FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies in patients with psoriatic arthritis, apremilast significantly modulated, but did not fully inhibit, plasma protein levels of IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3, and TNF-α.
Slovenian: V kliničnih študijah pri bolnikih s psoriatičnim artritisom je apremilast signifikantno moduliral plazemske koncentracije beljakovin IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3 in TNF-α, ni jih pa popolnoma inhibiral.
English: There was no clinically meaningful interaction between ketoconazole and apremilast.
Slovenian: Med ketokonazolom in apremilastom ni bilo klinično pomembnih interakcij.
English: Increased numbers of early resorptions and reduced numbers of ossified tarsals were observed at 20, 40, and 80 mg/kg/day.
Slovenian: Zvečano število zgodnjih resorpcij in zmanjšano število osificiranih tarzalnih kosti so opazili pri 20, 40 in 80 mg/kg/dan.
English: Otezla contains the active substance ‘apremilast'.
Slovenian: Zdravilo Otezla vsebuje učinkovino ‘apremilast'.
English: In animal studies in mice, no adverse effects on fertility were observed in males at exposure levels 3-fold clinical exposure and in females at exposure levels 1-fold clinical exposure.
Slovenian: V študijah na živalih niso ugotovili neželenih učinkov na plodnost pri mišjih samcih pri izpostavljenosti, ki je bila trikratnik klinične izpostavljenosti in pri mišjih samicah pri izpostavljenosti, ki je znašala 1-kratnik klinične izpostavljenosti.
English: Patients in these studies had a diagnosis of PsA for at least 6 months.
Slovenian: Bolniki so imeli potrjeno diagnozo PsA vsaj 6 mesecev pred vključitvijo v študije.
English: Otezla contains lactose (a type of sugar).
Slovenian: Zdravilo Otezla vsebuje laktozo (vrsta sladkorja).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Celgene
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Celgene
English: In general, PASI responses were achieved by week 16 and were maintained through week 32.
Slovenian: Na splošno so bolniki dosegli odzive PASI po 16 tednih, trajali pa so še po 32 tednih.
English: Based on the study design, patients whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at week 16.
Slovenian: Na podlagi zasnove študij so v 16. tednu bolnike, pri katerih se število občutljivih in oteklih sklepov ni zmanjšalo vsaj za 20 %, opredelili kot neodzivne na zdravljenje.
English: Patients with hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Slovenian: Bolniki z okvaro jeter Pri bolnikih z okvaro jeter prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Apremilast exposure is decreased when administered concomitantly with strong inducers of CYP3A4 (e.g. rifampicin) and may result in reduced clinical response.
Slovenian: Izpostavljenost apremilastu se zmanjša, kadar ga dajemo sočasno z močnimi spodbujevalci CYP3A4 (npr. rifampicinom), kar lahko zmanjša klinični odziv.
English: Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah organskih sistemov in pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Hence, clinically relevant drug-drug interactions are unlikely when apremilast is co-administered with drugs that are substrates or inhibitors of these transporters.
Slovenian: Klinično pomembne interakcije med apremilastom in zdravili, ki so substrati ali zaviralci teh prenašalcev, niso verjetne.
English: Following oral administration of radiolabelled apremilast, about 58% and 39% of the radioactivity is recovered in urine and faeces, respectively, with about 3% and 7% of the radioactive dose recovered as apremilast in urine and faeces, respectively.
Slovenian: Po peroralnem dajanju radioaktivno označenega apremilasta iz urina oziroma blata prestrežejo okrog 58 % oziroma 39 % radioaktivnosti, pri čemer je okrog 3 % oziroma 7 % prestreženega radioaktivnega odmerka v obliki apremilasta.
English: If your doctor considers you to be underweight, and you observe an unintentional loss of body weight while being treated with Otezla, you should talk to your doctor.
Slovenian: Če zdravnik meni, da ste presuhi, in med zdravljenjem z zdravilom Otezla opazite nenamerno zmanjševanje telesne mase, se posvetujte z zdravnikom.
English: Driving and using machines Otezla has no effect on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Otezla ne vpliva na sposobnost upravljanja vozil in strojev.
English: The safety and efficacy of apremilast were evaluated in two multicentre, randomised, double-blind, placebocontrolled studies (Studies ESTEEM 1 and ESTEEM 2) which enrolled a total of 1,257 patients with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥ 10%, Psoriasis Area and Severity Index (PASI) score ≥ 12, static Physician Global Assessment (sPGA) of ≥ 3 (moderate or severe), and who were candidates for phototherapy or systemic therapy.
Slovenian: Varnost in učinkovitost apremilasta so ocenili v dveh multicentričnih, randomiziranih, dvojno slepih študijah, kontroliranih s placebom (študiji ESTEEM 1 in ESTEEM 2), v katerih je bilo vključenih vsega skupaj 1.257 bolnikov z zmerno do hudo psoriazo v plakih, ki so imeli prizadete ≥ 10 % telesne površine (BSA - Body Surface Area), rezultat indeksa površine in jakosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 12, statično zdravnikovo splošno oceno (sPGA - static Physician Global Assessment) ≥ 3 (zmerna ali huda), in ki so bili kandidati za fototerapijo ali sistemsko zdravljenje.
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D barcode carrying the unique identifier included
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: The median time to loss of PASI-75 response among the patients re-randomised to placebo was 5.1 weeks.
Slovenian: Mediani čas do izgube odziva PASI 75 pri bolnikih, ponovno randomiziranih na placebo, je bil 5,1 tedna.
English: Consistent with apremilast being a substrate of CYP3A4, apremilast exposure is decreased when administered concomitantly with rifampicin, a strong inducer of CYP3A4.
Slovenian: Skladno s tem, da je apremilast substrat CYP3A4, se izpostavljenost apremilastu zmanjša, kadar ga dajemo sočasno z rifampicinom, ki je močan spodbujevalec CYP3A4.
English: • St John's Wort - a herbal medicine for mild anxiety and depression.
Slovenian: • šentjanževka - zeliščno zdravilo za zdravljenje blage anksioznosti in depresije.
English: Study Week
Slovenian: končni opazovani teden študije
English: Treatment with apremilast resulted in significant improvement in moderate to severe plaque psoriasis as demonstrated by the proportion of patients with PASI-75 response at week 16, compared to placebo.
Slovenian: Zdravljenje z apremilastom je povzročilo signifikantno izboljšanje zmerne do hude psoriaze v plakih, na kar kaže delež bolnikov z odzivom PASI 75 po 16 tednih zdravljenja v primerjavi s placebom.
English: Hypersensitivity reactions are uncommonly observed (see section 4.3).
Slovenian: Preobčutljivostne reakcije opazijo občasno (glejte poglavje 4.3).
English: If you forget to take Otezla
Slovenian: Če ste pozabili vzeti zdravilo Otezla
English: INFORMATION IN BRAILLE Otezla 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Otezla 10 mg
English: There is little information about the effects of Otezla in pregnancy.
Slovenian: O učinkih zdravila Otezla v nosečnosti je malo podatkov.
English: The safety and efficacy of apremilast were evaluated in 3 multi-centre, randomised, double-blind, placebocontrolled studies (Studies PALACE 1, PALACE 2, and PALACE 3) of similar design in adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with small molecule or biologic DMARDs.
Slovenian: Varnost in učinkovitost apremilasta so ovrednotili v treh podobno zasnovanih multicentričnih, randomiziranih, dvojno slepih, s placebom kontroliranih študijah (študije PALACE 1, PALACE 2 in PALACE 3) pri odraslih bolnikih z aktivnim PsA (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) kljub predhodnemu zdravljenju z nizkomolekularnimi ali biološkimi DMARDs.
English: Following 52 weeks of treatment, patients could continue on open-label apremilast 30 mg within the long-term extension of the ESTEEM 1 and ESTEEM 2 studies for a total duration of treatment up to 5 years (260 weeks).
Slovenian: Po 52 tednih zdravljenja so lahko bolniki nadaljevali z odprtim apremilastom v odmerku 30 mg v dolgoročnem podaljšanju študij ESTEEM 1 in ESTEEM 2, tako da je zdravljenje v celoti trajalo do 5 let (260 tednov).
English: What psoriatic arthritis is
Slovenian: Kaj je psoriatični artritis
English: The proportion of patients achieving PASI-50, -75 and -90 responses, and sPGA score of clear (0) or almost clear (1), are presented in Table 4 below.
Slovenian: Delež bolnikov, ki so dosegli odzive PASI 50, PASI 75 in PASI 90 ter rezultat sPGA brez vidnih bolezenskih sprememb (0) ali skoraj brez vidnih bolezenskih sprememb (1), so prikazani v preglednici 4 v nadaljevanju.
English: Of these patients, 12% achieved a PASI-75 response at week 52 with apremilast plus topical and/or phototherapy treatment.
Slovenian: Od teh bolnikov jih je 12 % doseglo odziv PASI 75 po 52 tednih zdravljenja z apremilastom skupaj s topikalnimi zdravili in/ali fototerapijo.
English: INFORMATION IN BRAILLE Otezla 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Otezla 30 mg
English: One qualifying psoriatic skin lesion (at least 2 cm in diameter) was also required in PALACE 3.
Slovenian: V študiji PALACE 3 so morali imeti bolniki tudi eno psoriatično kožno lezijo (vsaj 2 cm v premeru).
English: In a pre- and postnatal study, apremilast was administered orally to pregnant female mice at dosages of 10, 80 and 300 mg/kg/day from gestation day (GD) 6 to Day 20 of lactation.
Slovenian: V pre- in postnatalni študiji so dajali apremilast peroralno brejim mišjim samicam v odmerkih 10, 80 in 300 mg/kg/dan od 6. dneva gestacije (GD) do 20. dneva laktacije.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Particulars printed directly onto the wallet card with the blank blister sealed inside)
Slovenian: Pretisni omot (podatki, natisnjeni neposredno na zgibanko, pretisni omot brez napisa pa je zapečaten znotraj)
English: DMARDs N=497
Slovenian: N=497
English: After randomised withdrawal from therapy at week 32, approximately 70% of patients in Study ESTEEM 1, and 65.6% of patients in Study ESTEEM 2, regained PASI-75 (ESTEEM 1) or PASI-50 (ESTEEM 2) responses after re-initiation of apremilast treatment.
Slovenian: Po randomizirani odtegnitvi terapije v 32. tednu je približno 70 % bolnikov v študiji ESTEEM 1 in 65,6 % bolnikov v študiji ESTEEM 2 po ponovni uvedbi zdravljenja z apremilastom spet pridobilo odziv PASI 75 (ESTEEM 1) ali PASI 50 (ESTEEM 2).
English: Apremilast 30 mg twice daily
Slovenian: apremilast 30 mg dvakrat na dan +/DMARDs
English: Apremilast has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Apremilast nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Otezla 10 mg film-coated tablets
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Otezla 10 mg filmsko obložene tablete
English: Apremilast can be coadministered with a potent CYP3A4 inhibitor such as ketoconazole.
Slovenian: Apremilast lahko dajemo sočasno z močnim zaviralcem CYP3A4, na primer ketokonazolom.
English: Among patients who remained on the apremilast treatment to which they were randomised at study start, these improvements were maintained through week 52.
Slovenian: Pri bolnikih, ki so ostali na zdravljenju z apremilastom, na katerega so bili randomizirani v začetku študije, je to izboljšanje po 52 tednih še vedno trajalo.
English: The NOEL in the mouse for maternal toxicity and F1 generation was 10 mg/kg/day (1.3-fold clinical AUC).
Slovenian: NOEL pri miših glede toksičnosti za mater in generacijo F1 je bila 10 mg/kg/dan (1,3-kratna klinična AUC).
English: 19 film-coated tablets of 30 mg
Slovenian: 19 filmsko obloženih tablet po 30 mg
English: Among patients who remained on the apremilast treatment, to which they were initially randomised at study start, improvement in physical function and FACIT- fatigue was maintained through week 52.
Slovenian: Pri bolnikih, ki so ostali na zdravljenju z apremilastom, na katerega so bili randomizirani v začetku študije, se je izboljšanje telesnega delovanja in FACIT-utrujenost ohranilo do vključno 52. tedna.
English: DMARDs N=159
Slovenian: N=159
English: In PALACE 1, PALACE 2 and PALACE 3, improvements in Disease Activity Scale (DAS) 28 C-reactive protein (CRP) and in the proportion of patients achieving a modified PsA response criteria (PsARC) were greater in the apremilast group, compared to placebo at week 16 (nominal p-value p< 0.0004, p-value ≤0.0017, respectively).
Slovenian: V študijah PALACE 1, PALACE 2 in PALACE 3 so bila po 16 tednih izboljšanja na lestvici aktivnosti bolezni (DAS - Disease Activity Scale) 28 C-reaktivni protein (CRP) in v deležu bolnikov, ki so dosegli merila modificiranega odziva PsA (PsARC), večja v skupini z apremilastom v primerjavi s placebom (nominalna vrednost p je bila p<0,0004 oziroma p≤0,0017).
English: Psoriatic Arthritis
Slovenian: Psoriatični artritis
English: In a male mouse fertility study, apremilast at oral dosages of 1, 10, 25, and 50 mg/kg/day produced no effects on male fertility; the no observed adverse effect level (NOAEL) for male fertility was greater than 50 mg/kg/day 3-fold clinical exposure).
Slovenian: V študiji plodnosti mišjih samcev apremilast v peroralnih odmerkih 1, 10, 25 in 50 mg/kg/dan ni vplival na plodnost samcev; raven brez opaznega neželenega učinka (no observed adverse effect level (NOAEL)) za plodnost samcev je bila večja od 50 mg/kg/dan (3-kratna klinična izpostavljenost).
English: The use of low potency topical corticosteroids on the face, axillae, and groin, coal tar shampoo and/or salicylic acid scalp preparations was permitted throughout the studies.
Slovenian: Ves čas študij je bila dovoljena uporaba šibkih lokalnih kortikosteroidov na obrazu, v pazduhah in dimljah, šampona s premogovim katranom in/ali pripravkov za lasišče s salicilno kislino.
English: Among 832 patients initially randomised to apremilast 30 mg twice daily, 443 patients (53%) entered the open-label extension studies of ESTEEM 1 and ESTEEM 2, and of these 115 patients (26%) were still on treatment at week 260.
Slovenian: Od 832 bolnikov, ki so jih v začetku randomizirali na apremilast 30 mg dvakrat na dan, se je 443 bolnikov (53 %) vključilo v odprti podaljšani študiji ESTEEM 1 in ESTEEM 2, in od teh se je 115 bolnikov (26 %) v 260. tednu še vedno zdravilo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/002 56 film-coated tablets EU/1/14/981/003 168 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/981/002 56 filmsko obloženih tablet EU/1/14/981/003 168 filmsko obloženih tablet
English: In Study ESTEEM 1, patients randomised to apremilast at the start of the study who did not achieve a PASI75 response at week 32 were permitted to use concomitant topical therapies and/or UVB phototherapy between weeks 32 to 52.
Slovenian: V študiji ESTEEM 1 je bilo bolnikom, ki so bili v začetku študije randomizirani na apremilast in ki po 32 tednih niso dosegli odziva PASI 75, dovoljeno med 32. in 52. tednom sočasno uporabljati topikalna zdravila in/ali UVB fototerapijo.
English: In Studies ESTEEM 1 and ESTEEM 2, significant improvements in quality of life as measured by the Dermatology Life Quality Index (DLQI) and the SF-36v2MCS were demonstrated in patients receiving apremilast compared with placebo-treated patients (Table 4).
Slovenian: V študijah ESTEEM 1 in ESTEEM 2 so dokazali signifikantno izboljšanje kakovosti življenja, izmerjene z dermatološkim indeksom kakovosti življenja (Dermatology Life Quality Index (DLQI)) in s SF-36v2MCS pri bolnikih, ki so prejemali apremilast, v primerjavi z bolniki, ki so prejemali placebo (preglednica 4).
English: Apremilast-treated patients demonstrated statistically significant improvement in physical function, as assessed by the disability index of the health assessment questionnaire (HAQ-DI) change from baseline, compared to placebo at weeks 16 in PALACE 1, PALACE 2 and PALACE 3 and in the pooled studies Improvement in HAQ-DI scores was maintained at week 24.
Slovenian: Bolniki, zdravljeni z apremilastom, so pokazali statistično signifikantno izboljšanje telesnih funkcij, ocenjeno s spremembo od izhodišča, s pomočjo indeksa invalidnosti vprašalnika za oceno zdravstvenega stanja (HAQ-DI - disability index of the health assessment questionnaire) v primerjavi s placebom po 16 tednih v študijah PALACE 1, PALACE 2 in PALACE 3 in v združenih študijah.
English: In a combined female mouse fertility and embryo-foetal developmental toxicity study with oral dosages of 10, 20, 40, and 80 mg/kg/day, absolute and/or relative heart weights of maternal animals were increased at 20, 40, and 80 mg/kg/day.
Slovenian: V združeni študiji toksičnosti za plodnost mišjih samic in razvoj zarodka in plodu s peroralnimi odmerki 10, 20, 40 in 80 mg/kg/dan se je absolutna in/ali relativna masa srca pri samicah-materah zvečala pri 20, 40 in 80 mg/kg/dan.
English: During the Randomised Treatment Withdrawal Phase (weeks 32-52), patients originally randomised to apremilast who achieved at least a 75% reduction in their PASI score (PASI-75) (ESTEEM 1) or a 50% reduction in their PASI score (PASI-50) (ESTEEM 2) were re-randomised at week 32 to either placebo or apremilast 30 mg twice daily.
Slovenian: Med fazo odtegnitve randomiziranega zdravljenja (od 32. do 52. tedna) so bolnike, ki so bili prvotno randomizirani na apremilast in so dosegli vsaj 75-odstotno izboljšanje rezultata PASI (PASI 75) (ESTEEM 1) ali 50-odstotno izboljšanje rezultata PASI (PASI 50) (ESTEEM 2), v 32. tednu ponovno randomizirali na placebo oziroma na apremilast 30 mg dvakrat dnevno.
English: Otezla 30 mg film-coated tablets EU/1/14/981/002 - pack size of 56 tablets EU/1/14/981/003 - pack size of 168 tablets
Slovenian: EU/1/14/981/002 - velikost pakiranja 56 tablet EU/1/14/981/003 - velikost pakiranja 168 tablet
English: • The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate,
Slovenian: • Druge sestavine jedra tablete so mikrokristalna celuloza, laktoza monohidrat, premreženi natrijev karmelozat in magnezijev stearat.
English: In both studies, patients were randomised 2:1 to apremilast 30 mg twice daily or placebo for 16 weeks (placebo-controlled phase) and from weeks 16-32, all patients received apremilast 30 mg twice daily (maintenance phase).
Slovenian: V obeh študijah so bolnike randomizirali v razmerju 2:1 na apremilast 30 mg dvakrat dnevno ali placebo za 16 tednov (s placebom nadzorovana faza), od.
English: Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Slovenian: Bolnike in skrbnike je treba poučiti, naj o morebitnem spremenjenem vedenju ali razpoloženju in morebitnih samomorilnih mislih obvestijo zdravnika, ki jim je predpisal zdravilo.
English: Placebo patients who were considered non-responders were rerandomised 1:1 in a blinded fashion to either apremilast 20 mg twice daily or 30 mg twice daily.
Slovenian: Bolnike na placebu, ki so jih opredelili za neodzivne na zdravljenje, so v razmerju 1:1 še enkrat slepo randomizirali na apremilast 20 mg dvakrat na dan ali 30 mg dvakrat na dan.
English: Following 52 weeks of treatment, patients could continue on open label apremilast 20 mg or 30 mg within the long-term extension of the PALACE 1, PALACE 2, and PALACE 3 studies for a total duration of treatment up to 5 years (260 weeks).
Slovenian: Po 52 tednih zdravljenja so bolniki lahko nadaljevali z odprtim apremilastom v odmerku 20 mg ali 30 mg v dolgoročno podaljšanih študijah PALACE 1, PALACE 2 in PALACE 3, tako da je zdravljenje v celoti trajalo do 5 let (260 tednov).
English: Body weight loss
Slovenian: Izguba telesne mase
English: Warnings and precautions Talk to your doctor or pharmacist before taking Otezla.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Otezla se posvetujte z zdravnikom ali farmacevtom.
English: The mean observed weight loss in patients treated for up to 52 weeks with apremilast was 1.99 kg. A total of 14.3% of patients receiving apremilast had observed weight loss between 5-10% while 5.7% of the patients receiving apremilast had observed weight loss greater than 10%.
Slovenian: Skupno je 14,3 % bolnikov, ki so prejemali apremilast, opazilo zmanjšanje telesne mase med 5 in 10 %, medtem ko je 5,7 % bolnikov, ki so prejemali apremilast, opazilo izgubo telesne mase, večjo od 10 %.
English: At weeks 16 and 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) and in the skin manifestations of psoriasis were seen in the apremilast-treated patients.
Slovenian: Pri bolnikih, zdravljenih z apremilastom, so v 16. in 24. tednu opazili izboljšanje parametrov periferne aktivnosti, značilne za psoriatični artritis (npr. število oteklih sklepov, število bolečih/občutljivih sklepov, daktilitis in entezitis), in kožnih znakov psoriaze.
English: The no observed effect level (NOEL) for female fertility was 10 mg/kg/day (1.0-fold clinical exposure).
Slovenian: Raven brez opaznega učinka (no observed effect level (NOEL)) za plodnost samic je bila 10 mg/kg/dan (1,0-kratna klinična izpostavljenost).
English: If you experience severe diarrhoea, nausea, or vomiting, you should talk to your doctor.
Slovenian: Če imate hudo drisko, vas sili na bruhanje ali bruhate, povejte zdravniku.
English: MARKETING AUTHORISATION NUMBER(S) Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) EU/1/14/981/001
Slovenian: Otezla 10 mg, 20 mg, 30 mg filmsko obložene tablete (pakiranje za začetek zdravljenja) EU/1/14/981/001
English: • The one-month standard pack contains 56 x 30 mg film-coated tablets.
Slovenian: • Enomesečno standardno pakiranje vsebuje 56 x 30 mg filmsko obloženih tablet.
English: Apremilast undergoes extensive metabolism with only 3% and 7% of the administered parent compound recovered in urine and faeces, respectively.
Slovenian: Apremilast se obsežno presnavlja, tako da v urinu prestrežemo le 3 % in v blatu le 7 % dane izhodne spojine.
English: Apremilast dose should be reduced to 30 mg once daily in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 or CLcr < 30 mL/min).
Slovenian: Pri bolnikih s hudo okvaro ledvic (eGFR manj kot 30 ml/min/1,73 m2 ali CLcr < 30 ml/min) je treba zmanjšati odmerek apremilasta na 30 mg enkrat dnevno.
English: Treatment with apremilast resulted in significant improvements in the signs and symptoms of PsA, as assessed by the ACR 20 response criteria compared to placebo at weeks 16.
Slovenian: V 16. tednu je zdravljenje z apremilastom povzročilo signifikantno izboljšanje znakov in simptomov PsA, ocenjeno s kriteriji odziva po ACR 20, v primerjavi s placebom.
English: Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients were still on this treatment on week 52.
Slovenian: Od 497 bolnikov, ki so bili v začetku randomizirani na apremilast 30 mg dvakrat dnevno, se je 375 (75 %) bolnikov v 52. tednu še vedno zdravilo.
English: The maternal and developmental NOEL in the mouse was 10 mg/kg/day (1.3-fold clinical exposure).
Slovenian: NOEL za mater in razvoj pri miših je bila 10 mg/kg/dan (1,3-kratna klinična izpostavljenost).
English: The improvements were generally maintained in subjects who were re-randomised to apremilast at week 32 through week 52 (Table 5).
Slovenian: Izboljšanja so na splošno trajala pri preskušancih, ki so jih po 32 tednih ponovno randomizirali na apremilast, do 52. tedna (preglednica 5).