natgillin/translations-raw huggingface dataset:
Women of childbearing age should be advised to use an effective method of contraception during treatment.
Ženskam v rodni dobi je treba pojasniti, da morajo med zdravljenjem uporabljati učinkovito kontracepcijo.
In order to relieve a sudden attack of breathlessness it is very important that your doctor provides you with another medicine to be available to you at all times that can cope with such an attack.
Za lajšanje nenadnih napadov težkega dihanja je zelo pomembno, da vam zdravnik predpiše drugo zdravilo, ki učinkovito pomaga pri takšnih napadih in ga morate imeti vedno na razpolago.
You may take this medicine with or without food.
To zdravilo lahko jemljete s hrano ali brez nje.
PVC/PVDC aluminium blisters in packs of 28 tablets.
PVC/PVDC aluminijevi pretisni omoti v pakiranjih po 28 tablet.
The need to inform patients about the risks of Daxas and the precautions for safe use including:
Obveznost informiranja bolnikov o tveganjih zdravila Daxas in previdnostnih ukrepih za varno uporabo vključujoč:
2-Sided p-value
2-stranska p-vrednost
If possible take your medicine and this leaflet with you.
Če je mogoče vzemite zdravilo in to navodilo s seboj.
There is no evidence for a specific accumulation or retention of roflumilast or its metabolites in organs and fatty tissue.
Ni dokazov za specifično akumulacijo ali zadrževanje roflumilasta ali njegovih presnovkov v organih in maščobnem tkivu.
Before starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects.
Pred začetkom zdravljenja z zdravilom Daxas obvestite zdravnika, če imate kakršne koli simptome te vrste ali, če morebiti jemljete še dodatna zdravila, ker lahko katero od teh poveča verjetnost teh neželenih učinkov.
Roflumilast improved lung function after 4 weeks (sustained over 52 weeks).
Roflumilast je izboljšal pljučno funkcijo po 4 tednih (izboljšanje se je ohranilo vseh 52 tednov).
ANX 2.1 - The MAH commits to conduct a long-term comparative observational safety study.
DODATEK 2.1 - Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel primerjalno opazovalno študijo dolgoročne varnosti.
In a human spermatogenesis study, roflumilast 500 micrograms had no effects on semen parameters or reproductive hormones during the 3-month treatment period and the following 3-month off-treatment period.
V študiji vplivov na spermatogenezo pri človeku roflumilast v odmerku 500 mikrogramov ni vplival na parametre sperme ali reproduktivne hormone v 3-mesečnem obdobju zdravljenja in v 3-mesečnem obdobju po zaključku zdravljenja.
Rescue medicinal products (salbutamol or albuterol) were allowed on an as-needed basis.
Zdravila za prvo pomoč (salbutamol ali albuterol) so se smela uporabljati po potrebi.
Thus Daxas eases breathing problems.
Tako zdravilo Daxas olajša težave z dihanjem.
Do not take Daxas - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section
Ne jemljite zdravila Daxas - če ste alergični na roflumilast ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, druga sistemska zdravila za obstruktivne pljučne bolezni, oznaka ATC: R03DX07
Inhaled corticosteroids were used in 809 (61%) of the roflumilast treated patients, whereas the use of LABAs and theophylline was prohibited.
Inhalacijske kortikosteroide je uporabljalo 809 (61 %) bolnikov, ki so se zdravili z roflumilastom, medtem ko je bila uporaba LABA in teofilina prepovedana.
The respective reduction in exacerbations seen in patients without concomitant LABAs was on average 15% (p=0.0387).
Zmanjšanje pogostnosti poslabšanj pri bolnikih brez sočasnega zdravljenja z LABA je znašalo v povprečju 15 % (p = 0,0387).
When the activity of this protein is reduced, there is less inflammation in the lungs.
Posledica zmanjšane aktivnosti tega proteina je zmanjšanje vnetja v pljučih.
What Daxas is and what it is used for
Kaj je zdravilo Daxas in za kaj ga uporabljamo
The design of the studies was parallel-group, double-blind and placebo-controlled.
Študije so bile zasnovane kot vzporedne, dvojno-slepe, s placebom kontrolnimi skupinami.
AstraZeneca (AstraZeneca logo)
AstraZeneca (logotip AstraZeneca)
The primary endpoint was reduction in rate of moderate or severe COPD exacerbations per patient per year.
Primarni opazovani dogodek je bil zmanjšanje deleža zmernih ali hudih poslabšanj KOPB na bolnika na leto.
That patients or their caregivers should tell their doctor if the patient develops symptoms indicative of:
Da morajo bolniki ali njihovi skrbniki obvestiti zdravnika, če se pri bolniku pojavijo simptomi, ki so značilni za:
Persistent intolerability
Trajna intoleranca
That they should tell their doctor if they have a history of any of the following conditions
Da opozorijo zdravnika, če imajo v anamnezi katero koli od naslednjih stanj
The European Medicines Agency has waived the obligation to submit the results of studies with roflumilast in all subsets of the paediatric population in chronic obstructive pulmonary disease (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z roflumilastom za vse podskupine pediatrične populacije s kronično obstruktivno pljučno boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
10 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet
The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
Tveganje za zmanjšanje telesne mase pri podhranjenih bolnikih, potreba po spremljanju telesne mase ob vsakem obisku in potreba po prekinitvi zdravljenja v primeru nepojasnjenega ali klinično zaskrbljujočega zmanjšanja telesne mase.
The fact that Daxas is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.
Dejstvo, da zdravilo Daxas ni indicirano za zdravljenje bolnikov s KOPB izven odobrene indikacije, niti ni primerno za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
In one of three rat studies on fertility and embryofetal development, post-implantation losses were observed.
V eni od treh študij na podganah o plodnosti in embriofetalnem razvoju so zabeležili izgube po implantaciji.
Other medicines and Daxas
Druga zdravila in zdravilo Daxas
The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
Pomanjkanje kliničnih podatkov, ki bi podpirali kombinacijo s teofilinom, zato takšna kombinacija ni priporočljiva.
Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see also section 4.4).
Bolnikom in skrbnikom je treba naročiti, da zdravnika obvestijo o kakršnih koli samomorilnih mislih (glejte tudi poglavje 4.4).
Each film-coated tablet contains 188.72 mg lactose (as monohydrate).
Ena filmsko obložena tableta vsebuje 188,72 mg laktoze (v obliki monohidrata).
Roflumilast is extensively metabolised via Phase I (cytochrome P450) and Phase II (conjugation) reactions.
Roflumilast se izdatno presnavlja preko reakcij Faze I (citokrom P450) in Faze II (konjugacija).
After discontinuation of roflumilast, the majority of patients had regained body weight after 3 months.
Po prenehanju zdravljenja z roflumilastom je večina bolnikov pridobila svojo prejšnjo telesno maso v 3 mesecih.
In this case, roflumilast treatment should be reassessed (see section 4.4).
V takšnem primeru je treba zdravljenje z roflumilastom ponovno ovrednotiti (glejte poglavje 4.4).
Daxas 500 micrograms may need to be taken for several weeks to achieve its full effect (see sections 5.1 and 5.2).
Zdravilo Daxas 500 mikrogramov bo morda potrebno jemati nekaj tednov, preden bo doseglo svoj polni učinek (glejte poglavji 5.1 in 5.2).
250 micrograms once a day is a sub-therapeutic dose, and should be used only as a starting dose for the first 28 days (see sections 4.2 and 5.2).
250 mikrogramov enkrat na dan je subterapevtski odmerek in se ga mora uporabljati le kot začetni odmerek v prvih 28 dneh zdravljenja (glejte poglavji 4.2 in 5.2).
Both studies included moderate to severe patients with a non-reversible airway obstruction and a FEV1 of 40% to 70% of predicted.
Obe študiji sta vključevali bolnike z zmerno do hudo obliko nereverzibilne obstrukcije dihalnih poti in FEV1 od 40 % do 70 % pričakovane vrednosti.
Body weight of underweight patients should be checked at each visit.
Telesno maso podhranjenih bolnikov je treba meriti ob vsakem obisku.
Each pack contains 10, 14, 28, 30, 84 , 90 or 98 film-coated tablets.
Eno pakiranje vsebuje 10, 14, 28, 30, 84, 90 ali 98 filmsko obloženih tablet.
Therefore, there is a low probability of relevant interactions with substances metabolised by these P450 enzymes.
Zato je verjetnost za pomembno medsebojno delovanje s snovmi, ki jih presnavljajo ti encimi P450, majhna.
Food intake does not affect the total PDE4 inhibitory activity, but delays time to maximum concentration (tmax) of roflumilast by one hour and reduces Cmax by approximately 40%.
Vnos hrane ne vpliva na skupno inhibitorno delovanje na PDE4, podaljša pa čas do pojava maksimalne koncentracije (tmax) roflumilasta za eno uro in zmanjša Cmax za približno 40 %.
Most relevant findings in safety pharmacology and toxicology studies occurred at higher doses and exposure than that intended for clinical use.
Najpomembnejše ugotovitve v farmakoloških in toksikoloških študijah o varnosti so zabeležili pri višjih odmerkih in stopnjah izpostavljenosti, kot so namenjene za klinično uporabo.
Exacerbation Category
Kategorija poslabšanja
Roflumilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression.
Roflumilast je povezan s povečanim tveganjem za psihiatrične motnje, npr. nespečnostjo, tesnobo, napetostjo in depresijo.
The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.
Opozorilna kartica za bolnika mora vsebovati prostor, kamor bolniki lahko zabeležijo svojo telesno maso in datum tehtanja, bolnikom pa je treba naročiti, da opozorilno kartico za bolnike ob vsakem obisku prinesejo s seboj.
In the event of an unexplained and clinically concerning weight decrease, the intake of roflumilast should be stopped and body weight should be further followed-up.
V primeru nepojasnjenega in klinično zaskrbljujočega zmanjšanja telesne mase je treba prekiniti jemanje roflumilasta in še naprej spremljati telesno maso.
All patients should be informed about the risks of Daxas and the precautions for safe use and should be given a patient card before starting Daxas.
Vse bolnike je treba obvestiti o tveganjih zdravila Daxas in previdnostnih ukrepih za varno uporabo in jim je treba dati kartico za bolnike pred začetkom jemanja zdravila.
The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Daxas are provided with an updated Educational pack.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli vsi zdravniki, ki bodo predpisovali zdravilo Daxas, na razpolago posodobljeno izobraževalno gradivo.
Pregnancy There are limited amount of data from the use of roflumilast in pregnant women.
Nosečnost Podatkov o uporabi roflumilasta pri nosečnicah je malo.
Take all your medicines and this leaflet with you and provide full information of your current medications.
S seboj vzemite vsa zdravila, ki jih jemljete in to navodilo za uporabo ter zdravstvenemu osebju posredujte podrobne podatke o trenutnem zdravljenju.
The observed adverse reactions for roflumilast in Study RO-2455404-RD were in line with those already included in section 4.8.
Neželeni učinki roflumilasta, ki so jih opazili v študiji RO-2455-404-RD, so bili v skladu s tistimi, ki so že navedeni v poglavju 4.8.
The rate of exacerbations (as defined in the protocols) were not significantly reduced by roflumilast in the individual studies (relative risk reduction: 13.5% in Study M2-111 and 6.6% in Study M2-112; p= not significant).
Roflumilast ni pomembno zmanjšal pogostnosti poslabšanj (kot so opredeljena v protokolih) v posameznih študijah (zmanjšanje relativnega tveganja: 13,5 % v študiji M2-111 in 6,6 % v študiji M2-112; p = ni pomemben).
PVC/PVDC aluminium blisters in packs of 10, 14, 28, 30, 84, 90 or 98 film-coated tablets.
PVC/PVDC aluminijevi pretisni omoti v pakiranjih po 10, 14, 28, 30, 84, 90 ali 98 filmsko obloženih tablet.
Roflumilast targets the PDE4A, 4B and 4D splicing variants with similar potency in the nanomolar range.
Roflumilast deluje na različice encima PDE4A, 4B in 4D v nanomolarnem območju z enako jakostjo.
There is no evidence for an immunotoxic, skin sensitising or phototoxic potential.
Ni dokazov o potencialni imunotoksičnosti, senzibilizaciji kože ali fototoksičnosti.
Allergic reactions may affect the skin and in rare cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat.
Alergijske reakcije lahko prizadenejo kožo in v redkih primerih povzročijo otekanje očesnih vek, obraza, ustnic in jezika, kar lahko povzroči težave z dihanjem in/ali znižanje krvnega tlaka ter hitro bitje srca.
Short-acting anticholinergics (SAMAs) were allowed for those patients not taking LABAs.
Kratko-delujoče antiholinergike (SAMA) so lahko uporabljali bolniki, ki niso jemali LABA.
Each tablet contains 49.7 mg lactose (as monohydrate).
Ena tableta vsebuje 49,7 mg laktoze (v obliki monohidrata).
Rare instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression, usually within the first weeks of treatment (see section 4.8).
Redke primere samomorilnih misli in vedenja, vključno z samomorom so opazili pri bolnikih z ali brez zgodovine depresije; običajno v prvih tednih zdravljenja (glejte poglavje 4.8).
Furthermore, roflumilast attenuated influx of neutrophils and eosinophils into the airways of endotoxin challenged healthy volunteers.
Poleg tega je roflumilast zmanjšal dotok nevtrofilcev in eozinofilcev v dihalne poti pri zdravih prostovoljcih, izpostavljenih endotoksinu.
This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD).
To pripomore k zaustavitvi zoževanja dihalnih poti pri kronični obstruktivni pljučni bolezni (KOPB).
The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daxas and the potential risk of suicide.
Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daxas in potencialno tveganje za samomor.
Volume of distribution for single dose of 500 micrograms roflumilast is about 2.9 l/kg.
Volumen distribucije enkratnega odmerka 500 mikrogramov roflumilasta je približno 2,9 l/kg.
You may also experience sleeplessness (common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).
Pojavi se lahko tudi nespečnost (pogosti), tesnoba (občasni), živčnost (redki), napad panike (redki) ali depresija (redki).
Daxas is to be used in addition to bronchodilators.
Zdravilo Daxas se uporablja poleg bronhodilatatorjev.
Physicians should carefully assess the benefit risk balance of this treatment in patients with existing psychiatric symptoms or with history of depression.
Zdravniki morajo skrbno pretehtati koristi in tveganja ob zdravljenju bolnikov s prisotnimi psihiatričnimi simptomi ali z anamnezo depresije.
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.
Po intravenski ali peroralni uporabi radioaktivno označenega roflumilasta so približno 20 % radioaktivnosti odkrili v blatu in 70 % v urinu v obliki neaktivnih presnovkov.
Available pharmacokinetic data in animals have shown excretion of roflumilast or its metabolites in milk.
Razpoložljivi farmakokinetični podatki pri živalih kažejo, da se roflumilast ali njegovi presnovki izločajo z mlekom.
What you need to know before you take Daxas
Kaj morate vedeti, preden boste vzeli zdravilo Daxas
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.
Sočasna uporaba antacida (kombinacija aluminijevega hidroksida in magnezijevega hidroksida) ni spremenila absorpcije ali farmakokinetike roflumilasta ali njegovega N-oksida.
Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Bolnikov s kongestivnim srčnim popuščanjem (NYHA razred 3 in 4) niso preučevali, zato zdravljenje takšnih bolnikov ni priporočljivo.
The reduction of moderate or severe exacerbations with roflumilast and LABA compared to placebo and LABA was on average 21% (p=0.0011).
Pogostnost zmernih ali resnih poslabšanj z roflumilastom in LABA se je v primerjavi s placebom in LABA zmanjšala za povprečno 21 % (p = 0,0011).
Long-term administration at the 250 micrograms dose level may not induce sufficient PDE4 inhibition to exert clinical efficacy.
Dolgotrajna uporaba odmerka v velikosti 250 mikrogramov morda ne inducira zadostnega zaviranja PDE4, da bi bilo klinično učinkovito.
(N=969) Rate (n)
Roflumilast (N=969) Delež (n)
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.
Redke primere samomorilnih misli in vedenja, vključno z izvršenim samomorom so opazili pri bolnikih z in brez zgodovine depresije, običajno v prvih tednih zdravljenja.
The educational pack should contain the following:
Izobraževalno gradivo mora vsebovati naslednje:
Daxas should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Zdravila Daxas se ne sme uvesti oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
Maximum concentrations of the N-oxide metabolite are reached after about eight hours (ranging from 4 to 13 hours).
Presnovek N-oksid doseže maksimalne koncentracije po približno osmih urah (razpon od 4 do 13 ur).
Tabulated list of adverse reactions Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Tabelarični pregled neželenih učinkov V spodnji tabeli so neželeni učinki razvrščeni v skladu z navedbo pogostnosti po MedDRA:
These studies in rats with radiolabelled roflumilast also indicate low penetration across the blood-brain barrier.
Študije na podganah z radioaktivno označenim roflumilastom kažejo tudi blago prehajanje preko krvno-možganske pregrade.
You should check your body weight on a regular basis.
Redno morate preverjati telesno maso.
• Copies of the patient card to be given to patients or caregivers before they receive Daxas
• Kopije opozorilne kartice za bolnika, ki naj bi jih bolniki ali skrbniki prejeli pred začetkom jemanja zdravila Daxas
Titanium dioxide (E171) Iron oxide yellow (E172)
Obloga hipromeloza makrogol 4000 titanov dioksid (E171) rumeni železov oksid (E172)
The use of inhaled corticosteroids and theophylline was prohibited during the studies.
V času študije je bila uporaba inhalacijskih kortikosteroidov in teofilina prepovedana.
Roflumilast reduces the activity of phosphodiesterase-4, a protein occurring naturally in body cells.
Roflumilast zmanjša aktivnost fosfodiesteraze 4, proteina, ki se nahaja v celicah telesa.
The limited or missing information in patients with liver impairment.
Omejene ali pomanjkljive informacije o bolnikih z okvaro jeter.
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.
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.
Summary of COPD exacerbation endpoints in Study RO-2455-404-RD
Povzetek opazovanih dogodkov (poslabšanje KOPB) v študiji RO-2455-404-RD
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.
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.
What Daxas is and what it is used for What you need to know before you take Daxas How to take Daxas
Kaj je zdravilo Daxas in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Daxas Kako jemati zdravilo Daxas Možni neželeni učinki
This starting dose is intended to reduce adverse events and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose.
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.
The plasma clearance after short-term intravenous infusion of roflumilast is about 9.6 l/h.
Plazemski očistek po kratkotrajni intravenski infuziji roflumilasta znaša približno 9,6 l/h.
Description of selected adverse reactions * In clinical studies and post-marketing experience, rare instances of suicidal ideation and behaviour, including suicide, were reported.
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.
The potential risk of infections: Daxas should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
Potencialno tveganje za okužbe: zdravila Daxas se ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
In contrast to the two confirmative studies, a history of chronic bronchitis and of COPD exacerbations was not requested for patients' inclusion.
Za razliko od dveh potrditvenih študij anamneza kroničnega bronhitisa in poslabšanj KOPB ni bila pogoj za vključitev bolnikov v študijo.
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).
Učinek zdravila Daxas se lahko zmanjša, če istočasno jemljete rifampicin (antibiotik) ali fenobarbital, karbamazepin ali fenitoin (zdravila, ki so običajno predpisana za zdravljenje epilepsije).
Since roflumilast is highly protein bound, haemodialysis is not likely to be an efficient method of its removal.
Ker se roflumilast močno veže na proteine, ni mogoče pričakovati učinkovite odstranitve s hemodializo.