ZEMPREON CFC-FREE INHALER Salbutamol 100 microgram (as sulfate) pressurised inhaler metered dose (with counter)

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

salbutamol sulfate, Quantity: 120.5 microgram/actuation

Fáanlegur frá:

Alphapharm Pty Ltd

Lyfjaform:

Inhalation, pressurised

Samsetning:

Excipient Ingredients: norflurane

Stjórnsýsluleið:

Inhalation

Einingar í pakka:

200 metered dose

Gerð lyfseðils:

(S3) Pharmacist Only Medicine

Ábendingar:

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

Vörulýsing:

Visual Identification: Metal can with concave base fitted with a metering valve, containing a white to off-white suspension, fitted to an actuator. The internal surfaces of the can and valve are free from defects.; Container Type: Aerosol Can - Metered Dose; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2020-05-07

Upplýsingar fylgiseðill

ZEMPREON CFC-FREE
INHALER (WITH COUNTER)
_Salbutamol sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Read this leaflet carefully before you
use your medicine.
This leaflet does not have the
complete information about your
medicine. If you have any questions
about your medicine, you should ask
your doctor or pharmacist (also
known as a chemist).
All medicines have some risks.
Sometimes new risks are found even
when a medicine has been used for
many years.
If there is anything you do not
understand, ask your doctor or
pharmacist. If you want more
information, ask your doctor or
pharmacist.
This medicine is only one part of a
general plan to help you manage your
asthma or other chest condition. You
should discuss this plan with your
doctor. Ask your doctor to check
your treatment regularly.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS THE NAME OF
MY MEDICINE?
The name of your medicine is
ZEMPREON Inhaler. You may
know it better as a 'puffer'.
WHAT IS MY
ZEMPREON PUFFER
USED FOR?
Your ZEMPREON puffer helps you
to breathe more easily. When your
chest is tight or when you are
wheezing, ZEMPREON opens up the
breathing tubes in your lungs. Your
medicine is known as a
bronchodilator. Because your
ZEMPREON puffer gives fast relief
from your chest symptoms, it is often
called a 'reliever'.
Some people start wheezing or their
chest starts to feel tight when they
exercise. This is called exercise-
induced asthma. If you have
exercise-induced asthma, your doctor
may tell you to take one or two puffs
of your ZEMPREON puffer before
you exercise. This can help to
prevent the symptoms of exercise-
induced asthma.
BEFORE YOU TAKE YOUR
ZEMPREON PUFFER
_DO NOT TAKE:_
•
IF YOU HAVE EVER HAD AN ALLERGIC
REACTION TO SALBUTAMOL
SULFATE OR ANY OF THE INGREDIENTS
LISTED TOWARD THE END OF THIS
LEAFLET
•
TO STOP A MISCARRIAGE OR
PREMATURE LABOUR
•
IF THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED
•
IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
_TELL YOUR DOCTOR IF:_
You mus

Vara einkenni

AUSTRALIAN PRODUCT INFORMATION
ZEMPREON CFC-FREE INHALER
_Salbutamol (sulfate) _
1
NAME OF THE MEDICINE
Salbutamol sulfate B.P.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zempreon inhaler is a pressurised metered dose inhaler which delivers
100 micrograms of salbutamol (as
sulfate) per actuation.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pressurised inhalation
Zempreon Inhaler (with dose counter): Suspension contained in an
aluminium alloy can, sealed with a
metering valve. The canister has a counter attached to it and is
fitted with a plastic actuator incorporating an
atomising nozzle and fitted with a mouthpiece cover.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zempreon Inhaler is indicated for the relief of bronchospasm in
patients with asthma or chronic obstructive
pulmonary disease, and for acute prophylaxis against exercise-induced
asthma and other stimuli known to
induce bronchospasm.
4.2
DOSE AND METHOD OF ADMINISTRATION
Zempreon Inhaler is administered by the inhaled route only, to be
breathed in through the mouth.
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
glucocorticosteroid therapy should be
considered.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of administration
should only be increased on medical advice.
ADULTS AND CHILDREN
If required, one or two inhalations, repeated four-hourly. The
bronchodilator effect of each administration of
Zempreon inhaler lasts for at least four hours and more frequent use
should be unnecessary. The patient can
readily recognise any reduction in the length of action and should be
instructed to consult a doctor if the effect
of a previously adequate dose lasts for less than three hours.
For detailed instructions on how to use Zempreon inhaler refer to the
patient information leaflet.
Note 1: Failure to obtain relief from the inhaler may be a medic