ATROVENT ipratropium bromide monohydrate 21 microgram per metered dose inhalation aerosol can

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ipratropium bromide monohydrate, Quantity: 21 microgram/actuation

Available from:

Boehringer Ingelheim Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: ethanol absolute; citric acid; purified water; norflurane

Administration route:

Inhalation

Units in package:

200 metered doses

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Atrovent metered aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with asthma and chronic obstructive pulmonary disease (COPD).

Product summary:

Visual Identification: Clear, colourless liquid, free from suspended particles in a stainless steel canister with a metering valve.; Container Type: Aerosol Can - Metered Dose; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-05-05

Patient Information leaflet

ATROVENT
® METERED DOSE INHALER
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ATROVENT MDI?
Atrovent metered dose inhaler (Atrovent MDI) contains the active
ingredient ipratropium bromide monohydrate. Atrovent MDI is used
to make breathing easier for people with asthma or chronic obstructive
pulmonary disease (COPD).
For more information, see Section 1. Why am I using Atrovent MDI? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ATROVENT MDI?
Do not use if you have ever had an allergic reaction to ipratropium,
atropine or any medicines like atropine or any of the ingredients
listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Atrovent MDI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Atrovent MDI and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ATROVENT MDI?
Inhale each puff through the mouth. The usual doses are:
•
Adults: 2 to 4 puffs, three to four times daily (at regular
intervals), up to a maximum of 16 puffs a day
•
Children 6 to 12 years: 1 to 2 puffs, three to four times daily (at
regular intervals), up to a maximum of 8 puffs a day
•
Children under 6 years: 1 puff, three times daily (at regular
intervals)
More instructions can be found in Section 4. How do I use Atrovent
MDI? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ATROVENT MDI?
THINGS YOU
SHOULD DO
•
Stop using Atrovent MDI and tell your doctor immediately if you get
sudden chest tightness, coughing,
wheezing or breathlessness immediately after using Atrovent MDI.
•
Tell your doctor im

Summary of Product characteristics

ATROVENT Metered Aerosol PI0106-10
1
AUSTRALIAN
PRODUCT
INFORMATION
–
ATROVENT
®
(IPRATROPIUM
BROMIDE
MONOHYDRATE) PRESSURISED INHALATION AEROSOL
1 NAME OF THE MEDICINE
ipratropium bromide monohydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ATROVENT
contains
ipratropium
bromide
monohydrate
21
micrograms
[equivalent
to
20 micrograms of ipratropium bromide] per actuation.
Excipients with known effect
Contains 8.415 mg ethanol absolute per actuation.
For full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
ATROVENT is a pressurised inhalation solution.
Each ATROVENT metered dose aerosol can is filled with a clear,
colourless liquid, free from
suspended particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATROVENT metered aerosol is indicated as a bronchodilator for
maintenance treatment of
bronchospasm associated with asthma and chronic obstructive pulmonary
disease (COPD).
4.2 DOSE AND METHOD OF ADMINISTRATION
_Note: One puff (metered dose) of ATROVENT contains 21 micrograms of
ipratropium bromide _
_monohydrate [equivalent to 20 micrograms of ipratropium bromide]. _
If the response to the treatment is inadequate, medical advice should
be sought so that
appropriate measures can be taken. It is advisable not to greatly
exceed the recommended
daily dose as this suggests additional therapeutic modalities may be
needed.
If therapy does not produce a significant improvement or if the
patient’s condition gets worse,
medical advice must be sought in order to determine a new plan of
treatment. In the case of
acute or rapidly worsening dyspnoea, a doctor should be consulted
immediately.
ADULTS
Two puffs 3 to 4 times daily, although some patients may need up to 4
puffs at a time to obtain
maximum benefit during early treatment.
CHILDREN
Administration to children should be supervised by an adult.
6-12 years:
One or two puffs 3 to 4 times daily
Under 6 years:
One puff 3 times daily
Patients with poor inhaler technique will benefit from the consistent
use of a spacer device
with t