FrancophonIA/ELRC3.0 huggingface dataset:
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in tocilizumab plus MTX-treated patients was maintained in the second year of treatment.
Croatian: U otvorenoj fazi produžetka ispitivanja II inhibicija progresije strukturalnog oštećenja zglobova kod bolesnika koji se liječe tocilizumabom u kombinaciji s MTX-om održana je i u drugoj godini liječenja.
English: The usual dose of RoActemra is 8 mg per kg of body weight.
Croatian: Odrasli bolesnici s RA Uobičajena doza lijeka RoActemra je 8 mg po kilogramu tjelesne težine.
English: After removing the pre-filled pen from the refrigerator the pre-filled pen should be allowed to reach room temperature (18°C to 28°C) by waiting for 45 minutes, before injecting RoActemra.
Croatian: Kada se napunjena brizgalica izvadi iz hladnjaka, treba pričekati 45 minuta prije injekcije lijeka RoActemra da se napunjena brizgalica ugrije na sobnu temperaturu (18°C do 28°C).
English: Some side effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.
Croatian: Neke nuspojave su prijavljene češće: upaljen nos i grlo, proljev, niski broj bijelih krvnih stanica i povišene vrijednosti jetrenih enzima.
English: You will find detailed “Instructions for administration” at the end of this leaflet.
Croatian: Na kraju ove upute nalaze se detaljne
English: A total of 2,876 patients have been tested for anti-RoActemra antibodies in the 6-month controlled clinical trials.
Croatian: Ukupno je 2876 bolesnika ispitano na protutijela na lijek RoActemra u 6-mjesečnim kontroliranim kliničkim ispitivanjima.
English: The efficacy of subcutaneous administered RoActemra in alleviating the signs and symptoms of RA and radiographic response, was assessed in two randomised, double-blind, controlled, multi-center studies.
Croatian: Djelotvornost supkutano primijenjenog lijeka RoActemra u ublažavanju znakova i simptoma RA i radiološkog odgovora ocijenjena je u dvama randomiziranim, dvostruko slijepim, kontroliranim,
English: • fever and chills
Croatian: · vrućica i zimica
English: The rate of anaphylactic reactions (occurring in a total of 6/3778patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Croatian: Stopa anafilaktičkih reakcija (koje su se pojavile u ukupno 6/3778 bolesnika; 0,2%) bila je nekoliko puta viša pri primjeni doze od 4 mg/kg nego pri primjeni doze od 8 mg/kg.
English: Cellulitis, Pneumonia, Oral herpes simplex, Herpes zoster
Croatian: Infekcije i infestacije infekcije gornjeg dišnog sustava celulitis, pneumonija, oralni herpes simplex, herpes zoster divertikulitis
English: The median values of Tmax were 3 days after the RoActemra weekly dose and 4.5 days after the tocilizumab every other week dose.
Croatian: Bioraspoloživost supkutane formulacije iznosila je 0,8, dok je medijan vrijednosti Tmax iznosio 3 dana uz primjenu lijeka RoActemra svaki tjedan te 4,5 dana uz primjenu tocilizumaba svaki drugi tjedan.
English: Increases in haemoglobin levels were observed, through tocilizumab decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Croatian: Primijećeno je povećanje razine hemoglobina, jer tocilizumab smanjuje IL-6 posredovano povećanje hepcidina te tako povećava raspoloživost željeza.
English: Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
Croatian: U slučaju pojave simptoma ozbiljnih alergijskih reakcija, bolesnici moraju odmah potražiti liječničku pomoć (vidjeti dio 4.4).
English: RoActemra 20 mg/mL concentrate for solution for infusion Tocilizumab
Croatian: RoActemra 20 mg/ml koncentrat za otopinu za infuziju tocilizumab
English: Health-related and quality of life outcomes
Croatian: Ishodi povezani s kvalitetom života
English: • cold sores (oral herpes simplex), blisters
Croatian: · herpes zoster · groznica (herpes simplex na usnama), mjehurići
English: Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 13 out of 3778 patients (0.3%) treated with RoActemra during the controlled and open label clinical studies.
Croatian: Tijekom kontroliranih i otvorenih kliničkih ispitivanja, klinički značajne reakcije preosjetljivosti povezane s primjenom lijeka RoActemra koje zahtijevaju prestanak liječenja prijavljene su u ukupno 13 od 3778 bolesnika (0,3%) liječenih lijekom RoActemra.
English: Placebo + 52 weeks prednisone taper N=51
Croatian: Placebo + 52-tjedni režim postupnog smanjenja doze prednizona N=51
English: During the 6-month controlled period, in SC-I, the frequency of injection site reactions was 10.1% (64/631) and 2.4% (15/631) for the subcutaneous RoActemra and the subcutaneous placebo (intravenous group) weekly injections, respectively.
Croatian: Tijekom 6-mjesečnog kontroliranog razdoblja u ispitivanju SC-I, učestalost reakcija na mjestu injekcije iznosila je 10,1% (64/631) u skupini koja je primala supkutane injekcije lijeka RoActemra jedanput tjedno te 2,4% (15/631) u skupini koja je primala supkutane injekcije placeba jedanput tjedno
English: This was not observed in either of the placebo plus prednisone taper groups.
Croatian: To nije opaženo ni u jednoj od dviju skupina koje su primale placebo plus prednizon čija se doza postupno smanjivala.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu kod bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, one patient (1%, 1/100) in the RoActemra subcutaneous weekly group had a single transient occurence of decrease in platelet count to <100 × 103 / μL without associated bleeding events.
Croatian: Tijekom rutinskog laboratorijskog praćenja u 12-mjesečnom kontroliranom kliničkom ispitivanju lijeka RoActemra, u jednog bolesnika (1%, 1/100) koji je primao lijek RoActemra supkutano jednom tjedno zabilježena je samo jedna epizoda prolaznog smanjenja broja trombocita na < 100 x 103/µl, bez popratnih događaja krvarenja.
English: • Take the box containing the pre-filled pen out of the refrigerator.
Croatian: · Izvadite kutiju s napunjenom brizgalicom iz hladnjaka.
English: • To use the pre-filled pen, you first have to unlock the green Activation button.
Croatian: Slika H · Da biste primijenili lijek brizgalicom, najprije morate otključati zeleno dugme za aktivaciju.
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on tocilizumab clearance.
Croatian: Populacijske farmakokinetičke analize nisu ukazale ni na kakav učinak MTX-a, nesteroidnih protuupalnih lijekova ili kortikosteroida na klirens tocilizumaba.
English: These results are consistent with those observed in patients treated with intravenous RoActemra.
Croatian: Ti su rezultati u skladu s onima primijećenima u bolesnika liječenih lijekom RoActemra za intravensku primjenu.
English: Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label RoActemra 8 mg/kg in year 2.
Croatian: Od bolesnika koji su dovršili ispitivanje i koji su prvobitno randomizirani za placebo + MTX, njih 86% primalo je u drugoj godini u otvorenoj fazi ispitivanja lijek RoActemra u dozi od 8 mg/kg.
English: • Do not hold the syringe by the plunger while removing the needle-cap.
Croatian: · Štrcaljku ne smijete držati za klip dok skidate zatvarač igle.
English: Healthcare professionals should exercise caution when considering the use of RoActemra in patients with a history of recurring or chronic infections or with underlying conditions (e.g. diverticulitis, diabetes and interstitial lung disease which may predispose patients to infections.
Croatian: Liječnicima se savjetuje oprez prilikom odluke o primjeni lijeka RoActemra kod bolesnika s rekurentnim ili kroničnim infekcijama u anamnezi ili nekom drugom osnovnom bolešću (npr. divertikulitis, dijabetes i intersticijska bolest pluća), koja kod bolesnika stvara predispoziciju za infekcije.
English: ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients) Study I AMBITION
Croatian: Tablica 5: ACR odgovori u ispitivanjima kontroliranima placebom/MTX-om/DMARD lijekovima (% bolesnika) Ispitivanje I AMBITION
English: • Do not inject into areas that could be bothered by a belt or waistband.
Croatian: · Nemojte injicirati lijek u područja gdje bi kožu mogao nadražiti remen ili pojas.
English: These reactions were generally observed during the second to fifth infusions of RoActemra (see section 4.4).
Croatian: Te su reakcije u načelu zamijećene u razdoblju između primjene druge i pete infuzije lijeka RoActemra (vidjeti dio 4.4).
English: The rate of infections in the tocilizumab all exposure population was 163.7 per 100 patient years.
Croatian: Infekcije Stopa infekcija u cjelokupnoj populaciji izloženoj tocilizumabu iznosila je 163,7 na
English: Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Croatian: Prije nego što primite lijek RoActemra, liječnik će napraviti krvne pretrage kako bi provjerio imate li nizak broj leukocita, nizak broj trombocita ili povišene vrijednosti jetrenih enzima.
English: The primary endpoint at week 24 was the proportion of patients who achieved an ACR 20 response.
Croatian: Primarna mjera ishoda ispitivanja u 24. tjednu bila je udio bolesnika koji su postigli ACR 20 odgovor.
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: For SF-36, the mean change from baseline at week 24 in the mental component score was 6.22 for the subcutaneous arm and 6.54 for the intravenous arm, and for the physical component score was also similar with 9.49 for the subcutaneous arm and 9.65 for the intravenous arm.
Croatian: SF-36 srednja vrijednost promjene rezultata za mentalnu komponentu nakon 24 tjedna u odnosu na početnu vrijednost iznosila je 6,22 u skupini liječenoj supkutanom formulacijom te 6,54 u skupini liječenoj intravenskom formulacijom, dok je srednja vrijednost promjene rezultata za fizičku komponentu također bila slična, a iznosila je 9,49 u skupini koja je primala supkutanu formulaciju te 9,65 u skupini liječenoj intravenskom formulacijom.
English: pJIA (SC)
Croatian: pJIA (s.c.)
English: In patients who develop an ANC < 0.5 x 109/ l or a platelet count < 50 x 103/μL, continued treatment is not recommended.
Croatian: Kod bolesnika u kojih ABN padne ispod < 0,5 x 109/ l ili broj trombocita < 50 x 103/ μl, nastavak liječenja se ne preporučuje.
English: Your doctor will have to decide if you can still be given RoActemra.
Croatian: Vaš liječnik će morati odlučiti smije li dobiti lijek RoActemra.
English: Česká republika Roche s. r. o.
Croatian: Roche s. r. o.
English: Patients who completed Part I of the study and achieved at least a JIA ACR30 response at week 16 compared to baseline were eligible to enter the blinded withdrawal period (Part II) of the study.
Croatian: Bolesnici koji su završili I. dio ispitivanja i u 16. tjednu postigli najmanje odgovor JIA ACR30 u odnosu na početne vrijednosti mogli su ući u slijepo razdoblje izuzimanja lijeka iz liječenja (dio II
English: The rate of serious infections was numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (12.2 per 100 patient years) compared to patients weighing ≥30 kg, treated with 8 mg/kg tocilizumab (4.0 per 100 patient years).
Croatian: Stopa ozbiljnih infekcija bila je brojčano viša kod bolesnika tjelesne težine < 30 kg liječenih tocilizumabom u dozi od 10 mg/kg (12,2 na 100 bolesnik-godina) nego kod bolesnika tjelesne težine ≥ 30 kg liječenih tocilizumabom u dozi od 8 mg/kg (4,0 na 100 bolesnik-godina).
English: RA and CRS adult patients (≥ 30 kg)
Croatian: Odrasli bolesnici s RA i CRS-om (≥ 30 kg)
English: • Do not remove the pre-filled pen cap until you are ready to inject RoACTEMRA.
Croatian: · Nemojte skinuti zatvarač napunjene brizgalice sve dok ne budete spremni injicirati lijek
English: In study I, superiority of tocilizumab 8 mg/kg was demonstrated against the active comparator MTX.
Croatian: I pokazala se superiornost tocilizumaba u dozi od 8 mg/kg u odnosu na aktivni usporedni lijek MTX.
English: • Check that the pre-filled pen box is not damaged.
Croatian: · Pregledajte kutiju napunjene brizgalice kako biste se uvjerili da nije oštećena.
English: All efficacy comparisons vs Placebo + MTX.
Croatian: MTX-om; usporedba je bio placebo i MTX.
English: Infusion related reaction events in pJIA patients included but were not limited to headache, nausea and hypotension 2.
Croatian: Reakcije povezane s infuzijom kod bolesnika s pJIA obuhvaćale su, uz ostalo, glavobolju, mučninu i hipotenziju
English: • The front of your thigh or your abdomen except for the 2-inch (5cm) area around your navel are the recommended injection sites (See Figure D).
Croatian: · Preporučena mjesta za injiciranje su prednji dio bedara ili trbuh, osim područja 5 cm oko pupka (vidjeti Sliku D).
English: • If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
Croatian: · Ako dobijete alergijsku reakciju, kao što je stezanje u prsištu, zviždanje pri disanju, teška omaglica ili ošamućenost, oticanje usana ili kožni osip tijekom ili nakon infuzije, odmah o tome obavijestite liječnika.
English: • If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.
Croatian: · Ako dobijete alergijsku reakciju, kao što je stezanje u prsištu, zviždanje pri disanju, teška omaglica ili ošamućenost, oticanje usana, jezika i lica te svrbež, koprivnjača ili osip kože tijekom ili nakon injekcije, odmah o tome obavijestite liječnika.
English: What you need to know before you use RoActemra
Croatian: Što morate znati prije nego počnete primati lijek RoActemra
English: Serious hypersensitivity reactions have been reported in association with infusion of RoActemra (see section 4.8).
Croatian: Prijavljeni su slučajevi ozbiljne reakcije preosjetljivosti povezane s infuzijom lijeka RoActemra (vidjeti dio 4.8).
English: In SC-I, 1262 patients were randomized 1:1 to receive RoActemra subcutaneous 162 mg every week or RoActemra intravenous 8 mg/kg every four weeks in combination with non-biologic DMARD(s).
Croatian: U ispitivanju SC-I, 1262 bolesnika randomizirana su u omjeru 1:1 za liječenje lijekom RoActemra u supkutanoj dozi od 162 mg jedanput tjedno ili u intravenskoj dozi od 8 mg/kg jedanput svaka 4 tjedna, u kombinaciji s nebiološkim DMARD-ovima.
English: • Insert the needle all the way into the pinched skin at an angle between 45° to 90° with a quick,
Croatian: · Brzim i odlučnim pokretom ubodite iglu cijelom dužinom u nabor kože pod kutom između 45°
English: • If you have liver disease, tell your doctor.
Croatian: · Ako imate bolest jetre, obavijestite o tome liječnika.
English: The efficacy of RoActemra in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Croatian: Djelotvornost lijeka RoActemra u ublažavanju znakova i simptoma RA ocijenjena je u pet randomiziranih, dvostruko slijepih, multicentričnih ispitivanja.
English: The dose-response curve for tocilizumab flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in RoActemra concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with > 800 mg of RoActemra.
Croatian: Krivulja doza-odgovor za tocilizumab izravnava se pri višoj izloženosti, što rezultira manjim povećanjem djelotvornosti za svako dodatno povećanje koncentracije lijeka RoActemra tako da klinički značajna povećanja djelotvornosti nisu pokazana kod bolesnika liječenih s više od 800 mg lijeka RoActemra.
English: • The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, LArginine, L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections.
Croatian: · Drugi sastojci su L-histidin, L-histidinklorid hidrat, L-arginin, L-argininklorid, L-metionin, polisorbat 80, voda za injekcije.
English: When starting or stopping therapy with RoActemra, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin,
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. metilprednizolon, deksametazon (mogućnost nastupa sindroma ustezanja od oralnih glukokortikoida),
English: Children with sJIA (aged 2 and over)
Croatian: Djeca sa sJIA (2 godine i starija)
English: Some side effects are seen more often in children and adolescents: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Croatian: Neke su nuspojave češće prijavljene kod djece i adolescenata: upaljen nos i grlo, glavobolja, mučnina i nizak broj bijelih krvnih stanica.
English: The most common ISRs were erythema, pruritus, pain, and swelling at the injection site.
Croatian: Najčešće reakcije na mjestu injekcije bile su eritem, pruritus, bol i oticanje na mjestu injekcije.
English: Study SC-I evaluated patients with moderate to severe active RA who had an inadequate clinical response to their existing rheumatologic therapy, including one or more DMARD(s) where approximately 20% had a history of inadequate response to at least one TNF inhibitor.
Croatian: Ispitivanje SC-I ocjenjivalo je bolesnike s umjerenim do teškim oblikom aktivnog RA koji nisu imali odgovarajući klinički odgovor na postojeću reumatološku terapiju, uključujući jedan ili više DMARD-ova, a približno 20% bolesnika u anamnezi je imalo neodgovarajući odgovor na najmanje jedan TNF inhibitor.
English: Increases in haemoglobin levels were observed, through RoActemra decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Croatian: Primijećeno je povećanje razine hemoglobina, jer RoActemra smanjuje IL-6 posredovano povećanje hepcidina te tako povećava raspoloživost željeza.
English: Doses exceeding 800 mg per infusion are not recommended in CRS patients.
Croatian: Za bolesnike s CRS-om ne preporučuju se doze veće od 800 mg po infuziji.
English: Decreases in neutrophil and platelet counts have occurred following treatment with RoActemra 8 mg/kg in combination with MTX (see section 4.8).
Croatian: Zabilježeni su slučajevi smanjenja broja neutrofila i trombocita nakon primjene lijeka RoActemra u dozi od 8 mg/kg u kombinaciji s MTX-om (vidjeti dio 4.8).
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in RoActemra plus MTX-treated patients was maintained in the second year of treatment.
Croatian: U otvorenoj fazi produžetka ispitivanja II inhibicija progresije strukturalnog oštećenja zglobova kod bolesnika koji se liječe lijekom RoActemra u kombinaciji s MTX-om održana je i u drugoj godini liječenja.
English: Frequency category with preferred term
Croatian: Kategorija učestalosti s preporučenim pojmovima
English: For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended (see section 5.2).
Croatian: Za osobe čija je tjelesna težina veća od 100 kg, ne preporučuju se doze veće od 800 mg po infuziji
English: Viral reactivation
Croatian: Reaktivacija virusa
English: HR (99% CI) Time to first GCA flare¹ (Tocilizumab groups vs Placebo+52)
Croatian: HR (99% CI) Vrijeme do prvog razbuktavanja GCA¹ (skupine liječene tocilizumabom naspram placeba+52),
English: Available data suggest that clinical improvement is observed within 6 weeks of initiation of treatment with RoActemra.
Croatian: Dostupni podaci ukazuju na to da se kliničko poboljšanje postiže u roku od 6 tjedana od početka primjene lijeka RoActemra.
English: Consistent with the effect on acute phase reactants, treatment with RoActemra was associated with reduction in platelet count within the normal range.
Croatian: skladu s učinkom na reaktante akutne faze, liječenje lijekom RoActemra bilo je povezano sa smanjenjem broja trombocita u okviru normalnog raspona vrijednosti.
English: Interstitial Lung Disease
Croatian: Intersticijska bolest pluća
English: This medicine contains 26.55 mg sodium per maximum dose of 1200 mg. Take this into account if you are on a low-sodium diet.
Croatian: Ovaj lijek sadrži 26,55 mg natrija u maksimalnoj dozi od 1200 mg.
English: It is important to read, understand and follow these instructions so that you or your caregiver uses the RoActemra syringe correctly.
Croatian: Kako biste Vi ili Vaš skrbnik znali pravilno koristiti RoActemra štrcaljku, važno je da pročitate, razumijete i slijedite ove upute.
English: Both considerably lower than in the placebo plus 26 weeks and the placebo plus 52 weeks prednisone taper groups, 4023.5 mg and 5389.5 mg respectively.
Croatian: Obje te doze znatno su niže od onih zabilježenih u skupini koja je primala placebo plus 26-tjedni režim postupnog smanjivanja doze prednizona (4023,5 mg) i onoj koja je primala placebo plus 52-tjedni režim postupnog smanjivanja doze prednizona (5389,5 mg).
English: • There may be a little bleeding at the injection site.
Croatian: Nakon injekcije · Možda ćete primijetiti neznatno krvarenje na mjestu injiciranja.
English: Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice.
Croatian: U ispitivanju kronične toksičnosti na cinomolgus majmunima nije primijećen učinak na endokrine organe i reproduktivni sustav, niti je reproduktivnost bila izmijenjena kod miševa s deficijencijom IL-6.
English: RA and GCA
Croatian: RA i GCA
English: The half life of tocilizumab in pJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 10 mg/kg for body weight < 30 kg) during a dosing interval at steady state.
Croatian: Poluvijek tocilizumaba kod bolesnika s pJIA iznosi najviše 16 dana u obje kategorije tjelesne težine (8 mg/kg za tjelesnu težinu ≥ 30 kg ili 10 mg/kg za tjelesnu težinu < 30 kg) tijekom razdoblja doziranja u stanju dinamičke ravnoteže.
English: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with tocilizumab (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 tocilizumabom
English: The safety and efficacy of intravenous RoActemra in children below 2 years of age has not been established.
Croatian: Sigurnost i djelotvornost lijeka RoActemra za intravensku primjenu u djece mlađe od 2 godine nisu ustanovljene.
English: In the open label extension phase, decreases in platelet counts below 100 x 103/µl, occurred in 3% of patients in the tocilizumab group, without associated bleeding events.
Croatian: Tijekom otvorene faze produžetka ispitivanja smanjenje broja trombocita na razinu manju od 100 x 103/µl zabilježeno je kod 3% bolesnika iz skupine koja je primala tocilizumab, ali bez pridruženih događaja krvarenja.
English: In study I, superiority of RoActemra 8 mg/kg was demonstrated against the active comparator MTX.
Croatian: I pokazala se superiornost lijeka RoActemra u dozi od 8 mg/kg u odnosu na aktivni usporedni lijek MTX.