Budesma Pressurised Inhalation BP 200mcg

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

Budesonide BP

Tersedia dari:

BioCare Pharmaceutical (M) Sdn. Bhd.

INN (Nama Internasional):

Budesonide BP

Unit dalam paket:

9 gm; 9 gm

Diproduksi oleh:

GLENMARK PHARMACEUTICALS LTD

Selebaran informasi

_Consumer Medication Information Leaflet (RiMUP) _
BUDESMA PRESSURISED INHALATION BP
200MCG
Budesonide (200mcg/actuation)
1
WHAT IS IN THIS LEAFLET
1.
What Budesma Pressurised
Inhalation is used for
2.
How Budesma Pressurised
Inhalation works
3.
Before
you
use
Budesma
Pressurised Inhalation
4.
How
to
use
Budesma
Pressurised Inhalation
you
are
using
Pressurised
5.
While
Budesma
Inhalation
6.
Side effects
7.
Storage
and
disposal
of
Budesma
Pressurised
Inhalation
8.
Product description
9.
Manufacturer
and
product
registration holder
10.
Date of revision
WHAT
BUDESMA
PRESSURISED
INHALATION IS USED FOR
Budesma Pressurised Inhalation is
used for the regular treatment of
asthma.
HOW
BUDESMA
PRESSURISED
INHALATION WORKS
Budesma
Pressurised
Inhalation
belongs to a group medicines called
corticosteroids.
It
relieves
and
prevents
inflammation
in
the
airways
caused
by
asthma.
Budesma Pressurised Inhalation is
intended for regular use and not for
rapid
relief
of
acute
asthma
conditions. It may take some weeks
before you receive the full effect of
the treatment.
BEFORE
YOU
USE
BUDESMA
PRESSURISED INHALATION
_When you must not use it _
In case of hypersensitivity to the
active substance or to the excipient.
.
_Before you start to use it _
Tell your doctor or pharmacist if you
have any of the following conditions:
i)
Pulmonary
tuberculosis
(bacterial
infections
of
the
lungs),
ii)
Chicken pox,
iii) Measles
Replacement of systemic steroid
therapy (treatment that reaches cells
throughout the body by travelling
through the bloodstream) with
inhaled therapy may unmask
allergies such as allergic rhinitis
(inflammation of the inside of the
nose) or eczema previously
controlled by systemic therapy.
You should rinse your mouth out
with water after each dosage to
minimize the risk of fungal infection
in your mouth and throat. You must
contact your doctor if your asthma
gets worse. This may mean that the
dosage needs to be changed or that
you need other treatment.
In an acute asthma attack you must
use your fast-acting asthma
medicine.
_Ta

Karakteristik produk

PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE:
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
_For the use only of a Registered Medical Practitioner _
_or a Hospital or a Laboratory_
300 METERED DOSES
200 mcg /Actuation
CFC FREE
Budesma Pressurised
Inhalation BP 200 mcg
COMPOSITION
Each actuation delivers:
Budesonide BP
200 mcg
DESCRIPTION
White colour suspension filled in Aluminium aerosol can with silver
ferrule
valve provided with actuator suitable for oral inhalation, when
actuated a
metered spray is produced.
PHARMACOLOGY
Budesonide is a potent glucocorticoid that when given systemically has
standard
glucocorticoid
activity
and
binds
with
high
affinity
to
the
glucocorticoid receptor. The drug was developed primarily for topical
use.
Budesonide, if given systemically, has catabolic and antianabolic
effect on
proteins in peripheral tissues; it causes resistance to insulin and
impairs
the peripheral utilization of glucose as well as causing increased
calcium
loss from bone via the kidney. However budesonide depends for its
effects
on the local anti-inflammatory and immunosuppressive activity. It has
been
shown in animal studies to have a high ratio of topical to systemic
activity
compared
with
other
corticosteroids
including
beclomethasone
dipropionate,
flunisolide,
flucinolone
acetonide,
and
triamcinolone
acetonide. Results of a study of hamsters with induced ileitis
suggested
that the anti-inflammatory effect of budesonide was due to local
rather than
systemic
effects.
Inhaled
glucocorticoids
reduce
the
number
of
inflammatory cells such as eosinophils, lymphocytes and mast cells and
restore airway epithelial integrity in bronchial biopsy specimens
obtained
from mild asthmatic patients. Inhaled budesonide also reduces indices
of
eosinophil activation in asthma. These effects are likely to result
from
inhibition of transcription of several cytokines that are over
expressed in
asthma, in particular the interleukins IL-3, IL-4 and IL-5 and
granulocyte
macrophage
colony
stimulating
factor
(GM-CSF),
especially
from