FrancophonIA/ELRC3.0 huggingface dataset:
English: 4,764 patients were exposed to indacaterol up to one year at doses up to twice the maximum recommended dose.
Slovenian: 4.764 bolnikov je bilo izpostavljenih indakaterolu v trajanju do enega leta z uporabo odmerkov, ki so dosegali do dvakratno vrednost najvišjega priporočenega odmerka.
English: Use your inhaler at the same time each day, the effects last for 24 hours.
Slovenian: Inhalator uporabljajte vsak dan ob istem času, saj učinek zdravila traja 24 ur.
English: Most people are able to empty the capsule with one or two inhalations.
Slovenian: Večina ljudi lahko izprazni kapsulo z eno ali z dvema vdihoma.
English: Do not press the side buttons more than once.
Slovenian: Stranskih gumbov ne pritiskajte več kot enkrat.
English: Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and COPD patients.
Slovenian: Farmakokinetični podatki izvirajo iz številnih kliničnih študij, v katere so bili vključeni zdravi prostovoljci in bolniki s KOPB.
English: • Then breathe out.
Slovenian: • Nato izdihnite.
English: Hold breath:
Slovenian: Zadržite dih:
English: Oslif Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Slovenian: Uporaba zdravila Oslif Breezhaler je v času nosečnosti upravičena le v primeru, da pričakovane koristi presegajo možna tveganja.
English: If a dose is missed the next dose should be taken at the usual time the next day.
Slovenian: V primeru izpuščenega odmerka je treba naslednji odmerek vzeti naslednji dan ob običajnem času.
English: The dose should only be increased on medical advice.
Slovenian: Odmerek je mogoče zvišati samo po nasvetu zdravnika.
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.
Slovenian: Klinični razvojni program je obsegal eno 12-tedensko, dve 6-mesečni (od katerih so eno podaljšali na eno leto, da bi ocenili varnost in prenosljivost zdravila) in eno enoletno randomizirano kontrolirano študijo pri bolnikih s klinično diagnozo KOPB.
English: Absolute bioavailability of indacaterol after an inhaled dose was on average 43% to 45%.
Slovenian: Absolutna biološka uporabnost indakaterola po inhaliranju odmerka je bila povprečno od 43 do 45 %.
English: Always release the push buttons before inhalation.
Slovenian: Pred inhaliranjem vedno izpustite potisne gumbe.
English: 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.
Slovenian: Zdravnik vam lahko naroči, da uporabljate kapsule s 150 mikrogrami ali s 300 mikrogrami, kar je odvisno od vaše bolezni in odziva na zdravljenje.
English: There are no data from the use of indacaterol in pregnant women available.
Slovenian: Ni podatkov o uporabi indakaterola pri nosečnicah.
English: If you do, don't worry.
Slovenian: Če tudi vi kašljate, naj vas to ne skrbi.
English: All these findings occurred at exposures sufficiently in excess of those anticipated in humans.
Slovenian: Do vseh teh izsledkov je prišlo pri izpostavljenosti zdravilu, ki je v zadostni meri presegla izpostavljenost, predvideno pri ljudeh.
English: 1.0 b a n/e a
Slovenian: 1,0 b a n/o a
English: Limited treatment experience is available in individuals of African descent.
Slovenian: Izkušenj z zdravljenjem posameznikov afriškega rodu je malo.
English: Renal clearance of indacaterol was, on average, between 0.46 and 1.20 litres/hour.
Slovenian: Ledvični očistek indakaterola je bil v povprečju med 0,46 in 1,20 litra/uro.
English: The capsules contain lactose.
Slovenian: Kapsule vsebujejo laktozo.
English: • if you get high levels of sugar in your blood (diabetes).
Slovenian: • če se vam zviša raven glukoze v krvi (sladkorna bolezen).
English: • Pierce the capsule by firmly pressing together both side buttons at the same time.
Slovenian: • Kapsulo predrete tako, da oba stranska gumba istočasno močno stisnete skupaj.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
English: Percentage of patients who achieved MCID SGRQ†
Slovenian: 41 c odstotek bolnikov, ki so dosegli MCID SGRQ†
English: 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.
Slovenian: Morda boste opazili, da vam srce bije hitreje kot običajno, morda vas bo bolela glava ali boste zaspani ali pa vam bo slabo in morda boste bruhali.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Indacaterol is a chiral molecule with R-configuration.
Slovenian: Indakaterol je kiralna molekula z R-konfiguracijo.
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.
Slovenian: Ker gre za spontano sporočene neželene učinke iz populacije nedoločljive velikosti, ni vedno mogoče zanesljivo oceniti njihove pogostnosti ali ugotoviti vzročne povezanosti z izpostavljenostjo zdravilu.
English: Release the side buttons fully.
Slovenian: Stranska gumba povsem izpustite.
English: Never place a capsule directly into the mouthpiece.
Slovenian: Kapsule nikoli ne nameščajte neposredno na ustnik.
English: The frequency of notable QTcF intervals [i.e. >450 ms (males) and >470 ms (females)] and reports of hypokalaemia were similar to placebo.
Slovenian: O opaznih intervalih QTcF [kar pomeni >450 ms (pri moških) in >470 ms pri ženskah] in o hipokaliemiji so poročali s podobno pogostnostjo kot pri uporabi placeba.
English: The in vitro human serum and plasma protein binding was 94.1-95.3% and 95.1-96.2%, respectively.
Slovenian: In vitro je vezava na proteine v humanem serumu 94,1-95,3 %, na proteine v humani plazmi pa 95,1-96,2 %.
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).
Slovenian: V fazi III kliničnih študij so zdravstveni delavci na kliničnih obiskih bolnikov opažali, da je v povprečju pri 17-20 % bolnikov prišlo do občasnega kašlja, običajno v 15 sekundah po inhalaciji, z značilnim trajanjem 5 sekund (oziroma približno 10 sekund pri bolnikih, ki so bili kadilci).
English: Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse.
Slovenian: Takoj obvestite zdravnika, če se simptomi KOPB (zadihanost, piskanje v pljučih, kašelj) ne izboljšajo ali če se poslabšajo.
English: Do not blow into the mouthpiece.
Slovenian: Ne pihajte v ustnik.
English: If you experience coughing briefly after inhaling the medicine, do not worry.
Slovenian: Če kašljate kmalu po inhaliranju, naj vas to ne skrbi.
English: If there is powder left in the capsule:
Slovenian: Če je v kapsuli še prašek:
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).
Slovenian: Indakaterol se je izločal v blato predvsem v nespremenjeni osnovni obliki (54 % odmerka), v manjši meri pa še v obliki hidroksiliranih metabolitov indakaterola (23 % odmerka).
English: In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action.
Slovenian: V izoliranem humanem bronhusu indakaterol začne delovati hitro in deluje dolgotrajno.
English: An increase in the daily dose of Oslif Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Slovenian: Zviševanje dnevnega odmerka zdravila Oslif Breezhaler preko najvišjega odmerka 300 mikrogramov ni primerno.
English: Of these patients, 2,611 were on treatment with 150 microgram once daily and 1,157 on treatment with 300 microgram once daily.
Slovenian: Izmed teh bolnikov jih je 2.611 prejemalo odmerek 150 mikrogramov enkrat dnevno, 1.157 pa odmerek 300 mikrogramov enkrat dnevno.
English: Study design with a: indacaterol 150 microgram, salmeterol and placebo;
Slovenian: Zasnova študije z uporabo a: indakaterola 150 mikrogramov, salmeterola in placeba;
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%).
Slovenian: Najbolj pogosti neželeni učinki pri uporabi priporočenih odmerkov so bili nazofaringitis (14,3 %), okužbe zgornjih dihal (14,2 %), kašelj (8,2 %), glavobol (3,7 %) in mišični krči (3,5 %).
English: Do not inhale a double dose to make up for a forgotten dose.
Slovenian: Ne inhalirajte dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: As long as the capsule is empty, you have received enough of your medicine.
Slovenian: Če ste kapsulo izpraznili, ste prejeli dovolj zdravila.
English: Close the inhaler: Close the inhaler until you hear a “click”.
Slovenian: Zaprite inhalator: Ko zaprete inhalator, slišite "klik".
English: You may get all or most of the following: sore throat, runny nose, blocked nose, sneezing, coughing, headache.
Slovenian: Lahko se pojavijo vsi ali pa večina naslednjih simptomov: vnetje grla oziroma žrela, izcedek iz nosu, zamašen nos, kihanje, kašljanje, glavobol.
English: Put the empty capsule in your household waste.
Slovenian: Prazno kapsulo odvrzite med gospodinjske odpadke.
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.
Slovenian: K sistemski izpostavljenosti prispevata tako pljučna kot gastrointestinalna absorpcija; okoli 75 % sistemske izpostavljenosti je prispevala pljučna absorpcija in okoli 25 % gastrointestinalna absorpcija.
English: Effects on cardiac electrophysiology
Slovenian: Učinki na elektrofiziologijo srca
English: In clinical studies which included urine collection, the amount of indacaterol excreted unchanged via urine was generally lower than 2% of the dose.
Slovenian: V kliničnih študijah, v katerih so prestrezali urin, je bil delež nespremenjenega indakaterola, ki se je izločil z urinom, večinoma manjši od 2 % odmerka.
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).
Slovenian: Ne uporabljajte zdravila Oslif Breezhaler - če ste alergični na indakaterol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Open the inhaler to see if any powder is left in the capsule.
Slovenian: • Odprite inhalator in poglejte, ali je v kapsuli ostalo še kaj praška.
English: Indacaterol has not been shown to cause interactions with medicinal products administered concomitantly.
Slovenian: Ne kaže, da bi indakaterol povzročal interakcije s sočasno uporabljanimi zdravili.
English: Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients.
Slovenian: S starostjo se zviša najvišja koncentracija v plazmi in poveča sistemska izpostavljenost zdravilu, vendar prilagajanje odmerjanja pri starejših bolnikih ni potrebno.
English: It was observed with a higher frequency in female than in male patients and in current smokers than in ex-smokers.
Slovenian: Kašelj so pogosteje opažali pri ženskah kot pri moških in pri bolnikih, ki so bili kadilci, v primerjavi s tistimi, ki so prenehali kaditi.
English: Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life ranging from 45.5 to 126 hours.
Slovenian: Koncentracija indakaterola v serumu upada v več fazah s povprečnim končnim razpolovnim časom v obsegu od 45,5 do 126 ur.
English: Occasionally, very small pieces of the capsule can get past the screen and enter your mouth.
Slovenian: Občasno lahko zelo majhni delci kapsule zaidejo skozi mrežico v usta.
English: It is not known whether indacaterol/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se indakaterol/presnovki izločajo v materino mleko.
English: Prepare capsule:
Slovenian: Pripravite kapsulo:
English: Where required, cardioselective beta-adrenergic blockers should be preferred, although they should be administered with caution.
Slovenian: Kadar je potrebno, je treba izbrati kardioselektivne zaviralce adrenergičnih receptorjev beta, vendar jih je treba uporabljati previdno.
English: Check your inhaler to see if the capsule is empty and that you have received the full dose.
Slovenian: Preglejte, če je kapsula v inhalatorju prazna in ste prejeli celoten odmerek.
English: These studies included measures of lung function and of health outcomes such as dyspnoea, exacerbations and health-related quality of life.
Slovenian: Te študije so vključevale tudi meritve pljučne funkcije in zdravstvenih izidov, kot so dispneja, zagoni bolezni in z zdravjem povezana kakovost življenja.
English: If you do not hear a whirring noise: The capsule may be stuck in the capsule chamber.
Slovenian: Če ne slišite brnenja: Morda se je kapsula zataknila v vdolbini.
English: This medicine relaxes these muscles in the lungs, making it easier for air to get in and out of the lungs.
Slovenian: To zdravilo sprosti omenjene mišice v pljučih, zato zrak lažje vstopa v pljuča in izstopa iz njih.
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).
Slovenian: Še posebno pomembno je, da zdravniku poveste, če: zaradi težav z dihanjem uporabljate zdravila, ki so podobna zdravilu Oslif Breezhaler (na primer zdravila, kot sta salmeterol in formoterol).
English: • pain in muscles, bones or joints
Slovenian: • bolečine v mišicah, kosteh ali sklepih
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.
Slovenian: Če ste uporabili večji odmerek zdravila Oslif Breezhaler, kot bi smeli Če ste vdihnili preveč zdravila Oslif Breezhaler ali če kdo drug uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno medicinsko pomoč.
English: Contains lactose (see package leaflet for further information) and gelatin.
Slovenian: Vsebuje laktozo (za več podatkov glejte Navodilo za uporabo) in želatino.
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.
Slovenian: Povprečna sprememba frekvence srčnega utripa je znašala manj kot en udarec na minuto in do tahikardije ni prišlo pogosto, o njej so poročali s podobno pogostnostjo kot pri uporabi placeba.
English: • feeling of pressure or pain in the cheeks and forehead (inflammation of the sinuses)
Slovenian: • občutek pritiska in bolečina v licih in čelu (vnetje sinusov)
English: Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor agonists, ATC code: R03AC18
Slovenian: Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, bronhoselektivni agonisti adrenergičnih receptorjev beta-2, oznaka ATC: R03AC18
English: Oslif Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Slovenian: Kapsule Oslif Breezhaler je treba vedno shranjevati v pretisnem omotu in jih iz njega vzeti šele tik pred uporabo.
English: • swollen hands, ankles and feet (oedema)
Slovenian: • otekanje rok, gležnjev in stopal (edemi)
English: The capsules are transparent (uncoloured) and contain a white powder.
Slovenian: Kapsule so prosojne (neobarvane) in vsebujejo bel prašek.
English: Pooled efficacy analysis over 6 months' treatment demonstrated that the rate of COPD exacerbations was statistically significantly lower than the placebo rate.
Slovenian: Združena analiza učinkovitosti zdravila pri 6-mesečnem zdravljenju je pokazala, da je bila pogostnost zagonov KOPB statistično značilno manjša kot pri uporabi placeba.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Oslif Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Oslif Breezhaler za vse podskupine pediatrične populacije pri kronični obstruktivni pljučni bolezni (KOPB) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Oslif Breezhaler, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Do not wash your inhaler with water.
Slovenian: Inhalatorja ne umivajte z vodo.
English: In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Slovenian: Poleg tega so za agoniste adrenergičnih receptorjev beta-2 poročali, da povzročajo elektrokardiografske (EKG) spremembe, na primer zmanjševanje vala T, podaljšanje intervala QT in depresijo segmenta ST, vendar klinični pomen teh opažanj ni znan.
English: The powder in the capsules is for you to inhale.
Slovenian: Prašek v kapsulah je namenjen inhaliranju.
English: Cough is a common symptom in COPD.
Slovenian: Kašelj je sicer pogost simptom pri KOPB.
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).
Slovenian: 24-urni brohodilatatorni učinek zdravila Oslif Breezhaler se je ohranjal od prvega odmerka skozi celotno enoletno obdobje zdravljenja brez znakov zmanjševanja učinkovitosti (tahifilaksije).
English: These include: o steroids (e.g. prednisolone), o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, o medicines for breathing problems such as theophylline.
Slovenian: Med njimi so: o steroidi (na primer prednizolon), o diuretiki (tablete za odvajanje vode) za zdravljenju visokega krvnega tlaka, kot je hidroklorotiazid, o zdravila za težave z dihanjem, kot je teofilin.
English: In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder.
Slovenian: V škatli boste našli inhalator in kapsule (v pretisnih omotih), ki vsebujejo zdravilo v obliki praška za inhaliranje.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety database.
Slovenian: V preglednici 1 so neželeni učinki navedeni po MedDRA klasifikaciji organskih sistemov v bazi varnostnih podatkov za KOPB.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Oslif Breezhaler.
Slovenian: Sočasna uporaba drugih simpatikomimetičnih zdravil (samih ali v sklopu kombinacije zdravil) lahko okrepi neželene učinke zdravila Oslif Breezhaler.
English: Do not use this medicine if you notice that the pack is damaged or show signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je ovojnina poškodovana ali da je bila že odprta.
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Oslif Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic dose.
Slovenian: Povečanje izpostavljenosti zaradi interakcij ni zaskrbljujoče, in sicer zaradi izkušenj glede varnosti pri uporabi zdravila Oslif Breezhaler v kliničnih študijah s trajanjem do enega leta v odmerkih, ki so dosegali tudi dvakratni priporočeni terapevtski odmerek.
English: If you have questions about how long to continue your treatment with Oslif Breezhaler, talk to your doctor or pharmacist.
Slovenian: Če vas zanima, kako dolgo je treba nadaljevati z uporabo zdravila Oslif Breezhaler, se pogovorite s svojim zdravnikom ali farmacevtom.
English: The other ingredients include lactose and the capsule is made of gelatin.
Slovenian: Druga sestavina zdravila je laktoza, kapsula pa je iz želatine.
English: • Close the inhaler.
Slovenian: • Zaprite inhalator.
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.
Slovenian: KOPB je dolgotrajna bolezen in zdravilo Oslif Breezhaler morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
English: The median time to reach peak serum concentrations of indacaterol was approximately 15 min after single or repeated inhaled doses.
Slovenian: V povprečju je do najvišje koncentracije indakaterola v serumu prišlo približno 15 minut po inhaliranju enkratnega odmerka ali ponovljenih odmerkov.
English: There is no evidence that cough experienced post inhalation is associated with bronchospasm, exacerbations, deteriorations of disease or loss of efficacy.
Slovenian: Ni dokazov, da bi bil kašelj, do katerega pride po inhalaciji, povezan z brohospazmom, z zagoni oziroma s poslabšanji bolezni ali z izgubo učinka zdravila.
English: Oslif Breezhaler should be administered at the same time of the day each day.
Slovenian: Zdravilo Oslif Breezhaler je treba jemati vsak dan ob istem času.
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.
Slovenian: Ni znano, kakšna natančno naj bi bila vloga beta-2-adrenergičnih receptorjev v srcu, vendar zaradi njihove prisotnosti obstaja možnost, da celo visoko selektivni agonisti adrenergičnih receptorjev beta2 lahko vplivajo na srce.
English: In addition, patients treated with Oslif Breezhaler required significantly less rescue medication, had more days when no rescue medication was needed compared to placebo and had a significantly improved percentage of days with no daytime symptoms.
Slovenian: Poleg tega so bolniki, ki so uporabljali zdravilo Oslif Breezhaler, potrebovali bistveno manj nadomestnih zdravil in v primerjavi s tistimi, ki so uporabljali placebo, preživeli so več dni, ko niso potrebovali hitrih olajševalcev, pri njih se je bistveno povečal delež dni, ko preko dneva niso imeli simptomov.
English: Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk (see section 5.3).
Slovenian: Razpoložljivi farmakokinetični/toksikološki podatki pri živalih kažejo na izločanje indakaterola/presnovkov v mleko (glejte poglavje 5.3).
English: You should not use Oslif Breezhaler unless your doctor tells you so.
Slovenian: Zdravila Oslif Breezhaler ne smete uporabljati, razen če vam tako naroči zdravnik.
English: See “How to clean your inhaler”.
Slovenian: Glejte poglavje "Čiščenje inhalatorja".