natgillin/translations-raw huggingface dataset:
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.
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.
Post-implantation losses were not seen in rabbits.
Izgub po implantaciji pri kuncih niso opazili.
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).
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).
D-16515 Oranienburg Germany
D-16515 Oranienburg Nemčija
Total PDE4 inhibitory activity was slightly decreased in smokers.
Skupno inhibitorno delovanje na PDE4 je bilo blago zmanjšano pri kadilcih.
Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin) may reduce the therapeutic efficacy of roflumilast.
Uporaba močnih induktorjev encima citokroma P450 (npr. fenobarbital, karbamazepin, fenitoin) torej lahko zmanjša terapevtski učinek roflumilasta.
EU/1/10/636/008 28 tablets
EU/1/10/636/008 28 tablet
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.
Ves čas zdravljenja morate uporabljati učinkovito kontracepcijo, saj lahko zdravilo Daxas škodljivo vpliva na nerojenega otroka.
16515 Oranienburg Germany
16515 Oranienburg Nemčija
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.
Poleg tega študije in vitro niso pokazale indukcije CYP1A2, 2A6, 2C9, 2C19 ali 3A4/5 in le šibko indukcijo CYP2B6 z roflumilastom.
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.
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.
This mechanism of action and the selectivity also apply to roflumilast N-oxide, which is the major active metabolite of roflumilast.
Enak mehanizem delovanja in selektivnost veljata tudi za roflumilast N-oksid, ki je glavni aktivni presnovek roflumilasta.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorbcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Due to the physico-chemical properties, roflumilast is readily distributed to organs and tissues including fatty tissue of mice, hamster and rat.
Zaradi fizikalno-kemijskih lastnosti se roflumilast hitro distribuira v organe in tkiva miši, hrčka in podgane, vključno z maščobnim tkivom.
Daxas has no influence on the ability to drive and use machines.
Zdravilo Daxas nima vpliva na sposobnost vožnje in upravljanja strojev.
In clinical COPD studies, approximately 16% of patients experienced adverse reactions with roflumilast (compared to 5% in placebo).
V kliničnih študijah KOPB je približno 16 % bolnikov navajalo neželene učinke pri jemanju roflumilasta (v primerjavi s 5 % pri jemanju placeba).
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.
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.
Daxas is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms).
Zdravilo Daxas ni namenjeno zdravljenju nenadnih napadov težkega dihanja (akutni bronhospazmi).
These adverse reactions mainly occurred within the first weeks of therapy and mostly resolved on continued treatment.
Neželeni učinki so se večinoma pojavili v prvih tednih zdravljenja in so ob nadaljevanju zdravljenja izzveneli.
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).
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).
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.
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.
• insomnia, anxiety, depression, changes in behaviour or mood, suicidal ideation or behaviour
•nespečnost, tesnobo, depresijo, spremembe v vedenju ali razpoloženju, samomorilne misli ali vedenje
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.
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.
Driving and using machines Daxas has no influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Daxas nima vpliva na sposobnost vožnje in upravljanja strojev.
The patient card should contain the following key elements:
Opozorilna kartica za bolnika mora vsebovati naslednje ključne informacije:
Special clinical conditions
Posebna klinična stanja
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.
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.
Daxas will not help you in this situation.
Zdravilo Daxas v takšnih primerih ne pomaga.
In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported.
V kliničnih študijah in med spremljanjem zdravila po pridobitvi dovoljenja za promet so poročali o redkih primerih samomorilnih misli in vedenja (vključno s samomorom).
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%).
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 %).
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.
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.
Effects were similar, independent of previous treatment with inhaled corticosteroids or underlying treatment with LABAs.
Učinki so bili podobni, ne glede na predhodno zdravljenje z inhalacijskimi kortikosteroidi ali sočasno zdravljenje z LABA.
Therefore, the 250-micrograms dose should be used only as a starting dose (see sections 5.1 and 5.2).
Zato se mora odmerek 250 mikrogramov uporabljati le kot začetni odmerek (glejte poglavji 5.1 in
Maximum plasma concentrations of roflumilast typically occur approximately one hour after dosing (ranging from 0.5 to 2 hours) in the fasted state.
Plazemske koncentracije roflumilasta običajno dosežejo maksimalno vrednost eno uro po odmerku (razpon od 0,5 do 2 uri) na tešče.
You may also experience sleeplessness, anxiety, nervousness, or depressive mood.
Lahko se pojavijo tudi nespečnost, tesnoba, napetost ali depresivno razpoloženje.
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.
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.
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.
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.
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.
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.
The pharmacokinetics of roflumilast and its N-oxide metabolite are dose-proportional over a range of doses from 250 micrograms to 1,000 micrograms.
Farmakokinetika roflumilasta in njegovega N-oksid presnovka je v razponu odmerkov od 250 mikrogramov do 1.000 mikrogramov sorazmerna z velikostjo odmerka.
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).
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).
Adverse events rates were independent of concomitant treatment with inhaled corticosteroids.
Pogostnost neželenih dogodkov je bila neodvisna od sočasnega zdravljenja z inhalacijskimi kortikosteroidi.
Co-administration with theophylline resulted in an increase of 8% of the total PDE4 inhibitory activity (see section 4.4).
Sočasna uporaba teofilina je imela za posledico 8 % povečanje skupnega inhibitornega delovanja na PDE4 (glejte poglavje 4.4).
Adverse reactions with roflumilast in clinical COPD studies and post-marketing experience
Preglednica 1: Neželeni učinki roflumilasta v kliničnih študijah KOPB in izkušnje v obdobju trženja
• After 28 days - the recommended maintenance dose is one 500 micrograms tablet once daily.
• Po 28 dneh - Priporočeni vzdrževalni odmerek je ena tableta 500 mikrogramov enkrat na dan.
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).
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.
The absolute bioavailability of roflumilast following a 500 micrograms oral dose is approximately 80%.
Absolutna biološka uporabnost roflumilasta po peroralnem odmerku 500 mikrogramov znaša približno 80 %.
The recommended starting dose is one tablet of 250 micrograms roflumilast to be taken once daily, for 28 days.
Priporočeni začetni odmerek je ena tableta z 250 mikrogramov roflumilasta z odmerjanjem enkrat na dan, 28 dni.
If you forget to take Daxas
Če ste pozabili vzeti zdravilo Daxas
Patients should be advised to check their body weight on a regular basis.
Bolnikom je treba svetovati redno spremljanje telesne mase.
If you stop taking Daxas
Če ste prenehali jemati zdravilo Daxas
There is a lack of relevant experience with Daxas under these conditions.
V takšnih primerih ni ustreznih izkušenj z uporabo zdravila Daxas.
• Summary of Product Characteristics and Patient Information Leaflet for Daxas
• Povzetek glavnih značilnosti zdravila in navodilo za uporabo zdravila Daxas
If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure.
Če ste vzeli večji odmerek zdravila Daxas, kot bi smeli Če ste vzeli več tablet kot bi smeli, se lahko pojavijo naslednji simptomi: glavobol, slabost, driska, omotica, udarjanje srca, vrtoglavica, vlažna in hladna koža ter nizek krvni tlak.
In older people, females and in non-Caucasians, total PDE4 inhibitory activity was increased.
Pri starejših bolnikih, ženskah in ne-belcih je bilo skupno inhibitorno delovanje na PDE4 povečano.
No dose adjustment is recommended in these patients.
Pri teh skupinah bolnikov prilagajanje odmerkov ni priporočljivo.
Study RO-2455-404-RD was a one year study in COPD patients with a baseline (pre-bronchodilator) FEV1 <50% of predicted normal and a history of frequent exacerbations.
Študija RO-2455-404-RD je bila enoletna študija pri bolnikih s KOPB z izhodiščno (pred bronhodilatatorjem) vrednostjo FEV1 < 50 % pričakovane normalne vrednosti in anamnezo pogostih poslabšanj.
In the two six-month studies, pre-bronchodilator FEV1 was significantly improved by 49 ml (primary endpoint, p<0.0001) beyond the bronchodilator effect of concomitant treatment with salmeterol in Study M2-127 and by 80 ml (primary endpoint, p<0.0001) incremental to concomitant treatment with tiotropium in Study M2-128.
V teh dveh šestmesečnih študijah se je FEV1 pred bronhodilatatorjem statistično pomembno izboljšal za 49 ml (primarni klinični izid, p < 0,0001) preko bronhodilatatorskega učinka sočasnega zdravljenja s salmeterolom v študiji M2-127 in za 80 ml (primarni klinični izid, p < 0,0001) preko učinka sočasnega zdravljenja s tiotropijem v študiji M2-128.
In two confirmative replicate one-year studies (M2-124 and M2-125) and two supplementary six-month studies (M2-127 and M2-128), a total number of 4,768 patients were randomised and treated, of whom 2,374 were treated with roflumilast.
V dve potrditveni ponovljeni enoletni študiji (M2-124 in M2-125) in dve dodatni šestmesečni študiji (M2-127 in M2-128) je bilo randomiziranih skupno 4.768 bolnikov, od tega jih je bilo 2.374 zdravljenih z roflumilastom.
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Zdravilo Daxas je indicirano za vzdrževalno zdravljenje hude oblike kronične obstruktivne pljučne bolezni (KOPB) (FEV1 po bronhodilatatorju manjši od 50 % pričakovane vrednosti), povezane s kroničnim bronhitisom, pri odraslih bolnikih z anamnezo pogostih poslabšanj bolezni kot dopolnilo zdravljenju z bronhodilatatorji.
Difference of incidence between roflumilast and placebo was quantitatively greater with concomitant LAMA for weight decreased (7.2% vs 4.2%), decreased appetite (3.7% vs 2.0%), headache (2.4% vs 1.1%) and depression (1.4% vs -0.3%).
Pri sočasni uporabi LAMA so bile med roflumilastom in placebom ugotovljene kvantitativno večje razlike v pojavnosti zmanjšanja telesne mase (7,2 % v primerjavi s 4,2 %), zmanjšanja apetita (3,7 % v primerjavi z 2,0 %), glavobola (2,4 % v primerjavi z 1,1 %) in depresije (1,4 % v primerjavi z -0,3 %).
Daxas is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.
Zdravilo Daxas uporabljamo za vzdrževalno zdravljenje KOPB pri odraslih, ki so v preteklosti imeli pogosta poslabšanja simptomov KOPB in imajo kronični bronhitis.
Upon in vitro stimulation of human neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumour necrosis factor α, interferon γ and granzyme B.
Roflumilast in roflumilast N-oksid po in vitro stimulaciji človeških nevtrofilcev, monocitov, makrofagov ali limfocitov inhibirata sproščanje vnetnih mediatorjev, npr. levkotriena B4, reaktivnih vrst kisika, tumorje nekrotizirajočega faktorja α, interferona γ in grancima B.
Sudden attack of breathlessness
Nenaden napad težkega dihanja
After 28 days of treatment with the 250-micrograms starting dose, patients must be up-titrated to one tablet of 500 micrograms roflumilast, to be taken once daily.
Po 28 dneh zdravljenja z 250-mikrogramskim začetnim odmerkom se mora bolniku odmerek povečati na eno tableto s 500 mikrogramov roflumilasta z odmerjanjem enkrat na dan.
Two six-month supportive studies (M2-127 and M2-128) included patients with a history of COPD for at least 12 months prior to baseline.
Dve šestmesečni podporni študiji (M2-127 in M2-128) sta vključevali bolnike z anamnezo KOPB vsaj 12 mesecev pred vstopom v študijo.
Post-bronchodilator FEV1 showed a clinically significant improvement in favour of roflumilast by 56 mL over placebo (95% CI: 38, 73 mL).
Vrednost FEV1 po bronhodilatatorju kaže na klinično pomembno izboljšanje v korist roflumilasta nad placebom za 56 ml (95 % interval zaupanja: 38, 73 ml).
A major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2.
Glavna stopnja v presnovi roflumilasta je N-oksidacija roflumilasta v roflumilast N-oksid preko CYP3A4 in CYP1A2.
In patients with COPD, roflumilast reduced sputum neutrophils.
Pri bolnikih s KOPB je roflumilast znižal koncentracijo nevtrofilcev v sputumu.
That Daxas may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Da zdravilo Daxas lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na opozorilno kartico za bolnika.
However, Cmax and tmax of roflumilast N-oxide are unaffected.
Cmax in tmax roflumilast N-oksida ostaneta pri tem nespremenjena.
If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with roflumilast.
Če bolniki trpijo zaradi novih ali zaradi poslabšanja psihiatričnih simptomov ali če se ugotovi pojav samomorilnih misli ali poskus samomora, je priporočljivo prekiniti zdravljenje z roflumilastom.
The one-year studies included patients with a history of severe to very severe COPD [FEV1 (forced expiratory volume in one second) ≤50% of predicted] associated with chronic bronchitis, with at least one documented exacerbation in the previous year and with symptoms at baseline as determined by cough and sputum score.
Enoletni študiji sta vključevali bolnike z anamnezo hude do zelo hude oblike KOPB [FEV1 (forsirani ekspiracijski volumen v prvi sekundi) ≤ 50 % od pričakovane vrednosti], povezane s kroničnim bronhitisom, z vsaj enim zabeleženim poslabšanjem v preteklem letu in s simptomi ob vstopu v študijo, ki so jih opredelili z lestvicami za oceno kašlja in sputuma.
Interaction studies with CYP1A2/3A4 inhibitor enoxacin and the CYP1A2/2C19/3A4 inhibitors cimetidine and fluvoxamine, resulted in increases of the total PDE4 inhibitory activity of 25%, 47% and 59%, respectively.
V študijah medsebojnega delovanja z zaviralcem CYP1A2/3A4 enoksacinom in zaviralcema CYP1A2/2C19/3A4 cimetidinom in fluvoksaminom so ugotovili povečanje skupnega inhibitornega delovanja na PDE4 za 25 %, 47 % in 59 %.
What Daxas contains The active substance is roflumilast.
Kaj vsebuje zdravilo Daxas Učinkovina je roflumilast.
If patients suffer from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt, it is recommended to discontinue treatment with Daxas.
Če bolniki trpijo zaradi novih ali zaradi poslabšanja psihiatričnih simptomov ali če se ugotovi pojav samomorilnih misli ali poskus samomora, je priporočljivo prekiniti zdravljenje z zdravilom Daxas.
There is no relevant use of Daxas in the paediatric population (under 18 years) in the indication COPD.
Pediatrična populacija Uporaba zdravila Daxas za indikacijo KOPB pri pediatrični populaciji (mlajših od 18 let) ni primerna.
Inhibition of PDE4 leads to elevated intracellular cAMP levels and mitigates COPD-related malfunctions of leukocytes, airway and pulmonary vascular smooth muscle cells, endothelial and airway epithelial cells and fibroblasts in experimental models.
Inhibicija PDE4 povzroči povišanje znotrajceličnih koncentracij cAMP in v eksperimentalnih modelih ublaži motnje v delovanju levkocitov, gladkomišičnih celic dihalnih poti in pljučnega žilja, endotelijskih celic, celic respiratornega epitelija in fibroblastov v povezavi s KOPB.
Roflumilast is a PDE4 inhibitor, a non-steroid, anti-inflammatory active substance designed to target both the systemic and pulmonary inflammation associated with COPD.
Roflumilast je inhibitor PDE4, nesteroidna protivnetna učinkovina, zasnovana tako, da učinkuje na sistemsko in pljučno vnetje, povezano s KOPB.
Suicidal ideation and behaviour* Depression Nervousness Panic attack
Psihiatrične motnje nespečnost tesnoba samomorilne misli in vedenje* depresija napetost napad panike
What Daxas looks like and contents of the pack
Izgled zdravila Daxas in vsebina pakiranja
No interactions were observed with inhaled salbutamol, formoterol, budesonide and oral montelukast, digoxin, warfarin, sildenafil and midazolam.
Pri inhalacijah salbutamola, formoterola, budezonida, in peroralnem montelukastu, digoksinu, varfarinu, sildenafilu in midazolamu niso zabeležili učinkov medsebojnega delovanja.
It is not known whether roflumilast is dialysable by peritoneal dialysis.
Učinkovitost odstranjevanja roflumilasta s peritonealno dializo ni znana.
Treatment with roflumilast may lead to a higher risk of sleep disorders (mainly insomnia) in patients with a baseline body weight of <60 kg, due to a higher total PDE4 inhibitory activity found in these patients (see section 4.8).
Pri bolnikih z izhodiščno telesno maso, manjšo od 60 kg, se pri zdravljenju z roflumilastom lahko poveča tveganje za pojav motenj spanja (predvsem nespečnosti), zaradi večjega skupnega inhibitornega delovanja na PDE4, ki je bilo odkrito pri teh bolnikih (glejte poglavje 4.8).
Daxas tablets contain lactose.
Zdravilo Daxas vsebuje laktozo.
This might be the case in special populations that may have higher exposure, such as in black, non-smoking females (see section 5.2) or in patients concomitantly treated with CYP1A2/ 2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or the CYP1A2/3A4 inhibitor enoxacin (see section 4.5).
To utegne biti potrebno v posebnih populacijah z višjo izpostavljenostjo, npr. pri temnopoltih ženskah nekadilkah (glejte poglavje 5.2) ali pri bolnikih, ki se sočasno zdravijo z zaviralci CYP1A2/2C19/3A4 (kot sta fluvoksamin in cimetidin) ali zaviralcem CYP1A2/3A4 enoksacinom (glejte poglavje 4.5).
• insomnia, anxiety, depression, suicidal ideation or behaviour
• nespečnost, tesnoba, depresija, samomorilne misli ali vedenje