natgillin/translations-raw huggingface dataset:
In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%. 
U kliničkom ispitivanju u zdravih dobrovoljaca, cimetidin, inhibitor transporta organskih kationa za koji se vjeruje da doprinosi izlučivanju glikopironija putem bubrega, povećao je ukupnu izloženost (AUC) glikopironiju za 22% te smanjio bubrežni klirens za 23%.
Carcinogenicity studies in transgenic mice using oral administration and in rats using inhalation administration revealed no evidence of carcinogenicity at systemic exposures (AUC) of approximately 53-fold higher in mice and 75-fold higher in rats than the maximum recommended dose of 44 micrograms once daily for humans. 
Ispitivanja karcinogenosti u transgenih miševa korištenjem oralne primjene te u štakora korištenjem inhalacijske primjene nije otkrilo nikakve dokaze karcinogenosti pri sistemskim izloženostima (AUC) koje su bile otprilike 53 puta više u miševa i 75 puta više u štakora od maksimalne preporučene doze od 44 mikrograma jedanput na dan za ljude.
In COPD the muscles around the airways tighten. 
Kod KOPB-a mišići oko dišnih putova se stežu.
Acute intoxication by inadvertent oral ingestion of Tovanor Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%). 
Akutna intoksikacija slučajnim oralnim unosom kapsula Tovanor Breezhaler malo je vjerojatna zbog niske oralne bioraspoloživosti (oko 5%).
6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler 
6 x 1 kapsula + 1 inhalator 10 x 1 kapsula + 1 inhalator 12 x 1 kapsula + 1 inhalator 30 x 1 kapsula + 1 inhalator
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP) , koji se nalazi u Modulu 1.8.2
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of allergic reaction) 
• Osip, svrbež, koprivnjača, poteškoće u disanju ili gutanju, omaglica (mogući znakovi alergijske reakcije)
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 
SEKUNDARNA KUTIJA U VIŠESTRUKOM PAKIRANJU (BEZ PLAVOG OKVIRA)
On the first day of treatment inspiratory capacity under exercise was improved by 230 ml and exercise endurance time was improved by 43 seconds (an increase of 10%) compared to placebo. 
Prvog dana liječenja inspiratorni kapacitet pod naporom poboljšao se za 230 ml, a vrijeme izdržavanja napora poboljšalo se za 43 sekunde (povećanje od 10%) u usporedbi s placebom.
In the 12-month study, the improvements were 87 ml at 5 minutes and 143 ml at 15 minutes (both p<0.001). 
U 12-mjesečnom ispitivanju, poboljšanja su bila 87 ml nakon 5 minuta i 143 ml nakon 15 minuta (oba p<0,001).
In patients with COPD, pharmacokinetic steady-state of glycopyrronium was reached within one week of the start of treatment. 
U bolesnika s KOPB-om, farmakokinetičko stanje dinamičke ravnoteže glikopironija bilo je postignuto u roku od tjedan dana od početka liječenja.
The absolute bioavailability of glycopyrromium inhaled via Tovanor Breezhaler was estimated to be about 45% of the delivered dose. 
Procijenjeno je da je apsolutna bioraspoloživost glikopironija inhaliranog preko Tovanor Breezhalera oko 45% isporučene doze.
No specific side effects have been reported when Tovanor Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone). 
Nisu prijavljene posebne nuspojave kada se Tovanor Breezhaler primjenjivao istodobno s drugim lijekovima koji se primjenjuju za liječenje KOPB-a kao što su inhalatori za olakšavanje tegoba (npr. salbutamol), metilksantini (npr. teofilin) i/ili oralni i inhalacijski steroidi (npr. prednizolon).
- if you experience difficulties in breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction). 
- ako osjetite poteškoće u disanju ili gutanju, oticanje jezika, usana ili lica, kožni osip, svrbež i koprivnjaču (znakovi alergijske reakcije).
The magnitude of the effect was dependent on the degree of reversibility of airflow limitation at baseline (tested by administration of a short-acting muscarinic antagonist bronchodilator): Patients with the lowest degree of reversibility at baseline (<5%) generally exhibited a lower bronchodilator response than patients with a higher degree of reversibility at baseline (≥5%). 
Opseg učinka ovisio je o stupnju reverzibilnosti ograničenja protoka zraka na početku (testirano primjenom bronhodilatatora koji je kratkodjelujući muskarinski antagonist): Bolesnici s najnižim stupnjem reverzibilnosti na početku (<5%) općenito su imali niži bronhodilatacijski odgovor od bolesnika s višim stupnjem reverzibilnosti na početku (≥5%).
Tovanor Breezhaler is used as a maintenance treatment for your COPD. 
Tovanor Breezhaler se koristi kao terapija održavanja za Vaš KOPB.
INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF MULTIPACK 
UNUTARNJI POKLOPAC VANJSKE KARTONSKE KUTIJE JEDINIČNOG PAKIRANJA I SEKUNDARNE KUTIJE U VIŠESTRUKOM PAKIRANJU
Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( ) printed in black below a black bar. 
Prozirne narančaste kapsule koje sadrže bijeli prašak, sa šifrom proizvoda „GPL50“ otisnutom crnom bojom iznad, te logotipom tvrtke ( ) otisnutim crnom bojom ispod crne linije.
In a thorough QT study in 73 healthy volunteers, a single inhaled dose of glycopyrronium 352 micrograms (8 times the therapeutic dose) did not prolong the QTc interval and slightly reduced heart rate (maximal effect -5.9 bpm; average effect over 24 hours -2.8 bpm) when compared to placebo. 
U detaljnom ispitivanju QT intervala u 73 zdravih dobrovoljaca, jedna inhalirana doza glikopironija od 352 mikrograma (8 puta veća od terapijske doze) nije produljila QTc interval i blago je smanjila srčanu frekvenciju (maksimalan učinak -5,9 bpm (otkucaja u minuti); prosječni učinak tijekom 24 sata -2,8 bpm) u usporedbi s placebom.
This medicine contains an active substance called glycopyrronium bromide. 
Ovaj lijek sadrži djelatnu tvar koja se zove glikopironijev bromid.
In the pooled 6-month database the frequency of dry mouth was 2.2% versus 1.1%, of insomnia 1.0% versus 0.8%, and of gastroenteritis 1.4% versus 0.9%, for Tovanor Breezhaler and placebo respectively. 
U bazi objedinjenih 6-mjesečnih podataka učestalost suhih usta bila je 2,2% naspram 1,1%, nesanice 1,0% naspram 0,8%, te gastroenteritisa 1,4% naspram 0,9% za Tovanor Breezhaler odnosno placebo.
Secondary pharmacodynamic effects 
Sekundarni farmakodinamički učinci
In COPD patients with mild and moderate renal impairment (estimated glomerular filtration rate, eGFR ≥30 ml/min/1.73 m2) Tovanor Breezhaler can be used at the recommended dose. 
U bolesnika s KOPB-om i s blagim i umjerenim oštećenjem bubrega (procijenjena glomerularna filtracija, eGFR ≥30 ml/min/1,73 m2) Tovanor Breezhaler može se koristiti pri preporučenoj dozi.
Tovanor Breezhaler is a once-daily, long-term maintenance treatment and is not indicated for the initial treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. 
Tovanor Breezhaler je dugoročna terapija održavanja koja se primjenjuje jedanput na dan i nije indiciran za inicijalno liječenje akutnih epizoda bronhospazama, tj. za hitno ublažavanje simptoma.
Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 
Tovanor Breezhaler je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB).
What Tovanor Breezhaler contains - The active substance is glycopyrronium bromide. 
Što Tovanor Breezhaler sadrži - Djelatna tvar je glikopironijev bromid.
After three weeks of treatment the improvement in inspiratory capacity with Tovanor Breezhaler was similar to the first day (200 ml), exercise endurance time however had increased by 89 seconds (an increase of 21%) compared to placebo. 
Nakon tri tjedna liječenja poboljšanje u inspiratornom kapacitetu sa Tovanor Breezhalerom bilo je slično onome za prvi dan (200 ml), vrijeme izdržavanja napora se, međutim, povećalo za 89 sekundi (povećanje od 21%) u usporedbi s placebom.
The pooled analysis also showed fewer patients treated with Tovanor Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003). 
Objedinjena analiza također je pokazala da je manje bolesnika liječenih Tovanor Breezhalerom nego onih koji su primali placebo doživjelo egzacerbaciju koja je zahtijevala hospitalizaciju (1,7% u usporedbi s 4,2%, p=0,003).
The capsules must always be stored in the original blister in order to protect from moisture. 
Kapsule se moraju uvijek čuvati u originalnom blisteru radi zaštite od vlage.
• Dental caries 
• Zubni karijes
The effect on heart rate and QTc interval of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) administered intravenously was investigated in young healthy subjects. 
Učinak na srčanu frekvenciju i QTc interval 150 mikrograma glikopironijevog bromida (ekvivalentno količini od 120 mikrograma glikopironija) primijenjenog intravenski bio je ispitivan u zdravih dobrovoljaca.
In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the dose range of 44 to 176 micrograms. 
U bolesnika s KOPB-om i sistemska izloženost i ukupno urinarno izlučivanje glikopironija u farmakokinetičkom stanju dinamičke ravnoteže povećali su se otprilike proporcionalno dozi u rasponu doza od 44 do 176 mikrograma.
The capsules must only be removed immediately before use. 
Kapsule se moraju izvaditi neposredno prije primjene.
The following pack sizes are available: Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler. 
Dostupne su sljedeće veličine pakiranja: Pakiranje sadrži 6x1, 10x1, 12x1 ili 30x1 tvrdu kapsulu, zajedno s jednim inhalatorom.
Nausea2) 
Mučnina2)
Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (44 micrograms once daily) of Tovanor Breezhaler and were well tolerated. 
Vršne razine u plazmi i ukupna sistemska izloženost nakon primjene u venu 150 mikrograma glikopironijevog bromida (što je ekvivalentno 120 mikrograma glikopironija) u zdravih dobrovoljaca bile su oko 50 odnosno 6 puta više od vršne i ukupne izloženosti u stanju dinamičke ravnoteže postignute uz preporučenu dozu (44 mikrograma jedanput na dan) Tovanor Breezhalera i dobro su se podnosile.
These findings were similar to those seen in patients receiving tiotropium, 53.4% of whom responded with 1 point or greater improvement (p=0.009 compared to placebo). 
Ti su nalazi bili slični onima uočenima u bolesnika koji su primali tiotropij, od kojih je 53,4% odgovorilo s poboljšanjem od 1 boda ili većim (p=0,009 u usporedbi s placebom).
Store the capsules in the original blister in order to protect from moisture. 
Čuvati kapsule u originalnom blisteru radi zaštite od vlage.
• Do not use the Tovanor Breezhaler inhaler to take any other capsule medicine. 
• Nemojte koristiti Tovanor Breezhaler inhalator za uzimanje kapsula bilo kojeg drugog lijeka.
No dose adjustment is required in patients with hepatic impairment. 
Nije potrebna prilagodba doze u bolesnika sa oštećenjem jetre.
What Tovanor Breezhaler looks like and contents of the pack Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder. 
Kako Tovanor Breezhaler izgleda i sadržaj pakiranja Tovanor Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule su prozirne i narančaste te sadrže bijeli prašak.
The amount of glycopyrronium delivered is 44 micrograms. 
Količina isporučenog glikopironija je 44 mikrograma.
Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment. 
Glikopironij se uglavnom izlučuje preko bubrega pa se stoga ne očekuje veliko povećanje izloženosti u bolesnika s oštećenjem jetre.
In patients with severe renal impairment or end-stage renal disease requiring dialysis Tovanor Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2). 
U bolesnika s teškim oštećenjem bubrega ili bolešću bubrega u završnoj fazi koja zahtijeva dijalizu Tovanor Breezhaler smije se koristiti samo ako očekivane koristi premašuju potencijalni rizik obzirom da se u ovoj populaciji može povećati sistemska izloženost glikopironiju (vidjeti dijelove 4.4 i 5.2).
• Diarrhoea or stomach ache 
• Proljev ili trbuhobolja
Productive cough 
Produktivni kašalj
Patients with a history of cardiovascular disease 
Bolesnici s anamnezom kardivaskularne bolesti
Tovanor Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. 
Tovanor Breezhaler treba koristiti oprezno u bolesnika s glaukomom uskog kuta ili urinarnom retencijom.
Tovanor Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively. 
Tovanor Breezhaler jedanput na dan statistički značajno je smanjio korištenje lijeka za hitno ublažavanje simptoma (salbutamola) za 0,46 udisaja dnevno (p=0,005) tijekom 26 tjedana, odnosno za 0,37 udisaja dnevno (p=0,039) tijekom 52 tjedna, u usporedbi s placeboom za 6-mjesečno odnosno 12-mjesečno ispitivanje.
Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways. 
Gikopironij djeluje tako da blokira bronhokonstriktorno djelovanje acetilkolina na glatke mišićne stanice dišnih putova, te time širi dišne putove.
Peak exposures (Cmax) about 50-fold higher than after inhalation of glycopyrronium 44 micrograms at steady state were achieved and did not result in tachycardia or QTc prolongation. 
Bile su postignute vršne izloženosti (Cmax) oko 50 puta veće nakon inhalacije glikopironija 44 mikrograma u stanju dinamičke ravnoteže i nisu rezultirale tahikardijom ili produljenjem QTc intervala.
What Tovanor Breezhaler is and what it is used for 
Što je Tovanor Breezhaler i za što se koristi
Metabolism and nutrition disorders Hyperglycaemia 
Poremećaji metabolizma i prehrane Hiperglikemija
In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Tovanor Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Tovanor Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001). 
U 6-mjesečnom ispitivanju, postotak bolesnika koji su imali umjerenu ili tešku egzacerbaciju bio je 17,5% za Tovanor Breezhaler i 24,2% za placebo (omjer rizika: 0,69, p=0,023), a u 12-mjesečnom ispitivanju bio je 32,8% za Tovanor Breezhaler i 40,2% za placebo (omjer rizika: 0,66, p=0,001).
• Do not use the Tovanor Breezhaler capsules with any other inhaler. 
• Nemojte koristiti Tovanor Breezhaler kapsule s drugim inhalatorima.
For patients receiving tiotropium, 61.0% responded with a 4 point or greater improvement in SGRQ (p=0.004 compared to placebo). 
Za bolesnike koji su primali tiotropij, 61,0% je odgovorilo s poboljšanjem od 4 boda ili više u SGRQ-u (p=0,004 u usporedbi s placebom).
Tovanor Breezhaler contains lactose 
Tovanor Breezhaler sadrži laktozu
Show the pack of Tovanor Breezhaler. 
Pokažite pakiranje Tovanor Breezhalera.
In the 12-month study, Tovanor Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52. 
U 12-mjesečnom ispitivanju, Tovanor Breezhaler je doveo do statistički značajna poboljšanja u FEV1 u usporedbi s tiotropijem u prva 4 sata nakon doziranja prvog dana i nakon 26 tjedana, te numerički veće vrijednosti za FEV1 od tiotropija u prva 4 sata nakon doziranja nakon 12 tjedana i nakon 52 tjedna.
Tovanor Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index. 
Tovanor Breezhaler je također smanjio dispneju u mirovanju, mjereno korištenjem Prijelaznog indeksa dispneje.
Only use the capsules with the inhaler provided in this pack (Tovanor 
Koristite kapsule samo uz inhalator priložen u ovom pakiranju (Tovanor Breezhaler inhalator).
Check capsule is empty 
Provjerite je li kapsula prazna
Gastrointestinal disorders Dry mouth 
Poremećaji probavnog sustava Suha usta
Some side effects may be serious but are uncommon (may affect up to 1 in 100 people) 
Neke nuspojave mogu biti ozbiljne, ali su manje česte (mogu se javiti u do 1 na 100 osoba)
Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules 
Tovanor Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule
Tovanor Breezhaler is a single-dose inhaler. 
Tovanor Breezhaler je jednodozni inhalator.
A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease. 
Umjereno srednje povećanje ukupne sistemske izloženosti (AUClast) do 1,4 puta bilo je uočeno u ispitanika s blagim i umjerenim oštećenjem bubrega, te do 2,2 puta u ispitanika s teškim oštećenjem bubrega i bolešću bubrega u završnoj fazi.
Instructions for use of Tovanor Breezhaler inhaler 
Upute za primjenu Tovanor Breezhaler inhalatora
Some side effects are common (may affect up to 1 in 10 people) 
Neke su nuspojave česte (mogu se javiti u do 1 na 10 osoba)
At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05). 
Nakon 12 tjedana (primarna mjera ishoda), Tovanor Breezhaler povećao je najniži FEV1 za 72 ml u bolesnika s najnižim stupnjem reverzibilnosti (<5%) te za 113 ml u onih bolesnika koji su imali viši stupanj reverzibilnosti na početku (≥5%) u usporedbi s placebom (oba p<0,05).
Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium. 
Svaka isporučena doza (doza koja izlazi iz nastavka za usta inhalatora) sadrži 55 mikrograma glikopironijevog bromida što je ekvivalentno 44 mikrograma glikopironija.
Each capsule contains 50 micrograms glycopyrronium. 
Svaka kapsula sadrži 50 mikrograma glikopironija.
If you forget to inhale a dose, take one as soon as possible. 
Ako ste zaboravili primijeniti Tovanor Breezhaler Ako zaboravite inhalirati dozu, uzmite je čim bude moguće.
The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 44 micrograms of glycopyrronium. 
Primljena doza (doza koja izađe iz nastavka za usta na inhalatoru) odgovara količini od 44 mikrograma glikopironija.
In the 6-month study, Tovanor Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001). 
6-mjesečnom ispitivanju, Tovanor Breezhaler je povećao FEV1 nakon prve doze s poboljšanjem od 93 ml u rok od 5 minuta te 144 ml u roku od 15 minuta od primjene doze, u usporedbi s placebom (oba p<0,001).
- Do not push the capsule through the foil. 
- Ne gurajte kapsulu kroz foliju.
COPD exacerbations reduction 
Smanjenje egzacerbacija KOPB-a
Tovanor Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI). 
Tovanor Breezhaler koji se primjenjivao u dozi od 44 mikrograma jedanput na dan statistički značajno je smanjio gubitak daha ocijenjen prema Prijelaznom indeksu dispneje (eng.
The capsules must only be removed from the blister immediately before use. 
Kapsule se moraju izvaditi iz blistera neposredno prije primjene.
3) Seen more frequently for glycopyrronium than placebo in elderly >75 years only. 
3) Uočeno učestalije za glikopironij nego za placebo samo u starijih u dobi
In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2). 
U bolesnika s teškim oštećenjem bubrega (procijenjena glomerularna filtracija manja od 30 ml/min/1,73 m2), uključujući i one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Tovanor Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 5.2).
The steady-state mean peak and trough plasma concentrations of glycopyrronium for a 44 micrograms once-daily dosing regimen were 166 picograms/ml and 8 picograms/ml, respectively. 
Srednje vršne i najniže koncentracije glikopironija u plazmi u stanju dinamičke ravnoteže za režim doziranja s 44 mikrograma jedanput na dan bile su 166 pikograma/ml odnosno 8 pikograma/ml.
Respiratory, thoracic and mediastinal disorders Sinus congestion 
Poremećaji dišnog sustava, prsišta i sredoprsja Kongestija sinusa
In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Tovanor Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001). 
U objedinjenoj analizi prvih 6 mjeseci liječenja u 6- i 12-mjesečnom ispitivanju, u usporedbi s placebom Tovanor Breezhaler statistički značajno je produljio vrijeme do prve umjerene ili teške egzacerbacije i smanjio stopu umjerenih ili teških egzacerbacija KOPB-a (0,53 egzacerbacija na godinu u usporedbi s 0,77 egzacerbacija na godinu, p<0,001).
In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4). 
U bolesnika s teškim oštećenjem bubrega (eGFR <30 ml/min/1,73 m uključujući one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Tovanor Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 4.4).
At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001). 
Nakon 12 tjedana (primarna mjera ishoda), Tovanor Breezhaler je povećao najniži FEV1 za 108 ml u 6-mjesečnom ispitivanju te za 97 ml u 12-mjesečnom ispitivanju u usporedbi s placebom (oba p<0,001).
Other medicines and Tovanor Breezhaler 
Drugi lijekovi i Tovanor Breezhaler
Some side effects are uncommon (may affect up to 1 in 100 people) 
Neke nuspojave su manje česte (mogu se javiti u do 1 na 100 osoba)
Hypoaesthesia 
Hipoestezija
No studies have been conducted in patients with hepatic impairment. 
Nije bilo ispitivanja provedenih u bolesnika s oštećenjem jetre.