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

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

salbutamol sulfate, Quantity: 120.5 microgram/actuation (Equivalent: salbutamol, Qty 100 microgram/actuation)

Disponibil de la:

GlaxoSmithKline Australia Pty Ltd

Forma farmaceutică:

Inhalation, pressurised

Compoziție:

Excipient Ingredients: norflurane

Calea de administrare:

Inhalation

Unități în pachet:

200 metered dose

Tip de prescriptie medicala:

(S3) Pharmacist Only Medicine

Indicații terapeutice:

OTHER CONDITIONS: Do not puncture or incinerate even when empty as canister may explode. INDICATIONS: 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.

Rezumat produs:

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 Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2019-07-31

Prospect

VENTOLIN 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
VENTOLIN Inhaler. You may know
it better as a 'puffer'.
WHAT IS MY VENTOLIN
PUFFER USED FOR?
Your VENTOLIN puffer helps you
to breathe more easily. When your
chest is tight or when you are
wheezing, VENTOLIN opens up the
breathing tubes in your lungs. Your
medicine is known as a
bronchodilator. Because your
VENTOLIN 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 VENTOLIN puffer before
you exercise. This can help to
prevent the symptoms of exercise-
induced asthma.
BEFORE YOU TAKE YOUR
VENTOLIN 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

Caracteristicilor produsului

1
AUSTRALIAN PRODUCT INFORMATION
VENTOLIN INHALER CFC-FREE (SALBUTAMOL SULFATE) PRESSURISED
INHALATION
1
NAME OF THE MEDICINE
Salbutamol sulfate B.P.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VENTOLIN Inhaler is a pressurised metered dose inhaler which delivers
100 micrograms of
salbutamol (as sulfate) per actuation.
3
PHARMACEUTICAL FORM
Pressurised inhalation
VENTOLIN Inhaler (without dose counter): Suspension contained in an
aluminium alloy can,
sealed with a metering valve. The canister is fitted with a plastic
actuator incorporating an
atomising nozzle and fitted with a mouthpiece cover.
VENTOLIN 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
VENTOLIN 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
VENTOLIN 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 VENTOLIN 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
2
action and should be instructed to consult a doctor if the effect of a
previously adequate
dose lasts