FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in the adalimumab arm received an adalimumab SC injection (40 mg) q2w plus an IV placebo infusion q4w.
Croatian: Bolesnici u adalimumab skupini primali su s.c. injekciju adalimumaba (40 mg) svaka 2 tjedna te i.v. infuziju placeba svaka 4 tjedna.
English: • Do not try to take apart the pre-filled pen at any time.
Croatian: · Nikada nemojte pokušavati rastaviti napunjenu brizgalicu.
English: Patients demonstrate a comparable (to healthy subjects) decrease of absolute neutrophil counts following RoActemra administration (see section 4.8).
Croatian: Kod bolesnika je nakon primjene lijeka RoActemra primijećeno usporedivo (u odnosu na zdrave ispitanike) smanjenje apsolutnog broja neutrofila (vidjeti dio 4.8).
English: Following 1 year of treatment with tocilizumab plus MTX, 85% of patients (n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients (n=290) (p ≤ 0.001).
Croatian: (n=348) nije došlo do napredovanja strukturalnog oštećenja zglobova, definirano promjenom ukupnog rezultata po Sharp ljestvici od nula ili manje, u usporedbi sa 67% bolesnika liječenih placebom u kombinaciji s MTX (n=290) (p £ 0,001).
English: These may affect up to 1 in 10 patients
Croatian: Mogu se javiti u do 1 na 10 bolesnika
English: The overall clinical adverse event profile was similar between tocilizumab and adalimumab.
Croatian: Tocilizumab i adalimumab imali su sličan ukupan profil kliničkih nuspojava.
English: The most common ISRs were injection site erythema, swelling, hematoma, pain and pruritis.
Croatian: Najčešće reakcije na mjestu injekcije bile su eritem, oticanje, hematom, bol i pruritus na mjestu injekcije.
English: In the 6-month controlled studies the rate of all infections reported with tocilizumab 8 mg/kg plus DMARD treatment was 127 events per 100 patient years compared to 112 events per 100 patient years in the placebo plus DMARD group.
Croatian: 6-mjesečnim kontroliranim ispitivanjima stopa svih prijavljenih infekcija tijekom liječenja tocilizumabom u dozi od 8 mg/kg u kombinaciji s DMARD-om iznosila je 127 infekcija na 100 bolesnik-godina u usporedbi sa 112 infekcija na 100 bolesnik-godina u skupini koja je primala placebo i DMARD.
English: In general, side effects in pJIA patients were of a similar type to those in adults with RA.
Croatian: Nuspojave kod bolesnika s pJIA su, u načelu su slična onima kod odraslih s RA.
English: Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet.
Croatian: Opsežne upute za primjenu lijeka RoActemra u napunjenoj brizgalici nalaze se u Uputi o lijeku.
English: For MCS, the mean change from baseline to week 52 for both RoActemra weekly and every other weekly dose groups [7.28, 6.12, respectively] were higher than the placebo plus 52 weeks prednisone taper group [2.84] (although the differences were not statistically significant [weekly p=0.0252 for weekly, p=0.1468 for every other weekly]) and similar to the placebo plus 26 weeks prednisone taper group [6.67].
Croatian: odnosno 6,12) bila je veća nego u skupini koja je primala placebo plus 52-tjedni režim postupnog smanjenja doze prednizona (2,84) (premda razlike nisu bile statistički značajne [p = 0,0252 za primjenu jednom tjedno; p = 0,1468 za primjenu jednom svaki drugi tjedan]) te slična kao u skupini koja je primala placebo plus 26-tjedni režim postupnog smanjenja doze prednizona (6,67).
English: Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in tocilizumab-treated patients compared to control patients (1.3-2.1).
Croatian: Kod bolesnika liječenih tocilizumabom primijećeno je značajno smanjenje vrijednosti DAS28 (prosječno poboljšanje) od 3,1-3,4 u odnosu na početnu vrijednost, za razliku od kontrolnih ispitanika (1,3-2,1).
English: Each pre-filled syringe contains 162 mg tocilizumab in 0.9 mL.
Croatian: Jedna napunjena brizgalica sadrži 162 mg tocilizumaba u 0,9 ml.
English: Doses of 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable DMARDs.
Croatian: Doze od 8 mg/kg tocilizumaba ili placeba davale su se svaka četiri tjedna u kombinaciji sa stabilnom terapijom DMARD-ovima.
English: In all patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Croatian: Kod svih bolesnika vrijednosti lipida moraju se odrediti 4 do 8 tjedana nakon početka liječenja lijekom
English: In the 6-month controlled trials adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the RoActemra 8 mg/kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
Croatian: 6-mjesečnim kontroliranim ispitivanjima nuspojave povezane s infuzijom (odabrani događaji koji su se pojavili tijekom ili u roku od 24 sata od infuzije) prijavilo je 6,9% bolesnika koji su primali lijek RoActemra u dozi od 8 mg/kg zajedno s DMARD-om te 5,1% bolesnika koji su primali placebo s
English: • If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe) once every 2 weeks
Croatian: · Ako bolesnik teži manje od 30 kg: doza iznosi 162 mg (sadržaj 1 napunjene štrcaljke) jedanput svaka 2 tjedna
English: The study consisted of a 52-week blinded period (Part 1),
Croatian: Ispitivanje se sastojalo od 52-tjednog razdoblja slijepog liječenja
English: Very rare side effects:
Croatian: Rijetke nuspojave:
English: In the long-term exposure population the overall rate of gastrointestinal perforation was 0.28 events per 100 patient years.
Croatian: U populaciji s dugotrajnom izloženošću ukupna stopa perforacija u probavnom sustavu bila je 0,28 na 100 bolesnik-godina izloženosti.
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: A significantly higher proportion of patients in the tocilizumab 8 mg/kg + MTX and tocilizumab monotherapy groups met the primary endpoint compared with MTX alone.
Croatian: Primarnu mjeru ishoda postigao je značajno veći udio bolesnika u skupini koja je primala tocilizumab u dozi od 8 mg/kg + MTX i u skupini koja je primala monoterapiju tocilizumabom nego u skupini koja je primala samo MTX.
English: sJIA and pJIA Patients
Croatian: Bolesnici sa sJIA i pJIA
English: Certain types of vaccines should not be given while receiving RoActemra.
Croatian: Za vrijeme liječenja lijekom RoActemra ne smiju se primiti određene vrste cjepiva.
English: During routine laboratory monitoring in the tocilizumab all exposure population, a decrease in neutrophil count below 1 × 109/L occurred in 3.7% of patients.
Croatian: Prilikom rutinskog laboratorijskog praćenja cjelokupne populacije izložene tocilizumabu, kod 3,7% bolesnika primijećeno je smanjenje broja neutrofila na razinu nižu od 1 x 109/l.
English: Other Secondary Endpoints Time to first GCA flare¹ (Tocilizumab groups vs Placebo+26)
Croatian: O stale sekundarne mjere ishoda Vrijeme do prvog razbuktavanja GCA¹ (skupine liječene tocilizumabom naspram placeba+26),
English: Important: Do not touch the needle shield which is located at the tip of the pre-filled pen below the Window area (see Figure A), to avoid accidental needle stick injury.
Croatian: ispod prozorčića (vidjeti Sliku A), kako biste izbjegli nehotičnu ozljedu iglom.
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Croatian: systemic juvenile idiopathic arthritis, sJIA) kod bolesnika u dobi od dvije godine i starijih koji nisu dobro odgovorili na liječenje nesteroidnim protuupalnim lijekovima i sistemskim kortikosteroidima.
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Croatian: systemic juvenile idiopathic arthritis, sJIA) u bolesnika u dobi od 1 i više godina koji nisu dobro odgovorili na prethodno liječenje nesteroidnim protuupalnim lijekovima i sistemskim kortikosteroidima.
English: • RoActemra is used to treat adults and children aged 2 years and over with severe or lifethreatening cytokine release syndrome (CRS), a side-effect in patients treated with chimeric antigen receptor (CAR) T-cell therapies used to treat certain types of cancer.
Croatian: · RoActemra se koristi za liječenje odraslih bolesnika i djece u dobi od 2 i više godina s teškim ili po život opasnim sindromom otpuštanja citokina (engl. cytokine release syndrome,
English: *τ = 2 week or 1 week for the two SC regimens
Croatian: *τ = 2 tjedna ili 1 tjedan za dva supkutana režima
English: The overall clinical adverse event profile was similar between RoActemra and adalimumab.
Croatian: RoActemra i adalimumab imali su sličan ukupan profil kliničkih nuspojava.
English: Available non-clinical data do not suggest an effect on fertility under tocilizumab treatment.
Croatian: Dostupni neklinički podaci ne ukazuju ni na kakve učinke liječenja tocilizumabom na plodnost.
English: It is important to remain under your healthcare provider's care while using RoActemra.
Croatian: Važno je da tijekom liječenja lijekom RoActemra zdravstveni radnik nastavi pratiti Vaše stanje.
English: • If you miss your once every 2 weeks dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time.
Croatian: · Ako propustite dozu koju primjenjujete jedanput svaka 2 tjedna i ako je od propuštanja prošlo manje od 7 dana, injicirajte lijek čim se sjetite, a sljedeću dozu primijenite prema uobičajenom rasporedu.
English: The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg.
Croatian: Preporučeno doziranje u bolesnika starijih od 2 godine je 8 mg/kg jedanput svaka 4 tjedna za bolesnike tjelesne težine 30 kg ili veće, odnosno 10 mg/kg jedanput svaka 4 tjedna za bolesnike tjelesne težine manje od 30 kg.
English: In the 6-month controlled trials adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the tocilizumab 8 mg/kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
Croatian: 6-mjesečnim kontroliranim ispitivanjima nuspojave povezane s infuzijom (odabrani događaji koji su se pojavili tijekom ili u roku od 24 sata od infuzije) prijavilo je 6,9% bolesnika koji su primali tocilizumab u dozi od 8 mg/kg zajedno s DMARD-om te 5,1% bolesnika koji su primali placebo s
English: • In RA, GCA, pJIA and sJIA, 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 RA, GCA, pJIA i sJIA vrijednosti ALT-a/AST-a potrebno je određivati svakih 4 do 8 tjedana tijekom prvih 6 mjeseci liječenja te svakih 12 tjedana nakon toga.
English: It should be clear and colorless to pale yellow.
Croatian: Otopina je bezbojna do blijedo žućkasta.
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of tocilizumab monotherapy patients and 1.4% of tocilizumab plus DMARD patients, the majority of whom were discontinued permanently from tocilizumab treatment.
Croatian: Povišenje vrijednosti ALT/AST > 5 x iznad gornje granice normale bilo je primijećeno u 0,7% bolesnika na monoterapiji tocilizumabom i 1,4% bolesnika na terapiji tocilizumabom i DMARD-om; u većine tih bolesnika liječenje tocilizumabom je trajno prekinuto.
English: A higher frequency of injection site reactions was observed in the subcutaneous arms compared with placebo subcutaneous injections in the intravenous arms.
Croatian: U skupini bolesnika koji su primali supkutanu formulaciju lijeka primijećena je veća učestalost reakcija na mjestu injekcije nego u bolesnika koji su primali placebo supkutanom injekcijom u skupini liječenoj intravenskom formulacijom lijeka.
English: All patients treated with RoActemra should be given the Patient Alert Card. Suitability of the patient for subcutaneous home use should be assessed and patients should be instructed to inform a healthcare professional if they experience symptoms of an allergic reaction before administering the next dose.
Croatian: Treba procijeniti je li supkutana primjena lijeka kod kuće prikladna za bolesnika te ga uputiti da se u slučaju pojave simptoma alergijske reakcije obrati zdravstvenom radniku prije nego što primijeni sljedeću dozu.
English: • The RoACTEMRA pre-filled pen should not be reused.
Croatian: 4. korak: Zbrinite napunjenu brizgalicu · RoACTEMRA napunjena brizgalica ne smije se ponovno upotrijebiti.
English: The efficacy of tocilizumab in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Croatian: Djelotvornost tocilizumaba u ublažavanju znakova i simptoma RA ocijenjena je u pet randomiziranih,
English: Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 was observed in RoActemra-treated patients compared to control patients (1.3-2.1).
Croatian: Kod bolesnika liječenih lijekom RoActemra primijećeno je značajno smanjenje vrijednosti DAS28 (prosječno poboljšanje) od 3,1-3,4 u odnosu na početnu vrijednost, za razliku od kontrolnih ispitanika (1,3-2,1).
English: Seven patients (1.6%) developed positive anti-RoActemra antibodies; of these, six (1.4%) developed neutralizing anti-RoActemra antibodies.
Croatian: U 7 bolesnika (1,6%) razvila su se pozitivna protutijela na lijek RoActemra; u 6 od njih 7
English: In 6-month controlled clinical studies, the rate of serious infections with RoActemra 8 mg/kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group.
Croatian: 6-mjesečnim kontroliranim kliničkim ispitivanjima, stopa ozbiljnih infekcija uz lijek RoActemra u dozi od 8 mg/kg s DMARD-om iznosila je 5,3 infekcije na 100 bolesnik-godina izloženosti u usporedbi s 3,9 infekcija na 100 bolesnik-godina izloženosti u skupini koja je primala placebo i DMARD.
English: RoActemra is used for children aged 2 years and over who have active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Croatian: · RoActemra se koristi za liječenje djece sa sJIA. RoActemra se koristi za djecu u dobi od 2 ili više godina koja imaju aktivni sistemski juvenilni idiopatski artritis (sJIA), upalnu bolest koja uzrokuje bol i natečenost jednog ili više zglobova te vrućicu i osip.
English: In 6-month controlled clinical studies, the rate of serious infections with tocilizumab 8 mg/kg plus DMARDs was 5.3 events per 100 patient years exposure compared to 3.9 events per 100 patient years exposure in the placebo plus DMARD group.
Croatian: 6-mjesečnim kontroliranim kliničkim ispitivanjima, stopa ozbiljnih infekcija uz tocilizumab u dozi od 8 mg/kg s DMARD-om iznosila je 5,3 infekcije na 100 bolesnik-godina izloženosti u usporedbi s 3,9 infekcija na 100 bolesnik-godina izloženosti u skupini koja je primala placebo i DMARD.
English: The corresponding frequency category is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Croatian: Odgovarajuća kategorija učestalosti za svaku nuspojavu definirana je kako slijedi: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) ili vrlo rijetko (< 1/10 000).
English: The effects of tocilizumab on C-reactive protein (CRP), neutrophils and signs and symptoms of infection should be considered when evaluating a patient for a potential infection.
Croatian: Tijekom pregleda bolesnika na eventualnu infekciju, treba uzeti u obzir učinke tocilizumaba na C-reaktivni protein (CRP), neutrofile te znakove i simptome infekcije.
English: RoActemra 162 mg solution for injection in pre-filled syringe Tocilizumab
Croatian: RoActemra 162 mg otopina za injekciju u napunjenoj brizgalici tocilizumab
English: Max
Croatian: Min - Max
English: The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 140 sJIA patients treated with 8 mg/kg IV every 2 weeks (patients with a body weight ≥ 30 kg ) 12 mg/kg IV every 2 weeks (patients with a body weight < 30 kg), 162 mg SC every week (patients weighing ≥ 30 kg), 162 mg SC every 10 days or every 2 weeks (patients weighing below 30 kg).
Croatian: Farmakokinetika tocilizumaba odredila se populacijskom farmakokinetičkom analizom iz baze podataka koja se sastojala od 140 bolesnika oboljelih od sJIA koji su primali 8 mg/kg intravenski svaka 2 tjedna (bolesnici tjelesne težine ≥ 30 kg), 12 mg/kg intravenski svaka 2 tjedna (bolesnici tjelesne težine < 30 kg), 162 mg supkutano svaki tjedan (bolesnici tjelesne težine ≥ 30 kg) odnosno 162 mg supkutano svakih 10 dana ili svaka 2 tjedna (bolesnici tjelesne težine < 30 kg).
English: At the start, your doctor or nurse may inject RoActemra (ACTPen®).
Croatian: U početku će Vam lijek RoActemra (ACTPen®)
English: • If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled syringe) once every week
Croatian: · Ako bolesnik teži 30 kg ili više: doza iznosi 162 mg (sadržaj 1 napunjene štrcaljke) jedanput svaki tjedan
English: • If a dose is missed within 7 days, inject a dose as soon as you remember and give the next dose at the regular scheduled time.
Croatian: · Ako propustite dozu i ako je od propuštanja prošlo manje od 7 dana, injicirajte lijek čim se sjetite, a sljedeću dozu primijenite prema uobičajenom rasporedu.
English: The recommended posology in patients above 1 year of age is subcutaneous 162 mg once every week in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 2 weeks in patients weighing less than 30 kg.
Croatian: Preporučena doza kod bolesnika starijih od 1 godine je 162 mg supkutano jedanput svaki tjedan za bolesnike koji teže 30 kg ili više, odnosno 162 mg supkutano jedanput svaka 2 tjedna za bolesnike koji teže manje od 30 kg.
English: When platelet count > 100 x 103/ μL resume RoActemra dosing every other week and increase to every week injection as clinically appropriate.
Croatian: Privremeno prekinuti primjenu lijeka RoActemra Kad broj trombocita naraste na > 100 x 103/ μl, nastaviti s primjenom lijeka RoActemra jedanput svaka dva tjedna, a zatim povećati učestalost na jedanput tjedno, prema kliničkoj potrebi.
English: In the 6-month controlled trials decreases in platelet counts below 100 x 103/ μL occurred in 1.7% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 1% on placebo plus DMARDs.
Croatian: 6-mjesečnim kontroliranim ispitivanjima smanjenje broja trombocita na vrijednosti manju od 100 x 103/ μl nastalo je kod 1,7% bolesnika koji su primali tocilizumab u dozi od 8 mg/kg s DMARDom, u usporedbi s < 1% bolesnika koji su primali placebo s DMARD-om.
English: b Non-responder Imputation used for missing data.
Croatian: Za podatke koji nedostaju imputiran je broj bolesnika bez odgovora.
English: The safety of subcutaneous RoActemra in RA includes a double-blind, controlled, multicenter study, SC-I. SC-I was a non-inferiority study that compared the efficacy and safety of RoActemra 162 mg administered every week versus 8 mg/kg intravenous in 1262 patients with RA.
Croatian: SC-I je bilo ispitivanje neinferiornosti u kojemu su se uspoređivale djelotvornost i sigurnost lijeka RoActemra u supkutanoj dozi od 162 mg jedanput tjedno s primjenom intravenske doze od 8 mg/kg u 1262 bolesnika s RA.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU ŠTRCALJKU
English: Week 24 ACR20, n (%) ACR50, n (%) 165 (56.9)** 139 (47.6) ACR70, n (%) 112 (38.6)** Week 52 ACR20, n (%) ACR50, n (%) 162 (55.9)** 144 (49.3) ACR70, n (%) 125 (43.1)** 105 (36.0) HAQ-DI (adjusted mean change from baseline) Week 52
Croatian: 24. tjedan ACR20, n (%) 216 (74,5)* ACR50, n (%) 165 (56,9)**
English: Injection site reaction
Croatian: Reakcije na mjestu injekcije
English: The required amount of RoActemra concentrate (0.6 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag.
Croatian: Iz bočice se izvuče potrebna količina koncentrata lijeka RoActemra (0,6 ml/kg) i ubrizga u infuzijsku vrećicu od 50 ml.
English: The pre-filled syringe should not be shaken.
Croatian: Napunjena brizgalica ne smije se tresti.
English: Predicted mean ± SD PK parameters at steady-state after subcutaneous dosing in GCA
Croatian: Predviđena srednja vrijednost (± SD) farmakokinetičkih parametara u stanju dinamičke ravnoteže nakon supkutane primjene u bolesnika s GCA
English: Doses of 8 mg/kg RoActemra or placebo were given every four weeks in combination with stable DMARDs.
Croatian: Doze od 8 mg/kg lijeka RoActemra ili placeba davale su se svaka četiri tjedna u kombinaciji sa stabilnom terapijom DMARD-ovima.
English: If a pJIA patient misses a subcutaneous injection of RoActemra within 7 days of the scheduled dose, he/she should take the missed dose as soon as they remember and take the next dose at the regular scheduled time.
Croatian: Ako bolesnik s pJIA propusti supkutanu injekciju lijeka RoActemra i ako je prošlo manje od 7 dana od propuštene planirane doze, bolesnik treba primijeniti propuštenu dozu čim se sjeti, a sljedeću dozu primijeniti prema uobičajenom rasporedu.
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as tocilizumab, is introduced.
Croatian: Stoga, kad se primjenjuju lijekovi koji su snažni inhibitori citokina, kao što je tocilizumab, može doći do ponovnog porasta ekspresije CYP450.
English: The recommended posology in patients above 2 years of age is subcutaneous 162 mg once every 2 weeks in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 3 weeks in patients weighing less than 30 kg.
Croatian: Preporučena doza kod bolesnika starijih od 2 godine je 162 mg supkutano jedanput svaka 2 tjedna za bolesnike koji teže 30 kg ili više, odnosno 162 mg supkutano jedanput svaka 3 tjedna za bolesnike koji teže manje od 30 kg.
English: *τ = 2 week or 3 week for the two SC regimens
Croatian: *τ = 2 tjedna ili 3 tjedna za dva supkutana režima
English: In SC-I, a total of 625 patients treated with RoActemra 162mg weekly were tested for anti-RoActemra antibodies in the 6 month controlled period.
Croatian: Tijekom 6-mjesečnog kontroliranog razdoblja u ispitivanju SC-I, ukupno je 625 bolesnika liječenih lijekom RoActemra u dozi od 162 mg jedanput tjedno testirano na protutijela na lijek RoActemra.
English: Statistically significant improvements in haemoglobin levels were observed with RoActemra compared with DMARDs (p< 0.0001) at week 24.
Croatian: U 24. tjednu opaženo je statistički značajno poboljšanje u vrijednostima hemoglobina kod bolesnika liječenih lijekom RoActemra u usporedbi s bolesnicima liječenima DMARD lijekovima (p< 0,0001).
English: In the double-blind controlled studies 774 patients received RoActemra 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX/other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Croatian: U dvostruko slijepim kontroliranim ispitivanjima 774 bolesnika primala su lijek RoActemra u dozi od 4 mg/kg u kombinaciji s MTX-om, 1870 bolesnika primalo je tocilizumab u dozi od 8 mg/kg u kombinaciji s MTX-om/drugim DMARD-ovima, dok je njih 288 primalo tocilizumab u dozi od 8 mg/kg kao monoterapiju.
English: Interrupt RoActemra dosing
Croatian: Privremeno prekinuti primjenu lijeka RoActemra