Budeten® Inhaler 200mcg

国家: 马来西亚

语言: 英文

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

有效成分:

Budesonide BP

可用日期:

TENANG PHARMA SDN. BHD.

INN（国际名称）:

Budesonide BP

每包单位数:

200 ACTUATIONS

厂商:

TENANG PHARMA SDN. BHD.

资料单张

_Consumer Medication Information Leaflet (RiMUP) _
BUDETEN
® INHALER 200MCG
_Budesonide (200mcg/actuation) _
_Pressurised Metered-Dose Inhaler/Suspension _
___________________________________________________________________________________________
_
WHAT IS IN THIS LEAFLET:
a)
What Budeten
®
Inhaler is
used for
b)
How
Budeten
®
Inhaler
works
c)
Before you use Budeten
®
Inhaler
d)
How
to
use
Budeten
®
Inhaler
e)
While
you
are
using
Budeten
®
Inhaler
f)
Side effects
g)
Preparing
your
Budeten
®
Inhaler
h)
How to use your inhaler
i)
Storage
and
disposal
of
Budeten
®
Inhaler
j)
Product description
k)
Manufacturer
l)
Product
Registration
Holder
m)
Date of revision
WHAT
BUDETEN
®
INHALER
IS
USED FOR:
The name of your medicine is
Budeten
®
Inhaler
200mcg
(called
‘Budeten
®
Inhaler’
in
this leaflet). Budeten
®
Inhaler
contains
a
medicine
called
_budesonide_
,
a
glucocorticosteroid, which is a
type
of
steroid.
Each
puff
contains 200mcg
_budesonide. _
HOW
BUDETEN
®
INHALER
WORKS:
Budeten
®
Inhaler
works
by
reducing
and
preventing
swelling and inflammation
of the lungs.
BEFORE
YOU
USE
BUDETEN
®
INHALER
Some medications may increase
the effects of Budeten
®
Inhaler
and your doctor may wish to
monitor you carefully if you are
taking
these
medications
(including some medicines for
HIV such as cobicistat).
_When you must not use it: _
Do not take this medicine and
tell your doctor if:
a)
You
are
allergic
(hypersensitive)
to
_budesonide _
or any of the
other
ingredients
of
Budeten
®
Inhaler
b)
You
have
tuberculosis
(TB)
c)
You have a cold or chest
infection
d)
You have liver problems
_Before you start to use it: _
Check
with
your
doctor
or
pharmacist
before
taking
Budeten
®
Inhaler:
a)
If
you
are
pregnant
or
planning
to
become
pregnant.
b)
If you are breast feeding.
c)
If you have liver problems.
d)
If
you
are
taking
any
steroid medicines
_Taking other medicines: _
Tell your doctor about all the
medicines you take, including
prescription
and
non-
prescription
medicines,
vitamins,
and
herbal
supplements. Bude

产品特点

For Medical Professional Use Only
_ _
BUDETEN
® INHALER 200MCG
_Budesonide _
_pressurised metered-dose inhaler/suspension _
_ _
COMPOSITION
_Each _
metered dose inhaler contains
_budesonide BP _
200mcg.
_ _
DESCRIPTION
_Budeten_
_®_
_ Inhaler 200 mcg_
is a pressurised metered
dose inhaler containing not less than 200 actuations
of white or almost white suspension of
_budesonide _
filled in a 19 ml aluminium canister fitted with a 50
microlitres plastic and elastomeric metering valve
with a white polypropylene actuator and light pink
polypropylene dust cap and packed into individual
printed carton. Each actuation delivers 200 mcg of
_budesonide. _
PHARMACODYNAMICS
_Budesonide_
is a glucocorticoid with high topical anti-
inflammatory
effects.
_Budesonide’s_
activity,
measured as its affinity for glucocorticoid receptors is
approximately
15
times
higher
than
that
of
prednisolone.
The exact mechanism of action of glucocorticoid in
the treatment of asthma is not fully understood. Anti-
inflammatory effects such as inhibited release of
inflammatory mediators and inhibition of cytokine-
mediated immune response are probably important.
Clinically,
_budesonide_
reduced bronchial obstruction
during both the early and the late phase of an allergic
reaction.
In
hyper-reactive
patients,
_budesonide_
reduces the histamine and metacholine reactivity in
the airways.
PHARMACOKINETICS
_Absorption_
Peak plasma concentration (4.0 nmol/L after a dose
of 800g) of
_budesonide_
occurs within 30 minutes
following oral inhalation of
_budesonide_
. Maximum
plasma
concentration
and
area
under
the
plasma
concentration time profile increase linearly with dose
but are slightly (20-30%) higher following repeated
doses (3 weeks treatment) than after a single dose.
_Distribution _
Volume
of
distribution
of
inhaled
_budesonide_
is
approximately
3L/kg.
Plasma
protein
binding
averages 85-90%.
_Biotransformation _
_Budesonide_
undergoes an extensive degree (~90%) of
biotransformation on first passage through the liver to
metabolites of low glucoc