FrancophonIA/ELRC3.0 huggingface dataset:
English: The excretion of RoActemra in milk has not been studied in animals.
Croatian: Izlučivanje lijeka RoActemra u mlijeko nije se ispitivalo kod životinja.
English: RoActemra is not to be used in pregnancy unless clearly necessary.
Croatian: RoActemra se ne smije primjenjivati tijekom trudnoće, osim ako je to neophodno.
English: RoActemra subcutaneous formulation is not intended to be given to children with sJIA weighing less than 10 kg.
Croatian: Supkutana formulacija lijeka RoActemra nije namijenjena za primjenu u djece sa sJIA koja teže manje od 10 kg.
English: Concomitant administration of a single dose of 10 mg/kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Croatian: Istodobna primjena jedne doze tocilizumaba od 10 mg/kg i doze MTX-a od 10-25 mg jedanput tjedno nije imala klinički značajan učinak na izloženost MTX-u.
English: Study VI (WA19924), a 24 week double-blinded study that compared tocilizumab monotherapy with adalimumab monotherapy, evaluated 326 patients with RA who were intolerant of MTX or where continued treatment with MTX was considered inappropriate (including MTX inadequate responders).
Croatian: U ispitivanju VI (WA19924), dvostruko slijepom ispitivanju u trajanju od 24 tjedna u kojem se uspoređivalo monoterapiju tocilizumabom s monoterapijom adalimumabom, ocijenjeno je 326 bolesnika s RA koji nisu podnosili MTX ili u kojih se nastavak liječenja MTX-om smatrao neprikladnim (uključujući bolesnike s neprimjerenim odgovorom na MTX).
English: If you cannot start the injection you should ask for help from a caregiver or contact your healthcare provider.
Croatian: Ako ne možete započeti injekciju, zamolite skrbnika za pomoć ili se obratite svom zdravstvenom radniku.
English: The safety of RoActemra has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Croatian: Sigurnost lijeka RoActemra ispitivala se u 4 placebom kontrolirana ispitivanja (ispitivanja II, III, IV i V), jednom MTX-om kontroliranom ispitivanju (ispitivanje I) i njihovim produžecima (vidjeti dio 5.1).
English: ACR responses in study SC-I (% patients) at Week 24 SC-Ia
Croatian: Tablica 2. ACR odgovori u ispitivanju SC-I (% bolesnika) nakon 24 tjedna SC-Ia
English: There are no adequate data from the use of RoActemra in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka RoActemra kod trudnica.
English: Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku.
English: RoActemra administered to cynomolgus monkeys during early gestation, was observed to have no direct or indirect harmful effect on pregnancy or embryonal-foetal development.
Croatian: RoActemra primijenjena kod cinomolgus majmuna tijekom rane gestacije nije imala vidljive izravne ni neizravne štetne učinke na trudnoću niti razvoj embrija odnosno fetusa.
English: The efficacy of RoActemra for the treatment of CRS was assessed in a retrospective analysis of data from clinical trials of CAR T-cell therapies (tisagenlecleucel and axicabtagene ciloleucel) for hematological malignancies.
Croatian: CRS Djelotvornost lijeka RoActemra u liječenju CRS-a ocijenjena je u retrospektivnoj analizi podataka iz kliničkih ispitivanja lijekova za CAR T-staničnu terapiju hematoloških zloćudnih bolesti
English: In the RoActemra subcutaneous weekly group, a total of 6% (6/100) patients reported an adverse reaction occurring at the site of a subcutaneous injection.
Croatian: U skupini koja je primala lijek RoActemra supkutano jednom tjedno ukupno je 6% (6/100) bolesnika prijavilo nuspojavu na mjestu primjene supkutane injekcije.
English: Therefore, tocilizumab doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Croatian: Stoga se doze tocilizumaba veće od 800 mg po infuziji ne preporučuju (vidjeti dio 4.2).
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 5.7 mL/h in paediatric patients with systemic juvenile idiopathic arthritis.
Croatian: Linearni klirens ocjenjivao se kao parametar u populacijskoj farmakokinetičkoj analizi i iznosio je 5,7 ml/h u pedijatrijskih bolesnika sa sistemskim juvenilnim idiopatskim artritisom.
English: Table 6: Efficacy Results for Study VII (WA19926) on MTX-naïve, early RA patients
Croatian: Tablica 6: Rezultati djelotvornosti za ispitivanje VII (WA19926) u bolesnika u ranoj fazi RA koji prethodno nisu bili liječeni MTX-om
English: Two patients developed positive anti-tocilizumab antibodies with one of these patients having a hypersensitivity reaction leading to withdrawal.
Croatian: Kod dva su se bolesnika razvila pozitivna protutijela na tocilizumab, a jedan je od njih imao reakciju preosjetljivosti koja je uzrokovala povlačenje iz ispitivanja.
English: If appropriate, the dose of concomitant MTX and/or other medications should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated.
Croatian: Po potrebi treba prilagoditi dozu ili prekinuti primjenu MTX-a i/ili drugih lijekova koji se primjenjuju istodobno te privremeno prekinuti primjenu tocilizumaba do procjene kliničkog stanja.
English: • Place the needle-shield of the pre-filled pen against your pinched skin at a 90° angle (See
Croatian: · Položite zaštitni pokrov igle napunjene brizgalice na nabor kože pod kutom od 90° (vidjeti
English: It is very important to use RoActemra exactly as prescribed by the doctor.
Croatian: Veoma je važno da lijek RoActemra primjenjujete točno prema uputama liječnika.
English: In study SC-II, inhibition of structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde modified mean total Sharp score (mTSS).
Croatian: U ispitivanju SC-II radiološki se ocjenjivala inhibicija strukturnih oštećenja zglobova izražena kao promjena srednje vrijednosti ukupnog rezultata na van der Heijdeovoj modifikaciji Sharpove bodovne skale (engl. modified mean total Sharp score, mTSS) u odnosu na početnu vrijednost.
English: However, a slight increase in abortion/embryonal-foetal death was observed with high systemic exposure (> 100 x human exposure) in the 50 mg/kg/day high-dose group compared to placebo and other low-dose groups.
Croatian: Međutim, primijećeno je blago povišenje u stopi pobačaja/smrti embrija ili fetusa uz visoku sistemsku izloženost (> 100 x ljudske izloženosti) u skupini koja je primala visoku dozu od 50 mg/kg/dan u usporedbi sa skupinama koje su primale placebo odnosno nisku dozu.
English: The Patient's Global Assessment of disease activity was assessed on a 0-100mm Visual Analogue Scale (VAS).
Croatian: Bolesnikova opća ocjena aktivnosti bolesti temeljila se na vizualnoj analognoj ljestvici (engl. visual analogue scale, VAS) od 0 do 100 mm.
English: These reactions were generally observed during the second to fifth infusions of tocilizumab (see section 4.4).
Croatian: Te su reakcije u načelu zamijećene u razdoblju između primjene druge i pete infuzije tocilizumaba (vidjeti dio 4.4).
English: Rheumatoid arthritis patients demonstrated a similar pattern of absolute neutrophil counts following tocilizumab administration (see section 4.8).
Croatian: Kod bolesnika s reumatoidnim artritisom primijećen je sličan obrazac apsolutnog broja neutrofila nakon primjene tocilizumaba (vidjeti dio 4.8).
English: • Never reattach the needle-cap after removal.
Croatian: · Nikada nemojte vraćati zatvarač na iglu nakon što ga skinete.
English: Yes (N = 27)
Croatian: Da (N = 27)
English: Although IL-6 does not seem to be a critical cytokine for foetal growth or the immunological control of the maternal/foetal interface, a relation of this finding to RoActemra cannot be excluded.
Croatian: Premda se ne čini da IL-6 ima bitnu ulogu za fetalni rast ili imunološku kontrolu granice između majke i fetusa, ne može se isključiti korelacija između tih nalaza i liječenja lijekom RoActemra.
English: 1p<0.0001, tocilizumab vs. placebo
Croatian: 1p < 0,0001, tocilizumab u odnosu na placebo
English: Diluted product: After dilution, the prepared solution for infusion is physically and chemically stable in sodium chloride 9 mg/mL (0.9%) solution for injection at 30ºC for 24 hours.
Croatian: Razrijeđen lijek: Nakon razrjeđivanja, otopina za infuziju pripremljena s otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%) fizički je i kemijski postojana na temperaturi od 30°C tijekom 24 sata.
English: Limited information is available regarding switching patients from RoActemra intravenous formulation to RoActemra subcutaneous fixed dose formulation.
Croatian: Ograničeni su podaci o prelasku bolesnika s formulacije lijeka RoActemra za intravensku primjenu na formulaciju lijeka RoActemra u fiksnoj dozi za supkutanu primjenu.
English: At week 24, inhibition of structural damage was shown, with significantly less radiographic progression in patients receiving RoActemra subcutaneous compared to placebo (mean mTSS of 0.62 vs. 1.23, p=0.0149 (van Elteren).
Croatian: Nakon 24 tjedna inhibicija strukturnih oštećenja zgloba očitovala se u značajno manjoj radiološkoj progresiji bolesti u bolesnika koji su primali supkutani lijek RoActemra u usporedbi s bolesnicima koji su primali placebo (srednja vrijednost mTSS: 0,62 naspram 1,23, p=0,0149 [van Elteren]).
English: In the SC Study (WA28118), 46 of the 51 (90.2%) patients tested for anti-tocilizumab antibodies at baseline had at least one post-baseline screening assay result.
Croatian: U ispitivanju supkutane primjene (WA28118), za 46 od 51 (90,2%) bolesnika testiranog na protutijela na tocilizumab na početku ispitivanja postojali su rezultati još najmanje jednog testiranja provedenog nakon početka ispitivanja.
English: RoActemra versus adalimumab in monotherapy
Croatian: RoActemra u usporedbi s adalimumabom u monoterapiji
English: - Methotrexate
Croatian: - Metotreksat
English: • shingles (herpes zoster)
Croatian: · herpes zoster
English: The adjusted mean change in the pain VAS after 12 weeks of tocilizumab treatment was a reduction of 41 points on a scale of 0 - 100 compared to a reduction of 1 for placebo patients (p<0.0001).
Croatian: Prilagođena srednja promjena osjeta boli prema vizualnoj analognoj ljestvici (VAS) nakon 12 tjedana liječenja tocilizumabom bila je smanjenje za 41 bod na ljestvici od 0 do 100, u usporedbi sa smanjenjem od jednog boda kod bolesnika koji su primali placebo (p<0,0001).
English: Patients must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously.
Croatian: Bolesnici moraju težiti najmanje 10 kg kad primaju lijek RoActemra za supkutanu primjenu.
English: Following SC dosing in pJIA patients, the absorption half-life was around 2 days, and the bioavailability for the SC formulation in pJIA patients was 96%.
Croatian: Nakon supkutane primjene lijeka kod bolesnika s pJIA, poluvrijeme apsorpcije iznosilo je približno 2 dana, dok je bioraspoloživost za supkutanu formulaciju kod bolesnika s pJIA iznosila 96%.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Allow the pre-filled pen to sit at room temperature outside the box for 45 minutes before use
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Prije primjene izvadite napunjenu brizgalicu iz kutije i pričekajte 45 minuta da se ugrije na sobnu temperaturu
English: Diarrhea pJIA, sJIA
Croatian: proljev pJIA, sJIA
English: Evaluable patients had been treated with tocilizumab 8 mg/kg (12 mg/kg for patients < 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CRS; only the first episode of CRS was included in the analysis.
Croatian: Bolesnici pogodni za ocjenu liječeni su tocilizumabom u dozi od 8 mg/kg (12 mg/kg za bolesnike tjelesne težine < 30 kg), uz dodatnu primjenu visoke doze kortikosteroida ili bez nje, zbog teškog ili po život opasnog CRS-a; u analizu je uključena samo prva epizoda CRS-a.
English: In clinical trials, tocilizumab has not been studied in patients during an episode of active MAS.
Croatian: U kliničkim ispitivanjima tocilizumab nije ispitivan kod bolesnika tijekom epizode aktivnog MAS-a.
English: Side effects could occur at least up to 3 months after your last dose of RoActemra.
Croatian: Nuspojave mogu nastupiti još najmanje 3 mjeseca nakon zadnje doze lijeka RoActemra.
English: The efficacy of tocilizumab for the treatment of active sJIA was assessed in a 12 week randomised, double blind, placebo-controlled, parallel group, two arm study.
Croatian: Klinička djelotvornost Djelotvornost tocilizumaba u liječenju aktivnog sJIA procijenjena je tijekom 12-tjednog randomiziranog, dvostruko slijepog, placebom kontroliranog ispitivanja na dvije usporedne skupine bolesnika.
English: Two hundred and fifty one (251) patients with new-onset or relapsing GCA were enrolled and assigned to one of four treatment arms.
Croatian: U ispitivanje je bio uključen 251 bolesnik s novonastalim GCA ili relapsom GCA i randomiziran u jednu od četiri liječene skupine.
English: The clinical data are insufficient to assess the potential incidence of malignancy following exposure to tocilizumab.
Croatian: Nema dovoljno kliničkih podataka da bi se mogla procijeniti potencijalna incidencija malignih bolesti nakon izlaganja tocilizumabu.
English: The overall safety profile observed in the RoActemra treatment groups was consistent with the known safety profile of RoActemra (see Table 1).
Croatian: Cjelokupan sigurnosni profil primijećen u skupinama liječenima lijekom RoActemra bio je u skladu s poznatim sigurnosnim profilom lijeka RoActemra (vidjeti Tablicu 1).
English: • Do not leave the pre-filled pen unattended.
Croatian: · Nemojte ostaviti napunjenu brizgalicu bez nadzora.
English: calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Croatian: atorvastatin, blokatori kalcijevih kanala, teofilin, varfarin, fenprokoumon, fenitoin, ciklosporin ili benzodiazepini) jer će možda trebati povisiti doze tih lijekova kako bi se održao njihov terapijski učinak.
English: Talk to your doctor if you have any questions about giving yourself or a child patient you look after an injection.
Croatian: Razgovarajte s liječnikom ako imate ikakvih pitanja o samostalnom injiciranju lijeka sebi ili pedijatrijskom bolesniku o kojem skrbite.
English: Children with sJIA
Croatian: Djeca sa sJIA
English: • Keep out of the reach of children.
Croatian: · Čuvajte je izvan dohvata djece.
English: A total of 5.8% of patients experienced an elevation of indirect bilirubin of > 1 to 2 x ULN and 0.4% had an elevation of > 2 x ULN.
Croatian: Ukupno je 5,8% bolesnika imalo povećanje indirektnog bilirubina > 1 do 2 puta iznad gornje granice normale, a 0,4% ih je imalo povećanje > 2 puta iznad gornje granice normale.
English: In the 12 week controlled phase, the rate of serious infections in the intravenous RoActemra group was 11.5 per 100 patient years.
Croatian: Tijekom 12-tjedne kontrolirane faze ispitivanja stopa ozbiljnih infekcija u skupini koja je primala lijek RoActemra za intravensku primjenu bila je 11,5 na 100 bolesnik-godina.
English: A higher incidence of infections and infestations was reported in the RoActemra arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%).
Croatian: Veća incidencija infekcija i infestacija prijavljena je u skupini koja je primala lijek RoActemra (48% naspram 42%), a nije bilo razlike u incidenciji ozbiljnih infekcija (3,1%).
English: • Put the used pre-filled pen into your sharps container (see “How do I dispose of used pre-filled pens?”)
Croatian: · Odložite napunjenu brizgalicu u spremnik za oštre predmete (vidjeti dio 'Kako zbrinuti napunjene brizgalice?')
English: Approximately 90% of the steady-state (AUCτ) was reached by week 14 in the every other weekly and week 17 in the weekly dose groups.
Croatian: Približno 90% izloženosti u stanju dinamičke ravnoteže (AUCτ) postignuto je do 14. tjedna u skupini koja je primala lijek svaki drugi tjedan te do 17. tjedna u skupini koja je primala lijek jednom tjedno.
English: Study V evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies.
Croatian: Ispitivanje V uključilo je 499 bolesnika s neprimjerenim kliničkim odgovorom ili nepodnošenjem jednog ili više antagonista TNF-a u terapiji.
English: Parts of your RoACTEMRA pre-filled pen (See Figure A).
Croatian: Dijelovi RoACTEMRA napunjene brizgalice (vidjeti Sliku A).
English: Children with pJIA
Croatian: Djeca s pJIA
English: • To unlock it, press the pre-filled pen firmly against your pinched skin until the needle-shield is completely pushed in (See Figure I).
Croatian: · Da biste ga otključali, čvrsto pritisnite napunjenu brizgalicu o nabor kože sve dok se zaštitni pokrov igle do kraja ne ugura u brizgalicu (vidjeti Sliku I).
English: A total of 2,876 patients have been tested for anti-tocilizumab antibodies in the 6-month controlled clinical trials.
Croatian: Ukupno je 2876 bolesnika ispitano na protutijela na tocilizumab u 6-mjesečnim kontroliranim kliničkim ispitivanjima.
English: After dilution, RoActemra for RA, sJIA, pJIA, and CRS patients should be administered as an intravenous infusion over 1 hour.
Croatian: Nakon razrjeđenja, RoActemra se kod bolesnika s RA, sJIA, pJIA i CRS-om treba primijeniti u obliku jednosatne intravenske infuzije.
English: and total cholesterol value to ≥ 200 mg/dL at any time during study treatment, respectively.
Croatian: povišenje razine ukupnog kolesterola na ≥ 200 mg/dl u bilo kojem trenutku tijekom liječenja ispitivanim lijekom.
English: An increased frequency of these elevations was observed when potentially hepatotoxic drugs (e.g. MTX) were used in combination with RoActemra.
Croatian: Povećana učestalost takvih povišenja vrijednosti jetrenih enzima primijećena je kad su se u kombinaciji s lijekom RoActemra koristili potencijalno hepatotoksični lijekovi (npr. MTX).
English: Children and adolescents with pJIA (aged 2 and over)
Croatian: Djeca i adolescenti s pJIA (u dobi od 2 i više godina)
English: Drug-induced liver injury, Hepatitis, Jaundice, Very rare: Hepatic failure
Croatian: Poremećaji jetre i žuči oštećenje jetre uzrokovano djelovanjem lijeka, hepatitis, žutica; vrlo rijetko: zatajenje jetre
English: • Hold the pre-filled pen comfortably in 1 hand by the upper part, so that you can see the Window area of the pre-filled pen (See Figure F).
Croatian: · Jednom rukom uhvatite napunjenu brizgalicu za gornji dio, tako da možete vidjeti prozorčić na njoj (vidjeti Sliku F).
English: One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg administered intravenously.
Croatian: Prijavljen je jedan slučaj nehotičnog predoziranja u kojem je bolesnik s multiplim mijelomom primio jednu intravensku dozu od 40 mg/kg.
English: Most of the patients in the RA and GCA studies population pharmacokinetic analysis had normal renal function or mild renal impairment.
Croatian: Većina bolesnika u ispitivanjima populacijske farmakokinetike kod RA i GCA imala je normalnu bubrežnu funkciju ili blago oštećenje bubrega.
English: Tocilizumab administered to cynomolgus monkeys during early gestation, was observed to have no direct or indirect harmful effect on pregnancy or embryonal-foetal development.
Croatian: Tocilizumab primijenjen kod cinomolgus majmuna tijekom rane gestacije nije imao vidljive izravne ni neizravne štetne učinke na trudnoću niti razvoj embrija odnosno fetusa.
English: mTSS Erosion Score JSN 0.03 Radiographic Non-Progression n (%) (change from baseline in mTSS of ≤0)
Croatian: 52. tjedan mTSS 0,08*** stupanj erozije JSN 0,03 radiološka ne-progresija n (%) (promjena mTSS
English: RoActemra, in combination with methotrexate (MTX), is indicated for:
Croatian: 4.1 Terapijske indikacije RoActemra je u kombinaciji s metotreksatom (MTX) indicirana za:
English: Mild renal impairment (estimated creatinine clearance based on Cockcroft-Gault formula) did not impact the pharmacokinetics of RoActemra.
Croatian: Blago oštećenje bubrega (klirens kreatinina procijenjen na temelju Cockcroft-Gaultove jednadžbe) nije utjecalo na farmakokinetiku lijeka RoActemra.
English: • If you have had tuberculosis, tell your doctor.
Croatian: · Ako ste bolovali od tuberkuloze, obavijestite o tome liječnika.
English: In the 12 week controlled phase, 16% of patients in the tocilizumab group and 5.4% of patients in the placebo group experienced an event within 24 hours of infusion.
Croatian: Tijekom 12-tjedne kontrolirane faze ispitivanja kod 16% bolesnika iz skupine koja je primala tocilizumab te kod 5,4% bolesnika iz skupine koja je primala placebo pojavila se reakcija u roku od 24 sata od infuzije.
English: • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Croatian: · Nemojte injicirati lijek u madeže, ožiljke, modrice ni područja na kojima je koža bolna na dodir, crvena, tvrda ili oštećena.
English: Two subcutaneous doses of RoActemra (162 mg every week and 162 mg every other week) were compared to two different placebo control groups randomised 2:1:1:1.
Croatian: Uspoređivale su se dvije supkutane doze lijeka RoActemra (162 mg svaki tjedan i 162 mg svaki drugi tjedan) s dvjema različitim kontrolnim skupinama koje su primale placebo, uz randomizaciju u omjeru
English: When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. .
Croatian: Kad se započinje ili prestaje s terapijom tocilizumabom, treba nadzirati bolesnike koji uzimaju lijekove koji se individualno prilagođavaju i metaboliziraju putem CYP450 3A4, 1A2 ili 2C9 (npr.
English: Forty eight percent (48.1%, 39/81) of the patients treated with placebo flared compared with 25.6% (21/82) of tocilizumab treated patients.
Croatian: Pogoršanje upale zabilježeno je u 48 posto (48,1%, 39/81) bolesnika koji su primali placebo te u 25,6% (21/82) bolesnika liječenih tocilizumabom.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle.
Croatian: 0,9 ml otopine u napunjenoj štrcaljki (staklo tipa I) s pričvršćenom iglom.
English: Dose adjustments due to laboratory abnormalities (sJIA and pJIA)
Croatian: Prilagođavanje doze s obzirom na poremećene vrijednosti laboratorijskih nalaza (sJIA i pJIA)
English: Dispose of the syringe and do not use if:
Croatian: Zbrinite štrcaljku i nemojte je upotrijebiti: · ako je lijek mutan
English: In this study, ACR/EULAR remission (Boolean and Index) were also analysed as pre-specified exploratory endpoints, with higher responses observed in the tocilizumab groups.
Croatian: U ovom je ispitivanju kao unaprijed određena eksploracijska mjera ishoda analizirana i remisija prema ACR/EULAR kriterijima (definirana sukladno načelima Booleove algebre i sukladno indeksu aktivnosti bolesti), pri čemu su viši odgovori primijećeni u skupinama koje su primale tocilizumab.
English: Following SC dosing in sJIA patients, the absorption half-life was around 2 days, and the bioavailability for the SC formulation in sJIA patients was 95%.
Croatian: Nakon supkutane primjene lijeka kod bolesnika sa sJIA, poluvrijeme apsorpcije iznosilo je približno 2 dana, dok je bioraspoloživost za supkutanu formulaciju kod bolesnika sa sJIA iznosila 95%.
English: RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
Croatian: RoActemra se može primijeniti u monoterapiji (u slučaju nepodnošenja MTX-a ili kad liječenje MTX-om nije primjereno) ili u kombinaciji s MTX-om.
English: In healthy subjects administered RoActemra in doses from 2 to 28 mg/kg intravenously and 81 to 162 mg subcutaneously, absolute neutrophil counts decreased to their lowest 2 to 5 days following administration.
Croatian: Kod zdravih ispitanika koji su primali lijek RoActemra u intravenskim dozama od 2 do 28 mg/kg i supkutanim dozama od 81 do 162 mg, apsolutan broj neutrofila smanjio se na najnižu vrijednost 2 do 5 dana nakon primjene.