Aridol

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
11-06-2024
Shusha Tabia za bidhaa (SPC)
11-06-2024

Viambatanisho vya kazi:

Mannitol

Inapatikana kutoka:

Pharmaxis Ltd

Darasa:

Medicine Registered

Taarifa za kipeperushi

                                _Aridol CMI-Australia _
_ _
_Page 1 of 3 _
_Version: 2011-09-15 _
ARIDOL
®
 
MANNITOL 
 
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Aridol.  It does not 
contain all the available information.  
It does not take the place of talking to 
your doctor or pharmacist. 
All medicines have risks and benefits. 
Your doctor has weighed the risks of 
you taking Aridol against the benefits 
they expect it will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING AN ARIDOL TEST, ASK YOUR 
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE.  
You may need to read it again. 
WHAT ARIDOL IS USED FOR 
Aridol is a TEST to see if you have 
asthma or not. 
Aridol contains the active ingredient 
mannitol. 
Asthma is a condition causing 
inflammation of the airways, making 
it difficult to breathe sometimes.  
People with asthma are often very 
susceptible to factors in the 
environment such as exercise, dust, 
smoke and other irritants. 
Your doctor or another specifically 
trained healthcare professional will 
ask you to breathe in Aridol, using a 
small inhaler. 
•  For people who DO have ASTHMA, 
their airways will become 
narrower and so they may find it 
harder to breathe. 
•  People who DO NOT have ASTHMA 
will not experience their airways 
becoming narrower when 
breathing in Aridol.  They will 
still be able to breathe normally. 
 
As part of the test, you will be asked 
to blow into a tube that will measure 
the effect of Aridol on your lungs. 
This medicine is only used to see 
whether you have asthma. 
ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY AN ARIDOL TEST 
HAS BEEN ORDERED FOR YOU.   
BEFORE YOU START TO USE IT 
WHEN YOU MUST NOT USE IT 
DO NOT TAKE AN ARIDOL TEST if you 
have an
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                _Aridol PI-Australia _
_Page 1 of 7 _
_Version: 2006-03-22 _
PRODUCT INFORMATION 
ARIDOL  
MANNITOL POWDER FOR INHALATION 
NAME 
Mannitol. Also known as D-mannitol. 
The empirical formula is C
6
H
14
O
6
. Molecular weight is 182.2 
CAS number: 69-65-8. 
 
Structural Formula: 
 
 
 
 
 
 
DESCRIPTION 
Mannitol is a hexahydric alcohol. The powder is a white or almost
white, crystalline powder of free-
flowing granules. Mannitol is freely soluble in water, and
very slightly soluble in alcohol. Mannitol 
shows polymorphism. 
   
Mannitol is the only ingredient in the contents of Aridol
hard gelatin capsules.  Colouring agents are 
used on the caps of the 5, 10, 20 and 40 mg capsules (the 0
mg capsule and the bodies of the other 
capsules are clear). The colouring agents are titanium dioxide (5,
10, 20 and 40 mg), yellow iron 
oxide (10 mg) and red iron oxide (20 and 40 mg).  The delivered dose
from each of the 5, 10, 20 and 
40mg capsules is approximately 3, 8, 16 and 31mg, respectively. 
PHARMACOLOGY 
_PHARMACODYNAMICS _
When inhaled, mannitol induces an increase in osmolarity in the
airways similar to other bronchial 
provocation tests such as hypertonic saline, exercise and the
hyperpnea of dry air. The increase in 
osmolarity is associated with the release of a wide variety of
mediators of bronchoconstriction from 
inflammatory cells within the airways. These mediators then act via
specific receptors on bronchial 
smooth muscle to cause contraction and the airways to narrow.  The
airway response is most 
pronounced (hyperresponsiveness) in patients with asthma and
exercise-induced asthma.  The airway 
response to Aridol is measured using the forced expiratory volume in
one second (FEV
1
). The 
sensitivity to mannitol is reported as the delivered dose of
mannitol to cause a 15% reduction in FEV
1
.  
 
The involvement of airway inflammation has been demonstrated by a
reduction in the sensitivity to 
inhaled mann
                                
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