Ventolin Syrup

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Salbutamol sulfate 0.48 mg/mL equivalent to 0.4 mg/ml salbutamol (or 2 mg salbutamol per 5 mL);  

Saatavilla:

GlaxoSmithKline NZ Limited

INN (Kansainvälinen yleisnimi):

Salbutamol sulfate 0.48 mg/mL (equiv to 0.4 mg/ml salbutamol (or 2 mg salbutamol per 5 mL))

Annos:

2 mg/5mL

Lääkemuoto:

Syrup

Koostumus:

Active: Salbutamol sulfate 0.48 mg/mL equivalent to 0.4 mg/ml salbutamol (or 2 mg salbutamol per 5 mL)   Excipient: Citric acid monohydrate Hypromellose Orange flavour 17-42-8187 Purified water Saccharin sodium Sodium benzoate Sodium chloride Sodium citrate dihydrate

Kpl paketissa:

Bottle, glass, 150 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Cambrex Profarmaco Milano Srl

Käyttöaiheet:

Ventolin Syrup is indicated for the treatment or prevention of bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. 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. Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment. Ventolin Syrup is suitable oral therapy for children or those adults who prefer liquid medicines.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Bottle, glass, Type III amber glass bottle with child resistant cap - 150 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, glass, - 300 mL -  

Valtuutus päivämäärä:

1983-07-29

Pakkausseloste

VENTOLIN SYRUP
1
VENTOLIN SYRUP
_Salbutamol sulphate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take Ventolin Syrup.
This leaflet answers some common
questions about Ventolin Syrup. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits of you taking Ventolin
Syrup against the risks this medicine
could have for you.
IF THERE IS ANYTHING YOU DO NOT
UNDERSTAND OR IF YOU HAVE ANY
CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST. IF YOU WANT MORE
INFORMATION, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS VENTOLIN
SYRUP USED FOR?
Ventolin Syrup helps you breathe
more easily. Ventolin Syrup works
by opening up the airways tubes in
your lungs when your chest is tight
or when you are wheezing.
Ventolin Syrup belongs to a group of
medicines called bronchodilators.
Because the medicine in your syrup
gives 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
Ventolin Syrup. Ventolin Syrup is
not the only form of Ventolin
available. Your doctor will decide
which form of Ventolin is right for
you.
Your doctor may have prescribed
Ventolin Syrup for another reason.
Ventolin Syrup is not addictive.
BEFORE YOU TAKE
VENTOLIN SYRUP
_DO NOT TAKE IF: _
You must not take Ventolin Syrup:
•
if you have ever had an allergic
reaction to salbutamol sulphate or
any of the ingredients listed
toward the end of this leaflet.
(See "Ingredients)
•
to stop a miscarriage or premature
labour.
•
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
•
THE PA

Valmisteyhteenveto

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME _ _
VENTOLIN 2 mg/5 mL Syrup.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION _ _
Salbutamol 2 mg as sulphate in each 5 mL of a fruit-flavoured, sugar
free syrup,
which is devoid of artificial colouring agents.
For full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM_ _
Syrup.
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 bronchodilation
in reversible
airways obstruction due to asthma, chronic bronchitis and emphysema.
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. Failing
to respond to treatment with salbutamol may signal a need for urgent
medical advice
or treatment.
VENTOLIN Syrup is suitable oral therapy for children or those adults
who prefer
liquid medicines.
4.2
DOSE AND METHOD OF ADMINISTRATION
Route of administration: oral
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.
As there may be adverse effects associated with excessive dosing, the
dosage or
frequency of administration should only be increased on medical
advice.
2
DOSE
_ADULTS: _
The usual effective dose is 10 mL salbutamol (4 milligrams of
salbutamol) 3 or 4
times per day. If adequate bronchodilation is not obtained each single
dose may be
gradually increased to as much as 20 mL of syrup (8 milligrams
salbutamol).
Some patients obtain adequate relief with 5 mL of syrup (2 milligrams
salbutamol)
three or four times daily.
_PAEDIATRIC POPULATION: _
2-6 years: 2.5-5 mL of syrup (1-2 mg salbutamol) 3 or 4 time