Clenil 50mcg pressurized inhalation solution

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BECLOMETHASONE DIPROPIONATE

Boleh didapati daripada:

GERMAX SDN. BHD.

INN (Nama Antarabangsa):

BECLOMETHASONE DIPROPIONATE

Unit dalam pakej:

19ml mL

Dikeluarkan oleh:

CHIESI FARMACEUTICI SPA

Risalah maklumat

_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CLENIL PRESSURIZED INHALATION
SOLUTION
Beclomethasone Dipropionate (50mcg, 250mcg)
1
WHAT IS IN THIS LEAFLET
1. What Clenil Inhaler is used for
2. How Clenil Inhaler works
3. Before you use Clenil Inhaler
4. How to use Clenil Inhaler
5. While you are using it
6. Side effects
7. Storage and Disposal of Clenil Inhaler
8. Product Description
9. Manufacturer & Product Registration
Holder
10. Date of revision
WHAT CLENIL INHALER IS USED FOR
Clenil Inhaler is used for asthma.
HOW CLENIL INHALER WORKS
Beclomethasone
dipropionate
has
anti-
inflammatory and anti-allergic activity on
the nose and lung linings. It also reduces
swelling,
hypersecretion
and
inhibits
tightening of lung muscles.
BEFORE YOU USE CLENIL INHALER
_- When you must not use it _
Do not use Clenil Inhaler:
•
If you have tuberculosis.
•
If you have viral infection.
•
If
you
are
hypersensitive
to
beclomethasone, corticosteroid or other
ingredients
listed
at
the
end
of
this
leaflet.
If any of these applies to you, you should
not be given Clenil Inhaler.
Tell your doctor immediately.
_- Before you start to use it _
Use Clenil Inhaler regularly at prescribed
doses as the physician deems it suitable:
•
This product contains small amount of
ethanol
and
glycerol.
However,
the
quantities are negligible and do not
constitute
a
risk
if
you
are
taking
recommended doses.
•
Tell the doctor if you are suffering
from
liver
disease,
alchoholism,
seizures and brain disease.
•
Tell the doctor if you are pregnant and/
or lactating.
_- Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop. Your doctor may limit your use of
beclomethasone dipropionate or other
medicines, or you may need to take a
different medicine.
Some
medicines
may
increase
the
effects of Clenil Inhaler and your doctor
may wish to monitor you carefully if you
are taking medicines for HIV such as
cobicistat
or
antib

Ciri produk

COMPOSITION
Each canister contains:
ACTIVE INGREDIENT:
Beclometasone-dipropionate 10 mg (each actuation delivers 50
micrograms)
EXCIPIENTS: HFA 134a (norflurane), ethanol, glycerol.
Pressurised canister providing 200 inhalations of 50 micrograms of
beclometasone.
The product does not contain any substance damaging ozonosphere.
DESCRIPTION
Pressurised inhalation solution of beclomethasone dipropionate filled
into a can with a metering valve
and inserted in an actuator.
PHARMACODYNAMIC PROPERTIES
Beclomethasone dipropionate (BDP) is a pro-drug with weak
glucocorticoid receptor binding activity. It is
hydrolysed via esterase enzymes to the active metabolite
beclomethasone-17-monopropionate (B-17-MP),
which has high topical anti-inflammatory activity.
It has an intense and prolonged anti-inflammatory activity towards
croton oil-carrageenan-, formaldeyde,
egg-white-, and dextran-induced oedema, and towards the granulomatous
reaction by foreign bodies,
with effectiveness higher than that of other corticosteroids. CLENIL
®
has no thymolytic, splenolytic or
mineralcorticoid activity, if administered at the advised doses, and
does not inhibit the hypophysial-
adrenal function even after repeated administrations.
PHARMACOKINETIC PROPERTIES
ABSORPTION
When administered via inhalation, there is extensive conversion of
Beclomethasone dipropionate (BDP)
to active metabolite beclomethasone-17-monopropionate (B-17-MP) within
the lungs prior to systemic
absorption. In healthy male volunteers the absolute bioavailability
following inhalation is approximately
2% (95% CI 1-5%) and 62% (95% CI 47-83%) of the nominal dose for
unchanged BDP and B-17-MP
respectively. The systemic absorption of B-17-MP arises from both lung
deposition (approximately 36%)
and oral absorption of the swallowed dose (approximately 26%). BDP is
absorbed rapidly with peak
plasma concentrations first being observed (tmax) at 0.3h. B-17-MP
appears more slowly with a tmax of
1h. There is an approximately linear increase in systemic exposure
with increasing inhal