IPRAVENT ipratropium bromide 500 microgram/1 mL inhalation ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Preparatomtale Preparatomtale (SPC)
01-12-2017

Aktiv ingrediens:

ipratropium bromide monohydrate

Tilgjengelig fra:

Pfizer Australia Pty Ltd

Autorisasjon status:

Registered

Informasjon til brukeren

                                IPRAVENT
®
_INHALATION SOLUTION_
_Ipratropium bromide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ipravent.
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 using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IPRAVENT
INHALATION
SOLUTION IS USED FOR
Ipravent belongs to a group of
medicines known as anticholinergic
bronchodilators. Anticholinergic
bronchodilators work by relaxing the
bronchial tubes (air passages) that
carry air in and out of your lungs.
This makes breathing less difficult.
Ipravent is used to relieve the
symptoms of lung disease such as
asthma or chronic obstructive
bronchitis. It may be used in other
conditions where breathing is
difficult, such as after surgery or
during assisted ventilation.
Ipravent may be used for the
management of other conditions that
are not mentioned above. Your
doctor will be able to tell you about
the specific condition for which you
have been prescribed Ipravent.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT_
DO NOT USE IPRAVENT IF YOU HAVE AN
ALLERGY TO IPRATROPIUM BROMIDE OR
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
IF YOU ARE NOT SURE IF THIS APPLIES TO
YOU, CHECK WITH YOUR DOCTOR.
IPRAVENT SHOULD NOT BE GIVEN TO A
NEWBORN BABY.
DO NOT USE IT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK.
If you use it after the expiry date has
passed, it may not work as well.
DO NOT USE IT IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERING.
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF
1.
YOU HAVE ANY ALLERGIES TO:
•
any other medic
                                
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Preparatomtale

                                Version: pfpipraj10512
Supersedes: pupiprau10807
Page 1 of 8
PRODUCT INFORMATION
IPRAVENT
® INHALATION SOLUTION – UNIT DOSE
NAME OF THE MEDICINE
Ipratropium Bromide BP
Ipratropium bromide is a quaternary isopropyl derivative of atropine.
Its chemical name is
(1R, 3r, 5S, 8r)-3-[(RS) - (3 - hydroxy - 2 - phenylpropanoyl) oxy] -
8 - methyl - 8 - (1 -
methylethyl) - 8 - azoniabicyclo [3.2.1] octane bromide. It appears as
a white or almost
white, crystalline powder, soluble in water, freely soluble in
methanol and slightly soluble in
alcohol. The addition of an N-isopropyl group distinguishes the
molecule from atropine and
is responsible for a lower lipid solubility.
The structural formula is represented below.
Molecular Formula:
C
20
H
30
BrNO
3
Molecular Weight:
412.4
CAS Number:
22254-24-6
DESCRIPTION
Ipravent Inhalation Solution in Sterinebs is a clear, colourless to
almost colourless, sterile
solution. It contains ipratropium bromide monohydrate 261 g/mL
equivalent to 250 g
ipratropium bromide (anhydrous) or ipratropium bromide monohydrate 522
g/mL equivalent
to 500 g ipratropium bromide (anhydrous) and Sodium Chloride BP in
Water for Injections
BP. It does not contain preservatives.
Version: pfpipraj10512
Supersedes: pupiprau10807
Page 2 of 8
PHARMACOLOGY
CLASS OF DRUG
Anticholinergic bronchodilator.
MODE OF ACTION
Ipratropium bromide allows bronchodilation by inhibiting cholinergic
bronchomotor tone and
consequently, vagal reflexes mediating bronchoconstriction are
blocked. In this respect
ipratropium bromide is fundamentally different from
agonists. The onset of bronchodilator
response is seen within three to five minutes of administration. Peak
response is reached 1.5
to 2 hours after inhalation. The duration of significant
bronchodilator action is up to 6 hours.
Ipravent can be used in combination with
agonists.
There is evidence that in patients who respond to ipratropium bromide
greater relief of
bronchospasm can be achieved by the concurrent use of ipratropium
bromide, and
agonists,
as compared to tha
                                
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