Hepuri F.C. Tablet 0.5mg (Entecavir)

Страна: Малайзия

Език: английски

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

Активна съставка:

ENTECAVIR MONOHYDRATE

Предлага се от:

MEDISPEC (M) SDN.BHD

INN (Международно Name):

ENTECAVIR MONOHYDRATE

Броя в опаковка:

3 x 10 Tablets

Произведено от:

2ND PLANT STANDARD CHEM & PHARM CO LTD

Листовка

HEPURI F.C. TABLETS 0.5MG
®
Entecavir 0.5mg
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Hepuri _
is used for
2.
How
_Hepuri _
works
3.
Before you use
_Hepuri_
4.
How to use
_Hepuri_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Hepuri_
8.
Product Description
9.
Manufacturer and Product
Registration
Holder
10. Date of revision
WHAT _HEPURI _IS USED FOR
Entecavir
is used to treat chronic hepatitis B
virus (HBV) infection in adults with
compensated or decompensated
liver
disease or with HIV/HBV co-
infection who have received
prior
lamivudine therapy.
HOW _HEPURI _WORKS
Entecavir is an antiviral medication.
Entecavir prevents certain virus cells
from multiplying in your body
BEFORE YOU USE _HEPURI_
-
_ When you must not use it_
You should not take this medication if
you are allergic to entecavir, or any other
ingredients of
_Hepuri._
_Pregnancy and lactation_
Do not take
_Hepuri _
if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take
_Hepuri _
if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_ Before you start to use it_
Before you take entecavir, tell your
doctor if:
You have liver disease
You have kidney disease
You are suffered from HIV or
AIDS
You have lever transplant
You are infected with hepatitis C or
D
You are lactose intolerance
-
_ Taking other medicines_
Tell your doctor if you use any other
medicines, including medicines
purchased without a prescription from a
pharmacy, supermarket, or health food
store.
Before taking entecavir, tell your doctor
if you are using any of the following
drugs:
Lamivudine
Adefovir dipivoxil
Enofovir disoproxil
HOW TO USE _HEPURI_
-
_ How much to use_
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand the instructions on the
label, ask your doctor or pharmacist
for help.
Compensated liver disease
_Nucleoside naive patien

Данни за продукта

Hepuri F.C. Tablet 0.5mg (Entecavir)
1.
NAME AND DOSAGE FORM OF PRODUCT :
Hepuri F.C. Tablet 0.5mg (Entecavir)
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT :
Each tablet contains Entecavir monohydrate 0.53mg
3.
DESCRIPTION :
It occurs as a white tablet; film coated, triangular-shaped tablet,
branded “948” on one side
and “STD” on the other surface.
4.
THERAPEUTIC CLASS :
Antivirals
5.
INDICATIONS :
Entecavir are indicated for the treatment of chronic hepatitis B virus
(HBV) infection in adults
with evidence of active viral replication and either evidence of
persistent elevations in serum
alanine aminotransferases (ALT or AST) or histological active disease.
This indication is based on the reported histologic, virologic,
biochemical, and serological
response in:
a) nucleoside-treatment naive and lamivudine-resistant adult patient
with HBeAg positive and
HBeAg negative HBV infection with compensated liver disease
b) adult patent with chronic HBV infection and decompensated liver
disease
c) adult patient with HIV/HBV co-infection who have received prior
lamivudine therapy.
6.
DOSAGE AND ADMINISTRATION :
Compensated liver disease
_Nucleoside naive patients_
: The recommended dose of Entecavir is 0.5mg 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 1mg 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 must be taken on an empty stomach (empty means at least 2 hours
before and at least 2
hours after a meal).
Special Populations
_Patients with renal impairment_
Entecavir is predominantly eliminated by the kidney. The clearance of
entecavir decreases
with impaired (decreasing) creatinine clearance. Dosage adjustment o