FrancophonIA/ELRC3.0 huggingface dataset:
English: A decrease to the lower limit of normal occurred in 15 patients at some point in the study.
Croatian: U nekom je trenutku u ispitivanju smanjenje vrijednosti na donju granicu normalnog raspona nastupilo kod 15 bolesnika.
English: IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis.
Croatian: T stanica, indukcija sekrecije imunoglobulina, indukcija sinteze proteina akutne faze u jetri i stimulacija hemopoeze.
English: Consistent with the effect on acute phase reactants, treatment with tocilizumab was associated with reduction in platelet count within the normal range.
Croatian: skladu s učinkom na reaktante akutne faze, liječenje tocilizumabom bilo je povezano sa smanjenjem broja trombocita u okviru normalnog raspona vrijednosti.
English: • low fibrinogen levels in the blood (a protein involved in blood clotting).
Croatian: · reakcije na mjestu injekcije · niske razine fibrinogena u krvi (proteina koji sudjeluje u zgrušavanju krvi)
English: List of ADRs occurring in patients treated with RoActemra MedDRA System Organ Class
Croatian: Tablica 1: Popis nuspojava koje su se javile kod bolesnika liječenih lijekom RoActemra MedDRA klasifikacija organskih sustava
English: Patients who transition from tocilizumab IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified health care professional.
Croatian: Bolesnici koji prelaze s intravenske na supkutanu terapiju tocilizumabom prvu supkutanu dozu trebaju primiti kada je prema rasporedu predviđena sljedeća intravenska doza, pod nadzorom kvalificiranog zdravstvenog radnika.
English: Systemic Effects In the tocilizumab treated patients, 85% who had fever due to sJIA at baseline were free of fever (no temperature recording ≥ 37.5°C in the preceding 14 days) at week 12 versus 21% of placebo patients
Croatian: 85% bolesnika liječenih tocilizumabom koji su na početku ispitivanja imali vrućicu uzrokovanu sJIA, nakon 12 tjedana nije imalo vrućicu (nije zabilježena temperatura ≥ 37,5 °C tijekom prethodnih
English: Following subcutaneous dosing in RA patients, the time to peak serum RoActemra concentrations tmax was 2.8 days.
Croatian: Vrijeme do postizanja vršnih koncentracija lijeka RoActemra u serumu (tmax) nakon supkutane primjene u bolesnika s RA iznosilo je 2,8 dana.
English: If the pre-filled pen does not reach room temperature, this could cause your injection to feel uncomfortable and it could take longer to inject.
Croatian: Ako ne pričekate da se napunjena brizgalica ugrije na sobnu temperaturu, injekcija bi mogla biti neugodna i mogla bi trajati dulje.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.
Croatian: Ako se tijekom ili nakon liječenja pojave simptomi tuberkuloze (uporan kašalj, gubitak tjelesne težine, bezvoljnost, blaga vrućica) ili neka druga infekcija, odmah o tome obavijestite liječnika.
English: The recommended dose The dose for all adults is 162 mg (the content of 1 pre-filled pen) given once a week.
Croatian: Doza za sve odrasle osobe iznosi 162 mg (sadržaj 1 napunjene brizgalice) jedanput tjedno.
English: In clinical studies with tocilizumab, patients who screened positive for hepatitis were excluded.
Croatian: U klinička ispitivanja s tocilizumabom nisu bili uključeni bolesnici koji su bili pozitivni na hepatitis.
English: Following intravenous administration, tocilizumab undergoes biphasic elimination from the circulation.
Croatian: Nakon intravenske primjene, tocilizumab se eliminira iz krvotoka u dvije faze.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle containing 162 mg RoActemra assembled into a pre-filled pen.
Croatian: 0,9 ml otopine u napunjenoj štrcaljki (staklo tipa I) s pričvršćenom iglom, koja sadrži 162 mg lijeka RoActemra i uklopljena je u napunjenu brizgalicu.
English: The accumulation ratios for AUC, Cmin, and Cmax were 2.67, 6.02, and 2.12, respectively.
Croatian: Omjer kumulacije za AUC iznosio je 2,67, za Cmin 6,02, a za Cmax 2,12.
English: The usual dose of RoActemra depends on the patient's weight.
Croatian: Uobičajena doza lijeka RoActemra ovisi o bolesnikovoj tjelesnoj težini.
English: Most of the patients in the population pharmacokinetic analysis had normal renal function or mild renal impairment.
Croatian: Većina bolesnika u ispitivanju populacijske farmakokinetike imala je normalnu bubrežnu funkciju ili blago oštećenje bubrega.
English: NOTE: Once the needle-cap is removed, the syringe must be used immediately.
Croatian: Kad skinete zatvarač igle, štrcaljku morate odmah upotrijebiti.
English: Preparing for a RoACTEMRA Injection Find a comfortable space with a clean, flat, working surface.
Croatian: Pronađite udobno mjesto s čistom i ravnom radnom površinom.
English: Polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Croatian: Polisorbat 80, saharoza, natrijev hidrogenfosfat dodekahidrat, natrijev dihidrogenfosfat dihidrat i voda za injekcije.
English: Unadjusted difference in proportions (99.5% CI)
Croatian: Razlika u prilagođenoj srednjoj promjeni (95% CI)
English: Approximately half of the patients who developed an ANC < 1 x 109/ L did so within 8 weeks after starting therapy.
Croatian: U približno polovice bolesnika koji su imali apsolutni broj neutrofila < 1 x 109/ l smanjenje broja nastupilo je u roku od 8 tjedana od početka terapije.
English: Laboratory Value (cells x 109/ l )
Croatian: Laboratorijska vrijednost (broj stanica x 109/l)
English: RoActemra 162 mg SC every other weekly + 26 weeks prednisone taper N=49
Croatian: RoActemra 162 mg s.c. svaki drugi tjedan + 26-tjedni režim postupnog smanjenja doze prednizona N=49
English: Do not try to re-use the pre-filled pen.
Croatian: Nemojte pokušati ponovno upotrijebiti tu napunjenu brizgalicu.
English: • Check the Window area to see that it is filled with the purple indicator (See Figure L).
Croatian: Slika L · Pogledajte prozorčić kako biste se uvjerili da ga je ljubičasti indikator posve ispunio (vidjeti Sliku L).
English: No impact on RoActemra exposure was noted in these patients.
Croatian: U tih bolesnika nije primijećen utjecaj na izloženost lijeku RoActemra.
English: Abdominal pain, Mouth ulceration, Gastritis
Croatian: Poremećaji probavnog sustava bol u abdomenu, ulceracije u ustima, gastritis stomatitis, želučani ulkus
English: These factors need to be monitored while receiving RoActemra.
Croatian: Ovi se čimbenici moraju kontrolirati za vrijeme liječenja lijekom RoActemra.
English: Maintain dose
Croatian: Održavati postojeću dozu
English: Keep RoActemra out of the sight and reach of children.
Croatian: Lijek RoActemra čuvajte izvan pogleda i dohvata djece.
English: • ciclosporin, used to suppress your immune system during organ transplants
Croatian: · fenitoin, za liječenje epileptičnih napadaja · ciklosporin, za potiskivanje imunološkog sustava tijekom presađivanja organa
English: In general, the adverse drug reactions observed during or within 24 hours of an infusion were similar in nature to those seen in RA and sJIA patients, see section 4.8.
Croatian: Nuspojave na lijek primijećene tijekom ili unutar 24 sata nakon infekcije u načelu su bile slične naravi kao one zabilježene kod bolesnika s RA i sJIA, vidjeti dio 4.8.
English: The primary endpoint in the study was the difference in the proportion of patients who achieved an ACR20 response at week 24.
Croatian: Primarna mjera ishoda ispitivanja bila je razlika u udjelu bolesnika koji su postigli odgovor ACR20 nakon 24 tjedna.
English: In clinical trials, RoActemra has not been studied in patients during an episode of active MAS.
Croatian: U kliničkim ispitivanjima RoActemra nije ispitivana kod bolesnika tijekom epizode aktivnog MAS-a.
English: RoActemra is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Croatian: RoActemra je rekombinantno humanizirano antihumano monoklonsko protutijelo podskupine imunoglobulina G1 (IgG1) koje djeluje ciljano na topive i membranske receptore interleukina-6.
English: The clinical data are insufficient to assess the potential incidence of malignancy following exposure to RoActemra.
Croatian: Nema dovoljno kliničkih podataka da bi se mogla procijeniti potencijalna incidencija malignih bolesti nakon izlaganja lijeku RoActemra.
English: Yes (N = 23)
Croatian: Da (N = 23)
English: In GCA patients, no effect of cumulative corticosteroid dose on RoActemra exposure was observed.
Croatian: U bolesnika s GCA nije opažen nikakav učinak kumulativne doze kortikosteroida na izloženost lijeku RoActemra.
English: Study SC-II evaluated patients with moderate to severe active RA who had an inadequate clinical response to their existing rheumatologic therapy, including one or more DMARD(s) where approximately 20% had a history of inadequate response to at least one TNF inhibitor.
Croatian: SC-II ocjenjivalo je bolesnike s umjerenim do teškim oblikom aktivnog RA koji nisu imali odgovarajući klinički odgovor na postojeću reumatološku terapiju, uključujući jedan ili više DMARD-ova, a približno 20% bolesnika u anamnezi je imalo neodgovarajući odgovor na najmanje jedan TNF inhibitor.
English: Check the liquid in the RoACTEMRA pre-filled pen (See Figure C).
Croatian: Pregledajte tekućinu u RoACTEMRA napunjenoj brizgalici (vidjeti Sliku C).
English: Do not touch the needle-shield of the prefilled pen, because you may stick yourself with the needle.
Croatian: Nemojte dirati zaštitni pokrov igle napunjene brizgalice jer biste se mogli ubosti.
English: Safely dispose of the pre-filled pen in a sharps container and get a new one.
Croatian: Na siguran način odložite napunjenu brizgalicu u spremnik za oštre predmete i uzmite novu.
English: Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Croatian: Tocilizumab je rekombinantno humanizirano antihumano monoklonsko protutijelo podskupine imunoglobulina G1 (IgG1) koje djeluje ciljano na topive i membranske receptore interleukina-6.
English: • The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Croatian: · Drugi sastojci su saharoza, polisorbat 80, natrijev hidrogenfosfat dodekahidrat, natrijev dihidrogenfosfat dihidrat i voda za injekcije.
English: The rate of infection/serious infection events was balanced between the RoActemra weekly group (200.2/9.7 events per 100 patient years) vs. placebo plus 26 weeks prednisone taper (156.0/4.2 events per 100 patient years) and placebo plus 52 weeks taper (210.2/12.5 events per 100 patient years) groups.
Croatian: Stopa infekcija/ozbiljnih infekcija bila je ujednačena između skupine koja je primala lijek RoActemra jednom tjedno (200,2/9,7 događaja na 100 bolesnik-godina) te skupina koje su primale placebo plus 26-tjedni režim postupnog smanjivanja doze prednizona (156,0/4,2 događaja na 100 bolesnik-godina) odnosno placebo plus 52-tjedni režim postupnog smanjivanja doze prednizona (210,2/12,5 događaja na 100 bolesnik-godina).
English: The primary endpoint for each of the five studies was the proportion of patients who achieved an ACR 20 response at week 24.
Croatian: Primarna mjera ishoda u svakom od pet ispitivanja bila je udio bolesnika kod kojih se postigao ACR 20 odgovor u 24. tjednu.
English: • cough, shortness of breath
Croatian: · kašalj, nedostatak zraka
English: Response Rate
Croatian: Stopa odgovora
English: For the 162 mg every week dose, the predicted mean (±SD) steady-state AUC1week, Cmin and Cmax of RoActemra were 7970 ± 3432 µg•h/mL, 43.0 ± 19.8 µg/mL, and 49.8 ± 21.0 µg/mL, respectively.
Croatian: Pri dozi od 162 mg jedanput tjedno, predviđeni srednji (±SD) AUC1tjedan, Cmin odnosno Cmax lijeka RoActemra u stanju dinamičke ravnoteže iznosili su 7970 ± 3432 μg•sat/ml, 43,0 ± 19,8 μg/ml odnosno 49,8 ± 21,0 μg/ml.
English: RoActemra is for subcutaneous use.
Croatian: RoActemra je namijenjena za supkutanu primjenu.
English: ADRs from clinical trials and/or post marketing experience with RoActemra based on spontaneous case reports, literature cases and cases from non-interventional study programs are listed in Table 1 and are presented by MedDRA system organ class.
Croatian: Nuspojave lijeka RoActemra zabilježene u kliničkim ispitivanjima i/ili nakon stavljanja lijeka u promet na temelju spontano prijavljenih slučajeva, slučajeva opisanih u literaturi i slučajeva zabilježeni u sklopu programa neintervencijskih ispitivanja navedene su u tablici 1 prema MedDRA
English: GCA (SC)
Croatian: GCA (s.c)
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane hiperkolesterolemija*
English: If following pressing the activation button the purple indicator does not move, you must dispose of the pre-filled pen in a puncture resistant container.
Croatian: Ako se ljubičasti indikator ne pomakne nakon što pritisnete dugme za aktivaciju, morate odložiti napunjenu brizgalicu u neprobojan spremnik.
English: In Part II, patients were randomized to tocilizumab (same dose received in Part I) or placebo in a 1:1 ratio, stratified by concurrent MTX use and concurrent corticosteroid use.
Croatian: U dijelu II su bolesnici randomizirani u omjeru 1:1 u skupinu koja je primala tocilizumab (u dozi kao i u dijelu I) ili placebo, a stratificirani su prema istodobnoj primjeni MTX-a te istodobnoj primjeni kortikosteroida.
English: Tel: +385 1 47 22 333 Ireland
Croatian: Tel: + 385 1 47 22 333
English: EXP Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30 °C
Croatian: Kada se izvadi ih hladnjaka, RoActemra se mora primijeniti unutar 8 sati i ne smije se čuvati na temperaturi iznad 30°C
English: Fifty out of seventy five (67%) tocilizumab treated patients had a haemoglobin < LLN at baseline.
Croatian: Pedeset od sedamdeset i pet bolesnika (67%) liječenih tocilizumabom na početku ispitivanja imalo je razinu hemoglobina manju od donje granice normale.
English: Each mL concentrate contains 20 mg tocilizumab*.
Croatian: Jedan ml koncentrata sadrži 20 mg tocilizumaba.*
English: • low white blood cell counts shown by blood tests (neutropenia, leucopenia)
Croatian: · kašalj, nedostatak zraka · nizak broj bijelih krvnih stanica utvrđen krvnim pretragama (neutropenija, leukopenija)
English: • Once the needle is removed completely from the skin, you can release the plunger, allowing the needle-shield to protect the needle.
Croatian: · Kada iglu posve izvadite iz kože, možete otpustiti klip i tako omogućiti da zaštitni pokrov prekrije iglu (vidjeti Sliku H).
English: Cumulative glucocorticoid dose (mg) median at Week 52 (Tocilizumab groups vs Placebo+262) median at Week 52 (Tocilizumab groups vs Placebo +522)
Croatian: medijan u 52. tjednu (skupine liječene tocilizumabom naspram placeba+262) medijan u 52. tjednu (skupine liječene tocilizumabom naspram placeba+522)
English: In the long-term exposure population, the overall rate of infections with RoActemra was 108 events per 100 patient years exposure.
Croatian: U populaciji s dugotrajnom izloženošću, ukupna stopa infekcija pri liječenju lijekom RoActemra iznosila je 108 infekcija na 100 bolesnik-godina izloženosti.
English: Modify the dose of the concomitant MTX if appropriate Interrupt RoActemra dosing
Croatian: Ako je moguće, prilagoditi dozu istodobno primijenjenog MTX-a Privremeno prekinuti primjenu lijeka RoActemra
English: RoActemra binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Croatian: RoActemra se specifično veže i za topive i za membranske IL-6 receptore (sIL-6R i mIL-6R).
English: The steady-state profile following the RoActemra weekly dose was almost flat, with very little fluctuations between trough and peak values, while there were substantial fluctuations for the RoActemra every other weekly dose.
Croatian: Profil u stanju dinamičke ravnoteže nakon primjene lijeka RoActemra jednom tjedno gotovo je posve ravnomjeran, uz vrlo male fluktuacije između najnižih i vršnih vrijednosti, dok su kod primjene lijeka
English: If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance.
Croatian: Ako imate ikakvih pitanja u vezi sa štrcaljkom, obratite se svom zdravstvenom radniku ili ljekarniku za pomoć.
English: Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label tocilizumab 8 mg/kg in year 2.
Croatian: Od bolesnika koji su dovršili ispitivanje i koji su prvobitno randomizirani za placebo + MTX, njih 86% primalo je u drugoj godini u otvorenoj fazi ispitivanja tocilizumab u dozi od 8 mg/kg.
English: • the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
Croatian: · liječenje teškog oblika aktivnog i progresivnog reumatoidnog artritisa (RA) u odraslih bolesnika koji prethodno nisu liječeni MTX-om.
English: The most common events observed were nasopharyngitis and upper respiratory tract infections.
Croatian: Najčešće primijećeni događaji bili su nazofaringitis te infekcije gornjeg dišnog sustava.
English: A 52-week, open-label, multi-centre, PK/PD and safety study (WA28118) was conducted in paediatric patients with sJIA, aged 1 to 17 years, to determine the appropriate SC dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Croatian: Klinička djelotvornost Provedeno je 52-tjedno, otvoreno, multicentrično ispitivanje farmakokinetike/farmakodinamike i sigurnosti lijeka (WA28118) kod pedijatrijskih bolesnika sa sJIA u dobi od 1 do 17 godina kako bi se utvrdila odgovarajuća supkutana doza lijeka RoActemra kojom se postiže farmakokinetički/farmakodinamički i sigurnosni profil usporediv s onim kod primjene intravenskog režima.
English: Pre-filled Syringe parts
Croatian: Dijelovi napunjene štrcaljke
English: Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Croatian: Tocilizumab se specifično veže i za topive i za membranske IL-6 receptore (sIL-6R i mIL-6R).
English: If the expiration date has passed, safely dispose of the pre-filled pen in a sharps container and get a new one.
Croatian: Ako je rok valjanosti istekao, na siguran način odložite napunjenu brizgalicu u spremnik za oštre predmete i uzmite novu.
English: Very common side effects:
Croatian: Vrlo česte nuspojave:
English: Modify the dose of the concomitant MTX if appropriate For persistent increases in this range, reduce RoActemra dose to 4 mg/kg or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised
Croatian: U slučaju trajno povišenih vrijednosti u ovom rasponu, smanjiti dozu lijeka RoActemra na 4 mg/kg ili privremeno prekinuti primjenu lijeka RoActemra do normalizacije vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST).
English: Do not use RoActemra.
Croatian: Nemojte primijeniti lijek RoActemra.
English: RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Croatian: RoActemra se može primijeniti kao monoterapija u slučaju nepodnošenja MTX-a ili kada daljnje liječenje MTX-om nije primjereno.
English: A decrease in platelet count below 100 × 103 / μL was not observed in either of the placebo plus prednisone taper groups.
Croatian: Pad broja trombocita ispod 100 x 103/µl nije zabilježen ni u jednoj od dviju skupina koje su primale placebo plus prednizon čija se doza postupno smanjivala.
English: Corticosteroid Tapering
Croatian: Smanjivanje primjene kortikosteroida
English: mg/dL at any time during study treatment, respectively.
Croatian: ≥ 200 mg/dl u bilo kojem trenutku tijekom liječenja ispitivanim lijekom.
English: These proportions were highly significantly different (p<0.0001).
Croatian: Udjeli bolesnika iz dviju skupina značajno su se razlikovali (p < 0,0001).
English: • Check the expiration date on the RoACTEMRA pre-filled pen (See Figure A).
Croatian: · Provjerite rok valjanosti na RoACTEMRA napunjenoj brizgalici (vidjeti Sliku A).
English: • Do not use the pre-filled pen through clothing.
Croatian: · Nemojte injicirati lijek napunjenom brizgalicom kroz odjeću.
English: pJIA patients < 30 kg
Croatian: Bolesnici s pJIA < 30 kg
English: Decreases in neutrophil and platelet counts have occurred following treatment with tocilizumab 8 mg/kg in combination with MTX (see section 4.8).
Croatian: Zabilježeni su slučajevi smanjenja broja neutrofila i trombocita nakon primjene tocilizumaba u dozi od 8 mg/kg u kombinaciji s MTX-om (vidjeti dio 4.8).
English: The rate of anaphylactic reactions (occurring in a total of 8/4,009 patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Croatian: Stopa anafilaktičkih reakcija (koje su se pojavile u ukupno 8/4009 bolesnika; 0,2%) bila je nekoliko puta viša pri primjeni doze od 4 mg/kg nego pri primjeni doze od 8 mg/kg.
English: In the 12 week controlled phase, 4% of patients from the tocilizumab group experienced events occurring during infusion.
Croatian: Tijekom 12-tjedne kontrolirane faze ispitivanja u 4% bolesnika iz skupine koja je primala tocilizumab zabilježene su nuspojave tijekom infuzije.
English: RoActemra subcutaneous weekly dose also showed a clinically meaningful decrease in the risk for flare compared to placebo plus 26 weeks prednisone in patients who entered the trial with relapsing GCA as well as those with new-onset disease (Table 4).
Croatian: Primjena lijeka RoActemra supkutano jednom tjedno dovela je i do klinički značajnog smanjenja rizika od razbuktavanja u odnosu na placebo plus 26-tjedni režim postupnog smanjivanja doze prednizona u bolesnika koji su u ispitivanje ušli s relapsom GCA, kao i u onih s prvim nastupom bolesti (Tablica 4).
English: The long-term exposure population includes all patients who received at least one dose of tocilizumab either in the double-blind control period or open label extension phase in the studies.
Croatian: Populacija s dugotrajnom izloženošću uključuje sve bolesnike koji su u ispitivanjima primili najmanje jednu dozu tocilizumaba, bilo u dvostruko slijepom kontroliranom razdoblju ili otvorenom produžetku ispitivanja.
English: In clinical studies with RoActemra, patients who screened positive for hepatitis were excluded.
Croatian: U klinička ispitivanja lijeka RoActemra nisu bili uključeni bolesnici koji su bili pozitivni na hepatitis.
English: Week TCZ 8 mg/kg
Croatian: Tjedan TCZ 8 mg/ kg
English: • Hold your RoACTEMRA pre-filled pen with the green cap pointing down (See Figure C).
Croatian: · Držite RoACTEMRA napunjenu brizgalicu tako da je zeleni zatvarač usmjeren prema dolje (vidjeti Sliku C).
English: The accumulation ratios for AUC, Cmin, and Cmax were 6.32, 6.30, and 5.27, respectively.
Croatian: Omjer kumulacije za AUC iznosio je 6,32, za Cmin 6,30, a za Cmax 5,27.
English: When compared to the adult RA population, patients with sJIA experienced a higher frequency of nasopharyngitis, decrease in neutrophil counts, hepatic transaminases increased, and diarrhea.
Croatian: U usporedbi s odraslom populacijom s RA, kod bolesnika sa sJIA češće su se javljali nazofaringitis, smanjen broj neutrofila, povišene vrijednosti jetrenih transaminaza i proljev.
English: • Caution should be exercised when considering initiation of tocilizumab treatment in patients with elevated transaminases ALT or AST above 1.5x ULN.
Croatian: · podatke o riziku od hepatotoksičnosti · potreban je oprez kada se razmatra uvođenje liječenja tocilizumabom kod bolesnika kojima su vrijednosti transaminaza ALT ili AST više od 1,5 x GGN.