VENTOLIN NEBULES 2.5 mg2.5 ml

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

SALBUTAMOL SULPHATE EQV SALBUTAMOL

Beschikbaar vanaf:

GLAXOSMITHKLINE PTE LTD

ATC-code:

R03AC02

Dosering:

2.5 mg

farmaceutische vorm:

SOLUTION

Samenstelling:

SALBUTAMOL SULPHATE EQV SALBUTAMOL 2.5 mg

Toedieningsweg:

RESPIRATORY (INHALATION)

Prescription-type:

Prescription Only

Geproduceerd door:

GLAXOSMITHKLINE AUSTRALIA PTY LTD

Autorisatie-status:

ACTIVE

Autorisatie datum:

1991-01-12

Bijsluiter

DIRECTIONS FOR USE – : Before using your Ventolin
Nebules, please read this leaflet carefully and follow
these instructions.
Ventolin Nebules 2.5 mg – salbutamol (as sulfate) 2.5 mg
per 2.5 mL.
Ventolin Nebules 5 mg – salbutamol (as sulfate)
5 mg per 2.5 mL.
An
aqueous
preservative-free
solution
for
inhalation
made isotonic with sodium chloride.
FOR INHALATION ONLY
NOT FOR INJECTION - MUST NOT BE INGESTED
METHOD OF ADMINISTRATION
Do not open the foil pouch until the Nebules are required.
The contents of Ventolin Nebules are to be inhaled from a
nebuliser.
Prepare the nebuliser for filling (according to the
manufacturers’ instructions).
1) Open the foil pouch by tearing downwards from the
tear point, located on the right hand side of the seal at
the top of the pack (Diagram 1).
2) To
detach
one
Ventolin
Nebule
twist
the
Nebule
downwards and away while holding the other Nebules
securely (Diagram 2). Return the remaining Nebules to
the foil pouch.
3) Hold the top of the Nebule you have just removed
securely and twist the body to open (Diagram 3).
4) Place the open end of the Nebule well into the nebuliser
bowl and squeeze slowly (Diagram 4). Ensure that all
contents are emptied into the nebuliser bowl.
5) Assemble the nebuliser and use it as directed.
Make sure the mist does not get into your eyes.
6) After use discard any solution remaining in the nebuliser
bowl. Clean your nebuliser in the recommended way.
VENTOLIN
® NEBULES
®
10000000141586
BORONIA - ADDITIONAL ARTWORK INFORMATION PANEL
COMPONENT NAME
VENTOLIN NEBS LEAFLET ROM AU
COMPONENT NO.
10000000141586
SITE CHANGE NO.
201379085, 201379088
SPECIFICATION NO.
BLFT017
NOTE TO SUPPLIER: N/A
3
10000000141586
GSK-AUS-BORONIA-AUBOR
AUSTRALIA-AUS
VENTOLIN NEBULES N/A
LFT043
N/A
N/A 1
K 0 0 11.0PT 13.0PT 100% 11.0PT NO
PAGE 1 OF 2
GENERAL INSTRUCTION
After opening the foil pouch please:
1. Note date of opening.
2. Add 3 months to this date which will be the ‘discard
after’ date. If the 3 months discard date is later than
the expiry date, then the expiry

Productkenmerken

1
VENTOLIN™ NEBULES
SALBUTAMOL
QUALITATIVE AND QUANTITATIVE COMPOSITION
_VENTOLIN _
nebules 2.5mg: contain a concentration of salbutamol of 0.1% (1mg
salbutamol, as the sulphate, in 1ml). Each Nebule contains 2.5ml of
solution equivalent to
2.5mg salbutamol.
_VENTOLIN_
Nebules 5.0mg: contain a concentration of salbutamol of 0.2% (2mg
salbutamol, as the sulphate, in 1ml). Each Nebule contains 2.5ml of
solution equivalent to
5.0mg salbutamol.
PHARMACEUTICAL FORM
Nebuliser solution.
CLINICAL PARTICULARS
INDICATIONS
_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 (status asthmaticus).
DOSAGE AND ADMINISTRATION
Adults and Children
A suitable starting dose of salbutamol by wet inhalation is 2.5
milligrams. This may be
increased to 5 milligrams.
Treatment may be repeated four times daily.
Clinical efficacy of nebulised salbutamol in infants under 18 months
is uncertain. As
transient hypoxaemia may occur, supplemental oxygen therapy should be
considered.
_VENTOLIN_
Nebules are intended to be used undiluted. However, if prolonged
delivery
time is desirable (more than 10 minutes) dilution using sterile normal
saline as a diluent
may be required.
2
_VENTOLIN_
Nebules are to be used with a nebuliser, under the direction of a
physician.
The solution must not be injected, or swallowed.
Increasing use of beta-2agonists may be a sign of worsening asthma.
Under these
conditions a reassessment of the patient's therapy plan may be
required and concomitant
glucocorticosteroid therapy should be considered.
Delivery of the aerosol may be by facemask, 'T' piece or via an
endotracheal tube.
Intermittent positive pressure ventilation may be used but is rarely
necessary. When there
is a risk of anoxia through hypoventilation, oxygen should be added to
the inspired air.
As there may be adverse effects associated with excessive dosing, the
dosage or
frequency of administration should only be increased on medical
a