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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Butovent Pulvinal 200 micrograms/dose inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation provides 200 micrograms of salbutamol.
For excipient see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and children over 12 years:
-
Symptomatic treatment of asthma attacks.
-
Symptomatic treatment of exacerbations of asthma or of chronic obstructive
bronchitis with a reversible component.
-
Prevention of exercise-induced asthma.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Posology
Adults and children over 12 years:
Treatment of asthma attacks and exacerbations:
as soon as symptoms occur: 1 to 2 inhalations.
If the symptoms persist, the dose may be repeated
a few minutes later.
Prevention of exercise-induced asthma: 1 to 2 inhalations 15 to 30
minutes before exercise.
The lowest effective doses of inhaled
salbutamol are recommended to be used in
the treatment of asthma. In the long
term treatment it is recommended instead of regular use, to
use inhaled salbutamol when needed.
The daily dose should not exceed 8
inhalations per 24 hours (see section 4.4).
METHOD OF ADMINISTRATION.
Inhalation from the device through the mouthpiece.
_THE PHYSICIAN SHOULD
ENSURE THAT THE PATIENT CORRECTLY USES THE POWDER INHALER IN ACCORDANCE WITH THE INSTRUCTIONS _
_FOR USE REPORTED IN THE LEAFLET._
Inhalation powders are suitable for use in patients who
show poor hand/lung synchronisation.
This device is a “high
resistance” inhaler that requires a peak inspiratory
flow rate of at least 28 l/min to insure a
satisfactory lung disposition of the powder.
Therefore this medicinal product is not suitable for patients with
a low peak
inspiratory flow rate, such as children under 12 years.
This shoul
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