ARIDOL mannitol powder for inhalation composite pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

mannitol, Quantity: 0 mg

Verfügbar ab:

BTC Speciality Health Pty Ltd

INN (Internationale Bezeichnung):

Mannitol

Darreichungsform:

Capsule, hard

Zusammensetzung:

Excipient Ingredients: Gelatin

Verabreichungsweg:

Inhalation

Einheiten im Paket:

Combination pack: 1x empty capsule (clear/clear), 1x5 mg capsule (white/clear), 1x10 mg capsule (yellow/clear), 1x20 mg capsule (pink/clear), 15x40 mg capsules (red/clear) with 1xOsmohaler device

Verschreibungstyp:

Not Scheduled after consideration by Committee

Anwendungsgebiete:

Aridol is indicated for identifying bronchial hyperresponsiveness to assist in the diagnosis of asthma.

Produktbesonderheiten:

Visual Identification: Hard gelatin capsule-size 3, Clear body and cap printed with two white bands.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2006-04-11

Gebrauchsinformation

_Aridol CMI-Australia _
_ _
_Page 1 of 3 _
_Version: 17-May-2021 _
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 ALLERGY to:

mannitol

any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an allergic
reaction to a medicine may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of the
body; rash, itching or hives on the
skin.
DO NOT TAKE A

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION – ARIDOL (MANNITOL)
POWDER FOR INHALATION IN HARD CAPSULES COMPOSITE PACK
1
NAME OF THE MEDICINE
Mannitol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0 mg, 5 mg, 10 mg, 20 mg or 40 mg mannitol. The
delivered dose from
each of the 5, 10, 20 and 40 mg capsules is approximately 3, 8, 16 and
31 mg, respectively.
For the full list of excipients, see _section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Powder for inhalation in hard capsules
Hard gelatin capsule-size 3:
•
Empty capsule: Clear body and cap printed with two white bands.
•
5 mg capsule: Clear body/white cap with “5 mg” printed on body.
•
10 mg capsule: Clear body/yellow cap with "10 mg" printed on body.
•
20 mg capsule: Clear body/pink cap with "20 mg" printed on body.
•
40 mg capsule: Clear body/red cap with "40 mg" printed on body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Aridol is indicated for identifying bronchial hyperresponsiveness to
assist in the diagnosis of
asthma.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Aridol is supplied in kit form containing sufficient capsules to
complete one complete challenge,
and the inhalation device (Osmohaler™).
Prior to the challenge, spirometry should be performed and the
reproducibility of the resting
FEV
1
established.
The patient should be seated comfortably and encouraged to maintain
good posture to assist
the effective delivery of Aridol to the lungs. The test should proceed
as follows:
1.
Apply nose clip and subject should be directed to breathe through the
mouth
2.
Insert 0 mg capsule into inhalation device. Puncture capsule by
depressing buttons on side
of device slowly, and once only (a second puncture may fragment the
capsules)
3.
The patient should exhale completely, before inhaling from device in a
controlled rapid
deep inspiration
4.
At the end of deep inspiration, start 60 second timer, subject should
hold breath for 5
seconds and exhale through mouth before removal of nose clip
5.
At the end of 60 seconds, measure the