FrancophonIA/ELRC3.0 huggingface dataset:
English: In tocilizumab-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 tocilizumabom, 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: After week 52, all patients could receive open-label treatment with RoActemra 8 mg/kg.
Croatian: Nakon 52. tjedna, u otvorenoj fazi ispitivanja svi su bolesnici mogli primati lijek RoActemra u dozi od 8 mg/kg.
English: If an anaphylactic reaction or other serious hypersensitivity / serious infusion related reaction occurs, administration of RoActemra should be stopped immediately and RoActemra should be permanently discontinued.
Croatian: Ako se pojavi anafilaktička reakcija ili druga ozbiljna reakcija preosjetljivosti / ozbiljna reakcija povezana s infuzijom, potrebno je odmah zaustaviti infuziju lijeka RoActemra i primjenu lijeka RoActemra trajno prekinuti.
English: The majority of ISRs reported were Grade 1 events and all ISRs reported were non-serious and none required patient withdrawal from treatment or dose interruption.
Croatian: Većina prijavljenih reakcija na mjestu injekcije bila je 1. stupnja težine, nijedna prijavljena reakcija na mjestu injekcije nije bila ozbiljna i nijedna nije zahtijevala prekid liječenja ni odgodu doze.
English: As there are many co-morbid conditions that may affect laboratory values in sJIA,
Croatian: Budući da brojne popratne bolesti mogu utjecati na laboratorijske vrijednosti kod bolesnika sa sJIA ili pJIA,
English: Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet, see section 6.6.
Croatian: Opsežne upute za primjenu lijeka RoActemra u napunjenoj štrcaljki nalaze se u Uputi o lijeku, vidjeti dio 6.6.
English: • Hold the needle-shield of the syringe firmly with one hand and pull off the needle-cap with the other hand.
Croatian: · Jednom rukom čvrsto primite zaštitni pokrov igle na štrcaljki, a drugom rukom povucite zatvarač igle (vidjeti Sliku D).
English: Your doctor will perform blood tests before you are given RoActemra, and during your treatment, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Croatian: Prije nego što počnete primati lijek RoActemra i tijekom liječenja, liječnik će raditi krvne pretrage kako bi se provjerilo imate li nizak broj leukocita, nizak broj trombocita ili povišene vrijednosti jetrenih enzima.
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the RoActemra arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Croatian: Srednje povišenje vrijednosti LDL-a u odnosu na početnu vrijednost iznosilo je 0,64 mmol/l (25 mg/dl) kod bolesnika koji su primali lijek RoActemra te 0,19 mmol/l (7 mg/dl) kod bolesnika koji su primali adalimumab.
English: Fatal anaphylaxis has been reported after marketing authorisation during treatment with intravenous RoActemra (see section 4.4).
Croatian: Slučaj anafilaksije sa smrtnim ishodom prijavljen je tijekom liječenja lijekom RoActemra za intravensku primjenu nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: • Puncture-resistant container or sharps container for safe disposal of needle-cap and used syringe
Croatian: · sterilna pamučna vata ili gaza · neprobojan spremnik ili spremnik za oštre predmete, za sigurno odlaganje zatvarača igle i upotrijebljene štrcaljke
English: In Studies II, III and V, tocilizumab was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
Croatian: U Ispitivanjima II, III i V tocilizumab se primjenjivao intravenski svaka četiri tjedna u kombinaciji s MTX-om; usporedba je bio placebo i MTX.
English: These may affect up to 1 in every 100 patients
Croatian: Mogu se javiti u do 1 na svakih 100 bolesnika
English: As there are many co-morbid conditions that may effect laboratory values in pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Croatian: Budući da postoje brojne popratne bolesti koje mogu utjecati na laboratorijske vrijednosti kod bolesnika s pJIA, odluka o prekidu primjene tocilizumaba u slučaju poremećaja laboratorijskih nalaza mora se temeljiti na medicinskoj procjeni svakog bolesnika pojedinačno.
English: For study II (SC-II), patients were required to be > 18 years of age with moderate to severe active RA diagnosed according to ACR criteria who had at least 8 tender and 6 swollen joints at baseline.
Croatian: Za ispitivanje II (SC-II) bolesnici su morali imati više od 18 godina, umjeren do težak oblik aktivnog RA dijagnosticiran prema ACR kriterijima te najmanje 8 bolno osjetljivih i 6 otečenih zglobova na početku liječenja.
English: It is unknown whether tocilizumab is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se tocilizumab u majčino mlijeko u ljudi.
English: The total content (0.9 mL) of the pre-filled syringe should be administered as a subcutaneous injection.
Croatian: Potrebno je primijeniti ukupan sadržaj (0,9 ml) napunjene štrcaljke supkutanom injekcijom.
English: • phenytoin, used to treat convulsions
Croatian: · fenitoin, za liječenje epileptičnih napadaja
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Croatian: · Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: A statistically significant superior treatment effect was seen in favour of RoActemra over adalimumab in control of disease activity from baseline to week 24 for the primary endpoint of change in DAS28 and for all secondary endpoints (Table 7).
Croatian: U usporedbi s adalimumabom, liječenje lijekom RoActemra imalo je statistički značajan superioran učinak na kontrolu aktivnosti bolesti od početka liječenja do 24. tjedna za primarnu mjeru ishoda promjenu vrijednosti DAS28 - te za sve sekundarne mjere ishoda (Tablica 7).
English: Steady state was reached after 12 weeks for AUC and Cmin, and after 10 weeks for Cmax.
Croatian: Stanje dinamičke ravnoteže za AUC i Cmin postignuto je nakon 12 tjedana, a za Cmax nakon 10 tjedana.
English: • Do not use if medicine is cloudy, hazy, discolored or contains particles
Croatian: · Nemojte primijeniti lijek ako je mutan ili magličast, ako je promijenio boju ili ako sadrži čestice.
English: The long-term exposure population includes all patients who received at least one dose of RoActemra 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 lijeka RoActemra, bilo u dvostruko slijepom kontroliranom razdoblju ili u otvorenom produžetku ispitivanja.
English: Anaphylaxis (fatal)1,
Croatian: Poremećaji imunološkog sustava anafilaksija (sa smrtnim ishodom)1,2,3
English: All patients should be up-to-date with all their vaccinations before they start treatment with RoActemra.
Croatian: Svi bolesnici moraju primiti sva potrebna cjepiva prije početka liječenja lijekom RoActemra.
English: During routine laboratory monitoring in the tocilizumab all exposure population, 1% of patients had a decrease in platelet count to ≤ 50 × 103/µL without associated bleeding events.
Croatian: Prilikom rutinskog laboratorijskog praćenja cjelokupne populacije izložene tocilizumabu, kod 1% bolesnika primijećeno je smanjenje broja trombocita na ≤ 50 x 103/µl, ali nisu zabilježeni povezani događaji krvarenja.
English: Available data suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Croatian: Dostupni podaci ukazuju na to da se kliničko poboljšanje postiže u roku od 12 tjedana od početka primjene lijeka RoActemra.
English: INFORMATION IN BRAILLE roactemra 162 mg pen
Croatian: 16. PODACI NA BRAILLEOVOM PISMU roactemra 162 mg brizgalica
English: Dose adjustments due to laboratory abnormalities (see section 4.4).
Croatian: Prilagođavanje doze s obzirom na poremećene vrijednosti laboratorijskih nalaza (vidjeti dio 4.4).
English: The types of adverse drug reactions in the tocilizumab arm were consistent with the known safety profile of tocilizumab and adverse drug reactions were reported at a similar frequency compared with Table 1.
Croatian: Vrste nuspojava povezanih s primjenom lijeka u skupini koja je primala tocilizumab bile su u skladu s poznatim profilom sigurnosti tocilizumaba, a nuspojave su prijavljivane sa sličnom učestalošću kao u Tablici 1.
English: Both study treatments induced the same pattern of changes in laboratory safety parameters (decreases in neutrophil and platelet counts, increases in ALT, AST and lipids), however, the magnitude of change and the frequency of marked abnormalities was higher with RoActemra compared with adalimumab.
Croatian: Obje ispitivane skupine potaknule su isti uzorak promjena u laboratorijskim sigurnosnim parametrima (smanjeni broj neutrofila i trombocita, povišene vrijednosti ALT-a, AST-a i lipida).
English: Because RoActemra is given in one pre-filled syringe, it is unlikely that you will receive too much.
Croatian: Budući da se lijek RoActemra primjenjuje jednom napunjenom brizgalicom, mala je vjerojatnost da ćete primiti preveliku količinu lijeka.
English: Concentrate for solution for infusion 200 mg/10 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 200 mg/10 ml
English: During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with tocilizumab therapy.
Croatian: Tijekom 6 mjeseci kontroliranih kliničkih ispitivanja ukupna stopa perforacija u probavnom sustavu bila je 0,26 na 100 bolesnik-godina izloženosti terapiji tocilizumabom.
English: In Studies II, III and V, RoActemra was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
Croatian: Ispitivanjima II, III i V RoActemra se primjenjivala intravenski svaka četiri tjedna u kombinaciji s MTX-om; usporedba je bio placebo i MTX.
English: No patients treated with SC RoActemra experienced a decrease in platelet count to ≤50 × 103 / μL.
Croatian: Ni kod jednog bolesnika liječenog lijekom RoActemra za supkutanu primjenu nije zabilježeno smanjenje broja trombocita na razinu ≤ 50 × 103/μl.
English: The proportion of patients with serious adverse events was balanced between the treatment groups (tocilizumab 11.7% vs. adalimumab 9.9%).
Croatian: Udio bolesnika s ozbiljnim nuspojavama bio je izjednačen između obje ispitivane skupine (tocilizumab 11,7%,
English: RoActemra is used to improve the symptoms of sJIA and can be given in combination with methotrexate or alone.
Croatian: RoActemra se koristi za ublažavanje simptoma sJIA te se može davati u kombinaciji s metotreksatom ili samostalno.
English: RoActemra has not been studied in patients with severe renal impairment (see section 5.2).
Croatian: RoActemra se nije ispitivala kod bolesnika s teškim bubrežnim oštećenjem (vidjeti dio 5.2).
English: Doses of 8 mg/kg of tocilizumab were given every four weeks as monotherapy.
Croatian: Doze od 8 mg/kg tocilizumaba davale su se svaka četiri tjedna kao monoterapija.
English: You are not to be given RoActemra
Croatian: Ne smijete primiti lijek RoActemra
English: The proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was also comparable on the subcutaneous (65.2%) versus intravenous (67.4%) arms, with a weighted difference in proportions of - 2.3% (95% CI - 8.1, 3.4).
Croatian: Udio bolesnika koji su postigli klinički značajno poboljšanje HAQ-DI rezultata nakon 24 tjedna (promjena za ≥ 0,3 jedinice u odnosu na početnu vrijednost) bio je usporediv u skupini koja je primala supkutanu formulaciju (65,2%) i u onoj liječenoj intravenskom formulacijom (67,4%), pri čemu je ponderirana razlika u udjelima iznosila -2,3% (95% CI -8,1; 3,4).
English: • Low absolute neutrophil count (ANC) Laboratory Value (cells x 109/ L )
Croatian: · Nizak apsolutni broj neutrofila (ABN) Laboratorijska vrijednost (broj stanica x 109/l)
English: In Study I, RoActemra was administered intravenously every four weeks as monotherapy.
Croatian: U Ispitivanju I RoActemra se primjenjivala intravenski svaka četiri tjedna kao monoterapija.
English: It is recommended that all patients particularly paediatric or elderly patients, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating RoActemra therapy.
Croatian: preporučuje se da svi bolesnici, osobito pedijatrijski bolesnici ili oni starije dobi, prime sva cjepiva predviđena trenutnim smjernicama za imunizaciju.
English: RoActemra is used to improve the symptoms of pJIA and can be given in combination with methotrexate or alone.
Croatian: RoActemra se koristi za ublažavanje simptoma pJIA. Može se davati u kombinaciji s metotreksatom ili samostalno.
English: The half life of tocilizumab in sJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 12 mg/kg for body weight < 30 kg) at week 12.
Croatian: Poluvijek tocilizumaba je kod bolesnika sa sJIA iznosio najviše 16 dana u obje kategorije tjelesne težine (8 mg/kg za tjelesnu težinu ≥ 30 kg ili 12 mg/kg za tjelesnu težinu < 30 kg) nakon 12 tjedana.
English: In all studies, patients treated with RoActemra 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 5).
Croatian: U svim su ispitivanjima bolesnici liječeni lijekom RoActemra u dozi od 8 mg/kg imali statistički značajno više stope odgovora prema kriterijima ACR 20, 50 i 70 nakon 6 mjeseci u usporedbi s kontrolnim ispitanicima (Tablica 5).
English: After week 52, all patients could receive open-label treatment with tocilizumab 8 mg/kg.
Croatian: Nakon 52. tjedna, u otvorenoj fazi ispitivanja svi su bolesnici mogli primati tocilizumab u dozi od 8 mg/kg.
English: RA and GCA patients demonstrate a comparable (to healthy subjects) decrease of absolute neutrophil counts following RoActemra administration (see section 4.8).
Croatian: Kod bolesnika s RA i GCA je nakon primjene lijeka RoActemra primijećeno usporedivo (u odnosu na zdrave ispitanike) smanjenje apsolutnog broja neutrofila (vidjeti dio 4.8).
English: Placebo + 26 weeks prednisone taper N=50
Croatian: Placebo + 26-tjedni režim postupnog smanjenja doze prednizona N=50
English: Major clinical response
Croatian: Značajan klinički odgovor
English: List of ADRs occurring in patients with RA receiving tocilizumab as monotherapy or in combination with MTX or other DMARDs in the double-blind controlled period or during postmarketing experience
Croatian: Tablica 1: Popis nuspojava nastalih kod bolesnika s RA koji su primali tocilizumab kao monoterapiju ili u kombinaciji s MTX ili drugim antireumatskim lijekovima koji mijenjaju tijek bolesti, u dvostruko slijepom kontroliranom razdoblju ili nakon stavljanja lijeka u promet MedDRA klasifikacija organskih sustava
English: • If it is not used within 5 minutes of cap removal, the syringe must be disposed of in the puncture resistant container or sharps container and a new syringe must be used.
Croatian: · Ako je ne upotrijebite unutar 5 minuta nakon skidanja zatvarača, morate odložiti štrcaljku u neprobojan spremnik ili spremnik za oštre predmete i morate upotrijebiti novu štrcaljku.
English: In RA 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 broj neutrofila i trombocita treba pratiti tijekom 4 do 8 tjedana nakon početka liječenja te nakon toga u skladu sa standardnom kliničkom praksom.
English: 10 mg/kg Q4W below 30 kg
Croatian: 10 mg/kg svaka 4 tjedna manje od 30 kg
English: Reports of gastrointestinal perforation on RoActemra were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Croatian: Slučajevi perforacije u probavnom sustavu pri liječenju lijekom RoActemra bili su u prvom redu prijavljeni kao komplikacije divertikulitisa, uključujući generalizirani purulentni peritonitis, perforacije donjeg dijela gastrointestinalnog sustava, fistule i apsces.
English: Decreases below 0.5 x 109/ l were reported in 0.3% patients receiving tocilizumab 8 mg/kg plus DMARDs.
Croatian: Smanjenje broja neutrofila ispod 0,5 × 109/ l bilo je prijavljeno u 0,3% bolesnika koji su primali tocilizumab u dozi od 8 mg/kg i DMARD-ove.
English: In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of tocilizumab, 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 tocilizumaba razine simvastatina (CYP3A4) bile su snižene za 57% i dostigle su razinu sličnu ili malo višu od one opažene kod zdravih ispitanika.
English: If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of RoActemra should be stopped immediately, appropriate therapy initiated and tocilizumab should be permanently discontinued.
Croatian: Ako se pojavi anafilaktička reakcija ili druga ozbiljna reakcija preosjetljivosti, potrebno je odmah zaustaviti primjenu lijeka RoActemra, uvesti odgovarajuće liječenje i trajno prekinuti liječenje tocilizumabom.
English: *τ = 2 weeks for IV regimens
Croatian: *τ = 2 tjedna za intravenske režime
English: Do not use the syringe if the expiration date has passed.
Croatian: Štrcaljku ne smijete upotrijebiti ako je istekao rok valjanosti.
English: The syringe should not be shaken.
Croatian: Štrcaljka se ne smije tresti.
English: Doses of 8 mg/kg of RoActemra were given every four weeks as monotherapy.
Croatian: Doze od 8 mg/kg lijeka RoActemra davale su se svaka četiri tjedna kao monoterapija.
English: The assessment of the time to first GCA flare showed a significantly lower risk of flare for the RoActemra subcutaneous weekly group compared to placebo plus 26 weeks prednisone and placebo plus 52 weeks prednisone taper groups and for the RoActemra subcutaneous every other weekly group compared to placebo plus 26 weeks prednisone (when compared at a 0.01 significance level).
Croatian: Ocjena vremena do prvog razbuktavanja GCA pokazala je značajno manji rizik od razbuktavanja bolesti u skupini liječenoj lijekom RoActemra supkutano jednom tjedno u odnosu na skupine koje su primale placebo plus 26-tjedni režim postupnog smanjivanja doze prednizona i placebo plus 52-tjedni režim postupnog smanjivanja doze prednizona, kao i u skupini liječenoj lijekom RoActemra supkutano svaki drugi tjedan u odnosu na skupinu koja je primala placebo plus 26-tjedni režim postupnog smanjivanja doze prednizona (kada se usporedba provodila na razini značajnosti od 0,01).
English: Proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was higher for RoActemra subcutaneous every other week (58%) versus placebo
Croatian: Udio bolesnika koji su nakon 24 tjedna postigli klinički značajno poboljšanje HAQ-DI rezultata (promjena za ≥ 0,3 jedinice u odnosu na početnu vrijednost) bio je veći u skupini liječenoj supkutanom formulacijom lijeka RoActemra jedanput svaka dva tjedna (58%) nego u bolesnika koji su primali placebo (46,8%).
English: In the open label extension phase, elevation in ALT or AST ≥ 3 x ULN occurred in 12% and 4% of patients, respectively, in the tocilizumab group.
Croatian: Tijekom otvorene faze produžetka ispitivanja povišena razina ALT-a ili AST-a ≥ 3 puta iznad gornje granice normale zabilježena je kod 12% odnosno 4% bolesnika iz skupine koja je primala tocilizumab.
English: RoActemra subcutaneous injection is not recommended for use in children under 1 year of age.
Croatian: Ne preporučuje se primjena lijeka RoActemra za supkutanu injekciju u djece mlađe od 1 godine.
English: If you miss your weekly or once every other weekly dose more than 7 days or are not sure when to inject RoActemra, call your doctor or pharmacist.
Croatian: Ako je od propuštene doze koju primjenjujete jednom tjedno ili jedanput svaka dva tjedna prošlo više od 7 dana ili ako niste sigurni kada trebate injicirati lijek RoActemra, obratite se svom liječniku ili ljekarniku.
English: The concentrationdependent non-linear clearance plays a major role at low tocilizumab concentrations.
Croatian: Nelinearni klirens ovisan o koncentraciji igra veliku ulogu pri niskim koncentracijama tocilizumaba.
English: Seventeen (24%) tocilizumab treated patients versus 1 (3%) placebo patient were able to reduce their dose of corticosteroid by at least 20% without experiencing a subsequent JIA ACR30 flare or occurrence of systemic symptoms to week 12 (p=0.028).
Croatian: Dozu kortikosteroida, bez naknadnog pogoršanja upale na razini JIA ACR30 ili pojave sistemskih simptoma, do 12. tjedna uspjelo je smanjiti za najmanje 20% sedamnaest bolesnika liječenih tocilizumabom (24%) te jedan (3%) bolesnik koji je primao placebo (p=0,028).
English: • Throw away the green cap in a sharps container.
Croatian: · Bacite zeleni zatvarač u spremnik za oštre predmete.
English: It is unknown whether RoActemra is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se RoActemra u majčino mlijeko u ljudi.
English: 162 mg weekly
Croatian: 162 mg svaki tjedan
English: • Throw away used syringes in a puncture-resistant container or sharps container.
Croatian: · Upotrijebljene štrcaljke odložite u neprobojan spremnik ili spremnik za oštre predmete.
English: Keep the RoACTEMRA pre-filled pen and disposal container out of the reach of children.
Croatian: Držite RoACTEMRA napunjenu brizgalicu i spremnik za odlaganje izvan dohvata djece.
English: During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with RoActemra therapy.
Croatian: Tijekom 6 mjeseci kontroliranih kliničkih ispitivanja ukupna stopa perforacija u probavnom sustavu bila je 0,26 na 100 bolesnik-godina izloženosti terapiji lijekom RoActemra.
English: In Study I, tocilizumab was administered intravenously every four weeks as monotherapy.
Croatian: I tocilizumab se primjenjivao intravenski svaka četiri tjedna kao monoterapija.
English: Patients in the tocilizumab arm received an intravenous (IV) infusion of tocilizumab (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Croatian: Bolesnici u tocilizumab skupini primali su intravensku (i.v.) infuziju tocilizumaba (8 mg/kg) svaka 4 tjedna te supkutanu (s.c.) injekciju placeba svaka 2 tjedna.
English: Children with pJIA will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Croatian: Djeca s pJIA primat će lijek RoActemra jedanput svaka 4 tjedna dripom u venu (infuzijom u venu kap po kap) tijekom jednog sata.
English: When platelet count > 100 x 103/ μ resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
Croatian: Kad broj trombocita naraste na > 100 x 103/ μl, nastaviti s primjenom lijeka RoActemra u dozi od 4 mg/kg te povećavati dozu na 8 mg/kg, prema kliničkoj potrebi Potpuno prekinuti primjenu lijeka RoActemra
English: In general, the adverse drug reactions in patients with sJIA were similar in type to those seen in RA patients (see Undesirable Effects section above).
Croatian: Vrsta nuspojava opaženih kod bolesnika sa sJIA u načelu je bila slična onima primijećenima kod bolesnika s RA (vidjeti dio Nuspojave iznad).
English: RoActemra 162mg SC weekly + 26 weeks prednisone taper N=100
Croatian: RoActemra 162 mg s.c. svaki tjedan + 26-tjedni režim postupnog smanjenja doze prednizona N=100