FrancophonIA/ELRC3.0 huggingface dataset:
English: Similarly the proportion of patients achieving a DAS28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving tocilizumab 8 mg/kg plus DMARD than in patients receiving tocilizumab 4 mg/kg plus DMARD (p< 0.0001).
Croatian: Slično tome, udio bolesnika koji su postigli remisiju DAS28 (DAS28 < 2,6) bio je značajno viši (31% naspram 16%) kod bolesnika koji su primali tocilizumab u dozi od 8 mg/kg zajedno s DMARD-om nego kod bolesnika koji su primali tocilizumab u dozi od 4 mg/kg s DMARD-om (p< 0,0001).
English: RoActemra is supplied in a single use pre-filled syringe fitted into a needle safety device.
Croatian: Supkutana formulacija tocilizumaba primjenjuje se napunjenom štrcaljkom za jednokratnu uporabu koja ima sigurnosnu napravu za iglu.
English: The most commonly reported Adverse Drug Reactions (ADRs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Croatian: Najčešće prijavljene nuspojave na lijek bile su infekcije gornjeg dišnog sustava, nazofaringitis, glavobolja, hipertenzija i povišene vrijednosti ALT-a.
English: At the start, your doctor or nurse may inject RoActemra.
Croatian: U početku će Vam lijek RoActemra možda injicirati Vaš liječnik ili medicinska sestra.
English: A total of 28.8% (15/52) pJIA patients experienced ISRs to RoActemra SC.
Croatian: Reakcije na mjestu injekcije zabilježene su kod ukupno 28,8% (15/52) bolesnika s pJIA liječenih lijekom RoActemra za supkutanu primjenu.
English: Following intravenous administration, RoActemra undergoes biphasic elimination from the circulation.
Croatian: Nakon intravenske primjene, RoActemra se eliminira iz krvotoka u dvije faze.
English: Cytokine Release Syndrome (CRS) (adults and paediatrics) The recommended posology for treatment of CRS given as a 60-minute intravenous infusion is 8 mg/kg in patients weighing greater than or equal to 30 kg or 12 mg/kg in patients weighing less than 30 kg. RoActemra can be given alone or in combination with corticosteroids.
Croatian: Sindrom otpuštanja citokina (CRS) (odrasli i djeca) Preporučena doza za liječenje CRS-a, koja se primjenjuje u obliku 60-minutne intravenske infuzije, iznosi 8 mg/kg u bolesnika tjelesne težine 30 kg ili veće, odnosno 12 mg/kg u bolesnika tjelesne težine manje od 30 kg.
English: In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of RoActemra, to the level similar to, or slightly higher than, those observed in healthy subjects.
Croatian: U ispitivanju bolesnika s RA, tjedan dana nakon primjene jedne doze lijeka RoActemra razine simvastatina (CYP3A4) bile su snižene za 57% i dostigle su razinu sličnu ili malo višu od one opažene kod zdravih ispitanika.
English: The proportion of patients with serious adverse events was balanced between the treatment groups (RoActemra 11.7% vs. adalimumab 9.9%).
Croatian: Udio bolesnika s ozbiljnim nuspojavama bio je izjednačen između obje ispitivane skupine (RoActemra 11,7%,
English: Exploratory efficacy results showed that RoActemra SC improved median Juvenile Arthritis Disease Activity Score (JADAS)-71 for RoActemra naïve patients and maintained the median JADAS-71 for patients who switched from IV to SC RoActemra treatment over the entire course of the study for patients in both body weight groups (below 30 kg and ≥ 30 kg).
Croatian: Juvenile Arthritis Disease Activity Score, JADAS-71) kod bolesnika koji prethodno nisu bili liječeni tocilizumabom, te je održala sve eksploracijske parametre djelotvornosti kod bolesnika koji su prešli s intravenske na supkutanu primjenu lijeka RoActemra tijekom cijelog razdoblja ispitivanja u obje skupine bolesnika prema tjelesnoj težini (manje od 30 kg i ≥ 30 kg).
English: In RoActemra -treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
Croatian: Kod bolesnika liječenih lijekom RoActemra, smanjenje vrijednosti CRP-a na one u normalnom rasponu vidjele su se već u 2. tjednu, a smanjenje je održano tijekom čitavog razdoblja liječenja.
English: Peripheral oedema Hypersensitivity reaction, Injection site reaction
Croatian: Opći poremećaji i reakcije na mjestu primjene periferni edem, reakcija preosjetljivosti, reakcija na mjestu injekcije
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 162 mg/0.9 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 162 mg/0,9 ml
English: • Never reattach the green cap after removal.
Croatian: · Nikada nemojte vraćati zeleni zatvarač na brizgalicu.
English: Fatal anaphylaxis has been reported after marketing authorisation during treatment with tocilizumab (see section 4.4).
Croatian: Slučaj anafilaksije sa smrtnim ishodom prijavljen je tijekom liječenja tocilizumabom nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, elevation in
Croatian: Prilikom rutinskog laboratorijskog praćenja u 6-mjesečnom kontroliranom kliničkom ispitivanju lijeka
English: The dose-response curve for tocilizumab flattens at higher exposure,
Croatian: Krivulja doza-odgovor za lijek RoActemra izravnava se pri višoj izloženosti,
English: Adults will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Croatian: Odrasli će lijek RoActemra primati jedanput svaka 4 tjedna dripom u venu (infuzijom u venu kap po kap), u trajanju od jednog sata.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® 4 pre-filled pens
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici, ACTPen® 4 napunjene brizgalice
English: Total Sharp-Genant score Erosion score JSN score
Croatian: Ukupni rezultat prema Sharp-Genantovoj ljestvici Stupanj erozije Stupanj suženja zglobnog prostora
English: In the 52-week open-label SC Study (WA28118), 23.4% and 35.4% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥130 mg/dL and total cholesterol value to ≥200
Croatian: U 52-tjednom otvorenom ispitivanju supkutane primjene (WA28118) kod 23,4% bolesnika je nakon početka liječenja zabilježeno povišenje razine LDL-kolesterola na ≥ 130 mg/dl, a kod njih 35,4%
English: Radiographic Endpoints (mean change from baseline)
Croatian: Radiološke mjere ishoda (srednja promjena od početne vrijednosti)
English: The physician's global assessment of disease activity, as measured on a 0-100 mm scale, showed a greater reduction in disease activity for tocilizumab compared to placebo (adjusted mean changes of -45.2 mm vs -35.2 mm, p=0.0031).
Croatian: 0-100 mm, ukazala je na veće smanjenje aktivnosti bolesti kod primjene tocilizumaba nego kod primjene placeba (prilagođene srednje promjene -45,2 mm naspram -35,2 mm; p=0,0031).
English: Administration of RoActemra should be interrupted if a patient develops a serious infection until the infection is controlled (see section 4.8).
Croatian: Ako bolesnik razvije ozbiljnu infekciju, primjenu lijeka RoActemra treba privremeno prekinuti sve dok infekcija ne bude pod kontrolom (vidjeti dio 4.8).
English: RoActemra has been shown to inhibit sIL-6R and mIL-6R-mediated signalling.
Croatian: Pokazalo se da RoActemra inhibira prijenos signala posredovan sIL-6R i mIL-6R.
English: For the 162 every other week dose, the predicted mean (±SD) steady-state AUC2week, Cmin, and Cmax of RoActemra were 3430 ± 2660 µg•h/mL, 5.7 ± 6.8 µg/mL, and 13.2 ± 8.8 µg/mL, respectively.
Croatian: Pri dozi od 162 mg jedanput svaka dva tjedna, predviđeni srednji (±SD) AUC2tjedna, Cmin odnosno Cmax lijeka RoActemra u stanju dinamičke ravnoteže iznosili su 3430 ± 2660 μg•sat/ml, 5,7 ± 6,8 μg/ml odnosno 13,2 ± 8,8 μg/ml.
English: How to use RoActemra
Croatian: Kako primjenjivati lijek RoActemra
English: In the all exposure population the overall rate of serious infections was 4.7 events per 100 pt years.
Croatian: Ukupna stopa ozbiljnih infekcija u cjelokupnoj izloženoj populaciji iznosila je 4,7 događaja na
English: • If the Window area is not filled by the purple indicator then:
Croatian: · Ako ljubičasti indikator nije posve ispunio prozorčić: · Zaštitni pokrov igle možda se nije zaključao.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 162 mg of RoActemra (tocilizumab) in 0.9 mL.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena brizgalica sadrži 162 mg lijeka RoActemra (tocilizumab) u 0,9 ml.
English: The safety and immunogenicity observed for RoActemra administered subcutaneous was consistent with the known safety profile of intravenous RoActemra and no new or unexpected adverse drug reactions were observed (see Table 1).
Croatian: Sigurnost i imunogenost primijećene kod supkutano primijenjenog lijeka RoActemra bile su u skladu s poznatim sigurnosnim profilom lijeka RoActemra za intravensku primjenu te nisu primijećene nikakve nove niti neočekivane nuspojave na lijek (vidjeti Tablicu 1).
English: The mean change in HAQ-DI was maintained at Week 104 in the tocilizumab 8 mg/kg plus MTX group (-0.61).
Croatian: Srednja promjena prema HAQ-DI održana je u 104. tjednu u skupini koja je primala tocilizumab u dozi od 8 mg/kg u kombinaciji s MTX-om (-0,61).
English: Comprehensive instructions for the administration of RoActemra in a pre-filled pen are given in the package leaflet, see section 6.6.
Croatian: Opsežne upute za primjenu lijeka RoActemra u napunjenoj brizgalici nalaze se u Uputi o lijeku, vidjeti dio 6.6.
English: RoActemra is supplied as a 0.9 mL pre-filled syringe containing 162 mg tocilizumab solution for injection.
Croatian: RoActemra je dostupna u napunjenoj štrcaljki od 0,9 ml koja sadrži 162 mg tocilizumaba u otopini za injekciju.
English: ADRs in the pJIA and sJIA patients treated with tocilizumab are listed in the Table 2 and presented by MedDRA system organ class.
Croatian: Nuspojave kod bolesnika s pJIA i sJIA liječenih tocilizumabom navedene su u Tablici 2 prema
English: Similarly the proportion of patients achieving a DAS 28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving RoActemra 8 mg/kg plus DMARD than in patients receiving RoActemra 4 mg/kg plus DMARD (p< 0.0001).
Croatian: Slično tome, udio bolesnika koji su postigli remisiju DAS28 (DAS28 < 2,6) bio je značajno viši (31% naspram 16%) kod bolesnika koji su primali lijek RoActemra u dozi od 8 mg/kg zajedno s DMARD-om nego kod bolesnika koji su primali lijek RoActemra u dozi od 4 mg/kg s DMARD-om (p< 0,0001).
English: DMAR D
Croatian: DMARD-om.
English: JIA ACR Response Rates at Week 40 Relative to baseline (Percentage of Patients)
Croatian: Tablica 8: Stope JIA ACR odgovora u 40. tjednu u odnosu na početak liječenja (postotak bolesnika) Stopa odgovora
English: The mean [SD] change scores were as follows: RoActemra weekly plus 26 weeks 5.61 [10.115], RoActemra every other weekly plus 26 weeks 1.81 [8.836], placebo plus 26 weeks 0.26 [10.702], and placebo plus 52 weeks -1.63 [6.753].
Croatian: Srednja vrijednost (SD) promjene rezultata iznosila je 5,61 (10,115) za lijek RoActemra jednom tjedno plus 26 tjedana prednizona, 1,81 (8,836) za lijek RoActemra jednom svaki drugi tjedan plus 26 tjedana prednizona, 0,26 (10,702) za placebo plus 26 tjedana prednizona, te -1,63 (6,753) za placebo plus 52 tjedna prednizona.
English: In the SC Study (WA28118), a total of 41.2% (21/51) sJIA patients experienced ISRs to RoActemra SC.
Croatian: Reakcije na mjestu injekcije U ispitivanju supkutane primjene (WA28118) ukupno je 41,2% (21/51) bolesnika sa sJIA doživjelo reakcije na mjestu injekcije nakon primjene supkutane formulacije lijeka RoActemra.
English: • If a dose is missed by more than 7 days, or you are not sure when to inject RoActemra, call the doctor or pharmacist.
Croatian: · Ako propustite dozu i ako je od propuštanja prošlo više od 7 dana ili ako niste sigurni kada trebate injicirati lijek RoActemra, obratite se liječniku ili ljekarniku.
English: Hepatic transaminases increased pJIA
Croatian: Pretrage povišene vrijednosti jetrenih transaminaza pJIA
English: In RA and GCA patients, neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice.
Croatian: Kod bolesnika s RA i GCA broj neutrofila i trombocita treba pratiti tijekom 4 do 8 tjedana nakon početka liječenja te nakon toga u skladu sa standardnom kliničkom praksom.
English: RA and CRS Patients (≥ 30 kg)
Croatian: Bolesnici s RA i CRS-om (≥ 30 kg)
English: RoActemra has not been studied in patients with moderate to severe renal impairment (see section 5.2).
Croatian: RoActemra se nije ispitivala kod bolesnika s umjerenim do teškim bubrežnim oštećenjem (vidjeti dio 5.2).
English: The Marketing Authorisation Holder (MAH) shall provide an educational pack covering the therapeutic indications RA, sJIA, pJIA and GCA, targeting all physicians who are expected to prescribe/use RoActemra containing the following:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet (MAH) mora sastaviti edukativni materijal koji obuhvaća terapijske indikacije za reumatoidni artritis, sistemski juvenilni idiopatski artritis, poliartikularni juvenilni idiopatski artritis i arteritis divovskih stanica namijenjen svim liječnicima koji će propisivati ili primjenjivati lijek RoActemra, a mora sadržavati sljedeće: · informativni materijal za liječnike
English: At week 24, a significant reduction in DAS28 from baseline (mean improvement) of 3.5 was observed on both treatment arms, and a comparable proportion of patients had achieved DAS28 clinical remission (DAS28 < 2.6) on the subcutaneous (38.4%) and IV (36.9%) arms.
Croatian: Nakon 24 tjedna u obje je skupine primijećeno značajno smanjenje vrijednosti DAS28 (srednja vrijednost poboljšanja) od 3,5 u odnosu na početnu vrijednost, a udio bolesnika koji su postigli kliničku remisiju prema DAS28 (DAS28 < 2,6) bio je usporediv u skupini koja je primala supkutanu formulaciju (38,4%) i onoj koja je primala intravensku formulaciju (36,9%).
English: A statistically significant superior treatment effect was seen in favour of RoActemra over placebo in achieving steroid-free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper and with placebo plus 52 weeks prednisone taper.
Croatian: Zabilježen je statistički značajan superioran terapijski učinak lijeka RoActemra u odnosu na placebo u postizanju održane remisije bez primjene steroida u 52. tjednu uz lijek RoActemra plus 26-tjedni režim postupnog smanjivanja doze prednizona u odnosu na placebo plus 26-tjedni režim postupnog smanjivanja doze prednizona i placebo plus 52-tjedni režim postupnog smanjivanja doze prednizona.
English: Stop breast-feeding if you are to be given RoActemra, and talk to your doctor.
Croatian: Ako trebate primiti lijek RoActemra, prestanite dojiti i obratite se liječniku.
English: After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature (18°C to 28°C) by waiting for 25 to 30 minutes, before injecting RoActemra .
Croatian: Kada se napunjena štrcaljka izvadi iz hladnjaka, treba pričekati najmanje 25-30 minuta prije injekcije lijeka RoActemra da se napunjena štrcaljka ugrije na sobnu temperaturu (18°C do 28°C).
English: Children with sJIA will be given RoActemra once every 2 weeks through a drip in the vein (intravenous infusion) over one hour.
Croatian: Djeca sa sJIA primat će lijek RoActemra jedanput svaka dva tjedna dripom u venu (infuzijom u venu kap po kap) tijekom jednog sata.
English: In the open label extension phase (study WA18221), 13.2% and 27.7% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200
Croatian: Tijekom otvorene faze produžetka ispitivanja (ispitivanje WA18221), kod 13,2% bolesnika je nakon početka liječenja zabilježeno povišenje razine LDL-kolesterola na ≥ 130 mg/dl, a kod njih 27,7% povišenje razine ukupnog kolesterola na ≥ 200 mg/dl u bilo kojem trenutku tijekom liječenja ispitivanim lijekom..
English: Pharmacokinetic parameters of tocilizumab did not change with time.
Croatian: Farmakokinetički parametri tocilizumaba nisu se mijenjali s vremenom.
English: sJIA Patients
Croatian: Bolesnici sa sJIA
English: Of these 51 patients, 26 (51%) were naive to RoActemra and 25 (49%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Croatian: njih 26 (51%) prethodno nije bilo liječeno lijekom RoActemra, dok je njih 25 (49%) prethodno primalo lijek RoActemra za intravensku primjenu te je na početku ispitivanja prešlo na supkutanu formulaciju toga lijeka.
English: • Do not put the cap back on the pre-filled pen.
Croatian: · Nemojte vraćati zatvarač na napunjenu brizgalicu.
English: • Do not touch the syringe trigger fingers as this may damage the syringe
Croatian: · Nemojte dirati otpusne kvačice jer možete oštetiti štrcaljku.
English: Excipients with known effects Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Croatian: Jedna bočica od 80 mg sadrži 0,10 mmol (2,21 mg) natrija.
English: Concentrate for solution for infusion 80 mg/4 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 80 mg/4 ml
English: The PK of RoActemra in GCA patients were determined using a population PK model from an analysis dataset composed of 149 GCA patients treated with 162 mg subcutaneous every week or 162 mg subcutaneous every other week.
Croatian: Farmakokinetika lijeka RoActemra u bolesnika s GCA određivala se uz pomoć populacijskog farmakokinetičkog modela na temelju analize skupa podataka prikupljenih u 149 bolesnika s GCA liječenih supkutanom dozom od 162 mg primijenjenom svaki tjedan ili svaki drugi tjedan.
English: During routine laboratory monitoring in the 12 week controlled phase, a decrease in neutrophil counts below 1 x 109/l occurred in 7% of patients in the tocilizumab group, and no decreases in the placebo group.
Croatian: Prilikom rutinskog laboratorijskog praćenja bolesnika tijekom 12-tjedne kontrolirane faze ispitivanja smanjenje broja neutrofila na razinu manju od 1 x 109/l zabilježeno je u 7% bolesnika iz skupine koja je primala tocilizumab, a u skupini koja je primala placebo nisu zabilježene smanjene vrijednosti.
English: For persistent increases > 3 x ULN (confirmed by repeat testing, see 4.4.
Croatian: U slučaju da su vrijednosti trajno povišene > 3 x iznad GGN (potvrđeno ponovljenim testiranjem, vidjeti dio 4.4), potpuno prekinuti primjenu lijeka RoActemra.
English: RoActemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Croatian: cytokine release syndrome, CRS) izazvanog T-stanicama s kimeričnim antigenskim receptorima (engl. chimeric antigen receptor, CAR) u odraslih i pedijatrijskih bolesnika u dobi od 2 ili više godina.
English: Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with tocilizumab during the controlled and open label clinical studies.
Croatian: Tijekom kontroliranih i otvorenih kliničkih ispitivanja, klinički značajne reakcije preosjetljivosti povezane s primjenom tocilizumaba koje zahtijevaju prestanak liječenja prijavljene su u ukupno 56 od 4009 bolesnika (1,4%) liječenih tocilizumabom.
English: Available data with the IV formulation suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Croatian: Dostupni podaci o liječenju formulacijom za intravensku primjenu ukazuju na to da je kliničko poboljšanje primjetno unutar 12 tjedana od započinjanja liječenja lijekom RoActemra.
English: Patients were required to be >18 years of age with active RA diagnosed according to ACR criteria who had at least 8 tender and 6 swollen joints at baseline.
Croatian: Bolesnici su morali imati više od 18 godina, aktivan RA dijagnosticiran prema ACR kriterijima te najmanje 8 bolno osjetljivih i 6 otečenih zglobova na početku liječenja.
English: In patients treated with tocilizumab 8 mg/kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Croatian: Kod bolesnika liječenih tocilizumabom u dozi od 8 mg/kg značajna poboljšanja opažena su u svakoj pojedinoj komponenti odgovora prema ACR kriterijima, uključujući: zbrojeve osjetljivih i otečenih zglobova; bolesnikova i liječnikova prosudba općeg zdravstvenog statusa; indeks onesposobljenosti
English: During routine laboratory monitoring in the tocilizumab all exposure population, elevation in ALT or AST ≥ 3xULN occurred in 3.7% and <1% of patients, respectively.
Croatian: Prilikom rutinskog laboratorijskog praćenja cjelokupne populacije izložene tocilizumabu primijećena je povišena razina ALT-a odnosno AST-a ≥ 3 x iznad gornje granice normale u 3,7% odnosno < 1% bolesnika.
English: RA The recommended posology is subcutaneous 162 mg once every week.
Croatian: Preporučena doza iznosi 162 mg supkutano jedanput tjedno.
English: Some side effects were seen more often: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Croatian: Neke nuspojave su prijavljene češće: upaljen nos i grlo, glavobolja, mučnina i niski broj bijelih krvnih stanica.
English: The total patient exposure to RoActemra in the pJIA all exposure population was 184.4 patient years for IV and 50.4 patient years for SC tocilizumab.
Croatian: Sigurnosni profil lijeka RoActemra za supkutanu primjenu ocjenjivao se i kod 52 pedijatrijska bolesnika s pJIA. Ukupna izloženost lijeku RoActemra u cjelokupnoj izloženoj populaciji bolesnika s pJIA iznosila je 184,4 bolesnik-godine za intravensku formulaciju, odnosno 50,4 bolesnik-godine za supkutanu formulaciju tocilizumaba.
English: Change in EQ5D scores from baseline to week 52 were RoActemra weekly plus 26 weeks 0.10 [0.198], RoActemra every other weekly plus 26 weeks 0.05 [0.215], placebo plus 26 weeks 0.07 [0.293], and placebo plus 52 weeks -0.02 [0.159].
Croatian: Promjena rezultata upitnika EQ-5D od početka ispitivanja do 52. tjedna iznosila je 0,10 (0,198) za lijek RoActemra jednom tjedno plus 26 tjedana prednizona, 0,05 (0,215) za lijek RoActemra jednom svaki drugi tjedan plus 26 tjedana prednizona, 0,07 (0,293) za placebo plus 26 tjedana prednizona te -0,02 (0,159) za placebo plus 52 tjedna prednizona.
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.25 mL/h.
Croatian: Linearni klirens ocjenjivao se kao parametar u populacijskoj farmakokinetičkoj analizi i iznosio je 6,25 ml/h.
English: It is not known whether RoActemra is passed into breast milk.
Croatian: Nije poznato izlučuje li se RoActemra u majčino mlijeko.
English: Tocilizumab has been shown to inhibit sIL-6R and mIL-6R-mediated signalling.
Croatian: Pokazalo se da tocilizumab inhibira prijenos signala posredovan sIL-6R i mIL-6R.
English: Steady-state was reached following the first administration for Cmax and after 8 and 20 weeks for AUC and Cmin, respectively.
Croatian: Stanje dinamičke ravnoteže postiglo se nakon prve primjene za Cmax, nakon 8 tjedana za AUC i nakon 20 tjedana za Cmin.
English: If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time while not at the clinic during or following an RoACTEMRA injection you should seek emergency care immediately.
Croatian: RoACTEMRA primijetite simptome poput (između ostaloga) kožnog osipa, svrbeža, zimice, oticanja lica, usana, jezika ili grla, bolova u prsima, piskanja pri disanju, otežanog disanja ili gutanja, omaglice ili nesvjestice, odmah potražite liječničku pomoć.
English: Hypertriglyceridae mia
Croatian: hipertrigliceridemija