natgillin/translations-raw huggingface dataset:
• For patients, who have previously taken biologic medicines to treat ulcerative colitis (such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to continue giving 10 mg twice a day. 
• U slučaju bolesnika koji su prethodno uzimali biološke lijekove za liječenje ulceroznog kolitisa (poput onih koji sprječavaju aktivnost čimbenika nekroze tumora u tijelu), a ti im lijekovi nisu djelovali, liječnik može odlučiti da trebaju nastaviti s primjenom 10 mg dva puta dnevno.
Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. 
Rizik od infekcije može biti veći uz porast stupnjeva limfopenije, a kod procjene rizika od infekcije pojedinog bolesnika treba uzeti u obzir i broj limfocita.
Each prolonged-release tablet contains 152.23 mg of sorbitol. 
Jedna tableta s produljenim oslobađanjem sadrži 152,23 mg sorbitola.
Study PsA-II (OPAL BEYOND) evaluated 394 patients who had discontinued a TNF inhibitor due to lack of efficacy or intolerance; 36.0% had a previous inadequate response to > 1 biological DMARD. 
Ispitivanje PsA-II (OPAL BEYOND) ocjenjivalo je 394 bolesnika koji su prestali primati inhibitor TNF-a zbog izostanka djelotvornosti ili zbog nepodnošenja; 36,0% bolesnika imalo je prethodno neodgovarajući odgovor na > 1 biološki DMARD.
No dose adjustment is required in patients aged 65 years and older. 
Nije potrebna prilagodba doze u bolesnika u dobi od 65 godina i starijih.
Common ≥1/100 to <1/10 
Često ≥ 1/100 i < 1/10
After treatment with tofacitinib in RA patients, rapid decreases in serum C-reactive protein (CRP) were observed and maintained throughout dosing. 
Nakon liječenja tofacitinibom u bolesnika s RA, uočena su brza smanjenja u vrijednosti serumskog C-reaktivnog proteina (CRP) koja su se održala kroz doziranje.
Take your next tablet at the usual time and continue as before. 
Sljedeću tabletu uzmite u uobičajeno vrijeme, a sve daljnje doze nastavite uzimati prema uobičajenom rasporedu.
Cases of opportunistic infections have been reported (see section 4.4). 
Prijavljeni su slučajevi oportunističkih infekcija (vidjeti dio 4.4).
Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known. 
Slučajevi intersticijske bolesti pluća (neki od njih s fatalnim ishodom) prijavljeni su u bolesnika liječenih tofacitinibom u kliničkim ispitivanjima RA-a i u postmarketinškom praćenju, premda uloga inhibicije Janus kinaze (JAK) u ovim slučajevima nije poznata.
Patients with latent TB, who test positive, should be treated with standard antimycobacterial therapy before administering tofacitinib. 
Bolesnike s latentnom tuberkulozom, čiji je test pozitivan, treba liječiti standardnom antimikobakterijskom terapijom prije primjene tofacitiniba.
Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers. 
Istodobna primjena tofacitiniba nije imala utjecaj na farmakokinetiku oralnih kontraceptiva, levonorgestrela i etinilestradiola u zdravih ženskih dobrovoljaca.
Lab value (g/dL) 
Laboratorijska vrijednost (g/dl)
Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). 
Tofacitinib se može davati kao monoterapija kada se MTX ne podnosi ili kada liječenje MTX-om nije prikladno (vidjeti dijelove 4.4 i 4.5).
If therapy is interrupted, restarting treatment with tofacitinib can be considered. 
Ako dođe do privremenog prekida terapije, može se razmotriti ponovno liječenje tofacitinibom.
• who have resided or travelled in areas of endemic TB. 
• prebivali ili putovali u područja s endemskom tuberkulozom.
If taken with XELJANZ, they could alter the level of XELJANZ in your body, and the dose of XELJANZ may require adjustment. 
Ako se uzmu zajedno s lijekom XELJANZ, može doći do promjene razine lijeka XELJANZ u Vašem tijelu, zbog čega može biti potrebna prilagodba doze.
Excipient with known effect Each film-coated tablet contains 118.88 mg of lactose. 
Pomoćna tvar s poznatim učinkom Jedna filmom obložena tableta sadrži 118,88 mg laktoze.
The most common infections resulting in discontinuation of therapy were herpes zoster and pneumonia. 
Najčešće infekcije koje su rezultirale prekidom liječenja bile su herpes zoster i pneumonija.
Health-related quality of life was assessed by the Short Form Health Survey (SF-36). 
Short Form Health Survey, SF-36).
Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets. 
Jedno pakiranje sadrži 56, 112 ili 182 tablete, a jedna boca sadrži 60 ili 180 tableta.
Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely. 
S obzirom da se tofacitinib metabolizira putem enzima CYP3A4, vjerojatna je interakcija s lijekovima koji inhibiraju ili induciraju CYP3A4.
• with recurrent infections, 
• s rekurentnim infekcijama,
Less than or equal to 2 g/dL decrease and greater than or equal to 9.0 g/dL 
Pad manji od ili jednak 2 g/dl i vrijednost veća od ili jednaka 9,0 g/dl
Excipient with known effect Each film-coated tablet contains 59.44 mg of lactose. 
Pomoćna tvar s poznatim učinkom Jedna filmom obložena tableta sadrži 59,44 mg laktoze.
Increases were observed at this time point and remained stable thereafter. 
Porasti su uočeni u ovoj vremenskoj točki i ostali su stabilni nakon toga.
• Previous venous thromboembolism, either deep venous thromboembolism or pulmonary embolism 
• Prethodna venska tromboembolija, bilo duboka venska tromboembolija ili plućna embolija
The use of tofacitinib in combination with phosphodiesterase 4 inhibitors has not been studied in tofacitinib clinical studies. 
Primjena tofacitiniba u kombinaciji s inhibitorima fosfodiesteraze 4 nije ispitivana u kliničkim ispitivanjima tofacitiniba.
Rare (may affect up to 1 in 1,000 people): blood infection (sepsis), disseminated tuberculosis involving bones and other organs, other unusual infections, joint infections. 
Rijetko (mogu se javiti u manje od 1 na 1000 osoba): infekcija krvi (sepsa), prošireni oblik tuberkuloze koja zahvaća kosti i druge organe, druge neobične infekcije, infekcije zglobova.
Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the PK of tofacitinib. 
Nije vjerojatno da će inhibitori samog CYP2C19 ili P-glikoprotein značajno promijeniti farmakokinetiku tofacitiniba.
The risks and benefits of treatment should be considered prior to initiating tofacitinib in patients: 
Rizike i koristi liječenja treba razmotriti prije početka liječenja tofacitinibom u bolesnika:
In patients with RA, treatment up to 6 months with tofacitinib was associated with dose-dependent reductions of circulating CD16/56+ natural killer (NK) cells, with estimated maximum reductions occurring at approximately 8-10 weeks after initiation of therapy. 
U bolesnika s RA, liječenje tofacitinibom do 6 mjeseci bilo je povezano s o dozi ovisnim smanjenjem broja cirkulirajućih stanica ubojica CD16/56+ (engl. natural killer, NK), s procijenjenim maksimalnim smanjenjem koje se javlja približno 8-10 tjedana nakon početka liječenja.
In human cells, tofacitinib preferentially inhibits signalling by heterodimeric cytokine receptors that associate with JAK3 and/or JAK1 with functional selectivity over cytokine receptors that signal via pairs of JAK2. 
U ljudskim stanicama tofacitinib preferencijalno inhibira signaliziranje putem heterodimernih citokinskih receptora koji se povezuju s JAK3 i/ili JAK1, s funkcionalnom selektivnošću preko citokinskih receptora koji signaliziraju putem parova JAK2.
Other serious infections that were not reported in clinical studies may also occur (e.g., coccidioidomycosis). 
Mogu se javiti i druge ozbiljne infekcije koje nisu prijavljene u kliničkim ispitivanjima (npr. kokcidioidomikoza).
In contrast, tofacitinib has a high degree of selectivity against other kinases in the human genome. 
Usporedbe radi, tofacitinib ima veći stupanj selektivnosti s obzirom na druge kinaze u genomu čovjeka.
N=number of patients in the analysis set. 
N = broj bolesnika čiji su podaci uključeni u skup podataka za analizu.
Elderly patients 80 years of age were estimated to have less than 5% higher AUC relative to the mean age of 55 years. 
Ocijenjeno je kako je AUC u starijih bolesnika u dobi od 80 godina veći za manje od 5% u odnosu na bolesnike prosječne dobi od 55 godina.
Treatment with tofacitinib was associated with increases in lipid parameters such as total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. 
Liječenje tofacitinibom bilo je povezano s porastima lipidnih parametara kao što su ukupni kolesterol, lipoproteini niske gustoće (LDL) i lipoproteini visoke gustoće (HDL).
Improvements from baseline in SF-36v2 and FACIT-F were maintained through month 6 (OPAL BROADEN and OPAL BEYOND) and month 12 (OPAL BROADEN). 
Poboljšanja u odnosu na početne vrijednosti u upitnicima SF-36v2 i FACIT-F održala su se do 6. mjeseca (u ispitivanjima OPAL BROADEN i OPAL BEYOND) i 12. mjeseca (u ispitivanju OPAL BROADEN).
Assessment of lipid parameters should be performed after 8 weeks following initiation of tofacitinib therapy. 
Procjenu lipidnih parametara treba provesti nakon 8 tjedana od početka liječenja tofacitinibom.
Coadministration of tofacitinib with potent CYP inducers (e.g., rifampicin) may result in a loss of or reduced clinical response (see Figure 1). 
Istodobna primjena tofacitiniba sa snažnim induktorima enzima CYP (npr. rifampicinom) može rezultirati gubitkom ili smanjenjem kliničkog odgovora (vidjeti sliku 1).
Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone). 
Rupe u želucu ili crijevima najčešće se javljaju u osoba koje također uzimaju nesteroidne protuupalne lijekove ili kortikosteroide (npr. prednizon).
When ALC is greater than 750, treatment should be resumed as clinically appropriate. 
Kad je ALC veći od 750, nastaviti s liječenjem kako je klinički primjereno.
Open-label extension study (OCTAVE Open) 
Otvoreni nastavak ispitivanja (OCTAVE Open)
Gastrointestinal obstruction with a non-deformable prolonged-release formulation 
Gastrointestinalna opstrukcija kod primjene formulacije s produljenim oslobađanjem koja ne podliježe promjeni oblika
In clinical trials, tofacitinib was not evaluated in subjects with severe (Child Pugh C) hepatic impairment (see sections 4.2 and 4.4), or in patients screened positive for hepatitis B or C. 
U kliničkim ispitivanjima tofacitinib nije ocjenjivan u ispitanika s teškim (Child Pugh stadij C) oštećenjem jetre (vidjeti dijelove 4.2 i 4.4) ili u bolesnika koji su bili pozitivni na hepatitis B ili C u probiru.
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with tofacitinib. 
Probir na virusni hepatitis treba provesti u skladu s kliničkim smjernicama prije početka terapije tofacitinibom.
Table 9: Number (%) of subjects achieving DAS28-4(ESR) < 2.6 remission at months 3 and 6 
Tablica 9: Broj (%) ispitanika koji su postigli DAS28-4(ESR)< 2,6 remisiju u 3. i 6. mjesecu Vremenska točka
Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least 4 weeks prior to the visit at both week 24 and week 52. 
Održana remisija bez kortikosteroida bila je definirana kao stanje remisije bez uzimanja kortikosteroida najmanje 4 tjedna prije posjeta u 24. i 52. tjednu.
(CYPRUS BRANCH) Τηλ: +357 22 817690 
PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH) Τηλ: +357 22 817690
Your doctor may do blood tests for hepatitis before you start treatment with XELJANZ and while you are taking XELJANZ - if you have ever had any type of cancer. 
Vaš liječnik može napraviti krvne pretrage na hepatitis prije početka liječenja lijekom XELJANZ i dok uzimate XELJANZ - ako ste ikada imali bilo koji oblik raka.
In clinical trials, tofacitinib was not evaluated in patients with baseline creatinine clearance values (estimated by Cockroft-Gault equation) less than 40 mL/min (see section 4.2). 
U kliničkim ispitivanjima tofacitinib nije ocjenjivan u bolesnika s početnim vrijednostima klirensa kreatinina (procijenjeno Cockroft-Gaultovom jednadžbom) ispod 40 ml/min (vidjeti dio 4.2).
• The website repository shall contain: o The educational material in digital format o The patient alert card in digital format 
• Internetska stranica repozitorija će sadržavati: o Edukacijske materijale u digitalnom obliku o Karticu s upozorenjima za bolesnika u digitalnom obliku
For patients who have difficulties swallowing, tofacitinib tablets may be crushed and taken with water. 
U bolesnika s poteškoćama gutanja, tablete tofacitiniba mogu se zdrobiti i popiti s vodom.
Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure. 
Postignuta statistička značajnost unutar ACR-ovih kategorija (ACR50 i ACR70) pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
Tofacitinib with and without MTX in comparison to ADA with MTX 
Tofacitinib s MTX-om i bez njega, u usporedbi s ADA-om i MTX-om zajedno
Clearance mechanisms for tofacitinib are approximately 70% hepatic metabolism and 30% renal excretion of the parent drug. 
Klirens tofacitiniba odvija se približno 70% putem metabolizma u jetri i 30% izlučivanjem ishodišnog spoja bubrezima.
Mean LDL cholesterol/HDL cholesterol ratios and Apolipoprotein B (ApoB)/ApoA1 ratios were essentially unchanged in tofacitinib-treated patients. 
Srednje vrijednosti omjera LDL kolesterola/HDL kolesterola i omjera apolipoproteina B (ApoB)/ApoA1 u osnovi su bile nepromijenjene u bolesnika liječenih tofacitinibom.
Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation in some patients (see section 4.8 liver enzyme tests). 
Liječenje tofacitinibom bilo je povezano s povećanom incidencijom porasta jetrenih enzima u nekih bolesnika (vidjeti dio 4.8, pretrage jetrenih enzima).
The impact of tofacitinib on chronic viral hepatitis reactivation is unknown. 
Utjecaj tofacitiniba na reaktivaciju kroničnog virusnog hepatitisa nije poznat.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis. 
Liječenje treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa.
If you are a woman of childbearing age, you should use effective birth control during treatment with XELJANZ and for at least 4 weeks after the last dose. 
Ako ste žena u reproduktivnoj dobi, morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom XELJANZ i još najmanje 4 tjedna nakon uzimanja posljednje doze.
Patients should be managed according to clinical guidelines for the management of hyperlipidaemia. 
Bolesnike treba liječiti prema kliničkim smjernicama za liječenje hiperlipidemije.
Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia. 
Prekid doziranja može biti potreban za zbrinjavanje o dozi ovisnih odstupanja u laboratorijskim nalazima uključujući limfopeniju, neutropeniju i anemiju.
Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ. 
Vaš liječnik mora provjeriti Vaše razine kolesterola 8 tjedana nakon početka liječenja lijekom XELJANZ.
The risks and benefits of tofacitinib treatment should be considered prior to initiating therapy in patients with current or a history of malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing tofacitinib in patients who develop a malignancy. 
Rizike i koristi od liječenja tofacitinibom treba razmotriti prije početka terapije u bolesnika s trenutnom ili malignom bolesti u anamnezi, osim uspješno liječenog nemelanomskog raka kože (engl. non-melanoma skin cancer, NMSC), ili kada se razmatra nastavak terapije tofacitinibom u bolesnika koji razviju malignitet.
In enzymatic assays, tofacitinib inhibits JAK1, JAK2, JAK3, and to a lesser extent TyK2. 
U enzimatskim testovima tofacitinib inhibira JAK1, JAK2, JAK3 te u manjoj mjeri TyK2.
Patients should be closely monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy. 
Bolesnike treba pomno nadzirati zbog mogućeg razvoja znakova i simptoma tuberkuloze, uključujući bolesnike koji su imali negativni test na latentnu tuberkuloznu infekciju prije početka terapije.
Discontinuation and monitoring criteria for lymphopenia are discussed in section 4.2. 
Kriteriji za prekid i nadzor za limfopeniju objašnjeni su u dijelu 4.2.
In subjects with end-stage renal disease (ESRD), contribution of dialysis to the total clearance of tofacitinib was relatively small. 
End Stage Renal Disease, ESRD) doprinos dijalize ukupnom klirensu tofacitiniba bio je relativno mali.
Abbreviations: TNFi=tumour necrosis factor inhibitor; UC=ulcerative colitis. 
Kratice: TNFi = inhibitor čimbenika nekroze tumora; UC = ulcerozni kolitis.
Viral reactivation and cases of herpes virus reactivation (e.g., herpes zoster) were observed in clinical studies with tofacitinib. 
Reaktivacija virusa i slučajevi reaktivacije herpes virusa (primjerice, herpes zoster) zabilježeni su u kliničkim ispitivanjima tofacitiniba.
Signs of allergic reactions (unknown) include 
Znakovi alergijskih reakcija (nuspojave koje se javljaju s nepoznatom učestalošću) uključuju
Placebo + DMARD(s) 
Placebo + DMARD(ovi)
Women of childbearing potential should be advised to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose. 
Žene reproduktivne dobi treba savjetovati da koriste odgovarajuću kontracepciju tijekom liječenja tofacitinibom i do najmanje 4 tjedna nakon primjene zadnje doze.
Health-related and quality of life outcomes 
Ishodi povezani sa zdravljem i kvalitetom života
When given at a dose of 5 mg twice daily, tofacitinib plus MTX exhibited similar effects on mean progression of structural damage (not statistically significant). 
Primijenjen u dozi od 5 mg dva puta dnevno, tofacitinib i MTX pokazali su slične učinke na srednju vrijednost progresije strukturnog oštećenja (nije statistički značajno).
Dosing should be interrupted until haemoglobin values have normalised. 
Doziranje treba prekinuti sve dok se razina hemoglobina ne normalizira.
In the entire treatment experience with tofacitinib, the most commonly reported infection was nasopharyngitis, occurring in 18.2% of patients (211 patients). 
Cjelokupno iskustvo liječenja tofacitinibom pokazalo je da je nazofaringitis bio najčešće prijavljivana infekcija, a javio se u 18,2% bolesnika (211 bolesnika).
Confirmed increases in liver enzymes greater than 3 times the upper limit of normal (3x ULN) were uncommonly observed in RA patients. 
Potvrđeni porast jetrenih enzima veći od 3-struke vrijednosti gornje normalne granice (3 x GGN) zabilježeni su manje često u bolesnika s RA-om.
• Patients with long standing RA who have previously received two or more biological disease modifying antirheumatic drugs (DMARDs). 
• bolesnika s kroničnim oblikom RA koji su prethodno primili dva ili više bioloških antireumatskih lijekova koji modificiraju tijek bolesti (DMARD-ova).
Following long-term treatment (median duration of tofacitinib treatment of approximately 5 years), CD4+ and CD8+ counts showed median reductions of 28% and 27%, respectively, from baseline. 
Nakon dugotrajnog liječenja (medijan trajanja liječenja tofacitinibom od približno 5 godina), CD4+ i CD8+ broj pokazao je medijan smanjenja od 28% odnosno 27% u odnosu na početne vrijednosti.
XELJANZ contains lactose 
XELJANZ sadrži laktozu
The proportion of patients who discontinued treatment due to adverse reactions during first 3 months of the double-blind, placebo or MTX controlled studies was 3.8% for patients taking tofacitinib. 
Udio bolesnika koji su prekinuli liječenje zbog nuspojava tijekom prva 3 mjeseca dvostruko slijepog, placebom ili MTX-om kontroliranog ispitivanja, iznosio je 3,8% u bolesnika koji su uzimali tofacitinib.
Coadministration of potent inducers of CYP3A4 with tofacitinib is not recommended. 
Istodobna primjena snažnih induktora CYP3A4 s tofacitinibom se ne preporučuje.
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension (see Table 6, Adverse Drug Reactions [ADRs] based on all study durations). 
Najčešće prijavljene nuspojave tijekom prva 3 mjeseca u kontroliranim kliničkim ispitivanjima bile su glavobolja, infekcije gornjeg respiratornog trakta, nazofaringitis, proljev, mučnina i hipertenzija (vidjeti Tablicu 6, Nuspojave na temelju trajanja svih ispitivanja).
Blood creatine phosphokinase increased 
Porast kreatinin fosfokinaze u krvi
Key secondary efficacy endpoints 
Ključne sekundarne mjere ishoda djelotvornosti
Steady state concentrations are achieved in 24-48 hours with negligible accumulation after twice daily administration. 
Koncentracije u stanju dinamičke ravnoteže postignute su kroz 24-48 sati sa zanemarivom akumulacijom nakon primjene dva puta dnevno.
All metabolites have been observed in animal species and are predicted to have less than 10-fold potency than tofacitinib for JAK1/3 inhibition. 
Svi metaboliti su proučavani na animalnim modelima te se pretpostavlja da će njihova potentnost za inhibiciju JAK 1/3 iznositi manje od 10% vrijednosti tofacitiniba.
Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of the following conditions: 
Tofacitinib 10 mg dva puta dnevno kontraindiciran je u bolesnika koji imaju jedno ili više od sljedećih stanja:
For some patients, such as those who have failed prior tumour necrosis factor (TNF) antagonist therapy, consideration should be given to continuation of the 10 mg twice daily dose for maintenance in order to maintain therapeutic benefit (see section 5.1). 
Za neke od bolesnika, kao što su oni u kojih prethodna terapija antagonistima čimbenika nekroze tumora (engl. tumour necrosis factor, TNF) nije bila uspješna, potrebno je razmotriti nastavak primjene doze od 10 mg dva puta dnevno u terapiji održavanja kako bi se održala terapijska korist (vidjeti dio 5.1).
Health-related quality of life was assessed by SF-36v2, fatigue was assessed by the FACIT-F. 
Kvaliteta života povezana sa zdravljem ocijenjena je upitnikom SF-36v2, a umor upitnikom FACIT-F.
XELJANZ is used together with methotrexate to treat adult patients with active psoriatic arthritis. 
XELJANZ se koristi zajedno s metotreksatom u liječenju odraslih bolesnika s aktivnim psorijatičnim artritisom.
Study III (O RAL Standard) 
Ispitivanje III (ORAL Standard)
60 film-coated tablets 180 film-coated tablets 
60 filmom obloženih tableta 180 filmom obloženih tableta
Study PsA-I (OPAL BROADEN) evaluated 422 patients who had a previous inadequate response (due to lack of efficacy or intolerance) to a csDMARD (MTX for 92.7% of patients); 32.7% of the patients in this study had a previous inadequate response to > 1 csDMARD or 1 csDMARD and a targeted synthetic DMARD (tsDMARD). 
Ispitivanje PsA-I (OPAL BROADEN) ocjenjivalo je 422 bolesnika koji su prethodno imali neadekvatan odgovor (zbog izostanka djelotvornosti ili zbog nepodnošenja) na csDMARD (MTX za 92,7% bolesnika); 32,7% bolesnika u ovom ispitivanju prethodno je imalo neadekvatan odgovor na > 1 csDMARD ili 1 csDMARD te ciljni sintetski DMARD (engl. targeted synthetic DMARD, tsDMARD).
Steady state concentrations are achieved within 48 hours with negligible accumulation after once daily administration. 
Koncentracije u stanju dinamičke ravnoteže postignu se u roku od 48 sati, sa zanemarivom akumulacijom nakon primjene jednom dnevno.