PULMICORT TURBOHALER 100 Mcg/Acutuation Powder for Inhalation
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
02-06-2024
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Ingredient activ:
BUDESONIDE
Disponibil de la:
Clear Pharmacy
Codul ATC:
R03BA02
INN (nume internaţional):
BUDESONIDE
Dozare:
100 Mcg/Acutuation
Forma farmaceutică:
Powder for Inhalation
Tip de prescriptie medicala:
Product subject to prescription which may be renewed (B)
Zonă Terapeutică:
Glucocorticoids
Statutul autorizaţiei:
Authorised
Data de autorizare:
2010-11-26
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pulmicort Turbohaler 100 micrograms Inhalation Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains budesonide 100 micrograms
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
_Product imported from the UK:_
Breath-actuated, metered-dose, inhaler.
White to off white spherical granules which break into a fine powder on inhalation
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pulmicort is recommended in patients with bronchial asthma.
Pulmicort is indicated for the treatment of chronic obstructive pulmonary disease (COPD). Treatment should be
maintained where a beneficial response is obtained during the first 3-6 months of therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Pulmicort Turbohaler is for oral inhalation.
COPD
Adults (including the elderly): The recommended dose is 400 micrograms twice a day.
BRONCHIAL ASTHMA
When starting treatment, or during periods of severe asthma and whilst reducing or discontinuing the dosages of oral
corticosteroids, the dosage should be adjusted to the individual needs of the patient.
Adults: Recommended dosage: 200-1600 micrograms daily.
In mild to moderate asthma, a dose of 200-800 micrograms daily, in single or divided doses, may be used.
In severe asthma, the daily dosage may be increased to a maximum of 1600 micrograms, in divided doses.
Children 5 years of age and above (as children under 5 years may not be able to handle the device properly):
Recommended dosage: 200-800 micrograms daily, in single or divided doses. In severe asthma, the daily dosage may
be increased to a maximum of 800 micrograms, in divided doses.
Elderly: Dosage as for adults.
The maintenance dose should be the lowest possible. Administra
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