Valfix Film Coated Tablet 150mg

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

LAMIVUDINE

Tillgänglig från:

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

INN (International namn):

LAMIVUDINE

Enheter i paketet:

3 x 10 Tablets; 6 x 10 Tablets; 12 x 10 Tablets; 3 x 10 Tablets; 6 x 10 Tablets; 12 x 10 Tablets

Tillverkad av:

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

Bipacksedel

_Consumer Medication Information Leaflet (RiMUP_
_)_
VALFIX FILM COATED TABLET 150MG
Lamivudine (150mg)
1
WHAT IS IN THIS LEAFLET
1.
What VALFIX F.C. TABLET
150MG is used for
2.
How VALFIX F.C. TABLET
150MG works
3.
Before you use VALFIX F.C.
TABLET 150MG
4.
How
to
take
VALFIX
F.C.
TABLET 150MG
5.
While you are using VALFIX
F.C. TABLET 150MG
6.
Side effects
7.
Storage
and
disposal
of
VALFIX
F.C.
TABLET
150MG
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT VALFIX F.C. TABLET 150MG
IS USED FOR
Treating HIV infected adult & children
in combination with other antiretroviral
agents.
HOW VALFIX F.C. TABLET 150MG
WORKS
VALFIX F.C. TABLET 150MG is an
antiviral medicine that suppresses human
immunodeficiency
virus
(HIV).
It
belongs to a group of medicines called
nucleoside
analogue
reverse
transcriptase inhibitors (NRTIs).
BEFORE YOU USE VALFIX F.C. 150MG
TABLET
_When you must not take it _
When you are allergic to VALFIX F.C.
TABLET
150MG
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 150MG 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
150MG
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
150MG
may
interfere with each other. These include:
-
Co-trimoxazole
-
Emtricitabine
-
Cladribine
-
Other
medicinal
products
con

Produktens egenskaper

INGREDIENT(S):
Each tablet contains:
Lamivudine
................................................................................................................................................
150mg
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMIC AND PHARMACOKINETIC):
PHARMACODYNAMIC:
Lamivudine is a nucleoside analogue which has activity against human
immunodeficiency virus (HIV) and hepatitis B virus
(HBV). It is metabolised intracellularly to the active moiety,
lamivudine 5'-triphosphate. Its main mode of action is as a chain
terminator of viral reverse transcription. The triphosphate has
selective inhibitory activity against HIV-1 and HIV-2 replication _in
_
_vitro_, it is also active against zidovudine-resistant clinical
isolates of HIV. No antagonistic effects _ in vitro_ were seen with
lamivudine and other anti retrovirals (tested agents: abacavir,
didanosine, nevirapine and zidovudine).
PHARMACOKINETIC:
Absorption
Lamivudine is well absorbed from the gastrointestinal tract, and the
bioavailability of oral lamivudine in adults is normally
between 80 and 85%. Following oral administration, the mean time (t
max
) to maximal serum concentrations (C
max
) is about an
hour.
Co-administration of lamivudine with food results in a delay of t
max
and a lower C
max
. However, the extent (based on the AUC) of
lamivudine absorbed is not influenced.
Administration of crushed tablets with a small amount of semi-solid
food or liquid would not be expected to have an impact on
the pharmaceutical quality, and would therefore not be expected to
alter the clinical effect. This conclusion is based on the
physiochemical and pharmacokinetic data assuming that the patient
crushes and transfers 100% of the tablet and ingests
immediately.
Distribution
The mean volume of distribution is 1.3 l/kg. The observed half-life of
elimination is 5 to 7 hours. The mean systemic clearance
of lamivudine is approximately 0.32 l/h/kg, with predominantly renal
clearance (> 70%) via the organic cationic transport
system.
Lamivudine exhibits linear pharm