Salbutis (Salbutamol Inhalation Aerosol 100mcgdose CFC free)

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

SALBUTAMOL SULPHATE

Tilgjengelig fra:

MEDISPEC (M) SDN.BHD

INN (International Name):

SALBUTAMOL SULPHATE

Enheter i pakken:

1Units Units

Produsert av:

Jewim Pharmaceutical (Shandong) Co., Ltd

Informasjon til brukeren

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SALBUTIS (SALBUTAMOL INHALATION
AEROSOL 100MCG/DOSE CFC FREE)
Salbutamol sulphate (100mcg/dose) 1
WHAT IS IN THIS LEAFLET
1.
What SALBUTIS is used for
2.
How SALBUTIS works
3.
Before you use SALBUTIS
4.
How to use SALBUTIS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of SALBUTIS
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT SALBUTIS IS USED FOR
SALBUTIS provides short-acting (4 to
6
hours)
bronchodilatation
with
fast
onset (within 5 minutes) in reversible
airways obstruction.
It is particularly suitable for the relief
and prevention of asthma symptoms. It
should
be
used
to
relieve
symptoms
when they occur, and to prevent them in
those circumstances recognised by the
patient to precipitate an asthma attack
(e.g.
before
exercise
or
unavoidable
allergen exposure).
SALBUTIS is particularly valuable as
relief medication in mild, moderate or
severe asthma, provided that reliance on
it does not delay the introduction and
use
of
regular
inhaled
corticosteroid
therapy.
HOW SALBUTIS WORKS
Salbutamol
is
a
selective
β2-
adrenoceptor
agonist.
At
therapeutic
doses it acts on the β2-adrenoceptors of
bronchial muscle providing short acting
(4-6
hours)
bronchodilatation
with
a
fast
onset
(within
5
minutes)
in
reversible airways obstruction.
BEFORE YOU USE SALBUTIS
_-When you must not use it _
•
If you are allergic (hypersensitive)
to salbutamol sulphate or the other
ingredient HFA 134a.
_- Before you start to take it _
Check
with
your
doctor,
nurse
or
pharmacist if:
•
you have high blood pressure
•
you have an overactive thyroid
gland
•
you
have
a
history
of
heart
problems such as an irregular or
fast heartbeat or angina.
_ _
_- Taking other medicines _
Please
tell
your
doctor,
nurse
or
pharmacist if you are taking or have
recently taken any other medicines,
including
medicines
obtained
without a prescription. This includes
herbal medicines. Remember to take
this

Preparatomtale

SALBUTIS INHALER 100MCG/DOSE
CFC-free
NAME
Salbutamol Inhalation Aerosol BP CFC-free
STRENGTH
200 doses,each dose contains 100mcg Salbutamol BP and 4.5mg Absolute
ethanol
300 doses,each dose contains 100mcg Salbutamol BP and 4.5mg Absolute
ethanol
400 doses,each dose contains 100mcg Salbutamol BP and 4.5mg Absolute
ethanol
DOSAGE FORM
Aerosol
PRODUCT DESCRIPTION
Salbutamol Inhalation Aerosol is a kind of white or slight yellow
suspension mixed with just right
quantity of propellant and kept in a pressurised canister with a
metered valve system.
PHARMACODYNAMICS
Salbutamol is a selective β
2
-adrenoceptor agonist. At therapeutic doses it acts on the
β
2
-adrenoceptors of bronchial muscle providing short acting (4-6 hours)
bronchodilatation with a
fast onset (within 5 minutes) in reversible airways obstruction.
PHARMACOKINETICS
The
inspired aerosol’s
effect
begins
to act
in 5 minutes
and results
in maximum plasma
concentrations occurring within 2 to 4 hours.
The total
effective period lasts for
4-6 hours.
Salbutamol has an elimination half-life of 3-8 hours. Approximately
72% of the inhaled dose is
excreted within 24 hours in the urine,
and consists of
28% as unchanged drug and 44% as
metabolite.
INDICATION
Salbutamol
Inhalation Aerosol
provides short-acting (4 to 6 hours) bronchodilatation with fast
onset (within 5 minutes) in reversible airways obstruction.
It is particularly suitable for the relief and prevention of asthma
symptoms.
It should be used to
relieve symptoms when they occur, and to prevent them in those
circumstances recognised by the
patient to precipitate an asthma attack (e.g. before exercise or
unavoidable allergen exposure).
Salbutamol Inhalation Aerosol is particularly valuable as relief
medication in mild,
moderate or
severe asthma,
provided that
reliance on it
does not
delay the introduction and use of regular
inhaled corticosteroid therapy.
RECOMMENDED DOSE
In acute bronchospasm:
Adult dosage : 100 to 200 mcg daily.
Children dosage: 100 mcg daily. If required, the dose can be increased
t