FrancophonIA/ELRC3.0 huggingface dataset:
English: Carcinogenicity was assessed in a two-year rat study and a six-month transgenic mouse study.
Croatian: Karcinogenost je bila procijenjena u dvogodišnjem ispitivanju u štakora i šestomjesečnom transgeničkom ispitivanju u miševa.
English: Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and COPD patients.
Croatian: Farmakokinetički podaci su dobiveni iz brojnih ispitivanja u zdravih dobrovoljaca i u bolesnika s KOPB-om.
English: Close the inhaler: Close the inhaler until you hear a “click”.
Croatian: Zatvorite inhalator: Zatvorite inhalator tako da čujete „klik“.
English: • Ask your pharmacist how to dispose of medicines and inhalers no longer required.
Croatian: • Upitajte svog ljekarnika kako zbrinuti lijekove i inhalatore koje više ne trebate.
English: Never place a capsule directly into the mouthpiece.
Croatian: Nikada nemojte staviti kapsulu izravno u nastavak za usta.
English: Put a mark in today's box if it helps to remind you of when your next dose is due.
Croatian: Zabilježite uzimanje doze na kalendariću ako Vam to pomaže da se sjetite kada trebate uzeti sljedeću dozu.
English: 4,764 patients were exposed to indacaterol up to one year at doses up to twice the maximum recommended dose.
Croatian: 4764 bolesnika bila su liječena indakaterolom do jedne godine u dozama do dva puta većim od najveće preporučene doze.
English: As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise.
Croatian: Dok dišete kroz inhalator, kapsula se okreće u komori pa biste trebali čuti zujanje.
English: Hold breath:
Croatian: Zadržite dah:
English: Before placing the mouthpiece in your mouth, breathe out fully.
Croatian: Prije nego što nastavak stavite u usta, potpuno izdahnite.
English: 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.
Croatian: 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.
English: PA/Alu/PVC - Alu blister containing 10 hard capsules.
Croatian: PA/Al/PVC -Al blister koji sadrži po 10 tvrdih kapsula.
English: Absolute bioavailability of indacaterol after an inhaled dose was on average 43% to 45%.
Croatian: Potpuna bioraspoloživost indakaterola nakon inhalirane doze bila je u prosjeku 43% do 45%.
English: A decreased pregnancy rate has been observed in rats.
Croatian: Zapaženo je smanjenje stope trudnoća u štakora.
English: It was observed with a higher frequency in female than in male patients and in current smokers than in ex-smokers.
Croatian: On je češće bio zapažen u žena nego u muškaraca, te u pušača koji su u to vrijeme pušili u odnosu na bivše pušače.
English: • Pierce the capsule by firmly pressing together both side buttons at the same time.
Croatian: • Probušite kapsulu čvrstim pritiskom na bočne tipke s obje strane istodobno.
English: 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).
Croatian: 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).
English: In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder.
Croatian: U ovom pakiranju naći ćete inhalator i kapsule (u blisteru) koje sadrže lijek kao prašak inhalata.
English: The following pack sizes are available:
Croatian: Na tržištu su dostupna sljedeća pakiranja:
English: Limited treatment experience is available in individuals of African descent.
Croatian: Dostupna su ograničena iskustva o liječenju bolesnika afričkog podrijetla.
English: Patients should be instructed on how to administer the product correctly.
Croatian: Bolesnicima treba pokazati kako pravilno primjenjivati lijek.
English: 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.
Croatian: 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.
English: Contains lactose (see package leaflet for further information) and gelatin.
Croatian: Sadrži laktozu (vidjeti uputu o lijeku za dodatne informacije) i želatinu.
English: Percentage of patients who achieved MCID TDI†
Croatian: Postotak bolesnika koji su postigli MCID TDI†
English: 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%).
Croatian: 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%).
English: 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.
Croatian: 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.
English: Do not use Oslif Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Oslif Breezhaler - ako ste alergični na indakaterol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life ranging from 45.5 to 126 hours.
Croatian: Koncentracije indakaterola u serumu padale su na multifazni način, uz prosječni krajnji poluživot u rasponu od 45,5 do 126 sati.
English: Effects on cardiac electrophysiology
Croatian: Učinci na srčanu elektrofiziologiju
English: The oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4.
Croatian: Oksidativni metaboliti su nađeni u inkubaciji s rekombinantnim CYP1A1, CYP2D6 i CYP3A4.
English: The frequency of notable QTcF intervals [i.e. >450 ms (males) and >470 ms (females)] and reports of hypokalaemia were similar to placebo.
Croatian: >450 ms (muškarci) i >470 ms (žene)] i hipokalijemije bila je slična kao za placebo.
English: Study design with a: indacaterol 150 microgram, salmeterol and placebo;
Croatian: Dizajn ispitivanja s a: indakaterolom u dozi od 150 mikrograma, salmeterolom i placebom;
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: The other ingredients include lactose and the capsule is made of gelatin.
Croatian: Drugi sastojak je laktoza, a kapsula je načinjena od želatine.
English: There are no data from the use of indacaterol in pregnant women available.
Croatian: Nema dostupnih podataka o primjeni indakaterola u trudnica.
English: This medicine relaxes these muscles in the lungs, making it easier for air to get in and out of the lungs.
Croatian: Ovaj lijek opušta te mišiće u plućima, omogućava lakši protok zraka u i iz pluća.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety database.
Croatian: Nuspojave u Tablici 1 poredane su prema MedDRA klasifikaciji organskih sustava u bazi sigurnosnih podataka za KOPB.
English: The median time to reach peak serum concentrations of indacaterol was approximately 15 min after single or repeated inhaled doses.
Croatian: Medijan vremena postizanja vršnih koncentracija indakaterola u serumu bilo je približno 15 min nakon jednokratne ili ponovljenih inhaliranih doza.
English: • feeling of pressure or pain in the cheeks and forehead (inflammation of the sinuses)
Croatian: • osjećaj pritiska ili boli u obrazima i čelu (upala sinusa)
English: 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.
Croatian: 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.
English: • cold-like symptoms.
Croatian: • simptomi nalik prehladi.
English: Therefore the frequency was calculated from clinical trial experience.
Croatian: Stoga je učestalost nuspojava izračunata na temelju iskustava iz kliničkih ispitivanja.
English: Do not use this medicine if you notice that the pack is damaged or show signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili ako su vidljivi znakovi neovlaštenog otvaranja.
English: Relevant prolongations of QTcF were not detectable in comparison to placebo.
Croatian: Značajna produljenja QTcF se nisu uočavala u usporedbi s placebom.
English: The capsules contain lactose.
Croatian: Kapsule sadrže laktozu.
English: Renal clearance of indacaterol was, on average, between 0.46 and 1.20 litres/hour.
Croatian: Bubrežni klirens indakaterola u prosjeku je bio između 0,46 i 1,20 litara/sat.
English: 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.
Croatian: 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.
English: See package leaflet for how to use this medicine.
Croatian: Vidjeti uputu o lijeku radi načina korištenja ovog lijeka.
English: There is no evidence that cough experienced post inhalation is associated with bronchospasm, exacerbations, deteriorations of disease or loss of efficacy.
Croatian: Nema dokaza da je kašalj nakon inhalacije povezan s bronhospazmom, egzacerbacijama i pogoršanjem bolesti ili gubitkom djelotvornosti.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: How to use your inhaler
Croatian: Kako koristiti Vaš inhalator
English: Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution.
Croatian: Kada je potrebno, prednost treba dati kardioselektivnim beta-adrenergičkim blokatorima, iako ih treba oprezno primjenjivati.
English: The capsules are transparent (uncoloured) and contain a white powder.
Croatian: Kapsule su prozirne (bezbojne) te sadrže bijeli prašak.
English: 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).
Croatian: 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).
English: Insert capsule: Place the capsule into the capsule chamber.
Croatian: Umetnite kapsulu: Stavite kapsulu u komoru za kapsulu.
English: 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.
Croatian: KOPB je dugotrajna bolest i trebate primijeniti Oslif Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
English: 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.
Croatian: 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.
English: Therefore indacaterol should not be given together with betaadrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Croatian: Zbog toga indakaterol ne treba primjenjivati istodobno s beta-adrenergičkim blokatorima (uključujući kapi za oči), osim ako za to ne postoje jaki razlozi.
English: For instructions on use of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o pripremi lijeka prije primjene vidjeti dio 6.6.
English: Salmeterol twice a day
Croatian: Salmeterol dva puta na dan
English: Please read the following instructions carefully to learn how to use and care for your Oslif Breezhaler inhaler.
Croatian: Molimo Vas da pažljivo pročitate upute u nastavku kako biste naučili primjenjivati i brinuti se o svom Oslif Breezhaler inhalatoru.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: • Open the inhaler to see if any powder is left in the capsule.
Croatian: • Otvorite inhalator kako biste provjerili je li ostalo praška u kapsuli.
English: Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk (see section 5.3).
Croatian: Dostupni farmakokinetički/toksikološki podaci u životinja pokazuju da se indakaterola/metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
English: Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor agonists, ATC code: R03AC18
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova, selektivni agonisti beta-2-adrenergičkih receptora, ATK oznaka: R03AC18
English: The mean of the maximum changes in blood glucose were similar between Oslif Breezhaler and placebo.
Croatian: Srednja vrijednost najvećih promjena glukoze u krvi bila je slična za Oslif Breezhaler i placebo.
English: You should not use Oslif Breezhaler unless your doctor tells you so.
Croatian: Nemojte koristiti Oslif Breezhaler osim ako Vam to nije rekao liječnik.
English: On the inside of the pack there is a daily dose tracker.
Croatian: Na unutarnjoj strani pakiranja nalazi se kalendarić za praćenje dnevnih doza.
English: Due to the very low contribution of the urinary pathway to total body elimination, a study in renally impaired subjects was not performed.
Croatian: Zbog vrlo malog doprinosa mokraćnih puteva u ukupnoj eliminaciji iz tijela, ispitivanje u bolesnika s oštećenjem bubrega nije provedeno.
English: 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.
Croatian: 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.
English: It is not known whether indacaterol/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se indakaterol/metaboliti u majčino mlijeko u ljudi.
English: Talk to your doctor or pharmacist before using Oslif Breezhaler if you have asthma (in this case you should not use Oslif Breezhaler).
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Oslif Breezhaler ako imate astmu (u tom slučaju ne biste trebali koristiti Oslif Breezhaler). ako imate problema sa srcem.
English: This opens the inhaler.
Croatian: To otvara inhalator.
English: The 24-hour bronchodilator effect of Oslif Breezhaler was maintained from the first dose throughout a one-year treatment period with no evidence of loss in efficacy (tachyphylaxis).
Croatian: Bronhodilatacijski 24-satni učinak Oslif Breezhalera bio je zadržan od prve doze kroz jednogodišnje razdoblje liječenja bez dokaza gubitka djelotvornosti (tahifilaksija).
English: In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment (see section 4.5), which may increase the susceptibility to cardiac arrhythmias.
Croatian: U bolesnika s teškim KOPB-om hipokalijemija može biti potencirana hipoksijom i istodobno primijenjenim lijekovima (vidjeti dio 4.5), što može povećati osjetljivost za srčane aritmije.
English: In clinical studies which included urine collection, the amount of indacaterol excreted unchanged via urine was generally lower than 2% of the dose.
Croatian: U ispitivanjima koja su uključivala sakupljanje mokraće, količina indakaterola koja se izlučila nepromijenjena u mokraću u pravilu je bila manja od 2% doze.
English: In vitro investigations indicated that UGT1A1 is the only UGT isoform that metabolised indacaterol to the phenolic O-glucuronide.
Croatian: In vitro istraživanja su pokazala da je UGT1A1 jedina UGT izoforma koja je metabolizirala indakaterol do fenolnog O-glukuronida.
English: Beta-adrenergic blockers and beta2-adrenergic agonists may weaken or antagonise the effect of each other when administered concurrently.
Croatian: Beta-adrenergički blokatori i beta2-adrenergički agonisti mogu oslabiti ili djelovati antagonistički na učinak jedni drugima kada se istodobno primjenjuju.
English: Use of cardioselective beta blockers may be considered, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm.
Croatian: Treba razmotriti primjenu kardioselektivnih beta blokatora, ali samo uz liječnički nadzor i uz krajnji oprez, jer primjena beta-adrenergičkih blokatora može izazvati bronhospazam.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Ostali izvori informacija Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp) raises the systemic exposure of indacaterol by up to two-fold.
Croatian: Inhibicija ključnih čimbenika koji pridonose klirensu indakaterola, CYP3A4 i P-glikoprotein (P-gp), podiže sistemsku izloženost indakaterola do dva puta.
English: Prepare capsule:
Croatian: Pripremite kapsulu:
English: These studies included measures of lung function and of health outcomes such as dyspnoea, exacerbations and health-related quality of life.
Croatian: Ta su ispitivanja uključivala mjerenja plućne funkcije i zdravstvenih ishoda kao što su dispneja, egzacerbacije i kvaliteta života vezana za zdravlje.
English: If you have questions about how long to continue your treatment with Oslif Breezhaler, talk to your doctor or pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo trebate provoditi liječenje Oslif Breezhalerom, obratite se svom liječniku ili ljekarniku.
English: If you use more Oslif Breezhaler than you should If you have inhaled too much Oslif Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit.
Croatian: Ako ste udahnuli previše Oslif Breezhalera ili ako je netko drugi koristio Vaše kapsule, morate odmah obavijestiti svog liječniku ili otići u najbližu jedinicu hitne pomoći.
English: Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency.
Croatian: Indakaterol je dijelom agonist ljudskog beta2-adrenergičkog receptora s nanomolarnom snagom.
English: Indacaterol was excreted into human faeces primarily as unchanged parent substance (54% of the dose) and, to a lesser extent, hydroxylated indacaterol metabolites (23% of the dose).
Croatian: Indakaterol se izlučivao ljudskom stolicom ponajprije kao nepromijenjena izvorna tvar (54% doze) te, u manjem dijelu, kao hidroksilirani metabolit indakaterola (23% doze).
English: As with other inhalation therapy, administration of Oslif Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Croatian: Kao i kod drugih inhalacijskih terapija, primjena Oslif Breezhalera može dovesti do paradoksalnog bronhospazma koji može ugroziti život.
English: Do not blow into the mouthpiece.
Croatian: Nemojte puhati u nastavak za usta.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Oslif Breezhaler at the recommended doses than on placebo.
Croatian: Tijekom ispitivanja, klinički značajne promjene glukoze u krvi u pravilu su bile češće za 1-2% pri primjeni Oslif Breezhalera u preporučenim dozama nego pri primjeni placeba.
English: Cough is a common symptom in COPD.
Croatian: Kašalj je česti simptom KOPB-a.
English: Occasionally, very small pieces of the capsule can get past the screen and enter your mouth.
Croatian: Komadići kapsule mogu povremeno proći kroz rešetku i ući Vam u usta.
English: When you inhale it, it relaxes the muscles in the walls of the small air passages in the lungs.
Croatian: Kada ga udahnete, on opušta mišiće u stijenkama dišnih puteva u plućima.