Asthavent CFC free Inhaler (Salbutamol Pressurised Inhalation BP 100 mcgactuation)

País: Malásia

Língua: inglês

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

Ingredientes ativos:

Salbutamol Sulphate BP

Disponível em:

CIPLA MALAYSIA SDN BHD

DCI (Denominação Comum Internacional):

Salbutamol Sulphate BP

Unidades em pacote:

1Units Units; 1 Units Units

Fabricado por:

CIPLA LTD

Folheto informativo - Bula

ASTHAVENT CFC FREE INHALER
® _ _
SALBUTAMOL /100MCG _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
____________________________________________________________________________________
Page 1
WHAT IS IN THIS LEAFLET
1
What
ASTHAVENT
CFC
FREE
INHALER is used for
2
How
ASTHAVENT
CFC
FREE
INHALER works
3
Before you use ASTHAVENT CFC
FREE INHALER
4
How
to
use
ASTHAVENT
CFC
FREE INHALER
5
While you are using it
6
Side effects
7
Storage
and
Disposal
of
ASTHAVENT
CFC
FREE
INHALER
8
Product Description
9
Manufacturer
and
Product
Registration Holder
10
Date of Revision
WHAT
ASTHAVENT
CFC
FREE
INHALER IS USED FOR
Salbutamol sulphate inhaler is used to
treat breathing problems in people with
difficulty in breathing, asthma, chronic
bronchitis
and
emphysema
(disease
affecting the air sacs in the lungs). This
includes relieving and preventing asthma
brought on by exercise or other
“triggers”. These are things, which bring
on
asthma
symptoms
in
some
people.
Common
triggers
include
house
dust,
pollen, cats, dogs and cigarette smoke.
Salbutamol inhaler contains a propellant
called HFA 134a. This is less harmful to
the environment than older inhalers.
HOW
ASTHAVENT
CFC
FREE
INHALER WORKS
Salbutamol inhaler contains a medicine
called
salbutamol.
This
belongs
to
a
group
of
medicines
called
bronchodilators.
•
Bronchodilators help the airways in
your lungs to stay open. This makes
it easier for air to get in and out.
•
They help to relieve chest tightness,
wheezing and cough.
BEFORE
YOU
USE
ASTHAVENT
CFC
FREE INHALER
_- When you must not use it _
DO
NOT
USE
ASTHAVENT
CFC
FREE
INHALER
IF:
•
you are allergic (hypersensitive) to
salbutamol
sulphate
or
any
other
ingredients
of
this
medicinal
product.
_ _
-_ Before you start to use it _
TAKE SPECIAL CARE WITH ASTHAVENT CFC
FREE INHALER
Check
with
your
doctor,
nurse
or
pharmacist before taking your medicine
if:
•
you have a history of heart problems
such as an irregular or fast heartbeat
or angina, increased blood pressure
•
your asthma is active (for example
you have freq

Características técnicas

_For _
_the _
_use _
_of _
_Registered _
_Medical _
_Practitioner or a Hospital or a Laboratory _
_only _
ASTHAVENT CFC FREE INHALER
(Salbutamol Pressurised
Inhalation BP 100 mcg/actuation)
COMPOSITION
Each actuation delivers:
Salbutamol Sulphate BP equivalent to
Salbutamol ….....................….100 mcg
Suspended in
propellant HFA 134a…...............…q.s.
DOSAGE FORM
Pressurised Inhalation
PRODUCT DESCRIPTION
A one piece filled metal container fitted
with
a
valve
with
plastic
stem
and
printed
with
product
name,
batch
number
and
container
number.
On
visual examination there should be no
sign of physical damage such as dents,
buldged container bent valve & uneven
crimping.
PHARMACOLOGY
MECHANISM OF ACTION:
Salbutamol is a selective 2-adrenoceptor
agonist. At therapeutic doses, it acts on
the 2-adrenoceptors of bronchial muscle
with little or no action on 2-adrenoceptors
of
cardiac
muscle.
Salbutamol
thus
provides
short
acting
(4-6
hours)
bronchodilatation
with
a
fast
onset
(within 5 minutes) in reversible airways
obstruction.
PHARMACOKINETICS
Absorption Salbutamol appears to be
absorbed
from
the
respiratory
tract
over
several
hours
following
oral
inhalation. The peak plasma salbutamol
concentrations occurs in 2.5 hours.
Metabolism and Elimination
After oral inhalation of salbutamol in
healthy adults, the elimination half-life
of
unchanged
drug
was
determined
indirectly to be 3.8 hours.
Salbutamol is extensively metabolized
in the liver, mainly to salbutamol 4' O
sulfate which has little or no -adrenergic
stimulating effect and no -adrenergic
blocking effect.
Salbutamol
and
its
metabolites
are
rapidly excreted in urine and faeces.
After oral inhalation of salbutamol in
patients
with
asthma,
approximately
70% of a dose is excreted in urine as
unchanged
drug
and
metabolites
within 24 hours and 80-100% within 72
hours;
about
30%
of
the
dose
is
excreted
in
urine
unchanged
in
24
hours. About 10% of an inhaled dose of
salbutamol may be excreted in faeces.
INDICATIONS
Asthavent CFC-Free Inhaler provides
short-ac