EDOFLO Powder for Inhalation 200/6 Mcg/Dose
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-03-2023
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Active ingredient:
BUDESONIDE FORMOTEROL FUMATRATE DIHYDRATE
Available from:
AstraZeneca UK Limited
Dosage:
200/6 Mcg/Dose
Pharmaceutical form:
Powder for Inhalation
Authorization date:
2010-11-26
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Edoflo 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
Edoflo 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
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