FrancophonIA/ELRC3.0 huggingface dataset:
English: Tofacitinib 10 mg Twice Daily N=476
Croatian: Tofacitinib 10 mg dva puta dnevno N = 476
English: 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.
Croatian: placebom ili MTX-om kontroliranog ispitivanja, iznosio je 3,8% u bolesnika koji su uzimali tofacitinib.
English: 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.
Croatian: interleukin 17, interleukin 12/interleukin 23, anti-integrine i snažne kemijske imunosupresivne lijekove, uključujući azatioprin, merkaptopurin, ciklosporin i takrolimus.
English: Tofacitinib 5 mg Twice Daily N=384
Croatian: Tofacitinib 5 mg dva puta dnevno N=384
English: 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).
Croatian: 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).
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib
Croatian: NAZIV LIJEKA XELJANZ 10 mg tablete tofacitinib
English: Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX N=277 Srednja vrijednost (SD)a
English: 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.
Croatian: Nakon dugotrajnog liječenja (medijan trajanja liječenja tofacitinibom od približno 5 godina), CD4+ i
English: 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.
Croatian: (smanjena stopa gravidnosti; smanjenje broja žutih tijela, mjesta implantacije i živućih fetusa; i porast u ranoj resorpciji), okot i peri-/postnatalni razvoj.
English: Tofacitinib 5 mg Twice Daily N=344 Mean (SD)a
Croatian: Tofacitinib 5 mg dva puta dnevno N=344 Srednja vrijednost (SD)a
English: ACR20 Month 3 Month 6
Croatian: ACR20 3. mjesec 6. mjesec
English: 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.
Croatian: 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.
English: a. ≤3 weekly doses (MTX-naïve).
Croatian: ≤ 3 doze tjedno (MTX-naivni, tj. koji prethodno nisu liječeni metotreksatom).
English: Tofacitinib 10 mg Twice Daily N=197
Croatian: Tofacitinib 10 mg dva puta dnevno N = 197
English: Tofacitinib 5 mg Twice Daily N=198
Croatian: Tofacitinib 5 mg dva puta dnevno N = 198
English: 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).
Croatian: 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
English: Tofacitinib 10 mg Twice Daily + DMARD(s) N=315
Croatian: Tofacitinib 10 mg dva puta dnevno + DMARD(ovi) N=315
English: 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.
Croatian: 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.
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib
Croatian: NAZIV LIJEKA XELJANZ 5 mg tablete tofacitinib
English: 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.
Croatian: 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
English: Prophylactic zoster vaccination should be considered in accordance with vaccination guidelines.
Croatian: Potrebno je uzeti u obzir profilaktičko cijepljenje protiv herpesa zostera, sukladno smjernicama za cijepljenje.
English: Tofacitinib 10 mg Twice Daily + MTX N=290 Mean (SD)a
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX N=290 Srednja vrijednost (SD)a
English: 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.
Croatian: 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.
English: 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.
Croatian: (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.
English: Tofacitinib 10 mg Twice Daily N=429
Croatian: Tofacitinib 10 mg dva puta dnevno N = 429
English: • 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
Croatian: 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,
English: 5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
Croatian: 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).
English: Tofacitinib Twice Daily + MTX
Croatian: Tofacitinib dva puta dnevno + MTX
English: Table 3: Low Haemoglobin Value Low Haemoglobin Value (Section 4.4)
Croatian: Niska razina hemoglobina (dio 4.4)
English: ORAL Standard: MTX Inadequate Responders
Croatian: ORAL Standard: Bolesnici s neodgovarajućim odgovorom na MTX
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: Tablica 6: Nuspojave Klasifikacij a organskih sustava
English: 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.
Croatian: 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.
English: Placebo Tofacitinib 5 mg Twice Daily
Croatian: Placebo Tofacitinib 5 mg dva puta dnevno
English: 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
Croatian: 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
English: 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.
Croatian: PsA-a procijenjenih na temelju odgovora prema kriteriju ACR20, u usporedbi sa skupinom koja je primala placebo.
English: Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
Croatian: 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.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificira ne novotvorine
English: 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.
Croatian: lipoproteini niske gustoće (LDL) i lipoproteini visoke gustoće (HDL).
English: Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX Srednja vrijednost razlike od placebab
English: 4.1 Therapeutic indication
Croatian: 4.1 Terapijske indikacije Reumatoidni artritis
English: 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.
Croatian: 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.
English: Tofacitinib 5 mg Twice Daily + MTX N=376
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX N=376
English: 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.
Croatian: 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.
English: 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
Croatian: 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.
English: Tofacitinib 10 mg Twice Daily + MTX
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER PAKIRANJA S TABLETAMA OD 5 MG
English: HDPE bottles with silica gel desiccant and child-resistant caps containing 60 or 180 film-coated tablets.
Croatian: Jedna boca sadrži 60 ili 180 filmom obloženih tableta i silika gel kao sredstvo za sušenje.
English: d. Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE
Croatian: emocionalnoj funkciji i društvenoj funkciji) u ispitivanjima uvodnog liječenja (OCTAVE Induction 1,
English: Adalimumab 40 mg SC QOW + MTX
Croatian: Adalimumab 40 mg s.c. svaki drugi tjedan + MTX
English: For recommended modifications based on lymphocyte counts, see section 4.2.
Croatian: Za preporučene izmjene na temelju broja limfocita vidjeti dio 4.2. Neutrofili
English: 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.
Croatian: poboljšanja, DAS28= Rezultat aktivnosti bolesti za 28 zglobova, ESR = brzina sedimentacije eritrocita, HAQ-DI=Upitnik o zdravstvenom stanju - indeks onesposobljenosti, DMARD=
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER PAKIRANJA S TABLETAMA OD 10 MG
English: PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets
Croatian: OBLIK I SADRŽAJ 56 filmom obloženih tableta 112 filmom obloženih tableta 182 filmom obložene tablete
English: Tofacitinib 5 mg Twice Daily Tofacitinib 10 mg Twice Daily Placebo
Croatian: Tofacitinib 5 mg dva puta dnevno Tofacitinib 10 mg dva puta dnevno
English: - 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.
Croatian: (pogledajte dio 4). - ako imate problema s bubrezima - ako se planirate cijepiti, obavijestite svog liječnika.
English: MTX N=168 Mean (SD)
Croatian: N=168 Srednja vrijednost (SD)a
English: Corticosteroidfree remission among patients taking corticosteroids at baselinea,g
Croatian: tjednu među bolesnicima u remisiji prije početka terapijee,f Remisija bez kortikosteroida među bolesnicima koji su uzimali kortikosteroide prije početka terapijea,g
English: Placebo Tofacitinib 10 mg Twice Daily
Croatian: Placebo Tofacitinib 10 mg dva puta dnevno
English: Tofacitinib 10 mg Twice Daily + MTX N=309
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX N=309
English: ANNEX II
Croatian: Induction 2
English: Tofacitinib 5 mg Twice Daily + DMARD(s) N=312
Croatian: Tofacitinib 5 mg dva puta dnevno + DMARD(ovi) N=312
English: 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
Croatian: Uz prethodno neuspješno liječenje inhibitorom TNF-a Bez prethodno neuspješnog liječenja inhibitorom TNF
English: a Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
Croatian: a Dozu tofacitiniba treba sniziti na 5 mg dva puta dnevno u bolesnika koji primaju 10 mg dva puta dnevno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
Croatian: 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
English: Month 3 NA
Croatian: 3. mjesec NP
English: Tofacitinib 10 mg Twice Daily + MTX N=134
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX N=134
English: Reduce Tofacitinib Dosea Reduce Tofacitinib Dosea May Decrease Efficacy
Croatian: Sniziti dozu tofacitiniba a
English: Tofacitinib 5 mg Twice Daily + MTX N=316
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX N=316
English: Study VII (ORAL Strategy)
Croatian: Ispiztivanje VII (ORAL
English: With prior TNF inhibitor failure Without prior TNF inhibitor failureb
Croatian: Bez prethodno neuspješnog liječenja inhibitorom TNF-ab
English: Tofacitinib 5 mg Twice Daily + MTX N=133
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX N=133
English: Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ.
Croatian: 8 tjedana nakon početka liječenja lijekom XELJANZ.
English: Tofacitinib 5 mg Twice Daily Monotherapy N=241
Croatian: Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=241
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 5 MG BOTTLE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA BOCU S TABLETAMA OD 5 MG
English: 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).
Croatian: 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
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 10 MG BOTTLE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA BOCU S TABLETAMA OD 10 MG
English: Musculoskeletal pain
Croatian: Istegnuće mišića
English: Improvement of endoscopic appearance of the mucosab
Croatian: Poboljšanje endoskopskog izgleda sluzniceb
English: Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Croatian: Jedna filmom obložena tableta od 5 mg sadrži 5 mg tofacitiniba u obliku tofacitinibcitrata.
English: Tofacitinib 10 mg Twice Daily Mean Difference from MTXd (CI)
Croatian: Tofacitinib 10 mg dva puta dnevno Srednja vrijednost razlike od MTXd
English: 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%,
Croatian: Kratice: BSA = površina tijela; ΔLEI = promjena u odnosu na početnu vrijednost prema indeksu entezitisa (engl.
English: Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI)
Croatian: Tofacitinib 5 mg dva puta dnevno Srednja vrijednost razlike od MTXd
English: e. Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least
Croatian: Održana remisija bez kortikosteroida bila je definirana kao stanje remisije bez uzimanja kortikosteroida najmanje 4 tjedna prije posjeta u 24. i 52. tjednu.
English: XELJANZ 5 mg film-coated tablets
Croatian: XELJANZ 5 mg filmom obložene tablete
English: 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).
Croatian: remisiju, poboljšanje endoskopskog izgleda sluznice ili održanu remisiju bez kortikosteroida u 24.
English: 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.
Croatian: U kliničkim ispitivanjima ulceroznog kolitisa promjene u testovima jetrenih enzima opažene kod liječenja tofacitinibom bile su slične promjenama opaženim u kliničkim ispitivanjima RA.
English: Tofacitinib 5 mg Twice Daily Monotherapy N=370
Croatian: Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=370
English: 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).
Croatian: 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).
English: Least Squares Mean Change From Baseline in HAQ-DI Conventional Synthetic DMARD Inadequate Respondersa (TNFi-Naïve)
Croatian: antireumatik koji modificira tijek bolesti, IR=bolesnici s neodgovarajućim odgovorom, csDMARD= konvencionalni sintetski DMARD, TNFi=inhibitor čimbenika nekroze tumora, NP=nije primjenjivo,
English: Tuberculosis of central nervous system
Croatian: Urosepsa Diseminirana tuberkuloza
English: Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Croatian: Jedna filmom obložena tableta od 10 mg sadrži 10 mg tofacitiniba u obliku tofacitinibcitrata.
English: (TNFi-Naïve)
Croatian: (Kaplan-Meierove krivulje)
English: Tofacitinib 5 mg Twice Daily + MTX Mean Difference from Placebob (CI)
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX Srednja vrijednost razlike od placebab
English: • Your doctor may decide to extend the initial 10 mg twice a day treatment by an additional
Croatian: • 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.
English: 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,
Croatian: 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:
English: Patients receiving tofacitinib
Croatian: 5 mg tofacitiniba BID
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
Croatian: XELJANZ 5 mg filmom obložene tablete XELJANZ 10 mg filmom obložene tablete
English: 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).
Croatian: 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).
English: Tofacitinib 10 mg Twice Daily Monotherapy N=394
Croatian: Tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno N=394