Biosone 100mcgdose HFA Inhalation Aerosol

Страна: Малайзия

Език: английски

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

Активна съставка:

ANHYDROUS BECLOMETHASONE DIPROPIONATE

Предлага се от:

BIOCARE MANUFACTURING SDN. BHD.

INN (Международно Name):

ANHYDROUS BECLOMETHASONE DIPROPIONATE

Броя в опаковка:

1 Units

Произведено от:

BIOCARE MANUFACTURING SDN. BHD.

Листовка

BIOSONE
® 100 MCG/DOSE HFA INHALATION AEROSOL
Beclometasone dipropionate 100 mcg/dose
Page
1
of
3
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What Biosone® 100 mcg/dose HFA
Inhalation Aerosol is used for
2.
How Biosone®100 mcg/dose HFA
Inhalation Aerosol works
3.
Before
you
use
Biosone®
100
mcg/dose HFA Inhalation Aerosol
4.
How to use Biosone® 100 mcg/dose
HFA Inhalation Aerosol
5.
While you are using Biosone® 100
mcg/dose HFA Inhalation Aerosol
6.
Side effects
7.
Storage and disposal of Biosone®
100
mcg/dose
HFA
Inhalation
Aerosol
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT BIOSONE® 100 MCG/DOSE HFA
INHALATION AEROSOL IS USED FOR
The active component of Biosone® 100
mcg/dose
HFA
Inhalation
Aerosol
is
Beclometasone Dipropionate, which is
an anti-inflammatory corticosteroid. It
helps to prevent asthma in people who
need regular treatment. This is why it is
sometimes called ‘preventer’.
HOW
BIOSONE®
100
MCG/DOSE
HFA
INHALATION AEROSOL WORKS
Biosone® 100 mcg/dose HFA Inhalation
Aerosol works by reducing swelling and
irritation in the lungs. It is a pressurized,
metered-dose aerosol intended for oral
inhalation
only.
It
is
an
environment
friendly inhaler.
BEFORE
YOU
USE
BIOSONE®
100
MCG/DOSE HFA INHALATION AEROSOL
Some medicines may increase the effects
of
Biosone®
100
mcg/dose
HFA
Inhalation Aerosol and your doctor may
wish to monitor you carefully if you are
taking these medicines (including some
medicines for HIV such as cobicistat).
_ _
_ _
_ _
_ _
_-When you must not use it _
Do not take Biosone® 100 mcg/dose
HFA
Inhalation
Aerosol
if
you
are
allergic (hypersensitive) to:
_ _
•
Beclometasone Dipropionate
_ _
•
Lactose or milk protein
_ _
•
Any
of
the
other
ingredients
of
Biosone®
100
mcg/dose
HFA
Inhalation Aerosol.
_ _
•
Do not use Biosone® 100 mcg/dose
HFA Inhalation Aerosol if any of
the above apply to you. If you are
not sure, talk to your doctor, nurse
or
pharmacist
before
using
Biosone®
100

Данни за продукта

TM
TM
TM
DESCRIPTION:
Biosone HFA is a bulk preparation for inhalation, supplied in a
pressurised container. On visual examination, the pressurised
container has no
sign of physical damage or leakage. The product is a clear solution.
INDICATION:
Indicated for the prophylactic management of mild, moderate or severe
asthma.
PHARMACODYNAMICS
:
The active ingredient of Biosone 100 HFA Inhaler is Beclometasone
Dipropionate (BDP) (ATC-Code R03 BA01) a topical
corticosteroid endowed with potent anti-inflammatory and
anti-allergic activity on the airways mucosa. Beclometasone
dipropionate, administered
by inhalation and in recommended doses, has a glucocorticoid
anti-inflammatory action within the lungs but no systemic effect.
PHARMACOKINETICS:
Absorption when administered via inhalation by a MDI: Systemic
absorption of unchanged beclometasone dipropionate (BDP) occurs
through the lungs. There is negligible oral absorption of the
swallowed dose of unchanged BD. Prior to absorption there is extensive
conversion of BDP to
its active metabolite B-17-MP. The systemic absorption of B-17-MP
arises from both lung deposition (36%) and oral absorption of the
swallowed dose
(26%).The absolute bioavailability following inhalation is
approximately 2% and 62% of the nominal dose for unchanged BDP and
B-17-MP, respectively.
BDP is absorbed rapidly with peak plasma concentrations observed
(tmax) at 0.3 hour. B-17-MP appears more slowly with a tmax of 1 hour.
There is an
approximately linear increase in systemic exposure with increasing
inhaled dose. When administered orally the bioavailability of BDP is
negligible but
presystemic conversion to B-17-MP results in 41% of the dose being
absorbed as B-17-MP.
Distribution:
The tissue distribution at steady-state for BDP is moderate (20 L) but
more extensive for B-17-MP (424 L). Plasma protein binding is
moderately
high (87%). Biotransformation: BDP is cleared very rapidly from the
systemic circulation, by metabolism mediated via esterase enzymes that
are found in
most tissues. The main