ABALAM (Abacavir Sulfate and Lamivudine Tablet 600mg300mg)

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

ABACAVIR SULFATE; LAMIVUDINE

MAH:

CAMBER LABORATORIES SDN. BHD.

INN:

ABACAVIR SULFATE; LAMIVUDINE

units_in_package:

3 x 10s Tablets

manufactured_by:

Hetero Labs Limited

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ABALAM TABLETS
ABACAVIR SULFATE/LAMIVUDINE (600MG/300MG)
1
WHAT IS IN THIS LEAFLET?
1.
What ABALAM is used for?
2.
How ABALAM works
3.
Before you take ABALAM
4.
How to use ABALAM
5.
While you are using it
6.
Side effects
7.
Storage and disposal of ABALAM
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
11.
Serial Number
WHAT ABALAM IS USED FOR
ABALAM is used to treat HIV (human
immunodeficiency virus) infection in
adults, adolescents and in children
weighing at least 25 kg.
ABALAM
contains
two
active
ingredients that are used to treat HIV
infection:
abacavir
and
lamivudine.
These belong to a group of anti-retroviral
medicines
called
_nucleoside _
_analogue _
_reverse transcriptase inhibitors (NRTIs)_
.
HOW ABALAM WORKS
ABALAM
does
not
completely
cure
HIV infection; it reduces the amount of
virus in your body and keeps it at a low
level. It 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.
Not everyone responds to treatment with
ABALAM in the same way. Your doctor
will monitor the effectiveness of your
treatment.
BEFORE YOU TAKE ABALAM
_-When you must not use it _
Do not take ABALAM:
•
If you are allergic (hypersensitive) to
abacavir
(or
any
other
medicine
containing
abacavir
–
(e.g.,
Ziagen),
lamivudine
or
any
of
the
other
ingredients of this medicine.
You
are
more
likely
to
develop
this
reaction if you have a gene called HLA-
B*5701 (but you can get a reaction even
if you do not have this gene). You should
have been tested for this gene before
ABALAM was prescribed for you. If
you know you have this gene, tell your
doctor before you take ABALAM.
Carefully read all the information about
hypersensitivity
reactions
in
section
“Side Effect”.
Check with your doctor if you think this
applies to you. Do not take ABALAM.
_Pregnancy _
ABALAM is not recommended for use
during
pregnancy.
ABALAM
and
similar medicines may cau

SPC

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ABALAM (ABACAVIR SULFATE AND LAMIVUDINE TABLET 600MG/ 300MG)
Font size: 7
NAME OF ACTIVE INGREDIENT
Each film-coated tablet contains Abacavir 600mg and Lamivudine 300mg.
DOSAGE FORM
Film coated tablet.
PRODUCT DESCRIPTION
The tablets are orange, modified capsule shaped, film coated tablets,
debossed with ‘H’ on one
side and ‘A1’ on the other side.
702 mg of Abacavir Sulfate is equivalent to 600 mg of Abacavir.
PHARMACODYNAMICS
Pharmacotherapeutic group: Antivirals for systemic use, antivirals for
treatment of HIV
infections, combinations. ATC code: J05AR02.
_Mechanism of action: _
Abacavir and lamivudine are NRTIs and are potent selective inhibitors
of
HIV-1 and HIV-2 (LAV2 and EHO) replication. Both abacavir and
lamivudine are metabolised
sequentially by intracellular kinases to the respective
5'-triphosphate (TP) which are the active
moieties. Lamivudine-TP and carbovir-TP (the active triphosphate form
of abacavir) are
substrates for and competitive inhibitors of HIV reverse transcriptase
(RT). However, their main
antiviral activity is through incorporation of the monophosphate form
into the viral DNA chain,
resulting in chain termination. Abacavir and lamivudine triphosphates
show significantly less
affinity for host cell DNA polymerases.
No antagonistic effects in vitro were seen with lamivudine and other
antiretrovirals (tested
agents: didanosine, nevirapine and zidovudine). The antiviral activity
of abacavir in cell culture
was
not
antagonized
when
combined
with
the
nucleoside
reverse
transcriptase
inhibitors
(NRTIs) didanosine, emtricitabine, stavudine, tenofovir or zidovudine,
the non-nucleoside
reverse transcriptase inhibitor (NNRTI) nevirapine, or the protease
inhibitor (PI) amprenavir.
Antiviral Activity in vitro
Both abacavir and lamivudine have been shown to inhibit replication of
laboratory strains and
clinical isolates of HIV in a number of cell types, including
transformed T cell lines,
monocyte/macrophage
derived
lines
and
primary
cultures
of
activated
peripheral
blood
lymphocytes (