CP Pharma Salbutamol CFC-Free Metered Dose Inhaler 100mcgactuation

Land: Malasía

Tungumál: enska

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

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Download Vara einkenni (SPC)
04-10-2022

Virkt innihaldsefni:

SALBUTAMOL SULPHATE

Fáanlegur frá:

Hovid Pharmacy Sdn. Bhd.

INN (Alþjóðlegt nafn):

SALBUTAMOL SULPHATE

Einingar í pakka:

1 (200 actuations) Units

Framleitt af:

LABORATORIO ALDO-UNION S.L.

Upplýsingar fylgiseðill

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CP
PHARMA
SALBUTAMOL
CFC-FREE
METERED
DOSE
INHALER
100
MCG/ACTUATION
Salbutamol 100 mcg/actuation
1
WHAT IS IN THIS LEAFLET
1.
What CP Pharma Salbutamol CFC-
Free
Metered
Dose
Inhaler
100mcg/actuation is used for
2.
How CP Pharma Salbutamol CFC-
Free
Metered
Dose
Inhaler
100mcg/actuation works
3.
Before
you
use
CP
Pharma
Salbutamol
CFC-Free
Metered
Dose Inhaler 100mcg/actuation
4.
How to use CP Pharma Salbutamol
CFC-Free
Metered
Dose
Inhaler
100mcg/actuation
5.
While you are using
CP
Pharma
Salbutamol
CFC-Free
Metered
Dose Inhaler 100mcg/actuation
6.
Side effects
7.
Storage and Disposal of CP Pharma
Salbutamol
CFC-Free
Metered
Dose Inhaler 100mcg/actuation
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT CP PHARMA SALBUTAMOL CFC-
FREE
METERED
DOSE
INHALER
100MCG/ACTUATION IS USED FOR
CP
Pharma
Salbutamol
CFC-Free
Metered Dose Inhaler 100mcg/actuation
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
recognized by the patient to precipitate
an asthma attack (e.g. before exercise or
unavoidable allergen exposure).
HOW CP PHARMA SALBUTAMOL CFC-
FREE
METERED
DOSE
INHALER
100MCG/ACTUATION WORKS
CP
Pharma
Salbutamol
CFC-Free
Metered Dose Inhaler 100mcg/actuation
contains a medicine called salbutamol.
Each
actuation
contains
100mcg
of
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. CP Pharma Salbutamol CFC-
Free
Metered
Dose
Inhaler
100mcg/actuation
•
helps
to
open
up
the
airways
in
your lungs, making it easier for you
to breathe.
•
helps
to
relieve
chest
tightness,
wheezing
and
cough
associated
with asthma.
CP
Pharma
Salbutamol
CFC-Free
Metered Dose Inhaler 100mcg/actuation
contains a propellant called HFA 134a.
This is less harmful to the environment
than older inhalers. Older inhal
                                
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Vara einkenni

                                SALBUTAMOL
CFC-Free Metered Dose Inhaler 100mcg / actuation
VISALxx-0_4
PRODUCT DESCRIPTION
10 ml white and homogenous suspension aerosol dosed for
200 inhalations (MDI).
Aluminium aerosol can with 200 inhalations (10ml), containing
100 μg of salbutamol each acutuation, sealed with a metering
valve (50 μl of capacity), equipped with a polypropylene
plastic
oral
actuator-adapter
(or
mouthpiece)
and
polypropylene plastic cap. These elements are the ones that
are usually used in medicines for inhalatory use. The colour of
the inhaler is blue actuator with dark blue cap.
COMPOSITION
Each actuation contains 120 mcg of Salbutamol Sulphate
(equivalent to Salbutamol 100 mcg).
PHARMACODYNAMICS
Salbutamol
is
a
selective
beta
2
-adrenoceptor
agonist.
At
therapeutic
doses
it
acts
on
the
beta
2
-adrenoceptor
of
bronchial
muscle
providing
short
acting
(4
to
6
hour)
bronchodilation
with
a
fast
onset
(within
5
minutes)
in
reversible airways obstruction.
PHARMACOKINETICS
ABSORPTION
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.
DISTRIBUTION
Salbutamol is bound to plasma proteins to the extent of 10%.
METABOLISM
On reaching the systemic circulation, salbutamol becomes
accessible to hepatic metabolism and is excreted, primarily in
the urine, as unchanged drug and as the phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed from
the gastrointestinal tract and undergoes considerable first-pass
metabolism to the phenolic sulphate. Both unchanged drug
and conjugate are excreted primarily in the urine.
ELIMINATION
Salbutamol administered intravenously has a half-life of four to
six hours and is cleared partly renally and partly by metabolism
to the inactive 4'-O-sulphate (phenolic sulphate) which is also
excreted primarily in t
                                
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