FrancophonIA/ELRC3.0 huggingface dataset:
English: Linear pharmacokinetics were observed for glycopyrronium (dose range: 14.4 to 115.2 mcg) and formoterol (dose range: 2.4 to 19.2 mcg) after oral inhalation.
Croatian: Nakon peroralne inhalacije opažena je linearna farmakokinetika glikopironija (raspon doza: 14,4 do 115,2 μg) i formoterola (raspon doza: 2,4 do 19,2 μg).
English: Bevespi Aerosphere contains two bronchodilators: glycopyrronium a long-acting muscarinic antagonist (also referred to as an anticholinergic) and formoterol a long-acting β2-adrenergic agonist with a rapid onset of action.
Croatian: Bevespi Aerosphere sadrži dva bronhodilatatora: glikopironij, koji je dugodjelujući antagonist muskarinskih receptora (naziva se još i antikolinergikom), i formoterol, koji je dugodjelujući agonist β2-adrenoreceptora s brzim nastupom djelovanja.
English: A population pharmacokinetic analysis of glycopyrronium was performed based on data collected in a total of 311 subjects with COPD.
Croatian: Populacijska farmakokinetička analiza glikopironija provedena je na temelju podataka prikupljenih kod ukupno 311 ispitanika s KOPB-om.
English: • For inhalation use only.
Croatian: • Samo za inhaliranje.
English: The pharmacokinetics of glycopyrronium was best described by a two-compartment disposition model with first-order absorption and linear elimination.
Croatian: Farmakokinetika glikopironija najbolje je opisana modelom raspoloživosti s dva odjeljka, s apsorpcijom prvog reda i linearnom eliminacijom.
English: Step 8: Re-prime your Bevespi Aerosphere inhaler after each cleaning.
Croatian: 8. korak: Nakon svakog čišćenja ponovno pripremite inhalator lijeka Bevespi Aerosphere.
English: There are no relevant data on the use of Bevespi Aerosphere in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see sections 4.4 and 5.2).
Croatian: Nema relevantnih podataka o primjeni lijeka Bevespi Aerosphere kod bolesnika s teškim oštećenjem jetrene funkcije, pa kod tih bolesnika lijek treba primjenjivati uz oprez (vidjeti dio 4.4 i dio 5.2).
English: As glycopyrronium is predominantly renally excreted, patients with severe renal impairment (creatinine clearance of < 30 mL/min), including those with end-stage renal disease requiring dialysis, should only be treated with Bevespi Aerosphere if the expected benefit outweighs the potential risk (see section 5.2).
Croatian: Budući da se glikopironij pretežno izlučuje kroz bubrege, kod bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min), uključujući one u završnom stadiju bubrežne bolesti kojima je potrebna dijaliza, Bevespi Aerosphere smije se primjenjivati samo ako očekivana korist nadmašuje potencijalni rizik (vidjeti dio 5.2).
English: These include: o corticosteroids that you take by mouth (such as prednisolone), o diuretics (such as furosemide or hydrochlorothiazide) used for high blood pressure, o some medicines used to treat breathing conditions called methylxanthines (such as theophylline);
Croatian: Ti lijekovi uključuju: o kortikosteroide koji se uzimaju kroz usta (poput prednizolona) o diuretike (poput furosemida ili hidroklorotiazida), koji se koriste za visok krvni tlak o neke lijekove koji se koriste za liječenje dišnih tegoba, a zovu se metilksantini (poput teofilina)
English: CARTON - SINGLE INHALER
Croatian: KUTIJA - JEDAN INHALATOR
English: Figure 14 Step 1: Take the pressurised container out of the actuator (See Figure 15).
Croatian: 1. korak: Izvadite spremnik pod tlakom iz aktivatora (pogledajte Sliku 15).
English: However, because formoterol is primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver impairment.
Croatian: Međutim, budući da se formoterol prvenstveno eliminira metabolizmom jetre, kod bolesnika s teškim oštećenjem funkcije jetre može se očekivati povećana izloženost.
English: 120 actuations (1 inhaler).
Croatian: 120 potisaka (1 inhalator).
English: Immune system disorders Hypersensitivity reactions including rash and pruritus
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti, uključujući osip i pruritus manje često
English: Evidence of transfer of glycopyrronium and formoterol into maternal milk in rats has been reported.
Croatian: Zabilježeni su dokazi o tome da glikopironij i formoterol prelaze u mlijeko ženki štakora.
English: Following inhaled administration of Bevespi Aerosphere in subjects with COPD, glycopyrronium Cmax occurred at approximately 5 minutes, and formoterol Cmax occurred within 20 to 60 minutes.
Croatian: Nakon inhalacijske primjene lijeka Bevespi Aerosphere kod ispitanika s KOPB-om, glikopironij je dosegnuo Cmax nakon približno 5 minuta, dok je Cmax formoterola zabilježen unutar 20 - 60 minuta.
English: The typical clearance (CL/F) of glycopyrronium was 124 L/h.
Croatian: Tipičan klirens (CL/F) glikopironija iznosio je 124 l/h.
English: Since glycopyrronium is eliminated mainly by the renal route, drug interaction could potentially occur with medicinal products affecting renal excretion mechanisms.
Croatian: Budući da se glikopironij izlučuje prvenstveno kroz bubrege, moglo bi doći do potencijalne pojave interakcije s lijekovima koji utječu na mehanizme bubrežnog izlučivanja.
English: The tabulated list of adverse reactions is based on the experience with Bevespi Aerosphere in clinical trials and experience with the individual components.
Croatian: Tablični prikaz nuspojava temelji se na iskustvu s primjenom lijeka Bevespi Aerosphere u kliničkim ispitivanjima, kao i na iskustvu s primjenom njegovih pojedinačnih sastavnica.
English: No evidence of carcinogenicity was seen in 2-year studies in rats and mice.
Croatian: U 2-godišnjim ispitivanjima na štakorima i miševima nisu opaženi dokazi kancerogenosti.
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5).
Croatian: Kod bolesnika s teškim KOPB-om hipokalijemiju mogu potencirati hipoksija i lijekovi u istodobnoj primjeni (vidjeti dio 4.5).
English: Over the concentration range of 2-500 nmol/L, plasma protein binding of glycopyrronium ranged from 43% to 54%.
Croatian: U rasponu koncentracija od 2 do 500 nmol/l vezivanje glikopironija za proteine u plazmi kretalo se između 43% i 54%.
English: 120 actuations (1 inhaler)
Croatian: 120 potisaka (1 inhalator)
English: • difficulty passing urine (urinary retention)
Croatian: • otežano mokrenje (zadržavanje mokraće)
English: There are no data on the use of Bevespi Aerosphere in pregnant women.
Croatian: Nema podataka o primjeni lijeka Bevespi Aerosphere u trudnica.
English: Administration of Bevespi Aerosphere to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the infant (see section 5.3).
Croatian: Primjenu lijeka Bevespi Aerosphere kod dojilja treba razmotriti samo ako je očekivana korist za majku veća od bilo kojeg mogućeg rizika za dojenče (vidjeti dio 5.3).
English: For inhalation use.
Croatian: Za inhaliranje.
English: Bevespi Aerosphere is a pressurised inhalation, suspension.
Croatian: Bevespi Aerosphere je stlačeni inhalat, suspenzija.
English: Figure 17 Step 7: When the actuator is dry, gently press the pressurised container down in the actuator (See Figure 18).
Croatian: 7. korak: Nakon što se aktivator osuši, nježno u njega umetnite spremnik pod tlakom (pogledajte Sliku 18).
English: Bevespi Aerosphere comes as a pressurised container with a dose indicator, supplied with a white plastic actuator body and mouthpiece (see Figure 1 of the Instructions for Use at the end of this leaflet).
Croatian: Bevespi Aerosphere dolazi u spremniku pod tlakom s pokazivačem doze, koji se isporučuje zajedno s bijelim plastičnim aktivatorom s nastavkom za usta (pogledajte Sliku 1 u uputama za uporabu na kraju ove upute o lijeku).
English: Glycopyrronium is primarily cleared from the systemic circulation by renal excretion and hepatic impairment would therefore not be expected to lead to unsafe systemic exposure.
Croatian: Glikopironij se iz sistemske cirkulacije prvenstveno uklanja izlučivanjem kroz bubrege, pa se ne očekuje da bi oštećenje funkcije jetre moglo dovesti do sistemske izloženosti koja nije sigurna za bolesnika.
English: Bevespi Aerosphere is used to make breathing easier for adults who have a lung disease called chronic obstructive pulmonary disease (COPD).
Croatian: Bevespi Aerosphere koristi se da bi olakšao disanje odraslima koji imaju bolest pluća pod nazivom kronična opstruktivna plućna bolest (KOPB).
English: The use of Bevespi Aerosphere with the Aerochamber Plus Flow-Vu spacer in COPD patients increased the total systemic exposure to glycopyrronium (as measured by AUC0-12) by 16% while formoterol exposure was unchanged.
Croatian: Primjena lijeka Bevespi Aerosphere uz pomoć komore za inhaliranje Aerochamber Plus Flow-Vu kod bolesnika s KOPB-om povećala je ukupnu sistemsku izloženost glikopironiju (određenu na temelju vrijednosti AUC0-12) za 16%, dok je izloženost formoterolu ostala nepromijenjena.
English: Step 3: Hold the inhaler with the mouthpiece pointing towards you and breathe out as fully as you comfortably can through your mouth (See Figure 8).
Croatian: 3. korak: Držite inhalator tako da nastavak za usta bude usmjeren prema Vama i izdahnite kroz usta koliko god možete, do granice neugode (pogledajte Sliku 8).
English: Due to its anticholinergic activity, Bevespi Aerosphere should be used with caution in patients with symptomatic prostatic hyperplasia, urinary retention or with narrow-angle glaucoma (see section 4.8).
Croatian: Zbog njegova antikolinergičkog djelovanja, Bevespi Aerosphere treba primjenjivati uz oprez kod bolesnika sa simptomatskom hiperplazijom prostate, retencijom mokraće ili glaukomom uskog kuta (vidjeti dio 4.8).
English: Subjects with COPD with both low body weight and moderate-severe impaired renal function may have an approximate doubling of systemic exposure to glycopyrronium.
Croatian: Kod ispitanika s KOPB-om koji imaju i malu tjelesnu težinu i umjereno do teško oštećenje funkcije bubrega moguća je približno dvostruko veća sistemska izloženost glikopironiju.
English: • Bevespi Aerosphere comes with a dose indicator on the top of the pressurised container (See Figure 1).
Croatian: • Bevespi Aerosphere ima pokazivač doze na vrhu spremnika pod tlakom (pogledajte Sliku 1).
English: The effect of cimetidine, a probe inhibitor of OCT2 and MATE1, on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 22% and a slight decrease in renal clearance by 23% due to co-administration of cimetidine.
Croatian: Učinak cimetidina, probnog inhibitora prijenosnika OCT2 i MATE1, na raspoloživost inhaliranog glikopironija očitovao se kao ograničeno povećanje ukupne sistemske izloženosti glikopironiju (AUC0-t) za 22% i blago smanjenje bubrežnog klirensa za 23% zbog istodobne primjene cimetidina.
English: Based on available data, no adjustment of the dosage of Bevespi Aerosphere in geriatric patients is necessary.
Croatian: Prema dostupnim podacima nije potrebno prilagođavati dozu lijeka Bevespi Aerosphere kod starijih bolesnika.
English: Multipack containing 3 inhalers each with 120 actuations.
Croatian: Višestruko pakiranje koje sadrži 3 inhalatora, svaki sa 120 potisaka.
English: Other medicines and Bevespi Aerosphere
Croatian: Drugi lijekovi i Bevespi Aerosphere
English: Bevespi Aerosphere is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Croatian: Bevespi Aerosphere nije indiciran za liječenje akutnih epizoda bronhospazma, tj. kao terapija za hitno ublažavanje simptoma.
English: CYP2D6 and CYP2C have been identified as being primarily responsible for Odemethylation.
Croatian: Utvrđeno je da su za O-demetilaciju prvenstveno odgovorni CYP2D6 i CYP2C.
English: SGRQ total score
Croatian: Ukupan SGRQ rezultat
English: If you are not sure, talk to your doctor or pharmacist before using Bevespi Aerosphere.
Croatian: Ako niste sigurni, razgovarajte s liječnikom ili ljekarnikom prije nego primijenite Bevespi Aerosphere.
English: The systemic exposure (AUC0-12) in subjects with COPD with moderate-severe renal impairment (eGFR of 30-45 mL/min) is approximately 30% higher for glycopyrronium compared to subjects with COPD with normal renal function (eGFR of >90 mL/min).
Croatian: Sistemska izloženost glikopironiju (AUC0-12) približno je 30% veća kod ispitanika s KOPB-om i umjerenim do teškim oštećenjem funkcije bubrega (eGFR 30 - 45 ml/min) nego kod ispitanika s KOPB-om i normalnom funkcijom bubrega (eGFR > 90 ml/min).
English: The parts of your Bevespi Aerosphere inhaler (See Figure 1):
Croatian: Dijelovi inhalatora lijeka Bevespi Aerosphere (pogledajte Sliku 1):
English: • you have kidney or liver problems
Croatian: • ako imate bubrežnih ili jetrenih tegoba
English: Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Croatian: Bevespi Aerosphere indiciran je kao terapija održavanja bronhodilatacije za ublažavanje simptoma kod odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB) (vidjeti dio 5.1).
English: Do not use Bevespi Aerosphere if you are pregnant unless your doctor tells you that you can.
Croatian: Ako ste trudni, nemojte primjenjivati Bevespi Aerosphere, osim ako Vam liječnik ne kaže da možete.
English: Bevespi Aerosphere delivers the active ingredients directly to the airways in your lungs as you breathe in.
Croatian: Bevespi Aerosphere isporučuje djelatne tvari izravno u dišne putove u plućima tijekom udisaja.
English: Improvements compared to formoterol were observed in PINNACLE 2 (see Table 2).
Croatian: U ispitivanju PINNACLE 2 opažena su poboljšanja u odnosu na formoterol (vidjeti Tablicu 2).
English: Single-dose studies in humans found that very small amounts of glycopyrronium passed the placental barrier.
Croatian: Ispitivanja primjene jedne doze kod ljudi pokazala su da kroz posteljičnu barijeru prolaze vrlo male količine glikopironija.
English: INHALER LABEL (ACTUATOR)
Croatian: NALJEPNICA NA INHALATORU (AKTIVATOR)
English: Carton containing 1 inhaler with 120 actuations.
Croatian: Kutija koja sadrži 1 inhalator sa 120 potisaka.
English: Bevespi Aerosphere should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval (see section 4.4).
Croatian: Bevespi Aerosphere potrebno je primjenjivati uz oprez kod bolesnika koji se liječe lijekovima za koje je poznato da produljuju QTc interval (vidjeti dio 4.4).
English: Steady state is achieved within 2-3 days of repeated dosing of Bevespi Aerosphere, and the extent of exposure is approximately 2.3 times and 1.5 times higher than after the first dose, for glycopyrronium and formoterol, respectively.
Croatian: Nakon ponovljene primjene lijeka Bevespi Aerosphere, stanje dinamičke ravnoteže postiže se unutar 2 - 3 dana, a razina izloženosti glikopironiju i formoterolu približno je 2,3 odnosno 1,5 puta veća nego nakon primjene prve doze.
English: Talk to your doctor or pharmacist before using Bevespi Aerosphere if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Bevespi Aerosphere:
English: Co-administration of Bevespi Aerosphere with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see section 4.4 and section 4.9).
Croatian: Istodobna primjena lijeka Bevespi Aerosphere i drugih lijekova koji sadrže antikolinergike i/ili dugodjelujuće agoniste β2-adrenoreceptora nije se ispitivala te se ne preporučuje jer može potencirati poznate nuspojave koje se javljaju pri inhalaciji muskarinskih antagonista ili agonista β2-adrenoreceptora (vidjeti dijelove 4.4 i 4.9).
English: o Do not use the Bevespi Aerosphere actuator with any other medicine.
Croatian: o Nemojte koristiti aktivator za Bevespi Aerosphere ni s jednim drugim lijekom.
English: The excretion of formoterol was studied in six healthy subjects following simultaneous administration of radiolabelled formoterol via the oral and IV routes.
Croatian: Izlučivanje formoterola ispitivalo se kod šest zdravih ispitanika nakon istodobne peroralne i intravenske primjene radioaktivno označenog formoterola.
English: Figure 2c 100 puffs
Croatian: Slika 2c 100 udisaja
English: Using your Bevespi Aerosphere inhaler: Step 1: Remove the cap from the mouthpiece (See Figure 6).
Croatian: Uporaba inhalatora lijeka Bevespi Aerosphere: 1. korak: Skinite zatvarač s nastavka za usta (pogledajte Sliku 6).
English: • After priming 4 times, the dose indicator should be pointing to the right of “120” and your inhaler is now ready to use.
Croatian: • Nakon što ste postupak ponovili 4 puta, pokazivač doze trebao bi pokazivati desno od oznake „120“.
English: Figure 2b 110 puffs
Croatian: Slika 2b 110 udisaja
English: Studies evaluating the effect of renal impairment on the pharmacokinetics of glycopyrronium and formoterol have not been conducted.
Croatian: Nisu provedena ispitivanja utjecaja oštećenja funkcije bubrega na farmakokinetiku glikopironija i formoterola.
English: Multipack: 360 actuations (3 packs of 120 actuations)
Croatian: Višestruko pakiranje: 360 potisaka (3 inhalatora sa 120 potisaka).
English: There were improvements in trough FEV1 irrespective of age, sex, degree of airflow limitation, baseline symptoms, smoking status, or inhaled corticosteroid use.
Croatian: Poboljšanja najniže vrijednosti FEV1 zabilježena su neovisno o dobi, spolu, stupnju ograničenja protoka zraka te simptomima, pušačkom statusu ili primjeni inhalacijskih kortikosteroida na početku ispitivanja.
English: In COPD, the muscles around the airways tighten which makes breathing difficult.
Croatian: Kod bolesnika s KOPB-om mišići oko dišnih putova se stežu, što otežava disanje.
English: You may hear a soft click from the dose indicator as it counts down during use.
Croatian: Tijekom uporabe inhalatora možda ćete čuti tihi klik koji se javlja kada pokazivač doze odbrojava.
English: Table 2 Lung function, symptomatic and health related quality of life outcomes over 24 weeks Treatment comparisons with Bevespi
Croatian: Tablica 2. Ishodi povezani s plućnom funkcijom, simptomima i kvalitetom života vezanom uz zdravlje tijekom 24 tjedna
English: Patients who find it difficult to co-ordinate actuation with inspiration of breath may use Bevespi Aerosphere with a spacer to ensure proper administration of the product.
Croatian: Bolesnici koji imaju poteškoća s usklađivanjem aktivacije i udisaja mogu primjenjivati Bevespi Aerosphere uz pomoć komore za inhaliranje kako bi osigurali pravilnu primjenu lijeka.
English: Bevespi Aerosphere contains two active substances called glycopyrronium and formoterol fumarate dihydrate.
Croatian: Bevespi Aerosphere sadrži dvije djelatne tvari koje se zovu glikopironij i formoterolfumarat dihidrat.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk (see sections 4.4 and 5.2).
Croatian: Kod bolesnika s teškim oštećenjem bubrežne funkcije ili onih u završnom stadiju bubrežne bolesti kojima je potrebna dijaliza smije se primjenjivati samo ako očekivana korist nadmašuje potencijalni rizik (vidjeti dijelove 4.4 i 5.2).
English: Do not use Bevespi Aerosphere if you are breast-feeding unless your doctor tells you that you can.
Croatian: Ako dojite, nemojte primjenjivati Bevespi Aerosphere, osim ako Vam liječnik ne kaže da možete.
English: Animal reproduction studies with formoterol have shown a slightly reduced fertility in male rats at high systemic exposure and implantation losses, as well as decreased early postnatal survival and birth weight at considerably higher systemic exposures than those reached during clinical use.
Croatian: Ispitivanja učinka formoterola na reprodukciju kod životinja pokazala su neznatno smanjenu plodnost mužjaka štakora pri visokim razinama sistemske izloženosti, kao i gubitke ploda nakon implantacije te smanjeno preživljenje u ranoj postnatalnoj fazi i smanjenu težinu mladunčadi pri okotu, pri razinama izloženosti koje su bile znatno veće od onih koje se postižu tijekom kliničke primjene lijeka.
English: Actuator
Croatian: Aktivator
English: o Do not use the Bevespi Aerosphere pressurised container with an actuator from any other inhaler.
Croatian: o Nemojte koristiti spremnik lijeka Bevespi Aerosphere pod tlakom s aktivatorom nekog drugog inhalatora.
English: It is not known whether glycopyrronium or formoterol are excreted in human milk.
Croatian: Nije poznato izlučuju li se glikopironij ili formoterol u majčino mlijeko.
English: • Bevespi Aerosphere comes as a pressurised container with a dose indicator that fits into an actuator.
Croatian: • Bevespi Aerosphere dolazi u spremniku pod tlakom s pokazivačem doze, koji se ulaže u aktivator.
English: 1,2-distearoyl-sn-glycero-3-phosphocholine Calcium chloride
Croatian: 1,2-distearoil-sn-glicero-3-fosfokolin kalcijev klorid
English: The terminal elimination half-life of formoterol following oral inhalation derived via population pharmacokinetics analysis was 13 hours.
Croatian: Prema populacijskoj farmakokinetičkoj analizi, terminalno poluvrijeme eliminacije formoterola nakon peroralne inhalacije iznosilo je 13 sati.
English: Shake well before use.
Croatian: Prije uporabe lijek treba dobro protresti.
English: In three Phase III, 24-week studies (PINNACLE 1, PINNACLE 2 and PINNACLE 4) Bevespi Aerosphere provided improvements over placebo in lung function (as measured by morning pre-dose trough forced expiratory volume in 1 second [FEV1]), with a demonstrated onset of action at 5 minutes following administration of the first dose on Day 1 (improvement over placebo by 187 mL, 186 mL and 179 mL in PINNACLE 1, PINNACLE 2 and PINNACLE 4, respectively [p <0.001]).
Croatian: forced expiratory volume in 1 second, FEV1] prije primjene jutarnje doze), uz dokazan nastup djelovanja 5 minuta nakon primjene prve doze 1. dana (poboljšanje za 187 ml, 186 ml odnosno 179 ml u odnosu na placebo u ispitivanju PINNACLE 1, PINNACLE 2 odnosno PINNACLE 4 [p <0,001]).
English: Animal reproduction studies with glycopyrronium have shown reduced rat and rabbit fetal weights, and low body weight gain of rat offspring before weaning was observed at considerably higher systemic exposures than those reached during clinical use.
Croatian: Ispitivanja učinka glikopironija na reprodukciju životinja pokazala su smanjenu tjelesnu težinu fetusa štakora i kunića kao i smanjeni prirast tjelesne težine mladunčadi štakora prije prestanka sisanja pri razinama sistemske izloženosti značajno većima od onih koje se postižu tijekom kliničke primjene.
English: INHALER LABEL (PRESSURISED CONTAINER)
Croatian: NALJEPNICA NA INHALATORU (SPREMNIK POD TLAKOM)
English: Bevespi Aerosphere also showed improvements in peak FEV1 within 2 hours post-dose over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Croatian: Bevespi Aerosphere pokazao je i poboljšanja vršne vrijednosti FEV1 unutar 2 sata nakon primjene doze tijekom 24 tjedna u odnosu na placebo, glikopironij i formoterol (p<0,0001) [vidjeti Tablicu 2].
English: The inhaler is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with an orange dust cap. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed into a carton.
Croatian: Lijek dolazi u inhalatoru fiksnih doza pod tlakom, koji se sastoji od aluminijskog spremnika pod tlakom s pričvršćenim pokazivačem doze, a isporučuje se zajedno s bijelim plastičnim aktivatorom s nastavkom za usta prekrivenim narančastim zaštitnim zatvaračem.
English: How to use
Croatian: Kako primijeniti lijek
English: This means that there are 110 puffs of medicine left in the pressurised container (See Figure 2b).
Croatian: To znači da je u spremniku pod tlakom preostala količina lijeka dovoljna za 110 udisaja (pogledajte Sliku 2b).