natgillin/translations-raw huggingface dataset:
Ulunar Breezhaler demonstrated a statistically superior improvement versus tiotropium in the percentage of “days able to perform usual daily activities” over 26 weeks (LS mean treatment difference 8.45%, p<0.001).
Ulunar Breezhaler pokazao je statistički superiorno poboljšanje u odnosu na tiotropij u postotku „dana kada mogu obavljati uobičajene svakodnevne aktivnosti“ tijekom 26 tjedana (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 8,45%, p<0,001).
After three weeks of treatment, the improvement in inspiratory capacity with Ulunar Breezhaler was greater (LS mean treatment difference 320 ml, p<0.001) and exercise endurance time increased (LS mean treatment difference 59.5 seconds, p=0.006) compared to placebo.
Nakon tri tjedna liječenja, poboljšanje inspiratornog kapaciteta s Ulunar Breezhalerom bilo je veće (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 320 ml, p<0,001), a vrijeme izdržavanja napora povećalo se (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 59,5 sekundi, p=0,006) u usporedbi s placebom.
During treatment with Ulunar Breezhaler - Stop using this medicine and seek medical help immediately if you experience any of the following: eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes - these may be signs of an acute attack of narrow-angle glaucoma.
Tijekom liječenja Ulunar Breezhalerom - Prestanite uzimati ovaj lijek i odmah potražite medicinsku pomoć ako osjetite nešto od sljedećeg: bol ili nelagoda u oku, privremeno zamagljenje vida, aureole oko izvora svjetlosti ili obojane slike zajedno s crvenim očima - to bi mogli biti znakovi akutnog napada glaukoma uskog kuta. otežano disanje ili gutanje, oticanje jezika, usana ili lica, kožni osip, svrbež i koprivnjača (znakovi alergijske reakcije). stezanje u prsnom košu, kašljanje, piskanje ili nedostatak zraka odmah nakon primjene ovog lijeka - to mogu biti znaci stanja koje se naziva paradoksalni bronhospazam.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Drugi lijekovi i Ulunar Breezhaler Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Your Ulunar Breezhaler Inhaler pack contains:
Vaše pakiranje Ulunar Breezhaler inhalatora sadrži:
At 64 weeks, the reduction compared to tiotropium was statistically significant (LS mean treatment difference -2.69, p<0.001).
U 64 tjednu smanjenje u usporedbi s tiotropijem je bilo statistički značajno (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata -2,69, p<0,001).
At week 64, Ulunar Breezhaler showed numerical improvement over glycopyrronium (LS mean treatment difference 1.95%; p=0.175) and statistical improvement over tiotropium (LS mean treatment difference 4.96%; p=0.001).
U 64. tjednu, Ulunar Breezhaler je pokazao numeričko poboljšanje u odnosu na glikopironij (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 1,95%; p=0,175) i statističko poboljšanje u odnosu na tiotropij (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 4,96%; p=0,001).
• Do not use the Ulunar Breezhaler capsules with any other inhaler.
• Nemojte koristiti kapsule Ulunar Breezhaler s drugim inhalatorima.
In the 52-week active-controlled study, the mean pre-dose FEV1 was statistically significant in favour of Ulunar Breezhaler at all visits up to week 52 compared to fluticasone/salmeterol (LS mean treatment difference 62-86 ml, p<0.001).
U 52-tjednom, aktivno kontroliranom ispitivanju, srednji FEV1 prije primjene doze bio je statistički značajan u korist Ulunar Breezhalera na svim posjetima do 52. tjedna u usporedbi s flutikazonom/salmeterolom (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 62-86 ml, p<0,001).
Ulunar Breezhaler increased post-dose trough FEV1 by 200 ml compared to placebo at the 26-week primary endpoint (p<0.001) and showed statistically significant increases compared to each monotherapy component treatment arm (indacaterol and glycopyrronium) as well as the tiotropium treatment arm, as shown in the below table.
Ulunar Breezhaler je povećao najniži FEV1 nakon doze za 200 ml u usporedbi s placebom u primarnom ishodu u 26. tjednu (p<0,001) i pokazao statistički značajno povećanje u usporedbi sa svakom terapijskom skupinom koja je primala monoterapiju jednom od komponenti (indakaterolom i glikopironijem), kao i u terapijskoj skupini koja je primala tiotropij, kako je prikazano u tablici u nastavku.
Over 26 weeks, Ulunar Breezhaler statistically significantly reduced the use of rescue medication (salbutamol) by 0.96 puffs per day (p<0.001) compared to placebo, 0.54 puffs per day (p<0.001) compared to tiotropium and 0.39 puffs per day (p=0.019) compared to fluticasone/salmeterol.
Tijekom 26 tjedana Ulunar Breezhaler statistički značajno je smanjio primjenu lijeka za hitno ublažavanja simptoma (salbutamola) za 0,96 udisaja dnevno (p<0,001) u usporedbi s placebom, 0,54 udisaja dnevno (p<0,001) u usporedbi s tiotropijem i 0,39 udisaja dnevno (p=0,019) u usporedbi s flutikazonom/salmeterolom.
Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ulunar Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Na temelju kliničkih farmakokinetičkih karakteristika njegovih monoterapijskih komponenti, Ulunar Breezhaler može se koristiti u preporučenoj dozi u bolesnika s blagim do umjerenim oštećenjem bubrega.
The number of all COPD exacerbations/patient-years was 3.34 for Ulunar Breezhaler (2,893 events), 3.92 for glycopyrronium (3,294 events) and 3.89 for tiotropium (3,301 events).
Broj svih egzacerbacija KOPB-a/bolesnik-godine bio je 3,34 za Ulunar Breezhaler (2893 događaja), 3,92 za glikopironij (3294 događaja) i 3,89 za tiotropij (3301 događaja).
A higher proportion of patients demonstrated clinically meaningful response at week 26 on Ulunar Breezhaler as compared to tiotropium (68.1% Ulunar Breezhaler versus 59.2% tiotropium, p=0.016) and fluticasone/salmeterol (65.1% Ulunar Breezhaler versus 55.5% fluticasone/salmeterol, p=0.088).
Veći udio bolesnika pokazao je klinički značajan odgovor u 26. tjednu uz Ulunar Breezhaler u usporedbi s tiotropijem (68,1% Ulunar Breezhaler naspram 59,2% tiotropij, p=0,016) i flutikazonom/salmeterolom (65,1% Ulunar Breezhaler naspram 55,5% flutikazon/salmeterol, p=0,088).
Based on the clinical pharmacokinetic characteristics of its monotherapy components, Ulunar Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment.
Na temelju kliničkih farmakokinetičkih karakteristika njegovih monoterapijskih komponenti, Ulunar Breezhaler može se koristiti u preporučenoj dozi u bolesnika s blagim i umjerenim oštećenjem jetre.
Steady-state exposure to indacaterol after Ulunar Breezhaler inhalation was either similar or slightly lower than systemic exposure after indacaterol monotherapy product inhalation.
Izloženost indakaterolu u stanju dinamičke ravnoteže nakon inhalacije Ulunar Breezhalera bila je ili slična ili nešto niža od sistemske izloženosti nakon inhalacije monoterapije indakaterolom.
Novartis Farmacéutica SA Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Novartis Farmacéutica SA Ronda de Santa Maria 158
The number of all COPD exacerbations/patient-years was 3.59 for Ulunar Breezhaler (4,531 events) and 4.03 for fluticasone/salmeterol (4,969 events).
Broj svih egzacerbacija KOPB-a/bolesnik-godine bio je 3,59 za Ulunar Breezhaler (4531 događaj) i 4,03 za flutikazon/salmeterol (4969 događaja).
Ulunar Breezhaler 85 mcg/43 mcg inhalation powder indacaterol/glycopyrronium
Ulunar Breezhaler 85 μg/43 μg prašak inhalata indakaterol/glikopironij
How to store Ulunar Breezhaler Contents of the pack and other information Instructions for use of Ulunar Breezhaler inhaler
Sadržaj pakiranja i druge informacije Upute za primjenu Ulunar Breezhaler inhalatora
A higher percentage of patients receiving Ulunar Breezhaler responded with a clinically meaningful improvement in SGRQ score (defined as a decrease of at least 4 units from baseline) at week 26 compared to placebo (63.7% and 56.6% respectively, p=0.088) and tiotropium (63.7% Ulunar Breezhaler vs. 56.4% tiotropium, p=0.047), at week 64 compared to glycopyrronium and tiotropium (57.3% Ulunar Breezhaler versus 51.8% glycopyrronium, p=0.055; versus 50.8% tiotropium, p=0.051, respectively), and at week 52 compared to fluticasone/salmeterol (49.2% Ulunar Breezhaler vs. 43.7% fluticasone/salmeterol, odds ratio: 1.30, p<0.001).
Viši postotak bolesnika koji su primali Ulunar Breezhaler odgovorio je s klinički značajnim poboljšanjem rezultata SGRQ-a (definiranim kao smanjenje od najmanje 4 jedinice u odnosu na početnu vrijednost) u 26. tjednu u usporedbi s placebom (63,7% odnosno 56,6%, p=0,088) i tiotropijem (63,7% Ulunar Breezhaler naspram 56,4% tiotropij, p=0,047), u 64 tjednu u usporedbi s glikopironijem i tiotropijem (57,3% Ulunar Breezhaler naspram 51,8% glikopironij, p=0,055; naspram 50,8% tiotropij, p=0,051) i u 52. tjednu u usporedbi s flutikazonom/salmeterolom (49,2% Ulunar Breezhaler naspram 43,7% flutikazon/salmeterol, omjer izgleda: 1,30, p<0,001).
Ulunar Breezhaler - tiotropium
Ulunar Breezhaler - tiotropij
The Ulunar Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study.
Klinički razvojni program faze III za Ulunar Breezhaler uključivao je šest ispitivanja u koje je bilo uključeno više od 8000 bolesnika: 1) 26-tjedno placebom i aktivno kontrolirano (indakaterol jedanput na dan, glikopironij jedanput na dan, nemaskirani tiotropij jedanput na dan) ispitivanje; 2) 26-tjedno aktivno kontrolirano (flutikazon/salmeterol dvaput na dan) ispitivanje; 3)
The number of moderate or severe COPD exacerbations/patient-years was 0.94 for Ulunar Breezhaler (812 events), 1.07 for glycopyrronium (900 events) and 1.06 for tiotropium (898 events).
Broj umjerenih ili teških egzacerbacija KOPB-a po bolesniku-godini bio je 0,94 za Ulunar Breezhaler (812 događaja), 1,07 za glikopironij (900 događaja) i 1,06 za tiotropij (898 događaja).
How long to continue your treatment with Ulunar Breezhaler Keep using Ulunar Breezhaler for as long as your doctor tells you.
Nastavite primijenjivati Ulunar Breezhaler dokle god Vam liječnik kaže.
Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder.
Kako Ulunar Breezhaler izgleda i sadržaj pakiranja Ulunar Breezhaler 85 mikrograma/43 mikrograma prašak inhalata, tvrde kapsule su bezbojne i žute i sadrže bijeli do gotovo bijeli prašak.
Ulunar Breezhaler contains lactose
Ulunar Breezhaler sadrži laktozu
The number of moderate or severe COPD exacerbations/patient-years was 0.98 for Ulunar Breezhaler (1,265 events) and 1.19 for fluticasone/salmeterol (1,452 events).
Broj umjerenih ili teških egzacerbacija KOPB-a/bolesnikgodine bio je 0,98 za Ulunar Breezhaler (1265 događaja) i 1,19 za flutikazon/salmeterol (1452 događaja).
Ulunar Breezhaler - indacaterol
Ulunar Breezhaler - indakaterol
Steady-state exposure to glycopyrronium after Ulunar Breezhaler inhalation was similar to systemic exposure after glycopyrronium monotherapy product inhalation.
Izloženost glikopironiju u stanju dnamičke ravnoteže nakon inhalacije Ulunar Breezhalera bila je slična sistemskoj izloženosti nakon inhalacije monoterapije glikopironijem.
The mean pre-dose FEV1 (average of the values taken at -45 and -15 minutes prior to the morning dose of study medication) was statistically significant in favour of Ulunar Breezhaler at week 26 compared to fluticasone/salmeterol (least squares [LS] mean treatment difference 100 ml, p<0.001), at week 52 compared to placebo (LS mean treatment difference 189 ml, p<0.001) and at all visits up to week 64 compared to glycopyrronium (LS mean treatment difference 70-80 ml, p<0.001) and tiotropium (LS mean treatment difference 60-80 ml, p<0.001).
Srednji FEV1 prije primjene doze (prosjek vrijednosti izmjerenih -45 i -15 minuta prije jutarnje doze ispitivanog lijeka) bio je statistički značajan u korist Ulunar Breezhalera u 26. tjednu u usporedbi s flutikazonom/salmeterolom (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 100 ml, p<0,001), u 52. tjednu u usporedbi s placebom (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 189 ml, p<0,001) i na svim posjetima do 64. tjedna u usporedbi s glikopironijem (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 70-80 ml, p<0,001) i tiotropijem (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 60-80 ml, p <0,001).
Ulunar Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment.
Ulunar Breezhaler se može koristiti u preporučenoj dozi u bolesnika s blagim i umjerenim oštećenjem jetre.
Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules
Ulunar Breezhaler 85 mikrograma/43 mikrograma, prašak inhalata, tvrde kapsule
Multipack: 96 (4 packs of 24 x 1) capsules + 4 inhalers.
Višestruko pakiranje: 96 (4 pakiranja od 24x1) kapsula + 4 inhalatora.
In the 64-week study patients were enrolled who had severe to very severe COPD with a history of ≥1 moderate or severe COPD exacerbation in the previous year.
U četiri od navedenih ispitivanja bili su uključeni bolesnici koji su imali kliničku dijagnozu umjerenog do teškog KOPB s ≥1 umjerenom ili teškom egzacerbacijom KOPB-a u anamnezi u protekloj godini.
Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules indacaterol/glycopyrronium
Ulunar Breezhaler 85 mikrograma/43 mikrograma prašak inhalata, tvrde kapsule indakaterol/glikopironij
General disorders and administration site conditions Pyrexia1
Opći poremećaji i reakcije na mjestu primjene Pireksija
Multipack: 150 (15 packs of 10 x 1) capsules + 15 inhalers.
Višestruko pakiranje: 150 (15 pakiranja od 10x1) kapsula + 15 inhalatora.
Multipack: 150 (25 packs of 6 x 1) capsules + 25 inhalers.
Višestruko pakiranje: 150 (25 pakiranja od 6x1) kapsula + 25 inhalatora.
Ulunar Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Ulunar Breezhaler se može koristiti u preporučenoj dozi u bolesnika s blagim do umjerenim oštećenjem bubrega.
What Ulunar Breezhaler is used for
Za što se koristi Ulunar Breezhaler
What Ulunar Breezhaler is
Što je Ulunar Breezhaler
Ulunar Breezhaler statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI); it demonstrated a statistically significant improvement in the TDI focal score at week 26 compared to placebo (LS mean treatment difference 1.09, p<0.001), tiotropium (LS mean treatment difference 0.51, p=0.007) and fluticasone/salmeterol (LS mean treatment difference 0.76, p=0.003).
Transitional Dyspnoea Index, TDI); pokazao je statistički značajno poboljšanje u TDI fokalnom rezultatu u 26. tjednu u usporedbi s placebom (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 1,09, p<0,001), tiotropijem (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 0,51, p=0,007) i flutikazonom/salmeterolom (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata 0,76, p=0,003).
How much Ulunar Breezhaler to use
Koliko Ulunar Breezhalera primjenjivati
Ulunar Breezhaler has also shown a statistically significant effect on health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at 26 weeks compared to placebo (LS mean treatment difference -3.01, p=0.002) and tiotropium (LS mean treatment difference -2.13, p=0.009) and reductions versus indacaterol and glycopyrronium were -1.09 and -1.18, respectively.
St. George's Respiratory Questionnaire, SGRQ) na što upućuje smanjenje u ukupnom rezultatu na SGRQ-u u 26. tjedanu u usporedbi s placebom (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata -3,01, p=0,002) i tiotropijem (srednja vrijednost terapijske razlike dobivena metodom najmanjih kvadrata -2,13, p=0,009) i smanjenje naspram indakaterola i glikopironija bila su -1,09 odnosno -1,18.
How to use Ulunar Breezhaler
Kako primjenjivati Ulunar Breezhaler
How to store Ulunar Breezhaler
Kako čuvati Ulunar Breezhaler
(same class) to those in Ulunar Breezhaler (see section “Other medicines and Ulunar
- ako uzimate bilo koji lijek za plućnu bolest koji sadrži djelatne tvari koje su slične (iz iste skupine) kao i one u Ulunar Breezhaleru (pogledajte dio „Drugi lijekovi i Ulunar Breezhaler“).
In particular, please tell your doctor or pharmacist if you are using: - any medicines that may be similar to Ulunar Breezhaler (contain similar active substances).
Posebno Vas molimo da obavijestite svog liječnika ili ljekarnika ako uzimate: - bilo koji lijek koji može biti sličan Ulunar Breezhaleru (sadrži slične djelatne tvari). - lijekove zvane beta blokatori koji se mogu koristiti za visoki krvni tlak ili druge srčane probleme (kao što je propranolol), ili za problem s očima koji se zove glaukom (kao što je timolol). - lijekove koji snižavaju količinu kalija u Vašoj krvi.
Ulunar Breezhaler - glycopyrronium
Ulunar Breezhaler - glikopironij
Stop and Check:
Stanite i provjerite:
Throw away the bag.
Bacite vrećicu.
If this happens, try again.
U tom slučaju pokušajte ponovno.
It will also help you to remember to use it.
To će Vam također pomoći da ga se sjetite uzeti.
Some patients may not hear the ‘click'.
Neki bolesnici možda neće čuti ‘klik'.
1.0 unit
1,0 jedinica
What should you do if you accidently prepare a dose?
Što učiniti ako slučajno pripremite dozu?
The Instructions for Use is divided into the following sections:
Upute za uporabu podijeljene su na sljedeće dijelove:
30 doses 60 doses
30 doza 60 doza
Percentage of Patients who achieved MCID
Postotak bolesnika koji su postigli MCID
If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.
Ako želite prekinuti liječenje, prvo razgovarajte sa svojim liječnikom, jer se Vaši simptomi mogu pogoršati.
Allergic reactions may rarely occur (may affect up to 1 in 1,000 people).
Alergijske reakcije mogu se javiti rijetko (mogu se javiti u do 1 na 1000 osoba ).
The upper bound of the confidence interval excluded a pre-defined risk margin of 1.8.
Gornja granica intervala pouzdanosti nije uključivala unaprijed definiranu marginu rizika od 1,8.
The dose is not prepared.
Doza nije pripremljena.
2.5 Hold your breath for as long as possible.
2.5 Zadržite dah koliko god možete.
This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night.
Tako osiguravate da u Vašem tijelu uvijek ima dovoljna količina lijeka koja Vam olakšava disanje tijekom dana i noći.
You can use Bretaris Genuair any time before or after food or drink.
Lijek Bretaris Genuair možete koristiti u bilo koje vrijeme prije ili nakon hrane ili pića.
A risk to newborns/infants cannot be excluded.
Rizik za novorođenčad/dojenčad ne može se isključiti.
Date of first authorisation: 20 July 2012 Date of last renewal: 20 April 2017
Datum posljednje obnove odobrenja: 20. travnja 2017.
Always use this medicine exactly as your doctor or pharmacist has told you.
Uvijek uzmite lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.
If the control window still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough.
Ako kontrolni prozorčić ni tada ne postane crven, možda ste zaboravili otpustiti zeleni gumb prije inhalacije ili možda niste dovoljno snažno udahnuli.
Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.
Aklidinijev bromid treba koristiti tijekom trudnoće samo ako je očekivana korist veća od potencijalnih rizika.
In addition, an updated RMP should be submitted
Nadalje, nadopunjen RMP treba biti dostavljen:
The recommended dose is one inhalation twice a day in the morning and evening.
Preporučena doza je jedna inhalacija dvaput na dan, ujutro i navečer.
Control window Red = confirms correct inhalation
Kontrolni prozorčić Crveno = potvrđuje pravilnu inhalaciju
Deterioration of disease:
Pogoršanje bolesti:
When should you get a new inhaler?
Kada trebate nabaviti novi inhalator?
The MAH shall complete, within the stated timeframe, the below measures:
Nositelj odobrenja će, unutar navedenog vremenskog okvira, ispuniti sljedeće mjere:
Paradoxical bronchospasm:
Paradoksalni bronhospazam:
Therefore, please remember to pay attention to oral hygiene.
Stoga molimo nemojte zaboraviti voditi računa o higijeni usta.
How do you know that your inhaler is empty?
Kako ćete znati da je inhalator prazan?
Control window Green = inhaler ready to use
Kontrolni prozorčić Zeleno = inhalator je spreman za uporabu
NEVER use water to clean the inhaler, as this may damage your medicine.
NIKADA nemojte čistiti inhalator vodom jer to može oštetiti lijek.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, ako ste nedavno uzimali ili ako biste mogli uzeti bilo koje druge lijekove.
When you press the button all the way down, the control window changes from red to green.
Kada pritisnete gumb do kraja, boja kontrolnog prozorčića mijenja se iz crvene u zelenu.
All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.
Svi su bolesnici u anamnezi imali kardiovaskularnu ili cerebrovaskularnu bolest i/ili značajne faktore kardiovaskularnog rizika.
• When a red band appears in the dose indicator, this means you are nearing your last dose
• kada se u pokazivaču doze pojavi crvena traka, što znači da se približavate zadnjoj dozi
- if you see halos around lights or coloured images (glaucoma).
- ako vidite krugove (halo) oko svjetla ili obojene slike (glaukom).
The study had an event-driven design and was terminated once sufficient MACE events for the primary safety analysis were observed.
Ispitivanje je imalo dizajn vođen događajima, a prekinuto je nakon što je opažen dovoljan broj MACE događaja za primarnu analizu sigurnosti.
b MCID of at least - 4 units change in SGRQ.
b MCID promjena od najmanje - 4 jedinice u SGRQ.
1.68-fold c increase in likelihood
1,68-struko c povećanje vjerojatnosti
1.87-fold c increase in likelihood
1,87-struko c povećanje vjerojatnosti
It is important that you read this information as the Genuair may work differently from inhalers you have used previously.
Važno je da pročitate ove informacije jer Genuair možda radi drugačije nego inhalatori koje ste prije koristili.
For Instructions for Use, see section 6.6.
Za upute za uporabu vidjeti dio 6.6.
• If your inhaler appears to be damaged or if you lose the cap, or
• ako inhalator koji imate izgleda oštećeno ili ako izgubite kapicu
How does the dose indicator work?
Kako radi pokazivač doze?
If a dose is missed the next dose should be taken as soon as possible.
Ako se jedna doza propusti, drugu dozu treba uzeti što prije.
70.7% of patients completed the study per investigator assessment.
Ispitivanje je prema ocjeni ispitivača završilo 70,7% bolesnika.
These may be signs of a condition called bronchospasm.
To mogu biti znakovi stanja zvanog bronhospazam.