FrancophonIA/ELRC3.0 huggingface dataset:
English: For 300 mg doses, use 30 ml of Soliris (10 mg/ml)
Slovenian: Za 300 mg odmerke uporabite 30 ml zdravila Soliris (10 mg/ml) in dodajte 30 ml vehikla za redčenje.
English: Vaccines against serogroups A, C, Y, W 135 and B where available are recommended in preventing the commonly pathogenic meningococcal serogroups.
Slovenian: Cepiva proti seroskupinam A, C, Y, W 135 in B,
English: 6.1 List of excipients Sodium phosphate, monobasic Sodium phosphate, dibasic Sodium chloride
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat natrijev hidrogenfosfat natrijev klorid polisorbat 80
English: • upper respiratory tract infection, cough, throat pain (oropharyngeal pain), bronchitis, cold sores (herpes simplex)
Slovenian: • okužba zgornjih dihal, kašelj, bolečina v žrelu (orofaringealna bolečina), bronhitis, mehurčki na ustnicah (herpes simpleks), • driska, bruhanje, slabost (navzea), bolečine v trebuhu, izpuščaj, izpadanje las (alopecija),
English: • menstrual disorder
Slovenian: • spazem ustnih mišic, • menstrualne motnje,
English: Reduction in terminal complement activity and an increase in platelet count relative to baseline were observed after commencement of Soliris.
Slovenian: Po uvedbi zdravila Soliris so opazili zmanjšanje aktivnosti terminalnega komplementa in zvečanje števila trombocitov glede na izhodišče.
English: Pyrexia, Fatigue, Influenza like illness
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, utrujenost, gripi podobna bolezen nelagodje v prsnem košu,
English: CKD improvement by ≥1 stage, n (%)
Slovenian: tedni (razpon)1 stanje brez TMA dogodka, n (%)
English: In paediatric aHUS patients (aged 2 months to less than 18 years) included in the aHUS studies C08-002,
Slovenian: Varnostni profil pri pediatričnih bolnikih z aHUS (starih od 2 meseca do manj kot 18 let), ki so bili vključeni v študije aHUS C08-002, C08-003, C09-001r in C10-003, se je zdel podoben kot tisti, ki so ga opazovali pri odraslih bolnikih z aHUS.
English: Urticaria, Erythema, Petechiae, Hyperhidrosis, Dry skin
Slovenian: Bolezni kože in podkožja izpuščaj, pruritus, alopecija urtikarija, eritem, petehije, hiperhidroza,
English: Palpitation
Slovenian: koagulopatija
English: Diarrhoea, Vomiting, Nausea, Abdominal pain
Slovenian: Bolezni prebavil driska, bruhanje, navzea,
English: Supplemental Soliris Dose
Slovenian: Časovno usklajevanje dodatnega odmerka zdravila Soliris
English: TMA-event free status was defined as the absence for at least 12 weeks of the following: decrease in platelet count of > 25% from baseline, PE/PI, and new dialysis.
Slovenian: Stanje brez TMA dogodkov je bilo definirano kot odsotnost naslednjih parametrov vsaj 12 tednov: znižanje števila trombocitov za
English: Chest discomfort, Asthenia, Chest pain, Infusion site pain, Chills
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, bolečina v ustih in žrelu dispneja, epistaksa,
English: LDH level at baseline (median , U/L)
Slovenian: Izhodiščna LDH (enot/l), povprečje (SD)
English: (≥1/10,000 to <1/1,000)
Slovenian: Redki (≥ 1/10.000 do
English: Change in platelet count through week 26 (109/L)
Slovenian: C10-004 (N = 41) pri 26 tednih sprememba števila trombocitov do 26. tedna (109/l)
English: Soliris N = 97
Slovenian: N = 97
English: Adjusted adjudicated ARR
Slovenian: Očesne bolezni zamegljen vid draženje veznice
English: In all studies, the dose of eculizumab was 600 mg every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.
Slovenian: 7 ± 2 dni v obdobju 4 tednov, čemur je sledil odmerek 900 mg 7 ± 2 dni kasneje in nato odmerek
English: Paired t-test
Slovenian: Študija aHUS
English: Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (parents) Change from baseline at 12 weeks of PedsQLTM Multidimensional Fatigue (patients)
Slovenian: Multidimensional Fatigue« od izhodišča ob 12. tednu (starši) Atipični hemolitično uremični sindrom
English: Hepatobiliary disorders
Slovenian: mielodisplastični sindrom
English: Time from first diagnosis until screening in months, median (min, max) Time from current clinical TMA manifestation until screening in months, median (min, max)
Slovenian: Čas od nedavno klinično izražene TMA do presejalnih testov v mesecih, mediana (min, maks)
English: Treatment effect a
Slovenian: P - vrednost
English: The risks of stopping Soliris include an increase in the inflammation of your platelets, which may cause: - A significant fall in your platelets (thrombocytopenia), - A significant rise in destruction of your red blood cells, - Decreased urination (problems with your kidneys), - An increase in your serum creatinine level (problems with your kidneys), - Confusion or change in how alert you are, - Chest pain, or angina, - Shortness of breath, or - Thrombosis (blood clotting).
Slovenian: - bistven porast uničenja rdečih krvnih celic, - zmanjšano uriniranje (težave z ledvicami), - zvišanje ravni serumskega kreatinina (težave z ledvicami),
English: For intravenous use
Slovenian: Način uporabe
English: Double Blind
Slovenian: boleče dlesni
English: Date:
Slovenian: NN:
English: If you experience any of the following symptoms, you should immediately inform your doctor: - headache with nausea or vomiting - headache with a stiff neck or back - fever - rash - confusion - severe muscle aches combined with flu-like symptoms
Slovenian: - glavobol s slabostjo ali bruhanjem; - glavobol z otrdelim vratom ali hrbtom;
English: Posology
Slovenian: vrednost
English: Change From Baseline QMG Total Score
Slovenian: Izhodiščni rezultat lestvice QMG povprečje (SD)
English: Onbrez Breezhaler should only be used during pregnancy if the expected benefits outweigh the potential risks.
Slovenian: Uporaba zdravila Onbrez Breezhaler je v času nosečnosti upravičena le v primeru, da pričakovane koristi presegajo možna tveganja.
English: Do not use Onbrez Breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Onbrez Breezhaler - če ste alergični na indakaterol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: An increase in the daily dose of Onbrez Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Slovenian: Zviševanje dnevnega odmerka zdravila Onbrez Breezhaler preko najvišjega odmerka 300 mikrogramov ni primerno.
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Onbrez 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 Onbrez Breezhaler (na primer zdravila, kot sta salmeterol in formoterol).
English: If you use more Onbrez Breezhaler than you should If you have inhaled too much Onbrez 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 Onbrez Breezhaler, kot bi smeli Če ste vdihnili preveč zdravila Onbrez Breezhaler ali če kdo drug uporabi vaše kapsule, takoj obvestite zdravnika ali pojdite do najbližjega oddelka za nujno medicinsko pomoč.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Onbrez 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 Onbrez 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 Onbrez 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 Onbrez Breezhaler, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Onbrez Breezhaler capsules must always be stored in the blister, and only removed immediately before use.
Slovenian: Kapsule Onbrez Breezhaler je treba vedno shranjevati v pretisnem omotu in jih iz njega vzeti šele tik pred uporabo.
English: The 24-hour bronchodilator effect of Onbrez 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 Onbrez Breezhaler se je ohranjal od prvega odmerka skozi celotno enoletno obdobje zdravljenja brez znakov zmanjševanja učinkovitosti (tahifilaksije).
English: The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Onbrez 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 Onbrez Breezhaler v kliničnih študijah s trajanjem do enega leta v odmerkih, ki so dosegali tudi dvakratni priporočeni terapevtski odmerek.
English: Concomitant administration of other sympathomimetic medicinal products (alone or as part of combination therapy) may potentiate adverse reactions to Onbrez Breezhaler.
Slovenian: Sočasna uporaba drugih simpatikomimetičnih zdravil (samih ali v sklopu kombinacije zdravil) lahko okrepi neželene učinke zdravila Onbrez Breezhaler.
English: COPD is a long-term disease and you should use Onbrez Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Slovenian: KOPB je dolgotrajna bolezen in zdravilo Onbrez Breezhaler morate uporabljati vsak dan, ne le takrat, ko težko dihate ali imate katerega od drugih simptomov KOPB.
English: If you have questions about how long to continue your treatment with Onbrez Breezhaler, talk to your doctor or pharmacist.
Slovenian: Če vas zanima, kako dolgo je treba nadaljevati z uporabo zdravila Onbrez Breezhaler, se pogovorite s svojim zdravnikom ali farmacevtom.
English: In addition, patients treated with Onbrez 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 Onbrez 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: The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler.
Slovenian: Priporočeni odmerek je inhalacija vsebine ene 150-mikrogramske kapsule enkrat na dan z uporabo inhalatorja Onbrez Breezhaler.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Onbrez 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 Onbrez Breezhaler v priporočenih odmerkih, kot pri tistih, ki so jemali placebo.
English: Onbrez Breezhaler should be administered at the same time of the day each day.
Slovenian: Zdravilo Onbrez Breezhaler je treba jemati vsak dan ob istem času.
English: If signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash) occur, Onbrez 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 Onbrez Breezhaler takoj ukiniti in uvesti drugo zdravilo.
English: As with other inhalation therapy, administration of Onbrez Breezhaler may result in paradoxical bronchospasm that may be life-threatening.
Slovenian: Tako kot uporaba drugih inhalacijskih zdravil lahko uporaba zdravila Onbrez Breezhaler povzroči paradoksni bronhospazem, ki je lahko življenjsko nevaren.
English: The capsules must be administered only using the Onbrez Breezhaler inhaler (see section 6.6).
Slovenian: Kapsule so namenjene samo uporabi z inhalatorjem Onbrez Breezhaler (glejte poglavje 6.6).
English: You should not use Onbrez Breezhaler unless your doctor tells you so.
Slovenian: Zdravila Onbrez Breezhaler ne smete uporabljati, razen če vam tako naroči zdravnik.
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 Onbrez 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 Onbrez Breezhaler v odmerku 300 mikrogramov enkrat na dan.
English: If paradoxical bronchospasm occurs Onbrez Breezhaler should be discontinued immediately and alternative therapy substituted.
Slovenian: Če pride do paradoksnega bronhospazma, je treba takoj prenehati z jemanjem zdravila Onbrez Breezhaler in ga nadomestiti z drugačnim zdravljenjem.
English: Children and adolescents Onbrez 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 Onbrez Breezhaler.
English: Onbrez 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 Onbrez 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: 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 Onbrez 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 Onbrez 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: Onbrez 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 Onbrez 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 Onbrez Breezhaler and placebo.
Slovenian: Povprečji največjih sprememb v koncentraciji glukoze v krvi sta bili podobni pri uporabi zdravila Onbrez Breezhaler in pri uporabi placeba.
English: The inhalation of the content of one 300 microgram capsule once a day, using the Onbrez 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 Onbrez Breezhaler še dodatno klinično koristi pri zadihanosti zlasti bolnikom s hudo KOPB.
English: Your Onbrez Breezhaler pack: Each Onbrez Breezhaler pack contains: one Onbrez Breezhaler inhaler one or more blisters containing Onbrez Breezhaler capsules to be used in the inhaler.
Slovenian: Pakiranje zdravila Onbrez Breezhaler: Vsako pakiranje zdravila Onbrez Breezhaler vsebuje: en inhalator Onbrez Breezhaler en ali več pretisnih omotov s kapsulami Onbrez Breezhaler, ki jih vstavljate v inhalator.
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 Onbrez 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 Onbrez Breezhaler.
English: Paediatric population There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years).
Slovenian: Zdravilo Onbrez Breezhaler ni namenjeno za uporabo pri pediatrični populaciji (starost pod 18 let).
English: Therefore, long-acting beta2-adrenergic agonists such as Onbrez 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 Onbrez Breezhaler, pri bolnikih z ugotovljenim ali domnevnim podaljšanjem intervala QT in pri tistih, ki prejemajo zdravila z vplivom na interval QT, potrebna previdnost.
English: What Onbrez Breezhaler is and what it is used for What you need to know before you use Onbrez Breezhaler How to use Onbrez Breezhaler Possible side effects
Slovenian: Kaj je zdravilo Onbrez Breezhaler in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Onbrez Breezhaler Kako uporabljati zdravilo Onbrez Breezhaler Možni neželeni učinki
English: The Onbrez 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 Onbrez Breezhaler so bili vključeni bolniki s klinično diagnozo zmerne do hude KOPB.
English: Onbrez 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 Onbrez 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: Onbrez 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 Onbrez Breezhaler v primerjavi s placebom zmanjša hiperinflacijo pljuč, kar poveča inspiracijsko kapaciteto med naporom in v mirovanju.
English: At 600 microgram once-daily, the safety profile of Onbrez Breezhaler was overall similar to that of recommended doses.
Slovenian: Pri uporabi odmerka 600 mg enkrat na dan so bile varnostne lastnosti zdravila Onbrez Breezhaler večinoma podobne kot pri uporabi priporočenih odmerkov.
English: Upon initiation of treatment with Onbrez Breezhaler plasma glucose should be monitored more closely in diabetic patients.
Slovenian: Pri sladkornih bolnikih je treba po začetku zdravljenja z zdravilom Onbrez Breezhaler še bolj natančno spremljati koncentracije glukoze v plazmi.
English: Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Slovenian: Zdravilo Onbrez Breezhaler vsebuje zdravilno učinkovino indakaterol iz skupine zdravil, ki jih imenujemo bronhodilatatorji.
English: Please read the following instructions carefully to learn how to use and care for your Onbrez Breezhaler inhaler.
Slovenian: Skrbno preberite naslednja navodila, da boste znali uporabljati inhalator Onbrez Breezhaler in skrbeti zanj.
English: Onbrez Breezhaler has not been investigated in patients with not well controlled diabetes mellitus.
Slovenian: Uporabe zdravila Onbrez Breezhaler niso proučevali pri bolnikih, ki niso imeli dobro urejene sladkorne bolezni.
English: In the event of deterioration of COPD during treatment with Onbrez Breezhaler, a reevaluation of the patient and of the COPD treatment regimen should be undertaken.
Slovenian: Če pride med zdravljenjem z zdravilom Onbrez Breezhaler do poslabšanja KOPB, je treba ponovno pregledati bolnika in oceniti shemo zdravljenja KOPB.
English: Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Onbrez Breezhaler je indicirano za vzdrževalno brohodilatatorno zdravljenje obstrukcije dihalnih poti pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
English: Onbrez Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Slovenian: Zdravilo Onbrez Breezhaler ni indicirano za zdravljenje akutnih epizod bronhospazma, t.j.
English: There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.
Slovenian: O uporabi zdravila Onbrez Breezhaler pri bolnikih s hudo okvaro jeter ni na voljo nobenih podatkov.
English: What you need to know before you use Onbrez Breezhaler
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Onbrez Breezhaler
English: Onbrez Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Slovenian: Zdravilo Onbrez Breezhaler je pri odmerjanju 150 mikrogramov in 300 mikrogramov enkrat na dan klinično pomembno izboljšalo pljučno funkcijo.
English: What Onbrez Breezhaler is and what it is used for
Slovenian: Kaj je zdravilo Onbrez Breezhaler in za kaj ga uporabljamo
English: Onbrez 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 Onbrez Breezhaler nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: How long to continue your treatment with Onbrez Breezhaler Keep using your treatment with Onbrez Breezhaler for as long as your doctor tells you.
Slovenian: Kako dolgo je treba nadaljevati z uporabo zdravila Onbrez Breezhaler Zdravljenje z zdravilom Onbrez Breezhaler nadaljujte tako dolgo, kot vam naroči zdravnik.
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Onbrez Breezhaler at recommended therapeutic doses (see section 5.1).
Slovenian: V kliničnih študijah pri uporabi zdravila Onbrez Breezhaler v okviru terapevtskega odmerjanja niso opažali klinično pomembnih učinkov na podaljševanje intervala QTc (glejte poglavje 5.1).
English: What Onbrez Breezhaler contains - Each Onbrez Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Slovenian: Kaj vsebuje zdravilo Onbrez Breezhaler - Ena kapsula zdravila Onbrez Breezhaler 150 mikrogramov vsebuje 150 mikrogramov indakaterola v obliki indakaterolijevega maleata.