Ventolin 5mg Nebules

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Salbutamol sulfate

Dostupné z:

GlaxoSmithKline UK Ltd

ATC kód:

R03AC02

INN (Medzinárodný Name):

Salbutamol sulfate

Dávkovanie:

2mg/1ml

Forma lieku:

Nebuliser liquid

Spôsob podávania:

Inhalation

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 03010101; GTIN: 5000124135706

Príbalový leták

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN NEBULES 2.5 MG AND 5 MG
SALBUTAMOL 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 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 any side effects, talk to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Ventolin Nebules are and what they are used for
2
What you need to know before you use 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 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 quite
badly 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 nebuliser. This machine makes a fine mist for you to breathe
in through a face
mask.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN NEBULES
DO NOT USE VENTOLIN NEBULES IF:
•
you are allergic to salbutamol sulfate or any of the other ingredients
of this medicine
(listed in Section 6).
•
you unexpectedly go into early labour (premature labour) or thre

Súhrn charakteristických

1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Nebules 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plastic ampoule containing 2.5 ml of a sterile 0.2% w/v solution of
salbutamol (as Salbutamol
Sulfate BP) in normal saline.
3.
PHARMACEUTICAL FORM
Solution for inhalation via a nebuliser.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin Nebules are indicated in adults, adolescents and children
aged 4 to 11
years. For babies and children under 4 years of age, see Section 4.2.
Salbutamol
is
a
selective
β
2-agonist
providing
short-acting
(4-6
hour)
bronchodilation
with
a
fast
onset
(within
5
minutes)
in
reversible
airways
obstruction.
Ventolin Nebules are indicated for use in the routine management of
chronic
bronchospasm unresponsive to conventional therapy, and in the
treatment of acute
severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ventolin Nebules are for inhalation use only, to be breathed in
through the mouth, under the
direction of a physician, using a suitable nebuliser.
Private purchase of nebuliser devices for use at home to deliver
rescue therapy for the acute
treatment of asthma in children and adolescents is not recommended.
Only specialists in respiratory medicine should initiate and
clinically manage use of nebulisers
and associated nebulised medicines at home for acute treatment of
asthma in children and
adolescents.
Children should be trained in the correct use of their device to
deliver rescue therapy and use
should be supervised by a responsible adult.
Urgent medical assistance should be sought if worsening asthma
symptoms are not relieved by
rescue medicines, even if there is short-term recovery following use
of prescribed nebulised
medication.
The solution should not be injected or swallowed.
_Adults (including the elderly):_ 2.5 mg to 5 mg salbutamol up to four
times a day. Up to 40 mg per
day can be given under strict medical supervision in hospital.
_Paediatric Population _
Children aged 12 years and over: Dose as per adult population.
Children aged 4-11 years: 2.5 mg to 5