ISENTRESS 400mg TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RALTEGRAVIR POTASSIUM

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

RALTEGRAVIR POTASSIUM

Unit dalam pakej:

60Tablet Tablets

Dikeluarkan oleh:

MSD International GmbH T/A MSD Ireland (Ballydine)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ISENTRESS
®
TABLET
_ _
Raltegravir (400mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Isentress is taken for
2.
How Isentress works
3.
Before you take Isentress
4.
How to take Isentress
5.
While you are taking Isentress
6.
Side effects
7.
Storage and Disposal of
Isentress
8.
Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11.Serial Number
WHAT ISENTRESS IS USED FOR
Isentress is taken in combination
with other antiretroviral
medicinal to treat those who are
infected with HIV, the virus that
causes AIDS (Acquired Immune
Deficiency Syndrome).
WHAT IS HIV?
HIV (Human Immunodeficiency
Virus) is a blood-borne disease
spread by contact with blood,
sexual contact with an infected
individual, or from a mother to
infant transmission during
pregnancy or through
breastfeeding.
Your doctor has prescribed
Isentress to help control your
HIV infection. Isentress is not a
cure for HIV infection.
When taken with other anti-HIV
medicines, Isentress may reduce
the amount of HIV in your
blood (called "viral load") and
increase the number of CD4 (T)
cells. Reducing the amount of
HIV in the blood may keep your
immune system healthy, so it
can help fight infection.
Isentress may not have these
effects in all individuals.
Isentress does not cure HIV
infection or AIDS. It is very
important that you stay under
the care of your doctor during
treatment with Isentress.
Isentress does not reduce the
chance of passing HIV to others
through sexual contact, sharing
needles, or being exposed to
your blood. Continue to practice
safer sex. Use latex or
polyurethane condoms or other
barrier methods to lower the
chance of sexual contact with
any body fluids such as semen,
vaginal secretions or blood.
Never re-use or share needles.
Ask your doctor if you have any
questions about safer sex or how
to prevent passing HIV to other
people.
HOW ISENTRESS WORKS
Isentress blocks HIV integrase,
an enzyme that is needed for
HIV to make more virus.
BEFORE YOU TAKE ISENTRESS
_-

Ciri produk

LOCAL PRODUCT CIRCULAR
LPC-MK0518-T-112020B-MALAYSIA
TABLETS
ISENTRESS
® 400MG
(RALTEGRAVIR)
ISENTRESS
(raltegravir)
is an HIV integrase strand transfer inhibitor active against the
Human
Immunodeficiency Virus (HIV
-1).
The chemical name for raltegravir
potassium
is
N
-[(4-
Fluorophenyl)methyl]
-1,6-dihydro-5-
hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-
oxadiazol
-2-
yl)carbonyl]amino]ethyl]
-6-oxo-4-
pyrimidinecarboxamide monopotassium salt.
The
empirical
formula is C
20
H
20
FKN
6
O
5
and the molecular weight is 482.51. The
structural
formula is:
N
N
H
N
O
H
N
O
O
H
3
C
CH
3
H
3
C
O
N
N
O
H
3
C
F
K
C
AS Registry Number: 871038
-72-1
Raltegravir potassium is a white to off
-
white powder. It is soluble in water, slightly soluble in
methanol, very s
lightly soluble in ethan
ol and
acetonitrile and insoluble in isopropanol.
I. DESCRIPTION
II. COMPOSITION
I
IA. ACTIVE INGREDIENTS
Each 400mg film
-
coated tablet of ISENTRESS contains 434.4 mg of raltegravir potassium
(as
salt), equivalent to 400 mg of raltegravir (free phenol).
Each 400mg film-coated tablet of
ISENTRESS
contains the following inactive
ingredients:
microcrystalline
cellulose,
lactose
monohydrate,
calcium
phosphate
dibasic
anhydrous,
hypromellose
2208,
poloxamer
407 (contains 0.01% butylated
hydroxytoluene
as
antioxidant),
sodium stearyl fumarate,
magnesium
stearate. In
addition,
the film coating contains the
following inactive
ingredients:
polyvinyl
alcohol, titanium dioxide,
polyethylene
glycol 3350, talc,
red iron oxide and black iron
oxide.
Raltegravir
inhibits the catalytic activity of HIV
integrase,
an HIV-encoded enzyme that is
required for viral
replication.
Inhibition of
integrase
prevents the
covalent
insertion, or
integration,
of the HIV genome into the host cell genome during the early phase of
infection.
HIV genomes that fail to integrate cannot direct the production of new
infectious viral
particles,
so inhibiting
integration
prevents
propagation
of the viral infection.
Raltegravir
did not
significantly inhibit human phosphoryltr