Ventolin 5 mg/ml nebuliser solution

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

SALBUTAMOL

Dostępny od:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Kod ATC:

R03AC02

INN (International Nazwa):

SALBUTAMOL 5 mg/ml

Forma farmaceutyczna:

NEBULISER SOLUTION

Skład:

SALBUTAMOL 5 mg/ml

Typ recepty:

POM

Dziedzina terapeutyczna:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Status autoryzacji:

Authorised

Data autoryzacji:

2005-08-10

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN 5MG/ML NEBULISER
SOLUTION
salbutamol sulphate
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 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ventolin nebuliser solution is and what it is used for
2.
What you need to know before you use Ventolin nebuliser solution
3.
How to use Ventolin nebuliser solution
4.
Possible side effects
5.
How to store Ventolin nebuliser solution
6.
Contents of the pack and other information
7.
Instruction for use of the product
8.
Information for healthcare professionals only
1.
WHAT VENTOLIN NEBULISER SOLUTION IS AND WHAT IT IS USED FOR
Ventolin nebuliser solution contains salbutamol as the active
substance. Salbutamol is one of the group
of bronchodilators with rapid onset of action. Bronchodilators with
rapid onset of action release
muscles in the walls of the small bronchi in the lungs in a couple of
minutes.
Ventolin nebuliser solution :
−
Helps keep your airways passable (widened) and facilitates air flow
into/from the bronchi for
easier breathing.
−
Helps reduce tension on the chest, wheezes and cough and thus helps
you breathe more easily.
Your doctor has chosen this medicine because it is beneficial for you.
Ventolin nebuliser solution is
used to make breathing easier for patients with bronchial asthma and
other pulmonary diseases. Its
effects include mitigation and prevention of asthmatic symptoms caused
by stress and other “triggers”.
Frequent asthma triggers include domestic dust, pollen, cats, dogs and
cigarette smoke.
Bronchial asthma (asthma

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin 5 mg/ml nebuliser solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the solution contains salbutamol sulphate 6 mg,
corresponding to salbutamol 5 mg.
Excipient with known effect: 1 ml of the solution contains
approximately 0.1 mg of
benzalkonium- chloride (see section 4.4).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Nebuliser solution.
Clear, colourless to weakly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin nebuliser solution is administered to adults and adolescents
and to children aged 4 to 11
years.
Salbutamol is selective agonist of beta2-adrenoreceptors indicated for
treatment or prevention of
bronchospasm. Salbutamol induces rapid (within 5 minutes) short-term
(four-hour) bronchodilation to
address reversible airway obstruction caused by bronchial asthma,
chronic bronchitis and emphysema. In
patients with bronchial asthma salbutamol should be used for
mitigation of already existing symptoms or
symptoms that may cause asthmatic burst (for example before physical
stain or unavoidable contact with
an allergen).
In patients with persisting asthma bronchodilators should not be the
only or the main therapy.
In patients with persisting asthma not responding to salbutamol
therapy treatment with inhalation
corticosteroids is recommended for asthma control achievement and
maintenance. Patient non-response
to salbutamol therapy is a signal for the need of immediate medical
attention or change of therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Salbutamol in inhalation form is solely administered by inhalation
through the mouth.
The nebuliser solution should not be administered by injection or
swallowed.
Ventolin nebuliser solution is made exclusively for oral inhalation
from a nebuliser under medical
supervision. Ventolin nebuliser solution may be administered
intermittently or continually.
In most patients the therapeutic effect of salbutamol lasts for 4 to 6
hour