FrancophonIA/ELRC3.0 huggingface dataset:
English: The 2 key secondary endpoints were the proportion of patients with improvement of endoscopic appearance at week 52, and the proportion of patients with sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline of OCTAVE Sustain.
Croatian: Među bolesnicima u remisiji na početku ispitivanja OCTAVE Sustain 2 ključne sekundarne mjere ishoda bile su udio bolesnika s poboljšanjem endoskopskog izgleda u 52. tjednu i udio bolesnika s održanom remisijom bez kortikosteroida u 24. i 52. tjednu.
English: ORAL Scan: MTX inadequate responders
Croatian: ORAL Scan: Bolesnici s neodgovarajućim odgovorom na MTX
English: Prior TNFi failure Prior corticosteroid failure
Croatian: Prethodno neuspješno liječenje kortikosteroidima
English: ORAL Strategy: MTX inadequate responders
Croatian: ORAL Strategy: Bolesnici s neodgovarajućim odgovorom na MTX
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: 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, 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: 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: remisiju, poboljšanje endoskopskog izgleda sluznice ili održanu remisiju bez kortikosteroida u 24. i 52. tjednu među bolesnicima koji su bili u remisiji prije početka terapije, bio je veći među bolesnicima koji su uzimali 5 mg tofacitiniba dva puta dnevno ili 10 mg tofacitiniba dva puta dnevno nego u onih koji su primali placebo (tablica 18).
English: Dose adjustment in renal impairment for different strength tablets
Croatian: Klirens kreatinina Prilagodba doze kod oštećenja bubrega za tablete različitih jačina
English: Tofacitinib 10 mg twice daily N=429
Croatian: Tofacitinib 10 mg dva puta dnevno N = 429
English: Tofacitinib 5 mg film-coated tablets
Croatian: Tofacitinib 5 mg filmom obložene tablete
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 ocijenjenih na temelju odgovora prema kriteriju ACR20, u usporedbi sa skupinom koja je primala placebo.
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 5 mg tofacitiniba dva puta dnevno nego u bolesnika koji su primali placebo (nominalni p ≤ 0,05).
English: Tofacitinib twice daily + MTX
Croatian: Tofacitinib dva puta dnevno + MTX
English: 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).
Croatian: 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).
English: Tell your doctor immediately if you feel unwell.
Croatian: Ako se ne osjećate dobro, odmah se obratite liječniku.
English: BLISTER FOR 10 MG TABLETS
Croatian: BLISTERI ZA TABLETE OD 10 MG
English: EU/1/17/1178/012 28 prolonged-release tablets EU/1/17/1178/013 91 prolonged-release tablets
Croatian: EU/1/17/1178/012 28 tableta s produljenim oslobađanjem EU/1/17/1178/013 91 tableta s produljenim oslobađanjem
English: Month 3 Month 6 Month 12
Croatian: 3. mjesec 6. mjesec 12. mjesec
English: 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.
Croatian: 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.
English: 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).
Croatian: 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%
English: Tofacitinib 10 mg film-coated tablets
Croatian: Tofacitinib 10 mg filmom obložene tablete
English: XELJANZ is for oral use.
Croatian: XELJANZ se uzima kroz usta.
English: Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Croatian: Primarna mjera ishoda: Remisija je bila definirana kao klinička remisija (Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja koji iznosi 0.
English: 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: EU/1/17/1178/010 30 prolonged-release tablets EU/1/17/1178/011 90 prolonged-release tablets
Croatian: EU/1/17/1178/010 30 tableta s produljenim oslobađanjem EU/1/17/1178/011 90 tableta s produljenim oslobađanjem
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: 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: Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
Croatian: 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)
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: Placebo Tofacitinib 5 mg twice daily
Croatian: Placebo Tofacitinib 5 mg dva puta dnevno
English: 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.
Croatian: 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.
English: - Each 11 mg prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Croatian: - Jedna tableta s produljenim oslobađanjem od 11 mg sadrži 11 mg tofacitiniba (u obliku tofacitinibcitrata).
English: AST elevations greater than 3x ULN were observed in < 1.0% in both the tofacitinib 5 mg and 10 mg twice daily groups.
Croatian: 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.
English: 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: 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
English: Tofacitinib 10 mg twice daily + MTX
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX
English: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Croatian: Remisija je bila definirana kao klinička remisija (Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja 0.
English: N ORAL Step: TNF inhibitor inadequate responders Tofacitinib 5 mg twice daily + MTX
Croatian: N % ORAL Step: Bolesnici s neodgovarajućim odgovorom na TNF inhibitor Tofacitinib 5 mg dva puta dnevno + MTX
English: 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.
Croatian: 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.
English: Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 12 months.
Croatian: 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.
English: ΔLEIf Month 3 Month 6 Month 12
Croatian: ΔLEI 3. mjesec 6. mjesec 12. mjesec
English: 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: 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: mTSSc Baseline Month 6 Month 12
Croatian: ΔDSS 3. mjesec 6. mjesec 12. mjesec
English: Study I (O RAL
Croatian: Ispitivanje VI (ORAL
English: Included TNF Inhibitor naïve patients c.
Croatian: Uključuje bolesnike koji nisu prethodno primali inhibitor TNF-a c.
English: • Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
Croatian: • dozu tofacitiniba treba sniziti na 5 mg dva puta dnevno u bolesnika koji primaju 10 mg dva puta dnevno.
English: 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: 3 u 1,9% bolesnika, sveukupno za bolesnike liječene s 5 mg dva puta dnevno i 10 mg dva puta dnevno.
English: XELJANZ 11 mg prolonged-release tablets tofacitinib
Croatian: XELJANZ 11 mg tablete s produljenim oslobađanjem tofacitinib
English: 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.
Croatian: 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.
English: Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 6 months.
Croatian: 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.
English: • Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily.
Croatian: • dozu tofacitiniba treba sniziti na 5 mg jednom dnevno u bolesnika koji primaju 5 mg dva puta dnevno.
English: EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
Croatian: EU/1/17/1178/005 60 filmom obloženih tableta EU/1/17/1178/006 180 filmom obloženih tableta
English: Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of
Croatian: Remisija je bila definirana kao klinička remisija (ukupni Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja koji iznosi 0.
English: Tofacitinib 10 mg twice daily + MTX N=290 Mean (SD)a
Croatian: Tofacitinib od 10 mg dva puta dnevno + MTX N=290 Srednja vrijednost (SD)a
English: Table 14: Phase 3 clinical studies of tofacitinib 5 mg and 10 mg twice daily doses in patients with UC
Croatian: 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
English: Tofacitinib 10 mg twice daily + MTX N=309
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX N=309
English: Tofacitinib 5 mg twice daily + DMARD(s) N=312
Croatian: Tofacitinib 5 mg dva puta dnevno + DMARD(ovi) N=312
English: Table 6: Adverse drug reactions
Croatian: Tablica 6: Nuspojave
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Placebo Tofacitinib 10 mg twice daily
Croatian: Placebo Tofacitinib 10 mg dva puta dnevno
English: Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
Croatian: Dozu tofacitiniba treba sniziti na 5 mg dva puta dnevno u bolesnika koji primaju 10 mg dva puta dnevno.
English: Tofacitinib 10 mg twice daily Mean difference from MTXd (CI)
Croatian: Tofacitinib 10 mg dva puta dnevno Srednja vrijednost razlike od MTX (CI)
English: Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
Croatian: Jedna tableta sadrži 5 mg tofacitiniba (u obliku tofacitinibcitrata).
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)
English: XELJANZ 10 mg film-coated tablets
Croatian: XELJANZ 10 mg filmom obložena tableta
English: Tofacitinib 10 mg twice daily + MTX N=134
Croatian: Tofacitinib 10 mg dva puta dnevno + MTX N=134
English: Tofacitinib 5 mg twice daily + MTX N=316
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX N=316
English: Tofacitinib 10mg twice daily N=368 Mean (SD)a
Croatian: Tofacitinib 10 mg dva puta dnevno N=368 Srednja vrijednost (SD)
English: 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).
Croatian: 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.
English: ORAL Standard: MTX inadequate responders
Croatian: ORAL Standard: Bolesnici s neodgovarajućim odgovorom na MTX
English: Do not crush, split or chew.
Croatian: Tablete nemojte zdrobiti, prelomiti ili žvakati.
English: With prior TNF inhibitor failure
Croatian: Uz prethodno neuspješno liječenje inhibitorom TNF-a
English: Tofacitinib 5 mg twice daily Mean difference from MTXd (CI)
Croatian: Tofacitinib 5 mg dva puta dnevno Srednja vrijednost razlike od MTX (CI)
English: Switching between tofacitinib 5 mg film-coated tablets and tofacitinib 11 mg prolonged-release tablets
Croatian: Prelazak s tofacitinib filmom obloženih tableta od 5 mg na tofacitinib tablete s produljenim oslobađanjem od 11 mg, i obratno
English: 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.
Croatian: 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.
English: Tofacitinib 5 mg twice daily + MTX N=133
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX N=133
English: Adalimumab 40 mg SC QOW + MTX
Croatian: Adalimumab 40 mg s.c. svaki drugi tjedan + MTX 6. mjesec Placebo + MTX
English: Tofacitinib 5 mg twice daily monotherapy N=241
Croatian: Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=241
English: XELJANZ 5 mg film-coated tablets
Croatian: XELJANZ 5 mg filmom obložena tableta
English: 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).
Croatian: 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).
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 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).
English: XELJANZ 11 mg prolonged-release tablet contains sorbitol This medicine contains approximately 152 mg sorbitol in each prolonged-release tablet.
Croatian: Ovaj lijek sadrži približno 152 mg sorbitola u jednoj tableti s produljenim oslobađanjem.
English: EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
Croatian: EU/1/17/1178/001 60 filmom obloženih tableta EU/1/17/1178/002 180 filmom obloženih tableta
English: Each prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Croatian: Jedna tableta s produljenim oslobađanjem sadrži 11 mg tofacitiniba (u obliku tofacitinibcitrata).
English: HDPE bottles with silica gel desiccant and child-resistant polypropylene closure containing 60 or 180 film-coated tablets.
Croatian: Jedna boca sadrži 60 ili 180 filmom obloženih tableta i sredstvo za sušenje u obliku silika gela.
English: There were no confirmed decreases in ANC below 500 cells/mm3 observed in any treatment group.
Croatian: Ni u jednoj od ispitivanih skupina nije zabilježeno potvrđeno smanjenje ABN-a ispod 500 stanica/mm
English: 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.
Croatian: 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.
English: Month 3 NA
Croatian: 3 u
English: 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).
Croatian: 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
English: 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.
Croatian: 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.
English: Tofacitinib 10 mg twice daily
Croatian: Tofacitinib 10 mg dva puta dnevno
English: Tofacitinib 5 mg twice daily N=344 Mean (SD)a
Croatian: Tofacitinib 5 mg dva puta dnevno N=344 Srednja vrijednost (SD)
English: 6 months 2 years
Croatian: 6 mjeseci 1 godina 1 godina 2 godine 6 mjeseci 2 godine 1 godina
English: Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Croatian: Jedna tableta sadrži 10 mg tofacitiniba (u obliku tofacitinibcitrata).
English: Adalimumab 40 mg QOW + MTX
Croatian: Adalimumab 40 mg svaki drugi tjedan + MTX
English: 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.
Croatian: 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.
English: Tofacitinib 5 mg twice daily monotherapy N=370
Croatian: Tofacitinib u monoterapiji u dozi od 5 mg dva puta dnevno N=370
English: Tofacitinib 5 mg twice daily + MTX Mean difference from placebob (CI)
Croatian: Tofacitinib 5 mg dva puta dnevno + MTX Srednja vrijednost razlike od placeba (CI)
English: Placebo Placebo
Croatian: Placebo
English: TNFi inadequate responders b
Croatian: TNFi Bolesnici s neadekvatnim odgovorom