FLUVIR 30 (Oseltamivir Phosphate Capsules 30mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OSELTAMIVIR PHOSPHATE

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

OSELTAMIVIR PHOSPHATE

Unit dalam pakej:

3x10s Capsules

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FLUVIR (OSELTAMIVIR PHOSPHATE CAPSULES)_ _
Oseltamivir Phosphate 30mg, 45mg, 75mg
1
WHAT IS IN THIS LEAFLET
1.
What FLUVIR is used for
2.
How FLUVIR works
3.
Before you use FLUVIR
4.
How to use FLUVIR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of FLUVIR
8.
Product Description
9.
Manufacturer and
Product
Registration Holder
10.
Date of revision
1. WHAT FLUVIR_ _IS USED FOR
FLUVIR is used for the treatment of
influenza in children 6 to 12 months of
age
during
pandemic
influenza
outbreak, for treatment of influenza in
adults
and
children
age
1
year
and
above. FLUVIR is also indicated for
post exposure prevention in adults and
children age 1 year and above following
contact
with
clinically
diagnosed
influenza case when influenza virus is
circulating in the community.
_ _
2. HOW FLUVIR_ _WORKS
FLUVIR
contains
oseltamivir
which
belongs to a group of medicines named
neuraminidase
inhibitors.
These
medicines prevent the influenza virus
from spreading inside the body. They
help to ease or prevent the symptoms of
the influenza virus infection.
Influenza,
usually
called
flu,
is
an
infection caused by a virus. The signs of
flu often include a sudden fever (more
than 37.8°C), cough, runny or stuffy
nose,
headaches,
muscle
aches
and
extreme tiredness. These symptoms can
also be caused by other infections. True
influenza infection only occurs during
annual outbreaks (epidemics) when flu
viruses
are
spreading
in
the
local
community.
Outside
epidemic
periods,
flu-like
symptoms
are
usually
caused
by
a
different type of illness.
_FLUVIR is not a flu vaccine _
FLUVIR
is
not
a
vaccine:
it
treats
infection
or
prevents
the
flu
virus
spreading.
A
vaccine
gives
you
antibodies against the virus. FLUVIR
will not change the effectiveness of a flu
vaccine, and you might be prescribed
both by your doctor.
3.
BEFORE YOU USE
FLUVIR
_ _
_WHEN YOU MUST NOT TAKE IT _
Do not take or receive FLUVIR if:
•
YOU ARE ALLERGIC
(
_hyper-sensitive_
) to
oseltamivir
or
any
of
the
oth

Ciri produk

FLUVIR 75 (OSELTAMIVIR PHOSPHATE CAPSULES 75MG)
FLUVIR 45 (OSELTAMIVIR PHOSPHATE CAPSULES 45MG)
FLUVIR 30 (OSELTAMIVIR PHOSPHATE CAPSULES 30MG)
Font Size: 7
NAME OF ACTIVE INGREDIENT
FLUVIR 75 (Oseltamivir Phosphate Capsules 75mg)
Each capsule contains 98.5mg Oseltamivir Phosphate equivalent to 75mg
Oseltamivir.
FLUVIR 45 (Oseltamivir Phosphate Capsules 45mg)
Each capsule contains 59.1mg Oseltamivir Phosphate equivalent to 45mg
Oseltamivir.
FLUVIR 30 (Oseltamivir Phosphate Capsules 30mg)
Each capsule contains 39.4mg Oseltamivir Phosphate equivalent to 30mg
Oseltamivir.
DOSAGE FORM
Capsules
PRODUCT DESCRIPTIONS
FLUVIR 75 (Oseltamivir Phosphate Capsules 75mg):
Light yellow opaque cap / Grey opaque body size ‘2’ hard gelatin
capsules imprinted with ‘H’ on cap and
‘5’ on body with blue ink, filled with white to off white granular
powder.
FLUVIR 45 (Oseltamivir Phosphate Capsules 45mg):
Grey opaque cap / Grey opaque body size ‘4’ hard gelatin capsules
imprinted with 'H' on cap and '32' on
body with blue ink, filled with white to off white granular powder.
FLUVIR 30 (Oseltamivir Phosphate Capsules 30mg):
Light yellow opaque cap / Light yellow opaque body size ‘4’ hard
gelatin capsules imprinted with ‘H’ on
cap and ‘33’ on body with blue ink, filled with white to off white
granular powder.
PHARMACODYNAMICS
Oseltamivir phosphate is a pro-drug of the active metabolite
(oseltamivir carboxylate). The active metabolite
is a selective inhibitor of influenza virus neuraminidase enzymes,
which are glycoproteins found on the
virion surface. Viral neuraminidase enzyme activity is important both
for viral entry into uninfected cells and
for the release of recently formed virus particles from infected
cells, and for the further spread of infectious
virus in the body.
Oseltamivir carboxylate inhibits influenza A and B neuraminidases
_in vitro_
. Oseltamivir phosphate inhibits
influenza virus infection and replication
_in vitro_
. Oseltamivir given orally inhibits influenza A and B virus
replication and pa