENTECAVIR TABLETS 0.5MG)
TECAVIR 1 (ENTECAVIR TABLETS 1MG)_ _
Entecavir (0.5mg, 1mg)
1
WHAT IS IN THIS LEAFLET
1.
What TECAVIR is used for
2.
How TECAVIR works
3.
Before you use TECAVIR
4.
How to use TECAVIR
5.
While you using it
6.
Side effects
7.
Storage and Disposal of
TECAVIR
8.
Product Description
9.
Manufacturer and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
1. WHAT TECAVIR_ _IS USED FOR
Entecavir
tablets
is
anti-viral
medicines, used to treat chronic (long
term)
hepatitis
B
virus
(HBV)
infection in adults. Entecavir 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).
2. HOW TECAVIR_ _WORKS
Infection by the hepatitis B virus can
lead to damage to the liver. Entecavir
reduces the amount of virus in your
body, and improves the condition of
the liver.
3.
BEFORE YOU USE
TECAVIR
- _When you must not use it_
If you are allergic to entecavir or any
of
the
other
ingredients
of
this
medicine
_Pregnancy and lactation _
Do not take TECAVIR if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take TECAVIR if you are
breastfeeding.
Ask
your
doctor
or
pharmacist for advice before taking
any medicine.
- Before you start to use it
You should not take this medication
if you are allergic to entecavir, or if
you
also
have
HIV
(human
immunodeficiency virus) that is not
being treated.
If you have certain conditions, you
may
need
a
dose
adjustment
or
special
tests
to
safely
take
this
medication.
Before
you
take
entecavir, tell your doctor if you are
allergic to any drugs, or if you have:
•
HIV or AIDS;
•
kidney disease;
•
liver disease; or
•
if
you
have
had
a
liver
transplant.
Some people have developed a life-
threatening
condition
called
lactic
acidosis (excess of lactic acid in your
blood)
while
taking
entecavir.
Symptoms such as nausea, vomiting
and stomach

Карактеристике производа

TECAVIR 0.5/1
Entecavir Tablets 0.5mg and 1mg
Font size: 7
NAME OF THE PRODUCT
TECAVIR 0.5
(Entecavir Tablets 0.5 mg)
/ TECAVIR 1
(Entecavir Tablets 1 mg
NAME AND STRENGTH OF ACTIVE INGREDIENT TECAVIR 0.5
(Entecavir Tablets 0.5 mg)
Each film-coated tablet contains: Entecavir Tablets 0.5 mg
TECAVIR 1
(Entecavir Tablets 1 mg)
Each film-coated tablet contains: Entecavir Tablets 1 mg
DOSAGE FORM
Oral dosage form, tablet
PRODUCT DESCRIPTION
TECAVIR 0.5
(Entecavir Tablets 0.5 mg)
White to off white, triangle shaped, biconvex film- coated tablets
debossed with 'J' on one side and '110' on other side.
TECAVIR 1
(Entecavir Tablets 1 mg)
Pink, triangle shaped, biconvex, film-coated tablets, debossed with
'J' on one side and '111' on the other side.
PHARMACODYNAMICS/PHARMACOKINETICS PHARMACODYNAMICS
Pharmacotherapeutic group: antivirals for systemic use, nucleoside and
nucleotide reverse transcriptase inhibitors.
MECHANISM OF ACTION
Entecavir, 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 or cellular DNA polymerases α, β,
and
δ
with Ki 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 (Ki > 160
μM).
ANTIVIRAL ACTIVITY
Entecavir inhibited HBV DNA synthesis (50% reduction, EC
50
) at a concentration of 0.004 μMin human
HepG2 cells transfected with wild-type HBV. The median EC
50
value for entecavir against lamivudine- resistant HBV (rtL180M,
rtM204V) was 0.026 μM (range 0.010–0