APO-SALBUTAMOL salbutamol 5 mg/ 2.5mL (as sulfate) inhalation ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salbutamol sulfate, Quantity: 6 mg (Equivalent: salbutamol, Qty 5 mg)

Available from:

Cipla Australia Pty Ltd

INN (International Name):

salbutamol sulfate

Pharmaceutical form:

Inhalation, conventional

Composition:

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

Administration route:

Inhalation

Units in package:

30 x 2.5mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise induced asthma or in other situations known to induce bronchospasm.

Product summary:

Visual Identification: Clear colourless to pale yellow solution.; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2007-10-23

Patient Information leaflet

APO-SALBUTAMOL
_INHALATION AMPOULES_
_Contains the active ingredient salbutamol sulfate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 IS THIS MEDICINE
USED FOR
Salbutamol is inhaled into your lungs
to relieve the symptoms of asthma
and other breathing problems.
It may also be used before exercise
or at other times to keep your air
passages open if you start to wheeze
or have difficulty breathing each time
you exert yourself.
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,
air-borne pollution and other
irritants.
Salbutamol belongs to a family of
medicines called bronchodilators
(beta-2-agonists). These work rapidly
to open up the air passages in the
lungs of people suffering from
asthma, bronchitis, emphysema and
other breathing problems.
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 available only with
a doctor's prescription.
This medicine is not addictive
THIS MEDICATION IS DELIVERED
DIRECTLY TO YOUR LUNGS THROUGH A
DEVICE CALLED A NEBULISER.
APO-Salbutamol Inhalation
Ampoules may be used in children
aged between 4 and 12 years of age.
BEFORE YOU USE THIS
MEDICINE
_WHEN YOU MUST NOT USE IT_
DO NOT USE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
salbutamol
•
any of the ingredients listed at t

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-SALBUTAMOL (SALBUTAMOL SULFATE)
INHALATION AMPOULES
1
NAME OF THE MEDICINE
Salbutamol sulfate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mL ampoule contains salbutamol sulfate equivalent to either
salbutamol 2.5 mg or
5 mg.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Clear, colourless to pale yellow, sterile, isotonic solution for
inhalation. It does not contain a
preservative.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Relief of bronchospasm in patients with asthma or chronic obstructive
pulmonary
disease.
•
Acute prophylaxis against exercise-induced asthma or in other
situations known to
induce bronchospasm.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-SALBUTAMOL INHALATION SOLUTION is intended for administration by
inhalation.
DOSAGE
Increasing use of β
2
-agonists may be a sign of worsening asthma. Under these conditions a
reassessment
of
the
patient’s
therapy
plan
may
be
required
and
concomitant
glucocorticosteroid therapy should be considered.
Salbutamol solution is to be used under the direction of a doctor.
The solution may be delivered from any efficient nebulising device.
The solution must not be injected or ingested.
Salbutamol solution may be used to achieve bronchodilation as part of
an inhalation therapy
regimen or for patients requiring assisted ventilation.
There is a large safety margin between therapeutic effects and
unpleasant side effects.
Nevertheless, because of the possibility of uncontrolled dosage
associated with continuous
administration, intermittent administration of appropriate amounts of
salbutamol is preferred.
ADULTS AND CHILDREN
Children (4-12 years): 2.5 mg
Adults: 5 mg
2
This dosage may be repeated as necessary every four to six hours.
Important:
Fresh dilutions should be prepared for each inhalation and any
solution remaining in the
nebuliser after treatment should be discarded immediately. To avoid
contamination, nebulising
devices should be thoroughly cleaned after use a