FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not throw away used syringes or the puncture resistant container in household trash and do not recycle them.
Croatian: Upotrijebljene štrcaljke ili neprobojan spremnik ne smijete bacati u kućni otpad i ne smijete ih reciklirati.
English: This data does not suggest a relevant risk for cancer initiation and progression under tocilizumab treatment.
Croatian: Ti podaci ne ukazuju na relevantan rizik od nastanka i progresije raka tijekom liječenja tocilizumabom.
English: The Patient Information Pack should contain the following key elements:
Croatian: Informativni materijal za bolesnike mora sadržavati sljedeće ključne elemente:
English: • You should use a different place each time you give yourself an injection, at least three centimeters from the area you used for your previous injection.
Croatian: · Injekciju svaki puta morate primijeniti na drugo mjesto, koje je najmanje 3 cm udaljeno od mjesta prethodne injekcije.
English: The majority (67%) of patients were MTX-naïve.
Croatian: Većina bolesnika (67%) nikad prije nije primala MTX.
English: After 2 years of treatment with RoActemra plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Croatian: Nakon dvije godine liječenja lijekom RoActemra u kombinaciji s MTX-om, 14% bolesnika postiglo je značajan klinički odgovor (održavanje ACR70 odgovora 24 tjedna ili dulje).
English: Infections with neutropenia have been reported.
Croatian: Prijavljene su infekcije koje su uključivale neutropeniju.
English: Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Roche Registration GmbH Emil-Barell-Strasse 1
English: > 5x ULN Discontinue RoActemra.
Croatian: > 5x GGN Potpuno prekinuti primjenu lijeka RoActemra.
English: • benzodiazepines (e.g. temazepam), used to relieve anxiety
Croatian: · benzodiazepine (npr. temazepam), za uklanjanje tjeskobe
English: • Dispose of the full container as instructed by your healthcare provider or pharmacist.
Croatian: · Cijeli spremnik zbrinite sukladno uputama svog zdravstvenog radnika ili ljekarnika.
English: The majority was resolved without any treatment and none necessitated drug discontinuation.
Croatian: Većina njih povukla se bez liječenja, a niti jedna nije zahtijevala prekid liječenja.
English: • Choose a different injection site for each new injection at least 1 inch (2.5cm) from the last area you injected.
Croatian: · Za svaku injekciju odaberite drugo mjesto za injiciranje, koje je udaljeno najmanje 2,5 cm od mjesta primjene prethodne injekcije.
English: No (N = 58)
Croatian: Ne (N = 58)
English: RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.
Croatian: RoActemra sadrži djelatnu tvar tocilizumab, protein koji se sastoji od specifičnih imunosnih stanica (monoklonsko protutijelo), a blokira djelovanje specifične bjelančevine (citokina) koja se zove interleukin-6.
English: The pharmacokinetics of RoActemra is characterized by nonlinear elimination which is a combination of linear clearance and Michaelis-Menten elimination.
Croatian: Farmakokinetiku lijeka RoActemra karakterizira nelinearna eliminacija koja je kombinacija linearnog klirensa i eliminacije prema Michaelis-Mentenovu modelu.
English: Not allowing the syringe to come to room temperature could result in an uncomfortable injection and it may be difficult to depress the plunger.
Croatian: Ako ne pričekate da se štrcaljka ugrije na sobnu temperaturu, injekcija bi mogla biti neugodna i možda će biti teško pritisnuti klip do kraja.
English: After 2 years of treatment with tocilizumab plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Croatian: Nakon dvije godine liječenja tocilizumabom u kombinaciji s MTX-om, 14% bolesnika postiglo je značajan klinički odgovor (održavanje ACR70 odgovora 24 tjedna ili dulje).
English: RoActemra treatment must not be initiated in patients with active infections (see section 4.3).
Croatian: Liječenje lijekom RoActemra ne smije se započeti kod bolesnika s aktivnim infekcijama (vidjeti dio 4.3).
English: Neutrophils
Croatian: Neutrofili
English: DMARD - Disease modifying anti-rheumatic drug - p< 0.01, TCZ vs. PBO + MTX/DMARD - p< 0.0001, TCZ vs. PBO + MTX/DMARD
Croatian: DMARD - Antireumatski lijek koji modificira tijek bolesti - p< 0,01, TCZ u odnosu na PBO + MTX/DMARD - p< 0,0001, TCZ u odnosu na PBO + MTX/DMARD
English: FACIT-Fatigue change from baseline to week 52 scores were calculated for all groups.
Croatian: Promjena FACIT rezultata za umor od početka ispitivanja do 52. tjedna izračunavala se za sve skupine.
English: Each patient continued in Part II of the study until Week 40 or until the patient satisfied JIA ACR30 flare criteria (relative to Week 16) and qualified for escape to tocilizumab therapy (same dose received in Part I).
Croatian: Svaki je bolesnik sudjelovao u dijelu II ispitivanja do 40. tjedna ili dok nije zadovoljio kriterije za pogoršanje upale na razini JIA ACR30 (u odnosu na 16. tjedan) te se tako kvalificirao za prelazak na liječenje tocilizumabom (u dozi kao u dijelu I).
English: In healthy subjects administered tocilizumab in doses from 2 to 28 mg/kg, absolute neutrophil counts decreased to their lowest 3 to 5 days following administration.
Croatian: Kod zdravih ispitanika koji su primali tocilizumab u dozama od 2 do 28 mg/kg apsolutni broj neutrofila smanjio se na najnižu vrijednost 3 do 5 dana nakon primjene.
English: The efficacy population for the tisagenlecleucel cohort included 28 males and 23 females (total 51 patients) of median age 17 years (range, 3-68 years).
Croatian: 28 muškaraca i 23 žene (ukupno 51 bolesnik), čiji je medijan dobi iznosio 17 godina (raspon: 3 - 68 godina).
English: In the 12 week double-blind, controlled phase, 75 patients received treatment with tocilizumab (8 mg/kg or 12 mg/kg based upon body weight).
Croatian: Tijekom dvostruko slijepe kontrolirane faze u trajanju od 12 tjedana, 75 bolesnika liječeno je tocilizumabom (8 mg/kg ili 12 mg/kg, ovisno o tjelesnoj težini).
English: RoActemra AUC, Cmin and Cmax increased with increase of body weight.
Croatian: AUC, Cmin i Cmax lijeka RoActemra povećavali su se s povećanjem tjelesne težine.
English: RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Croatian: RoActemra je u kombinaciji s metotreksatom (MTX) indicirana za liječenje juvenilnog idiopatskog poliartritisa (pJIA; pozitivan ili negativan nalaz testa na reumatoidni faktor i prošireni oligoartritis) u bolesnika u dobi od 2 i više godina koji nisu dobro odgovorili na prethodno liječenje MTX-om.
English: • Reference to the Summary of Product Characteristics (e.g., link to EMA website)
Croatian: · referencu na sažetak opisa svojstava lijeka (npr. poveznicu na stranicu Europske agencije za lijekove)
English: Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Croatian: Hvatanje nabora kože važno je kako biste bili sigurni da ste lijek injicirali pod kožu (u masno tkivo), ali ne dublje (u mišić).
English: One event (angioedema) was considered serious and life-threatening, and the patient was discontinued from study treatment.
Croatian: (angioedem) smatrala ozbiljnom i opasnom po život te je taj bolesnik isključen iz ispitivanja.
English: In the majority of patients, there was no increase in atherogenic indices, and elevations in total cholesterol responded to treatment with lipid lowering agents.
Croatian: Kod većine bolesnika nije bilo porasta parametara aterogenosti, a povišene vrijednosti ukupnog kolesterola odgovarale su na liječenje antilipemicima.
English: The cumulative prednisone dose at week 52 was significantly lower in the two RoActemra dose groups compared to the two placebo groups (Table 3).
Croatian: Kumulativna doza prednizona u 52. tjednu bila je značajno niža u dvjema skupinama liječenima lijekom RoActemra nego u dvjema skupinama koje su primale placebo (Tablica 3).
English: The t1/2 of RoActemra was concentration-dependent.
Croatian: Vrijednost t1/2 lijeka RoActemra ovisila je o koncentraciji.
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 tocilizumab 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 tocilizumabom.
English: One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg.
Croatian: Prijavljen je jedan slučaj nehotičnog predoziranja u kojem je bolesnik s multiplim mijelomom primio jednu dozu od 40 mg/kg.
English: The safety profile of tocilizumab 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: Sigurnosni profil tocilizumaba ispitivan je 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: Effects can include strokes and blindness.
Croatian: Posljedice bolesti mogu biti moždani udari i sljepoća.
English: The tocilizumab 8 mg/kg + MTX group also showed statistically significant results across the key secondary endpoints.
Croatian: Skupina koja je primala tocilizumab u dozi od 8 mg/kg i MTX također je postigla statistički značajne rezultate za sve ključne sekundarne mjere ishoda.
English: CRS
Croatian: CRS-a.
English: Health related and quality of life outcomes
Croatian: Zdravstveni ishodi i ishodi povezani s kvalitetom života
English: DAS28 ≤ 3.2, n (%) ACR20 response, n (%) ACR50 response, n (%) ACR70 response, n (%)
Croatian: DAS28 ≤ 3,2, n (%) odgovor ACR20, n (%) odgovor ACR50, n (%) odgovor ACR70, n (%)
English: In Study II, in patients with an inadequate response to MTX, inhibition of structural joint damage was assessed radiographically and expressed as change in modified Sharp score and its components, the erosion score and joint space narrowing score.
Croatian: Radiološki odgovor U ispitivanju II se kod bolesnika s neprimjerenim odgovorom na MTX radiološki procijenila inhibicija strukturalnih oštećenja zglobova i izrazila kao promjena u modificiranom stupnjevanju prema Sharpu i njegovim sastavnicama, stupnju erozije i stupnju suženja zglobnog prostora.
English: • Alcohol pad
Croatian: · tupfer s alkoholom
English: The safety profile of intravenous RoActemra in pJIA has been studied in 188 patients from 2 to 17 years of age.
Croatian: Sigurnosni profil lijeka RoActemra za intravensku primjenu kod pJIA ispitan je kod 188 bolesnika u dobi od 2 do 17 godina.
English: Children and adolescents with sJIA (aged 1 year and over)
Croatian: Djeca i adolescenti sa sJIA (u dobi od 1 i više godina)
English: Tocilizumab AUC, Cmin and Cmax increased with increase of body weight.
Croatian: AUC, Cmin i Cmax tocilizumaba povećavali su se s povećanjem tjelesne težine.
English: In a randomized open-label study, adult RA patients treated with RoActemra and MTX were able to mount an effective response to both the 23-valent pneumococcal polysaccharide and tetanus toxoid vaccines which was comparable to the response seen in patients on MTX only.
Croatian: U randomiziranom otvorenom ispitivanju, odrasli bolesnici s RA liječeni lijekom RoActemra i MTX-om uspjeli su postići učinkovit odgovor i na 23-valentno pneumokokno polisaharidno cjepivo i na cjepivo koje sadrži toksoid tetanusa, koji je bio usporediv s odgovorom primijećenim u bolesnika liječenih samo MTX-om.
English: Twist and pull off the green cap with the other hand (See Figure E).
Croatian: Drugom rukom zakrenite zeleni zatvarač i povucite ga s brizgalice (vidjeti Sliku E).
English: All patients treated with RoActemra should be given the Patient Alert Card.
Croatian: Svi bolesnici koji se liječe lijekom RoActemra moraju dobiti od liječnika karticu s upozorenjima za bolesnike.
English: The interval between live vaccinations and initiation of RoActemra therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Croatian: Razdoblje koje treba proći između cijepljenja živim cjepivom i uvođenja lijeka RoActemra treba biti sukladno trenutno važećim smjernicama za cijepljenje koje se odnose na primjenu imunosupresivnih lijekova.
English: Given its long elimination half-life (t1/2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Croatian: S obzirom na dugo poluvrijeme eliminacije (t1/2), djelovanje tocilizumaba na aktivnost enzima CYP450 može trajati i nekoliko tjedana nakon prestanka liječenja.
English: • Do not remove the needle-cap until you are ready to inject
Croatian: · Nemojte skinuti zatvarač igle sve dok ne budete spremni za injiciranje.
English: Keep the green button pressed in and continue holding the pre-filled pen pressed firmly against your skin (See Figure J).
Croatian: Držite zeleno dugme za aktivaciju pritisnutim, a napunjenu brizgalicu čvrsto priljubljenom o kožu (vidjeti Sliku J).
English: MedDRA System Organ Class
Croatian: MedDRA klasifikacija organskih sustava
English: As recommended for other biological treatments, RA, sJIA and pJIA patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Croatian: Kao što se inače preporučuje kod biološke terapije, u bolesnika s RA, sJIA i pJIA treba provesti probir na latentnu tuberkulozu prije početka liječenja lijekom RoActemra.
English: Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate
Croatian: Ponovno započeti liječenje dozom od 4 mg/kg ili 8 mg/kg prema kliničkoj potrebi
English: This data does not suggest a relevant risk for cancer initiation and progression under RoActemra treatment.
Croatian: Ti podaci ne ukazuju na relevantan rizik od nastanka i progresije raka tijekom liječenja lijekom RoActemra.
English: Side effects could occur 3 months or more after your last dose of RoActemra.
Croatian: Nuspojave mogu nastupiti 3 ili više mjeseca nakon posljednje doze lijeka RoActemra.
English: Given its long elimination half-life (t1/2), the effect of RoActemra on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Croatian: S obzirom na dugo poluvrijeme eliminacije (t1/2), djelovanje lijeka RoActemra na aktivnost enzima CYP450 može trajati i nekoliko tjedana nakon prestanka liječenja.
English: Patients should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Croatian: Bolesnike treba savjetovati da se odmah obrate svom liječniku u slučaju pojave bilo kojeg simptoma koji ukazuje na infekciju, kako bi se osigurao brz pregled i primjereno liječenje.
English: 162 mg every other weekly
Croatian: 162 mg svaki drugi tjedan
English: Tocilizumab versus adalimumab in monotherapy
Croatian: Tocilizumab u usporedbi s adalimumabom u monoterapiji
English: The Physician Information pack should contain the following key elements:
Croatian: Informativni materijal za liječnike mora sadržavati sljedeće ključne elemente:
English: Viral reactivation (e.g. hepatitis B virus) has been reported with biologic therapies for RA.
Croatian: Pri liječenju RA biološkim lijekovima prijavljena je reaktivacija virusa (npr. virusa hepatitisa B).
English: All patients received background glucocorticoid (prednisone) therapy.
Croatian: Svi su bolesnici primali osnovnu terapiju glukokortikoidima (prednizon).
English: Physicians should be vigilant for symptoms potentially indicative of new-onset central demyelinating disorders.
Croatian: Liječnici moraju posebno paziti na simptome koji bi mogli ukazivati na pojavu demijelinizirajuće bolesti središnjeg živčanog sustava.
English: Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Croatian: Bolesnici sa simptomima koji mogu ukazivati na komplicirani divertikulitis, kao što su bol u abdomenu, hemoragija i/ili neobjašnjive probavne smetnje praćene vrućicom, moraju se pregledati bez odlaganja kako bi se na vrijeme utvrdilo postoji li divertikulitis uz koji može biti prisutna perforacija u probavnom sustavu.
English: However, your doctor may decide that you may inject RoActemra yourself.
Croatian: Međutim, liječnik može odlučiti da si lijek RoActemra možete injicirati i samostalno.
English: The data available so far does not suggest any effect on fertility from this treatment.
Croatian: Dosad dostupni podaci ne ukazuju ni na kakav učinak na plodnost prilikom ovog liječenja.
English: PHARMACEUTICAL FORM Solution for injection in pre-filled pen (ACTPen).
Croatian: OBLIK Otopina za injekciju u napunjenoj brizgalici (ACTPen).
English: All patients received background non-biologic DMARD(s).
Croatian: Svi su bolesnici primali osnovno liječenje nebiološkim DMARD-ovima.
English: Patients with sJIA must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously (see section 4.2).
Croatian: Bolesnici moraju težiti najmanje 10 kg kad primaju lijek RoActemra za supkutanu primjenu (vidjeti dio 4.2).
English: The pre-filled pen requires a firm injection site to properly activate.
Croatian: Mjesto za injiciranje mora biti čvrsto da bi se napunjena brizgalica mogla pravilno aktivirati.
English: The safety of RoActemra has been studied in 5 Phase III, double-blind controlled trials and their extension periods.
Croatian: Sigurnost lijeka RoActemra ispitivala se u 5 dvostruko slijepih kontroliranih ispitivanja faze III i njihovim produžecima.
English: Do not use the pre-filled pen if it appears to be damaged or if you have accidentally dropped the pre-filled pen.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako izgleda oštećeno ili ako Vam je slučajno pala.
English: Paediatric population sJIA Patients
Croatian: Pedijatrijska populacija Bolesnici sa sJIA
English: L-Histidine monohydrochloride monohydrate L-Arginine
Croatian: L-histidinklorid hidrat L-arginin
English: RoActemra should be used with caution in patients with previous history of intestinal ulceration or diverticulitis.
Croatian: RoActemra se mora primjenjivati s oprezom kod bolesnika s crijevnim ulceracijama ili divertikulitisom u anamnezi.
English: Always store the syringe in a refrigerator at a temperature of 2°C - 8°C.
Croatian: Štrcaljku uvijek čuvajte u hladnjaku na temperaturi od 2°C - 8°C.
English: • low counts for white blood cells, red blood cells and platelets in blood tests.
Croatian: · niske vrijednosti bijelih krvnih stanica, crvenih krvnih stanica i krvnih pločica u krvnim pretragama · zatajenje jetre
English: Patients (treated with or without MTX) were randomised (tocilizumab:placebo = 2:1) to one of two treatment groups, 75 patients received tocilizumab infusions every two weeks, either 8 mg/kg for patients ≥ 30 kg or 12 mg/kg for patients < 30 kg and 37 patients were assigned to receiving placebo infusions every two weeks.
Croatian: Bolesnici (liječeni u kombinaciji s MTX-om ili bez njega) su randomizirani u jednu od dvije skupine (tocilizumab:placebo = 2 : 1), pri čemu je 75 bolesnika svaka dva tjedna primalo infuzije tocilizumaba u dozi od 8 mg/kg za bolesnike ≥ 30 kg ili 12 mg/kg za bolesnike < 30 kg, a 37 bolesnika primalo je svaka dva tjedna infuzije placeba.
English: Concomitant administration of a single dose of 10 mg/kg RoActemra with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Croatian: Istodobna primjena jedne doze lijeka RoActemra od 10 mg/kg i doze MTX-a od 10-25 mg jedanput tjedno nije imala klinički značajan učinak na izloženost MTX-u.
English: The safety profile of subcutaneous RoActemra was evaluated in 51 paediatric patients (1 to 17 years of age) with sJIA.
Croatian: Sigurnosni profil lijeka RoActemra za supkutanu primjenu ocjenjivao se kod 51 pedijatrijskog bolesnika sa sJIA (u dobi od 1 do 17 godina).
English: Study V RADIATE
Croatian: Ispitivanje V RADIATE
English: From a microbiological point of view, the prepared solution for infusion should be used immediately.
Croatian: S mikrobiološkog stajališta, otopina za infuziju mora se primijeniti odmah nakon pripreme.
English: IgG levels decrease during therapy.
Croatian: Razine imunoglobulina G (IgG) tijekom liječenja se smanjuju.
English: Five patients (0.8%) developed positive anti-RoActemra antibodies; of these, all developed neutralizing anti-RoActemra antibodies.
Croatian: U 5 bolesnika (0,8%) razvila su se pozitivna protutijela na lijek RoActemra, a u svih 5 razvila su se neutralizirajuća protutijela na lijek RoActemra.
English: Early removal of the needle-cap can cause the medication to dry out and block the needle.
Croatian: Rano skidanje zatvarača može dovesti do toga da se lijek osuši i začepi iglu.
English: Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted.
Croatian: Smiju se razrijediti samo otopine koje su bistre do opalescentne, bezbojne do blijedožute boje i ne sadrže vidljive čestice.
English: The primary endpoint was the proportion of patients with a JIA ACR30 flare at week 40 relative to week 16.
Croatian: Primarna mjera ishoda bila je udio bolesnika s pogoršanjem upale na razini JIA ACR30 u 40. tjednu u odnosu na 16. tjedan.
English: All 112 patients were tested for anti-tocilizumab antibodies at baseline.
Croatian: Svih 112 bolesnika na početku je ispitivanja testirano na protutijela na tocilizumab.
English: In sJIA and pJIA patients, neutrophils and platelets should be monitored at the time of second infusion and thereafter according to good clinical practice, see section 4.2.
Croatian: Kod bolesnika sa sJIA i pJIA broj neutrofila i trombocita treba pratiti tijekom druge infuzije, a nakon toga u skladu s dobrom kliničkom praksom, vidjeti dio 4.2.
English: The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 1 year have not been established.
Croatian: Sigurnost i djelotvornost formulacije lijeka RoActemra za supkutanu primjenu u djece od rođenja do manje od 1 godine nisu ustanovljene.
English: Do not touch the trigger fingers on the syringe as this may damage the syringe.
Croatian: Nemojte dirati otpusne kvačice na štrcaljki jer možete oštetiti štrcaljku.
English: A higher incidence of infections and infestations was reported in the tocilizumab 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 tocilizumab (48% naspram 42%), a nije bilo razlike u incidenciji ozbiljnih infekcija (3,1%).
English: Clinical Efficacy
Croatian: Klinička djelotvornost
English: Such reactions may be more severe, and potentially fatal in patients who have experienced hypersensitivity reactions during previous infusions even if they have received premedication with steroids and antihistamines.
Croatian: Takve reakcije mogu biti teže i potencijalno smrtonosne kod bolesnika koji su već imali reakcije preosjetljivosti prilikom prethodnih infuzija, čak i ako prije iduće infuzije lijeka
English: The concentrate is a clear to opalescent, colourless to pale yellow liquid.
Croatian: Koncentrat je bistra do opalescentna, bezbojna do blijedožuta tekućina.
English: Therefore, RoActemra doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Croatian: Stoga se doze lijeka RoActemra veće od 800 mg po infuziji ne preporučuju (vidjeti dio 4.2).
English: ADA + Placebo (IV) N = 162
Croatian: ADA + Placebo (i.v.) N = 162