Ventolin Nebules 5mg/2.5ml Nebuliser Solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Salbutamol

Dostopno od:

GlaxoSmithKline (Ireland) Limited

Koda artikla:

R03AC; R03AC02

INN (mednarodno ime):

Salbutamol

Odmerek:

5 mg/2.5 millilitre(s)

Farmacevtska oblika:

Nebuliser solution

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Selective beta-2-adrenoreceptor agonists; salbutamol

Status dovoljenje:

Not marketed

Datum dovoljenje:

1998-04-17

Navodilo za uporabo

Reason for Update: Type IA removal of BC as BR site (Brexit)
Market: IE
Agency Approval date: 19/02/2021 (submission date for Type IA)
Text Date: 10/02/2021
Text Issue and Draft No.: Issue 5 Draft 1
- 1 -
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN NEBULES 2.5MG/2.5ML NEBULISER SOLUTION
VENTOLIN NEBULES 5 MG/2.5ML NEBULISER SOLUTION
SALBUTAMOL (AS SULFATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. 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 any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1
What Ventolin Nebules are and what they are used for
2
What you need to know before you take Ventolin Nebules
3
How to use Ventolin Nebules
4
Possible side effects
5
How to store Ventolin Nebules
6
Contents of the pack and other information
1
WHAT VENTOLIN NEBULES ARE AND WHAT THEY ARE USED FOR
Ventolin Nebules 2.5mg/2.5ml and 5 mg/2.5ml Nebuliser Solution (called
‘Ventolin Nebules’
in this leaflet) contain a medicine called salbutamol. This belongs to
a group of medicines
called fast-acting 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 Nebules are used to treat breathing problems in people with
asthma and other
chest illnesses. They are usually given to people who suffer seriously
from these conditions
when other forms of treatment do not help enough. Ventolin Nebules are
also given to treat
severe attacks of asthma.
A Nebule is a small plastic container that contains a liquid. The
liquid is put into a machine
called a n

Lastnosti izdelka

Health Products Regulatory Authority
11 March 2019
CRN008QGG
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventolin Nebules 5mg/2.5ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentration of salbutamol is 0.2%.
Each Nebule contains 5mg Salbutamol (as sulfate)
Each ml of solution contains 2mg salbutamol (as sulfate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
A clear colourless to pale yellow sterile isotonic aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ventolin Nebules are indicated in adults, adolescents and children 4
to 11 years. For babies and children under 4 years of age,
see section 4.2.
Ventolin Nebules are indicated for the treatment or routine management
of bronchospasm. They provide short acting (four
hours) bronchodilation in reversible airways obstruction due to asthma
and chronic obstructive pulmonary disease (COPD)
such as chronic bronchitis and emphysema. For patients with asthma
salbutamol may be used to relieve symptoms when they
occur and to manage them prior to a known trigger.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 12 years and over:_
A suitable starting dose of salbutamol by wet inhalation is 2.5
milligrams.
This may be increased to 5 milligrams. Treatment may be repeated up to
four times daily.
In adult dosing, up to 40 milligrams per day, can be given under
strict medical supervision in hospital for the treatment of
severe airways obstruction.
_ _
_Paediatric population _
For children aged 4 to 11 years: A suitable starting dose of
salbutamol by wet inhalation is 2.5 milligrams.
This may be increased to 5 milligrams. Treatment may be repeated up to
four times daily.
Other pharmaceutical forms may be more appropriate for administration
in children under 4 years old.
Clinical efficacy of nebulised salbutamol in infants under 18 months
is uncertain.
As transient hypoxaemia may occur, supplemental oxygen therapy should
be c