Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Salbutamol

Fáanlegur frá:

GlaxoSmithKline (Ireland) Limited

ATC númer:

R03CC; R03CC02

INN (Alþjóðlegt nafn):

Salbutamol

Skammtar:

1 milligram(s)/millilitre

Lyfjaform:

Concentrate for solution for infusion

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

Selective beta-2-adrenoreceptor agonists; salbutamol

Leyfisstaða:

Marketed

Leyfisdagur:

1975-11-10

Upplýsingar fylgiseðill

Reason for update: Type IB – Shelf life extension from 36 months to
48 months
HPRA Approval date:
Text Date: 06/02/2024
Text Issue and Draft No.: Issue 5 Draft 1
- 1 -
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN
500 MICROGRAMS/ML SOLUTION FOR INJECTION
SALBUTAMOL (AS SULFATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get side effects, talk to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1
What Ventolin Injection is and what it is used for
2
What you need to know before you use Ventolin Injection
3
How to use Ventolin Injection
4
Possible side effects
5
How to store Ventolin Injection
6
Contents of pack and other information
1
WHAT VENTOLIN INJECTION IS AND WHAT IT IS USED FOR
Ventolin
500 micrograms/ml Solution for
Injection
(called ‘Ventolin Injection’ in this leaflet)
contains a medicine called salbutamol. This belongs to a group of
medicines called ‘beta-
agonists’. It acts on special receptor sites in the lungs and in the
uterus (in women) to:
•
Help the airways in your lungs to stay open. This makes it easier for
air to get in and out.
•
It helps to relieve chest tightness, wheezing and cough.
•
Relax the muscles in the walls of the uterus. This may stop the
contractions associated
with labour.
Ventolin Injection is used in adults and adolescents (children aged 12
years and over):
•
To treat severe breathing problems in people with asthma and similar
conditions.
Ventolin Injection is also used in women who have unexpectedly gone
into early labour
(premature labour) between the 22nd and 37th week of gestation, to
provide a sh

Vara einkenni

Health Products Regulatory Authority
04 March 2024
CRN00F1PQ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml ampoule contains 5 mg salbutamol as salbutamol sulphate
(1mg/ml).
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear colourless to pale straw coloured sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ventolin Concentrate for Solution for Intravenous Infusion is
indicated in adults and adolescents (children aged 12 years and
over).
Ventolin Concentrate for Solution for Intravenous Infusion should be
administered under the direction of a physician. It is
indicated for two distinct clinical situations:
1. For the management of severe bronchospasm. It provides short acting
bronchodilation in reversible airways obstruction due
to asthma and chronic obstructive pulmonary disease (COPD) such as
chronic bronchitis and emphysema.
2. For the short-term management of uncomplicated premature labour. To
arrest labour between 22 and 37 weeks of
gestation in patients with no medical or obstetric contraindication to
tocolytic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Ventolin parenteral preparations are to be used under the direction of
a physician.
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.
Ventolin parenteral preparations should not to be administered in the
same syringe or infusion as any other medication.
The contents of the ampoules of Ventolin Concentrate Solution for
Intraven