Atazor-300 (Atazanavir Capsules 300 mg)

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

ATAZANAVIR SULFATE

Dostupné s:

MEDISPEC (M) SDN.BHD

INN (Mezinárodní Name):

ATAZANAVIR SULFATE

Jednotky v balení:

30capsule Capsules

Výrobce:

EMCURE PHARMACEUTICALS LIMITED

Informace pro uživatele

ATAZOR-300 (ATAZANAVIR CAPSULES 300MG)
Atazanavir Sulfate equivalent to Atazanavir 300mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Atazor Capsules is used for
2.
How Atazor Capsules works
3.
Before you use Atazor Capsules
4.
How to use Atazor Capsules
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
Atazor
Capsules
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ATAZOR CAPSULES
IS USED FOR
Atazor is a prescription medicine used
with other anti-HIV medicines to treat
people who are infected with the
human immunodeficiency virus (HIV).
HOW ATAZOR CAPSULES
WORKS
Atazor is a type of anti-HIV medicine
called
a
protease
inhibitor.
HIV
infection
destroys
CD4+
(T)
cells,
which
are
important
to
the
immune
system. The immune system helps fight
infection. After a large number of (T)
cells
are
destroyed,
AIDS
develops.
Atazor helps to block HIV protease, an
enzyme that is needed for the HIV virus
to
multiply.
Atazor
may
lower
the
amount
of
HIV
in
your
blood,
help
your body keep its supply of CD4+(T)
cells, and reduce the risk of death
and illness associated with HIV.
BEFORE YOU USE ATAZOR CAPSULES
-
_When you must not use it _
Do not take Atazor if you:
• are taking certain medicines. (See
‘Taking other medicines’) Serious life
threatening side effects or death may
happen. Before
you take Atazor, tell
your
health
care
provider
about
all
medicines you are taking or planning
to
take.
These
include
other
prescription
and
nonprescription
medicines,
vitamins,
and
herbal
supplements.
• are allergic to Atazor or to any of its
ingredients.
The
active
ingredient
is
atazanavir sulfate. See the end of this
leaflet for a complete list of ingredients
in
Atazor.
Tell
your
healthcare
provider if you think you have had an
allergic
reaction
to
any
of
these
ingredients.
_Pregnancy and lactation _
• IF YOU ARE PREGNANT OR PLANNING TO
BECOME PREGNANT.
It is not known if
Atazor
can
harm
your
unborn
baby.
Talk to your healthcar

Charakteristika produktu

PRODUCT NAME
ATAZOR 300
PACKAGING MATERIAL
PACK INSERT
SIZE : Foil Repeat Length
------
SIZE : Strip Size
------
SIZE : Carton/Label
-------------------
SIZE : PI - Open Size
PI - Close Size
L. 286 X H. 242 MM
L. 32 X H. 32 MM
REMARK (IF ANY) :
------
PM STYLE/TYPE :
-------------
SIZE : Foil Width
------
BLACK
SAP CODE :
516000242MY01
REFERENCE ARTWORK
--------------
REASON OF CHANGE :
NEW TEXT
PROOF 1
26.04.2019
COUNTRY :
MALAYSIA
PACK SIZE :
30 TAB
PROOF 2
BARCODE NO. :
------------------
PHARMACODE :
3097
NO. OF COLOURS :
1
MIN. FONT SIZE :
7 PT.
DEVELOPED FOR :
Emcure - Hinjawadi
Mr. Chandrashekhar
25.09.2019
11.10.2019
15.10.2019 (SIZE CHANGE)
PROOF 3
PROOF 4
286 MM NAME OF PRODUCT:
Atazor-300 (Atazanavir Capsules 300mg)
NAME & STRENGTH OF ACTIVE SUBSTANCE:
Atazanavir Sulfate equivalent to Atazanavir 300mg
DOSAGE FORM: Oral Capsules.
PRODUCT DESCRIPTION:
_ATAZOR CAPSULES -300 :_ Size '00' Capsules two piece grey cap and
white body, hard
gelatin capsules printed in white with 'ATV 300' on cap and in black
with 'ATV 300' on body,
filled with white to light yellow granules which may appear as powder.
PHARMACODYNAMICS:
Pharmacotherapeutic group: protease inhibitor, ATC code: J05A E08
Atazanavir is an azapeptide HIV-1 protease inhibitor. The compound
selectively inhibits
the virus-specific processing of viral Gag-Pol proteins in HIV-1
infected cells, thus
preventing formation of mature virions.
Antiviral activity in cell culture:
Atazanavir exhibits anti-HIV-1 activity with a mean 50% effective
concentration (EC50) in
the absence of human serum of 2 to 5 nM against a variety of
laboratory and clinical HIV-1
isolates grown in peripheral blood mononuclear cells, macrophages,
CEM-SS cells, and
MT-2 cells. ATV has activity against HIV-1 Group M subtype viruses A,
B, C, D, AE, AG, F,
G and J isolates in cell culture. ATV has variable activity against
HIV-2 isolates (1.9 to 3.2
nM), with EC50 values above the EC50 values of failure isolaes.
Two-drug combination
antiviral activity studies with ATV showed no antagonism