FrancophonIA/ELRC3.0 huggingface dataset:
English: The types of adverse drug reactions in the RoActemra arm were consistent with the known safety profile of RoActemra 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 lijek RoActemra bile su u skladu s poznatim profilom sigurnosti lijeka RoActemra, a nuspojave su prijavljivane sa sličnom učestalošću kao u Tablici 1.
English: In patients treated with RoActemra 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 lijekom RoActemra 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 (engl.
English: Transient or intermittent mild and moderate elevations of hepatic transaminases have been reported commonly with RoActemra treatment (see section 4.8).
Croatian: Kod liječenja lijekom RoActemra često su prijavljena prolazna ili povremena blaga do umjerena povišenja vrijednosti jetrenih transaminaza (vidjeti dio 4.8).
English: • injection site reactions
Croatian: · reakcije na mjestu injekcije
English: • body aches, fever, chills
Croatian: · bolova u tijelu, vrućice, zimice
English: sJIA and CRS Patients < 30 kg
Croatian: Bolesnici sa sJIA i CRS-om < 30 kg
English: For the 162 mg every week dosing regimen, the steady-state Cavg was 51% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg. For the 162 mg every other week regimen, the steady-state Cavg was 129% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg.
Croatian: Kod primjene doze od 162 mg svaki drugi tjedan Cavg u stanju dinamičke ravnoteže bio je 129% viši u bolesnika tjelesne težine manje od 60 kg u odnosu na bolesnike tjelesne težine između 60 i 100 kg.
English: The mean change in Patient's global VAS from baseline at week 52 was lower (showing greater improvement) in the RoActemra weekly and every other weekly dose groups [-19.0, -25.3, respectively] than in both placebo groups [placebo plus 26 weeks -3.4, placebo plus 52 weeks -7.2], although only the RoActemra every other weekly plus 26 weeks prednisone taper group showed a statistically significant difference compared to placebo [placebo plus 26 weeks taper p=0.0059, and placebo plus 52 weeks taper p=0.0081].
Croatian: Srednja vrijednost promjene bolesnikove opće ocjene prema VAS ljestvici od početka ispitivanja do 52. tjedna bila je manja (što ukazuje na veće poboljšanje) u skupini koja je primala lijek RoActemra jednom tjedno ili jednom svaki drugi tjedan (-19,0 odnosno -25,3) nego u objema skupinama koje su primale placebo (placebo plus 26 tjedana prednizona: -3,4; placebo plus 52 tjedna prednizona: -7,2), ali je samo skupina koja je primala lijek RoActemra jednom svaki drugi tjedan plus 26-tjedni režim postupnog smanjenja doze prednizona ostvarila statistički značajnu razliku u odnosu na placebo (p = 0,0059 za placebo plus 26-tjedno postupno smanjivanje doze; p = 0,0081 za placebo plus 52-tjedno postupno smanjivanje doze).
English: Thereafter, neutrophils recovered towards baseline in a dose dependent manner.
Croatian: Nakon toga neutrofili su se ponovno približavali početnoj vrijednosti, pri čemu je porast ovisio o dozi.
English: Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
Croatian: U aseptičkim uvjetima izvucite volumen sterilne, apirogene otopine natrijevog klorida za injekcije od 9 mg/ml (0,9%) iz infuzijske vrećice od 50 ml, koji je jednak volumenu koncentrata lijeka RoActemra potrebnom za dozu koja se daje bolesniku.
English: RoActemra helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks.
Croatian: RoActemra pridonosi smanjenju simptoma RA kao što su bolnost i oticanje zglobova te može olakšati obavljanje svakodnevnih zadataka.
English: Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Water for injections
Croatian: 6.1 Popis pomoćnih tvari saharoza polisorbat 80 natrijev hidrogenfosfat dodekahidrat natrijev dihidrogenfosfat dihidrat voda za injekcije
English: Patients < 30 kg were randomized 1:1 to receive either tocilizumab 8 mg/kg or 10 mg/kg IV every 4 weeks for 4 doses.
Croatian: Bolesnici tjelesne težine < 30 kg randomizirani su u omjeru 1:1 u skupinu koja je primala intravenski tocilizumab u dozi od 8 mg/kg ili 10 mg/kg svaka 4 tjedna tijekom 4 doze.
English: Tocilizumab PK Parameter
Croatian: Farmakokinetički parametar tocilizumaba
English: ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients)
Croatian: Tablica 3: ACR odgovori u ispitivanjima kontroliranima placebom/MTX-om/DMARD lijekovima (% bolesnika) Ispitivanje I AMBITION
English: In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the RoActemra group and 1.5 events per 100 patient years of exposure in the MTX group.
Croatian: U ispitivanju monoterapije stopa ozbiljnih infekcija iznosila je 3,6 infekcije na 100 bolesnik-godina izloženosti u skupini koja je primala lijek RoActemra te 1,5 infekcija na 100 bolesnik-godina izloženosti u skupini koja je primala MTX.
English: The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag.
Croatian: Iz bočice se izvuče potrebna količina koncentrata lijeka RoActemra (0,4 ml/kg) i ubrizga u infuzijsku vrećicu od 100 ml.
English: • simvastatin or atorvastatin, used to reduce cholesterol levels
Croatian: · metilprednizolon, deksametazon, za ublažavanje upale · simvastatin ili atorvastatin, za smanjenje razine kolesterola
English: Eleven (6.8%) patients in the RoActemra arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Croatian: Kod jedanaest (6,8%) bolesnika koji su primali lijek RoActemra te kod pet (3,1%) bolesnika koji su primali adalimumab primijećene su povišene vrijednosti ALT-a stupnja 2 ili više prema CTC-u.
English: In patients with baseline ALT or AST > 5 x ULN, treatment is not recommended.
Croatian: Kod bolesnika s početnim vrijednostima ALT-a ili AST-a > 5 x iznad gornje granice normale, ne preporučuje se liječenje lijekom RoActemra.
English: For recommended dose modifications based on ANC and platelet counts, see section 4.2.
Croatian: Za preporučene prilagodbe doze na temelju ukupnog broja neutrofila i broja trombocita, vidjeti dio 4.2.
English: Your healthcare provider should show you how to prepare and inject properly before you use the RoActemra syringe for the first time.
Croatian: Prije prve uporabe RoActemra štrcaljke Vaš zdravstveni radnik trebao bi Vam pokazati kako ćete pravilno pripremiti štrcaljku i injicirati lijek.
English: Exploratory Endpoints Week 24: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%) Week 52: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%)
Croatian: Eksploracijske mjere ishoda 24. tjedan: remisija prema ACR/EULAR (Boole), n (%) 47 (18,4) remisija prema ACR/EULAR (indeks bolesti), n (%) 73 (28,5) ‡
English: Your doctor will have to decide if they can still be given RoActemra.
Croatian: Vaš će liječnik morati odlučiti može li dijete ipak primiti lijek RoActemra.
English: • Look in the clear Window area.
Croatian: Slika C · Pogledajte kroz prozirni prozorčić.
English: Interrupt RoActemra dosing.
Croatian: Privremeno prekinuti primjenu lijeka RoActemra.
English: Patients in study SC-I had a mean Disease Activity Score (DAS28) at baseline of 6.6 and 6.7 on the subcutaneous and intravenous arms, respectively.
Croatian: Srednja vrijednost indeksa aktivnosti bolesti (DAS28) na početku ispitivanja SC-I iznosila je 6,6 u skupini liječenoj supkutanom formulacijom te 6,7 u skupini liječenoj intravenskom formulacijom lijeka.
English: All ISRs reported were non-serious Grade 1 events, and none of the ISRs required patient withdrawal from treatment or dose interruption.
Croatian: Sve prijavljene reakcije na mjestu injekcije bile su 1. stupnja težine i nisu bile ozbiljne te nijedna reakcija na mjestu injekcije nije zahtijevala prekid liječenja ni odgodu doze.
English: No dose adjustment is required in patients with mild renal impairment.
Croatian: Nije potrebno prilagođavati dozu kod bolesnika s blagim oštećenjem bubrega.
English: RoActemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks.
Croatian: RoActemra pridonosi smanjenju simptoma kao što su bolnost i oticanje zglobova te može olakšati obavljanje svakodnevnih zadataka.
English: • Low platelet count Laboratory Value (cells x 103/ μL)
Croatian: · Nizak broj trombocita Laboratorijska vrijednost (br. stanica x 103/ μl)
English: Eye disorders
Croatian: Poremećaji oka konjunktivitis
English: Eleven (6.8%) patients in the tocilizumab arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Croatian: Kod jedanaest (6,8%) bolesnika koji su primali tocilizumab te kod pet (3,1%) bolesnika koji su primali adalimumab primijećene su povišene vrijednosti ALT-a stupnja 2 ili više prema CTC-u.
English: In Study IV, tocilizumab was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
Croatian: U Ispitivanju IV tocilizumab se primjenjivao intravenski svaka četiri tjedna u kombinaciji s drugim DMARD-ovima i uspoređivao se s placebom u kombinaciji s drugim DMARD-ovima.
English: pJIA Patients
Croatian: Bolesnici s pJIA
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.7 mL/h in GCA patients,
Croatian: Linearni klirens procjenjivao se kao jedan od parametara u populacijskoj farmakokinetičkoj analizi, a iznosio je 6,7 ml/h u bolesnika s GCA.
English: Parenteral medicinal products should be inspected visually for particulate matter or discoloration prior to administration.
Croatian: Lijekovi za parenteralnu primjenu uvijek se moraju vizualno provjeriti prije primjene obraćajući pažnju na prisutnost čestica i promjenu boje.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/20 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 400 mg/20 ml
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 4 pre-filled syringes.
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj štrcaljki 4 napunjene štrcaljke.
English: • Do not fan or blow on the clean area.
Croatian: · Nemojte sušiti očišćeno područje vrućim zrakom niti puhanjem.
English: Patients in the RoActemra arm received an intravenous (IV) infusion of RoActemra (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Croatian: Bolesnici u skupini liječenoj lijekom RoActemra primali su intravensku (i.v.) infuziju lijeka RoActemra (8 mg/kg) svaka 4 tjedna te supkutanu (s.c.) injekciju placeba svaka 2 tjedna.
English: In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the tocilizumab group and 1.5 events per 100 patient years of exposure in the MTX group.
Croatian: U ispitivanju monoterapije stopa ozbiljnih infekcija iznosila je 3,6 infekcije na 100 bolesnik-godina izloženosti u skupini koja je primala tocilizumab te 1,5 infekcija na 100 bolesnik-godina izloženosti u skupini koja je primala MTX.
English: If following insertion of the needle you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.
Croatian: Ako nakon uboda igle ne možete pritisnuti klip, morate odložiti napunjenu štrcaljku u neprobojan spremnik za oštre predmete te upotrijebiti novu napunjenu štrcaljku.
English: The mean change from baseline at week 104 in total Sharp-Genant score was significantly lower for patients randomised to RoActemra 8 mg/kg plus MTX (p<0.0001) compared with patients who were randomised to placebo plus MTX.
Croatian: Srednja promjena ukupnog rezultata na Sharp-Genantovoj ljestvici u 104. tjednu u odnosu na početnu razinu bila je znatno manja za bolesnike randomizirane u skupinu koja je primala lijek RoActemra u dozi od 8 mg/kg u kombinaciji s MTX-om (p < 0,0001) u usporedbi s bolesnicima koji su randomizirani u skupinu koja je primala placebo i MTX.
English: When platelet count is > 100 x 103/µl resume RoActemra
Croatian: Kada se broj trombocita poveća na >100x103/μl, nastaviti primjenu lijeka RoActemra
English: Children and adolescents RoActemra is not recommended for use in children under 2 years of age.
Croatian: Ne preporučuje se primjena lijeka RoActemra za djecu mlađu od 2 godine.
English: The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA or GCA.
Croatian: Liječenje će propisati i započeti zdravstveni radnici s iskustvom u dijagnosticiranju i liječenju RA,
English: In RA and GCA patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Croatian: Kod bolesnika s RA i GCA vrijednosti lipida moraju se odrediti 4 do 8 tjedana nakon početka liječenja lijekom RoActemra.
English: resulting in smaller efficacy gains for each incremental increase in tocilizumab concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with > 800 mg of tocilizumab.
Croatian: 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: TCZ IV 8 mg/kg + DMARD
Croatian: TCZ 8 mg/kg + DMARD
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 80 mg/4 ml
English: During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, a decrease in neutrophil count below 1 × 109/L occurred in 2.9% of patients on the subcutaneous weekly dose.
Croatian: Prilikom rutinskog laboratorijskog praćenja u 6-mjesečnom kontroliranom kliničkom ispitivanju lijeka RoActemra SC-I, u 2,9% bolesnika liječenih supkutanom dozom jedanput tjedno primijećeno je smanjenje broja neutrofila na razinu nižu od 1 x 109/l.
English: Duration (days) Mean (SD)
Croatian: T rajanje (dani) Srednja vrijednost (SD) Medijan
English: Statistically significant improvements in haemoglobin levels were observed with tocilizumab compared with DMARDs (p< 0.0001) at week 24.
Croatian: U 24. tjednu opaženo je statistički značajno poboljšanje u vrijednostima hemoglobina kod bolesnika liječenih tocilizumabom u usporedbi s bolesnicima liječenima DMARD lijekovima (p< 0,0001).
English: Vigilance for the timely detection of serious infection is recommended for patients receiving immunosuppressive agents such as RoActemra for moderate to severe RA or GCA as signs and symptoms of acute inflammation may be lessened, due to suppression of the acute phase reactants.
Croatian: Kod bolesnika koji primaju imunosupresive poput lijeka RoActemra za liječenje umjerenog do teškog oblika RA ili GCA preporučuje se povećan oprez kako bi se na vrijeme otkrila prisutnost ozbiljne infekcije, jer znakovi i simptomi akutne upale mogu biti ublaženi zbog supresije reaktanata akutne faze.
English: At Week 52, the mean change in HAQ-DI was -0.58 in the RoActemra 8 mg/kg plus MTX group compared with -0.39 in the placebo + MTX group.
Croatian: U 52. tjednu srednja promjena prema HAQ-DI bila je -0,58 u skupini koja je primala lijek RoActemra u dozi od 8 mg/kg u kombinaciji s MTX-om, u usporedbi s -0,39 u skupini koja je primala placebo u kombinaciji s MTX-om.
English: In RA and GCA patients, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Croatian: Kod bolesnika s RA i GCA, vrijednosti ALT-a/AST-a moraju se određivati svakih 4 do 8 tjedana tijekom prvih 6 mjeseci liječenja te svakih 12 tjedana nakon toga.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE BRIZGALICE
English: The following parameters (predicted mean ± SD) were estimated for a dose of 8 mg/kg tocilizumab given every 4 weeks: steady-state area under curve (AUC) = 38000 ± 13000 h µg/mL, trough concentration (Cmin) = 15.9 ± 13.1 µg/mL and maximum concentration (Cmax) = 182 ± 50.4 µg/mL, and the accumulation ratios for AUC and Cmax were small, 1.32 and 1.09, respectively.
Croatian: Area under the plasma concentration time curve, AUC) = 38000 ± 13000 sat µg/ml, najniža koncentracija (Cmin) = 15,9 ± 13,1 mg/ml i vršna koncentracija (Cmax) = 182 ± 50,4 µg/ml.
English: uncommon (≥ 1/1,000 to < 1/100), rare (>1/10,000 to <1/1,000) or very rare (<1/10,000).
Croatian: (> 1/10 000 i < 1/1000) ili vrlo rijetko (< 1/10 000).
English: RoActemra is used for children aged 2 years and over with active polyarticular juvenile idiopathic arthritis (pJIA), an inflammatory disease that causes pain and swelling in one or more joints.
Croatian: · RoActemra se koristi za liječenje djece s pJIA. RoActemra se koristi za djecu u dobi od 2 ili više godina s aktivnim poliartikularnim juvenilnim idiopatskim artritisom (pJIA), upalnom bolešću koja uzrokuje bol i natečenost jednog ili više zglobova.
English: Vigilance for the timely detection of serious infection is recommended for patients receiving immunosuppressive agents such as RoActemra as signs and symptoms of acute inflammation may be lessened, due to suppression of the acute phase reactants.
Croatian: Kod bolesnika koji primaju imunosupresive poput lijeka RoActemra preporučuje se povećan oprez kako bi se na vrijeme otkrila prisutnost ozbiljne infekcije, jer znakovi i simptomi akutne upale mogu biti ublaženi zbog supresije reaktanata akutne faze.
English: 4 vials of 20 mL
Croatian: 1 bočica s 20 ml 4 bočice s 20 ml
English: • If following insertion of the needle, you cannot press down the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe (starting again at Step 2).
Croatian: · Držite klip pritisnutim dok vadite iglu pod istim kutom pod kojim ste je uboli u kožu (vidjeti Sliku G) · Ako nakon uboda igle ne možete pritisnuti klip, morate odložiti napunjenu štrcaljku u neprobojan spremnik za oštre predmete te upotrijebiti novu napunjenu štrcaljku (počevši ponovno od koraka 2).
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with RoActemra (see section 4.8).
Croatian: Prijavljeni su slučajevi ozbiljnih reakcija preosjetljivosti, uključujući anafilaksiju, povezanih s primjenom lijeka RoActemra (vidjeti dio 4.8).
English: In RA clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Croatian: U kliničkim ispitivanjima lijeka RoActemra primijećena su nagla smanjenja vrijednosti C-reaktivnog proteina (CRP), brzine sedimentacije eritrocita (SE), serumskog amiloida A (SAA) i fibrinogena.
English: In paediatric patients with pJIA, the central volume of distribution was 1.97 L, the peripheral volume of distribution was 2.03 L, resulting in a volume of distribution at steady state of 4.0 L.
Croatian: U pedijatrijskih bolesnika s pJIA središnji volumen distribucije iznosio je 1,97 l, a periferni volumen distribucije 2,03 l, što čini volumen distribucije od 4,0 l u stanju dinamičke ravnoteže.
English: 4 vials of 4 mL
Croatian: 1 bočica s 4 ml 4 bočice s 4 ml
English: It may harm them even if their signs of illness are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: SF-36 (mean change in mental and physical component scores) was significantly greater with RoActemra subcutaneous group (6.5 and 5.3) versus placebo (3.8 and 2.9).
Croatian: RoActemra (6,5 odnosno 5,3) nego u skupini koja je primala placebo (3,8 odnosno 2,9).
English: Use in the paediatric population sJIA, pJIA and CRS patients ≥ 30 kg
Croatian: Bolesnici sa sJIA, pJIA i CRS-om ≥ 30 kg
English: Platelets During routine laboratory monitoring in the 12 week controlled phase, 3% of patients in the placebo group and 1% in the tocilizumab group had a decrease in platelet count to ≤ 100 x 103/µl.
Croatian: Prilikom rutinskog laboratorijskog praćenja bolesnika tijekom 12-tjedne kontrolirane faze ispitivanja kod 3% bolesnika iz skupine koja je primala placebo te kod 1% bolesnika iz skupine koja je primala tocilizumab zabilježeno je smanjenje broja trombocita na ≤ 100 x 103/µl.
English: With routine laboratory monitoring it was seen that approximately 24% of patients receiving RoActemra in clinical trials experienced sustained elevations in total cholesterol ≥ 6.2 mmol/ l, with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/ l. Elevations in lipid parameters responded to treatment with lipid-lowering agents.
Croatian: Rutinskim laboratorijskim praćenjem ustanovljeno je da je u otprilike 24% bolesnika koji su u kliničkim ispitivanjima primali lijek RoActemra nastupilo trajno povišenje ukupnog kolesterola od ≥ 6,2 mmol/ l, a u njih 15% vrijednosti LDL bile su trajno povišene na ≥ 4,1 mmol/ l.
English: the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Croatian: odluka o prekidu primjene tocilizumaba u slučaju poremećaja laboratorijskih nalaza mora se temeljiti na medicinskoj procjeni pojedinog bolesnika.
English: List of ADRs occurring in patients treated with RoActemra.
Croatian: Tablica 1: Popis nuspojava koje su se javile kod bolesnika liječenih lijekom RoActemra
English: Prepare the Injection Site
Croatian: Mijenjajte mjesto injiciranja
English: The PCS mean change from baseline to week 52 was higher (showing more improvement) in the RoActemra weekly and every other weekly dose groups [4.10, 2.76, respectively] than in the two placebo groups [placebo plus 26 weeks; -0.28, placebo plus 52 weeks; -1.49], although only the comparison between RoActemra weekly plus 26 weeks prednisone taper group and placebo plus 52 weeks prednisone taper group (5.59, 99% CI: 8.6, 10.32) showed a statistically significant difference (p=0.0024).
Croatian: Srednja vrijednost promjene rezultata za fizičku komponentu od početka ispitivanja do 52. tjedna bila je veća (pokazala je veće poboljšanje) u skupini koja je primala lijek RoActemra jednom tjedno ili jednom svaki drugi tjedan (4,10 odnosno 2,76) nego u dvjema skupinama koje su primale placebo (placebo plus 26 tjedana prednizona: -0,28; placebo plus 52 tjedna prednizona: -1,49), premda je samo usporedba skupine koja je primala lijek RoActemra jednom tjedno plus 26-tjedni režim postupnog smanjenja doze prednizona i skupine koja je primala placebo plus 52-tjedni režim postupnog smanjenja doze prednizona (5,59; 99% CI: 8,6; 10,32) pokazala statistički značajnu razliku (p = 0,0024).
English: firm action.
Croatian: ALT/AST.
English: *τ = 1 week or 2 weeks for the two SC regimens
Croatian: *τ = 1 tjedan ili 2 tjedna za dva supkutana režima
English: There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA, sJIA or pJIA patients.
Croatian: Kombinacija s antagonistima faktora nekroze tumora (TNF) Nema iskustva s primjenom lijeka RoActemra zajedno s antagonistima TNF-a ili drugim biološkim lijekovima za liječenje bolesnika s RA, sJIA ili pJIA.