Ventolin Respirator Solution

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

SALBUTAMOL

Διαθέσιμο από:

Glaxo Wellcome UK Limited

Φαρμακολογική κατηγορία (ATC):

R03AC02

INN (Διεθνής Όνομα):

SALBUTAMOL

Φαρμακοτεχνική μορφή:

NEBULISER SOLUTION

Σύνθεση:

SALBUTAMOL 5 mg/ml

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2005-08-10

Φύλλο οδηγιών χρήσης

Reason for update: GDS025 Revised contraindication to specify non-IV
formulations contraindicated in obstetrics
MHRA Approval Date: 09/07/2015
Text Date: 12/03/2015
Text Issue and Draft No: Issue 3 draft 1
SPC Issue and Draft No.: Issue 3 draft 1
Agile Ref: CO-0115077
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GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN
® RESPIRATOR SOLUTION 5 mg/ml
SALBUTAMOL 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 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 Respirator Solution is and what it is used for
2
What you need to know before you take Ventolin Respirator Solution
3
How to take Ventolin Respirator Solution
4
Possible side effects
5
How to store Ventolin Respirator Solution
6
Contents of the pack and other information
1
WHAT VENTOLIN RESPIRATOR SOLUTION IS AND WHAT IT IS USED FOR
Ventolin Respirator Solution contains 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 Respirator Solution is used to treat breathing problems in
people with asthma and
other chest illnesses. It is usually given to people who suffer quite
badly from these
conditions when other forms of treatment do not help enough. Ventolin
Respirator Solution is
also used to treat severe attacks of asthma.
VENTOLIN RESPIRATOR SOLUTION MUST ONLY BE USED BY INHALATION FROM A
NEBULISER AND
MUST NO

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Respirator Solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aqueous, colourless to light yellow solution, pH 3.5, providing 5mg/ml
of
salbutamol (as Salbutamol Sulphate BP).
Excipients with known effect:
Benzalkonium chloride (see section 4.4)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for nebulisation.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ventolin Respirator Solution is indicated in adults, adolescents and
children
aged 4 to 11 years. For babies and children under 4 years of age, see
Section
4.2.
Ventolin Respirator Solution is 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 Respirator Solution is for inhalation use only, to be
breathed in
through the mouth, under the direction of a physician, using a
suitable
nebuliser. The solution should not be injected or swallowed. Ventolin
Respirator Solution may be administered intermittently or
continuously.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Intermittent administration
_Adults: _Ventolin Respirator solution 0.5ml (2.5mg of salbutamol)
should be
diluted to a final volume of 2ml with sterile normal saline. This may
be
increased to 1ml (5mg of salbutamol) diluted to a final volume of
2.5ml. The
resulting solution is inhaled from a suitably driven nebuliser until
aerosol
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generation ceases. Using a correctly matched nebuliser and driving
source this
should take about ten minutes.
Ventolin Respirator Solution may be used undiluted for intermittent
administration. For this, 2ml of Ventolin Respirator Solution (10mg of
salbutamol) is placed in the nebuliser and the patient allowed to
inhale the
nebulised solution until bronchodilatation is achieved. This usually
takes 3 - 5
minutes. Some adult pa