FrancophonIA/ELRC3.0 huggingface dataset:
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with LIFMIOR for up to approximately 6 years, including 231 patients treated with LIFMIOR in combination with methotrexate in the 2-year active-controlled study.
Croatian: Sto dvadeset devet (129) novih zloćudnih bolesti različitih vrsta zabilježeno je u 4114 bolesnika s reumatoidnim artritisom liječenih LIFMIORom u razdoblju do približno 6 godina u kliničkim ispitivanjima, uključujući 231 bolesnika liječenog LIFMIORom u kombinaciji s metotreksatom u dvogodišnjem ispitivanju s aktivnom kontrolom.
English: Powder: Mannitol (E421), sucrose, and trometamol.
Croatian: Prašak: manitol (E421), saharoza i trometamol
English: A 25 mg strength of LIFMIOR is available for doses of 25 mg.
Croatian: Za doze od 25 mg dostupna je jačina LIFMIORa od 25 mg.
English: • When the needle is completely inserted into the skin, release the skin that you are holding.
Croatian: • Kada je igla u cijelosti ušla u kožu, otpustite nabor kože koji ste držali.
English: ACR 70 Month 3
Croatian: ACR 70 3. mjesec b
English: • When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Croatian: • Kada se očišćeno područje kože osuši, jednom rukom uhvatite nabor kože i čvrsto držite.
English: Pancytopenia and aplastic anaemia
Croatian: Pancitopenija i aplastična anemija
English: 24 vials of powder 24 pre-filled syringes of 1 ml solvent 24 stainless steel injection needles 24 vial adaptors
Croatian: 16 jastučića natopljenih alkoholom24 bočice s praškom24 napunjene štrcaljke s 1 ml otapala 24 igle od nehrđajućeg čelika za ubrizgavanje 24 nastavka za bočicu
English: Based on pharmacokinetic data (see section 5.2), no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Croatian: Temeljem farmakokinetičkih podataka (vidjeti dio 5.2) u liječenju bolesnika s oštećenjembubrega ili jetre nije potrebna prilagodba doza.
English: Patients currently on methotrexate therapy (stable for ≥ 2 months) could continue at a stable dose of ≤ 25 mg/week methotrexate.
Croatian: Bolesnici koji su u tom trenutku primali metotreksat (stabilni  2 mjeseca) mogli su nastaviti s njegovom primjenom u stalnoj dozi od  25 mg tjedno.
English: • While holding the vial in one hand, remove the plastic packaging from the vial adaptor (see Diagram 5).
Croatian: • Dok držite bočicu u jednoj ruci, uklonite plastično pakiranje s nastavka za bočicu (vidjeti sliku
English: Your doctor may decide if you or the child need less anti-diabetic medicine while taking LIFMIOR.
Croatian: Liječnik može odlučiti trebate li Vi ili dijete za vrijeme liječenja LIFMIORom uzimati manju količinu lijeka za liječenje šećerne bolesti.
English: When the cleaned area of skin has dried, pinch and hold it firmly with one hand.
Croatian: Kada se očišćeno područje kože osuši, jednom rukom uhvatite nabor kože i čvrsto držite.
English: With twice weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Croatian: Pretpostavlja se da su koncentracije u stanju dinamičke ravnoteže, pri doziranju dva puta tjedno, otprilike dvostruko veće od onih zabilježenih nakon jednokratnih doza.
English: Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with LIFMIOR due to the development of neutralising antibodies in rodents.
Croatian: Ispitivanja karcinogenosti, kao i uobičajena procjena utjecaja na plodnost i postnatalne toksičnosti, nisu provedena s LIFMIORom zbog pojave neutralizirajućih protutijela u glodavaca.
English: • Inspect the expiry dates on both the vial label and the syringe label.
Croatian: • Provjerite rok valjanosti na naljepnici bočice i naljepnici štrcaljke.
English: There were no differences in rates of infection among patients treated with LIFMIOR and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
Croatian: Kod liječenja plak psorijaze nisu zabilježene razlike u stopi infekcija između bolesnika liječenih Lifmiorom i onih koji su primali placebo u placebom kontroliranim ispitivanjima u trajanju do 24 tjedna.
English: In study 4, the LIFMIOR-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
Croatian: U ispitivanju 4 skupina liječena LIFMIORom imala je veći udio bolesnika s PASI 75 u 12. tjednu (38%) u usporedbi sa skupinom liječenom placebom (2%) (p<0,0001).
English: Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months.
Croatian: Doze metotreksata postepeno su se povećavale tijekom prvih 8 tjedana ispitivanja od 7,5 mg tjedno do maksimalnih 20 mg tjedno te se s primjenom nastavilo tijekom najdulje 24 mjeseca.
English: Clear glass vial (4 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Croatian: Bočica od prozirnog stakla (4 ml, staklo tipa I) s gumenim čepom, aluminijskim prstenom i plastičnim flip-off zatvaračem.
English: The other ingredients are sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate and sodium phosphate dibasic dihydrate, and water for injections.
Croatian: Drugi sastojci su saharoza, natrijev klorid, L-argininklorid, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat i voda za injekcije.
English: In this study, most psoriatic arthritis patients receiving LIFMIOR were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving LIFMIOR.
Croatian: U ovom ispitivanju je većina bolesnika sa psorijatičnim artritisom koji su primali LIFMIOR mogla postići učinkovit imunološki odgovor B-stanica na pneumokokno polisaharidno cjepivo, iako su vrijednosti titra u agregatu bile umjereno niže, dok je nekoliko bolesnika imalo dvostruki porast titra u usporedbi s bolesnicima koji nisu primali LIFMIOR.
English: In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with LIFMIOR at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
Croatian: U jednom drugom otvorenom ispitivanju na jednoj skupini 60 bolesnika s oligoartritisom produljenog trajanja (15 bolesnika u dobi od 2 do 4 godine, 23 bolesnika u dobi od 5 do 11 godina i 22 bolesnika u dobi od 12 do 17 godina), 38 bolesnika s artritisom povezanim s entezitisom (u dobi od 12 do 17 godina) i 29 bolesnika s psorijatičnim artritisom (u dobi od 12 do 17 godina) bilo je liječeno LIFMIORom u dozi od 0,8 mg/kg (do najviše 50 mg po dozi) tjedno tijekom 12 tjedana.
English: ASAS 20 2 weeks
Croatian: ASAS 20 2 tjedna 3 mjeseca 6 mjeseci a
English: If the child develops symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Croatian: Ako dijete razvije simptome infekcije poput vrućice, zimice ili kašlja, odmah o tome obavijestite svog liječnika.
English: These mean concentrations in patients with paediatric plaque psoriasis were similar to the concentrations observed in patients with juvenile idiopathic arthritis (treated with 0.4 mg/kg etanercept twice weekly, up to maximum dose of 50 mg per week).
Croatian: Te srednje vrijednosti koncentracija u pedijatrijskih bolesnika s plak psorijazom bile su slične koncentracijama zabilježenim u bolesnika s juvenilnim idiopatskim artritisom (liječenih s 0,4 mg/kg etanercepta dva puta tjedno, do maksimalne doze od 50 mg tjedno).
English: Discontinuation of treatment should be considered in patients who show no response after 4 months.
Croatian: Mora se razmotriti prekid liječenja u bolesnika koji nisu pokazali odgovor na terapiju nakon 4 mjeseca.
English: Diagram 17
Croatian: Slika 17
English: Solvent Water for injections
Croatian: Otapalo voda za injekcije
English: Plaque psoriasis
Croatian: Plak psorijaza
English: In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Croatian: Kod plak psorijaze infiltracija upalnim stanicama uključujući i T stanice, vodi do porasta razine TNF-a u psorijatičnim lezijama u usporedbi s razinama istih u koži koja nije zahvaćena bolešću.
English: A different site should be used for each new injection.
Croatian: Svaku novu injekciju potrebno je dati na drugom mjestu.
English: Dispose of the needles and syringe as instructed by your doctor, nurse or pharmacist.
Croatian: Igle i štrcaljke odložite prema uputi liječnika, medicinske sestre ili ljekarnika.
English: In a controlled clinical trial of two years duration in adult rheumatoid arthritis patients, the combination of LIFMIOR and methotrexate did not result in unexpected safety findings, and the safety profile of LIFMIOR when given in combination with methotrexate was similar to the profiles reported in studies of LIFMIOR and methotrexate alone.
Croatian: U kontroliranom kliničkom ispitivanju u odraslih bolesnika s reumatoidnim artritisom u trajanju od dvije godine nisu nađeni neočekivani učinci kombinacije LIFMIORa i metotreksata s obzirom na sigurnost primjene te je sigurnosni profil LIFMIORa davanog u kombinaciji s metotreksatom bio sličan onima koji su opisani u ispitivanjima samo s LIFMIORom, odnosno samo s metotreksatom.
English: LIFMIOR 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection).
Croatian: LIFMIOR 25 mg dostupan je kao bijeli prašak i otapalo za otopinu za injekciju (prašak za injekciju).
English: In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Croatian: Kod plak psorijaze infiltracija upalnim stanicama uključujući i T stanice vodi do porasta razine TNF-a u psorijatičnim lezijama u usporedbi s razinama istih u koži koja nije zahvaćena bolešću.
English: • Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given LIFMIOR.
Croatian: • Rak: prije nego započnete liječenje LIFMIORom obavijestite svog liječnika ako imate ili ste ikad imali limfom (vrsta raka krvi) ili bilo koji drugi rak.
English: Doses of 25 mg of LIFMIOR (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
Croatian: Doza LIFMIORa od 25 mg (temeljena na rezultatima ispitivanja doze u bolesnika s reumatoidnim artritisom) ili placeba primijenjena je supkutano, dva puta tjedno, tijekom 6 mjeseci.
English: Do not rub the injection site.
Croatian: NEMOJTE trljati mjesto davanja injekcije.
English: A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept (n=370) during the first trimester with pregnancies not exposed to etanercept or other TNF-antagonists (n=164) (adjusted odds ratio 2.4, 95% CI: 1.0-5.5).
Croatian: U jednom opservacijskom ispitivanju koje je uspoređivalo trudnoće koje su bile izložene etanerceptu (n=370) tijekom prvog tromjesečja s trudnoćama koje nisu bile izložene etanerceptu ili drugim antagonistima TNF-a (n=164), zabilježena je viša stopa velikih urođenih mana (prilagođen omjer izgleda 2,4; 95% IC: 1,0-5,5).
English: Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Croatian: Liječenje psorijatičnog artritisa u adolescenata od navršenih 12 godina u kojih postoji neadekvatan odgovor na metotreksat ili ga dokazano ne podnose.
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of LIFMIOR per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of LIFMIOR per kg of bodyweight (up to a maximum of 50 mg) given once weekly.
Croatian: Za poliartikularni artritis ili produljeni oligoartritis u bolesnika u dobi od navršene 2 godine ili artritis povezan s entezitisom ili psorijatični artritis u bolesnika u dobi od navršenih 12 godina uobičajena doza je 0,4 mg LIFMIORa po kg tjelesne težine (do najviše 25 mg) primijenjena dva puta tjedno ili 0,8 mg LIFMIORa po kg tjelesne težine (do najviše 50 mg) primijenjena jednom tjedno.
English: Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Croatian: Liječenje artritisa povezanog s entezitisom u adolescenata od navršenih 12 godina u kojih postoji neadekvatan odgovor na konvencionalnu terapiju ili je dokazano ne podnose.
English: In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of LIFMIOR and methotrexate did not result in unexpected safety findings, and the safety profile of LIFMIOR when given in combination with methotrexate was similar to the profiles reported in studies of LIFMIOR and methotrexate alone.
Croatian: U kontroliranom kliničkom ispitivanju bolesnika s reumatoidnim artritisom u trajanju od dvije godine nisu nađeni neočekivani učinci kombinacije LIFMIORa i metotreksata s obzirom na sigurnost primjene te je sigurnosni profil LIFMIORa davanog u kombinaciji s metotreksatom bio sličan onima koji su opisani u ispitivanjima samo s LIFMIORom, odnosno samo s metotreksatom.
English: Diagram 15
Croatian: Slika 15
English: Differences from adults and other special considerations are discussed in the following paragraphs.
Croatian: U sljedećim se dijelovima navode razlike u odnosu na odrasle bolesnike i druge specifične okolnosti.
English: Diagram 5.
Croatian: Slika 5.
English: • Anti-diabetic medicines: Tell your doctor if the child has diabetes or is taking medicines to treat diabetes.
Croatian: • Lijekovi za liječenje šećerne bolesti: recite svojem liječniku ako dijete boluje od šećerne bolesti ili uzima lijekove za liječenje šećerne bolesti.
English: Diagram 8
Croatian: Slika 8
English: Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Croatian: Liječenje kronične teške plak psorijaze u djece i adolescenata od navršene 6. godine u kojih bolest nije adekvatno kontrolirana drugim sistemskim terapijama ili fototerapijom, ili ih bolesnici ne podnose.
English: The instructions below explain how to use the MYCLIC pen to inject LIFMIOR.
Croatian: Sljedeće upute objašnjavaju način primjene MYCLIC brizgalice za injiciranje LIFMIORa.
English: You should allow 15 to 30 minutes for the LIFMIOR solution in the syringe to reach room temperature.
Croatian: Pričekajte 15 do 30 minuta da otopina LIFMIORa u štrcaljki dosegne sobnu temperaturu.
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the LIFMIOR group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
Croatian: U analizi u kojoj se smatralo da su svi bolesnici koji su iz bilo kojeg razloga prekinuli sudjelovanje u ispitivanju imali napredovanje bolesti, postotak bolesnika bez progresije (promjena TSS ≤ 0,5) nakon 12 mjeseci bio je veći u skupini koja je primala LIFMIOR u usporedbi sa skupinom koja je primala placebo (73% naspram 47%, p≤0,001).
English: Instructions for preparing and giving an injection of LIFMIOR
Croatian: Upute za pripremu i primjenu injekcije LIFMIORa
English: • Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
Croatian: • Znakovi upale krvnih žila, kao što su bol, vrućica, crvenilo ili toplina na koži ili svrbež.
English: Doses of 25 mg of LIFMIOR (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
Croatian: Supkutano su davane doze od 25 mg LIFMIORa (na temelju ispitivanja o određivanju doze u bolesnika s reumatoidnim artritisom) odnosno placebo dva puta tjedno tijekom 6 mjeseci u 138 bolesnika.
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because LIFMIOR needs to be used with caution under these circumstances.
Croatian: • Kongestivno zatajenje srca: obavijestite svog liječnika ako ste Vi ili dijete imali kongestivno zatajenje srca, jer je u tom slučaju potreban oprez prilikom primjene LIFMIORa.
English: If the child has any of the above symptoms he/she may be having an allergic reaction to LIFMIOR, so you should seek immediate medical attention.
Croatian: Međutim, bilo koji od gore navedenih simptoma u djeteta može upućivati na alergijsku reakciju na LIFMIOR, stoga je potrebno odmah zatražiti pomoć liječnika.
English: The LIFMIOR pre-filled pen is available in a 50 mg strength.
Croatian: Lifmior napunjena brizgalica dostupna je u jačini od 50 mg.
English: HAQ Baseline Week 52
Croatian: HAQ Na početku 52. tjedan
English: If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Croatian: Ako Vi ili dijete dobijete simptome infekcije poput vrućice, zimice ili kašlja, odmah o tome obavijestite svog liječnika.
English: Using the MYCLIC pre-filled pen to inject LIFMIOR
Croatian: Uporaba napunjene brizgalice MYCLIC za ubrizgavanje LIFMIORa
English: A single 50 mg/ml injection of LIFMIOR was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Croatian: Pronašlo se da je jednokratna injekcija LIFMIORa od 50 mg/ml bioekvivalentna dvjema istodobno primijenjenim injekcijama od 25 mg/ml.
English: LIFMIOR is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown, solution for injection (solution for injection).
Croatian: LIFMIOR je dostupan kao napunjena štrcaljka koja sadrži bistru, bezbojnu do blijedožutu ili blijedosmeđu otopinu za injekciju (otopinu za injekciju).
English: • Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
Croatian: • Infekcije/šećerna bolest: obavijestite svog liječnika ako ste Vi ili dijete nedavno imali infekciju koja se vraćala ili bolujete od šećerne bolesti ili drugih poremećaja koji povećavaju sklonost prema infekcijama.
English: At week 12, more patients randomised to LIFMIOR had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.
Croatian: U 12. tjednu više bolesnika koji su randomizirani u skupinu koja je dobivala LIFMIOR imalo je pozitivni odgovor s obzirom na djelotvornost (npr. PASI 75) od onih koji su randomizirani u skupinu koja je dobivala placebo.
English: The safety and efficacy profiles of the two LIFMIOR treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Croatian: Profili djelotvornosti i sigurnosti za dva režima liječenja LIFMIORom bili su usporedivi nakon 8. tjedna u smislu njihovog učinka na znakove i simptome RA.
English: Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, LIFMIOR should be discontinued.
Croatian: Takve je bolesnike potrebno hitno pregledati, uključivši kompletnu krvnu sliku.
English: In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients.
Croatian: Općenito, štetni događaji u pedijatrijskih bolesnika s juvenilnim idiopatskim artritisom po učestalosti i obliku bili su slični onima zabilježenim u odraslih bolesnika.
English: Injection site reactions
Croatian: Reakcije na mjestu primjene injekcije
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).
Croatian: Razne zloćudne bolesti (uključujući karcinom dojke i pluća te limfom) zabilježene su, također, i u razdoblju nakon stavljanja LIFMIORa u promet (vidjeti dio 4.4).
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the LIFMIOR in combination with methotrexate group compared with the LIFMIOR alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
Croatian: U analizi u kojoj se smatralo da su svi bolesnici koji su iz bilo kojeg razloga prekinuli sudjelovanje u ispitivanju imali napredovanje bolesti, postotak bolesnika bez progresije (promjena TSS ≤ 0,5) u 24 mjeseca bio je veći kod kombinacije LIFMIORa s metotreksatom u usporedbi sa skupinom koja je uzimala samo LIFMIOR ili koja je uzimala samo metotreksat (62%, 50% odnosno 36%, p<0,05).
English: Your doctor will determine if preventive treatment for chickenpox is appropriate.
Croatian: Liječnik će odlučiti treba li poduzeti preventivno liječenje vodenih kozica.
English: Whether used alone or in combination with methotrexate, LIFMIOR can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Croatian: Bilo da se LIFMIOR primjenjuje sam ili u kombinaciji s metotreksatom, LIFMIOR može usporiti razvoj oštećenja na Vašim zglobovima uzrokovanih reumatoidnim artritisom i poboljšati
English: • Signs of blood disorders, such as bleeding, bruising, or paleness
Croatian: • Znakovi poremećaja krvi, kao što su krvarenje, modrice ili bljedilo.
English: Diagram 1
Croatian: Slika 1
English: In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which LIFMIOR was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with LIFMIOR or sulfasalazine alone.
Croatian: U kliničkom ispitivanju u odraslih bolesnika koji su primali uobičajene doze sulfasalazina, kojem je dodan LIFMIOR, bolesnici u skupini s ovom kombinacijom imali su statistički značajno sniženje srednje vrijednosti broja leukocita u usporedbi sa skupinama koje su liječene samo LIFMIORom ili samo sulfasalazinom.
English: However, your doctor may determine an alternative frequency at which to inject LIFMIOR.
Croatian: Međutim, liječnik može odrediti drukčiju učestalost primjene LIFMIORa.
English: The needle cover of the pre-filled syringe contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by, or when LIFMIOR is administered to, persons with known or possible latex sensitivity.
Croatian: Pokrov za iglu na napunjenoj štrcaljki sadrži lateks (suhu prirodnu gumu) koji može izazvati reakcije preosjetljivosti u osoba s poznatom ili mogućom preosjetljivošću na lateks, koje rukuju štrcaljkom ili u kojih se primijenjuje LIFMIOR.
English: In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).
Croatian: U dvostruko slijepim fazama kontroliranih kliničkih ispitivanja koja su dozvoljavala istodobno liječenje etanerceptom i metotreksatom, učestalost (kumulativna incidencija) štetnih događaja povišenih jetrenih enzima bila je 4,18% (česta učestalost).