natgillin/translations-raw huggingface dataset:
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. 
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.
UNIQUE IDENTIFIER - 2D BARCODE 2 D barcode carrying the unique identifier included 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
The median time to loss of PASI-75 response among the patients re-randomised to placebo was 5.1 weeks. 
Mediani čas do izgube odziva PASI 75 pri bolnikih, ponovno randomiziranih na placebo, je bil 5,1 tedna.
Consistent with apremilast being a substrate of CYP3A4, apremilast exposure is decreased when administered concomitantly with rifampicin, a strong inducer of CYP3A4. 
Skladno s tem, da je apremilast substrat CYP3A4, se izpostavljenost apremilastu zmanjša, kadar ga dajemo sočasno z rifampicinom, ki je močan spodbujevalec CYP3A4.
• St John's Wort - a herbal medicine for mild anxiety and depression. 
• šentjanževka - zeliščno zdravilo za zdravljenje blage anksioznosti in depresije.
Study Week 
končni opazovani teden študije
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. 
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.
Hypersensitivity reactions are uncommonly observed (see section 4.3). 
Preobčutljivostne reakcije opazijo občasno (glejte poglavje 4.3).
If you forget to take Otezla 
Če ste pozabili vzeti zdravilo Otezla
INFORMATION IN BRAILLE Otezla 10 mg 
PODATKI V BRAILLOVI PISAVI Otezla 10 mg
There is little information about the effects of Otezla in pregnancy. 
O učinkih zdravila Otezla v nosečnosti je malo podatkov.
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. 
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.
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). 
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).
What psoriatic arthritis is 
Kaj je psoriatični artritis
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. 
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.
Of these patients, 12% achieved a PASI-75 response at week 52 with apremilast plus topical and/or phototherapy treatment. 
Od teh bolnikov jih je 12 % doseglo odziv PASI 75 po 52 tednih zdravljenja z apremilastom skupaj s topikalnimi zdravili in/ali fototerapijo.
INFORMATION IN BRAILLE Otezla 30 mg 
PODATKI V BRAILLOVI PISAVI Otezla 30 mg
One qualifying psoriatic skin lesion (at least 2 cm in diameter) was also required in PALACE 3. 
V študiji PALACE 3 so morali imeti bolniki tudi eno psoriatično kožno lezijo (vsaj 2 cm v premeru).
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. 
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.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Particulars printed directly onto the wallet card with the blank blister sealed inside) 
Pretisni omot (podatki, natisnjeni neposredno na zgibanko, pretisni omot brez napisa pa je zapečaten znotraj)
DMARDs N=497 
N=497
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. 
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).
Apremilast 30 mg twice daily 
apremilast 30 mg dvakrat na dan +/DMARDs
Apremilast has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Apremilast nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
QUALITATIVE AND QUANTITATIVE COMPOSITION Otezla 10 mg film-coated tablets 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Otezla 10 mg filmsko obložene tablete
Apremilast can be coadministered with a potent CYP3A4 inhibitor such as ketoconazole. 
Apremilast lahko dajemo sočasno z močnim zaviralcem CYP3A4, na primer ketokonazolom.
Among patients who remained on the apremilast treatment to which they were randomised at study start, these improvements were maintained through week 52. 
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.
The NOEL in the mouse for maternal toxicity and F1 generation was 10 mg/kg/day (1.3-fold clinical AUC). 
NOEL pri miših glede toksičnosti za mater in generacijo F1 je bila 10 mg/kg/dan (1,3-kratna klinična AUC).
19 film-coated tablets of 30 mg 
19 filmsko obloženih tablet po 30 mg
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. 
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.
DMARDs N=159 
N=159
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). 
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).
Psoriatic Arthritis 
Psoriatični artritis
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). 
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).
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. 
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.
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. 
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.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/002 56 film-coated tablets EU/1/14/981/003 168 film-coated tablets 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/981/002 56 filmsko obloženih tablet EU/1/14/981/003 168 filmsko obloženih tablet
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. 
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.
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). 
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).
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. 
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.
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. 
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.
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. 
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.
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 
EU/1/14/981/002 - velikost pakiranja 56 tablet EU/1/14/981/003 - velikost pakiranja 168 tablet
• The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate, 
• Druge sestavine jedra tablete so mikrokristalna celuloza, laktoza monohidrat, premreženi natrijev karmelozat in magnezijev stearat.
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). 
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.
Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. 
Bolnike in skrbnike je treba poučiti, naj o morebitnem spremenjenem vedenju ali razpoloženju in morebitnih samomorilnih mislih obvestijo zdravnika, ki jim je predpisal zdravilo.
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. 
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.
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). 
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).
Body weight loss 
Izguba telesne mase
Warnings and precautions Talk to your doctor or pharmacist before taking Otezla. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Otezla se posvetujte z zdravnikom ali farmacevtom.
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%. 
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 %.
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. 
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.
The no observed effect level (NOEL) for female fertility was 10 mg/kg/day (1.0-fold clinical exposure). 
Raven brez opaznega učinka (no observed effect level (NOEL)) za plodnost samic je bila 10 mg/kg/dan (1,0-kratna klinična izpostavljenost).
If you experience severe diarrhoea, nausea, or vomiting, you should talk to your doctor. 
Če imate hudo drisko, vas sili na bruhanje ali bruhate, povejte zdravniku.
MARKETING AUTHORISATION NUMBER(S) Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) EU/1/14/981/001 
Otezla 10 mg, 20 mg, 30 mg filmsko obložene tablete (pakiranje za začetek zdravljenja) EU/1/14/981/001
• The one-month standard pack contains 56 x 30 mg film-coated tablets. 
• Enomesečno standardno pakiranje vsebuje 56 x 30 mg filmsko obloženih tablet.
Apremilast undergoes extensive metabolism with only 3% and 7% of the administered parent compound recovered in urine and faeces, respectively. 
Apremilast se obsežno presnavlja, tako da v urinu prestrežemo le 3 % in v blatu le 7 % dane izhodne spojine.
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). 
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.
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. 
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.
Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients were still on this treatment on week 52. 
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.
The maternal and developmental NOEL in the mouse was 10 mg/kg/day (1.3-fold clinical exposure). 
NOEL za mater in razvoj pri miših je bila 10 mg/kg/dan (1,3-kratna klinična izpostavljenost).
The improvements were generally maintained in subjects who were re-randomised to apremilast at week 32 through week 52 (Table 5). 
Izboljšanja so na splošno trajala pri preskušancih, ki so jih po 32 tednih ponovno randomizirali na apremilast, do 52. tedna (preglednica 5).
Physical signs of maternal toxicity associated with delivering pups were also observed in one mouse at each of 80 and 300 mg/kg/day. 
Telesne znake toksičnosti za mater, povezane s skotitvijo mladičev, so opazili tudi pri eni miši pri odmerku 80 mg/kg/dan in pri eni miši pri odmerku 300 mg/kg/dan.
4 film-coated tablets of 20 mg 
4 filmsko obložene tablete po 20 mg
Reduced foetal weights and retarded ossification of the supraoccipital bone of the skull were observed at 40 and 80 mg/kg/day. 
Zmanjšano maso plodov in zapoznelo osifikacijo supraokcipitalne kosti lobanje so ugotovili pri 40 in 80 mg/kg/dan.
What Otezla looks like and contents of the pack 
Izgled zdravila Otezla in vsebina pakiranja
Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients entered the long term extension studies, and of these, 221 patients (59%) were still on this treatment at week 260. 
Od 497 bolnikov, ki so bili v začetku randomizirani na apremilast 30 mg dvakrat na dan, se je 375 bolnikov (75 %) vključilo v dolgoročne podaljšane študije, in od teh se je 221 bolnikov (59 %) v 260. tednu še vedno zdravilo.
The safety of apremilast was not evaluated in PsA or PSOR patients with moderate or severe renal impairment in the clinical studies. 
Pri bolnikih s PsA ali PSOR z zmerno ali hudo okvaro ledvic varnosti apremilasta v kliničnih študijah niso ocenjevali.
Figure 1 Proportion of ACR 20/50/70 responders through week 52 in the pooled analysis of studies PALACE 1, PALACE 2 and PALACE 3 (NRI*) 
Delež bolnikov z odzivom ACR 20/50/70 do 52. tedna z analizo podatkov združenih študij PALACE 1, PALACE 2 in PALACE 3 (NRI*)
Among patients who remained on the apremilast treatment to which they were randomised at study start, DAS28(CRP) score and PsARC response were maintained through week 52. 
Pri bolnikih, ki so ostali na zdravljenju z apremilastom, na katerega so bili randomizirani že v začetku študije, sta oba parametra, to je rezultat DAS28 (CRP) in odziv PsARC po 52 tednih še vedno trajala.
At week 24, all remaining placebo-treated patients were switched to either apremilast 20 or 30 mg twice daily. 
Po 24 tednih so vsem preostalim bolnikom, ki so prejemali placebo, začeli dajati apremilast 20 mg ali 30 mg dvakrat na dan.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg, 20 mg ali 30 mg apremilasta.
Apremilast is the major circulating component following oral administration. 
Apremilast je glavna spojina, ki po peroralnem dajanju kroži v telesu.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. 
Predklinični podatki na podlagi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
a Includes subjects re-randomised to APR 30 twice daily at week 32 with a baseline value and a post-baseline value at the evaluated study week. 
16. teden 32. teden 52. teden a Vključuje preskušance, ki so bili po 32 tednih ponovno randomizirani na APR 30 dvakrat na dan z izhodiščno vrednostjo in s po-izhodiščno vrednostjo v ocenjevanem tednu študije.
There was no pharmacokinetic interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate. 
Med apremilastom in peroralnimi kontracepcijskimi sredstvi, ki vsebujejo etinilestradiol in norgestimat, ni bilo farmakokinetičnih interakcij.
DMARDs N=496 
N=496
Patients with hepatic impairment The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment. 
Bolniki z okvaro jeter Varnosti apremilasta pri bolnikih s PsA ali PSOR, ki imajo okvaro jeter, niso ocenjevali.
A total of 1,493 patients were randomised and treated with either placebo, apremilast 20 mg or apremilast 30 mg given orally twice daily. 
V študije je bilo vključenih 1.493 bolnikov, ki so po randomizaciji prejemali placebo ali dvakrat dnevno apremilast 20 mg ali apremilast 30 mg.
The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. 
Če bolniki poročajo o predhodnih ali obstoječih psihiatričnih simptomih ali v primeru načrtovanega sočasnega zdravljenja z drugimi zdravili, ki lahko povzročijo psihiatrične dogodke, je treba skrbno oceniti tveganja in koristi uvedbe ali nadaljevanja zdravljenja z apremilastom.
In Study ESTEEM 2, approximately 80.3% of patients re-randomised to apremilast at week 32 had a PASI50 response at week 52. 
V študiji ESTEEM 2 je imelo približno 80,3 % bolnikov, ki so jih po 32 tednih ponovno randomizirali na apremilast, po 52 tednih odziv PASI 50.
• common cold (nasopharyngitis) 
• navadni prehlad (nazofaringitis),
Otezla is for oral use. 
Zdravilo Otezla je za peroralno uporabo.
In a monkey embryo-foetal developmental toxicity study, oral dosages of 20, 50, 200, and 1000 mg/kg/day resulted in a dose-related increase in prenatal loss (abortions) at dosages of 50 mg/kg/day and above; no test article-related effect in prenatal loss was observed at 20 mg/kg/day (1.4-fold clinical exposure). 
V študiji toksičnosti za razvoj zarodka in plodu pri opici so peroralni odmerki 20, 50, 200 in 1.000 mg/kg/dan povzročili z odmerkom povezane pogostejše predporodne izgube (splave) pri odmerkih 50 mg/kg/dan in večjih odmerkih; nobenih učinkov, povezanih s predmetom testiranja, na predporodne izgube niso opazili pri 20 mg/kg/dan (1,4-kratna klinična izpostavljenost).
Pre- and post-natal development 
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