ASTHALIN HFA METERED DOSE INHALER 100MCGACTUATION

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

SALBUTAMOL SULPHATE

MAH:

CIPLA MALAYSIA SDN BHD

INN:

SALBUTAMOL SULPHATE

units_in_package:

200 Units; 200 Units

manufactured_by:

MEDISPRAY LABORATORIES PVT LTD

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ASTHALIN HFA INHALER
® _ _
SALBUTAMOL SULPHATE (100 MICROGRAMS)
____________________________________________________________________________________
Page 1
WHAT IS IN THIS LEAFLET
1.
What
ASTHALIN
INHALER
is
used for
2.
How ASTHALIN INHALER works
3.
Before
you
use
ASTHALIN
INHALER
4.
How to use ASTHALIN INHALER
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ASTHALIN INHALER
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ASTHALIN INHALER IS USED
FOR
Asthalin inhaler is used 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).
HOW ASTHALIN INHALER WORKS
Asthalin inhaler contains a medicine
called salbutamol. This belongs to a
group
of
medicines
called
bronchodilators. Bronchodilators relax
the muscles in the walls of the small
airway passages in the lungs.
Asthalin
•
Helps to open up the airways in your
lungs, making it easier for you to
breath.
•
Helps
to
relieve
chest
tightness,
wheezing and cough associated with
asthma.
Asthalin inhaler contains a propellant
called HFA 134a. This is less harmful
to the environment than older inhalers.
BEFORE
YOU
USE
ASTHALIN
INHALER
_- When you must not use it _
Do not use Asthalin inhaler:
•
If you are allergic (hypersensitive)
to salbutamol sulphate or any of the
other ingredients of this medicinal
product.
If you think any of these apply to you,
do
not
use
Asthalin
until
you
have
checked with your doctor.
_Pregnancy and brestfeeding _
Asthalin
inhaler
is
not
usually
recommended
for
use
during
pregnancy. If you are pregnant, or think
you could be, or if you are planning to
become pregnant, do not take Asthalin
inhaler
without
checking
with
your
doctor. Your doctor will consider the
benefit to you and the risk to your baby
of taking Asthalin inh

SPC

_For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory _
ASTHALIN HFA INHALER
SALBUTAMOL PRESSURISED INHALATION BP 100 ΜG / DOSE
COMPOSITION
Each actuation delivers
Salbutamol Sulphate BP equivalent to Salbutamol …………. 100 µg
Suspended in Propellant HFA-134a…………………………. q.s
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, bulged container bent valve stem and uneven
crimping. A white coloured
powder is obtained after opening the container.
PHARMACOLOGY
_PHARMACODYNAMICS _
Salbutamol stimulates β-adrenergic receptors and has little or no
effect on the α-adrenergic receptors.
Salbutamol is relatively selective β2-adrenergic agonist.
β-adrenergic agonists stimulate the
production of cyclic adenosine-3’,5’-monophosphate (AMP) by
activation of the enzyme adenyl
cyclase. Cyclic AMP appears to mediate numerous cellular responses.
Increased intracellular cyclic
AMP enhances the activity of cAMP dependent protein kinase A, which
inhibits the phosphorylation
of myosin and lowers intracellular calcium concentrations, resulting
in smooth muscle relaxation.
Increased intracellular cyclic AMP concentrations also are associated
with inhibition of the release of
mediators from mast cells in airways.
_PHARMACOKINETICS _
Absorption
Salbutamol appears to be absorbed from the respiratory tract over
several hours following oral
inhalation. The peak plasma salbutamol concentrations occur 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 β-adrenergic
stimulating effect and no β-adrenergic
blocking effect. Salbutamol and its metabolites are rapidly excre