Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SALBUTAMOL
Chiesi Farmaceutici S.p.A.
200 Microgram
Inhalation Powder, Capsule
2001-07-13
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 Read the complete document