AERON 250 ipratropium bromide (as monohydrate) 250 microgram/mL inhalation ampoule

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

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

제공처:

Viatris Pty Ltd

약제 형태:

Inhalation, conventional

구성:

Excipient Ingredients: water for injections; hydrochloric acid; sodium chloride

관리 경로:

Inhalation

패키지 단위:

30 ampoules

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

For moderate asthma 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.

제품 요약:

Visual Identification: A clear colourless solution essentially free from foreign particles.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2005-03-18

환자 정보 전단

AERON
® 250/500
_ipratropium bromide monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AERON.
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
AERON against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT AERON IS USED
FOR
This medicine 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.
AERON contains the active
ingredient ipratropium bromide
monohydrate. It belongs to a group
of medicines called anticholinergic
bronchodilators.
AERON 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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
AERON
_WHEN YOU MUST NOT USE IT_
DO NOT USE AERON IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
ipratropium bromide
monohydrate or any other
medicines used to treat breathing
problems
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines
which contain atropine or
medicine

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION
AERON
® 250/500
_ipratropium bromide monohydrate conventional inhalation _
1
NAME OF THE MEDICINE
Ipratropium bromide monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AERON ampoule contains 250 micrograms/mL or 500 micrograms/mL of
ipratropium bromide as the
active ingredient.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
AERON is a clear colourless solution essentially free from foreign
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
AERON 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 to 8
L/minute. Administration of AERON via a
nebuliser is intended for those patients who cannot use a metred dose
aerosol.
Dosage is dependent on the mode of inhalation and the quality of
nebulisation. The duration of inhalation can
be controlled by the dilution volume. It is advisable not to greatly
exceed the recommended daily dose as this
suggests additional therapeutic modalities may be needed.
Diluted solutions should be freshly prepared before use and any
solution remaining in the nebuliser on
completion of inhalation should be discarded.
After opening the unit dose ampoule, the solution should be used as
soon as possible and any unused solution
discarded immediately.
Note:
The dosage should be adapted to the individual requirements of the
patient; patients should also be kept under
medical supervision during treatment. Unless otherwise prescribed, the
following doses are recommended:
ADULTS
The recommended dosage is 261 to 522 micrograms (equivalent 250 to 500
micrograms ipratropium bromide)
four times daily, diluted to 2 to 3 mL wit