Ventolin Syrup 2mg/5ml

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

SALBUTAMOL SULPHATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

SALBUTAMOL SULPHATE

Unit dalam pakej:

100 ml

Dikeluarkan oleh:

PT GLAXO WELLCOME INDONESIA

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
VENTOLIN SYRUP
Salbutamol sulphate (2 mg /5 ml)
WHAT IS IN THIS LEAFLET
1.
What VENTOLIN is used for
2.
How VENTOLIN works
3.
Before you use VENTOLIN
4.
How to use VENTOLIN
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
VENTOLIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT VENTOLIN IS USED FOR
VENTOLIN is used for the
relief of:
•
bronchial asthma
•
chronic bronchitis
(inflammation of the airways
that carry air to your lungs).
•
emphysema (damages to the
air sacs (alveoli) in your
lungs)
The syrup is used when children
and adults cannot use an inhaler
device.
HOW VENTOLIN WORKS
VENTOLIN Syrup contains a
medicine called salbutamol. This
belongs to a group of medicines
called bronchodilators.
Bronchodilators help the airways
in your lungs to stay open. This
makes it easier for air to get in
and out.
They help to relieve chest
tightness, wheezing and cough.
BEFORE YOU USE VENTOLIN
-
_When you must not use it_
Do not take VENTOLIN Syrup:
•
if you are allergic to
salbutamol sulphate or any of
the other ingredients of this
medicine.
•
If you unexpectedly go into
early labour (premature
labour) or threatened abortion.
-
_Before you start to use it_
Talk to your doctor, nurse or
pharmacist before taking
VENTOLIN Syrup if:
•
you have hypoxia (deficiency
in the amount of oxygen
reaching the tissues)
•
you are diabetic
•
you have an overactive
thyroid gland
•
you have severe heart disease
(such as ischaemic heart
disease, irregular heart
rhythm, severe heart failure).
Tell your doctor if you
experience symptoms such as
chest pain, dyspnoea (shortness
of breath) or other symptoms of
worsening heart disease.
If you are pregnant or breast-
feeding, think you may be
pregnant or are planning to have
a baby, ask your doctor or
pharmacist for advice before
taking this medicine
-
_Taking other medicines_
Tell your doctor, nurse or
pharmacist if you are taking,
have recently taken or might
tak

Ciri produk

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VENTOLIN SYRUP
SALBUTAMOL SULPHATE
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin
Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 2 mg Salbutamol (as Salbutamol Sulphate).
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
Relief of bronchospasm in bronchial asthma of all types, chronic
bronchitis
and emphysema.
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 prepared
purified water
BP.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in
section 6.1.
Non-i.v. formulations of VENTOLIN must not be used to arrest
uncomplicated premature labour or threatened abortion.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bronchodilators should no