Budesonide/Formoterol Sandoz 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:

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

Gerð lyfseðils:

Receptbelagt

Vörulýsing:

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

Leyfisstaða:

Avregistrerad

Leyfisdagur:

2018-05-24

Vara einkenni

SANDOZ
Business use only
Page 1 of 23
1.3.1 spc-label-pl - common-spc – 11,400
(SE/H/1689/001 change 174927)
20200529
BUDESONIDE+FORMOTEROL FUMARATE 160 MCG + 4.5 MCG /
1 DOS INHALATION POWDER
722-2816.00
HTTP://WWW.ARX.COM/ABOUT-COSIGN-DIGITAL-SIGNATURESSUMMARY OF PRODUCT
CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
{Budesonide/Formoterol Sandoz, 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 (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.
SANDOZ
Business use only
Page 2 of 23
1.3.1 spc-label-pl - common-spc – 11,400
(SE/H/1689/001 change 174927)
20200529
BUDESONIDE+FORMOTEROL FUMARATE 160 MCG + 4.5 MCG /
1 DOS INHALATION POWDER
722-2816.00
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