RELENZA ROTADISK 5MG

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

ZANAMIVIR

Dostupné s:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Mezinárodní Name):

ZANAMIVIR

Jednotky v balení:

5Units Units

Výrobce:

GLAXOSMITHKLINE AUSTRALIA PTY LTD

Informace pro uživatele

1
RELENZA ROTADISK
Zanamivir (5 mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
WHAT IS IN THIS LEAFLET
1.
What RELENZA is used for
2.
How RELENZA works
3.
Before you use RELENZA
4.
How to use RELENZA
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
RELENZA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT RELENZA IS USED FOR
Relenza is used to treat flu
(
_influenza virus infection_
). It
reduces the symptoms of flu, and
helps you recover more quickly.
Relenza is also used to help
prevent you from getting flu,
during a flu outbreak.
HOW RELENZA WORKS
Relenza contains zanamivir,
which belongs to a group of
medicines called antivirals.
Relenza is not a substitute for flu
vaccination. You still need to
talk to your doctor about
whether you need to be
vaccinated against flu.
Adults and children aged 5 years
or more can be treated with
Relenza.
BEFORE YOU USE RELENZA
-
_When you must not use it _
_ _
Do not take Relenza if:
•
if you are allergic
(hypersensitive) to
zanamivir or any other
ingredients of Relenza
If you think this applies to you,
don’t use Relenza until you have
checked with your doctor.
Relenza contains lactose and
milk proteins. If you have a
severe intolerance to lactose or
any other sugars, or to milk
protein, check with your doctor
that Relenza is suitable for you.
-
_Before you start to use it _
Your doctor needs to know if
you have:
•
asthma
•
any other lung disease that
causes breathing problems (for
example emphysema, COPD
or chronic bronchitis).
Tell your doctor before you use
Relenza, so that he or she can
supervise you more closely to
check that your condition is
being controlled.
Using Relenza with inhaled
medication for breathing
problems
•
If you use inhaled medication
for asthma or any other
breathing problem, carry on
using your inhaler(s) at the
usual times.
•
If you have been advised to
use Relenza at the same time
of day as your other inhaled
medication, use the other
medication a few minutes
be

Charakteristika produktu

CONFIDENTIAL
_____________________________________________________________________________________
[GSK logo]
RELENZA
Zanamivir
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each _RELENZA ROTADISK_ consists of four regularly spaced double foil
blisters each containing a white to
off-white micronised powder mixture of zanamivir (5 mg) and lactose
(20 mg).
PHARMACEUTICAL FORM
Inhalation powder.
CLINICAL PARTICULARS
INDICATIONS
TREATMENT OF INFLUENZA:_RELENZA_ is indicated for treatment of both
influenza A and B in adults and
children (5 years and older).
PROPHYLAXIS: _RELENZA_ is indicated for prophylaxis of both influenza
A and B in adults and children ( 5
years and older).
Vaccination remains the primary method of preventing and controlling
influenza.
_RELENZA_ is indicated for prophylaxis of influenza A and B during
community outbreaks only in
circumstances where such prophylaxis is justified (such as when
vaccine that antigenically matches
circulating influenza is not available or there is a pandemic).
It is not recommended for routine prophylaxis against influenza
infection.
DOSAGE AND ADMINISTRATION
_RELENZA_ is for administration to the respiratory tract by oral
inhalation only, using the _DISKHALER_ device
provided.
Patients scheduled to take inhaled drugs, e.g. fast acting
bronchodilators, at the same time as _RELENZA_
should be advised to administer that drug prior to administration of
_RELENZA_.
•
_Adults _
TREATMENT OF INFLUENZA
The recommended dose of _RELENZA_ is two inhalations (2 x 5 mg) twice
daily for five days, providing a
total daily inhaled dose of 20mg.
For maximum benefit, treatment should begin as soon as possible
(preferably within two days) after onset
of symptoms.
PROPHYLAXIS OF INFLUENZA
The recommended dose of _RELENZA_ is two inhalations (2 x 5 mg) once
daily for 10 days, providing a total
daily inhaled dose of 10 mg. This may be increased up to 28 days if
the period of exposure risk extends
beyond 10 days.
The full course of prophylaxis therapy should be completed as
prescribed.
CONFIDEN