Airbufo Forspiro 160 mikrogram/4,5 mikrogram/inhalation Inhalationspulver, avdelad dos

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

budesonid; formoterolfumaratdihydrat

זמין מ:

Sandoz A/S

קוד ATC:

R03AK07

INN (שם בינלאומי):

budesonide; formoterol

כמות:

160 mikrogram/4,5 mikrogram/inhalation

טופס פרצבטיות:

Inhalationspulver, avdelad dos

הרכב:

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

סוג מרשם:

Receptbelagt

leaflet_short:

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

מצב אישור:

Godkänd

תאריך אישור:

2018-05-24

מאפייני מוצר

SANDOZ
Page 1 of 23
1.3.1 spc-label-pl - common-pl – 11,401
(SE/H/1690/001 change 174927)
20180412
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
{Airbufo Forspiro, 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
SANDOZ
Page 2 of 23
1.3.1 spc-label-pl - common-pl – 11,401
(SE/H/1690/001 change 174927)
20180412
BUDESONIDE+FORMOTEROL FUMARATE 160 MCG + 4.5 MCG /
1 DOS INHALATION POWDER
722-2816.00
-
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