natgillin/translations-raw huggingface dataset:
• Breathe in rapidly but steadily and as deeply as you can. 
• Udahnite brzo, ali postojano te što dublje možete.
If the capsule is empty, there is no need for concern. 
Ako je kapsula prazna, nemate razloga za brigu.
In case such effects occur, treatment may need to be discontinued. 
Ako se pojave ovi učinci, liječenje treba prekinuti.
Do not press the side buttons more than once. 
Nemojte pritisnuti bočne tipke više od jedanput.
You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit. 
Možda ćete primijetiti da vaše srce kuca brže nego obično, ili možda imate glavobolju, osjećate se pospano, osjećate mučninu ili morate povraćati.
All these findings occurred at exposures sufficiently in excess of those anticipated in humans. 
Svi ovi nalazi javili su se pri izloženostima koje su bile više od onih očekivanih u ljudi.
Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it. 
Bolesnike koji ne osjete poboljšanje u disanju treba upitati gutaju li lijek umjesto da ga inhaliraju.
• if you get high levels of sugar in your blood (diabetes). 
• ako imate visoku razinu šećera u krvi (dijabetes).
Put the empty capsule in your household waste. 
Odbacite praznu kapsulu u svoj kućni otpad.
If you experience coughing briefly after inhaling the medicine, do not worry. 
Ako kašljete ubrzo nakon udisanja lijeka, nemojte brinuti.
The maximum dose is 300 microgram once daily. 
Najveća doza je 300 mikrograma jedanput na dan.
Within each system organ class, adverse reactions are ranked by frequency in descending order according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
Unutar svake skupine prema učestalosti, nuspojave su navedene u padajućem nizu prema sljedećem dogovoru: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Your doctor may tell you to use the 150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment. 
Liječnik Vam može reći da koristite kapsulu od 150 mikrograma ili kapsulu od 300 mikrograma ovisno o Vašem stanju i kakav je Vaš odgovor na liječenje.
See “How to clean your inhaler”. 
Vidjeti „Kako čistiti svoj inhalator“.
• Hold the inhaler as shown in the picture. 
• Držite inhalator kako je prikazano na slici.
This medicine contains lactose (milk sugar). 
Ovaj lijek sadrži laktozu (mliječni šećer).
• Inhale the medicine again by repeating steps 8 and 9. 
• Ponovno udahnite lijek ponavljajući 8. i 9. korak.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete , obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
Check your inhaler to see if the capsule is empty and that you have received the full dose. 
Provjerite svoj inhalator da vidite je li kapsula prazna i jeste li primili punu dozu.
Children and adolescents Oslif Breezhaler should not be given to children or adolescents below the age of 18 years 
Djeca i adolescenti Oslif Breezhaler se ne smije davati djeci ili adolescentima mlađim od 18 godina.
• You should hear a “click” as the capsule is being pierced. 
• Trebate čuti „klik“ kada se probuši kapsula.
Please read the instructions at the end of this leaflet for more information about how to use the inhaler. 
Molimo Vas da pročitate upute na kraju ove upute o lijeku za više informacija o korištenju inhalatora.
Table 2 Symptom relief at 6 months treatment duration 
Tablica 2 Smanjenje simptoma tijekom 6 mjeseci liječenja
Oslif Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks. 
Oslif Breezhaler se može koristiti tijekom trudnoće samo ako je očekivana korist veća od mogućih rizika.
Date of first authorisation: 30 November 2009 Date of latest renewal: 18 September 2014 
Datum posljednje obnove odobrenja: 18. rujan 2014.
• swollen hands, ankles and feet (oedema) 
• otečene šake, gležnjevi i stopala (edem)
Always release the push buttons before inhalation. 
Uvijek oslobodite bočne tipke prije inhalacije.
Ask your doctor or pharmacist for advice before taking any medicine. 
Obratite se svom liječniku ili ljekarniku za savjet prije uzimanja bilo kojeg lijeka.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijekdefinirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. 
U izoliranom ljudskom bronhu indakaterol ima brz početak djelovanja i dugo trajanje djelovanja.
The in vitro human serum and plasma protein binding was 94.1-95.3% and 95.1-96.2%, respectively. 
In vitro vezanje na ljudske proteine seruma i plazme bilo je 94,1-95,3%, odnosno 95,1-96,2%.
Metabolic and transporter based interactions 
Metaboličke interakcije i interakcije temeljene na transporteru
Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients. 
Najveća koncentracija u plazmi i ukupna sistemska izloženost raste s dobi, ali nije potrebno prilagođavati dozu u starijih bolesnika.
Oslif Breezhaler should be administered at the same time of the day each day. 
Oslif Breezhaler treba primjenjivati svakog dana u isto vrijeme.
Mass balance was complete with ≥90% of the dose recovered in the excreta. 
Masena bilanca je bila potpuna uz ≥90% doze prikupljene u izlučevinama.
After you have finished taking your medicine: 
Kada završite primjenu svog lijeka:
Indacaterol was not embryotoxic or teratogenic in rats or rabbits. 
Indakaterol nije bio embriotoksičan niti teratogen u štakora i kunića.
• Then breathe out. 
• Zatim izdahnite.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako seone neće javiti kod svakoga.
You will experience a sweet flavour as the medicine goes into your lungs. 
Osjetit ćete slatki okus dok Vam lijek ulazi u pluća.
The mean age of patients was 64 years, with 48% of patients aged 65 years or older, and the majority (80%) was Caucasian. 
Prosječna starost bolesnika bila je 64 godine, od toga je 48% bolesnika imalo 65 godina ili više, a većina su bili bijelci (80%).
REMEMBER: 
ZAPAMTITE:
This helps open up the airways, making it easier to get air in and out. 
To pomaže otvaranju dišnih puteva, olakšavajući ulazak i izlazak zraka.
If a dose is missed the next dose should be taken at the usual time the next day. 
U slučaju propuštene doze, sljedeću dozu treba uzeti sljedećeg dana u isto vrijeme.
Carcinogenicity was assessed in a two-year rat study and a six-month transgenic mouse study. 
Karcinogenost je bila procijenjena u dvogodišnjem ispitivanju u štakora i šestomjesečnom transgeničkom ispitivanju u miševa.
Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and COPD patients. 
Farmakokinetički podaci su dobiveni iz brojnih ispitivanja u zdravih dobrovoljaca i u bolesnika s KOPB-om.
Close the inhaler: Close the inhaler until you hear a “click”. 
Zatvorite inhalator: Zatvorite inhalator tako da čujete „klik“.
• Ask your pharmacist how to dispose of medicines and inhalers no longer required. 
• Upitajte svog ljekarnika kako zbrinuti lijekove i inhalatore koje više ne trebate.
Never place a capsule directly into the mouthpiece. 
Nikada nemojte staviti kapsulu izravno u nastavak za usta.
Put a mark in today's box if it helps to remind you of when your next dose is due. 
Zabilježite uzimanje doze na kalendariću ako Vam to pomaže da se sjetite kada trebate uzeti sljedeću dozu.
4,764 patients were exposed to indacaterol up to one year at doses up to twice the maximum recommended dose. 
4764 bolesnika bila su liječena indakaterolom do jedne godine u dozama do dva puta većim od najveće preporučene doze.
As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise. 
Dok dišete kroz inhalator, kapsula se okreće u komori pa biste trebali čuti zujanje.
Hold breath: 
Zadržite dah:
Before placing the mouthpiece in your mouth, breathe out fully. 
Prije nego što nastavak stavite u usta, potpuno izdahnite.
The clinical development programme included one 12-week, two six-month (one of which was extended to one year to evaluate safety and tolerability) and one one-year randomised controlled studies in patients with a clinical diagnosis of COPD. 
Klinički razvojni program uključivao je jedno ispitivanje u trajanju od 12 tjedana, dva ispitivanja u trajanju od šest mjeseci (od kojih je jedno bilo produljeno do jedne godine za procjenu sigurnosti primjene i podnošljivosti) i jedno randomizirano kontrolirano ispitivanje u trajanju od jedne godine u bolesnika s kliničkom dijagnozom KOPB-a.
PA/Alu/PVC - Alu blister containing 10 hard capsules. 
PA/Al/PVC -Al blister koji sadrži po 10 tvrdih kapsula.
Absolute bioavailability of indacaterol after an inhaled dose was on average 43% to 45%. 
Potpuna bioraspoloživost indakaterola nakon inhalirane doze bila je u prosjeku 43% do 45%.
A decreased pregnancy rate has been observed in rats. 
Zapaženo je smanjenje stope trudnoća u štakora.
It was observed with a higher frequency in female than in male patients and in current smokers than in ex-smokers. 
On je češće bio zapažen u žena nego u muškaraca, te u pušača koji su u to vrijeme pušili u odnosu na bivše pušače.
• Pierce the capsule by firmly pressing together both side buttons at the same time. 
• Probušite kapsulu čvrstim pritiskom na bočne tipke s obje strane istodobno.
In Phase III clinical studies, healthcare providers observed during clinic visits that on average 17-20% of patients experienced a sporadic cough that occurred usually within 15 seconds following inhalation and typically lasted for 5 seconds (about 10 seconds in current smokers). 
U ispitivanjima faze III zdravstveni djelatnici su opazili da je tijekom kliničkih posjeta u prosjeku 17-20% bolesnika imalo sporadični kašalj koji se obično javljao 15 sekundi nakon inhalacije i trajao oko 5 sekundi (oko 10 sekundi u pušača koji su u to vrijeme pušili).
In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder. 
U ovom pakiranju naći ćete inhalator i kapsule (u blisteru) koje sadrže lijek kao prašak inhalata.
The following pack sizes are available: 
Na tržištu su dostupna sljedeća pakiranja:
Limited treatment experience is available in individuals of African descent. 
Dostupna su ograničena iskustva o liječenju bolesnika afričkog podrijetla.
Patients should be instructed on how to administer the product correctly. 
Bolesnicima treba pokazati kako pravilno primjenjivati lijek.
These were reported voluntarily from a population of uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a causal relationship to exposure to the medicinal product. 
Ta izvješća o nuspojavama dobrovoljno je poslala populacija neutvrđene veličine te stoga nije uvijek moguće pouzdano procijeniti učestalost nuspojava ili utvrditi njihovu uzročno-posljedičnu vezu s izloženošću lijeku.
Contains lactose (see package leaflet for further information) and gelatin. 
Sadrži laktozu (vidjeti uputu o lijeku za dodatne informacije) i želatinu.
Percentage of patients who achieved MCID TDI† 
Postotak bolesnika koji su postigli MCID TDI†
The most common adverse reactions at the recommended doses were nasopharyngitis (14.3%), upper respiratory tract infection (14.2%), cough (8.2%), headache (3.7%) and muscle spasms (3.5%). 
Najčešće nuspojave uz preporučene doze su bile nazofaringitis (14,3%), infekcije gornjeg dišnog sustava (14,2%), kašalj (8,2%), glavobolja (3,7%) i spazam mišića (3,5%).
Mean heart rate changes were less than one beat per minute, and tachycardia was infrequent and reported at a similar rate as under placebo treatment. 
Srednje promjene srčanog ritma bile su manje od jednog udarca u minuti, a tahikardija je bila rijetka i prijavljena po sličnoj stopi kao i pri liječenju placebom.
Do not use Oslif Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6). 
Nemojte primjenjivati Oslif Breezhaler - ako ste alergični na indakaterol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life ranging from 45.5 to 126 hours. 
Koncentracije indakaterola u serumu padale su na multifazni način, uz prosječni krajnji poluživot u rasponu od 45,5 do 126 sati.
Effects on cardiac electrophysiology 
Učinci na srčanu elektrofiziologiju
The oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4. 
Oksidativni metaboliti su nađeni u inkubaciji s rekombinantnim CYP1A1, CYP2D6 i CYP3A4.
The frequency of notable QTcF intervals [i.e. >450 ms (males) and >470 ms (females)] and reports of hypokalaemia were similar to placebo. 
>450 ms (muškarci) i >470 ms (žene)] i hipokalijemije bila je slična kao za placebo.
Study design with a: indacaterol 150 microgram, salmeterol and placebo; 
Dizajn ispitivanja s a: indakaterolom u dozi od 150 mikrograma, salmeterolom i placebom;
If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Oslif Breezhaler should be discontinued immediately and alternative therapy instituted. 
Ako znakovi koji se pojave ukazuju na alergijsku reakciju (osobito poteškoće u disanju ili gutanju, oticanje jezika, usana i lica, urtikarija, osip na koži), primjenu Oslif Breezhaler treba odmah prekinuti i uvesti alternativnu terapiju.
In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Oslif Breezhaler (i.e. medicines such as salmeterol and formoterol). 
Posebno Vas molimo da obavijestite svog liječnika ako uzimate: lijekove za probleme s disanjem koji su slični Oslif Breezhaleru (tj. lijekovi kao što su salmeterol i formoterol).
The other ingredients include lactose and the capsule is made of gelatin. 
Drugi sastojak je laktoza, a kapsula je načinjena od želatine.
There are no data from the use of indacaterol in pregnant women available. 
Nema dostupnih podataka o primjeni indakaterola u trudnica.
This medicine relaxes these muscles in the lungs, making it easier for air to get in and out of the lungs. 
Ovaj lijek opušta te mišiće u plućima, omogućava lakši protok zraka u i iz pluća.
Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety database. 
Nuspojave u Tablici 1 poredane su prema MedDRA klasifikaciji organskih sustava u bazi sigurnosnih podataka za KOPB.
The median time to reach peak serum concentrations of indacaterol was approximately 15 min after single or repeated inhaled doses. 
Medijan vremena postizanja vršnih koncentracija indakaterola u serumu bilo je približno 15 min nakon jednokratne ili ponovljenih inhaliranih doza.
• feeling of pressure or pain in the cheeks and forehead (inflammation of the sinuses) 
• osjećaj pritiska ili boli u obrazima i čelu (upala sinusa)
Therefore, this shows no concern for a pro-arrhythmic potential related to QT-interval prolongations at recommended therapeutic doses or at twice the maximum recommended dose. 
To je, dakle, pokazalo da se ne treba brinuti oko proaritmičkog potencijala vezanog za produljenje QT-intervala u preporučenim terapijskim dozama ili pri dozama dva puta većim od najviše preporučene doze.
• cold-like symptoms. 
• simptomi nalik prehladi.
Therefore the frequency was calculated from clinical trial experience. 
Stoga je učestalost nuspojava izračunata na temelju iskustava iz kliničkih ispitivanja.
Do not use this medicine if you notice that the pack is damaged or show signs of tampering. 
Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili ako su vidljivi znakovi neovlaštenog otvaranja.
Relevant prolongations of QTcF were not detectable in comparison to placebo. 
Značajna produljenja QTcF se nisu uočavala u usporedbi s placebom.
The capsules contain lactose. 
Kapsule sadrže laktozu.
Renal clearance of indacaterol was, on average, between 0.46 and 1.20 litres/hour. 
Bubrežni klirens indakaterola u prosjeku je bio između 0,46 i 1,20 litara/sat.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Oslif Breezhaler therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Oslif Breezhaler uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
See package leaflet for how to use this medicine. 
Vidjeti uputu o lijeku radi načina korištenja ovog lijeka.
There is no evidence that cough experienced post inhalation is associated with bronchospasm, exacerbations, deteriorations of disease or loss of efficacy. 
Nema dokaza da je kašalj nakon inhalacije povezan s bronhospazmom, egzacerbacijama i pogoršanjem bolesti ili gubitkom djelotvornosti.
In COPD patients, single doses of 10 times the maximum recommended therapeutic dose were associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval. 
U bolesnika s KOPB-om, jednokratne doze 10 puta veće od najveće preporučene terapijske doze bile su povezane s umjerenim povećanjem pulsa, sistoličkog krvnog tlaka i QTc intervala.
The precise function of beta2-adrenergic receptors in the heart is not known, but their presence raises the possibility that even highly selective beta2-adrenergic agonists may have cardiac effects. 
Točna funkcija beta2-adrenergičkih receptora u srcu nije poznata, ali njihova prisutnost povećava mogućnost da čak i visoko selektivni beta2-adrenergički agonisti mogu imati srčane učinke.
How to use your inhaler 
Kako koristiti Vaš inhalator
Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution. 
Kada je potrebno, prednost treba dati kardioselektivnim beta-adrenergičkim blokatorima, iako ih treba oprezno primjenjivati.
The capsules are transparent (uncoloured) and contain a white powder. 
Kapsule su prozirne (bezbojne) te sadrže bijeli prašak.
This cough experienced post inhalation did not lead to any patient discontinuing from the studies at the recommended doses (cough is a symptom in COPD and only 8.2% of patients reported cough as an adverse event). 
Taj kašalj koji se javljao nakon inhalacija nije doveo do prekida liječenja niti u jednog bolesnika u ovim ispitivanjima uz preporučene doze (kašalj je simptom KOPB-a i ukupno je samo 8,2% bolesnika prijavilo kašalj kao štetan događaj).
Insert capsule: Place the capsule into the capsule chamber. 
Umetnite kapsulu: Stavite kapsulu u komoru za kapsulu.
COPD is a long-term disease and you should use Oslif Breezhaler every day and not only when you have breathing problems or other symptoms of COPD. 
KOPB je dugotrajna bolest i trebate primijeniti Oslif Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
Systemic exposure results from a composite of pulmonary and gastrointestinal absorption; about 75% of systemic exposure was from pulmonary absorption and about 25% from gastrointestinal absorption. 
Sistemska izloženost je rezultat zbroja plućne i gastrointestinalne apsorpcije; oko 75% sistemske izloženosti je rezultat plućne apsorpcije dok je 25% rezultat apsorpcije iz probavnog sustava.
Therefore indacaterol should not be given together with betaadrenergic blockers (including eye drops) unless there are compelling reasons for their use. 
Zbog toga indakaterol ne treba primjenjivati istodobno s beta-adrenergičkim blokatorima (uključujući kapi za oči), osim ako za to ne postoje jaki razlozi.
For instructions on use of the medicinal product before administration, see section 6.6. 
Za uputu o pripremi lijeka prije primjene vidjeti dio 6.6.
Salmeterol twice a day 
Salmeterol dva puta na dan
Please read the following instructions carefully to learn how to use and care for your Oslif Breezhaler inhaler. 
Molimo Vas da pažljivo pročitate upute u nastavku kako biste naučili primjenjivati i brinuti se o svom Oslif Breezhaler inhalatoru.
Nevertheless, it is considered unlikely that indacaterol will affect reproductive or fertility performance in humans following inhalation of the maximum recommended dose (see section 5.3). 
Međutim, smatra se da je mala vjerojatnost da bi indakaterol utjecao na reprodukciju ili plodnost u ljudi nakon inhalacije najveće preporučene doze (vidjeti dio 5.3).
In vitro investigations have indicated that indacaterol has negligible potential to cause metabolic interactions with medicinal products at the systemic exposure levels achieved in clinical practice. 
In vitro istraživanja su ukazala da indakaterol ima neznatan potencijal uzrokovanja metaboličkih interakcija s lijekovima pri razinama sistemske izloženosti koje se postižu u kliničkoj praksi.
• Open the inhaler to see if any powder is left in the capsule. 
• Otvorite inhalator kako biste provjerili je li ostalo praška u kapsuli.
Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk (see section 5.3). 
Dostupni farmakokinetički/toksikološki podaci u životinja pokazuju da se indakaterola/metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor agonists, ATC code: R03AC18 
Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova, selektivni agonisti beta-2-adrenergičkih receptora, ATK oznaka: R03AC18
The mean of the maximum changes in blood glucose were similar between Oslif Breezhaler and placebo. 
Srednja vrijednost najvećih promjena glukoze u krvi bila je slična za Oslif Breezhaler i placebo.
You should not use Oslif Breezhaler unless your doctor tells you so. 
Nemojte koristiti Oslif Breezhaler osim ako Vam to nije rekao liječnik.
On the inside of the pack there is a daily dose tracker. 
Na unutarnjoj strani pakiranja nalazi se kalendarić za praćenje dnevnih doza.
Due to the very low contribution of the urinary pathway to total body elimination, a study in renally impaired subjects was not performed. 
Zbog vrlo malog doprinosa mokraćnih puteva u ukupnoj eliminaciji iz tijela, ispitivanje u bolesnika s oštećenjem bubrega nije provedeno.
Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10-50% of the total adrenergic receptors. 
Premda su beta2-receptori predominantni adrenergički receptori u bronhijalnim glatkim mišićima, a beta1-receptori predominantni receptori u ljudskom srcu, u ljudskom srcu postoje i beta2- adrenergički receptori koji čine 10-50% ukupnih adrenergičkih receptora.
It is not known whether indacaterol/metabolites are excreted in human milk. 
Nije poznato izlučuje li se indakaterol/metaboliti u majčino mlijeko u ljudi.