ATROVENT UNIT DOSE VIALS ipratropium bromide 250 micrograms/1 mL (as monohydrate) conventional inhalation ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ipratropium bromide monohydrate, Quantity: 261 microgram/mL (Equivalent: ipratropium bromide, Qty 250 microgram/mL)

Available from:

Boehringer Ingelheim Pty Ltd

Pharmaceutical form:

Inhalation, conventional

Composition:

Excipient Ingredients: purified water; sodium chloride; hydrochloric acid

Administration route:

Inhalation

Units in package:

30 x 1mL, 10 x 1mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Moderate asthmatic attacks; chronic forms of asthma; asthma in patients with diminished cardiac reserve; chronic obstructive bronchitis with bronchospasm; bronchospasm during or after surgery, use during assisted ventilation with a respirator. Administration of Atrovent via a nebuliser is intended for those patients who cannot use a metered dose aerosol.

Product summary:

Visual Identification: Clear colourless or almost colourless liquid free from suspended particles; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-26

Patient Information leaflet

ATROVENT UDVS CMI0119-05
1
ATROVENT
® UDV
_ATROVENT 250 ΜG/1 ML AND ATROVENT ADULT 500 ΜG/1 ML UNIT DOSE VIAL
(UDV) _
_ipratropium bromide monohydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Atrovent UDV.
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 or pharmacist
has weighed the risks of you using
Atrovent UDV against the benefits it
is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ATROVENT UDV IS
USED FOR
Atrovent UDV is used to treat:

asthma

chronic obstructive bronchitis

people who have difficulty
breathing during or after surgery
using assisted ventilation.
Asthma is a disease where the lining
of the lungs becomes inflamed (red
and swollen), making it difficult to
breathe. This may be due to an
allergy to house dust mites, smoke or
other irritants.
Chronic obstructive bronchitis is a
lung condition that can cause
difficulty in breathing, wheeziness
and constant coughing.
Atrovent UDV contains the active
ingredient ipratropium bromide
monohydrate. It belongs to a group
of medicines called anticholinergic
bronchodilators.
Atrovent UDV opens up the air
passages in people suffering from
asthma, chronic bronchitis and
difficulty breathing during or after
surgery.
It begins to act quickly after use but
may take up to 2 hours to give
maximum benefit.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ATROVENT
UDV HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have

Summary of Product characteristics

ATROVENT Inhalation Solutions PI0059-14
1
AUSTRALIAN PRODUCT INFORMATION – ATROVENT
® (IPRATROPIUM BROMIDE MONOHYDRATE)
INHALATION SOLUTION
1. NAME OF THE MEDICINE
ipratropium bromide monohydrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of ATROVENT Inhalation Solution contains ipratropium bromide
monohydrate 261
micrograms (equivalent to 250 micrograms ipratropium bromide).
Each 1 mL of ATROVENT UNIT DOSE VIAL (UDV) contains ipratropium
bromide monohydrate 261
micrograms (equivalent to 250 micrograms ipratropium bromide).
Each 1 mL of ATROVENT ADULT UNIT DOSE VIALS (UDV) contains ipratropium
bromide
monohydrate 522 micrograms (equivalent to 500 micrograms ipratropium
bromide).
Excipients with known effect:
ATROVENT Inhalation Solution contains 0.1 mg benzalkonium chloride in
each mL and disodium
edetate.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
ATROVENT is an inhalation solution.
ATROVENT Inhalation Solution - clear, colourless or almost colourless
liquid, free from suspended
particles in multidose bottle. Contains benzalkonium chloride as the
preservative.
ATROVENT UDV - preservative free, clear, colourless or almost
colourless liquid, free from
suspended particles.
ATROVENT ADULT UDV - preservative free, clear, colourless or almost
colourless liquid, free from
suspended particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moderate asthmatic attacks; chronic forms of asthma; asthma in
patients with diminished cardiac
reserve; chronic obstructive bronchitis with bronchospasm;
bronchospasm during or after surgery,
use during assisted ventilation with a respirator.
Administration of ATROVENT via a nebuliser is intended for those
patients who cannot use a
metered dose aerosol.
4.2 DOSE AND METHOD OF ADMINISTRATION
ATROVENT solution can be administered via a range of commercially
available nebulising devices.
Where wall oxygen is available, solutions are best administered at a
flow rate of 6-8 litres per minute.
Dosage is dependent on the mo