FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
Croatian: Jedna bočica od 400 mg sadrži 0,39 mmol (8,85 mg) natrija.
English: Events of cholesterol increased were less frequently reported in the sJIA population than in the adult RA population.
Croatian: Povišene vrijednosti kolesterola manje su često prijavljivane kod populacije sa sJIA nego kod odrasle populacije s RA.
English: Caution should be exercised when considering initiation of RoActemra treatment in patients with a low platelet count (i.e. platelet count below 100 x 103/ μL).
Croatian: Potreban je oprez kad se razmatra uvođenje liječenja lijekom RoActemra kod bolesnika s niskim brojem trombocita (broj trombocita manji od 100 x 103/ μl).
English: RoActemra monotherapy should not be used for the treatment of acute relapses (see 4.4).
Croatian: RoActemra se ne smije primjenjivati u monoterapiji za liječenje akutnih relapsa (vidjeti dio 4.4).
English: After 12 weeks or at the time of escape, due to disease worsening, patients were treated in the open label phase at weight appropriate dosing.
Croatian: Nakon 12 tjedana ili prelaska na aktivni lijek zbog pogoršanja bolesti, bolesnici su liječeni u otvorenoj fazi ispitivanja, u kojoj su primali doze u skladu sa svojom tjelesnom težinom.
English: All patients, especially children, should be up-to-date with all their vaccinations before they start treatment with RoActemra.
Croatian: Svi bolesnici, osobito djeca, moraju primiti sva potrebna cjepiva prije početka liječenja lijekom RoActemra.
English: • Low absolute neutrophil count (ANC)
Croatian: · Nizak apsolutni broj neutrofila (ABN)
English: • abdominal pain/tenderness and/or change in bowel function
Croatian: · bolova u trbuhu/osjetljivosti trbuha na dodir i/ili promjena u radu crijeva
English: In the 12 week controlled phase, the rate of all infections in the intravenous RoActemra group was 344.7 per 100 patient years and 287.0 per 100 patient years in the placebo group.
Croatian: Tijekom 12-tjedne kontrolirane faze ispitivanja, stopa svih infekcija u skupini koja je primala lijek RoActemra za intravensku primjenu bila je 344,7 na 100 bolesnik-godina, a u skupini koja je primala placebo 287,0 na 100 bolesnik-godina.
English: Events of cholesterol increased were less frequently reported in the pJIA population than in the adult RA population.
Croatian: Povišene vrijednosti kolesterola prijavljene su manje često u populaciji s pJIA nego u odrasloj populaciji s RA.
English: During the withdrawal phase (Part II), the percentage of patients achieving JIA ACR 30, 50, and 70 responses at Week 40 relative to baseline are shown in Table 8.
Croatian: Tijekom razdoblja izuzimanja lijeka iz liječenja (dio II) postoci bolesnika koji su postigli odgovor JIA ACR 30, 50 i 70 u 40. tjednu u odnosu na početak liječenja prikazani su u tablici 8.
English: TCZ + Placebo (SC) N = 163
Croatian: TCZ + Placebo (s.c.) N = 163
English: Key Secondary Endpoints
Croatian: Ključne sekundarne mjere ishoda
English: The usual dose of RoActemra depends on your weight.
Croatian: Uobičajena doza lijeka RoActemra ovisi o tjelesnoj težini.
English: RoActemra is for single-use only.
Croatian: RoActemra je namijenjena samo za jednokratnu primjenu.
English: The nonlinear part of RoActemra elimination leads to an increase in exposure that is more than dose-proportional.
Croatian: RoActemra dovodi do povećanja izloženosti koje je veće od proporcionalnoga dozi.
English: If the plunger is not fully depressed the needle shield will not extend to cover the needle when it is removed.
Croatian: Ako se klip ne pritisne do kraja, zaštitni pokrov igle možda neće izaći i prekriti iglu kada se ona izvadi iz kože.
English: The recommended dose modifications, including tocilizumab discontinuation, based on transaminases levels, in line with SmPC section 4.2.
Croatian: Preporučene prilagodbe doze, uključujući prekid liječenja tocilizumabom, na temelju vrijednosti transaminaza provode se u skladu s dijelom 4.2 sažetka opisa svojstava lijeka.
English: • Return any remaining pre-filled pens in the box to the refrigerator.
Croatian: · Vratite kutiju s ostalim napunjenim brizgalicama u hladnjak.
English: As recommended for other biological treatments, all patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Croatian: Kao što se inače preporučuje kod biološke terapije, u svih bolesnika treba provesti probir na latentnu tuberkulozu prije početka liječenja lijekom RoActemra.
English: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with RoActemra (see section 4.8).
Croatian: Povišene vrijednosti lipida uključujući ukupni kolesterol, lipoproteine niske gustoće (LDL), lipoproteine visoke gustoće (HDL) i trigliceride opažene su kod bolesnika liječenih lijekom RoActemra (vidjeti dio 4.8).
English: * p<0.01, tocilizumab vs. placebo
Croatian: *p < 0,01, tocilizumab u odnosu na placebo
English: The excretion of tocilizumab in milk has not been studied in animals.
Croatian: Izlučivanje tocilizumaba u mlijeko nije se ispitivalo kod životinja.
English: - Joint space narrowing - p≤ 0.0001, TCZ vs. PBO + MTX - p< 0.005, TCZ vs. PBO + MTX
Croatian: - Tocilizumab - p≤ 0,0001, TCZ u usporedbi s PBO + MTX - p< 0,005, TCZ u usporedbi s PBO + MTX
English: • Do not try to re-cap your syringe.
Croatian: · Nemojte pokušavati vratiti zatvarač na štrcaljku.
English: Reporting suspected adverse reactions after authorization of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja lijeka važno je prijavljivanje sumnji na njegove nuspojave.
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving tocilizumab compared to control (Table 4).
Croatian: Inhibicija strukturalnih oštećenja zgloba očitovala se u značajno manjoj radiološkoj progresiji bolesti kod bolesnika koji su primali tocilizumab nego kod kontrolnih bolesnika (Tablica 4).
English: RoActemra has a minor influence on the ability to drive and use machines (see section 4.8, dizziness).
Croatian: RoActemra malo utječe na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8,
English: Nervous system disorders Headache pJIA
Croatian: Poremećaji živčanog sustava glavobolja pJIA
English: Dose modify concomitant DMARDs (RA) or immunomodulatory agents (GCA) if appropriate.
Croatian: Ako je moguće, prilagodite dozu istodobno primijenjenih DMARD-ova (RA) ili imunomodulatora (GCA).
English: • If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor.
Croatian: · Ako je bolesnik nedavno cijepljen ili planira biti cijepljen, morate o tome obavijestiti liječnika.
English: • Preparation of injection/infusion
Croatian: · podatke o pripremi injekcije/infuzije · podatke o brzini infuzije
English: For persistent increases in this range, reduce RoActemra dose frequency to every other week injection or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised.
Croatian: U slučaju trajno povišenih vrijednosti u ovom rasponu, smanjiti učestalost primjene injekcija na jedanput svaka dva tjedna ili privremeno prekinuti primjenu lijeka RoActemra do normalizacije vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST).
English: Active hepatic disease and hepatic impairment
Croatian: Aktivna bolest jetre i oštećenje jetre
English: RoActemra is not recommended for use with other biological agents.
Croatian: Ne preporučuje se primjena lijeka RoActemra s drugim biološkim lijekovima.
English: • calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure
Croatian: · blokatore kalcijevih kanala (npr. amlodipin), za liječenje povišenog krvnog tlaka · teofilin, za liječenje astme
English: In a pooled analysis of studies II, III and IV, the proportion of patients achieving an ACR 20, 50 and 70 response was significantly higher (59% vs. 50%, 37% vs. 27%, 18% vs. 11%, respectively) in the tocilizumab 8 mg/kg plus DMARD vs. the tocilizumab 4 mg/kg plus DMARD group (p< 0.03).
Croatian: U objedinjenoj analizi ispitivanja II, III i IV, udio bolesnika koji su postigli odgovor ACR 20, 50 odnosno 70 bio je značajno viši (59% naspram 50%, 37% naspram 27%, odnosno 18% naspram 11%) u skupini koja je primala tocilizumab u dozi od 8 mg/kg zajedno s DMARD-om nego u skupini koja je primala tocilizumab u dozi od 4 mg/kg zajedno s DMARD-om (p< 0,03).
English: The radiographic response of subcutaneous administered RoActemra was assessed in a double-blind, controlled, multicenter study in patients with active RA (SC-II).
Croatian: Radiološki odgovor Radiološki odgovor pri primjeni supkutane formulacije lijeka RoActemra ocijenjen je u dvostruko slijepom, kontroliranom, multicentričnom ispitivanju u bolesnika s aktivnim RA (SC-II).
English: INFORMATION IN BRAILLE roactemra 162 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU roactemra 162 mg
English: • high blood fat (cholesterol) levels
Croatian: · povišena razina masnoće (kolesterola) u krvi
English: • the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
Croatian: · liječenje umjerenog do teškog oblika aktivnog RA u odraslih bolesnika koji nisu pokazali primjeren odgovor ili nisu podnosili prethodnu terapiju s jednim ili s više antireumatskih lijekova koji mijenjaju tijek bolesti (engl. disease-modifying anti-rheumatic drug - DMARD) ili antagonistima tumor nekrotizirajućeg čimbenika (TNF).
English: The median doses for escape patients in the RoActemra weekly and every other weekly groups were 3129.75 mg and 3847 mg, respectively.
Croatian: Medijan doze za liječenje razbuktavanja bolesti u bolesnika koji su primali lijek RoActemra jednom tjedno odnosno jednom svaki drugi tjedan iznosio je 3129,75 mg odnosno 3847 mg.
English: • Liver enzyme abnormalities Laboratory Value
Croatian: · Poremećene vrijednosti jetrenih enzima Laboratorijska vrijednost
English: The safety profile of intravenous RoActemra in sJIA has been studied in 112 patients from 2 to 17 years of age.
Croatian: Sigurnosni profil lijeka RoActemra za intravensku primjenu ispitan je kod 112 bolesnika sa sJIA u dobi od 2 do 17 godina.
English: • Do not reuse the same pre-filled pen.
Croatian: · Nemojte ponovno upotrijebiti istu napunjenu brizgalicu.
English: This study evaluated the efficacy of IV tocilizumab 4 or 8 mg/kg every 4 weeks/MTX combination therapy, IV tocilizumab 8 mg/kg monotherapy and MTX monotherapy in reducing the signs and symptoms and rate of progression of joint damage for 104 weeks.
Croatian: U ovom se ispitivanju ocjenjivala djelotvornost kombinirane terapije tocilizumabom za intravensku primjenu u dozi od 4 ili 8 mg/kg svaka 4 tjedna i MTX-om, monoterapije tocilizumabom za intravensku primjenu u dozi od 8 mg/kg te monoterapije MTX-om na smanjenje znakova i simptoma te brzine progresije oštećenja zglobova tijekom 104 tjedna.
English: The recommended dose The dose for RA and GCA adults is 162 mg (the content of 1 pre-filled syringe) given once a week.
Croatian: Doza za odrasle osobe s RA i GCA iznosi 162 mg (sadržaj 1 napunjene štrcaljke) jedanput tjedno.
English: > 3 x ULN to 5x ULN
Croatian: > 3 do 5 × GGN
English: RoActemra is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion.
Croatian: RoActemra je dostupna u bočicama koje sadrže 4 ml, 10 ml ili 20 ml koncentrata za otopinu za infuziju.
English: • Wipe the injection site with an alcohol pad in a circular motion and let it air dry to reduce the chance of getting an infection.
Croatian: Pripremite mjesto za injiciranje · Kružnim pokretima obrišite mjesto za injiciranje tupferom s alkoholom i pričekajte da se osuši na zraku kako biste smanjili rizik od infekcije.
English: Decrease in neutrophil count sJIA
Croatian: smanjen broj neutrofila sJIA
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: • RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Croatian: · RoActemra se koristi za liječenje odraslih bolesnika s umjerenim do teškim aktivnim oblikom autoimune bolesti koja se zove reumatoidni artritis (RA), u slučaju da prethodna liječenja nisu bila dovoljno učinkovita.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Ispitivanja interakcija provedena su samo u odraslih.
English: A patient or parent/guardian can self-inject RoActemra only if the physician determines that it is appropriate and the patient or parent/guardian agrees to medical follow-up as necessary and has been trained in proper injection technique.
Croatian: RoActemra samo ako liječnik to ocijeni prikladnim te ako bolesnik ili roditelj/skrbnik pristanu na medicinsko praćenje prema potrebi i ako su svladali pravilnu tehniku injiciranja.
English: Patients in studies I - V had a mean Disease Activity Score (DAS28) of 6.5-6.8 at baseline.
Croatian: Disease Activity Score, DAS28) od 6,5 do 6,8.
English: Do not use the pre-filled pen if the expiration date has passed because it may not be safe to use.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako je istekao rok valjanosti jer možda nije sigurna za uporabu.
English: RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
Croatian: Liječenje lijekom RoActemra usporava oštećenje hrskavice i kostiju zglobova uzrokovano bolešću i poboljšava sposobnost obavljanja svakodnevnih aktivnosti.
English: Manufacturer Roche Pharma AG Emil-Barell-Str. 1
Croatian: Roche Pharma AG Emil-Barell-Str.
English: Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Croatian: Jedna bočica od 200 mg sadrži 0,20 mmol (4,43 mg) natrija.
English: The adjusted mean change in the pain VAS after 40 weeks of tocilizumab treatment was 32.4 mm on a 0-100 mm scale compared to a reduction of 22.3 mm for placebo patients (highly statistically significant; p=0.0076).
Croatian: Prilagođena srednja promjena osjeta boli prema vizualnoj analognoj (VAS) nakon 40 tjedana liječenja tocilizumabom iznosila je 32,4 mm na ljestvici od 0-100 mm, dok je kod bolesnika koji su primali placebo zabilježeno smanjenje od 22,3 mm (visoka statistička značajnost; p=0,0076).
English: The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids.
Croatian: Preporučena doza iznosi 162 mg supkutano jedanput tjedno u kombinaciji s glukokortikoidom čija se doza postupno smanjuje.
English: • cough, chest discomfort/tightness, shortness of breath
Croatian: · kašlja, nelagode/stezanja u prsima, nedostatka zraka
English: L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, LMethionine, Polysorbate 80, Water for injections.
Croatian: L-histidin, L-histidinklorid hidrat, L-arginin, L-argininklorid, L-metionin, polisorbat 80, voda za injekcije.
English: Frequency categories with preferred terms
Croatian: Kategorije učestalosti s preporučenim pojmovima
English: * Includes elevations collected as part of routine laboratory monitoring (see text below) 1 See section 4.3
Croatian: *Uključuje povećanja vrijednosti zabilježena u sklopu rutinskog laboratorijskog praćenja (vidjeti tekst u nastavku)
English: pJIA Patients:
Croatian: Bolesnici s pJIA:
English: Radiographic mean changes over 52 weeks in Study II PBO + MTX (+ TCZ from week 24) N = 393
Croatian: Tablica 4: Radiološki utvrđene srednje promjene tijekom 52 tjedna u Ispitivanju II PBO + MTX (+ TCZ od 24. tjedna) N = 393
English: Hepatic impairment:
Croatian: Hematološki poremećaji:
English: Patients randomized to tocilizumab had fewer ACR30 flares and higher overall ACR responses than patients receiving placebo regardless of a history of prior biologic use.
Croatian: ACR30 te veće ukupne ACR odgovore nego bolesnici koji su primali placebo, neovisno o prethodnoj primjeni bioloških lijekova.
English: There are limited data available on overdose with RoActemra.
Croatian: Nema mnogo dostupnih podataka o predoziranju lijekom RoActemra.
English: The safety and efficacy of RoActemra subcutaneous formulation in children with conditions other than sJIA or pJIA have not been established.
Croatian: Sigurnost i djelotvornost supkutane formulacije lijeka RoActemra kod djece ustanovljene su samo za sJIA i pJIA.
English: Suitability of the patient or parent/guardian for subcutaneous home use should be assessed and patients or parent/guardian instructed to inform a healthcare professional before administering the next dose if they experience symptoms of an allergic reaction.
Croatian: Treba procijeniti je li supkutana primjena lijeka kod kuće prikladna za bolesnika ili roditelja/skrbnika te ih uputiti da se u slučaju pojave simptoma alergijske reakcije obrate zdravstvenom radniku prije nego što primijene sljedeću dozu.
English: • Patient alert card - to address the risk of getting infections which can become serious if not treated.
Croatian: - radi opisa rizika od razvoja infekcija, koje mogu postati ozbiljne ako se ne liječe.
English: Based on the current characterization of PK, RoActemra trough concentration at steady state are 50% higher in this population relative to average concentrations in a large dataset from the RA population.
Croatian: RoActemra zabilježene u stanju dinamičke ravnoteže 50% veće nego prosječne koncentracije u velikom skupu podataka prikupljenih u populaciji bolesnika s RA.
English: • If you have any further questions, ask your doctor or nurse.
Croatian: · Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
English: Cumulative glucocorticoid dose
Croatian: Kumulativna doza glukokortikoida
English: The safety profile comes from 4158 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in RA studies (n=4009), while the remaining experience comes from GCA (n=149) studies.
Croatian: Sigurnosni profil proizlazi iz podataka prikupljenih u 4158 bolesnika izloženih lijeku RoActemra u kliničkim ispitivanjima; većina bolesnika sudjelovala je u ispitivanjima primjene kod RA (n=4009),
English: A 52-week, open-label, multicenter, PK-PD and safety study was conducted in paediatric patients with pJIA, aged 1 to 17 years old, to determine the appropriate subcutaneous dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Croatian: Provedeno je 52-tjedno, otvoreno, multicentrično ispitivanje farmakokinetike/farmakodinamike i sigurnosti lijeka kod pedijatrijskih bolesnika s pJIA 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: In GCA patients, at steady state, the effective t ½ of RoActemra varied between 18.3 and 18.9 days for 162 mg weekly regimen, and between 4.2 and 7.9 days for 162 mg every other weekly regimen.
Croatian: Efektivni poluvijek lijeka RoActemra u stanju dinamičke ravnoteže u bolesnika s GCA varirao je između 18,3 i 18,9 dana uz primjenu doze od 162 mg jednom tjedno te između 4,2 i 7,9 dana uz primjenu doze od 162 mg svaki drugi tjedan.
English: JIA ACR response rates at week 12 (% patients)
Croatian: Tablica 7: Stope JIA ACR odgovora nakon 12 tjedana (% bolesnika)
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving RoActemra compared to control (Table 6).
Croatian: Inhibicija strukturalnih oštećenja zgloba očitovala se u značajno manjoj radiološkoj progresiji bolesti kod bolesnika koji su primali lijek RoActemra nego kod kontrolnih bolesnika (Tablica 6).
English: Do not use this medicine after the expiry date which is stated on the pre-filled syringe label and carton (EXP).
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici napunjene brizgalice i kutiji (EXP ili Rok valjanosti).
English: Adult patients with RA
Croatian: Doziranje Bolesnici s RA
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za razrjeđivanje prije primjene
English: If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid any injury with the needle.
Croatian: Ako igla nije prekrivena, pažljivo odložite napunjenu brizgalicu u spremnik za oštre predmete, kako biste izbjegli bilo kakvu ozljedu iglom.
English: sJIA (SC)
Croatian: sJIA (s.c.)
English: Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo + 52) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo + 52) HR (99% CI)
Croatian: Vrijeme do prvog razbuktavanja GCA¹ (bolesnici s relapsom; skupine liječene tocilizumabom naspram placeba+26), HR (99% CI) Vrijeme do prvog razbuktavanja GCA¹ (bolesnici s relapsom; skupine liječene tocilizumabom naspram placeba+52), HR (99% CI) Vrijeme do prvog razbuktavanja GCA¹ (bolesnici s novonastalom bolešću; skupine liječene tocilizumabom naspram placeba+26), HR (99% CI)
English: Pack sizes of 1 and 4 vials.
Croatian: Veličine pakiranja: 1 i 4 bočice.
English: However, if you are worried, talk to your doctor or nurse.
Croatian: Međutim, ako Vas to brine, obratite se svom liječniku ili medicinskoj sestri.
English: • If you cannot remove the green cap you should ask a caregiver for help or contact your healthcare provider.
Croatian: · Ako ne možete skinuti zeleni zatvarač, zamolite skrbnika za pomoć ili se obratite svom zdravstvenom radniku.
English: • upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache
Croatian: · infekcije gornjih dišnih putova s tipičnim simptomima poput kašlja, začepljenog nosa, curenja iz nosa, grlobolje ili glavobolje
English: • children and adolescents, aged 1 year and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Croatian: · djece i adolescenata u dobi od 1 ili više godina s aktivnim sistemskim juvenilnim idiopatskim artritisom (sJIA), upalnom bolešću koja uzrokuje bol i natečenost jednog ili više zglobova te vrućicu i osip.
English: Each of the RoActemra-treated groups and one of the placebo-treated groups followed a pre-specified prednisone-taper regimen over 26 weeks, while the second placebo-treated group followed a pre-specified prednisone-taper regimen over 52 weeks, designed to be more in keeping with standard practice.
Croatian: Obje skupine liječene lijekom RoActemra i jedna od skupina koje su primale placebo pridržavale su se unaprijed specificiranog 26-tjednog režima postupnog smanjivanja doze prednizona, dok je druga skupina koja je primala placebo slijedila unaprijed specificiran 52-tjedni režim postupnog smanjivanja doze prednizona, koji je bio dizajniran više u skladu s uobičajenom praksom.
English: Caution should be exercised when considering initiation of RoActemra treatment in patients with elevated ALT or AST > 1.5 x ULN.
Croatian: Potreban je oprez kad se razmatra liječenje lijekom RoActemra kod bolesnika s vrijednostima ALT-a ili AST-a > 1,5 x iznad gornje granice normale.