BUDFOR Powder for Inhalation 400/12 Microgram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

BUDESONIDE FORMOTEROL FUMATRATE DIHYDRATE

Available from:

AstraZeneca UK Limited

Dosage:

400/12 Microgram

Pharmaceutical form:

Powder for Inhalation

Authorization date:

2011-01-07

Summary of Product characteristics

                                
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Budfor 400micrograms/12micrograms/Inhalation, Inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 320 micrograms/inhalation and
formoterol fumarate dihydrate 9 micrograms/inhalation.
Each metered dose contains: budesonide 400 micrograms
/
inhalation and formoterol fumarate dihydrate
12 micrograms/inhalation.
Excipient: Lactose monohydrate 491 micrograms per dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
White powder
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Asthma
Budfor is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-
acting
2
adrenoceptor agonist) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short
-acting
2
adrenoceptor agonists.
or
-
patients already adequately controlled on both inhaled corticosteroids and long-acting
2
adrenoceptor agonists.
COPD
Symptomatic treatment of patients with severe COPD (FEV
1
< 50% predicted normal) and a history of repeated
exacerbations, who have significant symptoms despite regular therapy with long
-acting bronchodilators.
4.2 Posology and method of administration
                                
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