FrancophonIA/ELRC3.0 huggingface dataset:
English: The effective half-life, calculated from the accumulation of indacaterol after repeated dosing ranged from 40 to 52 hours which is consistent with the observed time-to-steady state of approximately 12-14 days.
Slovenian: Efektivni razpolovni čas, izračunan iz kopičenja indakaterola po večkratnem odmerjanju, je znašal od 40 do 52 ur, kar se ujema z ugotovljenim časom do stanja dinamičnega ravnovesja, ki je približno 12-14 dni.
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.
Slovenian: Pri bolnikih s hudo KOPB lahko hipoksija in sočasna zdravila še poglobijo hipokaliemijo (glejte poglavje 4.5), kar lahko poveča možnost za razvoj aritmij.
English: In vitro investigations indicated that UGT1A1 is the only UGT isoform that metabolised indacaterol to the phenolic O-glucuronide.
Slovenian: V raziskavah in vitro se je pokazalo, da je UGT1A1 edina izooblika UGT, ki presnavlja indakaterol v fenolni O-glukuronid.
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.
Slovenian: V kliničnih študijah so bile klinično opazne spremembe v koncentraciji glukoze v krvi večinoma za 1-2 % bolj pogoste pri bolnikih, ki so jemali zdravilo Oslif Breezhaler v priporočenih odmerkih, kot pri tistih, ki so jemali placebo.
English: Insert capsule: Place the capsule into the capsule chamber.
Slovenian: Vstavite kapsulo: Kapsulo namestite v vdolbino za kapsulo.
English: Systemic exposure to indacaterol increased with increasing dose (150 microgram to 600 microgram) in a dose proportional manner.
Slovenian: Sistemska izpostavljenost indakaterolu se je povečevala sorazmerno z višino odmerka (od 150 mikrogramov do 600 mikrogramov).
English: There was a rapid onset of action within 5 minutes after inhalation, with an increase in FEV1 relative to baseline of 110-160 ml, comparable to the effect of the fast-acting beta2-agonist salbutamol 200 microgram and statistically significantly faster compared to salmeterol/fluticasone 50/500 microgram.
Slovenian: Začetek delovanja je bil hiter, v prvih 5 minutah po inhalaciji, s povečanjem FEV1 za 110-160 ml od izhodiščne vrednosti, kar je primerljivo z delovanjem hitrodelujočega agonista adrenergičnih receptorjev beta-2 salbutamola v odmerku 200 mikrogramov in statistično značilno hitreje kot pri salmeterolu/flutikazonu 50/500 mikrogramov.
English: A decreased pregnancy rate has been observed in rats.
Slovenian: Pri podganah so opažali zmanjšano pogostnost zanositev.
English: Relevant prolongations of QTcF were not detectable in comparison to placebo.
Slovenian: Pomembnejšega podaljšanja intervala QTcF v primerjavi s tistim pri uporabi placeba ni bilo mogoče zaznati.
English: REMEMBER:
Slovenian: NE POZABITE:
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassiumsparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution is required (see section 4.4).
Slovenian: Sočasno zdravljenje z derivati metilksantina, s steroidi ali z diuretiki, ki ne varčujejo s kalijem, lahko okrepi možne hipokaliemične učinke agonistov adrenergičnih receptorjev beta-2, zato je pri sočasni uporabi potrebna previdnost (glejte poglavje 4.4).
English: Children and adolescents Oslif Breezhaler should not be given to children or adolescents below the age of 18 years
Slovenian: Otroci in mladostniki Otroci in mladostniki, ki so stari manj kot 18 let, ne smejo prejemati zdravila Oslif Breezhaler.
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.
Slovenian: Če pride do znakov, ki kažejo na alergijsko reakcijo (zlasti oteženega dihanja ali požiranja, otekanja jezika, ustnic in obraza, urtikarije ali izpuščaja), je treba zdravljenje z zdravilom Oslif Breezhaler takoj ukiniti in uvesti drugo zdravilo.
English: As with other inhalation therapy, administration of Oslif Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Slovenian: Tako kot uporaba drugih inhalacijskih zdravil lahko uporaba zdravila Oslif Breezhaler povzroči paradoksni bronhospazem, ki je lahko življenjsko nevaren.
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.
Slovenian: Pri bolnikih s KOPB so bili posamezni odmerki, ki so dosegali 10-kratni najvišji priporočeni terapevtski odmerk, povezani z zmernim povečanjem srčnega utripa, zvišanjem sistoličnega krvnega tlaka in podaljšanjem intervala QTc.
English: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Oslif Breezhaler inhaler.
Slovenian: Priporočeni odmerek je inhalacija vsebine ene 150-mikrogramske kapsule enkrat na dan z uporabo inhalatorja Oslif Breezhaler.
English: Due to the very low contribution of the urinary pathway to total body elimination, a study in renally impaired subjects was not performed.
Slovenian: Ker ima izločanje z urinom tako majhen pomen pri celotnem izločanju iz organizma, niso izvedli nobene študije pri bolnikih z okvaro ledvic.
English: As you breathe in through the inhaler, the capsule spins around in the chamber and you should hear a whirring noise.
Slovenian: Ko vdihujete skozi inhalator, se kapsula v vdolbini vrti, zato morate slišati brnenje.
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).
Slovenian: Zaradi kašlja po inhalaciji nobenemu od bolnikov ni bilo treba prekiniti sodelovanja v študiji ob priporočenih odmerkih (kašelj je sicer simptom KOPB, a je le 8,2 % bolnikov poročalo o kašlju kot o neželenem učinku).
English: An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia.
Slovenian: Preveliko odmerjanje indakaterola verjetno povzroča prekomerno izražene učinke, ki so sicer značilni za stimulanse beta-2-adrenergičnega sistema: tahikardijo, tremor, palpitacije, glavobol, navzeo, bruhanje, zaspanost, ventrikularne aritmije, presnovno acidozo, hipokaliemijo in hiperglikemijo.
English: If paradoxical bronchospasm occurs Oslif Breezhaler should be discontinued immediately and alternative therapy substituted.
Slovenian: Če pride do paradoksnega bronhospazma, je treba takoj prenehati z jemanjem zdravila Oslif Breezhaler in ga nadomestiti z drugačnim zdravljenjem.
English: • Place the mouthpiece in your mouth and close your lips firmly around it.
Slovenian: • Ustnik namestite v usta in ga trdno objemite z ustnicami.
English: Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl methacrylate acrylonitrile butadiene styrene.
Slovenian: Telo in pokrov inhalatorja sta iz akrilonitril-butadien-stirena, potisni gumbi so, narejeni iz metil-metakrilat-akrilonitril-butadien-stirena.
English: PA/Alu/PVC - Alu blister containing 10 hard capsules.
Slovenian: Pretisni omot iz PA/Alu/PVC - Alu vsebuje 10 trdih kapsul.
English: After you have inhaled the medicine:
Slovenian: Ko ste zdravilo inhalirali:
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.
Slovenian: Kljub temu, da so v gladkem mišičju bronhusov od adrenergičnih receptorjev prisotni predvsem receptorji beta-2, v humanem srcu pa predvsem receptorji beta-1, so tudi v humanem srcu prisotni beta-2 adrenergični receptorji, ki lahko predstavljajo 10-50 % vseh adrenergičnih receptorjev.
English: Oslif Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and should not be used in asthma due to the absence of long-term outcome data in asthma.
Slovenian: Zdravilo Oslif Breezhaler je dolgodelujoči agonist adrenergičnih receptorjev beta-2, ki je indiciran samo za zdravljenje KOPB in se ne sme uporabljati pri astmi, saj ni nobenih podatkov o dolgoročnih rezultatih pri zdravljenju astme.
English: Systemic exposures (AUC) in rats and mice at the no-observed adverse effect levels in these studies were at least 7- and 49-fold higher, respectively, than in humans treated with Oslif Breezhaler once a day at a dose of 300 microgram.
Slovenian: V teh študijah je bila raven sistemske izpostavljenosti (AUC) brez pomembnih neželenih učinkov pri miših najmanj 7-krat višja, pri podganah pa najmanj 49-krat višja od izpostavljenosti pri ljudeh, ki prejemajo zdravilo Oslif Breezhaler v odmerku 300 mikrogramov enkrat na dan.
English: The pharmacological effects of beta2-adrenoceptor agonists are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic monophosphate).
Slovenian: Farmakološko delovanje agonistov adrenergičnih receptorjev beta-2 je vsaj deloma mogoče pripisati stimulaciji znotrajcelične adenilat-ciklaze, encima, ki katalizira pretvorbo adenozin-trifosfata (ATP) v ciklični adenozin-3',5'-monofosfat (ciklični monofosfat).
English: The capsules must be administered only using the Oslif Breezhaler inhaler (see section 6.6).
Slovenian: Kapsule so namenjene samo uporabi z inhalatorjem Oslif Breezhaler (glejte poglavje 6.6).
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.
Slovenian: Zaviranje delovanja dveh dejavnikov, ki sta bistveno vpletena v izločanje indakaterola - CYP3A4 in P-glikoproteina (P-gp), do dvakrat poveča sistemsko izpostavljenost indakaterolu.
English: Some people occasionally cough soon after inhaling the medicine.
Slovenian: Nekateri ljudje občasno začno kašljati kmalu po inhaliranju zdravila.
English: The decrease in serum potassium is usually transient, not requiring supplementation.
Slovenian: Znižana koncentracija kalija v krvi je običajno le prehodna in zaradi nje ni treba nadomeščati kalija.
English: Before placing the mouthpiece in your mouth, breathe out fully.
Slovenian: Preden vstavite ustnik v usta, izdihnite globoko, kolikor morete.
English: As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III study, there was no clinically relevant difference in the development of arrhythmic events monitored over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients receiving recommended doses of Oslif Breezhaler treatment and those patients who received placebo or treatment with tiotropium.
Slovenian: Kot se je pokazalo pri 605 bolnikih s KOPB v 26-tedenski, dvojno slepi, s placebom kontrolirani študiji faze III, med bolniki, ki so prejemali priporočene odmerka zdravila Oslif Breezhaler, in tistimi, ki so prejemali placebo ali zdravljenje s tiotropijem, ni prišlo do klinično pomembnih razlik glede razvoja aritmičnih dogodkov, ki so jih spremljali 24 ur ob izhodišču, nato pa še do 3-krat v 26tedenskem obdobju zdravljenja.
English: Your Oslif Breezhaler pack: Each Oslif Breezhaler pack contains: one Oslif Breezhaler inhaler one or more blister containing Oslif Breezhaler capsules to be used in the inhaler.
Slovenian: Pakiranje zdravila Oslif Breezhaler: Vsako pakiranje zdravila Oslif Breezhaler vsebuje: en inhalator Oslif Breezhaler en ali več pretisnih omotov s kapsulami Oslif Breezhaler, ki jih vstavljate v inhalator.
English: In vitro studies have shown that indacaterol, a long-acting beta2-adrenergic agonist, has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors and 20-fold greater agonist activity compared to beta3receptors.
Slovenian: Rezultati raziskav in vitro so pokazali, da ima indakaterol, dolgodelujoč agonist adrenergičnih receptorjev beta-2, več kot 24-krat večjo agonistično aktivnost na receptorje beta-2 kot na receptorje beta-1 in 20-krat večjo kot na receptorje beta-3.
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.
Slovenian: Razmisliti velja o uporabi kardioselektivnih zaviralcev adrenergičnih receptorjev beta, vendar le pod zdravniškim nadzorom in z izjemno previdnostjo, saj zaviralci adrenergičnih receptorjev beta lahko sprožijo bronhospazem.
English: Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose.
Slovenian: Inhaliranje visokih odmerkov agonistov adrenergičnih receptorjev beta-2 lahko povzroči zvišanje koncentracije glukoze v plazmi.
English: To breathe the medicine deeply into your airways:
Slovenian: Da bi zdravilo lahko vdihnili globoko v dihalne poti:
English: Oslif Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Slovenian: Zdravila Oslif Breezhaler se ne sme uporabljati v povezavi z drugimi dolgodelujočimi agonisti adrenergičnih receptorjev beta-2 oziroma z zdravili, ki vsebujejo dolgodelujoče agoniste adrenergičnih receptorjev beta-2.
English: The mean of the maximum changes in blood glucose were similar between Oslif Breezhaler and placebo.
Slovenian: Povprečji največjih sprememb v koncentraciji glukoze v krvi sta bili podobni pri uporabi zdravila Oslif Breezhaler in pri uporabi placeba.
English: The inhalation of the content of one 300 microgram capsule once a day, using the Oslif Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD.
Slovenian: Pokazalo se je, da inhalacija vsebine ene 300-mikrogramske kapsule enkrat na dan z uporabo inhalatorja Oslif Breezhaler še dodatno klinično koristi pri zadihanosti zlasti bolnikom s hudo KOPB.
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).
Slovenian: Kljub temu velja, da ni skoraj nobene možnosti, da bi indakaterol pri inhalaciji najvišjega priporočenega odmerka vplival na sposobnost za razmnoževanje ali plodnost pri ljudeh (glejte poglavje 5.3).
English: It will also help you to remember to use it.
Slovenian: Poleg tega si boste laže zapomnili, da morate vzeti zdravilo.
English: Breathe out:
Slovenian: Izdihnite:
English: Like other beta2-adrenergic agonists, indacaterol may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms.
Slovenian: Tako kot drugi agonisti adrenergičnih receptorjev beta-2, tudi indakaterol pri nekaterih bolnikih lahko klinično pomembno vpliva na kardiovaskularni sistem, kar se kaže kot povečan srčni utrip, zvišan krvni tlak in/ali povzročanje drugih simptomov.
English: Both doses demonstrated statistically significant improvements in symptom relief over placebo for dyspnoea and health status (as evaluated by Transitional Dyspnoea Index [TDI] and St. George's Respiratory Questionnaire [SGRQ], respectively).
Slovenian: Oba odmerka sta v primerjavi s placebom statistično značilno zmanjšala simptome, in sicer dispnejo in zdravstveno stanje glede na oceno sprememb dispneje po indeksu spreminjanja dispneje v času (TDITransitional Dyspnoea Index) in rezultate vprašalnika St. George's Respiratory Questionnaire (SGRQ).
English: A double-blind, placebo- and active (moxifloxacin)-controlled study for 2 weeks in 404 healthy volunteers demonstrated maximum mean (90% confidence intervals) prolongations of the QTcF interval (in milliseconds) of 2.66 (0.55, 4.77) 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) following multiple doses of 150 microgram, 300 microgram and 600 microgram, respectively.
Slovenian: Rezultati dvojno slepe 2-tedenske študije, kontrolirane s placebom in aktivno (z moksifloksacinom) pri 404 zdravih prostovoljcih so pokazali največje povprečno podaljšanje intervala QTcF za 2,66 milisekund (meje 90-odstotnega intervala zaupanja: 0,55, 4,77) po večkratnem odmerjanju 150 mikrogramov, za 2,98 milisekund (meje 90-odstotnega intervala zaupanja: 1,02, 4,93) po večkratnem odmerjanju 300 mikrogramov in za 3,34 milisekund (meje 90-odstotnega intervala zaupanja:0,86, 5,82) po večkratnem odmerjanju 600 mikrogramov.
English: What Oslif Breezhaler is and what it is used for What you need to know before you use Oslif Breezhaler How to use Oslif Breezhaler Possible side effects
Slovenian: Kaj je zdravilo Oslif Breezhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Oslif Breezhaler Kako uporabljati zdravilo Oslif Breezhaler Možni neželeni učinki
English: Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at an exposure 14-fold higher than in humans treated with Oslif Breezhaler.
Slovenian: Čeprav indakaterol ni vplival na splošno sposobnost za razmnoževanje v študiji plodnosti pri podganah, so v študiji obdobja pred razvojem in po zaključenem razvoju pri podganah opažali zmanjšano število nosečnosti v generaciji F1 pri izpostavljenosti zdravilu, ki je bila 14-krat večja kot pri ljudeh, ki prejemajo zdravilo Oslif Breezhaler.
English: Like other beta2-adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
Slovenian: Kot drugi agonisti adrenergičnih receptorjev beta-2 lahko indakaterol zavira porod zaradi relaksantnega učinka na gladko mišičje maternice.
English: Paediatric population There is no relevant use of Oslif Breezhaler in the paediatric population (under 18 years).
Slovenian: Zdravilo Oslif Breezhaler ni namenjeno za uporabo pri pediatrični populaciji (starost pod 18 let).
English: When you inhale it, it relaxes the muscles in the walls of the small air passages in the lungs.
Slovenian: Ko zdravilo vdihnete, sprosti mišice v steni malih cevk, po katerih prihaja zrak v pljuča.
English: Therefore, long-acting beta2-adrenergic agonists such as Oslif Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Slovenian: Iz navedenih razlogov je pri uporabi dolgodelujočih agonistov adrenergičnih receptorjev beta-2 , kot je zdravilo Oslif Breezhaler, pri bolnikih z ugotovljenim ali domnevnim podaljšanjem intervala QT in pri tistih, ki prejemajo zdravila z vplivom na interval QT, potrebna previdnost.
English: c: indacaterol 300 microgram, formoterol and placebo MCID = minimal clinically important difference (≥1 point change in TDI, ≥4 point change in SGRQ) n/e= not evaluated at six months
Slovenian: MCID = najmanjša klinično pomembna sprememba (minimal clinically important difference) (≥1 enota pri indeksu spreminjanja dispneje TDI; ≥4 točke razlike pri vprašalniku SGRQ) n/o= ni bilo ocenjeno po šestih mesecih zdravljenja
English: The Oslif Breezhaler Phase III clinical development programme involved patients with a clinical diagnosis of moderate to severe COPD.
Slovenian: V klinični program faze III v razvoju zdravila Oslif Breezhaler so bili vključeni bolniki s klinično diagnozo zmerne do hude KOPB.
English: Oslif Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Oslif Breezhaler olajša dihanje odraslim bolnikom, ki imajo težave z dihanjem zaradi pljučne bolezni z imenom kronična obstruktivna pljučna bolezen (KOPB).
English: Table 2 Symptom relief at 6 months treatment duration
Slovenian: Preglednica 2 Zmanjševanje simptomov po 6 mesecih zdravljenja zdravljenje odmerek (v mikrogramih)
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Slovenian: Agonisti adrenergičnih receptorjev beta-2 lahko pri nekaterih bolnikih povzročijo pomembno hipokaliemijo, zaradi katere lahko pride do neželenih kardiovaskularnih učinkov.
English: Immediately before use, with dry hands, remove one capsule from the blister.
Slovenian: Tik pred uporabo vzemite s suhimi rokami eno kapsulo iz pretisnega omota.
English: What you need to know before you use Oslif Breezhaler
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Oslif Breezhaler
English: Increased incidences of benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle in rats were consistent with similar findings reported for other beta2-adrenergic agonists.
Slovenian: Pri podganah so opažali povečani incidenci benignega ovarijskega leiomioma in fokalne hiperplazije gladkega mišičja jajčnika, kar se ujema s podobnimi izsledki, ki so jih opisovali pri drugih agonistih adrenergičnih receptorjev beta-2.
English: Inhale the medicine: To breathe the medicine deeply into your airways:
Slovenian: Vdihnite zdravilo: Da bi zdravilo lahko vdihnili globoko v dihalne poti:
English: Both doses resulted in an increase of 40-50 ml over open-label tiotropium 18 microgram once a day (150 microgram, p=0.004; 300 microgram, p=0.01).
Slovenian: Oba navedena odmerka sta povzročila povečanje za 40-50 ml v primerjavi z odprtim zdravljenjem s tiotropijem v odmerku 18 mikrogramov enkrat na dan (150 mikrogramov: p=0,004; 300 mikrogramov: p=0,01).
English: Upon initiation of treatment with Oslif Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Slovenian: Pri sladkornih bolnikih je treba po začetku zdravljenja z zdravilom Oslif Breezhaler še bolj natančno spremljati koncentracije glukoze v plazmi.
English: Please read the following instructions carefully to learn how to use and care for your Oslif Breezhaler inhaler.
Slovenian: Skrbno preberite naslednja navodila, da boste znali uporabljati inhalator Oslif Breezhaler in skrbeti zanj.
English: • if you get symptoms of an allergic reaction such as rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).
Slovenian: • če se pojavijo simptomi alergijske reakcije, kot so izpuščaj, srbenje, urtikarija, oteženo dihanje ali požiranje, omotičnost (občasen neželeni učinek),
English: Indacaterol was not embryotoxic or teratogenic in rats or rabbits.
Slovenian: Pri podganah in kuncih indakaterol ni bil niti embriotoksičen niti teratogen.
English: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Slovenian: Dolgodelujoči agonisti adrenergičnih receptorjev beta-2 lahko pri uporabi za zdravljenje astme povečajo tveganje za resne neželene učinke, ki so povezani z astmo, med drugim za smrt zaradi astme.
English: Oslif Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Slovenian: Zdravilo Oslif Breezhaler vsebuje zdravilno učinkovino indakaterol iz skupine zdravil, ki jih imenujemo bronhodilatatorji.
English: Each inhaler should be disposed of after 30 days of use.
Slovenian: Vsak inhalator je treba po 30 dneh uporabe zavreči.
English: The oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4.
Slovenian: Pri inkubaciji z rekombinantnimi CYP1A1, CYP2D6 in CYP3A4 so odkrili oksidativne metabolite.