natgillin/translations-raw huggingface dataset:
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. 
placebom ili MTX-om kontroliranog ispitivanja, iznosio je 3,8% u bolesnika koji su uzimali tofacitinib.
XELJANZ is not recommended for use with medicines that depress the immune system, including so-called targeted biologic (antibody) therapies, such as those that inhibit tumour necrosis factor, interleukin-17, interleukin-12/interleukin-23, anti-integrins, and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus. 
interleukin 17, interleukin 12/interleukin 23, anti-integrine i snažne kemijske imunosupresivne lijekove, uključujući azatioprin, merkaptopurin, ciklosporin i takrolimus.
Tofacitinib 5 mg Twice Daily N=384 
Tofacitinib 5 mg dva puta dnevno N=384
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 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, u usporedbi s 18,4% (103 bolesnika) u skupini koja je primala placebo i DMARD (ukupno 559 bolesnika).
NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib 
NAZIV LIJEKA XELJANZ 10 mg tablete tofacitinib
Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a 
Tofacitinib 5 mg dva puta dnevno + MTX N=277 Srednja vrijednost (SD)a
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
Tofacitinib was shown to be teratogenic in rats and rabbits, and have effects in rats on female fertility (decreased pregnancy rate; decreases in the numbers of corpora lutea, implantation sites, and viable foetuses; and an increase in early resorptions), parturition, and peri/postnatal development. 
(smanjena stopa gravidnosti; smanjenje broja žutih tijela, mjesta implantacije i živućih fetusa; i porast u ranoj resorpciji), okot i peri-/postnatalni razvoj.
Tofacitinib 5 mg Twice Daily N=344 Mean (SD)a 
Tofacitinib 5 mg dva puta dnevno N=344 Srednja vrijednost (SD)a
ACR20 Month 3 Month 6 
ACR20 3. mjesec 6. mjesec
In the controlled portion of the RA Phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively. 
U kontroliranom dijelu ispitivanja RA-a faze 3 uz osnovno liječenje DMARD-ovima (0 - 3 mjeseca) (ispitivanja II-V, vidjeti dio 5.1), porast ALT-a veći od 3 x GGN zabilježen je u 0,9%, 1,24% odnosno 1,14% bolesnika koji su primali placebo, 5 mg tofacitiniba, odnosno 10 mg tofacitiniba dva puta dnevno.
a. ≤3 weekly doses (MTX-naïve). 
≤ 3 doze tjedno (MTX-naivni, tj. koji prethodno nisu liječeni metotreksatom).
Tofacitinib 10 mg Twice Daily N=197 
Tofacitinib 10 mg dva puta dnevno N = 197
Tofacitinib 5 mg Twice Daily N=198 
Tofacitinib 5 mg dva puta dnevno N = 198
Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo in physical component summary (PCS) and mental component summary (MCS) scores, and in all 8 domains of the SF-36 in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2). 
Primjena 10 mg tofacitiniba dva puta dnevno dovela je do većeg poboljšanja rezultata profila fizičkog zdravlja (engl. physical component summary, PCS) i profila duševnog zdravlja (engl. mental component summary, MCS) u odnosu na početne vrijednosti u usporedbi s placebom te u pogledu svih
Tofacitinib 10 mg Twice Daily + DMARD(s) N=315 
Tofacitinib 10 mg dva puta dnevno + DMARD(ovi) N=315
Patients receiving tofacitinib 5 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 5 mg ili 10 mg dva puta dnevno nađeno je značajno poboljšanje 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.
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib 
NAZIV LIJEKA XELJANZ 5 mg tablete tofacitinib
In the long-term safety all exposure population, the overall rates of serious infections were 2.4 and 3.0 patients with events per 100 patient-years for 5 mg and 10 mg twice daily tofacitinib groups, respectively. 
U ispitivanjima dugoročne sigurnosti za cjelokupnu izloženost populacije, ukupne stope ozbiljnih infekcija bile su 2,4 i 3,0 bolesnika s događajem na 100 bolesnik-godina za skupine koje su primale
Prophylactic zoster vaccination should be considered in accordance with vaccination guidelines. 
Potrebno je uzeti u obzir profilaktičko cijepljenje protiv herpesa zostera, sukladno smjernicama za cijepljenje.
Tofacitinib 10 mg Twice Daily + MTX N=290 Mean (SD)a 
Tofacitinib 10 mg dva puta dnevno + MTX N=290 Srednja vrijednost (SD)a
In the RA Phase 3 monotherapy study (0-24 months) (study VI, see section 5.1), ALT elevations greater than 3x ULN were observed in 7.1%, 3.0%, and 3.0% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively. 
U ispitivanju RA-a faze 3 uz monoterapiju (0 - 24 mjeseci) (ispitivanje VI, vidjeti dio 5.1), porast ALT-a veći od 3 x GGN zabilježen je u 7,1%, 3,0% odnosno 3,0% bolesnika koji su primali MTX, 5 mg tofacitiniba, odnosno 10 mg tofacitiniba dva puta dnevno.
Exposure in monkeys at the no observed adverse effect level (NOAEL) for the lymphomas was approximately 1 or 0.5 times the clinical exposure level of 5 mg or 10 mg twice daily. 
(NOAEL) za limfome u majmuna bila je približno 1 ili 0,5 puta veća od razine izloženosti uz dozu od 5 mg ili 10 mg dva puta dnevno u kliničkoj primjeni.
Tofacitinib 10 mg Twice Daily N=429 
Tofacitinib 10 mg dva puta dnevno N = 429
• The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using XELJANZ o That treatment with XELJANZ may increase the risk of infections and non melanoma skin cancer o That patients should inform health professionals if they are planning to receive any vaccine or become pregnant o Signs or symptoms of the following safety concern and when to seek attention from a HCP: infections, herpes zoster reactivation, non-melanoma skin cancer, transaminase elevation and potential for drug-induced liver injury, gastrointestinal perforation, interstitial lung disease, increased immunosuppression when used in combination with biologics and immunosuppressants including B lymphocyte depleting agents, increased risk of adverse events when XELJANZ is administered in combination with MTX, increased exposure to XELJANZ when co-administered with CYP3A4 and CYP2C19 
uključujući hitna stanja, da bolesnik uzima XELJANZ o Da liječenje lijekom XELJANZ može povećati rizik od infekcije i nemelanomskog raka kože o Da bolesnici trebaju obavijestiti zdravstvene radnike ako planiraju primiti bilo koje cjepivo ili trudnoću o Znakove ili simptome sljedećih problema s obzirom na sigurnost primjene te kad potražiti pomoć zdravstvenog radnika: infekcije, reaktivacija herpes zostera, nemelanomski rak kože, porast transaminaza i potencijal za lijekom uzrokovano oštećenje jetre,
5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13). 
U 3. mjesecu u bolesnika koji su primali 5 mg tofacitiniba dva puta dnevno poboljšanje fizičkih funkcija (p ≤ 0,05) u odnosu na početne vrijednosti bilo je veće nego u bolesnika koji su primali placebo (vidjeti Tablicu 13).
Tofacitinib Twice Daily + MTX 
Tofacitinib dva puta dnevno + MTX
Table 3: Low Haemoglobin Value Low Haemoglobin Value (Section 4.4) 
Niska razina hemoglobina (dio 4.4)
ORAL Standard: MTX Inadequate Responders 
ORAL Standard: Bolesnici s neodgovarajućim odgovorom na MTX
ANNEX III LABELLING AND PACKAGE LEAFLET 
Tablica 6: Nuspojave Klasifikacij a organskih sustava
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. 
Ulcerozni kolitis 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.
Placebo Tofacitinib 5 mg Twice Daily 
Placebo Tofacitinib 5 mg dva puta dnevno
MARKETING AUTHORISATION NUMBER(S) 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 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET 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
Treatment with tofacitinib resulted in significant improvements in some signs and symptoms of PsA, as assessed by the ACR20 response criteria compared to placebo at month 3. 
PsA-a procijenjenih na temelju odgovora prema kriteriju ACR20, u usporedbi sa skupinom koja je primala placebo.
Patients receiving tofacitinib 5 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 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 
Dobroćudne, zloćudne i nespecificira ne novotvorine
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. 
lipoproteini niske gustoće (LDL) i lipoproteini visoke gustoće (HDL).
Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob 
Tofacitinib 10 mg dva puta dnevno + MTX Srednja vrijednost razlike od placebab
4.1 Therapeutic indication 
4.1 Terapijske indikacije Reumatoidni artritis
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
In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm3 occurred in 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. 
U populaciji s RA-om u ispitivanju dugoročne sigurnosti potvrđeno je smanjenje ALC-a ispod 500 stanica/mm3 u 1,3% bolesnika, odnosno ALC između 500 i 750 stanica/mm3 u 8,4% bolesnika, sveukupno za bolesnike liječene s 5 mg dva puta dnevno i 10 mg dva puta dnevno.
MARKETING AUTHORISATION NUMBER(S) 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 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET 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 13.
Tofacitinib 10 mg Twice Daily + MTX 
Tofacitinib 10 mg dva puta dnevno + MTX
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER PAKIRANJA S TABLETAMA OD 5 MG
HDPE bottles with silica gel desiccant and child-resistant caps containing 60 or 180 film-coated tablets. 
Jedna boca sadrži 60 ili 180 filmom obloženih tableta i silika gel kao sredstvo za sušenje.
d. Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE 
emocionalnoj funkciji i društvenoj funkciji) u ispitivanjima uvodnog liječenja (OCTAVE Induction 1,
Adalimumab 40 mg SC QOW + MTX 
Adalimumab 40 mg s.c. svaki drugi tjedan + MTX
For recommended modifications based on lymphocyte counts, see section 4.2. 
Za preporučene izmjene na temelju broja limfocita vidjeti dio 4.2. Neutrofili
DAS28=Disease Activity Score 28 joints, ESR=Erythrocyte Sedimentation Rate, HAQ-DI=Health Assessment Questionnaire Disability Index, DMARD=disease-modifying antirheumatic drug, IR=inadequate responder, csDMARD=conventional synthetic DMARD, TNFi=tumour necrosis factor inhibitor, NA=not applicable, ADA=adalimumab, MTX=methotrexate. 
poboljšanja, DAS28= Rezultat aktivnosti bolesti za 28 zglobova, ESR = brzina sedimentacije eritrocita, HAQ-DI=Upitnik o zdravstvenom stanju - indeks onesposobljenosti, DMARD=
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER PAKIRANJA S TABLETAMA OD 10 MG
PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets 
OBLIK I SADRŽAJ 56 filmom obloženih tableta 112 filmom obloženih tableta 182 filmom obložene tablete
Tofacitinib 5 mg Twice Daily Tofacitinib 10 mg Twice Daily Placebo 
Tofacitinib 5 mg dva puta dnevno Tofacitinib 10 mg dva puta dnevno
- 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. 
(pogledajte dio 4). - ako imate problema s bubrezima - ako se planirate cijepiti, obavijestite svog liječnika.
MTX N=168 Mean (SD) 
N=168 Srednja vrijednost (SD)a
Corticosteroidfree remission among patients taking corticosteroids at baselinea,g 
tjednu među bolesnicima u remisiji prije početka terapijee,f Remisija bez kortikosteroida među bolesnicima koji su uzimali kortikosteroide prije početka terapijea,g
Placebo Tofacitinib 10 mg Twice Daily 
Placebo Tofacitinib 10 mg dva puta dnevno
Tofacitinib 10 mg Twice Daily + MTX N=309 
Tofacitinib 10 mg dva puta dnevno + MTX N=309
ANNEX II 
Induction 2
Tofacitinib 5 mg Twice Daily + DMARD(s) N=312 
Tofacitinib 5 mg dva puta dnevno + DMARD(ovi) N=312
With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failure b 
Uz prethodno neuspješno liječenje inhibitorom TNF-a Bez prethodno neuspješnog liječenja inhibitorom TNF
a Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily. 
a Dozu tofacitiniba treba sniziti na 5 mg dva puta dnevno u bolesnika koji primaju 10 mg dva puta dnevno.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1178/005 60 filmom obloženih tableta EU/1/17/1178/006 180 filmom obloženih tableta
Month 3 NA 
3. mjesec NP
Tofacitinib 10 mg Twice Daily + MTX N=134 
Tofacitinib 10 mg dva puta dnevno + MTX N=134
Reduce Tofacitinib Dosea Reduce Tofacitinib Dosea May Decrease Efficacy 
Sniziti dozu tofacitiniba a
Tofacitinib 5 mg Twice Daily + MTX N=316 
Tofacitinib 5 mg dva puta dnevno + MTX N=316
Study VII (ORAL Strategy) 
Ispiztivanje VII (ORAL
With prior TNF inhibitor failure Without prior TNF inhibitor failureb 
Bez prethodno neuspješnog liječenja inhibitorom TNF-ab
Tofacitinib 5 mg Twice Daily + MTX N=133 
Tofacitinib 5 mg dva puta dnevno + MTX N=133
Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ. 
8 tjedana nakon početka liječenja lijekom XELJANZ.
Tofacitinib 5 mg Twice Daily Monotherapy N=241 
Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=241
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 5 MG BOTTLE IMMEDIATE PACKAGING 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA BOCU S TABLETAMA OD 5 MG
Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement from baseline compared to placebo in the SF-36v2 physical functioning domain, the SF-36v2 physical component summary score, and FACIT-F scores at month 3 in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05). 
U 3. mjesecu u ispitivanjima OPAL BROADEN i OPAL BEYOND poboljšanje u domeni fizičkih funkcija u upitniku SF-36v2, u sažetom rezultatu upitnika fizičkog funkcioniranja SF-36v2 i rezultatima upitnika FACIT-F u odnosu na početnu vrijednost bilo je veće u bolesnika koji su primali
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 10 MG BOTTLE IMMEDIATE PACKAGING 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA BOCU S TABLETAMA OD 10 MG
Musculoskeletal pain 
Istegnuće mišića
Improvement of endoscopic appearance of the mucosab 
Poboljšanje endoskopskog izgleda sluzniceb
Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib. 
Jedna filmom obložena tableta od 5 mg sadrži 5 mg tofacitiniba u obliku tofacitinibcitrata.
Tofacitinib 10 mg Twice Daily Mean Difference from MTXd (CI) 
Tofacitinib 10 mg dva puta dnevno Srednja vrijednost razlike od MTXd
Abbreviations: BSA=body surface area; ΔLEI=change from baseline in Leeds Enthesitis Index; ΔDSS=change from baseline in Dactylitis Severity Score; ACR20/50/70=American College of Rheumatology ≥ 20%, 50%, 
Kratice: BSA = površina tijela; ΔLEI = promjena u odnosu na početnu vrijednost prema indeksu entezitisa (engl.
Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI) 
Tofacitinib 5 mg dva puta dnevno Srednja vrijednost razlike od MTXd
e. Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least 
Održana remisija bez kortikosteroida bila je definirana kao stanje remisije bez uzimanja kortikosteroida najmanje 4 tjedna prije posjeta u 24. i 52. tjednu.
XELJANZ 5 mg film-coated tablets 
XELJANZ 5 mg filmom obložene tablete
improvement of endoscopic appearance of the mucosa, or sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline (Table 18). 
remisiju, poboljšanje endoskopskog izgleda sluznice ili održanu remisiju bez kortikosteroida u 24.
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 testovima jetrenih enzima opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
Tofacitinib 5 mg Twice Daily Monotherapy N=370 
Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=370
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). 
odnosno 28% u bolesnika koji su primali placebo i 53% u bolesnika koji su primali adalimumab 40 mg supkutano jednom svaka 2 tjedna (samo u ispitivanju OPAL BROADEN).
Least Squares Mean Change From Baseline in HAQ-DI Conventional Synthetic DMARD Inadequate Respondersa (TNFi-Naïve) 
antireumatik koji modificira tijek bolesti, IR=bolesnici s neodgovarajućim odgovorom, csDMARD= konvencionalni sintetski DMARD, TNFi=inhibitor čimbenika nekroze tumora, NP=nije primjenjivo,
Tuberculosis of central nervous system 
Urosepsa Diseminirana tuberkuloza
Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib. 
Jedna filmom obložena tableta od 10 mg sadrži 10 mg tofacitiniba u obliku tofacitinibcitrata.
(TNFi-Naïve) 
(Kaplan-Meierove krivulje)
Tofacitinib 5 mg Twice Daily + MTX Mean Difference from Placebob (CI) 
Tofacitinib 5 mg dva puta dnevno + MTX Srednja vrijednost razlike od placebab
• Your doctor may decide to extend the initial 10 mg twice a day treatment by an additional 
• Možda će liječnik odlučiti produžiti Vaše početno liječenje dozom od 10 mg primijenjeno dva puta dnevno za dodatnih 8 tjedana (ukupno 16 tjedana), nakon koje slijedi liječenje dozom od 5 mg primijenjenom dva puta dnevno.
In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily achieved the following endpoints at week 52 of OCTAVE Sustain as compared to placebo: remission, 
U obje podskupine bolesnika, bez obzira jesu li prethodno uspješno ili neuspješno liječeni inhibitorom TNF-a, udio bolesnika koji je u 52. tjednu ispitivanja OCTAVE Sustain ostvario sljedeće ishode:
Patients receiving tofacitinib 
5 mg tofacitiniba BID
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets 
XELJANZ 5 mg filmom obložene tablete XELJANZ 10 mg filmom obložene tablete
a. Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Key secondary endpoint: Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern). 
Ključna sekundarna mjera ishoda: Poboljšanje endoskopskog izgleda sluznice bilo je definirano kao Mayo endoskopski podrezultat 0 (normalna ili neaktivna bolest) ili 1 (eritem, smanjen vaskularni uzorak).
Tofacitinib 10 mg Twice Daily Monotherapy N=394 
Tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno N=394
If you are not sure regarding any of the information provided above, please contact your doctor. 
Imat ćete ili ste nedavno imali veliku operaciju Ako niste sigurni odnose li se gore navedene informacije na Vas, obratite se svom liječniku.
Tofacitinib 10 mg Twice Daily Monotherapy N=243 
Tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno N=243
Other malignancies were observed in clinical studies and the post-marketing setting, including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. 
između ostalih, rak pluća, rak dojke, melanom, rak prostate i rak gušterače.
With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failureb 
Bez prethodno neuspješnog liječenja inhibitorom TNF-ab Poboljšanje endoskopskog izgleda sluznicec
s r.o. 
TNF-a.
Time 
Vremenska točka
X-Ray 
MTX-IR
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana 
Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0) 1 52 11 400
a. Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Included TNF Inhibitor naïve patients. 
Remisija je bila definirana kao klinička remisija (Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja koji iznosi 0.
EXPIRY DATE 
Mjera ishoda Vrijeme
HAQ-DI 
I DOHVATA
Creatinine Clearance 
Prijavljivanje nuspojava
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