VENTOLIN SYRUP

国: イスラエル

言語: 英語

ソース: Ministry of Health

即購入

製品の特徴 製品の特徴 (SPC)
13-12-2023
公開評価報告書 公開評価報告書 (PAR)
17-08-2016

有効成分:

SALBUTAMOL AS SULFATE

から入手可能:

GLAXO SMITH KLINE (ISRAEL) LTD

ATCコード:

R03AC02

医薬品形態:

SYRUP

構図:

SALBUTAMOL AS SULFATE 2 MG / 5 ML

投与経路:

PER OS

処方タイプ:

Required

製:

FARMACLAIR, FRANCE

治療群:

SALBUTAMOL

治療領域:

SALBUTAMOL

適応症:

Relief of bronchospasm in bronchial asthma of all types,chronic bronchitis,efmphysema.

承認日:

2014-08-31

情報リーフレット

                                PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician's prescription only
Ventolin Syrup
Each teaspoon (5 ml) contains:
Salbutamol (as Sulfate) 2 mg
For the list of the inactive and allergenic ingredients in the
medicine, see
section 2 – “Important information about some of the ingredients
in the
medicine” and section 6 – “Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Ventolin Syrup is intended for the relief of bronchospasm related to
asthma,
chronic bronchitis and emphysema.
Therapeutic group:
Selective beta-2 adrenoceptor agonist.
Ventolin Syrup contains a medicine called salbutamol. It 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.
Ventolin Syrup is used when children and adults cannot use an inhaler
device.
2. BEFORE USING THE MEDICINE
Special warnings regarding use of the medicine
Before the treatment with Ventolin Syrup, tell the physician if:
•
you have high blood pressure
•
you are diabetic
•
you have an overactive thyroid gland
•
you have a history of heart problems such as an irregular or fast
heartbeat
or angina
•
you are taking xanthine derivatives (such as theophylline) or steroids
to
treat asthma
•
you are taking diuretics, sometimes used to treat high blood pressure
or a
heart condition.
Children and adolescents
Ventolin Syrup is not intended for children and babies below the age
of 2
years.
Drug interactions
If you are taking, or have rece
                                
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製品の特徴

                                Page 1 of 9
VENTOLIN SYRUP
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 2 mg Salbutamol (as Sulfate).
Excipient with known effect:
5.6 mg sodium per 5 ml dose,
10.0 mg sodium benzoate per 5 ml dose,
1.9 mg propylene glycol per 5 ml dose.
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 for the relief of bronchospasm in
bronchial asthma of all types, chronic bronchitis and emphysema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral
Ventolin syrup is suitable oral therapy for children and adults who
are unable
to use an inhaler device.
Bronchodilators should not be the only or main treatment in patients
with
severe or unstable asthma. Severe asthma requires regular medical
assessment
as death may occur. Patients with severe asthma have constant symptoms
and
frequent exacerbations, with limited physical capacity, and PEF values
below
60% predicted at baseline with greater than 30% variability, usually
not
returning entirely to normal after a bronchodilator. These patients
will require
a high dose inhaled (e.g. >1mg/day) beclomethasone dipropionate) or
oral
corticosteroid therapy. Sudden worsening of symptoms may require
increase
costicosteroid dosage which should be administered under urgent
medical
supervision.
Adults
The minimum starting dose is 2 mg three times a day given as 5 ml
syrup. The
Page 2 of 9
usual effective dose is 4 mg (10 ml syrup) three or four times a day,
which
may be increased to a maximum of 8 mg (20 ml 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 1 mg as 2.5 ml of syrup
three times
daily. This may be increased to 2 mg as 5 ml o
                                
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