natgillin/translations-raw huggingface dataset:
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). 
U oba ispitivanja bolesnici su bili randomizirani u omjeru 2:1 na apremilast od 30 mg dvaput na dan ili placebo do 16. tjedna (placebom kontrolirana faza), a od 16. do 32. tjedna svi su bolesnici primali apremilast od 30 mg dvaput na dan (faza održavanja).
Patients previously treated with DMARDs or biologics who received apremilast achieved a greater ACR 20 response at week 16 than patients receiving placebo. 
Bolesnici prethodno liječeni DMARD ili biološkim lijekovima koji su primali apremilast, postigli su veći odgovor ACR 20 u 16. tjednu nego bolesnici koji su primali placebo.
Apremilast is well absorbed with an absolute oral bioavailability of approximately 73%, with peak plasma concentrations (Cmax) occurring at a median time (tmax) of approximately 2.5 hours. 
Apremilast se dobro apsorbira i nakon peroralne primjene apsolutna bioraspoloživost mu je približno 73%, a vršnu koncentraciju u plazmi (Cmax) postiže za medijan vremena (tmax) od približno 2,5 sati.
PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. 
PDE4 je fosfodiesteraza specifična za ciklički adenozin monofosfat (cAMP) i fosfodiesteraza dominantna u upalnim stanicama.
The adverse drug reactions were determined based on data from the apremilast clinical development programme and post-marketing experience. 
Nuspojave na lijek određene su na temelju podataka dobivenih u programu kliničkog razvoja apremilasta i iz razdoblja nakon stavljanja lijeka u promet.
Change in SF-36 MCS h, mean± SD 
Promjena u DLQIg, srednja vrijednost± SD Promjena u SF-36 MCS h, srednja vrijednost± SD
In clinical trials in patients with psoriasis, apremilast decreased lesional skin epidermal thickness, inflammatory cell infiltration, and expression of pro-inflammatory genes, including those for inducible nitric oxide synthase (iNOS), IL-12/IL-23p40, IL-17A, IL-22 and IL-8. 
U kliničkim ispitivanjima bolesnika s psorijazom, apremilast je smanjio debljinu epidermisa psorijatične kože, infiltraciju upalnih stanica i ekspresiju proupalnih gena, uključujući one za inducibilnu sintazu dušikova oksida (iNOS), IL-12/IL-23p40, IL-17A, IL-22 i IL-8.
Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) PVC/ aluminium foil blisters containing 27 film-coated tablets (4 x10 mg, 4x 20 mg, 19 x 30 mg). 
Otezla 10 mg, 20 mg, 30 mg filmom obložene tablete (pakiranje za započinjanje liječenja) Blisteri od PVC/aluminijske folije sadrže 27 filmom obloženih tableta (4 x 10 mg, 4 x 20 mg, 19 x 30 mg).
Apremilast is extensively metabolised by both CYP and non-CYP mediated pathways including oxidation, hydrolysis, and conjugation, suggesting inhibition of a single clearance pathway is not likely to cause a marked drug-drug interaction. 
Apremilast se opsežno metabolizira putevima sa i bez posredovanja enzima CYP, uključujući oksidaciju, hidrolizu i konjugaciju, što upućuje na to da nije vjerojatno da će inhibicija jednog puta klirensa prouzročiti izrazitu interakciju lijekova.
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. 
U ispitivanjima na životinjama nisu opaženi štetni učinci na plodnost u mužjaka miševa pri razini izloženosti 3 puta većoj od kliničke izloženosti, a u ženki pri razini izloženosti 1 puta većoj od kliničke izloženosti.
The median time to loss of PASI-75 response among the patients re-randomised to placebo was 5.1 weeks. 
Medijan vremena do gubitka odgovora PASI-75 među bolesnicima koji su bili ponovno randomizirani na placebo iznosio je 5,1 tjedan.
Physical signs of maternal toxicity associated with delivering pups were also observed in one mouse at each of 80 and 300 mg/kg/day. 
Tjelesni znakovi maternalne toksičnosti povezani s okoćivanjem mladunčadi također su opaženi u jedne ženke miša pri svakoj dozi od 80 i 300 mg/kg na dan.
The other most commonly reported adverse reactions include upper respiratory tract infections (8.4%), headache (7.9%), and tension headache (7.2%) and are mostly mild to moderate in severity. 
Druge najčešće prijavljene nuspojave uključuju infekcije gornjih dišnih puteva (8,4%), glavobolju (7,9%) i tenzijsku glavobolju (7,2%).
Response to apremilast was rapid, with significantly greater improvements in the signs and symptoms of psoriasis, including PASI, skin discomfort/pain and pruritus, compared to placebo by week 2. 
Odgovor na apremilast bio je brz, sa značajno većim poboljšanjima znakova i simptoma psorijaze, uključujući PASI, nelagodu/bol kože i pruritus, u usporedbi s onima koji su primali placebo do 2. tjedna.
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. 
Apremilast, peroralni malomolekulski inhibitor fosfodiesteraze 4 (PDE4), djeluje unutarstanično kako bi modulirao mrežu proupalnih i protuupalnih medijatora.
Patients with each subtype of PsA were enrolled in the 3 studies, including symmetric polyarthritis (62.0%), asymmetric oligoarthritis (26.9%), distal interphalangeal (DIP) joint arthritis (6.2%), arthritis mutilans (2.7%), and predominant spondylitis (2.1%). 
U ta 3 ispitivanja uključeni su bolesnici sa svakim podtipom psorijatičnog artritisa, uključujući simetrični poliartritis (62,0%), asimetrični oligoartritis (26,9%), artritis distalnih interfalangealnih zglobova (6,2%), mutilirajući artritis (2,7%) i predominantni spondilitis (2,1%).
8 subjects with severe renal impairment to whom a single dose of 30 mg apremilast was administered, the AUC and Cmax of apremilast increased by approximately 89% and 42%, respectively. 
U 8 ispitanika s teškim oštećenjem funkcije bubrega kojima je primijenjena jedna doza od 30 mg apremilasta, vrijednost AUC-a apremilasta povećala se za približno 89%, a Cmax za 42%.
There is no meaningful difference in the PK of apremilast between mild or moderate renally impaired subjects and matched healthy subjects (N=8 each). 
U farmakokinetici apremilasta nema značajne razlike između ispitanika s blagim ili umjerenim oštećenjem funkcije bubrega i podudarnih zdravih ispitanika (N = 8 u svakoj od tih skupina).
Apremilast can be coadministered with a potent CYP3A4 inhibitor such as ketoconazole. 
Apremilast se može primjenjivati istodobno s jakim inhibitorom enzima CYP3A4 kao što je ketokonazol.
There have been post-marketing reports of severe diarrhoea, nausea, and vomiting associated with the use of apremilast. 
Nakon stavljanja lijeka u promet prijavljeni su teški proljev, mučnina i povraćanje povezani uz primjenu apremilasta.
Clinical response at week 16 in studies ESTEEM 1 and ESTEEM 2 (FAS a, LOCFb) ESTEEM 1 
Tablica 4. Klinički odgovor u 16. tjednu u ispitivanjima ESTEEM 1 i ESTEEM 2 (FASa LOCFb)
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. 
Primjena topikalnih kortikosteroida male potentnosti na licu, pazušnim jamama i preponama, šampona na bazi katrana kamenog ugljena i/ili pripravaka za vlasište sa salicilnom kiselinom bila je dopuštena tijekom cijelog trajanja ispitivanja.
Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake klasifikacije organskog sustava i skupine učestalosti, nuspojave su prikazane redoslijedom prema sve manjoj ozbiljnosti.
Apremilast exposure is decreased when administered concomitantly with strong inducers of CYP3A4 (e.g. rifampicin) and may result in reduced clinical response. 
Izloženost apremilastu smanjuje se kada se primjenjuje istodobno s jakim induktorima enzima CYP3A4 (npr. rifampicin) i za posljedicu može imati smanjeni klinički odgovor.
There are limited data about the use of apremilast in pregnant women. 
Podaci o primjeni apremilasta u trudnica su ograničeni.
Patients who did not achieve the designated PASI response by week 32, or who were initially randomised to placebo, remained on apremilast until week 52. 
Bolesnici koji nisu postigli naznačeni PASI odgovor do 32. tjedna ili koji su prvotno bili randomizirani na placebo, ostali su na apremilastu do 52. tjedna.
Insomnia Depression 
Često nesanica depresija
• St John's Wort - a herbal medicine for mild anxiety and depression. 
• gospina trava - biljni lijek za liječenje blage anksioznosti i depresije.
Carcinogenicity studies 
Ispitivanja kancerogenosti
The clinical benefit of apremilast was also demonstrated regardless of prior psoriasis medication usage and response to prior psoriasis treatments. 
Klinička dobrobit apremilasta dokazana je i bez obzira na prethodnu upotrebu lijekova protiv psorijaze i odgovor na prethodna liječenja psorijaze (tablica 6).
Day 1 - Day 7 
1. - 7. dana
What plaque psoriasis is 
Što je plak psorijaza
Day 8 - Day 14 
8. - 14. dana
The most commonly reported adverse reactions with apremilast are gastrointestinal (GI) disorders including diarrhoea (15.7%) and nausea (13.9%). 
Najčešće prijavljene nuspojave uz primjenu apremilasta jesu poremećaji probavnog sustava, uključujući proljev (15,7%) i mučninu (13,9%).
Otezla has also been shown to improve the quality of life in patients with psoriasis or psoriatic arthritis. 
Pokazalo se također da Otezla poboljšava kvalitetu života bolesnika s psorijazom ili psorijatičnim artritisom.
Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. 
Bolesnike i njegovatelje potrebno je uputiti da obavijeste liječnika koji propisuje lijek o svim promjenama u ponašanju ili raspoloženju te o svim suicidalnim idejama.
In the PsA or PSOR clinical studies, the safety profile observed in patients with mild renal impairment was comparable to patients with normal renal function. 
U kliničkim ispitivanjima psorijatičnog artritisa ili psorijaze, sigurnosni profil opažen u bolesnika s blagim oštećenjem funkcije bubrega bio je sličan onome u bolesnika s normalnom funkcijom bubrega.
The exposure in elderly subjects (65 to 85 years of age) is about 13% higher in AUC and about 6% higher in Cmax for apremilast than that in young subjects (18 to 55 years of age). 
Izloženost apremilastu viša je oko 13% u AUC-u i oko 6% u vrijednosti Cmax u ispitanika starije dobi (od 65 do 85 godina) nego u mladih ispitanika (od 18 do 55 godina).
Body weight loss 
Gubitak tjelesne težine
Patients who achieved PASI-50 at week 32 
Bolesnici koji su postigli rezultat PASI-50 u 32. tjednu
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. 
Među bolesnicima koji su ostali na terapiji apremilastom na koju su randomizirani na početku ispitivanja, rezultat DAS28(CRP) i odgovor PsARC održali su se do 52. tjedna.
In psoriasis, treatment with Otezla results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease. 
U psorijazi, liječenje lijekom Otezla rezultira smanjenjem psorijatičnih plakova na koži te drugih znakova i simptoma bolesti.
Hence, apremilast coadministered with substrates of CYP enzymes is unlikely to affect the clearance and exposure of active substances that are metabolised by CYP enzymes. 
Stoga nije vjerojatno da će apremilast primijenjen istodobno sa supstratima enzima CYP utjecati na klirens i izloženost djelatnim tvarima koje metaboliziraju enzimi CYP.
PASIc 75, n (%) sPGAd of Clear or Almost Clear, n (%) PASI 50, n (%) PASI 90, n (%) Percent Change BSAe (%) mean± SD 
PASIc 75, n (%) sPGAd bez znakova ili gotovo bez znakova, n (%) 11 (3,9) PASI 50, n (%)
Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1). 
Lijek Otezla, primijenjen sam ili u kombinaciji s antireumatskim lijekovima koji mijenjaju tijek bolesti (DMARD) indiciran je za liječenje aktivnog psorijatičnog artritisa (PsA) u odraslih bolesnika koji nisu imali odgovarajući odgovor ili nisu podnosili prethodnu DMARD terapiju (vidjeti dio 5.1).
From post-marketing experience, elderly patients ≥ 65 years of age may be at a higher risk of complications of severe diarrhoea, nausea and vomiting (see section 4.4). 
≥ 65 godina mogu biti pod povećanim rizikom od komplikacija poput teškog proljeva, mučnine i povraćanja (vidjeti dio 4.4).
The clinical benefit of apremilast was demonstrated across multiple subgroups defined by baseline demographics and baseline clinical disease characteristics (including psoriasis disease duration and patients with a history of psoriatic arthritis). 
Klinička dobrobit apremilasta dokazana je u više podskupina definiranih prema početnim demografskim podacima i kliničkim karakteristikama bolesti prije liječenja (uključujući trajanje psorijaze i bolesnike s psorijatičnim artritisom u anamnezi).
Otezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). 
Lijek Otezla indiciran je za liječenje umjerene do teške kronične plak psorijaze u odraslih bolesnika u kojih nije bilo odgovora ili im je kontraindicirana ili ne podnose drugu sistemsku terapiju uključujući ciklosporin, metotreksat ili psoralen i ultraljubičasto
Of these patients, 12% achieved a PASI-75 response at week 52 with apremilast plus topical and/or phototherapy treatment. 
Od tih bolesnika 12% postiglo je odgovor PASI-75 u 52. tjednu uz liječenje apremilastom i topikalnom terapijom i/ili fototerapijom.
x 20 mg tablets and 19 x 30 mg tablets. 
4 tablete x 10 mg, 4 tablete x 20 mg i 19 tableta x 30 mg.
In particular, tell your doctor or pharmacist before taking Otezla if you are taking any of the following medicines: 
Osobito je važno da prije nego što uzmete lijek Otezla, liječnika ili ljekarnika obavijestite ako uzimate neke od sljedećih lijekova:
A total of 1,493 patients were randomised and treated with either placebo, apremilast 20 mg or apremilast 30 mg given orally twice daily. 
Ukupno 1493 bolesnika randomizirano je i liječeno ili placebom ili apremilastom od 20 mg ili apremilastom od 30 mg davanim peroralno dvaput na dan.
Patients who achieved PASI-75 at week 32 
Bolesnici koji su postigli rezultat PASI-75 u 32. tjednu
Responses observed in the apremilast treated group were similar in patients receiving and not receiving concomitant DMARDs, including MTX. 
Odgovori opaženi u skupini liječenoj apremilastom bili su slični u bolesnika koji jesu i onih koji nisu istodobno primali DMARD lijekove, uključujući metotreksat.
QUALITATIVE AND QUANTITATIVE COMPOSITION Otezla 10 mg film-coated tablets 
KVALITATIVNI I KVANTITATIVNI SASTAV Otezla 10 mg filmom obložene tablete
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%. 
U ukupno 14,3% bolesnika koji su primali apremilast opažen je gubitak težine između 5-10%, dok je u 5,7% bolesnika koji su primali apremilast opaženi gubitak težine bio veći od 10%.
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. 
Nakon peroralne primjene radioaktivno obilježenog apremilasta, oko 58% radioaktivnosti nađe se u mokraći i oko 39% u stolici, s oko 3% radioaktivne doze pronađene u obliku apremilasta u mokraći i oko 7% u stolici.
In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy. 
U kliničkim ispitivanjima apremilast se primjenjivao istodobno s topikalnom terapijom (uključujući kortikosteroide, šampone na bazi katrana kamenog ugljena te pripravke za vlasište sa salicilnom kiselinom) i terapijom ultraljubičastim B zrakama (UVB).
The median duration of PsA disease was 5 years. 
Medijan trajanja psorijatičnog artritisa iznosio je 5 godina.
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 
Otezla 30 mg filmom obložene tablete EU/1/14/981/002 - pakiranje od 56 tableta EU/1/14/981/003 - pakiranje od 168 tableta
Study Week 
Tjedan ispitivanja
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. 
Sigurnost i djelotvornost apremilasta procijenjene su u 3 multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja (ispitivanja PALACE 1, PALACE 2 i PALACE 3) sličnog dizajna u odraslih bolesnika s aktivnim psorijatičnim artritisom (≥ 3 otečena zgloba i ≥ 3 bolna zgloba) unatoč prethodnom liječenju malomolekulskim ili biološkim DMARD lijekovima.
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. 
Što je psorijatični artritis Psorijatični artritis je upalna bolest zglobova, obično popraćena psorijazom, upalnom bolesti kože.
Persistence of effect among subjects randomised to APR 30 twice daily at week 0 and rerandomised to APR 30 twice daily at week 32 to week 52 
Tablica 5. Postojanost učinka među ispitanicima randomiziranim na APR 30 dvaput na dan u 0. tjednu koji su ponovno randomizirani na APR 30 dvaput na dan od 32. do 52. tjedna
Other medicines and Otezla 
Drugi lijekovi i Otezla
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. 
Nakon obustave randomiziranog liječenja u 32. tjednu, približno 70% bolesnika u ispitivanju ESTEEM 1 i 65,6% bolesnika u ispitivanju ESTEEM 2 vratilo se na odgovore PASI-75 (ESTEEM 1) ili PASI-50 (ESTEEM 2) poslije ponovnog uvođenja terapije apremilastom.
The mean baseline PASI score was 19.07 (median 16.80), and the proportion of patients with sPGA score of 3 (moderate) and 4 (severe) at baseline was 70.0% and 29.8%, respectively with a mean baseline BSA involvement of 25.19% (median 21.0%). 
Srednja vrijednost početnog rezultata PASI bila je 19,07 (medijan 16,80), a udio bolesnika s početnim rezultatom sPGA od 3 (umjereno) i 4 (teško) iznosio je 70,0% odnosno 29,8%, uz srednju vrijednost za početnu zahvaćenost tjelesne površine od 25,19% (medijan 21,0%).
• The three-month standard pack contains 168 x 30 mg film-coated tablets. 
• Standardno pakiranje za tri mjeseca liječenja sadrži 168 filmom obloženih tableta x 30 mg.
In vitro, apremilast has little to no inhibitory effect (IC50>10µM) on Organic Anion Transporter (OAT)1 and OAT3, Organic Cation Transporter (OCT)2, Organic Anion Transporting Polypeptide (OATP)1B1 and OATP1B3, or breast cancer resistance protein (BCRP) and is not a substrate for these transporters. 
Organic Anion Transporting Polypeptide, OATP)1B1 i OATP1B3 ili na protein otpornosti raka dojke na lijekove (BCRP) i nije supstrat tih prijenosnika.
Similar ACR responses were observed in patients with different PsA subtypes, including DIP. 
Slični odgovori prema kriterijima ACR opaženi su u bolesnika s različitim podtipovima psorijatičnog artritisa, uključujući distalne interfalangealne zglobove.
The clinical responses were maintained in the same parameters of peripheral activity and in the skin manifestations of psoriasis in the open-label extension studies for up to 5 years of treatment. 
U otvorenim nastavcima ispitivanja, klinički odgovori za te iste parametre periferne aktivnosti te kožne manifestacije psorijaze održali su se do 5 godina liječenja.
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. 
U 16. i 24. tjednu, u bolesnika liječenih apremilastom opažena su poboljšanja u parametrima periferne aktivnosti karakterističnim za psorijatični artritis (npr. broj otečenih zglobova, broj bolnih/osjetljivih zglobova, daktilitis i entezitis) i u manifestacijama psorijaze na koži.
• common cold (nasopharyngitis) 
• obična prehlada (nazofaringitis)
For patients who remained on apremilast in the open label extension of ESTEEM 1 and ESTEEM 2 studies, improvements were generally maintained in PASI score, affected BSA, itch, nail and quality of life measures for up to 5 years. 
U bolesnika koji su nastavili primati apremilast u otvorenim nastavcima ispitivanja ESTEEM 1 i ESTEEM 2, poboljšanja u rezultatu PASI, zahvaćenoj površini tijela, svrbežu, zahvaćenosti noktiju i mjerama kvalitete života obično su se održala do 5 godina.
INFORMATION IN BRAILLE Otezla 10 mg 
16. PODACI NA BRAILLEOVOM PISMU Otezla 10 mg
PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, IL-17 and other inflammatory cytokines. 
Inhibicija PDE4 povećava unutarstanične razine cAMP-a, što zauzvrat, modulacijom ekspresije citokina TNF-α, IL-23, IL-17 i drugih upalnih citokina, smanjuje upalni odgovor.
Week 16 Week 32 
16. tjedan 32. tjedan
If patients develop severe diarrhoea, nausea, or vomiting, discontinuation of treatment with apremilast may be necessary. 
Ako se u bolesnika pojavi teški proljev, mučnina ili povraćanje, možda bude potrebno prekinuti uzimanje apremilasta.
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. 
U kombiniranom ispitivanju plodnosti ženke miša i embriofetalne razvojne toksičnosti pri peroralnim dozama od 10, 20, 40 i 80 mg/kg na dan, apsolutne i/ili relativne težine srca majki povećale su se pri dozama od 20, 40 i 80 mg/kg na dan.
At week 24, all remaining placebo-treated patients were switched to either apremilast 20 or 30 mg twice daily. 
U 24. tjednu, svi preostali bolesnici koji su liječeni placebom prebačeni su u skupine koje su primale apremilast od 20 ili 30 mg dvaput na dan.
Consistent with apremilast being a substrate of CYP3A4, apremilast exposure is decreased when administered concomitantly with rifampicin, a strong inducer of CYP3A4. 
Dosljedno činjenici da je apremilast supstrat CYP3A4, izloženost apremilastu smanjuje se kada se primjenjuje istodobno s rifampicinom, jakim induktorom CYP3A4.
20 mg (brown) 
20 mg (smeđa)
What Otezla contains 
Što Otezla sadrži
Increased peri- and postnatal pup deaths and reduced pup body weights during the first week of lactation were observed at ≥ 80 mg/kg/day (≥ 4.0-fold clinical exposure). 
Povećana perinatalna i postnatalna smrtnost mladunčadi te smanjena težina mladunčadi u prvom tjednu laktacije opaženi su pri dozi ≥ 80 mg/kg na dan (≥ 4,0 puta većoj od kliničke izloženosti).