FrancophonIA/ELRC3.0 huggingface dataset:
English: In OPAL BROADEN, Minimal Disease Activity (MDA) response was achieved by 26.2%, 25.5% and 6.7% of tofacitinib 5 mg BID, adalimumab and placebo treated patients, respectively (tofacitinib 5 mg BID treatment difference from placebo 19.5% [95% CI: 9.9, 29.1]) at month 3.
Croatian: U 3. mjesecu u ispitivanju OPAL BROADEN odgovor minimalne aktivnosti bolesti bio je postignut u 26,2%, 25,5% i 6,7% bolesnika liječenih s 5 mg tofacitiniba dva puta dnevno, adalimumabom odnosno placebom (razlika između liječenja s 5 mg tofacitiniba dva puta dnevno i placeba iznosila je 19,5% [95% CI: 9,9; 29,1]).
English: • who have been exposed to TB,
Croatian: • bili izloženi tuberkulozi
English: In ORAL Scan, mean SF-36 improvements were maintained to 12 months in tofacitinib-treated patients.
Croatian: U ORAL Scan ispitivanju, srednje vrijednosti poboljšanja u SF-36 održana su do 12 mjeseci u bolesnika liječenih tofacitinibom.
English: Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
Croatian: Tofacitinib u tom smislu nije ispitivan i treba izbjegavati njegovu upotrebu u kombinaciji s biološkim lijekovima poput antagonista TNF, antagonista interleukina (IL)-1R, antagonista IL-6R, monoklonskih protutijela anti-CD20, antagonista IL-17, antagonista IL-12/IL-23, anti-integrina, selektivnih modulatora kostimulacije i potentnih imunosupresiva poput azatioprina, 6-merkaptopurina, ciklosporina i takrolimusa zbog mogućnosti povećane imunosupresije i povećanog rizika od infekcije.
English: After intravenous administration, the volume of distribution is 87 L. Approximately 40% of circulating tofacitinib is bound to plasma proteins.
Croatian: Približno 40% cirkulirajućeg tofacitiniba vezano je na proteine plazme.
English: In the randomised 8-week Phase 2/3 induction studies, the proportions of patients with infections were 21.1% (198 patients) in the tofacitinib 10 mg twice daily group compared to 15.2% (43 patients) in the placebo group.
Croatian: U randomiziranim 8-tjednim ispitivanjima uvodnog liječenja faze 2/3 udio bolesnika s infekcijama bio je 21,1% (198 bolesnika) u skupini liječenoj s 10 mg tofacitiniba dva puta dnevno, u usporedbi s 15,2% (43 bolesnika) u skupini koja je primala placebo.
English: • fever and chills
Croatian: • vrućicu i zimicu
English: 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: Signs of serious infections (common) include
Croatian: Znakovi teških infekcija (nuspojave koje se javljaju s čestom učestalošću) uključuju
English: Hibernomas (malignancy of brown adipose tissue) were observed in female rats at exposures greater than or equal to 83 or 41 times the clinical exposure level at 5 mg or 10 mg twice daily.
Croatian: Hibernomi (maligniteti smeđeg adipoznog tkiva) uočeni su kod ženki štakora pri izloženostima većim ili jednakim 83 ili 41 x od razine izloženosti uz dozu od 5 mg ili 10 mg dva puta dnevno u kliničkoj primjeni.
English: Table 13: Change from baseline in HAQ-DI in PsA studies OPAL BROADEN and OPAL BEYOND
Croatian: PsA-a OPAL BROADEN i OPAL BEYOND
English: Ciclosporine
Croatian: Ciklosporin
English: • wheezing
Croatian: • piskanje
English: It is not recommended to initiate tofacitinib treatment in patients with a haemoglobin value less than 9 g/dL.
Croatian: Ne preporučuje se započeti liječenje tofacitinibom u bolesnika u kojih je razina hemoglobina manja od 9 g/dl.
English: Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
Croatian: Tofacitinib u tom smislu nije ispitivan i treba izbjegavati njegovu upotrebu u kombinaciji s biološkim lijekovima poput antagonista TNF, antagonista interleukina (IL)-1R, antagonista IL-6R, monoklonskih protutijela anti-CD20, selektivnih modulatora kostimulacije i potentnih imunosupresiva poput azatioprina, 6-merkaptopurina, ciklosporina i takrolimusa zbog mogućnosti povećane imunosupresije i povećanog rizika od infekcije.
English: Psoriatic arthritis • The recommended dose is 5 mg twice a day.
Croatian: Psorijatični artritis • Preporučena doza je 5 mg primijenjena dva puta dnevno.
English: NA ORAL Sync: DMARD inadequate responders
Croatian: NP ORAL Sync: Bolesnici s neodgovarajućim odgovorom na DMARD
English: • rheumatoid arthritis
Croatian: • reumatoidni artritis
English: Tablet core microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza laktoza hidrat umrežena karmelozanatrij magnezijev stearat
English: Tofacitinib 11 mg prolonged-release tablets contains sorbitol.
Croatian: Tofacitinib tablete s produljenim oslobađanjem od 11 mg sadrže sorbitol.
English: OCTAVE induction study 2
Croatian: Ispitivanje uvodnog liječenja OCTAVE Induction 2
English: • Patients with an ALC less than 1,000 cells/mm
Croatian: • bolesnika u kojih je apsolutni broj limfocita manji od 1000 stanica/mm
English: Swallow XELJANZ 11 mg prolonged-release tablets whole in order to ensure the entire dose is delivered correctly.
Croatian: Progutajte XELJANZ 11 mg tabletu s produljenim oslobađanjem cijelu kako bi se osigurala ispravna primjena cijele doze.
English: Potential for tofacitinib to influence the PK of other medicinal products
Croatian: Utjecaj tofacitiniba na farmakokinetiku drugih lijekova
English: • psoriatic arthritis
Croatian: • psorijatični artritis
English: Patients who completed 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) but did not achieve clinical response or patients who completed or withdrew early due to treatment failure in the maintenance study (OCTAVE Sustain) were eligible for OCTAVE Open.
Croatian: Open bili su podobni oni bolesnici koji su završili sudjelovanje u jednom od ispitivanja uvodnog liječenja (OCTAVE Induction 1 ili OCTAVE Induction 2), ali nisu postigli klinički odgovor, odnosno bolesnici koji su završili sudjelovanje ili su se prijevremeno povukli zbog neuspješnog liječenja iz ispitivanja terapije održavanja (OCTAVE Sustain).
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, je pokazao poboljšanje fizičke funkcije mjereno pomoću Upitnika o zdravstvenom stanju - indeksa onesposobljenosti (engl.
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: Package leaflet: Information for the patient XELJANZ 11 mg prolonged-release tablets tofacitinib
Croatian: Uputa o lijeku: Informacije za bolesnika XELJANZ 11 mg tablete s produljenim oslobađanjem tofacitinib
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: Patients treated with tofacitinib who are Japanese or Korean, or patients with long standing RA who have previously received two or more biological DMARDs, or patients with an ALC less than 1,000 cells/mm3, or patients treated with 10 mg twice daily may have an increased risk of herpes zoster (see section 4.4).
Croatian: Bolesnici liječeni tofacitinibom, koji su Japanci ili Korejci, bolesnici s dugotrajnim RA koji su prethodno primili dva ili više bioloških DMARD-ova, bolesnici u kojih je apsolutni broj limfocita manji od 1000 stanica/mm
English: • Mean LDL cholesterol increased by 15% in the tofacitinib 5 mg twice daily arm and 20% in the tofacitinib 10 mg twice daily arm at month 12, and increased by 16% in the tofacitinib 5 mg twice daily arm and 19% in the tofacitinib 10 mg twice daily arm at month 24.
Croatian: • Srednja vrijednost LDL kolesterola porasla je u 12. mjesecu za 15% u skupini koja je primala 5 mg tofacitiniba dva puta dnevno te za 20% u skupini koja je primala 10 mg tofacitiniba dva puta dnevno, a u 24. mjesecu za 16% u skupini koja je primala 5 mg tofacitiniba dva puta dnevno te za 19% u skupini koja je primala 10 mg tofacitiniba dva puta dnevno.
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/m
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, normalisation 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: 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: Ne preporučuje se primjena lijeka XELJANZ s lijekovima koji potiskuju imunološki sustav, uključujući tzv. ciljne biološke lijekove (protutijela), poput onih koji koče čimbenik nekroze tumora, interleukin 17, interleukin 12/interleukin 23, anti-integrine i snažne kemijske imunosupresivne lijekove, uključujući azatioprin, merkaptopurin, ciklosporin i takrolimus.
English: In general, fewer side effects were seen when XELJANZ was used alone than in combination with methotrexate in rheumatoid arthritis.
Croatian: Općenito, kod liječenja reumatoidnog artritisa, manje nuspojava zabilježeno je kada se lijek XELJANZ uzimao sam nego kada se uzimao u kombinaciji s metotreksatom.
English: Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily (see section 4.2).
Croatian: Dozu tofacitiniba treba sniziti na 5 mg jednom dnevno u bolesnika koji primaju 5 mg dva puta dnevno (vidjeti dio 4.2).
English: Impact of other medicinal products on PK of tofacitinib
Croatian: Utjecaj drugih lijekova na farmakokinetiku tofacitiniba
English: Package leaflet: Information for the patient XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets tofacitinib
Croatian: Uputa o lijeku: Informacije za bolesnika XELJANZ 5 mg filmom obložene tablete XELJANZ 10 mg filmom obložene tablete tofacitinib
English: If you notice any of the following serious side effects you need to tell a doctor straight away.
Croatian: Ako primijetite bilo koju od nuspojava navedenih u nastavku, odmah se obratite svom liječniku.
English: Statistically significant ACR20 response rates were observed with tofacitinib 5 mg BID in both studies as early as week 2 (first post-baseline assessment) in comparison to placebo.
Croatian: U usporedbi s placebom, statistički značajne stope odgovora prema ACR20 zabilježene su s 5 mg tofacitiniba primjenjivanim dva puta dnevno u oba ispitivanja već u 2. tjednu (prva procjena nakon početka terapije).
English: Sustained corticosteroidfree remission among patients in remission at baseline
Croatian: Održana remisija bez kortikosteroida među bolesnicima u remisiji prije početka terapije
English: This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition.
Croatian: Liječnik specijalist koji zna kako liječiti Vaše stanje će Vam propisivati ovaj lijek i pratiti
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 (including increased LDL), weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, joint sprain, 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 (mogu 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 (uključujući povišeni LDL kolesterol), porast tjelesne težine, dehidracija, istegnuće mišića, bol u mišićima i zglobovima, upala tetive (tendinitis), oticanje zgloba, istegnuće 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: Tofacitinib dose should be reduced to 5 mg (as film-coated tablet) once daily in patients receiving 11 mg (as prolonged-release tablet) once daily (see section 4.2).
Croatian: Dozu tofacitiniba treba sniziti na 5 mg (u obliku filmom obložene tablete) primijenjenih jednom dnevno u bolesnika koji primaju 11 mg (u obliku tablete s produljenim oslobađanjem) jednom dnevno (vidjeti dio 4.2).
English: BLISTER FOR 11 MG TABLETS
Croatian: BLISTER ZA TABLETE OD 11 MG
English: MT X-IR
Croatian: MTX-IR
English: Abdominal pain Vomiting Diarrhoea Nausea
Croatian: Bol u abdomenu Povraćanje Proljev
English: For persistent (2 sequential values in this range on routine testing) decrease in this range, dosing should be reduced or interrupted until ALC is greater than 750.
Croatian: Kod perzistirajućeg (2 uzastopna rezultata u tom rasponu kod rutinskog testiranja) smanjenja u tom rasponu, doziranje treba sniziti ili prekinuti dok ALC ne bude veći od 750.
English: BLISTER FOR 5 MG TABLETS
Croatian: BLISTER ZA TABLETE OD 5 MG
English: For patients (total 1,750) on monotherapy, the rates were 48.9 and 41.9 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively.
Croatian: U bolesnika (ukupno 1750) na monoterapiji, stope su bile 48,9, odnosno 41,9 bolesnik s događajem na 100 bolesnik-godina za 5 mg, odnosno za 10 mg dva puta dnevno.
English: System organ class
Croatian: Klasifikacij a organskih sustava
English: Patients who experience a decrease in response on tofacitinib 5 mg twice daily maintenance therapy may benefit from an increase to tofacitinib 10 mg administered twice daily.
Croatian: Bolesnici u kojih se smanji odgovor na terapiju održavanja s 5 mg tofacitiniba dva puta dnevno mogu imati koristi od povećanja doze na 10 mg tofacitiniba koji se uzima dva puta dnevno.
English: ACR20 mT SS DAS284(ESR)<2.6 Month 3:
Croatian: 6. mjesec: ACR20 mTSS DAS284(ESR) < 2
English: • Mean HDL cholesterol increased by 17% in the tofacitinib 5 mg twice daily arm and 18% in the tofacitinib 10 mg twice daily arm at month 12, and increased by 19% in the tofacitinib 5 mg twice daily arm and 20% in the tofacitinib 10 mg twice daily arm at month 24.
Croatian: • Srednja vrijednost HDL kolesterola porasla je u 12. mjesecu za 17% u skupini koja je primala 5 mg tofacitiniba dva puta dnevno te za 18% u skupini koja je primala 10 mg tofacitiniba dva puta dnevno, a u 24. mjesecu za 19% u skupini koja je primala 5 mg tofacitiniba dva puta dnevno te za 20% u skupini koja je primala 10 mg tofacitiniba dva puta dnevno.
English: If you take more XELJANZ than you should If you take more tablets than you should, immediately tell your doctor or pharmacist.
Croatian: Ako uzmete više tableta nego što ste trebali, odmah obavijestite svog liječnika ili ljekarnika.
English: Improvement in sleep was assessed using the Sleep Problems Index I and II summary scales of the Medical Outcomes Study Sleep (MOS-Sleep) measure at month 3 in all studies.
Croatian: Medical Outcomes Study Sleep, MOS-Sleep) u 3. mjesecu u svim ispitivanjima.
English: Tel: 1800 633 363 (toll free)
Croatian: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)
English: Key features Monotherapy Various csDMARDs
Croatian: Različiti csDMARD -ovi
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/mm
English: Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Croatian: Pneumonija uzrokovana Pneumocystis jirovecii Pneumokokna pneumonija Bakterijska pneumonija Encefalitis Atipična mikobakterijska infekcija Infekcija citomegalovirus om
English: Benign thymomas were observed in female rats at 187 or 94 times the clinical exposure level at 5 mg or 10 mg twice daily.
Croatian: Benigni timomi uočeni su kod ženki štakora pri izloženosti 187 ili 94 x većoj od izloženosti uz dozu od 5 mg ili 10 mg dva puta dnevno u kliničkoj primjeni.
English: XELJANZ 5 mg film-coated tablets XELJANZ 5 mg film-coated tablet is white and round in appearance.
Croatian: XELJANZ 5 mg filmom obložene tablete XELJANZ 5 mg filmom obložena tableta bijele je boje i okruglog oblika.
English: Patients from OCTAVE Induction 1 or OCTAVE Induction 2 who did not achieve clinical response after 8 weeks in OCTAVE Open were to be discontinued from OCTAVE Open.
Croatian: Bolesnici koji su bili uključeni u ispitivanje uvodnog liječenja OCTAVE Induction 1 ili OCTAVE Induction 2 te koji nisu postigli klinički odgovor nakon 8 tjedana sudjelovanja u nastavku ispitivanja OCTAVE
English: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Croatian: U kliničkim ispitivanjima RA-a zabilježena je veća incidencija nuspojava uz kombinaciju tofacitiniba s MTX-om u odnosu na monoterapiju tofacitinibom.
English: p<0.0001 for tofacitinib 5 mg twice daily versus placebo.
Croatian: p < 0,0001 za 5 mg tofacitiniba dva puta dnevno naspram placeba.
English: In the maintenance study (OCTAVE Sustain), tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily demonstrated greater maintenance of improvement compared to placebo in PCS and MCS scores, and in all 8 domains of the SF-36 at week 24 and week 52.
Croatian: U ispitivanju održavanja (OCTAVE Sustain) primjena 5 mg tofacitiniba dvaput dnevno ili 10 mg tofacitiniba dvaput dnevno dovela je do boljeg održavanja poboljšanja rezultata profila fizičkog zdravlja i profila duševnog zdravlja u usporedbi s placebom te rezultata u svih 8 područja upitnika SF-36 u 24. i 52. tjednu.
English: In the randomised 52-week phase 3 maintenance study, the proportion of patients with infections were 35.9% (71 patients) in the 5 mg twice daily and 39.8% (78 patients) in the 10 mg twice daily tofacitinib groups, compared to 24.2% (48 patients) in the placebo group.
Croatian: U randomiziranom 52-tjednom ispitivanju terapije održavanja faze 3 udio bolesnika s infekcijama bio je 35,9% (71 bolesnik) u skupini koja je primala 5 mg tofacitiniba dva puta dnevno i 39,8% (78 bolesnika) u skupini koja je primala 10 mg tofacitiniba dva puta dnevno, u odnosu na 24,2% (48 bolesnika) u skupini koja je primala placebo.
English: Month 3 Month 6 Month 12 Month 24
Croatian: 3. mjesec 6. mjesec 12. mjesec 24. mjesec
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 mg 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: p<0.0001 for tofacitinib 10 mg twice daily versus placebo.
Croatian: p < 0,0001 za 10 mg tofacitiniba dva puta dnevno naspram placeba.
English: It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm
Croatian: Preporuča se ne započinjati doziranje u bolesnika čiji je apsolutan broj limfocita (engl. absolute lymphocyte count, ALC) manji od 750 stanica/mm
English: Maintenance (OCTAVE Sustain)
Croatian: Ispitivanje terapije održavanja OCTAVE Sustain
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: Doza je bila povećana na 10 mg tofacitiniba, uz primjenu dva puta dnevno u ispitivanju OCTAVE Open, bolesnicima koji su klinički odgovor u jednom od ispitivanja uvodnog liječenja (OCTAVE 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: MTX N=168 Mean (SD)
Croatian: N=168 Srednja vrijednost (SD)
English: XELJANZ 10 mg film-coated tablets XELJANZ 10 mg film-coated tablet is blue and round in appearance.
Croatian: XELJANZ 10 mg filmom obložene tablete XELJANZ 10 mg filmom obložena tableta plave je boje i okruglog oblika.
English: Patients receiving tofacitinib 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: ≤3 weekly doses (MTX-naïve).
Croatian: ≤ 3 doze tjedno (MTX-naivni, tj. koji prethodno nisu liječeni metotreksatom).
English: NA ORAL Start: MTX-naïve
Croatian: ORAL Start: MTX-naivni (bolesnici koji nisu liječeni metotreksatom) MTX