SALTAMOL 100 mcgdose HFA METERED DOSE INHALER

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Salbutamol sulphate BP (Micronised

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

Salbutamol sulphate BP (Micronised

Unit dalam pakej:

1 Units

Dikeluarkan oleh:

Square Phamarceuticals Ltd.

Risalah maklumat

SALTAMOL 100MCG/DOSE HFA METERED
DOSE INHALER
Salbutamol Sulphate as Salbutamol 100 mcg/puff
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What
_ Saltamol _
is used for
2. How
_Saltamol_
works
3. Before you use
_Saltamol_
4. How to use
_Saltamol_
5. While you are using it
6. Side effects
7. Storage and Disposal of
_ Saltamol_
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT _SALTAMOL_ IS USED FOR
Salbutamol is used:
•
To
provide
short-acting
bronchodilation (allowing increased
airflow to and from the lungs) with
fast
onset
in
reversible
airway
obstruction.
•
To relieve the symptoms of asthma
when
they
occur,
and
to
prevent
them
in
those
circumstances
recognized
by
the
patient
to
precipitate
an
asthma
attack
(e.g.
before
exercise
or
unavoidable
allergen exposure).
•
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 _SALTAMOL_ WORKS
_Saltamol _
contains salbutamol which
works
by
relaxing
muscles
in
the
air
passages of the lungs. It helps to keep
the
airways
open,
making
it
easier
to
breathe.
BEFORE YOU USE _SALTAMOL_
-
_When you must not use it _
Do not use
_Saltamol_
if you have allergic
to
Salbutamol
or
any
ingredient
of
_Saltamol. _
_ _
Should
not
use
salbutamol
to
arrest
premature labour or threatened abortion.
_ _
_Pregnancy and lactation _
Safety in pregnant women has not been
established.
_Saltamol _
should not be used
during
pregnancy
unless
clearly
necessary.
_Saltamol _
is probably secreted in breast
milk,
it
requires
careful
consideration
when nursing.
_ _
-
_Before you start to use it _
Tell your doctor or pharmacist if:
•
You
experience
a
different
taste
upon inhalation compared to their
previous inhaler.
•
You have a severe asthma.
•
The
effective
dose
of
inhaled
salbutamol fails to give relief lasting
at least 3 hours.
•
Short-acting
relief
bronchodilator
treatment becomes less effectiv

Ciri produk

SALTAMOL 100 MCG/DOSE HFA METERED DOSE INHALER
‘Salbutamol Sulphate as Salbutamol 100mcg/puff’
PRODUCT DESCRIPTION
An easily actuated aerosol having plastic actuator of blue color body
and light blue color cap
embossed “SQUARE” logo on cap. The canister contains a suspension
of Salbutamol Sulphate along
with a propellant filled in a metallic can which is fitted with a
metering valve; imprinted with
Batch no., Mfg date and Exp date.
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 hour)
bronchodilation with a fast onset
(within 5 minutes) in reversible airways obstruction.
_Special Patient Populations_
_Children < 4 years of age_
Patients < 4 years with bronchospasm associated with reversible
obstructive airways disease, show
that salbutamol Evohaler has a safety profile comparable to that in
children ≥ 4 years, adolescents
and adults.
PHARMACOKINETICS
Salbutamol administered intravenously has a half-life of 4 to 6 hours
and is cleared partly renally and
partly by metabolism to the inactive 4'-O-sulfate (phenolic sulfate)
which is also excreted primarily in
the urine. The faeces are a minor route of excretion.
After administration by the inhaled route between 10 and 20% of the
dose reaches the lower airways.
The remainder is retained in the delivery system or is deposited in
the oropharynx from where it is
swallowed. The fraction deposited in the airways is absorbed into the
pulmonary tissues and
circulation, but is not metabolised by the lung. On reaching the
systemic circulation it becomes
accessible to hepatic metabolism and is excreted, primarily in the
urine, as unchanged drug and as
the phenolic sulfate.
The swallowed portion of an inhaled dose is absorbed from the
gastrointestinal tract and undergoes
considerable first-pass metabolism to the phenolic sulfate. Both
unchanged drug and conjugate are
excreted primarily in the urine. Most of a dose of salbutamol given
intraveno