FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, roflumilast attenuated influx of neutrophils and eosinophils into the airways of endotoxin challenged healthy volunteers.
Slovenian: Poleg tega je roflumilast zmanjšal dotok nevtrofilcev in eozinofilcev v dihalne poti pri zdravih prostovoljcih, izpostavljenih endotoksinu.
English: This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD).
Slovenian: To pripomore k zaustavitvi zoževanja dihalnih poti pri kronični obstruktivni pljučni bolezni (KOPB).
English: The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daxas and the potential risk of suicide.
Slovenian: Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daxas in potencialno tveganje za samomor.
English: Volume of distribution for single dose of 500 micrograms roflumilast is about 2.9 l/kg.
Slovenian: Volumen distribucije enkratnega odmerka 500 mikrogramov roflumilasta je približno 2,9 l/kg.
English: You may also experience sleeplessness (common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).
Slovenian: Pojavi se lahko tudi nespečnost (pogosti), tesnoba (občasni), živčnost (redki), napad panike (redki) ali depresija (redki).
English: Daxas is to be used in addition to bronchodilators.
Slovenian: Zdravilo Daxas se uporablja poleg bronhodilatatorjev.
English: Physicians should carefully assess the benefit risk balance of this treatment in patients with existing psychiatric symptoms or with history of depression.
Slovenian: Zdravniki morajo skrbno pretehtati koristi in tveganja ob zdravljenju bolnikov s prisotnimi psihiatričnimi simptomi ali z anamnezo depresije.
English: Following intravenous or oral administration of radiolabelled roflumilast, about 20% of the radioactivity was recovered in the faeces and 70% in urine as inactive metabolites.
Slovenian: Po intravenski ali peroralni uporabi radioaktivno označenega roflumilasta so približno 20 % radioaktivnosti odkrili v blatu in 70 % v urinu v obliki neaktivnih presnovkov.
English: Available pharmacokinetic data in animals have shown excretion of roflumilast or its metabolites in milk.
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo, da se roflumilast ali njegovi presnovki izločajo z mlekom.
English: What you need to know before you take Daxas
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Daxas
English: Co-administration with an antacid (combination of aluminium hydroxide and magnesium hydroxide) did not alter the absorption or pharmacokinetics of roflumilast or its N-oxide.
Slovenian: Sočasna uporaba antacida (kombinacija aluminijevega hidroksida in magnezijevega hidroksida) ni spremenila absorpcije ali farmakokinetike roflumilasta ali njegovega N-oksida.
English: Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Slovenian: Bolnikov s kongestivnim srčnim popuščanjem (NYHA razred 3 in 4) niso preučevali, zato zdravljenje takšnih bolnikov ni priporočljivo.
English: The reduction of moderate or severe exacerbations with roflumilast and LABA compared to placebo and LABA was on average 21% (p=0.0011).
Slovenian: Pogostnost zmernih ali resnih poslabšanj z roflumilastom in LABA se je v primerjavi s placebom in LABA zmanjšala za povprečno 21 % (p = 0,0011).
English: Long-term administration at the 250 micrograms dose level may not induce sufficient PDE4 inhibition to exert clinical efficacy.
Slovenian: Dolgotrajna uporaba odmerka v velikosti 250 mikrogramov morda ne inducira zadostnega zaviranja PDE4, da bi bilo klinično učinkovito.
English: (N=969) Rate (n)
Slovenian: Roflumilast (N=969) Delež (n)
English: Rare instances of suicidal ideation and behaviour, including completed suicide, have been observed in patients with and without a history of depression, usually in the first weeks of treatment.
Slovenian: Redke primere samomorilnih misli in vedenja, vključno z izvršenim samomorom so opazili pri bolnikih z in brez zgodovine depresije, običajno v prvih tednih zdravljenja.
English: The educational pack should contain the following:
Slovenian: Izobraževalno gradivo mora vsebovati naslednje:
English: Daxas should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Slovenian: Zdravila Daxas se ne sme uvesti oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
English: Maximum concentrations of the N-oxide metabolite are reached after about eight hours (ranging from 4 to 13 hours).
Slovenian: Presnovek N-oksid doseže maksimalne koncentracije po približno osmih urah (razpon od 4 do 13 ur).
English: Tabulated list of adverse reactions Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Slovenian: Tabelarični pregled neželenih učinkov V spodnji tabeli so neželeni učinki razvrščeni v skladu z navedbo pogostnosti po MedDRA:
English: These studies in rats with radiolabelled roflumilast also indicate low penetration across the blood-brain barrier.
Slovenian: Študije na podganah z radioaktivno označenim roflumilastom kažejo tudi blago prehajanje preko krvno-možganske pregrade.
English: You should check your body weight on a regular basis.
Slovenian: Redno morate preverjati telesno maso.
English: • Copies of the patient card to be given to patients or caregivers before they receive Daxas
Slovenian: • Kopije opozorilne kartice za bolnika, ki naj bi jih bolniki ali skrbniki prejeli pred začetkom jemanja zdravila Daxas
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Slovenian: Obloga hipromeloza makrogol 4000 titanov dioksid (E171) rumeni železov oksid (E172)
English: The use of inhaled corticosteroids and theophylline was prohibited during the studies.
Slovenian: V času študije je bila uporaba inhalacijskih kortikosteroidov in teofilina prepovedana.
English: Roflumilast reduces the activity of phosphodiesterase-4, a protein occurring naturally in body cells.
Slovenian: Roflumilast zmanjša aktivnost fosfodiesteraze 4, proteina, ki se nahaja v celicah telesa.
English: The limited or missing information in patients with liver impairment.
Slovenian: Omejene ali pomanjkljive informacije o bolnikih z okvaro jeter.
English: This study should be appropriate to compare the incidences of all-cause mortality, major cardiovascular events, new diagnosis of cancer, all-cause hospitalisation, hospitalisation related to respiratory disease, suicide or hospitalisation for suicide attempt, and new diagnosis of depression, tuberculosis or viral hepatitis B or C in roflumilast treated COPD patients compared with COPD patients not treated with roflumilast.
Slovenian: Študija mora biti zasnovana tako, da bo lahko primerjala pojavnost umrljivosti zaradi vseh vzrokov, pojavnost pomembnejših kardiovaskularnih dogodkov, novo odkritega raka, hospitalizacij zaradi vseh vzrokov, hospitalizacij zaradi bolezni dihal, samomorov ali hospitalizacij zaradi poskusa samomora in pojavnost novo odkrite depresije, tuberkuloze ali virusnega hepatitisa B ali C pri bolnikih s KOPB, ki se zdravijo z roflumilastom, v primerjavi z bolniki s KOPB, ki se ne zdravijo z roflumilastom.
English: Summary of COPD exacerbation endpoints in Study RO-2455-404-RD
Slovenian: Povzetek opazovanih dogodkov (poslabšanje KOPB) v študiji RO-2455-404-RD
English: An early distribution phase with marked penetration into tissues is followed by a marked elimination phase out of fatty tissue most probably due to pronounced break-down of parent compound to roflumilast N-oxide.
Slovenian: Zgodnji fazi distribucije z obsežnim prodiranjem v tkiva sledi obsežna faza eliminacije iz maščobnega tkiva, najverjetneje zaradi izdatnega razgrajevanja osnovne spojine v roflumilast N-oksid.
English: What Daxas is and what it is used for What you need to know before you take Daxas How to take Daxas
Slovenian: Kaj je zdravilo Daxas in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Daxas Kako jemati zdravilo Daxas Možni neželeni učinki
English: This starting dose is intended to reduce adverse events and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose.
Slovenian: Navedeni začetni odmerek je namenjen zmanjševanju neželenih učinkov in verjetnosti, da bi bolnik prenehal uporabljati zdravilo v času uvedbe zdravljenja, vendar pa je začetni odmerek subterapevtski.
English: The plasma clearance after short-term intravenous infusion of roflumilast is about 9.6 l/h.
Slovenian: Plazemski očistek po kratkotrajni intravenski infuziji roflumilasta znaša približno 9,6 l/h.
English: Description of selected adverse reactions * In clinical studies and post-marketing experience, rare instances of suicidal ideation and behaviour, including suicide, were reported.
Slovenian: Opis izbranih neželenih učinkov * V kliničnih študijah in pri izkušnjah v obdobju trženja so poročali o redkih primerih samomorilnih misli in vedenja, vključno s samomorom.
English: The potential risk of infections: Daxas should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Slovenian: Potencialno tveganje za okužbe: zdravila Daxas se ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
English: In contrast to the two confirmative studies, a history of chronic bronchitis and of COPD exacerbations was not requested for patients' inclusion.
Slovenian: Za razliko od dveh potrditvenih študij anamneza kroničnega bronhitisa in poslabšanj KOPB ni bila pogoj za vključitev bolnikov v študijo.
English: The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy).
Slovenian: Učinek zdravila Daxas se lahko zmanjša, če istočasno jemljete rifampicin (antibiotik) ali fenobarbital, karbamazepin ali fenitoin (zdravila, ki so običajno predpisana za zdravljenje epilepsije).
English: Since roflumilast is highly protein bound, haemodialysis is not likely to be an efficient method of its removal.
Slovenian: Ker se roflumilast močno veže na proteine, ni mogoče pričakovati učinkovite odstranitve s hemodializo.
English: The study assessed the effect of roflumilast on COPD exacerbation rate in patients treated with fixed combinations of LABA and inhaled corticosteroids, compared to placebo.
Slovenian: V študiji so vrednotili učinek roflumilasta na delež poslabšanj KOPB pri bolnikih, ki so se zdravili s fiksnimi kombinacijami LABA in inhalacijskih kortikosteroidov v primerjavi s placebom.
English: Post-implantation losses were not seen in rabbits.
Slovenian: Izgub po implantaciji pri kuncih niso opazili.
English: The numbers of patients who died due to any reason were equal for those treated with placebo or roflumilast (42 deaths each group; 2.7% each group; pooled analysis).
Slovenian: Število umrlih bolnikov zaradi katerega koli vzroka je bilo v skupini s placebom in v skupini z roflumilastom enako (42 smrtnih izidov v vsaki skupini oz. 2,7 % v vsaki skupini; analiza združenih podatkov).
English: D-16515 Oranienburg Germany
Slovenian: D-16515 Oranienburg Nemčija
English: Total PDE4 inhibitory activity was slightly decreased in smokers.
Slovenian: Skupno inhibitorno delovanje na PDE4 je bilo blago zmanjšano pri kadilcih.
English: Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin) may reduce the therapeutic efficacy of roflumilast.
Slovenian: Uporaba močnih induktorjev encima citokroma P450 (npr. fenobarbital, karbamazepin, fenitoin) torej lahko zmanjša terapevtski učinek roflumilasta.
English: EU/1/10/636/008 28 tablets
Slovenian: EU/1/10/636/008 28 tablet
English: You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daxas may be harmful for the unborn baby.
Slovenian: Ves čas zdravljenja morate uporabljati učinkovito kontracepcijo, saj lahko zdravilo Daxas škodljivo vpliva na nerojenega otroka.
English: 16515 Oranienburg Germany
Slovenian: 16515 Oranienburg Nemčija
English: In addition, in vitro studies demonstrated no induction of the CYP1A2, 2A6, 2C9, 2C19, or 3A4/5 and only a weak induction of CYP2B6 by roflumilast.
Slovenian: Poleg tega študije in vitro niso pokazale indukcije CYP1A2, 2A6, 2C9, 2C19 ali 3A4/5 in le šibko indukcijo CYP2B6 z roflumilastom.
English: While adverse reactions like diarrhoea, nausea, abdominal pain and headache mainly occur within the first weeks of therapy and mostly resolve on continued treatment, roflumilast treatment should be reassessed in case of persistent intolerability.
Slovenian: Neželeni učinki kot npr. driska, slabost, bolečine v trebuhu in glavobol se največkrat pojavijo v prvih tednih zdravljenja in ob nadaljevanju zdravljenja večinoma izginejo; v primeru trajne intolerance pa je treba zdravljenje z roflumilastom ponovno ovrednotiti.
English: This mechanism of action and the selectivity also apply to roflumilast N-oxide, which is the major active metabolite of roflumilast.
Slovenian: Enak mehanizem delovanja in selektivnost veljata tudi za roflumilast N-oksid, ki je glavni aktivni presnovek roflumilasta.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorbcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Due to the physico-chemical properties, roflumilast is readily distributed to organs and tissues including fatty tissue of mice, hamster and rat.
Slovenian: Zaradi fizikalno-kemijskih lastnosti se roflumilast hitro distribuira v organe in tkiva miši, hrčka in podgane, vključno z maščobnim tkivom.
English: Manufacturer Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
Slovenian: Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
English: Daxas has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Daxas nima vpliva na sposobnost vožnje in upravljanja strojev.
English: In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
Slovenian: V kliničnih študijah KOPB je približno 16 % bolnikov navajalo neželene učinke pri jemanju roflumilasta (v primerjavi s 5 % pri jemanju placeba).
English: You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Slovenian: Vi ali vaš skrbnik morata tudi takoj obvestiti zdravnika o kakršnih koli spremembah v vedenju ali razpoloženju in kakršnih koli samomorilnih mislih, ki bi se utegnile pojaviti.
English: Daxas is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Slovenian: Zdravilo Daxas ni namenjeno zdravljenju nenadnih napadov težkega dihanja (akutni bronhospazmi).
English: These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment.
Slovenian: Neželeni učinki so se večinoma pojavili v prvih tednih zdravljenja in so ob nadaljevanju zdravljenja izzveneli.
English: A pre-specified sensitivity analysis using the negative binomial regression model treatment showed a statistically significant difference of -14.2% (rate ratio: 0.86; 95% CI: 0.74 to 0.99).
Slovenian: Vnaprej določena analiza občutljivosti na osnovi modela negativne binomske regresije zdravljenja je pokazala statistično pomembno razliko -14,2 % (razmerje deležev: 0,86; 95 % interval zaupanja: 0,74 do 0,99).
English: In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess and arterial hypotension.
Slovenian: V študijah I. faze so zabeležili povečano pogostnost naslednjih simptomov po enkratnih peroralnih odmerkih 2.500 mikrogramov in enkratnem odmerku 5.000 mikrogramov (desetkrat večji odmerek od priporočenega): glavobol, gastrointestinalne motnje, omotica, palpitacije, vrtoglavica, vlažna in hladna koža ter arterijska hipotenzija.
English: • insomnia, anxiety, depression, changes in behaviour or mood, suicidal ideation or behaviour
Slovenian: •nespečnost, tesnobo, depresijo, spremembe v vedenju ali razpoloženju, samomorilne misli ali vedenje
English: The potential cardiac risk: Daxas has not been studied in patients in congestive heart failure (NYHA grade3 and 4); hence, it is not recommended in this population.
Slovenian: Potencialno tveganje za srce: zdravilo Daxas ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
English: Driving and using machines Daxas has no influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Daxas nima vpliva na sposobnost vožnje in upravljanja strojev.
English: The patient card should contain the following key elements:
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednje ključne informacije:
English: Special clinical conditions
Slovenian: Posebna klinična stanja
English: Based on further in vitro results in human hepatic microsomes, therapeutic plasma concentrations of roflumilast and roflumilast N-oxide do not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11.
Slovenian: Na podlagi nadaljnjih rezultatov študij na mikrosomih človeških jeter in vitro je bilo ugotovljeno, da terapevtske plazemske koncentracije roflumilasta in roflumilast N-oksida ne inhibirajo CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5 ali 4A9/11.
English: Daxas will not help you in this situation.
Slovenian: Zdravilo Daxas v takšnih primerih ne pomaga.
English: In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported.
Slovenian: V kliničnih študijah in med spremljanjem zdravila po pridobitvi dovoljenja za promet so poročali o redkih primerih samomorilnih misli in vedenja (vključno s samomorom).
English: The most commonly reported adverse reactions were diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%).
Slovenian: Najpogostejši neželeni učinki so bili driska (5,9 %), znižanje telesne mase (3,4 %), navzea (2,9 %), bolečine v trebuhu (1,9 %) in glavobol (1,7 %).
English: The clinical data with Daxas in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daxas should be used with caution in these patients.
Slovenian: Klinični podatki o uporabi zdravila Daxas pri bolnikih z blago okvaro jeter stopnje Child-Pugh A ne zadostujejo, da bi lahko priporočili prilagoditev odmerka (glejte poglavje 5.2), zato je pri teh bolnikih treba zdravilo Daxas uporabljati previdno.
English: Effects were similar, independent of previous treatment with inhaled corticosteroids or underlying treatment with LABAs.
Slovenian: Učinki so bili podobni, ne glede na predhodno zdravljenje z inhalacijskimi kortikosteroidi ali sočasno zdravljenje z LABA.
English: Therefore, the 250-micrograms dose should be used only as a starting dose (see sections 5.1 and 5.2).
Slovenian: Zato se mora odmerek 250 mikrogramov uporabljati le kot začetni odmerek (glejte poglavji 5.1 in
English: Maximum plasma concentrations of roflumilast typically occur approximately one hour after dosing (ranging from 0.5 to 2 hours) in the fasted state.
Slovenian: Plazemske koncentracije roflumilasta običajno dosežejo maksimalno vrednost eno uro po odmerku (razpon od 0,5 do 2 uri) na tešče.
English: You may also experience sleeplessness, anxiety, nervousness, or depressive mood.
Slovenian: Lahko se pojavijo tudi nespečnost, tesnoba, napetost ali depresivno razpoloženje.
English: At screening, patients were required to have had at least one exacerbation in the previous year and on standard of care COPD maintenance treatment for at least 12 weeks.
Slovenian: Med presejanjem je bil pogoj za vključitev v študijo najmanj eno poslabšanje v predhodnem letu ob standardnem vzdrževalnem zdravljenju KOPB, ki je trajalo najmanj 12 tednov.
English: The mechanism of action is the inhibition of PDE4, a major cyclic adenosine monophosphate (cAMP)-metabolizing enzyme found in structural and inflammatory cells important to the pathogenesis of COPD.
Slovenian: Mehanizem delovanja je inhibicija PDE4, pomembnega encima za presnovo cikličnega adenozin monofosfata (cAMP), ki se nahaja v strukturnih in vnetnih celicah s pomembno vlogo v patogenezi KOPB.
English: In 1-year studies (M2-124, M2-125), a decrease of body weight occurred more frequently in patients treated with roflumilast compared to placebo-treated patients.
Slovenian: V enoletnih študijah (M2-124, M2-125) je pri bolnikih, zdravljenih z roflumilastom, pogosteje prišlo do zmanjšanja telesne mase v primerjavi z bolniki, ki so prejemali placebo.
English: The pharmacokinetics of roflumilast and its N-oxide metabolite are dose-proportional over a range of doses from 250 micrograms to 1,000 micrograms.
Slovenian: Farmakokinetika roflumilasta in njegovega N-oksid presnovka je v razponu odmerkov od 250 mikrogramov do 1.000 mikrogramov sorazmerna z velikostjo odmerka.
English: Patients receiving a 500 micrograms dose once a day had a median PDE4 inhibitory activity of 1.2 (0.35, 2.03) and those receiving a 250 micrograms dose once a day had a median PDE4 inhibitory activity of 0.6 (0.20, 1.24).
Slovenian: Bolniki, ki so prejemali odmerek 500 mikrogramov enkrat na dan, so imeli mediano inhibitorno aktivnost PDE4 1,2 (0,35; 2,03), tisti, ki so prejemali odmerek 250 mikrogramov enkrat na dan, pa so imeli mediano inhibitorno aktivnost PDE4 0,6 (0,20; 1,24).
English: Adverse events rates were independent of concomitant treatment with inhaled corticosteroids.
Slovenian: Pogostnost neželenih dogodkov je bila neodvisna od sočasnega zdravljenja z inhalacijskimi kortikosteroidi.
English: Co-administration with theophylline resulted in an increase of 8% of the total PDE4 inhibitory activity (see section 4.4).
Slovenian: Sočasna uporaba teofilina je imela za posledico 8 % povečanje skupnega inhibitornega delovanja na PDE4 (glejte poglavje 4.4).
English: Adverse reactions with roflumilast in clinical COPD studies and post-marketing experience
Slovenian: Preglednica 1: Neželeni učinki roflumilasta v kliničnih študijah KOPB in izkušnje v obdobju trženja
English: • After 28 days - the recommended maintenance dose is one 500 micrograms tablet once daily.
Slovenian: • Po 28 dneh - Priporočeni vzdrževalni odmerek je ena tableta 500 mikrogramov enkrat na dan.
English: This effect seems to be due to an ADCP (4-Amino-3,5-dichloro-pyridine) N-oxide intermediate specifically formed in rodent olfactory mucosa, with special binding affinity in these species (i.e. mouse, rat and hamster).
Slovenian: Zdi se, da je ta učinek posledica vmesne spojine ADCP (4-amino 3,5-diklor piridin) N-oksida, ki nastaja specifično na vohalni sluznici glodavcev in ima posebno vezavno afiniteto pri teh vrstah (t.j.
English: The absolute bioavailability of roflumilast following a 500 micrograms oral dose is approximately 80%.
Slovenian: Absolutna biološka uporabnost roflumilasta po peroralnem odmerku 500 mikrogramov znaša približno 80 %.
English: The recommended starting dose is one tablet of 250 micrograms roflumilast to be taken once daily, for 28 days.
Slovenian: Priporočeni začetni odmerek je ena tableta z 250 mikrogramov roflumilasta z odmerjanjem enkrat na dan, 28 dni.
English: If you forget to take Daxas
Slovenian: Če ste pozabili vzeti zdravilo Daxas
English: Patients should be advised to check their body weight on a regular basis.
Slovenian: Bolnikom je treba svetovati redno spremljanje telesne mase.
English: If you stop taking Daxas
Slovenian: Če ste prenehali jemati zdravilo Daxas