Talgan Nebulizer suspension 1mg2ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BUDESONIDE

Boleh didapati daripada:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

BUDESONIDE

Unit dalam pakej:

20x2 ml

Dikeluarkan oleh:

Genetic S.p.A.

Risalah maklumat

TALGAN NEBULIZER SUSPENSION
Budesonide (0.25 mg/ml, 0.5 mg/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Talgan is used for
2.
How
Talgan
_ _
works
3.
Before you use Talgan
4.
How to use Talgan
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Talgan
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TALGAN_ _IS USED FOR
Talgan
is
used
for
the
treatment
of
asthma.
HOW TALGAN WORKS
Talgan
contains
a
medicine
called
budesonide. This belongs to a group of
medicines called corticosteroids. It works
by reducing and preventing swelling and
inflammation in the airways caused by
asthma.
BEFORE YOU USE TALGAN
_When you must not use it _
_ _
In case of allergy or hypersensitivity to
the Budesonide or to any of the other
ingredients of Talgan.
_Pregnancy and lactation _
Do not take Talgan if you are pregnant,
trying to get pregnant or think you may be
pregnant.
Do not take Talgan if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
_ _
-
_Before you start use it _
_ _
Tell your doctor or pharmacist if:
• You have a lung infection.
• You have a cold or chest infection.
• You have liver problems.
-
_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.
This is because Talgan can affect the
way some medicines work and some
medicines can have an effect on Talgan.
In
particular,
tell
your
doctor
or
pharmacist if you are taking any of the
following medicines:
•
Steroid medicines.
•
Medicines to treat fungal infections
(such
as
itraconazole
and
ketoconazole).
HOW TO USE TALGAN
•
Always use Talgan exactly as your
doctor, nurse or pharmacist has told
you. Ask one of them for advice if you
are not sure.
•
The solution in a single dose unit must
be put into a nebuliser and made into
a fine mist before it can be breathed in.
It is then inhal

Ciri produk

TALGAN NEBULIZER SUSPENSION 0.5 MG/2ML
TALGAN NEBULIZER SUSPENSION 1 MG/2ML
Budesonide
DESCRIPTION
_Talgan Nebulizer suspension 0.5 mg/2ml _
Preparation for inhalation in form of inhalation solution. Sterile
nebuliser suspension. White to off-
white suspension in plastic single dose units.
_Talgan Nebulizer suspension 1 mg/2ml _
Preparation for inhalation in form of inhalation solution. Sterile
nebuliser suspension. White to off-
white suspension in plastic single dose units.
COMPOSITION
_Talgan Nebulizer suspension 0.5 mg/2ml _
Each ml nebuliser suspension contains 0.25mg of Budesonide.
_Talgan Nebulizer suspension 1 mg/2ml _
Each ml nebuliser suspension contains 0.50mg of Budesonide.
PHARMACODYNAMICS
Budesonide is a glucocorticosteroid which possesses a high local
anti-inflammatory action, with a lower
incidence and severity of adverse effects than those seen with oral
corticosteroids.
The precise mechanism of action of glucocorticosteroids in the
treatment of asthma is not fully
understood. Anti-inflammatory effects (including T-cells, eosinophilic
cells and mast cells) such as
inhibition of the release of inflammatory mediators and inhibition of
cytokine-mediated immune
response, are probably important. The strength of budesonide, measured
as affinity for glucocorticoid
receptors, is approximately 15 times stronger than that of
prednisolone. Glucocorticoids reduce airway
inflammation and thus reduce airway hyper-responsiveness to a variety
of stimuli, as well as to effectively
prevent exercise-induced asthma.
Regular
treatment
with
glucocorticoids
improves
lung
function,
reduces
the
number
of
acute
exacerbations and reduces surrogate markers of airway inflammation
including decreased eosinophils in
sputum and decreased exhaled NO.
The most important aspect of inhaled glucocorticoids is that they
exert their effects locally and have much
reduced systemic exposure thus reducing side effects substantially.
Following inhalation the proportion
of drug absorbed and which together with the swallowed fraction could
r