FrancophonIA/ELRC3.0 huggingface dataset:
English: Coadministration of tofacitinib 11 mg prolonged-release tablet with a high-fat meal resulted in no changes in AUC while Cmax was increased by 27%.
Croatian: Istodobna primjena tofacitinib tablete s produljenim oslobađanjem od 11 mg s obrocima s visokim udjelom masti nije dovela do promjena u vrijednosti AUC-a, dok se Cmax povećao za 27 %.
English: Prior to initiating tofacitinib, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Croatian: Prije početka liječenja tofacitinibom preporučuje se da su svi bolesnici procijepljeni prema trenutnim smjernicama za cijepljenje.
English: Study VII (O RAL Strategy)
Croatian: Ispitivanje VII (ORAL Strategy)
English: Placebo Placebo MTX MTX, ADA
Croatian: Kontrola Placebo Placebo Placebo Placebo Placebo MTX MTX, ADA
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificira ne novotvorine (uključujući ciste i polipe)
English: Month 6 (placebo subjects with < 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
Croatian: 3. mjesec 6. mjesec (ispitanici koji su primali placebo i imali <20% poboljšanja u broju otečenih i bolnih zglobova prebačeni su na tofacitinib u 3. mjesecu).
English: In the RA long-term safety populations, elevations in the lipid parameters remained consistent with what was seen in the controlled clinical studies.
Croatian: U populacijama s RA-om u ispitivanju dugoročne sigurnosti povišenja lipidnih parametara ostala su dosljedna onima viđenim u kontroliranim kliničkim ispitivanjima.
English: In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
Croatian: U kontroliranom kliničkom ispitivanju bolesnika s RA koji počinju liječenje s 10 mg tofacitiniba dva puta dnevno ili placebom, broj bolesnika s odgovorom na cjepivo protiv influence bio je sličan u obje skupine: tofacitinib (57%) i placebo (62%).
English: XELJANZ has been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together with methotrexate.
Croatian: Dokazano je da XELJANZ smanjuje bol i oticanje zglobova te poboljšava sposobnost obavljanja dnevnih aktivnosti, kada se daje sam ili zajedno s metotreksatom.
English: All patients were required to have 1 concomitant csDMARD; 83.9% of patients received concomitant MTX, 9.5% of patients received concomitant sulfasalazine, and 5.7% of patients received concomitant leflunomide.
Croatian: Svi bolesnici morali su istodobno primati 1 csDMARD; 83,9% bolesnika primalo je istodobno MTX, 9,5% bolesnika istodobno je primalo sulfasalazin i 5,7% bolesnika istodobno je primalo leflunomid.
English: Pharmacokinetics in patients
Croatian: Farmakokinetika u bolesnika
English: For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance.
Croatian: U bolesnika koji ne ostvare adekvatnu terapijsku korist do 8. tjedna, uvodna doza od 10 mg dva puta dnevno može se produžiti dodatnih 8 tjedana (ukupno 16 tjedana), nakon koje slijedi primjena 5 mg dva puta dnevno za održavanje.
English: The MAH shall ensure that in each Member State where XELJANZ is marketed, all healthcare professionals and patients/carers who are expected to prescribe or use XELJANZ have access to/are provided with the following educational package:
Croatian: • Nositelj odobrenja mora osigurati da su svim zdravstvenim radnicima i bolesnicima/skrbnicima od kojih se očekuje propisivanje ili primjena lijeka XELJANZ u svim zemljama članicama u kojima je XELJANZ stavljen u promet, dostupni sljedeći paket edukacijskih materijala: edukacijski materijali za liječnike
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: 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: Durability of effect was assessed by ACR20, ACR50, ACR70 response rates in studies of duration of up to two years.
Croatian: Trajnost učinka ocijenjena pomoću stopa odgovora prema kriterijima ACR 20, 50 i 70 u ispitivanjima koja su trajala do dvije godine.
English: • Patient information pack
Croatian: • paket s informacijama za bolesnika
English: Treatment with tofacitinib was associated with an increased incidence of lymphopenia compared to placebo.
Croatian: Liječenje tofacitinibom bilo je povezano s povećanom incidencijom limfopenije u usporedbi s placebom.
English: Combined use of tofacitinib with ciclosporine should be avoided
Croatian: Kombiniranu primjenu tofacitiniba s ciklosporinom treba izbjegavati
English: Tofacitinib 11 mg prolonged-release tablets must be taken whole in order to ensure the entire dose is delivered correctly.
Croatian: Tofacitinib tablete s produljenim oslobađanjem od 11 mg moraju se progutati cijele kako bi se osigurala ispravna primjena cijele doze.
English: If live zoster vaccine is administered; it should only be administered to patients with a known history of chickenpox or those that are seropositive for varicella zoster virus (VZV).
Croatian: Ako se primjenjuje živo cjepivo protiv herpes zostera, treba ga primijeniti samo u bolesnika s poznatom anamnezom preboljenih vodenih kozica ili u onih koji su seropozitivni na virus varicella zoster (VZV).
English: Caution is also recommended in patients with a history of chronic lung disease as they may be more prone to infections.
Croatian: Potreban je oprez u bolesnika s kroničnom bolesti pluća u anamnezi, jer mogu biti skloniji infekcijama.
English: Caution should be used when administering tofacitinib 11 mg prolonged-release tablets to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
Croatian: Potreban je oprez prilikom primjene tofacitinib tableta s produljenim oslobađanjem od 11 mg u bolesnika s postojećim teškim gastrointestinalnim suženjem (patološkim ili jatrogenim).
English: Antituberculosis therapy should also be considered prior to administration of tofacitinib in patients who test negative for TB but who have a past history of latent or active TB and where an adequate course of treatment cannot be confirmed; or those who test negative but who have risk factors for TB infection.
Croatian: Također treba razmotriti primjenu antituberkulozne terapije prije početka liječenja tofacitinibom u bolesnika u kojih je test na tuberkulozu negativan, ali koji su u anamnezi imali latentnu ili aktivnu tuberkulozu te se ne može potvrditi jesu li bili liječeni na odgovarajući način; ili u bolesnika u kojih je test negativan ali imaju čimbenike rizika za infekciju tuberkulozom.
English: If you develop cancer while taking XELJANZ your doctor will review whether to stop XELJANZ treatment - if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ - 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: Ako dobijete rak dok se liječite lijekom XELJANZ, liječnik će razmotriti je li potrebno prekinuti uzimanje lijeka XELJANZ - ako ste u velikom riziku od razvoja raka kože, liječnik Vam može preporučiti redovite kožne pretrage dok uzimate XELJANZ - ako ste imali divertikulitis (vrsta upale debelog crijeva) ili čir na želucu ili crijevima (pogledajte dio 4) - ako imate problema s bubrezima - ako se planirate cijepiti, obavijestite svog liječnika.
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 incidencija herpes zostera veća u:
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism (see also section 4.3).
Croatian: Tofacitinib 10 mg dva puta dnevno kontraindiciran je u bolesnika s visokim rizikom za plućnu emboliju (također vidjeti dio 4.3).
English: Rheumatoid arthritis and psoriatic arthritis
Croatian: Reumatoidni artritis i psorijatični artritis
English: N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
Croatian: N = 101 za placebo, N = 101 za 5 mg tofacitiniba dva puta dnevno, N = 87 za 10 mg tofacitiniba dva puta dnevno.
English: N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
Croatian: N = 59 za placebo, N = 65 za 5 mg tofacitiniba dva puta dnevno, N = 55 za 10 mg tofacitiniba dva puta dnevno.
English: No dose adjustment
Croatian: Nema prilagodbe doze
English: Concomitant administration with MTX 15-25 mg once weekly had no effect on the PK of tofacitinib in RA patients (see Figure 1).
Croatian: Istodobna primjena s MTX-om od 15 do 25 mg jednom na tjedan nije imala učinka na farmakokinetiku tofacitiniba u bolesnika s RA (vidjeti sliku 1).
English: • If maintaining XELJANZ 5 mg twice a day did not work for you, your doctor may decide to increase the dose to 10 mg twice a day.
Croatian: • Ako doza održavanja od 5 mg dva puta dnevno u Vas nije djelovala, liječnik Vam može odlučiti povećati dozu na 10 mg dva puta dnevno.
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer (see Table 6 in section 4.8).
Croatian: U bolesnika koji imaju povećani rizik od raka kože preporučuju se periodični pregledi kože (vidjeti Tablicu 6 u dijelu 4.8).
English: White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one side and “JKI 5” on the other.
Croatian: Bijela, okrugla tableta promjera 7,9 mm, s utisnutim znakom „Pfizer“ na jednoj strani i „JKI 5“ na drugoj strani.
English: A patient with no previous history of varicella infection and no anti-varicella antibodies at baseline experienced dissemination of the vaccine strain of varicella 16 days after vaccination.
Croatian: Bolesnik bez prethodne infekcije vodenim kozicama u anamnezi i bez protutijela protiv vodenih kozica na početku iskusio je diseminaciju cjepnog soja vodenih kozica 16 dana nakon cijepljenja.
English: Other malignancies were observed in clinical studies and the post-marketing setting, including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer.
Croatian: Ostali maligniteti zabilježeni u kliničkim ispitivanjima i postmarketinškom praćenju uključivali su, između ostalih, rak pluća, rak dojke, melanom, rak prostate i rak gušterače.
English: Local endoscopy read
Croatian: Lokalno očitani endoskopski nalazi
English: Treatment failure was defined as an increase in Mayo score of ≥ 3 points from maintenance study baseline, accompanied by an increase in rectal bleeding subscore by ≥ 1 point, and an increase of endoscopic subscore of ≥ 1 point yielding an absolute endoscopic subscore of ≥ 2 after a minimum treatment of 8 weeks in the study.
Croatian: Neuspješno liječenje bilo je definirano kao povećanje Mayo rezultata za ≥ 3 boda od početne vrijednosti ispitivanja terapije održavanja, praćeno povećanjem podrezultata rektalnog krvarenja za ≥ 1 bod i povećanjem endoskopskog podrezultata za ≥ 1 bod što je rezultiralo apsolutnim endoskopskim podrezultatom od ≥ 2 nakon minimalnog trajanja liječenja od 8 tjedana u ispitivanju.
English: Efficacy may be regained by 8 weeks of 10 mg twice daily therapy (see section 5.1).
Croatian: Djelotvornost se može ponovno ostvariti uzimanjem doze od 10 mg dva puta dnevno tijekom 8 tjedana (vidjeti dio 5.1).
English: Aluminium foil/PVC backed aluminium foil blisters containing 14 film-coated tablets.
Croatian: Blisteri od aluminijske folije s podlogom od aluminijske folije/PVC-a, koji sadrže 14 filmom obloženih tableta.
English: Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval)
Croatian: Razlika tofacitinib minus placebo dobivena metodom najmanjih kvadrata (95% CI = 95%-tni interval pouzdanosti)
English: Month 6: ACR50
Croatian: 6. mjesec: ACR50
English: There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other medicinal products utilising a non-deformable prolonged-release formulation.
Croatian: U bolesnika s poznatim strikturama rijetko su prijavljeni opstruktivni simptomi povezani s gutanjem drugih lijekova u formulaciji s produljenim oslobađanjem koja ne podliježe promjeni oblika.
English: • severe dizziness or light-headedness
Croatian: • tešku omaglicu ili ošamućenost
English: Urosepsis Disseminated TB Necrotizing fasciitis
Croatian: Urosepsa Diseminirana tuberkuloza Nekrotizirajući fasciitis
English: • Patients treated with 10 mg twice daily.
Croatian: • bolesnika liječenih s 10 mg dva puta dnevno.
English: Evidence of humoral and cell-mediated responses to VZV was observed in both tofacitinib and placebo-treated patients at 6 weeks.
Croatian: Dokaz humoralnih i stanično posredovanih odgovora na VZV zabilježen je kroz 6 tjedana i u bolesnika liječenih tofacitinibom i u bolesnika koji su primali placebo.
English: In ORAL Scan and ORAL Start, inhibition of progression of structural joint damage was assessed radiographically and expressed as mean change from baseline in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at months 6 and 12.
Croatian: U ispitivanjima ORAL Scan i ORAL Start, radiološki se procjenjivala inhibicija progresije strukturnog oštećenja zgloba u 6. i 12. mjesecu, izražena kao srednja vrijednost promjene skora na modificiranoj Sharpovoj bodovnoj skali u odnosu na početnu vrijednost i njenim komponentama, skoru za erozije i sužavanja zglobnog prostora (engl. joint space narrowing, JSN).
English: ANC less than 500
Croatian: ABN manji od 500
English: Pyrexia Oedema peripheral Fatigue
Croatian: Pireksija Periferni edem Umor
English: • persistent headaches
Croatian: • ustrajne glavobolje
English: If there has been a loss of response, reinduction with tofacitinib 10 mg twice daily may be considered.
Croatian: Ako je došlo do gubitka odgovora, može se razmotriti ponovljeno uvodno liječenje uz primjenu 10 mg tofacitiniba dva puta dnevno.
English: Following oral administration of tofacitinib 11 mg prolonged-release tablet, peak plasma concentrations are reached at 4 hours and half-life is ~6 hours.
Croatian: Nakon peroralne primjene tofacitinib tablete s produljenim oslobađanjem od 11 mg, vršne koncentracije u plazmi dostižu se za 4 sata a poluvijek iznosi približno 6 sati.
English: The recommended dose is one 11 mg prolonged-release tablet administered once daily.
Croatian: Preporučena doza je jedna tableta s produljenim oslobađanjem od 11 mg primijenjena jednom dnevno.
English: In RA patients, coadministration of tofacitinib with MTX 15-25 mg once weekly decreased the AUC and Cmax of MTX by 10% and 13%, respectively.
Croatian: U bolesnika s RA, istodobna primjena tofacitiniba i MTX-a od 15 do 25 mg jednom tjedno smanjila je AUC i Cmax MTX-a za 10%, odnosno za 13%.
English: In patients who have responded to treatment with tofacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Croatian: Primjena kortikosteroida u bolesnika s odgovorom na liječenje tofacitinibom može se smanjiti i/ili trajno prekinuti u skladu sa standardnom skrbi.
English: Month 6: mT SS ACR70
Croatian: 6. mjesec: mTSS ACR70
English: Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one side and “JKI 10” on the other.
Croatian: Plava, okrugla tableta promjera 9,5 mm, s utisnutim znakom „Pfizer“ na jednoj strani i „JKI 10“ na drugoj strani.
English: The overall incidence rate of infections with tofacitinib in the long-term safety all exposure population (total 4,867 patients) was 46.1 patients with events per 100 patient-years (43.8 and 47.2 patients with events for 5 mg and 10 mg twice daily, respectively).
Croatian: Ukupna stopa incidencije infekcija uz tofacitinib u ispitivanju dugoročne sigurnosti za cjelokupnu izloženu populaciju (ukupno 4867 bolesnika) bila je 46,1 bolesnik s događajem na 100 bolesnikgodina (43,8 odnosno 47,2 bolesnika s događajem za 5 mg i 10 mg dva puta dnevno).
English: Dyslipidaemia Hyperlipidaemia Dehydration
Croatian: Dislipidemija Hiperlipidemi ja
English: TNF=tumour necrosis factor; N=number of patients in the analysis set.
Croatian: TNF = čimbenik nekroze tumora; N = broj bolesnika čiji su podaci uključeni u skup podataka za analizu.
English: ORAL Step: TNF inhibitor inadequate responders N=118
Croatian: ORAL Step: Bolesnici s neodgovarajućim odgovorom na TNF inhibitore N=118
English: Population DMARD-IR DMARD-IR MTX-IR MTX-IR TNFi-IR MTX-naïve a
Croatian: MTX-IR MTX-IR TNFi-IR MTXnaivni
English: XELJANZ is used to reduce the signs and symptoms of ulcerative colitis when you did not respond well enough or were intolerant to previous ulcerative colitis treatment.
Croatian: XELJANZ se koristi za ublažavanje znakova i simptoma ulceroznog kolitisa kada niste imali dovoljno dobar odgovor na prethodno liječenje ulceroznog kolitisa ili ga niste dobro podnosili.
English: In all studies, patients treated with either 5 mg or 10 mg twice daily tofacitinib had statistically significant ACR20, ACR50 and ACR70 response rates at month 3 and month 6 versus placebo (or versus MTX in ORAL Start) treated patients.
Croatian: U svim ispitivanjima bolesnici liječeni bilo s 5 mg ili 10 mg tofacitiniba dnevno imali su statistički značajne ACR20, ACR50 i ACR70 stope odgovora u 3. i 6. mjesecu u odnosu na bolesnike koji su primali placebo (ili u odnosu na MTX u ispitivanju Oral Start).
English: Dyspnoea Sinus congestion
Croatian: Dispneja Kongestija sinusa
English: The pharmacologic activity of tofacitinib is attributed to the parent molecule.
Croatian: Farmakološka aktivnost tofacitiniba pripisuje se ishodišnom spoju.
English: The efficacy and safety of tofacitinib for the treatment of adult patients with moderately to severely active UC (Mayo score 6 to 12 with endoscopy subscore ≥ 2 and rectal bleeding subscore ≥ 1) were assessed in 3 multicentre, double-blind, randomised, placebo-controlled studies: 2 identical induction studies (OCTAVE Induction 1 and OCTAVE Induction 2) followed by 1 maintenance study (OCTAVE Sustain).
Croatian: Djelotvornost i sigurnost tofacitiniba kod liječenja odraslih bolesnika s umjerenim do teškim, aktivnim ulceroznim kolitisom (rezultat prema sustavu bodovanja Mayo od 6 do 12 s endoskopskim podrezultatom ≥ 2 i podrezultatom rektalnog krvarenja ≥ 1) ispitivane su u 3 multicentrična, dvostruko slijepa, randomizirana, placebom kontrolirana ispitivanja: 2 jednaka ispitivanja uvodnog liječenja (OCTAVE Induction 1 i OCTAVE Induction 2) nakon kojih je uslijedilo 1 ispitivanje terapije održavanja (OCTAVE Sustain).
English: Solo)
Croatian: (ORAL Solo)
English: Lymphocyte counts less than 750 cells/mm3 were associated with an increased incidence of serious infections.
Croatian: Potvrđeni ALC manji od 750/mm 3 bio je povezan s povećanom incidencijom ozbiljnih infekcija
English: At month 12, 96% and 98% of patients receiving tofacitinib 5 mg twice daily, and adalimumab 40 mg subcutaneously every 2 weeks, respectively, did not have radiographic progression (mTSS increase from baseline less than or equal to 0.5).
Croatian: U 12. mjesecu u 96% i 98% bolesnika koji su primali tofacitinib 5 mg dva puta dnevno, odnosno adalimumab 40 mg supkutano svaka 2 tjedna, nije zabilježena radiološka progresija (povećanje rezultata na modificiranoj Sharpovoj bodovnoj skali u odnosu na početnu vrijednost manje od ili jednako 0,5).
English: Overall, the safety profile observed in patients with active PsA treated with tofacitinib was consistent with the safety profile observed in patients with RA treated with tofacitinib.
Croatian: Sveukupno, profil sigurnosti zabilježen u bolesnika s aktivnim PsA-om liječenih tofacitinibom bio je dosljedan profilu sigurnosti zabilježenom u bolesnika s RA-om liječenih tofacitinibom.
English: Pneumonia Influenza Herpes zoster Urinary tract infection Sinusitis Bronchitis Nasopharyngitis Pharyngitis
Croatian: Pneumonija Influenca Herpes zoster Infekcija urinarnog trakta Sinusitis Bronhitis Nazofaringitis Faringitis
English: Treatment with tofacitinib was associated with dose-dependent increases in B cell counts.
Croatian: Liječenje tofacitinibom bilo je povezano s porastima broja B stanica ovisnim o dozi.
English: XELJANZ is used to treat adult patients with moderate to severe active rheumatoid arthritis, a long-term disease that mainly causes pain and swelling of your joints.
Croatian: XELJANZ se koristi u liječenju odraslih bolesnika s umjerenim do teškim aktivnim reumatoidnim artritisom, dugotrajnom bolesti koja uglavnom uzrokuje bolnost i oticanje Vaših zglobova.
English: ANC 500-1,000
Croatian: ABN 500 - 1000
English: 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: The proportion of patients in both tofacitinib groups who had treatment failure was lower compared to placebo at each time point as early as week 8, the first time point where treatment failure was assessed, as shown in Figure 2.
Croatian: Udio bolesnika s neuspješnim liječenjem u obje skupine liječene tofacitinibom bio je manji u usporedbi s placebom u svakoj vremenskoj točki već od 8. tjedna, a to je bila prva vremenska točka u kojoj je liječenje ocijenjeno kao neuspješno, kako je prikazano na slici 2.
English: In study OPAL BROADEN, the progression of structural joint damage was assessed radiographically utilising the van der Heijde modified Total Sharp Score (mTSS) and the proportion of patients with radiographic progression (mTSS increase from baseline greater than 0.5) was assessed at month 12.
Croatian: U ispitivanju OPAL BROADEN u 12. se mjesecu radiološki procjenjivala progresija strukturnog oštećenja zglobova prema van der Heijdeovoj modifikaciji Sharpove bodovne skale (mTSS) i udio bolesnika s radiološkom progresijom (povećanje rezultata na modificiranoj Sharpovoj bodovnoj skali u odnosu na početnu vrijednost veće od 0,5).
English: Analysis of erosion and JSN scores were consistent with overall results.
Croatian: Analiza erozije i rezultata JSN bila je u skladu s ukupnim rezultatima.
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism.
Croatian: Tofacitinib 10 mg dva puta dnevno kontraindiciran je u bolesnika s visokim rizikom za plućnu emboliju.
English: Subjects with mild (creatinine clearance 50-80 mL/min), moderate (creatinine clearance 30-49 mL/min), and severe (creatinine clearance < 30 mL/min) renal impairment had 37%, 43% and 123% higher AUC, respectively, compared to subjects with normal renal function (see section 4.2).
Croatian: Ispitanici s blagim (klirens kreatinina 50-80 ml/min), umjerenim (klirens kreatinina 30 -49 ml/min) i teškim (klirens kreatinina <30 ml/min) oštećenjem bubrega imali su 37%, 43% odnosno 123% veću AUC u usporedbi s ispitanicima s normalnom funkcijom bubrega (vidjeti dio 4.2).
English: It is not known whether tofacitinib is secreted in human milk.
Croatian: Nije poznato izlučuje li se tofacitinib u majčino mlijeko.
English: OCTAVE induction study 2 Central endoscopy read
Croatian: Ispitivanje uvodnog liječenja OCTAVE Induction 2 Centralno očitani endoskopski nalazi
English: Aluminium foil/PVC backed aluminium foil blisters containing 7 prolonged-release tablets.
Croatian: Blisteri od aluminijske folije s podlogom od aluminijske folije/PVC-a, koji sadrže 7 tableta s produljenim oslobađanjem.