FLUHALT CAPSULES 75 MG

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

OSELTAMIVIR PHOSPHATE

Prieinama:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Tarptautinis Pavadinimas):

OSELTAMIVIR PHOSPHATE

Vienetai pakuotėje:

10Capsule Capsules; 100Capsule Capsules

Pagaminta:

RANBAXY (MALAYSIA) SDN. BHD.

Pakuotės lapelis

FLUHALT Capsule
Page 1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FLUHALT CAPSULES
_OSELTAMIVIR PHOSPHATE CAPSULES 75MG _
WHAT IS IN THIS LEAFLET
1.
What
FLUHALT
is
used for
2.
How
FLUHALT
works
3.
Before you use
FLUHALT
4.
How to use
FLUHALT
5.
While you are using
FLUHALT
6.
Side effects
7.
Storage
and
disposal
of
FLUHALT
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUHALT CAPSULES ARE USED
FOR
Your doctor has prescribed
FLUHALT
CAPSULES
to you for the treatment or
prevention of influenza.
HOW FLUHALT CAPSULES WORKS
FLUHALT CAPSULES
belongs to a
group of medicines named
“neuraminidase inhibitors”. These
medicines prevent the influenza virus
from spreading inside the body and so
help to ease or prevent the symptoms
arising from the influenza virus
infection.
Influenza is an infection caused by the
influenza virus. The signs (symptoms)
of influenza include the
sudden onset of
fever (more than 37.8 °C), cough, runny
or stuffy nose, headaches, muscle aches
and often extreme fatigue. These
symptoms may also be caused by
infections other than influenza. True
influenza infection only occurs during
annual outbreaks (epidemics) at times
when influenza viruses are spreading in
the local community. Outside of the
epidemic period, these symptoms will
mainly be caused by a different type of
infection or illness.
Ask your doctor if you have any
questions about why this medicine has
been prescribed for you.
FLUHALT CAPSULES
are available in
strength of 75mg.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU USE FLUHALT CAPSULES
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FLUHALT CAPSULES

If you have previously had sever
allergic reaction (hypersensitive)
associated with the use of
oseltamivir or to any of the capsule
ingredients listed (symptoms of an
allergic reaction may include skin
r

Prekės savybės

1
_For the Use Only of a Registered Medical _
_Pr_
_actitione_
_r_
PRESCRIBING INFORMATION
FLUHALT
CAPSULES
(OSELTAMIVIR PHOSPHATE CAPSULES 75 M
G)
COMPOSITION
Each hard gelatin capsule contains: Oseltamivir Phosphate equivalent
Oseltamivir…………….75 mg
EXCIPIENTS: Croscarmellose Sodium, Povidone, Pregelatinized Starch,
Talc Purified, Sodium Stearyl
Fumarate, Purified Water.
PRODUCT DESCRIPTION
Size ‘2’ capsule with yellow cap and light grey body printed in
blue ink with OS 75 on both cap and
body, containing white to off white powder.
DESCRIPTION
FLUHALT CAPSULES contain oseltamivir phosphate which has the chemical
name - (3R,4R,5S)-4-
acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid,
ethyl
ester,
phosphate
(1:1).
The chemical formula is C
16
H
28
N
2
O
4
(free base). The molecular weight is 312.4 for oseltamivir free
base and 410.4 for oseltamivir phosphate salt. The structural formula
is as given below:
OSELTAMIVIR
PHOSPHATE
2
INDICATIONS
_TREATMENT OF INFLUENZA_
Oseltamivir is indicated for the treatment of influenza in children 6
to 12 months of age during a
pandemic influenza outbreak.
Oseltamivir is indicated for the treatment of influenza in adults and
children > 1 year of age.
Treatment should commence as soon as possible but no later than
forty-eight hours after the onset of the
initial symptoms of infection.
_PROPHYLAXIS OF INFLUENZA_
Oseltamivir is indicated for post exposure prophylaxis in adults and
children >1 year of age following
contact with a clinically diagnosed influenza case when influenza
virus is circulating in the community.
DOSE AND METHOD OF ADMINISTRATION
FLUHALT CAPSULES 75 MG (Oseltamivir Capsules 75 mg) may not be
suitable for all dosages and
therefore, other suitable available strengths and/or dosage forms
(e.g. suspension) of oseltamivir should
be used in such cases.
Oseltamivir may be taken with or without food. However, oseltamivir
taken with food may enhance
tolerability in some patients.
During situations when commercially manufactured oseltami