Ventolin

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Salbutamol sulfate 120.5ug equivalent to 100 µg dose (10% excess may be added to compensate for manufacturing loss);  

Доступно од:

GlaxoSmithKline NZ Limited

INN (Међународно име):

Salbutamol sulfate 120.5 µg (= 100 µg dose; 10% excess may be added to compensate for manufacturing loss)

Дозирање:

100 mcg/dose

Фармацеутски облик:

Aerosol inhaler, metered dose

Састав:

Active: Salbutamol sulfate 120.5ug equivalent to 100 µg dose (10% excess may be added to compensate for manufacturing loss)   Excipient: Norflurane

Јединице у пакету:

Inhaler, metered, 200 dose units

Класа:

Prescription

Тип рецептора:

Prescription

Произведен од:

Glaxo Operations UK Ltd

Терапеутске индикације:

Salbutamol is a selective ?2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. For patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a known trigger. Bronchodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failure to respond promptly or fully to such rescue medication signals a need for urgent medical advice and treatment.

Резиме производа:

Package - Contents - Shelf Life: Inhaler, metered, - 200 dose units - 24 months from date of manufacture stored at or below 30°C

Датум одобрења:

1997-03-12

Информативни летак

VENTOLIN CFC-FREE INHALER
1
VENTOLIN CFC-FREE
INHALER
_Salbutamol (as sulfate) Inhaler 100 microgram per actuation _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
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 INFORMATION. YOU MAY
NEED TO READ IT AGAIN.
WHAT IS THE NAME OF
MY MEDICINE?
The name of your medicine is
VENTOLIN CFC-Free inhaler.
WHAT DOES MY
VENTOLIN INHALER DO?
Your VENTOLIN CFC-Free inhaler
helps you to breathe more easily.
When your chest is tight or when you
are wheezing, the VENTOLIN opens
up the breathing tubes in your lungs.
Your medicine is known as a
bronchodilator. Because your
VENTOLIN CFC-Free inhaler gives
fast relief from your chest symptoms,
it is often called a 'reliever puffer'.
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 CFC-Free
inhaler before you exercise. This can
help to prevent the symptoms of
exercise-induced asthma.
BEFORE YOU USE YOUR
INHALER
You must tell your doctor:
•
the names of any other medicines
you are already taking, including
those from the pharmacy and
supermarket.
•
If you have had to stop taking this
or any other asthma medicine
•
If you are allergic to any
medicine, foods, dyes or
preservatives
•
If you are having treatment for a
thyroid problem
•
If you are

Карактеристике производа

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ventolin Inhaler (CFC-Free) 100 micrograms
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin Inhaler (CFC-Free) is a pressurised metered-dose inhaler
which delivers 100
micrograms salbutamol (as sulfate) per actuation, into the mouthpiece
of a specially
designed actuator. The inhaler also contains the CFC-free propellant
HFA134a.
_ _
For the full list of excipients, see section 6.1 List of excipients. _
_
3.
PHARMACEUTICAL FORM
Inhaler, aerosol, metered
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salbutamol is a selective beta-
2
adrenoceptor agonist indicated for the treatment or
prevention of bronchospasm. It provides short acting (four hours)
bronchodilation in
reversible airways obstruction due to asthma, chronic bronchitis and
emphysema. For
patients with asthma salbutamol may be used to relieve symptoms when
they occur
and to prevent them prior to a known trigger.
Bronchodilators should not be the only or main treatment in patients
with persistent
asthma. In patients with persistent asthma unresponsive to salbutamol,
treatment with
inhaled corticosteroids is recommended to achieve and maintain
control. Failure to
respond promptly or fully to such rescue medication signals a need for
urgent medical
advice and treatment.
4.2 DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Ventolin Inhaler (CFC-Free) is administered by the oral inhaled route
only, to be
breathed in through the mouth.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
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.
2
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult a
spacer device may be used with the Ventolin Inhaler (CFC-Free).
Babies and young children may benefit from use of a spacer device with
the Ventolin
Inhaler (CFC-Free).
As there may be adverse effect