Ventolin syrup

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

salbutamol (salbutamol sulfate)

Available from:

Farmaclair

ATC code:

R03AC02

INN (International Name):

salbutamol (salbutamol sulfate)

Dosage:

2mg/5ml

Pharmaceutical form:

syrup

Units in package:

150ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-04-02

Patient Information leaflet

VENTOLIN™ SYRUP
Salbutamol sulphate
QUALITATIVE AND QUANTITATIVE COMPOSITION
_VENTOLIN_ Syrup contains 2 mg salbutamol, as sulphate, in each 5 ml
of syrup.
PHARMACEUTICAL FORM
Syrup.
CLINICAL PARTICULARS
Indications
_VENTOLIN_ 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 _VENTOLIN,_ treatment with
inhaled corticosteroids is
recommended to achieve and maintain control. Failing to respond to
treatment with _VENTOLIN_ may
signal a need for urgent medical advice or treatment.
_VENTOLIN_ syrup is indicated for the relief of bronchospasm in
bronchial asthma of all types, chronic
bronchitis and emphysema.
_VENTOLIN_ Syrup is suitable oral therapy for children or those adults
who prefer liquid medicines.
Dosage and Administration
_VENTOLIN_ 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.
•
Adults
The usual effective dose is 10 ml salbutamol (4 mg 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 mg salbutamol).
Some patients obtain adequate relief with 5 ml of syrup (2 mg
salbutamol) 3 or 4 times daily).
•
Children
2-6 years 2.5 to 5 ml of syrup (1 to 2 mg salbutamol) 3 or 4 times
daily.
6-12 years 5 ml of syrup (2 mg salbutamol) 3 or 4 times daily.
Over 12 years 5 to 10 ml of syrup (2 to 4 mg salbutamol) 3 or 4 t

Summary of Product characteristics

Ventolin Syrup
Summary
of
Product
Characteristics
Updated
07-Nov-2014I
1. Name of
the medicinal
product
Ventolin
Syrup
2. Qualitative and quantitative composition
Each 5 ml
contains
2 mg Salbutamol
(as Salbutamol
Sulfate).
Excipient
with known
effect:
Sodium
For the full
list
of
excipients,
see section
6.1
3. Pharmaceutical
form
Syrup
4. Clinical
particulars
4.1 Therapeutic
indications
Ventolin
syrup
is indicated
in adults,
adolescents
and children
aged 2 to 12 years.
Salbutamol
is a selective
beta-2
adrenoceptor
agonist
providing
short-acting
(4-6 hour)
bronchodilation
in reversible
airways
obstruction.
Ventolin
syrup can be used in the
management
of
asthma,
bronchospasm
and/or
reversible
airways
obstruction.
Relief
of
bronchospasm
in bronchial
asthma
of
all
types.
Ventolin
syrup
is suitable
oral
therapy
for
children
and adults who are unable
to use an
inhaler
device.
4.2 Posology
and method
of
administration
Route of
administration:
oral
Adults
The minimum starting
dose is 2mg three times
a day given as 5ml
syrup.
The usual
effective
dose is 4mg (10ml
syrup)
three or
four
times
a day,
which
may be increased
to
a maximum of
8mg (20ml
syrup)
three or four
times
a day if
adequate
bronchodilation
is
not
obtained.
Elderly
In elderly
patients
or
in those known to be unusually
sensitive
to beta-adrenergic
stimulant
drugs,
it
is advisable
to initiate
treatment
with the minimum starting
dose.
_Paediatric_
_Population_
2 - 6 years:
the minimum starting dose
is 1mg as 2.5ml
of
syrup three times
daily.
This
may be increased
to 2mg as 5ml
of
syrup three or four
times daily.
6 - 12 years:
the minimum starting
dose is 2mg as 5ml
syrup three times
daily.
This may
be increased
to four
times
daily.
Over
12 years:
the minimum starting
dose is 2mg three times
daily given
as 5ml
syrup.
This may be increased
to 4mg as 10ml
syrup three or
four
times
daily.
Ventolin
is well
tolerated
by children
so that,
if
necessary,
these doses
may be
cautiously
increased
to the maximum dose.
For
lower
doses
the syrup may be diluted
with freshly
pre