ZIDOHOPE 300mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
10-08-2020
Ciri produk Ciri produk (SPC)
10-08-2020

Bahan aktif:

ZIDOVUDINE

Boleh didapati daripada:

Paxten Sdn Bhd

INN (Nama Antarabangsa):

ZIDOVUDINE

Unit dalam pakej:

60 Tablets

Dikeluarkan oleh:

Macleods Pharmaceuticals Ltd

Risalah maklumat

                                _Consumer Medication Information Leaflet (RiMUP) _
ZIDOHOPE 300MG TABLETS
Zidovudine (300mg)
. 1
WHAT IS IN THIS LEAFLET
1.
What Zidohope is used for
2.
How Zidohope works
3.
Before you use Zidohope
4.
How to take Zidohope
5.
While
you
are
using
Zidohope
6.
Side Effects
7.
Storage
and
Disposal
of
Zidohope
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ZIDOHOPE IS USED FOR
Zidohope is used to treat HIV
(human
immunodeficiency
virus) infection.
If you’re pregnant, your doctor
may
want
you
to
take
Zidovudine tablets to help you
prevent passing on HIV to your
unborn baby.
HOW ZIDOHOPE WORKS
The
active
ingredient
in
Zidohope
300mg
Tablets
is
zidovudine.
Zidovudine
is
a
type of medicine known as an
anti-retroviral.
It
belongs to
a
group
of
medicines
called
nucleoside
analogue
reverse
transcriptase
inhibitors
(NRTI’s).
Zidovudine does not get rid of
HIV
infection;
it
reduces
the
amount of virus in your body,
and
keeps
it
at
a
low
level.
Zidovudine
also
increases
the
CD4 cell count in your blood.
CD4 cells are a type of white
blood cells that are important in
helping
your
body
to
fight
infection.
BEFORE YOU USE ZIDOHOPE
_-When you must not take it _
-
if
you
are
allergic
to
zidovudine or any of the other
ingredients of this medicine
- If you have a very low white
blood
cell
count (neutropenia)
or
a
very
low
red
blood
cell
count (anaemia).
_-Before you start to take it _
Inform
your
doctor
or
pharmacist
if
you
have
the
below
problems.
They
will
consider the risk and benefit of
taking Zidohope before giving it
to you.
-
If
you
have
ever
had
liver
disease (including hepatitis B or
C)
- If you’re seriously overweight
(especially if you’re a woman)
- If you’re diabetic and using
insulin.
-
If
you
have
bone
marrow
compromise
problem
or
are
taking bone marrow suppressive
medicines
- If you have kidney problem.
If any of the above applies to
you
and
you
are
given
Zidohope, you may need extra
check-ups,
including
blood
tests, while you’re taking your
medication.
_-Taki
                                
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Ciri produk

                                _ _
_ZIDOVUDINE TABLETS USP 300 MG_
MACLEODS PHARMACEUTICALS LTD.
PACKAGE INSERT
For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
ZIDOHOPE 300MG TABLETS
COMPOSITION:
Each film coated tablet contains:
Zidovudine USP……………300mg
DESCRIPTION:
White, circular, biconvex, film coated tablets having “ML8”
debossed on the periphery of one
side and plain surface on other side.
PHARMACOLOGY:
PHARMACODYNAMICS
Pharmacotherapeutic group: nucleoside analogue , ATC code: J05A F01
Mode of action:
Zidovudine is an antiviral agent which is highly active in vitro
against retroviruses including
the Human Immunodeficiency Virus (HIV).
Zidovudine is phosphorylated in both infected and uninfected cells to
the monophosphate (MP)
derivative by cellular thymidine kinase. Subsequent phosphorylation of
zidovudine-MP to the
diphosphate
(DP),
and
then
the
triphosphate
(TP)
derivative
is
catalysed
by
cellular
thymidylate kinase and non-specific kinases respectively.
Zidovudine-TP acts as an inhibitor of
and substrate for the viral reverse transcriptase. The formation of
further proviral DNA is
blocked by incorporation of zidovudine-MP into the chain and
subsequent chain termination.
Competition by zidovudine-TP for HIV reverse transcriptase is
approximately 100-fold greater
than for cellular DNA polymerase alpha.
Clinical virology:
The relationships between in vitro susceptibility of HIV to zidovudine
and clinical response to
therapy remain under investigation. In vitro sensitivity testing has
not been standardised and
results may therefore vary according to methodological factors.
Reduced in vitro sensitivity to
zidovudine has been reported for HIV isolates from patients who have
received prolonged
courses of Zidovudine therapy. The available information indicates
that for early HIV disease,
the frequency and degree of reduction of in vitro sensitivity is
notably less than for advanced
disease.
The reduction of sensitivity with the emergence of zidovudine
resistant strains limits the
usefulness o
                                
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