BUDFOR Powder for Inhalation 200/6 Microgram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
BUDESONIDE FORMOTEROL FUMATRATE DIHYDRATE
Available from:
AstraZeneca UK Limited
Dosage:
200/6 Microgram
Pharmaceutical form:
Powder for Inhalation
Authorization date:
2011-01-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Budfor 200micrograms/6micrograms/Inhalation, Inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 160 micrograms/inhalation and
formoterol fumarate dihydrate 4.5 micrograms/inhalation.
Each
metered
dose
contains:
budesonide
200 micrograms
/
inhalation
and
formoterol
fumarate
dihydrate
6 micrograms
/
inhalation.
Excipient: Lactose monohydrate 730 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
Route of administration: For inhalation use
ASTHMA
Budfor is not intended for the initial management of asthma. The dosage of the components of Budfor is individual and
should be adjusted to the severity of the disease. This should be considered not only when treatment with combination
products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a
combination of doses other than those available in the combination inhaler, appropriate do
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