SALBUTAMOL CIPLA salbutamol 5mg/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: sulfuric acid; water for injections; sodium chloride

Administration route:

Inhalation

Units in package:

30 x 2.5 mL 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:

2006-10-18

Patient Information leaflet

Salbutamol CMI
Salbutamol Cipla
Page
1
of
5
SALBUTAMOL CIPLA
_SALBUTAMOL SULFATE _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet
carefully before you use your
medicine.
This leaflet answers some
common questions about
Salbutamol Cipla cipules. 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
taking Salbutamol Inhalation
Solution against the benefits
they expect it will 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 SALBUTAMOL CIPLA
CIPULES ARE USED FOR
Salbutamol Cipla Cipules
contains the active substance,
salbutamol which is known
as a bronchodilator. It helps
you breathe more easily.
When your chest is tight or
when you are wheezing,
Salbutamol Cipla Cipules
opens up the breathing tubes
in your lungs.
Because the medicine in your
Salbutamol Cipla Cipules
gives fast relief from your
chest symptoms, it is often
called a 'reliever'. There are
other types of medicines that
prevent wheezing or chest
tightness. These medicines
are called 'preventers' and
must be used every day. Your
doctor may tell you to use a
'preventer' in addition to your
Salbutamol Cipla Cipules.
SALBUTAMOL INHALATION
SOLUTION ARE NOT THE ONLY
FORM OF SALBUTAMOL
AVAILABLE. YOUR DOCTOR WILL
DECIDE WHICH FORM OF
SALBUTAMOL IS RIGHT FOR YOU.
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.
BEFORE YOU USE SALBUTAMOL
CIPLA CIPULES
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT USE SALBUTAMOL
INHALATION SOLUTION IF YOU
HAVE AN ALLERGY TO
SALBUTAMOL SULFATE OR ANY
OTHER INGREDIENTS IN
SALBUTAMOL CIPLA CIPULES
(SEE INGREDIENTS) DO NOT TAKE SALBUTAMOL
CIPLA CIPULES TO STOP A
MISCARRIAGE OR PREMATURE
LABOUR.
DO NOT TAKE THIS MEDICINE
AFTER THE EXPIRY

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - SALBUTAMOL CIPLA (SALBUTAMOL
SULFATE) INHALATION
1 NAME OF THE MEDICINE
Salbutamol sulfate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains Salbutamol 2.5mg/2.5mL or 5mg/2.5mL as
salbutamol sulfate.
Salbutamol sulfate 1.2 mg is approximately equivalent to salbutamol 1
mg
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Conventional inhalation
Clear colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
Increasing use of beta-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 gluco-corticosteroid
therapy should be considered.
Salbutamol Cipla ampoule/s are to be used under the direction of a
doctor.
The solution must not be injected or ingested.
Salbutamol Cipla ampoule/s 2.5mg/2.5mL and 5mg/2.5mL may be delivered
from any efficient
nebulising device.
Salbutamol Cipla ampoule/s may be used to achieve bronchodilatation as
part of an inhalation therapy
regime 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 Cipla
ampoule/s is preferred.
Use in Adults and Children
_Children_
: 4-12 years. 2.5mg
_Adults_
: 5mg
This dosage may be repeated as necessary every 4-6 hours. Any solution
remaining in the nebuliser
after completion of therapy should be discarded.
_Important. _
Fresh dilutions should be prepared for each inhalation and any
solution remaining in the
nebuliser after treatment should be discarded immediat