Entecavir Sandoz®Film-Coated Tablet 1mg

Riik: Malaisia

keel: inglise

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

Toimeaine:

ENTECAVIR MONOHYDRATE

Saadav alates:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Rahvusvaheline Nimetus):

ENTECAVIR MONOHYDRATE

Ühikuid pakis:

100 Tablets; 90 Tablets; 60 Tablets; 30 Tablets

Valmistatud:

LEK PHARMACEUTICALS D.D.

Infovoldik

_Consumer Medication Information Leaflet (RiMUP) _
ENTECAVIR SANDOZ
® FILM-COATED TABLET 0.5MG & 1MG
Entecavir (as monohydrate) 0.5mg & 1mg
WHAT IS IN THIS LEAFLET:
1.
What Entecavir Sandoz is used for
2.
How Entecavir Sandoz works
3.
Before you use Entecavir Sandoz
4.
How to use Entecavir Sandoz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Entecavir
Sandoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ENTECAVIR SANDOZ IS
USED FOR
Entecavir Sandoz is indicated for the
treatment of long term (chronic) hepatitis
B virus infection in adults with evidence
of active viral replication
.
HOW ENTECAVIR SANDOZ
WORKS
Entecavir Sandoz 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 ENTECAVIR
SANDOZ
_When you must not use it _
Do not take Entecavir Sandoz if:
•
You have hypersensitivity to
entecavir or any component of
Entecavir Sandoz
_. _
•
You are HIV/HBV co-infected patient
and also not receiving highly active
antiretroviral therapy (HAART).
Do not take Entecavir Sandoz if you are
pregnant, trying to get pregnant or think
you may be pregnant, unless considered
essential by the physician.
Do not take Entecavir Sandoz if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
Entecavir Sandoz 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
Entecavir Sandoz 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

Toote omadused

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Sandoz Film-Coated Tablet 0.5 mg
Entecavir Sandoz Film-Coated Tablet 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Sandoz Film-Coated Tablet 0.5 mg
Each tablet contains 0.5 mg entecavir (as monohydrate).
Entecavir Sandoz Film-Coated Tablet 1 mg
Each tablet contains 1 mg entecavir (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Entecavir Sandoz Film-Coated Tablet 0.5 mg
White, round, film coated tablet with debossment on both sides,
“SZ” on one side and “108” on the other
side.
Entecavir Sandoz Film-Coated Tablet 1 mg
Pink, round, film coated tablet with debossment on both sides,
“SZ” on one side and “109” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entecavir Sandoz 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 Sandoz:
•
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
RECOMMENDED DOSAGE
_Compensated liver disease _
_ _
_Nucleoside naive patients: _The recommended dose of Entecavir Sandoz
is 0.5mg orally once daily with or
without food.
_Lamivudine-refr