Starflu-75 (Oseltamivir Capsule 75mg)

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

OSELTAMIVIR PHOSPHATE

Inapatikana kutoka:

GERMAX SDN. BHD.

INN (Jina la Kimataifa):

OSELTAMIVIR PHOSPHATE

Vitengo katika mfuko:

10Capsule Capsules

Viwandani na:

Strides Pharma Science Limited

Taarifa za kipeperushi

_Consumer Medication Information Leaflet (RiMUP) _
STARFLU CAPSULE 75MG
Oseltamivir (75mg)
1
WHAT IS IN THIS LEAFLET
1.
What Oseltamivir Capsule
75mg is used for
2.
How
Oseltamivir Capsule
75mg works
3.
Before you use Oseltamivir
Capsule 75mg
4.
How to take Oseltamivir
Capsule 75mg
5.
While
you
are
using
Oseltamivir Capsule 75mg
6.
Side Effects
7.
Storage and
Disposal of
Oseltamivir Capsule 75mg
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
WHAT
OSELTAMIVIR
CAPSULE
75MG IS USED FOR
Oseltamivir capsules is used for
adults, adolescents, and children
1 year old or older.
Oseltamivir
capsules
is
prescribed to you for treating flu
(influenza). It can be used when
you have flu symptoms, and the
flu
virus
is
known
to
be
circulating in your community.
Oseltamivir capsule is prescribed
for preventing flu. It can be used
if you have been in contact with
someone
who
has
flu.
This
is
generally decided on a case-by-
case basis.
HOW
OSELTAMIVIR
CAPSULE
75MG WORKS
Oseltamivir
capsules
contains
oseltamivir, which belongs to a
group
of
medicines
named
neuraminidase
inhibitors.
These
medicines prevent the flu virus
from spreading inside the body.
They help to ease or prevent the
symptoms
of
the
flu
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
0
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 infection or
illness.
BEFORE
YOU
TAKE
OSELTAMIVIR
CAPSULE 75MG
_-When you must not take it _
Do not take Oseltamivir Capsule
if:
•
if
you
are
allergic
(hypersensitive) to oseltamivir
or any of the other ingredients
of Oseltamivir capsules.
_-Before you start to take it _
Before
you
take
Oseltamivir
caps

Tabia za bidhaa

xxxx
STARFLU-75
OSELTAMIVIR CAPSULES 75MG
PRODUCT DESCRIPTION
:
White to off white powder filled in size 2 hard gelatin capsule with
cream cap &
brown body printed OP on cap and 75 on body in black.
COMPOSITION:
Each capsule contains Oseltamivir phosphate equivalent to Oseltamivir
75mg.
PHARMACOLOGY:
Oseltamivir is an ethyl ester prodrug requiring ester hydrolysis for
conversion to
the active form, oseltamivir carboxylate. The proposed mechanism of
action of
oseltamivir is inhibition of influenza virus neuraminidase with the
possibility of
alteration of virus particle aggregation and release.
The concentrations of oseltamivir carboxylate required for inhibition
of influenza virus
were highly variable depending on the assay method used and the virus
tested. The
50% and 90% inhibitory concentrations (IC 50 and IC 90 ) were in the
range of 0.0008
μ
M to >35
μ
M and 0.004
μ
M to >100
μ
M, respectively (1
μ
M=0.284
μ
g/mL). The
relationship between the in vitro antiviral activity in cell culture
and the inhibition of
influenza virus replication in humans has not been established.
PHARMACOKINETICS:
_Absorption: _
Oseltamivir is readily absorbed from the GIT after oral administration
of oseltamivir phosphate (pro-drug) and is extensively converted by
predominantly
hepatic esterases to the metabolite (oseltamivir carboxylate). At
least 75% of an oral
dose reaches the systemic circulation as the metabolite. Exposure to
the pro-drug is
<5% relative to the active metabolite. Plasma concentrations of both
pro-drug and
active metabolite are proportional to dose and are unaffected by
co-administration
with
food.
_Distribution: _
The mean volume of distribution (Vss) of the active metabolite
is
approximately 23L in humans, a volume equivalent extracellular body
fluid. Since
neuraminidase activity is extracellular, oseltamivir carboxylate
distributes to all sites of
influenza virus spread. The binding of the oseltamivir carboxylate to
human plasma
protein is negligible (approximately 3%).
_Metabolism: _
Oseltamivir is exte