FrancophonIA/ELRC3.0 huggingface dataset:
English: Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known.
Croatian: Slučajevi intersticijske bolesti pluća (neki od njih s fatalnim ishodom) prijavljeni su u bolesnika liječenih tofacitinibom u kliničkim ispitivanjima RA-a i u postmarketinškom praćenju premda uloga inhibicije Janus kineze (JAK) u ovim slučajevima nije poznata.
English: Each film-coated tablet contains 59.44 mg of lactose.
Croatian: Jedna filmom obložena tableta sadrži 59,44 mg laktoze.
English: Rare (may affect up to 1 in 1,000 people): blood infection (sepsis), disseminated tuberculosis involving bones and other organs, other unusual infections, joint infections.
Croatian: Rijetko (može se javiti u manje od 1 na 1000 osoba): infekcije krvi (sepsa), diseminirani oblik tuberkuloze koji uključuje kosti i druge organe, druge neobične infekcije, infekcije zglobova.
English: Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation in some patients (see section 4.8 liver enzyme tests).
Croatian: Liječenje tofacitinibom bilo je povezano s povećanom incidencijom porasta jetrenih enzima u nekih bolesnika (vidjeti dio 4.8 testovi jetrenih enzima).
English: Analysis of erosion and JSN scores were consistent with overall results.
Croatian: Analize erozije i rezultata JSN bile su u skladu s ukupnim rezultatima.
English: Severity index; PASI75=≥ 75% improvement in PASI.
Croatian: Psoriasis Area and Severity index, PASI); PASI75 = poboljšanje od ≥ 75% prema indeksu PASI.
English: Study PsA-II (OPAL BEYOND) evaluated 394 patients who had discontinued a TNF inhibitor due to lack of efficacy or intolerance; 36.0% had a previous inadequate response to > 1 biological DMARD.
Croatian: Ispitivanje PsA-II (OPAL BEYOND) procjenjivalo je 394 bolesnika koji su prestali primati inhibitor TNF-a zbog izostanka djelotvornosti ili zbog nepodnošenja; 36,0% bolesnika imalo je prethodno neodgovarajući odgovor na > 1 biološki DMARD.
English: If you are a woman of childbearing age, you should use effective birth control during treatment with XELJANZ and for at least 4 weeks after the last dose.
Croatian: Ako ste žena u reproduktivnoj dobi, morate koristiti učinkovitu kontracepciju tijekom liječenja lijekom XELJANZ i još najmanje 4 tjedna nakon posljednje doze.
English: In clinical trials, tofacitinib was not evaluated in subjects with severe (Child Pugh C) hepatic impairment (see sections 4.2 and 4.4), or in patients screened positive for hepatitis B or C.
Croatian: U kliničkim ispitivanjima tofacitiniba nije procjenjivan u ispitanika s teškim (Child Pugh stadij C) oštećenjem jetre (vidjeti dijelove 4.2 i 4.4) ili u bolesnika koji su bili pozitivni na hepatitis B ili C u probiru.
English: Enrolled patients had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or a TNF inhibitor.
Croatian: Bolesnici uključeni u ispitivanje bili su prethodno neuspješno liječeni najmanje 1 konvencionalnom terapijom, uključujući kortikosteroide, imunomodulatore i/ili inhibitor
English: Table 9: Number (%) of Subjects Achieving DAS28-4(ESR) < 2.6 Remission at Months 3 and 6 Time Point
Croatian: Tablica 9: Broj (%) ispitanika koji su postigli DAS28-4(ESR)< 2,6 remisiju u 3. i 6. mjesecu
English: Study IV (ORAL Scan)
Croatian: Ispitivanje IV (ORAL Scan)
English: Changes in circulating T-lymphocyte counts and T-lymphocyte subsets (CD3+, CD4+ and CD8+) were small and inconsistent.
Croatian: limfocita (CD3+, CD4+ i CD8+) bile su male i nedosljedne.
English: Month 6: mTSS ACR70
Croatian: 6. mjesec: mTSS ACR70
English: Women of childbearing potential should be advised to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose.
Croatian: Žene reproduktivne dobi treba savjetovati da koriste odgovarajuću kontracepciju tijekom liječenja tofacitinibom i do najmanje 4 tjedna nakon zadnje doze.
English: Study II (ORAL Sync)
Croatian: Ispitivanje II (ORAL Sync)
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer (see Table 6 in section 4.8).
Croatian: Bolesnicima koji su u povećanom riziku od raka kože preporučuju se povremeni pregledi kože (vidjeti Tablicu 6 u dijelu 4.8).
English: Health-related quality of life was assessed by SF-36v2, fatigue was assessed by the FACIT-F.
Croatian: Kvaliteta života povezana sa zdravljem procijenjena je upitnikom SF-36v2, a umor upitnikom FACIT-F.
English: • fluconazole, ketoconazole, clotrimazole, itraconazole, and voriconazole, used to treat fungal infections
Croatian: • flukonazol, ketokonazol, klotrimazol, itrakonazol i vorikonazol, koji se koriste u liječenju gljivičnih infekcija.
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 15 do 25 mg jednom na tjedan nije imala učinka na farmakokinetiku tofacitiniba u bolesnika s RA (vidjeti sliku 1).
English: If drug-induced liver injury is suspected, the administration of tofacitinib should be interrupted until this diagnosis has been excluded.
Croatian: Ako se sumnja na jatrogenu ozljedu jetre, primjenu tofacitiniba treba prekinuti dok se ova dijagnoza ne isključi.
English: In RA patients, the oral clearance of tofacitinib does not vary with time, indicating that treatment with tofacitinib does not normalise CYP enzyme activity.
Croatian: U bolesnika s RA, oralni klirens lijeka XELJANZ ne mijenja se s vremenom što upućuje na zaključak da liječenje tofacitinibom ne normalizira aktivnost CYP enzima.
English: Study PsA-I (OPAL BROADEN) evaluated 422 patients who had a previous inadequate response (due to lack of efficacy or intolerance) to a csDMARD (MTX for 92.7% of patients); 32.7% of the patients in this study had a previous inadequate response to > 1 csDMARD or 1 csDMARD and a targeted synthetic DMARD (tsDMARD).
Croatian: Ispitivanje PsA-I (OPAL BROADEN) procjenjivalo je 422 bolesnika koji su prethodno imali neadekvatan odgovor (zbog izostanka djelotvornosti ili zbog nepodnošenja) na csDMARD (MTX za 92,7% bolesnika); 32,7% bolesnika u ovom ispitivanju prethodno je imalo neadekvatan odgovor na > 1 csDMARD ili 1 csDMARD te ciljni sintetski DMARD (engl. targeted synthetic DMARD,
English: In clinical trials, tofacitinib was not evaluated in patients with baseline creatinine clearance values (estimated by Cockroft-Gault equation) less than 40 mL/min (see section 4.2).
Croatian: kliničkim ispitivanjima tofacitinib nije procjenjivan u bolesnika s početnim vrijednostima klirensa kreatinina (procijenjeno Cockroft-Gaultovom jednadžbom) ispod 40 ml/min (vidjeti dio 4.2).
English: Additional monitoring tests
Croatian: Dodatne pretrage u praćenju
English: Lymphocyte counts less than 750 cells/mm3 were associated with an increased incidence of serious infections.
Croatian: Broj limfocita manji od 750 stanica/mm3 bio je povezan s povećanom incidencijom ozbiljnih infekcija.
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, a u kojih se ne može potvrditi jesu li bili liječeni na odgovarajući način; ili u bolesnika u kojih je test negativan ali koji imaju čimbenike rizika za infekciju tuberkulozom.
English: • Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within
Croatian: • Možda će liječnik odlučiti prekinuti Vaše liječenje lijekom XELJANZ ako XELJANZ ne bude djelovao unutar 16 tjedana.
English: MTX-IR MTX-IR TNFi-IR MTX-naïvea MTX-IR
Croatian: MTX-IR MTX-IR TNFi-IR MTXnaivnia
English: CYP Rifampicin
Croatian: Induktor CYP enzima Rifampicin
English: Study VI (ORAL Start)
Croatian: Ispitivanje VI (ORAL Start)
English: Study V (ORAL Step)
Croatian: Ispitivanje V (ORAL Step)
English: Study I (ORAL Solo)
Croatian: Ispitivanja Ispitivanje I (ORAL Solo)
English: The efficacy and safety of tofacitinib were assessed in 6 randomised, double-blind, controlled multicentre studies in patients greater than 18 years of age with active RA diagnosed according to American College of Rheumatology (ACR) criteria.
Croatian: Djelotvornost i sigurnost tofacitiniba procijenjena je u 6 randomiziranih, dvostruko slijepih, kontroliranih multicentričnih ispitivanja u bolesnika starijih od 18 godina s aktivnim RA dijagnosticiranim prema kriterijima Američkog društva za reumatologiju (engl.
English: If you are taking XELJANZ and breast-feeding, you must stop breast-feeding until you talk to your doctor about stopping treatment with XELJANZ.
Croatian: Ako uzimate XELJANZ i dojite, morate prestati dojiti dok ne porazgovarate s liječnikom o prekidu liječenja lijekom XELJANZ.
English: Laboratory parameters
Croatian: Laboratorijski parametri Limfociti
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2, and is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Croatian: Breast Cancer Resistance Protein, BCRP), OATP1B1/1B3 ili OCT1/2, te nije inhibitor MDR1, OATP1B1/1B3, OCT2, OAT1/3 ili MRP pri klinički relevantnim koncentracijama.
English: XELJANZ 5 mg film-coated tablet contains approximately 59 mg lactose in each tablet and XELJANZ 10 mg film-coated tablet contains approximately 119 mg lactose in each tablet.
Croatian: XELJANZ 5 mg filmom obložene tablete sadrže približno 59 mg laktoze u jednoj tableti, a XELJANZ 10 mg filmom obložene tablete sadrže približno 119 mg laktoze u jednoj tableti.
English: Population DMARD-IR DMARDIR
Croatian: Populacija DMARDIR
English: Placebo Placebo Placebo Placebo Placebo MTX
Croatian: Kontrola Placebo Placebo Placebo Placebo Placebo MTX MTX, ADA
English: Tofacitinib is not an inhibitor or inducer of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and is not an inhibitor of UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7).
Croatian: niti induktor CYP enzima (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP3A4) i nije inhibitor UGT enzima (UGT1A1, UGT1A4, UGT1A6, UGT1A9 i UGT2B7).
English: Tofacitinib was secreted in milk of lactating rats at concentrations approximately 2-fold those in serum from 1 to 8 hours postdose.
Croatian: Tofacitib se izlučivao u mlijeko liječenih ženki štakora u koncentracijama približno dva puta većima od onih u serumu od 1 do 8 sati nakon doze.
English: • Patients with an ALC less than 1,000 cells/mm3 (see section 4.2).
Croatian: • bolesnika u kojih je apsolutni broj limfocita manji od 1000 stanica/mm3 (vidjeti dio 4.2)
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/mm3 ili bolesnici liječeni s 10 mg dva puta dnevno mogu biti u većem riziku od herpes zostera (vidjeti dio 4.4).
English: Combined use of Tofacitinib with Ciclosporine should be avoided
Croatian: Kombiniranu primjenu tofacitiniba s ciklosporinom treba izbjegavati
English: Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure.
Croatian: e Postignuta statistička značajnost unutar ACR-ovih kategorija (ACR50 i ACR70) pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
English: g. 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: Haemoglobin should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
Croatian: Hemoglobin treba nadzirati na početku liječenja, nakon 4 do 8 tjedana liječenja te nakon toga svaka 3
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 varicelle zoster (VZV).
English: Changes in total serum IgG, IgM, and IgA levels over 6-month tofacitinib dosing in patients with RA were small, not dose-dependent and similar to those seen on placebo, indicating a lack of systemic humoral suppression.
Croatian: Promjene u ukupnim serumskim razinama IgG, IgM i IgA tijekom 6-mjesečnog doziranja tofacitiniba u bolesnika s RA bile su male, nisu bile ovisne o dozi i bile su slične onima nađenim uz placebo,
English: No Dose Adjustment
Croatian: Nema prilagodbe doze
English: The efficacy and safety of tofacitinib were assessed in 2 randomised, double-blind, placebo-controlled Phase 3 studies in adult patients with active PsA (≥ 3 swollen and ≥ 3 tender joints).
Croatian: Djelotvornost i sigurnost primjene tofacitiniba procijenjeni su u 2 randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze 3 provedena u odraslih bolesnika s aktivnim PsA-om (≥ 3
English: ≥1/1,000 to
Croatian: ≥ 1/1000 i
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,
English: Gastritis Dyspepsia
Croatian: Gastritis Dispepsija
English: In OPAL BROADEN, previous treatment with TNF inhibitor was not allowed.
Croatian: U ispitivanju OPAL BROADEN nije bilo dozvoljeno prethodno liječenje inhibitorom
English: mTSS=modified Total Sharp Score, ACR20(70)=American College of Rheumatology ≥20% (≥70%) improvement,
Croatian: mTSS=skor na modificiranoj Sharpovoj bodovnoj skali, ACR20(70)= ACR odgovor ≥ 20% (≥ 70%)
English: Durability of effect was assessed by ACR20, ACR50, ACR70 response rates in studies of duration of up to two years.
Croatian: Trajnost učinka procijenjena pomoću stopa odgovora prema kriterijima ACR 20, 50 i 70 u ispitivanjima koja su trajala do dvije godine.
English: Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Croatian: Pneumonija uzrokovana Pneumocystis jirovecii Pneumokokna pneumonija Bakterijska pneumonija Encefalitis
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 izloženost populacije (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: 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: There was no evidence of a relationship between serious or opportunistic infections or herpes zoster and lymphocyte subset counts (see section 4.2 for absolute lymphocyte count monitoring).
Croatian: Nije bilo dokaza odnosa između ozbiljnih ili oportunističkih infekcija ili herpesa zostera i broja limfocita u podskupinama (vidjeti dio
English: In all studies, patients treated with either 5 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: Month 3 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.
English: Coadministration with ketoconazole (strong CYP3A4 inhibitor), fluconazole (moderate CYP3A4 and potent CYP2C19 inhibitor), tacrolimus (mild CYP3A4 inhibitor) and ciclosporine (moderate CYP3A4 inhibitor) increased tofacitinib AUC, while rifampicin (potent CYP inducer) decreased tofacitinib AUC.
Croatian: Istodobna primjena ketokonazola (snažni inhibitor CYP3A4), flukonazola (umjereni CYP3A4 i snažni inhibitor CYP2C19), takrolimusa (blagi inhibitor CYP3A4) i ciklosporina (umjereni inhibitor CYP3A4) povećala je AUC tofacitiniba, dok je rifampicin (snažni CYP induktor) smanjio AUC tofacitiniba.
English: Tofacitinib was secreted in the milk of lactating rats (see section 5.3).
Croatian: Tobacitinib se izlučivao u mlijeko liječenih ženki štakora (vidjeti dio 5.3).
English: * p<0.0001; † p<0.001; ‡ p<0.05.
Croatian: Klinički odgovord * p < 0,0001; † p < 0,001; ‡ p < 0,05.
English: NMSCs have been reported in patients treated with tofacitinib.
Croatian: NMSC su prijavljeni u bolesnika liječenih tofacitinibom.
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 procijenjeno kao neuspješno, kako je prikazano na slici 2.
English: • The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening of the patient o Vaccination course to be completed before treatment o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
Croatian: o Liste testova koje treba provesti tijekom inicijalnog probira bolesnika o Shemu cijepljenja koja mora biti dovršena prije početka liječenja o Odgovarajuće komorbiditete uz koje se savjetuje oprez kod primjene lijeka XELJANZ i stanja u kojima se XELJANZ ne smije primijeniti o Listu konkomitantnih lijekova koji nisu kompatibilni s liječenjem lijekom XELJANZ o Potrebu rasprave s bolesnikom o rizicima povezanim s primjenom lijeka XELJANZ, osobito u pogledu infekcija, herpes zostera, tuberkuloze (TBC) i drugih oportunističkih infekcija, maligniteta, gastrointestinalne perforacije, intersticijske bolesti pluća i poremećaja u vrijednostima laboratorijskih testova o Potrebu praćenja bilo kakvih znakova i simptoma te poremećaja vrijednosti laboratorijskih testova za ranu identifikaciju gore navedenih rizika.
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E171), macrogol 3350, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Croatian: Drugi sastojci su mikrokristalična celuloza, laktoza hidrat (pogledajte dio 2.), umrežena karmelozanatrij, magnezijev stearat, hipromeloza 6cP (E464), titanijev dioksid (E171), makrogol 3350, triacetin (E1518), bojila FD&C Blue #2/Indigo Carmine Aluminum Lake (E132) i FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
English: Tofacitinib exposure is decreased when coadministered with potent CYP inducers (e.g., rifampicin).
Croatian: Izloženost tofacitinibu je smanjena uz istodobnu primjenu sa snažnim CYP induktorima (npr.
English: Combined use of Tofacitinib with Tacrolimus should be avoided
Croatian: Kombiniranu primjenu tofacitiniba s takrolimusom treba izbjegavati
English: The risk of NMSC may be higher in patients treated with tofacitinib 10 mg twice daily than in patients treated with 5 mg twice daily.
Croatian: Rizik od NMSC-a može biti veći u bolesnika liječenih s 10 mg tofacitiniba dva puta dnevno nego u bolesnika liječenih s 5 mg dva puta dnevno.
English: As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section
Croatian: Kao mjera opreza, primjena tofacitiniba tijekom trudnoće je kontraindicirana (vidjeti dio 4.3).
English: • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Aktivna tuberkuloza (TBC), ozbiljne infekcije poput sepse ili oportunističkih infekcija (vidjeti dio 4.4).
English: Hepatic enzyme increased Transaminases increased Liver function test abnormal Gamma glutamyltransferase increased Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
Croatian: Povišene vrijednosti transaminaza Abnormalne vrijednosti testova jetrene funkcije Povišena vrijednost gamaglutamil transferaze Povišena vrijednost kreatinina u krvi
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
Croatian: 4.2 Doziranje i način primjene Liječenje treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju stanja za koja je tofacitinib indiciran.
English: Table 5: Dose Adjustment for Renal Impairment Renal
Croatian: Tablica 5: Prilagodba doze kod oštećenja bubrega Oštećenje bubrega
English: XELJANZ 10 mg film-coated tablet is blue and round in appearance.
Croatian: XELJANZ 10 mg filmom obložena tableta je plave boje i okruglog izgleda.