ATROVENT ipratropium bromide 250 micrograms/mL (as monohydrate) conventional inhalation bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

ipratropium bromide monohydrate, Quantity: 0.261 mg/mL (Equivalent: ipratropium bromide, Qty 0.25 mg/mL)

Dostupné z:

Boehringer Ingelheim Pty Ltd

Forma lieku:

Inhalation, conventional

Zloženie:

Excipient Ingredients: purified water; benzalkonium chloride; sodium chloride; hydrochloric acid; disodium edetate

Spôsob podávania:

Inhalation

Počet v balení:

20mL

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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.

Prehľad produktov:

Visual Identification: Colourless, or almost colourless, solution.; Container Type: Bottle; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

1992-11-18

Príbalový leták

ATROVENT
®
_INHALATION SOLUTION_
_ipratropium bromide monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Atrovent Inhalation
Solution.
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 Atrovent
Inhalation Solution 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 THE MEDICINE.
You may need to read it again.
WHAT ATROVENT
INHALATION SOLUTION IS
USED FOR
Atrovent Inhalation Solution is used
to treat:
•
asthma
•
chronic obstructive bronchitis
•
people who have difficulty
breathing during or after surgery
using assisted ventilation.
Asthma is a lung condition 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 Inhalation Solution contains
the active ingredient ipratropium
bromide monohydrate. It belongs to a
group of medicines called
anticholinergic bronchodilators.
Atrovent Inhalation Solution 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
INHALATION SOLUTION HAS BEEN
PRESCRIBED FOR YOU.
Your

Súhrn charakteristických

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