natgillin/translations-raw huggingface dataset:
In OPAL BEYOND, MDA was achieved by 22.9% and 14.5% of tofacitinib 5 mg BID and placebo treated patients, respectively, however tofacitinib 5 mg BID did not achieve nominal statistical significance (treatment difference from placebo 8.4% [95% CI: -1.0, 17.8] at month 3). 
Međutim, 5 mg tofacitiniba primjenjivanog dva puta dnevno nije postigao nominalnu statističku značajnost (razlika u liječenju u odnosu na placebo iznosila je 8,4% [95% CI: -1,0; 17,8] u 3. mjesecu).
Tell your doctor immediately if you feel unwell. 
Ako se ne osjećate dobro, odmah se obratite liječniku.
BLISTER FOR 10 MG TABLETS 
BLISTERI ZA TABLETE OD 10 MG
EU/1/17/1178/012 28 prolonged-release tablets EU/1/17/1178/013 91 prolonged-release tablets 
EU/1/17/1178/012 28 tableta s produljenim oslobađanjem EU/1/17/1178/013 91 tableta s produljenim oslobađanjem
Month 3 Month 6 Month 12 
3. mjesec 6. mjesec 12. mjesec
In this study, AST elevations greater than 3x ULN were observed in 1.65%, 0.41% and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively. 
U ovom ispitivanju porast AST-a veći od 3 x GGN zabilježen je u 1,65%, 0,41% odnosno 0% bolesnika koji su primali placebo, 5 mg tofacitiniba, odnosno 10 mg tofacitiniba dva puta dnevno.
The HAQ-DI responder rate (response defined as having decrease from baseline of ≥ 0.35) at month 3 in studies OPAL BROADEN and OPAL BEYOND was 53% and 50%, respectively in patients receiving tofacitinib 5 mg twice daily, 31% and 28%, respectively in patients receiving placebo, and 53% in patients receiving adalimumab 40 mg subcutaneously once every 2 weeks (OPAL BROADEN only). 
U 3. mjesecu u ispitivanjima OPAL BROADEN i OPAL BEYOND stopa bolesnika s odgovorom prema upitniku HAQ-DI (odgovor je definiran kao smanjenje od početne vrijednosti od ≥ 0,35) iznosila je 53% odnosno 50% u bolesnika koji su primali 5 mg tofacitiniba dva puta dnevno, 31%
Tofacitinib 10 mg film-coated tablets 
Tofacitinib 10 mg filmom obložene tablete
XELJANZ is for oral use. 
XELJANZ se uzima kroz usta.
Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. 
Primarna mjera ishoda: Remisija je bila definirana kao klinička remisija (Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja koji iznosi 0.
XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets 
XELJANZ 5 mg filmom obložene tablete XELJANZ 10 mg filmom obložene tablete
EU/1/17/1178/010 30 prolonged-release tablets EU/1/17/1178/011 90 prolonged-release tablets 
EU/1/17/1178/010 30 tableta s produljenim oslobađanjem EU/1/17/1178/011 90 tableta s produljenim oslobađanjem
The incidence rates and types of serious infections in the UC clinical studies were generally similar to those reported in RA clinical studies with tofacitinib monotherapy treatment groups. 
U skupinama liječenim tofacitinibom u monoterapiji, stope incidencije i vrste ozbiljnih infekcija u kliničkim ispitivanjima ulceroznog kolitisa uglavnom su bile slične onima prijavljenim u kliničkim ispitivanjima RA.
Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval) 
Podaci iz 6. i 12. mjeseca su srednje vrijednosti promjena u odnosu na početne vrijednosti Razlika tofacitinib minus MTX dobivena metodom najmanjih kvadrata (95% CI = 95%-tni interval pouzdanosti)
In the controlled portion of the RA phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT elevations greater than 3x ULN were observed in 1.65%, 0.41%, and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively. 
U kontroliranom dijelu ispitivanja RA-a faze 3 uz monoterapiju (0 - 3 mjeseca) (ispitivanje I, vidjeti dio 5.1), porast ALT-a veći od 3 x GGN zabilježen je u 1,65%, 0,41% odnosno 0% bolesnika koji su primali placebo, 5 mg tofacitiniba, odnosno 10 mg tofacitiniba dva puta dnevno.
Tofacitinib 5 mg twice daily + MTX N=376 
Tofacitinib 5 mg dva puta dnevno + MTX N=376
Placebo Tofacitinib 5 mg twice daily 
Placebo Tofacitinib 5 mg dva puta dnevno
In the RA long-term extension studies, on background DMARDs, ALT elevations greater than 3x ULN were observed in 1.8% and 1.6% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively. 
U dugoročnim nastavcima ispitivanja RA-a uz osnovno liječenje DMARD-ovima, porast ALT-a veći od 3 x GGN zabilježen je u 1,8% bolesnika koji su primali 5 mg tofacitiniba i u 1,6% bolesnika koji su primali 10 mg tofacitiniba dvaput dnevno.
- Each 11 mg prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate). 
- Jedna tableta s produljenim oslobađanjem od 11 mg sadrži 11 mg tofacitiniba (u obliku tofacitinibcitrata).
AST elevations greater than 3x ULN were observed in < 1.0% in both the tofacitinib 5 mg and 10 mg twice daily groups. 
Porast AST-a veći od 3 x GGN zabilježen je u < 1,0% bolesnika i u skupinama liječenim s 5 mg i onim s 10 mg tofacitiniba dvaput dnevno.
EU/1/17/1178/007 56 film-coated tablets EU/1/17/1178/008 112 film-coated tablets EU/1/17/1178/009 182 film-coated tablets 
EU/1/17/1178/007 56 filmom obloženih tableta EU/1/17/1178/008 112 filmom obloženih tableta EU/1/17/1178/009 182 filmom obložene tablete
Tofacitinib 10 mg twice daily + MTX 
Tofacitinib 10 mg dva puta dnevno + MTX
Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. 
Remisija je bila definirana kao klinička remisija (Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja 0.
N ORAL Step: TNF inhibitor inadequate responders Tofacitinib 5 mg twice daily + MTX 
N % ORAL Step: Bolesnici s neodgovarajućim odgovorom na TNF inhibitor Tofacitinib 5 mg dva puta dnevno + MTX
This treatment difference from placebo was similar between tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily in the subgroup of patients without prior TNF inhibitor failure. 
Ova razlika u liječenju u odnosu na placebo bila je slična u podskupini bolesnika bez prethodno neuspješnog liječenja inhibitorom TNF-a koji su liječeni s 5 mg tofacitiniba primijenjenog dva puta dnevno i onih liječenih s 10 mg tofacitiniba primijenjenog dva puta dnevno.
Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 12 months. 
Bolesnici koji su bili randomizirani u skupinu liječenu tofacitinibom primali su tofacitinib 5 mg dva puta dnevno ili 10 mg dva puta dnevno tijekom 12 mjeseci.
ΔLEIf Month 3 Month 6 Month 12 
ΔLEI 3. mjesec 6. mjesec 12. mjesec
EU/1/17/1178/003 56 film-coated tablets EU/1/17/1178/004 182 film-coated tablets EU/1/17/1178/014 112 film-coated tablets 
EU/1/17/1178/003 56 filmom obloženih tableta EU/1/17/1178/004 182 filmom obložene tablete EU/1/17/1178/014 112 filmom obloženih tableta
mTSSc Baseline Month 6 Month 12 
ΔDSS 3. mjesec 6. mjesec 12. mjesec
Study I (O RAL 
Ispitivanje VI (ORAL
Included TNF Inhibitor naïve patients c. 
Uključuje bolesnike koji nisu prethodno primali inhibitor TNF-a c.
• Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily. 
• dozu tofacitiniba treba sniziti na 5 mg dva puta dnevno u bolesnika koji primaju 10 mg dva puta dnevno.
0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% of patients for the 5 mg twice daily and 10 mg twice daily doses combined. 
3 u 1,9% bolesnika, sveukupno za bolesnike liječene s 5 mg dva puta dnevno i 10 mg dva puta dnevno.
XELJANZ 11 mg prolonged-release tablets tofacitinib 
XELJANZ 11 mg tablete s produljenim oslobađanjem tofacitinib
Tofacitinib 5 mg or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in ORAL Solo and ORAL Sync. 
Bolesnici liječeni tofacitinibom 5 mg ili 10 mg dva puta dnevno pokazali su značajno veće poboljšanje fizičkih funkcija u usporedbi s onima koji su primali placebo već u 2. tjednu u ispitivanjima ORAL Solo i ORAL Sync.
Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 6 months. 
Bolesnici koji su bili randomizirani u skupinu liječenu tofacitinibom primali su tofacitinib 5 mg dva puta dnevno ili 10 mg dva puta dnevno tijekom 6 mjeseci.
• Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily. 
• dozu tofacitiniba treba sniziti na 5 mg jednom dnevno u bolesnika koji primaju 5 mg dva puta dnevno.
EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets 
EU/1/17/1178/005 60 filmom obloženih tableta EU/1/17/1178/006 180 filmom obloženih tableta
Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 
Remisija je bila definirana kao klinička remisija (ukupni Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja koji iznosi 0.
Tofacitinib 10 mg twice daily + MTX N=290 Mean (SD)a 
Tofacitinib od 10 mg dva puta dnevno + MTX N=290 Srednja vrijednost (SD)a
Table 14: Phase 3 clinical studies of tofacitinib 5 mg and 10 mg twice daily doses in patients with UC 
Tablica 14: Klinička ispitivanja faze 3 tofacitiniba u dozi od 5 mg i 10 mg dva puta dnevno u bolesnika s ulceroznim kolitisom Ispitivanje uvodnog liječenja OCTAVE Induction 1
Tofacitinib 10 mg twice daily + MTX N=309 
Tofacitinib 10 mg dva puta dnevno + MTX N=309
Tofacitinib 5 mg twice daily + DMARD(s) N=312 
Tofacitinib 5 mg dva puta dnevno + DMARD(ovi) N=312
Table 6: Adverse drug reactions 
Tablica 6: Nuspojave
In the RA long-term extension studies, on monotherapy, ALT elevations greater than 3x ULN were observed in 1.1% and 1.4% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively. 
U dugoročnim nastavcima ispitivanja RA-a, uz monoterapiju tofacitinibom porast ALT-a veći od 3 x GGN zabilježen je u 1,1% bolesnika koji su primali 5 mg i u 1,4% bolesnika koji su primali 10 mg dvaput dnevno.
In controlled phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg film-coated tablets twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients). 
U kontroliranim kliničkim ispitivanjima faze 3, stope infekcija kroz 0-3 mjeseci u skupinama koje su primale tofacitinib u monoterapiji bile su 16,2% (100 bolesnika) uz dozu od 5 mg filmom obloženih tableta dvaput dnevno (ukupno 616 bolesnika), odnosno 17,9% (115 bolesnika) uz dozu od 10 mg dvaput dnevno (ukupno 642 bolesnika) u usporedbi s 18,9% (23 bolesnika) u skupini koja je primala placebo (ukupno 122 bolesnika).
Placebo Tofacitinib 10 mg twice daily 
Placebo Tofacitinib 10 mg dva puta dnevno
Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily. 
Dozu tofacitiniba treba sniziti na 5 mg dva puta dnevno u bolesnika koji primaju 10 mg dva puta dnevno.
Tofacitinib 10 mg twice daily Mean difference from MTXd (CI) 
Tofacitinib 10 mg dva puta dnevno Srednja vrijednost razlike od MTX (CI)
Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate). 
Jedna tableta sadrži 5 mg tofacitiniba (u obliku tofacitinibcitrata).
Tofacitinib 5 mg twice daily + MTX N=277 Mean (SD)a 
Tofacitinib 5 mg dva puta dnevno + MTX N=277 Srednja vrijednost (SD)
XELJANZ 10 mg film-coated tablets 
XELJANZ 10 mg filmom obložena tableta
Tofacitinib 10 mg twice daily + MTX N=134 
Tofacitinib 10 mg dva puta dnevno + MTX N=134
Tofacitinib 5 mg twice daily + MTX N=316 
Tofacitinib 5 mg dva puta dnevno + MTX N=316
Tofacitinib 10mg twice daily N=368 Mean (SD)a 
Tofacitinib 10 mg dva puta dnevno N=368 Srednja vrijednost (SD)
Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo at week 8 in the total and all 4 domain scores of the Inflammatory Bowel Disease Questionnaire (IBDQ) (bowel symptoms, systemic function, emotional function, and social function) in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2). 
Inflammatory Bowel Disease Questionnaire, IBDQ) (crijevnim simptomima, sistemskoj funkciji, emocionalnoj funkciji i društvenoj funkciji) u ispitivanjima uvodnog liječenja (OCTAVE Induction 1, OCTAVE Induction 2), u usporedbi s placebom.
ORAL Standard: MTX inadequate responders 
ORAL Standard: Bolesnici s neodgovarajućim odgovorom na MTX
Do not crush, split or chew. 
Tablete nemojte zdrobiti, prelomiti ili žvakati.
With prior TNF inhibitor failure 
Uz prethodno neuspješno liječenje inhibitorom TNF-a
Tofacitinib 5 mg twice daily Mean difference from MTXd (CI) 
Tofacitinib 5 mg dva puta dnevno Srednja vrijednost razlike od MTX (CI)
Switching between tofacitinib 5 mg film-coated tablets and tofacitinib 11 mg prolonged-release tablets 
Prelazak s tofacitinib filmom obloženih tableta od 5 mg na tofacitinib tablete s produljenim oslobađanjem od 11 mg, i obratno
Patients randomised to placebo were advanced in a blinded manner at month 3 to either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily and received treatment until month 6. 
Bolesnici randomizirani u skupinu koja je primala placebo, prebačeni su u 3. mjesecu na zaslijepljen način na 5 mg tofacitiniba dva puta dnevno ili 10 mg tofacitiniba dva puta dnevno te je njihovo liječenje trajalo do 6. mjeseca.
Tofacitinib 5 mg twice daily + MTX N=133 
Tofacitinib 5 mg dva puta dnevno + MTX N=133
Adalimumab 40 mg SC QOW + MTX 
Adalimumab 40 mg s.c. svaki drugi tjedan + MTX 6. mjesec Placebo + MTX
Tofacitinib 5 mg twice daily monotherapy N=241 
Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=241
XELJANZ 5 mg film-coated tablets 
XELJANZ 5 mg filmom obložena tableta
In controlled phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients). 
U kontroliranim kliničkim ispitivanjima faze 3, stope infekcija kroz 0-3 mjeseci u skupinama koje su primale tofacitinib u monoterapiji bile su 16,2% (100 bolesnika) uz dozu od 5 mg dvaput dnevno (ukupno 616 bolesnika), odnosno 17,9% (115 bolesnika) uz dozu od 10 mg dvaput dnevno (ukupno 642 bolesnika) u usporedbi s 18,9% (23 bolesnika) u skupini koja je primala placebo (ukupno 122 bolesnika).
In controlled phase 3 clinical studies with background DMARDs, the rates of infections over 0-3 months in the 5 mg twice daily (total 973 patients) and 10 mg twice daily (total 969 patients) tofacitinib plus DMARD group were 21.3% (207 patients) and 21.8% (211 patients), respectively, compared to 18.4% (103 patients) in the placebo plus DMARD group (total 559 patients). 
U kontroliranim kliničkim ispitivanjima faze 3 s osnovnim liječenjem DMARD-ovima, stope infekcija kroz 0-3 mjeseci bile su 21,3% (207 bolesnika) u skupini koja je primala 5 mg dva puta dnevno (ukupno 973 bolesnika) i 21,8% (211 bolesnika) u skupini koja je primala 10 mg dva puta dnevno (ukupno 969 bolesnika) tofacitiniba i DMARD-a, u usporedbi s 18,4% (103 bolesnika) u skupini koja je primala placebo i DMARD (ukupno 559 bolesnika).
XELJANZ 11 mg prolonged-release tablet contains sorbitol This medicine contains approximately 152 mg sorbitol in each prolonged-release tablet. 
Ovaj lijek sadrži približno 152 mg sorbitola u jednoj tableti s produljenim oslobađanjem.
EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets 
EU/1/17/1178/001 60 filmom obloženih tableta EU/1/17/1178/002 180 filmom obloženih tableta
Each prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate). 
Jedna tableta s produljenim oslobađanjem sadrži 11 mg tofacitiniba (u obliku tofacitinibcitrata).
HDPE bottles with silica gel desiccant and child-resistant polypropylene closure containing 60 or 180 film-coated tablets. 
Jedna boca sadrži 60 ili 180 filmom obloženih tableta i sredstvo za sušenje u obliku silika gela.
There were no confirmed decreases in ANC below 500 cells/mm3 observed in any treatment group. 
Ni u jednoj od ispitivanih skupina nije zabilježeno potvrđeno smanjenje ABN-a ispod 500 stanica/mm
Patients receiving tofacitinib 5 mg or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan. 
U bolesnika koji su primali tofacitinib u dozi od 5 mg ili 10 mg dva puta dnevno došlo je do značajnog poboljšanja u odnosu na početne vrijednosti u obje ljestvice u usporedbi s bolesnicima koji su primali placebo u ispitivanjima ORAL Sync, ORAL Standard i ORAL Scan.
Month 3 NA 
3 u
Dose should be reduced to 5 mg film-coated tablets once daily when the indicated dose in the presence of normal hepatic function is 11 mg prolonged-release tablet once daily (see section 5.2). 
Dozu treba sniziti na 5 mg jednom dnevno u obliku filmom obložene tablete kada indicirana doza u slučaju normalne funkcije bubrega iznosi 11 mg jednom dnevno u obliku tablete s produljenim oslobađanjem (vidjeti dio
Patients receiving tofacitinib 5 mg or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies. 
U bolesnika koji su primali tofacitinib u dozi od 5 mg ili 10 mg dva puta dnevno nađeno je značajno smanjenje umora u odnosu na početne vrijednosti u usporedbi s bolesnicima koji su primali placebo u svih 5 ispitivanja.
Tofacitinib 10 mg twice daily 
Tofacitinib 10 mg dva puta dnevno
Tofacitinib 5 mg twice daily N=344 Mean (SD)a 
Tofacitinib 5 mg dva puta dnevno N=344 Srednja vrijednost (SD)
6 months 2 years 
6 mjeseci 1 godina 1 godina 2 godine 6 mjeseci 2 godine 1 godina
Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate). 
Jedna tableta sadrži 10 mg tofacitiniba (u obliku tofacitinibcitrata).
Adalimumab 40 mg QOW + MTX 
Adalimumab 40 mg svaki drugi tjedan + MTX
Patients randomised to placebo were advanced in a blinded manner at month 3 to either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily and received treatment until month 12. 
Bolesnici randomizirani u skupinu koja je primala placebo, prebačeni su u 3. mjesecu na zaslijepljen način na tofacitinib 5 mg dva puta dnevno ili na 10 mg dva puta dnevno te je njihovo liječenje trajalo do 12. mjeseca.
Tofacitinib 5 mg twice daily monotherapy N=370 
Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=370
Tofacitinib 5 mg twice daily + MTX Mean difference from placebob (CI) 
Tofacitinib 5 mg dva puta dnevno + MTX Srednja vrijednost razlike od placeba (CI)
Placebo Placebo 
Placebo
TNFi inadequate responders b 
TNFi Bolesnici s neadekvatnim odgovorom
Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily. 
Dozu treba sniziti na 5 mg jednom dnevno kada indicirana doza u slučaju normalne funkcije bubrega iznosi 5 mg dva puta dnevno.
Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal renal function is 10 mg twice daily. 
Dozu treba sniziti na 5 mg dva puta dnevno kada indicirana doza u slučaju normalne funkcije bubrega iznosi 10 mg dva puta dnevno.
Control 
Pretrage
XELJANZ 5 mg film-coated tablets tofacitinib 
XELJANZ 5 mg filmom obložene tablete tofacitinib
Vaccine studies 
Ispitivanja s cjepivima
Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal hepatic function is 5 mg twice daily. 
Dozu treba sniziti na 5 mg jednom dnevno kada indicirana doza u slučaju normalne funkcije jetre iznosi 5 mg dva puta dnevno.
In the clinical studies in UC, changes in liver enzyme tests observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA. 
U kliničkim ispitivanjima ulceroznog kolitisa promjene u pretragama jetrenih enzima opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
XELJANZ 10 mg film-coated tablets tofacitinib 
XELJANZ 10 mg filmom obložene tablete tofacitinib
Remissiona With prior TNF inhibitor failure 
Prethodno neuspješno liječenje inhibitorom TNF-a
Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib. 
Jedna filmom obložena tableta sadrži 5 mg tofacitiniba u obliku tofacitinibcitrata.
Tofacitinib 10 mg twice daily monotherapy N=394 
Tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno N=394
Tofacitinib 10 mg twice daily monotherapy N=243 
Tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno N=243
You can start the Xeljanz 11 mg prolonged-release tablets once daily the day following the last dose of XELJANZ 5 mg film-coated tablets. 
Dan nakon što ste uzeli zadnju dozu XELJANZ 5 mg filmom obloženih tableta možete započeti s uzimanjem XELJANZ 11 mg tableta s produljenim oslobađanjem, koje trebate uzimati jednom dnevno.
Each film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib. 
Jedna filmom obložena tableta sadrži 10 mg tofacitiniba u obliku tofacitinibcitrata.
Switching between tofacitinib 11 mg prolonged-release tablets and tofacitinib 5mg film-coated tablets 
Prelazak s tofacitinib tableta s produljenim oslobađanjem od 11 mg na tofacitinib filmom obložene tablete od 5 mg, i obratno
Tofacitinib 10 mg twice daily + MTX Mean difference from placebob 
Tofacitinib 10 mg dva puta dnevno + MTX Srednja vrijednost razlike od placeba (CI)
In the clinical studies in UC, changes in lipids observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA. 
U kliničkim ispitivanjima ulceroznog kolitisa promjene u lipidima opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
• skin blisters 
• mjehure na koži
Each prolonged-release tablet contains tofacitinib citrate, equivalent to 11 mg tofacitinib. 
Jedna tableta s produljenim oslobađanjem sadrži 11 mg tofacitiniba u obliku tofacitinibcitrata.
- if you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach or intestines (see section 4) - if you have kidney problems - if you are planning to get vaccinated, tell your doctor. 
- ako imate problema s bubrezima - ako se planirate cijepiti, obavijestite svog liječnika.
Examination of age, sex, race, baseline disease activity and PsA subtype did not identify differences in response to tofacitinib. 
Ispitivanja dobi, spola, rase, početne aktivnosti bolesti i podtipa
Included TNF Inhibitor naïve patients. 
Uključuje bolesnike koji nisu prethodno primali inhibitor TNF-a.
In the clinical studies in UC, changes in ALC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA. 
U kliničkim ispitivanjima ulceroznog kolitisa promjene u ALC-u opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
• stomach ache 
Steatoza jetre
Table 3: Low haemoglobin value Low haemoglobin value (Section 4.4) 
Niska razina hemoglobina (vidjeti dio 4.4)
Creatinine clearance 
Prijavljivanje nuspojava
In the clinical studies in UC, changes in ANC observed with tofacitinib treatment were similar to the changes observed in clinical studies in RA. 
U kliničkim ispitivanjima ulceroznog kolitisa promjene u ABN-u opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
CARTON FOR 11 MG BLISTER PACK 
KUTIJA ZA BLISTER PAKIRANJA S TABLETAMA OD 11 MG
Certain types of vaccines should not be given when taking XELJANZ. 
Bolesnik koji uzima XELJANZ ne smije biti cijepljen određenim cjepivima.
Without prior TNF inhibitor failureb 
Bez prethodno neuspješnog liječenja inhibitorom TNF-a b
Date of first authorisation: 22nd May 2017 
Datum prvog odobrenja: 22. svibnja 2017
Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made. 
Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2 međutim nije moguće dati preporuku o doziranju.
Severe hypotension (< 90/50 mmHg) 
Teška hipotenzija (< 90/50 mmHg)