Ventolin 500 micrograms/ml Solution for Injection

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Salbutamol

Fáanlegur frá:

GlaxoSmithKline (Ireland) Limited

ATC númer:

R03AC; R03AC02

INN (Alþjóðlegt nafn):

Salbutamol

Skammtar:

500 microgram(s)/millilitre

Lyfjaform:

Solution for injection

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 to 3 years to 48
months.
Market: IE
Agency Approval date:
Text Date: 02/02/2024
Text Issue 5 Draft 1
1
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN
1 MG/ML
CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION
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 any 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
Infusion is and what it is used for
2
What you need to know before you use Ventolin Infusion
3
How to use Ventolin
Infusion
4
Possible side effects
5
How to store Ventolin Infusion
6
Contents of the pack and other information
1
WHAT VENTOLIN INFUSION IS AND WHAT IT IS USED FOR
Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion
(called ‘Ventolin Infusion’
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 Infusion 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 Infusion is also used in women who have unexpectedly gone
into early labour
(premature labour) between the 22nd and 37th week of gestation, to
provi

Vara einkenni

Health Products Regulatory Authority
04 March 2024
CRN00F1PQ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventolin 500 micrograms/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 500 micrograms salbutamol as salbutamol sulphate.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Solution for injection. (Injection)
A colourless to pale straw coloured sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ventolin Injection is indicated in adults and adolescents (children
aged 12 years and over).
Ventolin Injection 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 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 be administered in the
same syringe or infusion as any other medication.
ADULTS AND ADOLESCENTS (CHILDREN AGED 12 YEARS AND OVER):-
_In bronchospasm and status asthmaticus:_
Subcutaneous Route:- 500 micrograms (8 mcg/kg bodyweight) and repeated
every four hours as re