Šalis: Švedija
kalba: švedų
Šaltinis: Läkemedelsverket (Medical Products Agency)
budesonid; formoterolfumaratdihydrat
Sandoz A/S
R03AK07
budesonide; formoterol
160 mikrogram/4,5 mikrogram/inhalation
Inhalationspulver, avdelad dos
laktitolmonohydrat Hjälpämne; budesonid 160 mikrog Aktiv substans; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans
Receptbelagt
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
Avregistrerad
2018-05-24
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 Perskaitykite visą dokumentą