Ventolin 5mg/ml respirator solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Salbutamol sulfate

Available from:

GlaxoSmithKline UK Ltd

ATC code:

R03AC02

INN (International Name):

Salbutamol sulfate

Dosage:

5mg/1ml

Pharmaceutical form:

Nebuliser liquid

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010101; GTIN: 5000124421601

Patient Information leaflet

- 1 -
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 NOT BE INJECTED OR SWALLOWED.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VENTOLIN RESPIRATOR SOLUTION
DO NOT TAKE VENTOLIN RESPIRATOR SOLUTION IF:

you are allergic to salbutamol sulfate or any of the other ingredients
of this medicine
(listed in Section 6).

you unexpectedly

Summary of Product characteristics

OBJECT 1
VENTOLIN RESPIRATOR SOLUTION
Summary of Product Characteristics Updated 03-Aug-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Ventolin
®
Respirator
®
Solution 5 mg/ml.
2. Qualitative and quantitative composition
Aqueous, colourless to light yellow solution, pH 3.5, providing 5
mg/ml of salbutamol (as Salbutamol
Sulfate 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 0.5 ml (2.5 mg of salbutamol)
should be diluted to a final volume of
2 ml with sterile normal saline. This may be increased to 1 ml (5 mg
of salbutamol) diluted to a final
volume of 2.5 ml. The resulting solution is inhaled from a suitably
driven nebuliser until aerosol
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, 2 ml of
Ventolin Respirator Solution (10 mg of salbutamol) is placed in the
nebuliser and the patient allowed to
inhale the nebulised solution until bronchodilation is achieved. This
usuall