FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported infections were upper respiratory tract infections and nasopharyngitis (3.7% and 3.2%, respectively).
Slovenian: Najpogosteje poročane okužbe so bile okužbe zgornjih dihal (3,7 %) in nazofaringitis (3,2 %).
English: Assessment of lipid parameters should be performed after 8 weeks following initiation of tofacitinib therapy.
Slovenian: Vrednosti lipidnih parametrov je treba oceniti 8 tednov po uvedbi zdravljenja s tofacitinibom.
English: Other side effects which have been observed with XELJANZ are listed below.
Slovenian: Drugi neželeni učinki, ki so jih opazili pri jemanju zdravila XELJANZ, so navedeni spodaj.
English: Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
Slovenian: Eno pakiranje vsebuje 56, 112 ali 182 tablet, ena plastenka pa vsebuje 60 ali 180 tablet.
English: No evidence of stereo conversion in human samples was detected.
Slovenian: Pri človeških vzorcih niso odkrili dokazov o stereo-konverziji.
English: Tofacitinib, alone or in combination with MTX, has shown improvements in physical function, as measured by the HAQ-DI.
Slovenian: Tofacitinib je samostojno ali v kombinaciji z MTX pokazal izboljšanje telesne funkcije, izmerjeno z indeksom HAQ-DI.
English: Prior to launch of XELJANZ in each Member State, the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila XELJANZ na trg v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
English: Tofacitinib was administered as monotherapy (i.e., without concomitant use of biologics and immunosuppressants) for UC.
Slovenian: Tofacitinib so dajali kot monoterapijo (tj. brez sočasne uporabe bioloških zdravil in imunosupresivov) za zdravljenje UK.
English: Before you start XELJANZ, you should be up to date with all recommended vaccinations.
Slovenian: Pred začetkom zdravljenja z zdravilom XELJANZ morate opraviti vsa priporočena cepljenja.
English: TNF=tumour necrosis factor; N=number of patients in the analysis set.
Slovenian: TNF = tumorje nekrotizirajoči faktor, n = število bolnikov v analizirani skupini.
English: In those patients experiencing liver enzyme elevation, modification of treatment regimen, such as reduction in the dose of concomitant DMARD, interruption of tofacitinib, or reduction in tofacitinib dose, resulted in decrease or normalisation of liver enzymes.
Slovenian: Pri tistih bolnikih z zvečanimi vrednostmi jetrnih encimov je prilagoditev režima zdravljenja, kot je zmanjšanje odmerka sočasno uporabljenega DMARD, prekinitev zdravljenja s tofacitinibom ali zmanjšanje odmerka tofacitiniba, povzročila zmanjšanje vrednosti jetrnih encimov ali povrnitev na normalne vrednosti.
English: For patients who have difficulties swallowing, tofacitinib tablets may be crushed and taken with water.
Slovenian: Bolnikom, ki imajo težave s požiranjem, se lahko tablete tofacitiniba zdrobi in jih vzamejo z vodo.
English: Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
Slovenian: Indukcijsko zdravljenje s tofacitinibom je treba prekiniti pri vsakem bolniku, pri katerem po 16 tednih ne opazimo nobene koristi zdravljenja.
English: Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection.
Slovenian: Bolniki z revmatoidnim artritisom, ki jemljejo kortikosteroide, so lahko dovzetnejši za okužbe.
English: If needed, your doctor may interrupt your XELJANZ treatment to reduce the risk of infection (white blood cell counts) or anaemia (red blood cell counts).
Slovenian: Če bo treba, lahko zdravnik zdravljenje z zdravilom XELJANZ za nekaj časa prekine, da zmanjša tveganje za okužbo (število belih krvnih celic) ali anemijo (število rdečih krvnih celic).
English: • fluconazole, ketoconazole, used to treat fungal infections
Slovenian: • flukonazol in ketokonazol, ki se uporabljata za zdravljenje glivičnih okužb.
English: CD19+ B cell counts showed no further increases after long-term tofacitinib treatment.
Slovenian: Število celic B CD19+ se po dolgotrajnem zdravljenju s tofacitinibom ni dodatno zvečalo.
English: Cases of opportunistic infections have been reported (see section 4.4).
Slovenian: Poročali so o primerih oportunističnih okužb (glejte poglavje 4.4).
English: • For patients, who have previously taken biologic medicines to treat ulcerative colitis (such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to continue giving 10 mg twice a day.
Slovenian: • Pri bolnikih, ki so predhodno jemali biološka zdravila za zdravljenje ulceroznega kolitisa (kot so tista, ki zavirajo delovanje tumorje nekrotizirajočega faktorja v telesu) in ta niso bila učinkovita, se zdravnik lahko odloči za nadaljevanje zdravljenja z odmerkom 10 mg dvakrat na dan.
English: Treatment with tofacitinib resulted in significant improvements in some signs and symptoms of PsA, as assessed by the ACR20 response criteria compared to placebo at month 3.
Slovenian: Zdravljenje s tofacitinibom je povzročilo bistveno izboljšanje nekaterih znakov in simptomov PsA, ocenjeno po merilih za odziv ACR20, v primerjavi s placebom po 3 mesecih.
English: Tofacitinib is well-absorbed, with an oral bioavailability of 74%.
Slovenian: Tofacitinib se dobro absorbira, peroralna biološka uporabnost pa je 74 %.
English: In patients who have responded to treatment with tofacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Slovenian: Pri bolnikih, ki se odzovejo na zdravljenje s tofacitinibom, lahko zmanjšamo odmerek kortikosteroidov in/ali prekinemo zdravljenje z njimi v skladu s standardno oskrbo.
English: In the entire treatment experience with tofacitinib, the most commonly reported infection was nasopharyngitis, occurring in 18.2% of patients (211 patients).
Slovenian: V vseh preskušanjih zdravljenja s tofacitinibom je bila okužba, o kateri so najpogosteje poročali, nazofaringitis, ki se je pojavil pri 18,2 % bolnikov (211 bolnikov).
English: Health-related quality of life was assessed by SF-36v2, fatigue was assessed by the FACIT-F.
Slovenian: Z zdravjem povezano kakovost življenja so ocenili z vprašalnikom SF-36v2, utrujenost pa s funkcijsko oceno FACIT-F.
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.
Slovenian: Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom XELJANZ in še vsaj 4 tedne po zadnjem odmerku uporabljati učinkovito metodo kontracepcije.
English: Coadministration of tofacitinib with potent CYP inducers (e.g., rifampicin) may result in a loss of or reduced clinical response (see Figure 1).
Slovenian: Sočasna uporaba tofacitiniba in močnih induktorjev CYP (npr. rifampicina) lahko povzroči izgubo ali zmanjšanje kliničnega odziva (glejte sliko 1).
English: A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Slovenian: Bolniku, pri katerem se med zdravljenjem s tofacitinibom pojavi nova okužba, je treba nemudoma opraviti celovito diagnostično obravnavo, primerno za imunoinkompetentnega bolnika, uvesti ustrezno protimikrobno zdravljenje in bolnika skrbno spremljati.
English: Child Pugh A No dose adjustment required.
Slovenian: Child-Pugh A Prilagajanje odmerka ni potrebno.
English: The proportion of patients who discontinued treatment due to adverse reactions during first 3 months of the double-blind, placebo or MTX controlled studies was 3.8% for patients taking tofacitinib.
Slovenian: Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje v prvih 3 mesecih dvojno slepih, s placebom ali MTX nadzorovanih preskušanj, je bil 3,8 % pri bolnikih, ki so prejemali tofacitinib.
English: Caution should be exercised when considering initiation of tofacitinib treatment in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST), particularly when initiated in combination with potentially hepatotoxic medicinal products such as MTX.
Slovenian: Pri razmisleku o uvedbi zdravljenja s tofacitinibom pri bolnikih z zvečanimi vrednostmi alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST) je potrebna previdnost, zlasti ob uvedbi v kombinaciji s potencialno hepatotoksičnimi zdravili, kot je MTX.
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.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): okužba krvi (sepsa), razsejana tuberkuloza, ki zajame kosti in druge organe, ter druge neobičajne okužbe, okužbe sklepov.
English: Your doctor should perform blood tests before you start taking XELJANZ, and after 4 to 8 weeks of treatment and then every 3 months, to determine if you have a low white blood cell (neutrophil or lymphocyte) count, or a low red blood cell count (anaemia).
Slovenian: Zdravnik vam mora pred začetkom jemanja zdravila XELJANZ in po 4 do 8 tednih zdravljenja ter nato vsake 3 mesece opraviti krvne preiskave, da preveri, če imate zmanjšano število belih krvnih celic (nevtrofilcev ali limfocitov) ali rdečih krvnih celic (anemijo).
English: Pharmacotherapeutic groups: Immunosuppressants, Selective Immunosuppressants; ATC code: L04AA29
Slovenian: Farmakoterapevtski skupini: zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti; oznaka ATC: L04AA29.
English: Asian patients
Slovenian: Bolniki azijske rase
English: What XELJANZ is and what it is used for
Slovenian: Kaj je zdravilo XELJANZ in za kaj ga uporabljamo
English: • Patients with long standing RA who have previously received two or more biological disease modifying antirheumatic drugs (DMARDs).
Slovenian: • bolnikih z dolgotrajnim RA, ki so predhodno prejemali dva ali več bioloških imunomodulirajočih antirevmatičnih zdravil (DMARD),
English: They must not be crushed, split or chewed.
Slovenian: Ne smemo jih zdrobiti, razpoloviti ali žvečiti.
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:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, kjer je zdravilo XELJANZ na trgu, vsem zdravstvenim delavcem in bolnikom/skrbnikom, ki bodo predvidoma predpisovali oziroma uporabljali zdravilo XELJANZ, zagotoviti dostop do naslednjih izobraževalnih gradiv:
English: Tofacitinib was discontinued and the patient recovered after treatment with standard doses of antiviral medication.
Slovenian: Zdravljenje s tofacitinibom so prekinili, bolnik pa je po zdravljenju s standardnimi odmerki protivirusnih zdravil okreval.
English: Overall infections
Slovenian: Splošne okužbe
English: Ulcerative colitis is an inflammatory disease of the large bowel.
Slovenian: Ulcerozni kolitis je vnetna bolezen debelega črevesa.
English: After treatment with tofacitinib in RA patients, rapid decreases in serum C-reactive protein (CRP) were observed and maintained throughout dosing.
Slovenian: Po zdravljenju s tofacitinibom so pri bolnikih z RA opazili hitra zmanjšanja vrednosti C-reaktivnega proteina (CRP) v serumu, ki so se ohranila ves čas odmerjanja.
English: DAS28-4(ESR) response
Slovenian: Odziv DAS28-4(ESR)
English: Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the PK of tofacitinib.
Slovenian: Ni verjetno, da bi sami zaviralci CYP2C19 ali P-glikoprotein pomembno spremenili farmakokinetiko tofacitiniba.
English: The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
Slovenian: Ocenjujejo, da je variabilnost vrednosti AUC tofacitiniba med preskušanci (odstotek koeficienta variance) približno 27 %.
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).
Slovenian: Ni dokazov o povezavi med resnimi ali oportunističnimi okužbami ali herpes zostrom in številom celic podskupin limfocitov (za spremljanje absolutnega števila limfocitov glejte poglavje 4.2).
English: Tofacitinib was secreted in milk of lactating rats at concentrations approximately 2-fold those in serum from 1 to 8 hours postdose.
Slovenian: Tofacitinib se je izločal v mleko pri doječih podganah pri koncentracijah, ki so bile približno 2-krat večje od koncentracij v serumu 1 do 8 ur po odmerjanju.
English: Patients in the phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Slovenian: Pri bolnikih v preskušanjih 3. faze je bila povprečna ocena aktivnosti bolezni (DAS28-4[ESR]) ob izhodišču 6,1-6,7.
English: • Previous venous thromboembolism, either deep venous thromboembolism or pulmonary embolism
Slovenian: • predhodna venska trombembolija - globoka venska tromboza ali pljučna embolija,
English: - The active substance is tofacitinib.
Slovenian: - Učinkovina je tofacitinib.
English: The most common infections resulting in discontinuation of therapy were herpes zoster and pneumonia.
Slovenian: Najpogostejši okužbi, zaradi katerih so prekinili zdravljenje, sta bili herpes zoster in pljučnica.
English: Take your next 11 mg prolonged-release tablet at the usual time and continue as before.
Slovenian: Naslednjo 11 mg tableto s podaljšanim sproščanjem vzemite ob običajnem času in nadaljujte z jemanjem kot običajno.
English: • who have resided or travelled in areas of endemic mycoses,
Slovenian: • ki so bivali na območjih z endemičnimi mikozami ali so tja potovali,
English: The clinical significance of this is unknown, however, similar results were obtained in a separate vaccine study with influenza and pneumococcal polysaccharide vaccines in patients receiving long-term tofacitinib 10 mg twice daily.
Slovenian: Klinični pomen tega ni znan, vendar so podobne rezultate dobili tudi v drugem preskušanju s cepivi, v katerem so uporabili cepivo proti gripi in polisaharidno cepivo proti pnevmokokom pri bolnikih, ki so dolgotrajno prejemali 10 mg tofacitiniba dvakrat na dan.
English: Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).
Slovenian: Resne okužbe so lahko pogostejše pri ljudeh, ki jemljejo tudi kortikosteroide (npr. prednizon).
English: What you need to know before you take XELJANZ
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo XELJANZ
English: All metabolites have been observed in animal species and are predicted to have less than 10-fold potency than tofacitinib for JAK1/3 inhibition.
Slovenian: Vse presnovke so opazili pri živalskih vrstah in predvidevajo, da imajo manj kot 10-kratno jakost zaviranja kinaz JAK1/3 kot tofacitinib.
English: In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib.
Slovenian: V nekliničnih preskušanjih so opazili učinke na imunski in hematopoetski sistem, ki so jih pripisali farmakološkim značilnostim (zaviranje encimov JAK) tofacitiniba.
English: Changes in CRP observed with tofacitinib treatment do not reverse fully within 2 weeks after discontinuation, indicating a longer duration of pharmacodynamic activity compared to the half-life.
Slovenian: Spremembe vrednosti CRP, ki so jih opazili pri zdravljenju s tofacitinibom, se v 2 tednih po prekinitvi zdravljenja niso v celoti povrnile na izhodiščne vrednosti, kar kaže na daljše trajanje farmakodinamične aktivnosti v primerjavi z razpolovnim časom.
English: The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
Slovenian: Tofacitinib se presnavlja predvsem preko encima CYP3A4, z manjšim prispevkom encima CYP2C19.
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).
Slovenian: Tofacitiniba v kliničnih preskušanjih niso ocenjevali pri bolnikih z očistkom kreatinina (ocenjenim po CockcroftGaultovi enačbi), manjšim od 40 ml/min (glejte poglavje 4.2).
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.
Slovenian: Pred uporabo tofacitiniba je treba pretehtati tudi možnost zdravljenja TB pri bolnikih z negativnim testom na TB, ki imajo latentno ali aktivno TB v anamnezi in pri katerih ni mogoče potrditi ustreznega poteka zdravljenja; ali pri katerih je bil test negativen, vendar imajo dejavnike tveganja za okužbo s TB.
English: The use of tofacitinib in combination with phosphodiesterase 4 inhibitors has not been studied in tofacitinib clinical studies.
Slovenian: Uporabe tofacitiniba v kombinaciji z zaviralci fosfodiesteraze tipa 4 v kliničnih preskušanjih tofacitiniba niso preučevali.
English: In the RA long-term safety population, the pattern and incidence of confirmed decreases in ANC remained consistent with what was seen in the controlled clinical studies (see section 4.4).
Slovenian: V populaciji z RA, pri kateri so preučevali dolgoročno varnost, sta vzorec in incidenca potrjenega zmanjšanja ANC ostala skladna z opažanji v nadzorovanih kliničnih preskušanjih (glejte poglavje 4.4).
English: An approximate linear relationship between body weight and volume of distribution was observed, resulting in higher peak (Cmax) and lower trough (Cmin) concentrations in lighter patients.
Slovenian: Opazili so približno linearno povezavo med telesno maso in volumnom porazdelitve, kar je pri bolnikih z manjšo telesno maso povzročilo večjo največjo (Cmax) in nižjo najnižjo (Cmin) koncentracijo.
English: Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure.
Slovenian: Statistično značilnost znotraj družine ACR (ACR50 in ACR70) so dosegli pri p ≤ 0,05 po vnaprej določenem postopku testiranja s postopno regresijo.
English: Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.
Slovenian: Bolnike, pri katerih se na novo pojavijo trebušni znaki in simptomi, je treba takoj pregledati za zgodnje odkrivanje perforacije prebavil.
English: - if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
Slovenian: - če imate veliko tveganje za pojav kožnega raka, vam bo zdravnik morda svetoval, naj vam med jemanjem zdravila XELJANZ opravljajo redne preglede kože.
English: Pharmacokinetics in patients
Slovenian: Farmakokinetika pri bolnikih
English: Excipient with known effect Each film-coated tablet contains 59.44 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena filmsko obložena tableta vsebuje 59,44 mg laktoze.
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.
Slovenian: Učinkovitost in varnost tofacitiniba so ocenili v 6 randomiziranih, dvojno slepih, nadzorovanih, multicentričnih preskušanjih pri bolnikih, starejših od 18 let, z aktivnim RA, diagnosticiranim po merilih Ameriške akademije za revmatologijo (ACR - American College of Rheumatology).
English: The PK profile of tofacitinib is characterised by rapid absorption (peak plasma concentrations are reached within 0.5-1 hour), rapid elimination (half-life of ~3 hours) and dose-proportional increases in systemic exposure.
Slovenian: Za farmakokinetični profil tofacitiniba so značilni hitra absorpcija (največje koncentracije v plazmi doseže v 0,5-1 uri), hitro izločanje (razpolovni čas je približno 3 ure) in odmerku sorazmerna zvečanja sistemske izpostavljenosti.
English: For some patients, such as those who have failed prior tumour necrosis factor (TNF) antagonist therapy, consideration should be given to continuation of the 10 mg twice daily dose for maintenance in order to maintain therapeutic benefit (see section 5.1).
Slovenian: Pri nekaterih bolnikih, kot so tisti, pri katerih je bilo predhodno zdravljenje z antagonistom tumorje nekrotizirajočega faktorja (TNF) neučinkovito, je treba razmisliti o nadaljnji uporabi odmerka 10 mg dvakrat na dan za vzdrževalno zdravljenje, da bi ohranili korist zdravljenja (glejte poglavje 5.1).
English: The available data have also shown that there are no major differences in tofacitinib AUC between White, Black and Asian patients.
Slovenian: Razpoložljivi podatki so pokazali tudi, da med belopoltimi, temnopoltimi in azijskimi bolniki ni večjih razlik v vrednosti AUC tofacitiniba.
English: If taken with XELJANZ, they could alter the level of XELJANZ in your body, and the dose of XELJANZ may require adjustment.
Slovenian: Če jih jemljete skupaj z zdravilom XELJANZ, lahko spremenijo raven zdravila XELJANZ v telesu, zato bo odmerek zdravila XELJANZ morda treba prilagoditi.
English: Time to treatment failure in maintenance study OCTAVE sustain (Kaplan-Meier Curves)
Slovenian: Čas do prenehanja učinkovitosti zdravljenja v preskušanju vzdrževalnega zdravljenja OCTAVE Sustain (Kaplan-Meierjeve krivulje)
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer (see Table 6 in section 4.8).
Slovenian: Pri bolnikih z zvečanim tveganjem za kožnega raka je priporočljivo redno pregledovanje kože (glejte preglednico 6 v poglavju 4.8).
English: Try to take your tablet (one 11 mg prolonged-release tablet) at the same time each day, e.g., morning or evening.
Slovenian: Tableto (eno 11 mg tableto s podaljšanim sproščanjem) poskusite vzeti vsak dan ob isti uri, tj. zjutraj ali zvečer.
English: Abbreviations: TNFi=tumour necrosis factor inhibitor; UC=ulcerative colitis.
Slovenian: Okrajšave: TNFi = zaviralec tumorje nekrotizirajočega faktorja (Tumour Necrosis Factor inhibitor); UK = ulcerozni kolitis.
English: Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).
Slovenian: Do predrtja v želodcu ali črevesju najpogosteje pride pri ljudeh, ki jemljejo tudi nesteroidna protivnetna zdravila ali kortikosteroide (npr. prednizon).
English: Signs of allergic reactions (unknown) include
Slovenian: Znaki alergijskih reakcij (neznana pogostnost) vključujejo:
English: The primary endpoint in OCTAVE Sustain was the proportion of patients in remission at week 52.
Slovenian: Primarni opazovani dogodek v preskušanju OCTAVE Sustain je bil delež bolnikov, ki so bili po 52 tednih v remisiji.
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.
Slovenian: V preskušanju PsA-II (OPAL BEYOND) so ocenili 394 bolnikov, ki so prekinili zdravljenje z antagonistom TNF zaradi nezadostne učinkovitosti ali intolerance; 36,0 % se jih je predhodno nezadostno odzvalo na > 1 biološko DMARD.
English: Asian RA patients are known to be at higher risk of interstitial lung disease, thus caution should be exercised in treating these patients.
Slovenian: Tveganje za intersticijsko pljučno bolezen je večje pri bolnikih azijske rase z RA, zato je pri zdravljenju teh bolnikov potrebna previdnost.