Bofunir 160 mikrogram/4,5 mikrogram/inhalation, Inhalationspulver, avdelad dos

Country: Svíþjóð

Tungumál: sænska

Heimild: Läkemedelsverket (Medical Products Agency)

Virkt innihaldsefni:

budesonid; formoterolfumaratdihydrat

Fáanlegur frá:

Sandoz A/S

ATC númer:

R03AK07

INN (Alþjóðlegt nafn):

budesonide; formoterol

Skammtar:

160 mikrogram/4,5 mikrogram/inhalation,

Lyfjaform:

Inhalationspulver, avdelad dos

Samsetning:

laktosmonohydrat Hjälpämne; budesonid 160 mikrog Aktiv substans; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans

Gerð lyfseðils:

Receptbelagt

Vörulýsing:

Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 6 x 60 doser; Inhalator, 4 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 2 x 60 doser

Leyfisstaða:

Avregistrerad

Leyfisdagur:

2018-05-07

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
{Bofunir, 160 micrograms/4.5 micrograms/inhalation, inhalation powder,
pre-dispensed}
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (inhaled dose) contains 160 micrograms of
budesonide and 4.5 micrograms of
formoterol fumarate dihydrate.
Each metered dose (pre-dispensed dose contained in the blister)
contains 194.7 micrograms of
budesonide and 6.1 micrograms of formoterol fumarate dihydrate.
Excipient with known effect
Lactose monohydrate: 5.4 mg per metered dose
and 4.4 mg per delivered dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White to off-white or slightly yellow powder with no agglomerates.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
[Nationally completed name] is indicated in adults and adolescents (12
years and older) for the regular
treatment of asthma, where use of a combination (inhaled
corticosteroid and long-acting β
2
adrenoceptor agonist) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled short-
acting β
2
adrenoceptor agonists.
or
-
patients already adequately controlled on both inhaled corticosteroids
and long-acting β
2
adrenoceptor agonists.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
[Nationally completed name] is indicated in adults, aged 18 years and
older, for the symptomatic
treatment of patients with COPD with forced expiratory volume in 1
second (FEV
1
) <70% predicted
normal (post bronchodilator) and an exacerbation history despite
regular bronchodilator therapy (see
also section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: for inhalation use.
Posology
ASTHMA
[Nationally completed name] is not intended for the initial management
of asthma. The required dose
of each component of [Nationally completed name] is individual and
should be adjusted to the
severity of the disease. This should be considered not only when
treatment with com