FrancophonIA/ELRC3.0 huggingface dataset:
English: OCTAVE Induction Study 2 Central Endoscopy Read
Croatian: Ispitivanje uvodnog liječenja OCTAVE Induction 2 Centralno očitani endoskopski nalazi
English: c. Normalization of endoscopic appearance of the mucosa was defined as a Mayo endoscopic subscore of 0.
Croatian: c. Normalizacija endoskopskog izgleda sluznice bila je definirana kao Mayo endoskopski podrezultat koji iznosi 0.
English: ORAL Step: TNF Inhibitor Inadequate Responders N=118
Croatian: N=188 ORAL Step: Bolesnici s neodgovarajućim odgovorom na TNF inhibitore N=118
English: NA ORAL Sync: DMARD Inadequate Responders
Croatian: ORAL Sync: Bolesnici s neodgovarajućim odgovorom na DMARD
English: In patients treated with tofacitinib, the incidence of herpes zoster appears to be increased in:
Croatian: Čini se da je u bolesnika liječenih tofacitinibom rizik od herpesa zostera veći u:
English: In post-marketing experience, cases of drug hypersensitivity associated with tofacitinib administration have been reported.
Croatian: U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi preosjetljivosti na lijek povezani s primjenom tofacitiniba.
English: Tuberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Croatian: Tuberkuloza Divertikulitis Pijelonefritis Celulitis Herpes simplex Virusni gastroenteritis Virusna infekcija
English: c. Co-primary endpoints as follows: mean change from baseline in mTSS; percent of subjects achieving ACR20 or ACR70 responses; mean change from baseline in HAQ-DI; percent of subjects achieving a DAS28-4(ESR) <2.6 (remission).
Croatian: modified Total Sharp Score); postotak ispitanika koji su postigli ACR20 ili ACR70 odgovore; srednja promjena u odnosu na početne vrijednosti u HAQ-DI; postotak ispitanika koji postižu DAS28-4(ESR) < 2,6 (remisija).
English: c Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Croatian: c Globalno postignuta statistička značajnost pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
English: After 8 weeks on tofacitinib 10 mg twice daily in OCTAVE Open, remission was achieved in 35% (20/58) patients who received tofacitinib 5 mg twice daily in OCTAVE Sustain and 40% (40/99) patients with dose interruption in OCTAVE Sustain.
Croatian: Nakon što su 8 tjedana primali 10 mg tofacitiniba dva puta dnevno u ispitivanju OCTAVE Open, remisiju je postiglo 35 % (20/58) bolesnika koji su primali 5 mg tofacitiniba dva puta dnevno u ispitivanju OCTAVE Sustain i 40 % (40/99) bolesnika čija je doza lijeka bila ukinuta u ispitivanju
English: Local Endoscopy Read
Croatian: Lokalno očitani endoskopski nalazi
English: *Spontaneous reporting data
Croatian: *Podaci iz spontanog prijavljivanja Opis odabranih nuspojava
English: Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib.
Croatian: kriptokokna infekcija, histoplazmoza, ezofaringealna kandidijaza, multidermatomski herpes zoster, citomegalovirus, infekcija BK virusom i listerioza bile su prijavljene uz tofacitinib.
English: The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.
Croatian: Ulcerozni kolitis Najčešće nuspojave prijavljene u bolesnika koji su primali 10 mg tofacitiniba dva puta dnevno u ispitivanjima uvodnog liječenja bile su glavobolja, nazofaringitis, mučnina i artralgija.
English: c. 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: Poboljšanje endoskopskog izgleda sluznice bilo je definirano kao Mayo endoskopski podrezultat 0 (normalna ili neaktivna bolest) ili 1 (eritem, smanjen vaskularni uzorak).
English: Note: Reference group is administration of tofacitinib alone.
Croatian: *CI = interval pouzdanosti Napomena: Referentna skupina je primjena samo tofacitiniba.
English: INFORMATION IN BRAILLE XELJANZ 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU XELJANZ 10 mg
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals o Prescriber checklist o Patient alert card o A reference to the website with the educational material and patient alert card
Croatian: o Sažetak opisa svojstava lijeka o Vodič za zdravstvene radnike o Kontrolnu listu za propisivača o Karticu s upozorenjima za bolesnika o Referencu na internetsku stranicu s edukacijskim materijalima i karticom s upozorenjima za bolesnika
English: What XELJANZ looks like and contents of the pack XELJANZ 5 mg film-coated tablet is white and round in appearance.
Croatian: Kako XELJANZ izgleda i sadržaj pakiranja XELJANZ 5 mg filmom obložena tableta je bijele boje i okruglog izgleda.
English: For recommended modifications based on haemoglobin level, see section 4.2.
Croatian: Za preporučene izmjene na temelju razine hemoglobina vidjeti dio 4.2.
English: In the MTX group, 70% of patients experienced no radiographic progression at month 6 compared to 83% and 90% of patients treated with tofacitinib 5 or 10 mg twice daily respectively, both significant versus MTX.
Croatian: U skupini koja je primala MTX, u 70% bolesnika radiološki nalaz nije pokazao progresiju u 6. mjesecu u usporedbi s 83% odnosno 90% bolesnika liječenih s 5 mg ili 10 mg tofacitiniba dva puta dnevno, oboje signifikantno naspram MTX.
English: Lymphoma was observed in 3 of 8 adult monkeys at 6 or 3 times the clinical tofacitinib exposure level (unbound AUC in humans at a dose of 5 mg or 10 mg twice daily), and 0 of 14 juvenile monkeys at 5 or 2.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Croatian: Limfom je nađen kod 3 od 8 odraslih majmuna pri razini izloženosti tofacitinibu 6 ili 3 puta većoj od kliničkih (AUC za nevezani lijek u ljudi uz dozu od 5 mg ili 10 mg dvaput dnevno) te kod 0 od 14 mladih majmuna uz razinu izloženosti 5 ili 2,5 puta veću od razine izloženosti uz dozu od 5 mg ili
English: Remission among patients in remission at baselinea,f
Croatian: Remisija među bolesnicima u remisiji prije početka terapijea,f
English: Prior TNFi failure Prior corticosteroid failure
Croatian: TNF-a Prethodno neuspješno liječenje kortikosteroidima
English: As early as week 2, the earliest scheduled study visit, and at each visit thereafter, significant differences were observed between tofacitinib 10 mg twice daily and placebo in the change from baseline in rectal bleeding and stool frequency, and partial Mayo score.
Croatian: Već u 2. tjednu, kada je bio zakazan najraniji posjet u sklopu ispitivanja, i pri svakom kasnijem posjetu bile su opažene značajne razlike između primjene 10 mg tofacitiniba dva puta dnevno i placeba u promjeni od početne vrijednosti za rektalno krvarenje i učestalosti stolice te parcijalnom
English: If therapy is interrupted, restarting treatment with tofacitinib can be considered.
Croatian: Ponovno liječenje ulceroznog kolitisa Ako dođe do privremenog prekida terapije, može se razmotriti ponovno liječenje tofacitinibom.
English: The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Croatian: PsA-om i UC-om te su prikazane prema klasifikaciji organskih sustava i kategorijama učestalosti koje su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i
English: In the 10 mg twice daily tofacitinib monotherapy group the rate was 1.6 patients with events per 100 patientyears, the rate was 0 events per 100 patient-years for the placebo group, and the rate was 1.9 patients with events per 100 patient-years for the MTX group.
Croatian: U skupini koja je primala tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno stopa je bila 1,6 bolesnika s događajem na 100 bolesnik-godina, za placebo je stopa bila 0 događaja na 100 bolesnik-godina, a za skupinu koja je primala MTX stopa je bila 1,9 bolesnika s događajem na 100 bolesnik-godina.
English: Liver enzyme tests
Croatian: Testovi jetrenih enzima
English: For recommended modifications based on ANC, see section 4.2.
Croatian: Za preporučene izmjene na temelju ABN vidjeti dio 4.2.
English: Table 12: Proportion (%) of PsA Patients Who Achieved Clinical Response and Mean Change from Baseline in OPAL BROADEN and OPAL BEYOND Studies Conventional Synthetic DMARD Inadequate Responders a
Croatian: Tablica 12: Udio (%) bolesnika s PsA-om koji su postigli klinički odgovor i srednju vrijednost promjene u odnosu na početnu vrijednost u ispitivanjima OPAL BROADEN i OPAL BEYOND
English: INFORMATION IN BRAILLE XELJANZ 5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU XELJANZ 5 mg
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati XELJANZ Lijek čuvajte izvan pogleda i dohvata djece.
English: Inadequate response to at least one conventional synthetic DMARD (csDMARD) due to lack of efficacy and/or intolerability.
Croatian: a Neadekvatan odgovor na najmanje jedan konvencionalni sintetski DMARD (csDMARD) zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
English: Dose Adjustment
Croatian: Prilagodba doze
English: • hives (itching or skin rash)
Croatian: • koprivnjača (svrbež ili osip na koži)
English: If the history of chickenpox is considered doubtful or unreliable it is recommended to test for antibodies against VZV.
Croatian: Ako se vodene kozice ne mogu sa sigurnošću potvrditi iz povijesti bolesti, preporučuje se napraviti test na protutijela protiv VZV.
English: Treatment Group
Croatian: Liječena skupina
English: PASI75g Month 3
Croatian: PASI75g 3. mjesec 6. mjesec 12. mjesec
English: Sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baselined
Croatian: Održana remisija bez kortikosteroida u 24. i 52. tjednu među bolesnicima u remisiji prije početka terapijed
English: Uncommon (may affect up to 1 in 100 people): tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol, weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).
Croatian: Manje često (može se javiti u manje od 1 na 100 osoba): tuberkuloza, infekcija bubrega, infekcija kože, herpes simplex ili herpes usta, nizak broj bijelih krvnih stanica, povišeni jetreni enzimi u krvi (znak problema s jetrom), porast kreatinina u krvi (mogući znak problema s bubrezima), povišeni kolesterol, porast tjelesne težine, dehidracija, istegnuće mišića, bol u mišićima i zglobovima, upala tetive (tendinitis), oticanje zgloba, neuobičajeni osjeti, loš san, začepljenje sinusa, nedostatak zraka ili otežano disanje, crvenilo kože, svrbež, masna jetra, bolna upala stijenke malih „džepova“ tankog crijeva (divertikulitis), virusne infekcije, virusne infekcije koje zahvaćaju probavni sustav, neke vrste raka kože (nemelanomski tip).
English: 2 years 6 months 2 years
Croatian: 6 mjeseci 1 godina 1 godina 2 godine 6 mjeseci 2 godine 1 godina
English: Time to onset was rapid (as early as week 2 in studies ORAL Solo, ORAL Sync, and ORAL Step) and the magnitude of response continued to improve with duration of treatment.
Croatian: Sync i ORAL Step) i magnituda odgovora nastavila se poboljšavati s trajanjem liječenja.
English: Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2,000 cells/mm3) compared to placebo.
Croatian: U usporedbi s placebom, liječenje tofacitinibom bilo je povezano s povećanom incidencijom neutropenije (manje od 2000 stanica/m3).
English: Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
Croatian: Pad veći od 2 g/dl ili vrijednost manja od 8,0 g/dl
English: *p <0.05, ***p<0.0001 versus placebo, SC=subcutaneous, QOW=every other week, N=number of subjects analysed, DAS28=Disease Activity Scale 28 joints, ESR=Erythrocyte Sedimentation Rate.
Croatian: 6. mjesec *p < 0,05, ***p < 0,0001 naspram placeba, s.c.=supkutano, N=broj analiziranih ispitanika, DAS28=Indeks aktivnosti bolesti za 28 zglobova, ESR=brzina sedimentacije eritrocita
English: In the placebo plus MTX group, 78% of patients experienced no radiographic progression (mTSS change less than or equal to 0.5) at month 6 compared to 89% and 87% of patients treated with tofacitinib 5 or 10 mg (plus MTX) twice daily respectively, (both significant versus placebo plus MTX).
Croatian: U skupini koja je primala placebo uz MTX, u 78% bolesnika radiološki nalaz u 6. mjesecu nije pokazao progresiju (mTSS promjena manja ili jednaka 0,5) u usporedbi s 89% bolesnika liječenih s 5 mg, odnosno 87% bolesnika liječenih s 10 mg tofacitiniba dva puta dnevno (uz MTX) (oboje signifikantno naspram placeba uz MTX).
English: It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm3.
Croatian: Ne preporučuje se započeti ili nastaviti liječenje tofacitinibom u bolesnika čiji je dokazani broj limfocita manji od 750 stanica/mm3.
English: d. Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or 1.
Croatian: Klinički odgovor bio je definiran kao smanjenje početne vrijednosti Mayo rezultata za ≥ 3 boda i ≥ 30 % uz popratno smanjenje podrezultata rektalnog krvarenja za ≥ 1 bod ili apsolutni podrezultat rektalnog krvarenja od 0 ili 1.
English: Noneb csDMARDs MTX MTX MTX Noneb
Croatian: MTX MTX MTX Nemab
English: QUALITATIVE AND QUANTITATIVE COMPOSITION XELJANZ 5 mg film-coated tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV XELJANZ 5 mg filmom obložene tablete
English: Active control (ADA)
Croatian: Aktivna kontrola (adalimuma b)
English: Table 18: Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 52 by TNF Inhibitor Therapy Subgroup (OCTAVE Sustain, Central Endoscopy Read)
Croatian: Tablica 18: Udio bolesnika koji su ostvarili primarne i ključne sekundarne ishode djelotvornosti u 52. tjednu u podskupini liječenoj inhibitorom TNF-a (ispitivanje OCTAVE Sustain, centralno očitani endoskopski nalazi)
English: Table 7: Phase 3 Clinical Trials of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with RA
Croatian: Tablica 7: Klinička ispitivanja faze 3 tofacitiniba u dozama od 5 i 10 mg dva puta dnevno u bolesnika s RA
English: Placebo + MTX N=156
Croatian: ishoda Vrijeme Placebo + MTX N=156
English: Tofacitinib, alone or in combination with MTX, has shown improvements in physical function, as measured by the HAQ-DI.
Croatian: Tofacitinib, sam ili u kombinaciji s metotreksatom, pokazao je poboljšanje fizičke funkcije mjereno pomoću Upitnika o zdravstvenom stanju - indeksa onesposobljenosti (engl.
English: Clinical responsed
Croatian: Klinički odgovord
English: *** p<0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
Croatian: p < 0,0001, tofacitinib naspram placebo + MTX, N = broj bolesnika, NP = nije primjenjivo, HAQ-DI = Upitnik o zdravstvenom stanju - indeks onesposobljenosti
English: Improvements were also observed in the EuroQoL 5-Dimension (EQ-5D) and various domains of the Work Productivity and Activity Impairment (WPAI-UC) questionnaire in both induction and maintenance studies compared to placebo.
Croatian: Poboljšanja su ujedno opažena i u upitniku EuroQoL 5-Dimension (EQ-5D) i raznim područjima
English: Tofacitinib 10 mg Twice Daily + DMARD(s) ORAL Sync: DMARD Inadequate Responders
Croatian: Tofacitinib 10 mg dva puta dnevno + DMARD(ovi) ORAL Sync: Bolesnici s neodgovarajućim odgovorom na DMARD
English: Table 15: Proportion of Patients Meeting Efficacy Endpoints at Week 8 (OCTAVE Induction Study 1 and OCTAVE Induction Study 2) OCTAVE Induction Study 1 Central Endoscopy Read
Croatian: Tablica 15: Udio bolesnika koji su ostvarili ishode djelotvornosti u 8. tjednu (ispitivanja uvodnog liječenja OCTAVE Induction 1 i OCTAVE Induction 2) Ispitivanje uvodnog liječenja OCTAVE Induction 1 Centralno očitani endoskopski nalazi
English: A significantly greater proportion of patients in both the tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily treatment groups achieved the following endpoints at week 52 as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, normalization of endoscopic appearance of the mucosa, maintenance of clinical response, remission among patients in remission at baseline, and sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline, as shown in Table 17.
Croatian: U ispitivanim skupinama koje su uzimale 5 mg tofacitiniba dva puta dnevno i 10 mg tofacitiniba dva puta dnevno, značajno je veći udio bolesnika ostvario sljedeće ishode u 52. tjednu u usporedbi s placebom: remisiju, poboljšanje endoskopskog izgleda sluznice, normalizaciju endoskopskog izgleda sluznice, održavanje kliničkog odgovora, remisiju među bolesnicima koji su bili u remisiji prije početka terapije i održanu remisiju bez kortikosteroida u 24. i 52. tjednu među bolesnicima koji su bili u remisiji prije početka terapije, kako je prikazano u tablici 17.
English: Vaccinations
Croatian: Tuberkuloza
English: PHARMACEUTICAL FORM AND CONTENTS 60 film-coated tablets
Croatian: OBLIK I SADRŽAJ 60 filmom obloženih tableta 180 filmom obloženih tableta
English: Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
Croatian: Potvrđeni ALC manji od 750/mm3 bio je povezan s povećanom incidencijom ozbiljnih infekcija
English: The most common serious infections reported with tofacitinib were pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis.
Croatian: Najčešće ozbiljne nuspojave prijavljene uz tofacitinib bile su pneumonija, celulitis, herpes zoster, infekcija urinarnog trakta,
English: Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Croatian: d Globalno postignuta statistička značajnost pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
English: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).
Croatian: ulcerative colitis, UC) u odraslih bolesnika koji su na liječenje konvencionalnom terapijom ili biološkim lijekom imali neadekvatan odgovor, izgubili odgovor ili ta liječenja nisu podnosili (vidjeti dio 5.1).
English: It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm3.
Croatian: Preporuča se ne započinjati doziranje u bolesnika čiji je apsolutan broj limfocita (engl. absolute lymphocyte count, ALC) manji od 750 stanica/mm3.
English: improvement, NA=not applicable, MTX=methotrexate.
Croatian: ADA=adalimumab, MTX=metotreksat.
English: Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, joint sprain, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.
Croatian: Često (mogu se javiti u manje od 1 na 10 osoba): plućna infekcija (pneumonija i bronhitis), herpes zoster, infekcija nosa, grla ili ždrijela (nazofaringitis), gripa, upala sinusa, infekcija mokraćnog mjehura (cistitis), bol u ždrijelu (faringitis), povišeni mišićni enzimi u krvi (znak problema s mišićima), bol u želucu (trbuhu) (koji može biti od upale želučane sluznice), povraćanje, proljev, mučnina, loša probava, istegnuće zgloba, nizak broj crvenih krvnih stanica (anemija), vrućica, umor,
English: 70% improvement; csDMARD=conventional synthetic disease-modifying antirheumatic drug; N=number of randomised and treated patients; NA=Not applicable, as data for placebo treatment is not available beyond month 3 due to placebo advanced to tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor; PASI=Psoriasis Area and
Croatian: Dactylitis Severity Score, DSS); ACR20/50/70 = poboljšanje od ≥ 20%, 50%, 70% prema kriterijima Američkog reumatološkog društva; csDMARD = konvencionalni sintetski antireumatik koji modificira tijek bolesti; N = broj randomiziranih i liječenih bolesnika; NP = nije primjenjivo budući da nema podataka za liječenje placebom nakon 3. mjeseca zbog prelaska s placeba na 5 mg tofacitiniba dva puta dnevno ili 10 mg tofacitiniba dva puta dnevno; TNFi = inhibitor čimbenika nekroze tumora (engl. tumour necrosis factor inhibitor); PASI = indeks zahvaćenosti i težine psorijaze (engl.
English: Table 2: Low Absolute Neutrophil Count Low Absolute Neutrophil Count (ANC) (see section 4.4)
Croatian: Tablica 2: _Nizak apsolutni broj neutrofila Nizak apsolutni broj neutrofila (ABN) (dio 4.4) Laboratorijska vrijednost (broj stanica/mm3)
English: Dose adjustment No dose adjustment is required when used in combination with MTX.
Croatian: Kada se koristi u kombinaciji s MTX-om, prilagodba doze nije potrebna.
English: Nominal p<0.0001 for active treatment versus placebo at month 3.
Croatian: NP * Nominalni p ≤ 0,05; *** Nominalni p < 0,0001 za aktivno liječenje u odnosu na placebo u 3. mjesecu.
English: Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines.
Croatian: XELJANZ ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Patients in the Phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Croatian: Disease Activity Score, DAS28-4[ESR]) od 6,1 do 6,7.
English: It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Croatian: Preporuča se ne započinjati doziranje u bolesnika čiji je apsolutni broj neutrofila (ABN) manji od 1000 stanica/mm3.
English: Patients who achieved clinical response in 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) with tofacitinib 10 mg twice daily but experienced treatment failure after their dose was reduced to tofacitinib 5 mg twice daily or following treatment interruption in OCTAVE Sustain (i.e., were randomised to placebo), had their dose increased to tofacitinib 10 mg twice daily in OCTAVE Open.
Croatian: Induction 1 ili OCTAVE Induction 2) postigli uz 10 mg tofacitiniba dva puta dnevno, ali su imali neuspješno liječenje nakon što je doza bila snižena na 5 mg tofacitiniba dva puta dnevno ili nakon prekida liječenja u ispitivanju OCTAVE Sustain (odnosno nakon što su bili randomizirani za primanje placeba).
English: ACR20 mTSS DAS284(ESR)<2.6 Month 3:
Croatian: 6. mjesec: ACR20 mTSS DAS284(ESR) < 2