Valfix Film Coated Tablet 100mg

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

LAMIVUDINE

Beszerezhető a:

Y.S.P. INDUSTRIES (M) SDN. BHD.

INN (nemzetközi neve):

LAMIVUDINE

db csomag:

500tablet Tablets; 1,000tablet Tablets; 100tablet Tablets; 60tablet Tablets; 100tablet Tablets; 500tablet Tablets; 30tablet Tablets; 1,000tablet Tablets; 30tablet Tablets; 60tablet Tablets

Gyártó:

Y.S.P. INDUSTRIES (M) SDN. BHD.

Betegtájékoztató

_Consumer Medication Information Leaflet (RiMUP_
_)_
1 |
VALFIX FILM COATED TABLET 100MG
Lamivudine (100mg)
WHAT IS IN THIS LEAFLET
1.
What VALFIX F.C. TABLET is used
for
2.
How VALFIX F.C. TABLET works
3.
Before
you
use
VALFIX
F.C.
TABLET.
4.
How to take VALFIX F.C. TABLET.
5.
While
you
are
using
VALFIX
F.C.
TABLET
6.
Side effects
7.
Storage and disposal of VALFIX F.C.
TABLET
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT VALFIX F.C. TABLET IS USED FOR
Treatment of patients ≥ 16 years of age with
chronic hepatitis B and evidence of hepatitis B
virus (HBV) replication.
HOW VALFIX F.C. TABLET
WORKS
VALFIX
F.C.
TABLET
is
an
antiviral
medicine that suppresses the hepatitis B virus
and belongs to a group of medicines called
nucleoside
analogue
reverse
transcriptase
inhibitors (NRTIs).
BEFORE YOU USE VALFIX F.C. TABLET
_When you must not take it _
When
you
are
allergic
to
VALFIX
F.C.
TABLET or any other ingredient listed at the
end of this leaflet. Check with your doctor if
you think this applies to you.
_Before you start to take it _
Tell your doctor if you are allergic to any other
medicines
or
have
any
other
medical
conditions.
_If you have Kidney Disease: _
Discuss the use of VALFIX F.C. TABLET with
your doctor or health care provider if you have
kidney disease.
_If _
_you _
_have _
_Liver _
_Disease/Liver _
_Transplantation: _
Please speak with your doctor or health care
provider if you have a history of liver disease.
In the case where treatment with VALFIX F.C.
TABLET is discontinued for any reason, patient
should periodically monitor for liver function.
_Taking other medicines _
Tell your doctor if you are taking any other
medicines, including any that you buy without a
prescription
from
pharmacy,
supermarket
or
health food shop.
Some medicines when taken with VALFIX
F.C.
TABLET
may
interfere
with
each
other. These include:
-
Zalcitabine
and
Emtricitabine,
medicine to treat HIV infection.
-
Other
medicinal
products
containing lamivudine.
HOW TO TAKE VALFIX F.

Termékjellemzők

INGREDIENT(S):
Each tablet contains:
Lamivudine
................................................................................................................................
100
mg
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMIC AND PHARMACOKINETIC):
PHARMACODYNAMIC:
Lamivudine is an antiviral agent which is highly active against
hepatitis B virus (HBV) in all cell lines tested and
in experimentally infected animals.
Lamivudine is metabolised by both infected and uninfected cells to the
triphosphate (TP) derivative which is
the active form of the parent compound. The intracellular half-life of
the triphosphate in hepatocytes is 17-19
hrs _in vitro_. Lamivudine-TP acts as a substrate for the HBV viral
polymerase. The formation of further viral DNA
is blocked by incorporation of lamivudine-TP into the chain and
subsequent chain termination.
Lamivudine-TP does not interfere with normal cellular deoxynucleotide
metabolism. It is also only a weak
inhibitor of mammalian DNA polymerases α and β. Furthermore,
lamivudine-TP has little effect on mammalian
cell DNA content.
In assays relating to potential drug effects on mitochondrial
structure and DNA content and function,
lamivudine lacked appreciable toxic effects. It has a very low
potential to decrease mitochondrial DNA content,
is not permanently incorporated into mitochondrial DNA and does not
act as an inhibitor of mitochondrial DNA
polymerase
γ
.
PHARMACOKINETIC:
Absorption
Lamivudine is well absorbed from the gastrointestinal tract, and the
bioavailability of oral lamivudine in adults is
normally between 80-85%. Following oral administration, the mean time
(tmax) to maximal serum
concentrations (Cmax) is about an hour. At therapeutic dose levels ie.
100mg once daily, Cmax is in the order
of 1.1-1.5 mcg/ml and trough levels were 0.015-0.02mcg/ml.
Co-administration of lamivudine with food resulted in a delay of tmax
and a lower Cmax (decreased by up to
47%). However, the extent (based on the AUC) of lamivudine absorbed
was not influenced, therefore
lamivudine can be