FrancophonIA/ELRC3.0 huggingface dataset:
English: Oslif Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies.
Slovenian: Zdravilo Oslif Breezhaler je v odmerkih 150 in 300 mikrogramov na dan v več kliničnih farmakodinamičnih študijah in študijah učinkovitosti dosledno dosegalo klinično pomembno izboljšanje pljučne funkcije znotraj 24 ur (kar so merili z forsiranim ekspiracijskim volumnom v prvi sekundi, FEV1).
English: Inhalation powder, hard capsule
Slovenian: prašek za inhaliranje, trde kapsule
English: At 600 microgram once-daily, the safety profile of Oslif Breezhaler was overall similar to that of recommended doses.
Slovenian: Pri uporabi odmerka 600 mg enkrat na dan so bile varnostne lastnosti zdravila Oslif Breezhaler večinoma podobne kot pri uporabi priporočenih odmerkov.
English: The 300 microgram dose resulted in a 170-180 ml increase compared to placebo (p<0.001) and a 100 ml increase compared to formoterol 12 microgram twice a day (p<0.001).
Slovenian: Odmerek 300 mikrogramov je povzročil povečanje za 170-180 ml v primerjavi s placebom (p<0,001) in povečanje za 100 ml v primerjavi s formoterolom v odmerku 12 mikrogramov dvakrat na dan (p<0,001).
English: How long to continue your treatment with Oslif Breezhaler Keep using your treatment with Oslif Breezhaler for as long as your doctor tells you.
Slovenian: Kako dolgo je treba nadaljevati z uporabo zdravila Oslif Breezhaler Zdravljenje z zdravilom Oslif Breezhaler nadaljujte tako dolgo, kot vam naroči zdravnik.
English: Oslif Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Slovenian: Uporabe zdravila Oslif Breezhaler niso proučevali pri bolnikih, ki niso imeli dobro urejene sladkorne bolezni.
English: 300 microgram, tiotropium and placebo;
Slovenian: 150 in 300 mikrogramov, tiotropija in placeba;
English: Note:
Slovenian: Pozor:
English: Oslif Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory capacity during exercise and at rest, compared to placebo.
Slovenian: Pokazalo se je, da zdravilo Oslif Breezhaler v primerjavi s placebom zmanjša hiperinflacijo pljuč, kar poveča inspiracijsko kapaciteto med naporom in v mirovanju.
English: Immune system disorders Hypersensitivity
Slovenian: Bolezni imunskega sistema preobčutljivost občasni
English: • Open the inhaler and carefully loosen the capsule by tapping the base of the inhaler.
Slovenian: • Odprite inhalator in z rahlim trkanjem po dnu inhalatorja previdno sprostite kapsulo.
English: If the capsule is not empty then inhale again as directed.
Slovenian: Če kapsula ni prazna, nadaljujte z inhaliranjem po navodilih.
English: Start date
Slovenian: Datum začetka uporabe
English: Hold the base of the inhaler firmly and tilt the mouthpiece.
Slovenian: Trdno držite spodnji del inhalatorja in nagnite ustnik.
English: Wipe the mouthpiece inside and outside to remove any powder with a clean, dry lint-free cloth.
Slovenian: S čisto, suho krpico, ki ne pušča vlaken, z notranje in zunanje strani obrišite prah z ustnika.
English: In the event of deterioration of COPD during treatment with Oslif Breezhaler, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.
Slovenian: Če pride med zdravljenjem z zdravilom Oslif Breezhaler do poslabšanja KOPB, je treba ponovno pregledati bolnika in oceniti shemo zdravljenja KOPB.
English: There was no evidence of a concentration-delta QTc relationship in the range of doses evaluated.
Slovenian: Rezultati niso kazali nikakršne povezave med koncentracijo zdravila in dolžino intervala delta QTc v okviru preučevanih odmerkov.
English: This opens the inhaler.
Slovenian: S tem odprete inhalator.
English: There are no data available for use of Oslif Breezhaler in patients with severe hepatic impairment.
Slovenian: O uporabi zdravila Oslif Breezhaler pri bolnikih s hudo okvaro jeter ni na voljo nobenih podatkov.
English: Treatment comparison compared to placebo showed a ratio of rates of 0.68 (95% CI [ 0.47, 0.98]; p-value 0.036) and 0.74 (95% CI [0.56, 0.96]; pvalue 0.026) for 150 microgram and 300 microgram, respectively.
Slovenian: Primerjava zdravljenja z uporabo placeba je pri odmerku 150 mikrogramov pokazala razmerje pogostnosti 0,68 (meje 95-odstotnega intervala zaupanja: 0,47, 0,98; vrednost p: 0,036), pri odmerku 300 mikrogramov pa 0,74 (meje 95odstotnega intervala zaupanja: 0,56, 0,96; vrednost p 0,026).
English: Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Oslif Breezhaler je indicirano za vzdrževalno brohodilatatorno zdravljenje obstrukcije dihalnih poti pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: Please read the instructions at the end of this leaflet for more information about how to use the inhaler.
Slovenian: Več o uporabi inhalatorja boste našli v navodilih na koncu tega Navodila za uporabo.
English: Capsule shell
Slovenian: Kapsul Oslif
English: • if you have difficulty breathing with wheezing or coughing (uncommon).
Slovenian: • če pride do oteženega dihanja s piskanjem ali kašljanjem (občasen neželeni učinek).
English: How to store Oslif Breezhaler Contents of the pack and other information
Slovenian: Shranjevanje zdravila Oslif Breezhaler Vsebina pakiranja in dodatne informacije
English: Oslif Breezhaler has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Oslif Breezhaler nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Indacaterol is a partial agonist at the human beta2-adrenergic receptor with nanomolar potency.
Slovenian: Indakaterol je delni agonist humanih beta-2-adrenergičnih receptorjev, ki deluje že v nanomolarni koncentraciji.
English: Oslif Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Slovenian: Zdravilo Oslif Breezhaler je pri odmerjanju 150 mikrogramov in 300 mikrogramov enkrat na dan klinično pomembno izboljšalo pljučno funkcijo.
English: Additional information Some people may occasionally cough briefly soon after inhaling the medicine.
Slovenian: Dodatne informacije Nekateri ljudje začno kmalu po inhaliranju kašljati.
English: • Hold the inhaler upright with the mouthpiece pointing up.
Slovenian: • Inhalator držite pokonci z ustnikom obrnjenim navzgor.
English: Do not use Oslif Breezhaler capsules with any other inhaler, and do not use Oslif Breezhaler inhaler to take any other capsule medicine.
Slovenian: Breezhaler ne uporabljajte z nobenim drugim inhalatorjem, inhalatorja Oslif Breezhaler pa ne uporabljajte za inhaliranje drugih zdravil iz kapsul.
English: This helps open up the airways, making it easier to get air in and out.
Slovenian: To odpre dihalno pot, zato laže vdihnete in izdihnete.
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.
Slovenian: Rezultati in vitro raziskav kažejo, da ima indakaterol pri ravneh sistemske izpostavljenosti, do katerih pride v klinični praksi, le zanemarljivo majhno možnost za povzročanje metaboličnih interakcij.
English: • Dispose of each inhaler after 30 days of use.
Slovenian: • Vsak inhalator po 30 dneh uporabe zavrzite.
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Oslif Breezhaler at recommended therapeutic doses (see section 5.1).
Slovenian: V kliničnih študijah pri uporabi zdravila Oslif Breezhaler v okviru terapevtskega odmerjanja niso opažali klinično pomembnih učinkov na podaljševanje intervala QTc (glejte poglavje 5.1).
English: Put a mark in today's box if it helps to remind you of when your next dose is due.
Slovenian: V pakiranju zdravila lahko najdete koledarček za beleženje vsakodnevnega odmerjanja: označite, da ste danes že vzeli zdravilo, tako da boste vedeli, kdaj je na vrsti naslednji odmerek.
English: It may harm them,
Slovenian: • če vam srce bije nepravilno (občasen neželeni učinek),
English: After you have finished taking your medicine:
Slovenian: Ko zaključite z inhaliranjem zdravila:
English: What Oslif Breezhaler contains - Each Oslif Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Slovenian: Kaj vsebuje zdravilo Oslif Breezhaler - Ena kapsula zdravila Oslif Breezhaler 150 mikrogramov vsebuje 150 mikrogramov indakaterola v obliki indakaterolijevega maleata.
English: What Oslif Breezhaler is and what it is used for
Slovenian: Kaj je zdravilo Oslif Breezhaler in za kaj ga uporabljamo
English: If you forget to inhale a dose, inhale just one dose at the usual time the next day.
Slovenian: Če ste pozabili uporabiti zdravilo Oslif Breezhaler Če pozabite inhalirati odmerek, naslednji dan ob običajnem času inhalirajte samo en odmerek.
English: Driving and using machines It is unlikely that Oslif Breezhaler will affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Po vsej verjetnosti zdravilo Oslif Breezhaler ne vpliva na vašo sposobnost upravljanja vozil in strojev.
English: A diastereomer of the hydroxylated derivative, a N-glucuronide of indacaterol, and C- and N-dealkylated products were further metabolites identified.
Slovenian: Določili so še naslednje metabolite: diastereomer hidroksiliranega derivata, N-glukuronid indakaterola ter C- in N-dealkilirana presnovka.
English: Oslif Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Slovenian: Zdravilo Oslif Breezhaler ni indicirano za zdravljenje akutnih epizod bronhospazma, t.j.
English: Do not take the inhaler apart.
Slovenian: Inhalatorja ne razstavljajte.
English: For inhalation use only.
Slovenian: Samo za inhalacijo.
English: • Ask your pharmacist how to dispose of medicines and inhalers no longer required.
Slovenian: • O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
English: Talk to your doctor or pharmacist before using Oslif Breezhaler if you have asthma (in this case you should not use Oslif Breezhaler).
Slovenian: Pred začetkom uporabe zdravila Oslif Breezhaler se posvetujte z zdravnikom ali farmacevtom: če imate astmo (v tem primeru ne smete uporabljati zdravila Oslif Breezhaler), če imate težave s srcem, če imate epilepsijo, če imate težave s ščitnico (hipertiroidizem), če imate sladkorno bolezen.
English: Open inhaler:
Slovenian: Odprite inhalator:
English: Mass balance was complete with ≥90% of the dose recovered in the excreta.
Slovenian: V izločkih so prestregli ≥90 % odmerka, kar ustrezno dopolni masno bilanco.
English: - Each Oslif Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Slovenian: - Ena kapsula zdravila Oslif Breezhaler 300 mikrogramov vsebuje 300 mikrogramov indakaterola v obliki indakaterolijevega maleata.
English: What Oslif Breezhaler looks like and content of the pack In this pack, you will find an inhaler, together with capsules in blister.
Slovenian: Izgled zdravila Oslif Breezhaler in vsebina pakiranja Pakiranje vsebuje inhalator skupaj s kapsulami v pretisnih omotih.
English: Musculoskeletal pain
Slovenian: • mišični krč
English: Immediate hypersensitivity reactions have been reported after administration of Oslif Breezhaler.
Slovenian: Poročali so o primerih takojšnje preobčutljivostne reakcije po odmerjanju zdravila Oslif Breezhaler.
English: Only use the capsules with the inhaler provided in this pack (Oslif Breezhaler inhaler).
Slovenian: Kapsule uporabljajte samo z inhalatorjem, ki je priložen v škatli (z inhalatorjem Oslif Breezhaler).
English: Mean peak improvements in FEV1 relative to baseline were 250-330 ml at steady state.
Slovenian: V stanju dinamičnega ravnovesja je bilo povprečno izboljšanje najvišje vrednosti FEV1 250-330 ml od izhodiščne vrednosti.
English: At the 12-week primary endpoint (24-hour trough FEV1), the 150 microgram dose resulted in a 130-180 ml increase compared to placebo (p<0.001) and a 60 ml increase compared to salmeterol 50 microgram twice a day (p<0.001).
Slovenian: Po 12 tednih je odmerek 150 mikrogramov pri primarnem cilju študije (ki je bil najnižja vrednost FEV1 v 24-urni meritvi) povzročil povečanje za 130-180 ml v primerjavi s placebom (p<0,001) in povečanje za 60 ml v primerjavi s salmeterolom v odmerku 50 mikrogramov dvakrat na dan (p<0,001).
English: Transparent (uncoloured) capsules containing a white powder, with “IDL 300” printed in blue above a blue bar and company logo ( ) printed in blue below the blue bar.
Slovenian: Prosojne (neobarvane) kapsule, ki vsebujejo bel prašek in imajo modro tiskano oznako "IDL 300" nad modro črto in modro tiskan zaščitni znak družbe ( ) pod modro črto.
English: The usual dose is to inhale the content of one capsule each day.
Slovenian: Koliko zdravila Oslif Breezhaler je treba uporabljati Običajni odmerek je inhaliranje vsebine ene kapsule vsak dan.
English: Oslif Breezhaler is a single-dose inhalation device.
Slovenian: Oslif Breezhaler je inhalator za inhaliranje posameznih odmerkov.
English: • You should hear a “click” as the capsule is being pierced.
Slovenian: • Ko se kapsula predre, se mora slišati "klik".
English: Oslif Breezhaler contains lactose
Slovenian: Zdravilo Oslif Breezhaler vsebuje laktozo
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Oslif Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Slovenian: Kot velja za druge agoniste adrenergičnih receptorjev beta-2, je tudi pri indakaterolu potrebna previdnost pri uporabi pri bolnikih s kardiovaskularnimi boleznimi (s koronarno boleznijo, po akutnem miokardnem infarktu, z aritmijami, s hipertenzijo), pri bolnikih s konvulzivnimi motnjami ali s hipertiroidizmom in pri bolnikih, ki so neobičajno odzivni na agoniste adrenergičnih receptorjev beta-2, čeprav pri uporabi zdravila Oslif Breezhaler v okviru priporočenega odmerjanja običajno ni opaziti klinično pomembnih učinkov na kardiovaskularni sistem.
English: After oral administration of radiolabelled indacaterol in a human ADME (absorption, distribution, metabolism, excretion) study, unchanged indacaterol was the main component in serum, accounting for about one third of total drug-related AUC over 24 hours.
Slovenian: V študiji absorpcije, porazdelitve, presnove in izločanja pri ljudeh je bila po peroralnem odmerjanju radioaktivno označenega indakaterola glavna sestavina v serumu nespremenjeni indakaterol.
English: Dispose of each inhaler after 30 days of use.
Slovenian: Vsak inhalator po 30 dneh uporabe zavrzite.
English: Metabolism and nutrition disorders Diabetes mellitus and hyperglycaemia
Slovenian: Presnovne in prehranske motnje sladkorna bolezen in hiperglikemija občasni
English: Transparent (uncoloured) capsules containing a white powder, with “IDL 150” printed in black above a black bar and company logo ( ) printed in black below the black bar.
Slovenian: Prosojne (neobarvane) kapsule, ki vsebujejo bel prašek in imajo črno tiskano oznako "IDL 150" nad črno črto in črno tiskan zaščitni znak družbe ( ) pod črno črto.
English: Other medicines and Oslif Breezhaler
Slovenian: Druga zdravila in zdravilo Oslif Breezhaler
English: The Oslif Breezhaler inhaler enables you to inhale the medicine contained in an Oslif Breezhaler capsule.
Slovenian: S pomočjo inhalatorja Oslif Breezhaler lahko inhalirate zdravilo, ki je v kapsuli Oslif Breezhaler.
English: Carton containing 30 capsules and one Oslif Breezhaler inhaler.
Slovenian: Škatla vsebuje 30 kapsul in en inhalator Oslif Breezhaler.
English: At the recommended doses, the adverse reaction profile of Oslif Breezhaler in patients with COPD shows clinically insignificant systemic effects of beta2-adrenergic stimulation.
Slovenian: Pri uporabi priporočenih odmerkov so bili med neželenimi učinki zdravila Oslif Breezhaler pri bolnikih s KOPB klinično nepomembni sistemski učinki beta-2-adrenergične stimulacije.
English: INSTRUCTIONS FOR USE OF OSLIF BREEZHALER INHALER
Slovenian: NAVODILA ZA UPORABO INHALATORJA OSLIF BREEZHALER
English: Oslif Breezhaler capsules must not be swallowed.
Slovenian: Kapsul Oslif Breezhaler se ne sme pogoltniti.
English: 54 c a
Slovenian: 54 c a b
English: • Only use the Oslif Breezhaler inhaler contained in this pack.
Slovenian: • Uporabljajte samo inhalator Oslif Breezhaler, ki je priložen temu pakiranju.
English: Percentage of days with no rescue medication use a
Slovenian: 0,4 b odstotek dni brez uporabe nadomestnega zdravila a b b b a n/o a b
English: Carton containing 10 capsules and one Oslif Breezhaler inhaler.
Slovenian: Škatla vsebuje 10 kapsul in en inhalator Oslif Breezhaler.
English: • Do not swallow the capsules.
Slovenian: • Kapsul ne smete pogoltniti.
English: Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol included tachycardia, arrhythmias and myocardial lesions in dogs.
Slovenian: Pri psih so med učinki na kardiovaskularni sistem, ki jih ima inadakaterol zaradi svojega agonističnega delovanja na receptorje beta-2, opažali aritmije in poškodbe miokarda.
English: When you start a new pack, use the new Oslif Breezhaler inhaler that is supplied in the pack.
Slovenian: Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Oslif Breezhaler, ki je priložen pakiranju.
English: Never wash the Oslif Breezhaler inhaler with water.
Slovenian: Inhalatorja Oslif Breezhaler nikoli ne umivajte z vodo.
English: • When you start a new pack, only use the new Oslif Breezhaler inhaler that is supplied in the pack.
Slovenian: • Ko odprete novo škatlo z zdravilom, začnite uporabljati tudi nov inhalator Oslif Breezhaler, ki je priložen pakiranju.
English: Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol.
Slovenian: Ena kapsula vsebuje indakaterolijev maleat, kar ustreza 150 mikrogramom indakaterola.
English: 300 capsules + 30 inhalers
Slovenian: 300 kapsul + 30 inhalatorjev
English: • Open the mouthpiece again, and remove the empty capsule by tipping it out of the capsule chamber.
Slovenian: • Spet odprite ustnik in odstranite kapsulo.
English: Show the pack of Oslif Breezhaler.
Slovenian: Tam pokažite škatlo z zdravilom Oslif Breezhaler.
English: Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Oslif Breezhaler.
Slovenian: Poročila o preobčutljivosti izhajajo iz izkušenj z uporabo zdravila Oslif Breezhaler po njegovem prihodu na trg.
English: Carton containing 30 capsules and 1 inhaler.
Slovenian: Škatla, ki vsebuje 30 kapsul in 1 inhalator.
English: Renal impairment No dose adjustment is required for patients with renal impairment.
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerjanja ni potrebno.
English: Infections and infestations Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni okužbe zgornjih dihal pogosti nazofaringitis pogosti sinusitis pogosti
English: 58 b
Slovenian: 53 a 58 b
English: Each capsule contains 24.6 mg lactose.
Slovenian: Pomožna(e) snov(i) z znanim učinkom: Ena kapsula vsebuje 24,6 mg laktoze.
English: Lung function
Slovenian: Pljučna funkcija
English: Do not store the capsules in the Oslif Breezhaler inhaler.
Slovenian: Kapsul ne shranjujte v inhalatorju Oslif Breezhaler.
English: 90 capsules + 3 inhalers
Slovenian: 90 kapsul + 3 inhalatorji
English: Pull off the cap.
Slovenian: Snemite pokrovček.
English: Each capsule contains 24.8 mg lactose.
Slovenian: Pomožna(e) snov(i) z znanim učinkom: Ena kapsula vsebuje 24,8 mg laktoze.
English: Musculoskeletal and connective tissue disorders Muscle spasm
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični krči pogosti bolečine v mišicah občasni mišičnoskeletna bolečina občasni
English: Carton containing 10 capsules and 1 inhaler.
Slovenian: Škatla, ki vsebuje 10 kapsul in 1 inhalator.
English: The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 240 microgram indacaterol.
Slovenian: Odmerek indakaterolijevega maleata, ki pride skozi ustnik inhalatorja, ustreza 240 mikrogramom indakaterola.
English: • sore throat
Slovenian: • vnetje žrela in grla
English: Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol.
Slovenian: Ena kapsula vsebuje indakaterolijev maleat, kar ustreza 300 mikrogramom indakaterola.
English: How to clean your inhaler
Slovenian: Čiščenje inhalatorja
English: medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol).
Slovenian: S tem lahko povečate možnost za neželene učinke; jemljete zdravila, ki jih imenujemo zaviralci adrenergičnih receptorjev beta in jih uporabljamo pri zdravljenju visokega krvnega tlaka ali drugih težav s srcem (na primer propranolol) ali pa pri bolezni oči, ki jo imenujemo glavkom (na primer timolol); jemljete zdravila, ki znižujejo raven kalija v krvi.
English: • if you get crushing chest pain, (common).
Slovenian: • če začutite stiskajočo bolečino v prsih (pogost neželeni učinek),
English: 60 capsules + 2 inhalers
Slovenian: 60 kapsul + 2 inhalatorja
English: Only use the Oslif Breezhaler inhaler contained in this pack.
Slovenian: Uporabljajte samo inhalator Oslif Breezhaler, ki je priložen temu pakiranju.
English: The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 120 microgram indacaterol.
Slovenian: Odmerek indakaterolijevega maleata, ki pride skozi ustnik inhalatorja, ustreza 120 mikrogramom indakaterola.
English: The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on Day 14 compared to Day 1, was in the range of 2.9 to 3.5 for once-daily inhaled doses between 150 microgram and 600 microgram.
Slovenian: Pri enkrat dnevnem inhaliranju odmerkov od 150 mikrogramov do 600 mikrogramov je bilo povprečno razmerje kopičenja indakaterola, kar pomeni AUC v 24-urnem odmernem intervalu na 14. dan v primerjavi s 1. dnem, v obsegu od 2,9 do 3,5.
English: How to use Oslif Breezhaler
Slovenian: Kako uporabljati zdravilo Oslif Breezhaler
English: No dose adjustment is required for patients with mild and moderate hepatic impairment.
Slovenian: Pri bolnikih z blago in zmerno okvaro jeter prilagajanje odmerjanja ni potrebno.
English: The Oslif Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Slovenian: S pomočjo inhalatorja Oslif Breezhaler boste lahko vdihnili (inhalirali) zdravilo, ki je v kapsuli.
English: Never blow into the mouthpiece of the Oslif Breezhaler inhaler.
Slovenian: Nikoli ne pihajte v ustnik inhalatorja Oslif Breezhaler.
English: It is not harmful if these pieces are swallowed or inhaled.
Slovenian: Če te delce pogoltnete ali vdihnete, vam to ne bo škodovalo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 30. november 2009
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.
Slovenian: Na podlagi teh rezultatov ni nobenega razloga za zaskrbljenost, da bi uporaba priporočenih terapevtskih odmerkov ali odmerkov, ki bi bili dvakrat višji od najvišjega priporočenega odmerka, lahko spodbujala razvoj aritmij v povezavi s podaljšanjem intervala QT.