FrancophonIA/ELRC3.0 huggingface dataset:
English: Reports of gastrointestinal perforation on tocilizumab were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Croatian: Slučajevi perforacije u probavnom sustavu pri liječenju tocilizumabom bili su u prvom redu prijavljeni kao komplikacije divertikulitisa, uključujući generalizirani purulentni peritonitis,
English: The potential for central demyelination with RoActemra is currently unknown.
Croatian: Za sada nije poznato kolika je mogućnost izazivanja demijelinizacije središnjeg živčanog sustava pri primjeni lijeka RoActemra.
English: Keep the pre-filled syringes in the outer carton to protect it from light and keep them dry.
Croatian: Napunjene štrcaljke čuvajte u vanjskoj kutiji radi zaštite od svjetlosti te ih čuvajte na suhome mjestu.
English: Studies I-V enrolled patients ≥ 18 years of age with active RA diagnosed according to the American College of Rheumatology (ACR) criteria and who had at least eight tender and six swollen joints at baseline.
Croatian: Ispitivanja I-V uključila su bolesnike u dobi od ³ 18 godina koji su imali aktivni RA dijagnosticiran prema kriterijima Američkog društva za reumatologiju ACR (engl.
English: • mouth or skin blisters
Croatian: · plikovi u ustima ili po koži · bol u želucu
English: The total clearance of RoActemra was concentration-dependent and is the sum of the linear and non-linear clearance.
Croatian: Ukupni klirens lijeka RoActemra ovisio je o koncentraciji i bio je jednak zbroju linearnog i nelinearnog klirensa.
English: Mean (SD) * p<0.0001 ** p<0.005 (threshold for significance for primary and key secondary tests of superiority) ***Descriptive p value <0.005 ****Flare: recurrence of GCA signs or symptoms and/or ESR ≥30 mm/h - Increase in the prednisone dose required Remission: absence of flare and normalization of the CRP Sustained remission: remission from week 12 to week 52 -Patients must adhere to the protocol-defined prednisone taper ¹ analysis of the time (in days) between clinical remission and first disease flare 2 p-values are determined using a Van Elteren analysis for non-parametric data § statistical analyses has not been performed
Croatian: ***opisna p-vrijednost < 0,005 ****Razbuktavanje: ponovna pojava znakova i simptoma GCA i/ili brzina sedimentacije eritrocita ≥30 mm/hpotrebno je povećanje doze prednizona
English: Each pack contains 4 pre-filled syringes with multipacks containing 12 (3 packs of 4) pre-filled syringes.
Croatian: Jedno pakiranje sadrži 4 napunjene štrcaljke, a višestruka pakiranja sadrže 12 (3 pakiranja od 4) napunjenih štrcaljki.
English: • diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
Croatian: · divertikulitis (vrućica, mučnina, proljev, zatvor, bol u trbuhu) · crvena i otečena područja u ustima · povišene masnoće u krvi (trigliceridi) · želučani vrijed
English: Hepatic impairment: No formal study of the effect of hepatic impairment on the pharmacokinetics of tocilizumab has been conducted.
Croatian: Oštećenje funkcije jetre: Nisu provedena formalna ispitivanja učinka oštećenja jetrene funkcije na farmakokinetiku tocilizumaba.
English: > 1 to 3 x ULN Modify the dose of the concomitant MTX if appropriate For persistent increases in this range, interrupt RoActemra until ALT/AST have normalized.
Croatian: > 3x do 5x GGN Ako je moguće, prilagoditi dozu istodobno primijenjenog MTX-a.
English: Storage
Croatian: Čuvanje
English: Reported serious infections were similar to those seen in RA patients with the addition of varicella and otitis media.
Croatian: Prijavljene ozbiljne infekcije bile su slične onima zabilježenima kod bolesnika s RA, uz što su još zabilježene i vodene kozice te upala srednjeg uha.
English: Eligible patients received RoActemra dosed according to body weight (BW), with patients weighing
Croatian: Bolesnici koji su ispunjavali kriterije za sudjelovanje u ispitivanju primali su lijek RoActemra u dozi određenoj prema tjelesnoj težini (TT).
English: In RA, pJIA and sJIA 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, pJIA i sJIA 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: In general, the ADRs in sJIA patients were similar in type to those seen in RA patients, see section 4.8.
Croatian: Vrsta nuspojava zabilježenih kod bolesnika sa sJIA u načelu je bila slična onima zabilježenima kod bolesnika s RA, vidjeti dio 4.8.
English: In the double-blind controlled studies, 774 patients received tocilizumab 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Croatian: U dvostruko slijepim kontroliranim kliničkim ispitivanjima, 774 bolesnika primala su tocilizumab u dozi od 4 mg/kg u kombinaciji s MTX-om, 1870 bolesnika primala su tocilizumab u dozi od 8 mg/kg u kombinaciji s MTX-om ili drugim antireumatskim lijekovima koji mijenjaju tijek bolesti (DMARD-ovi), dok je288 bolesnika primalo tocilizumab u dozi od 8 mg/kg kao monoterapiju.
English: Renal impairment:
Croatian: Česte nuspojave:
English: The primary efficacy endpoint assessed by the proportion of patients achieving steroid free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper, was met (Table 4).
Croatian: Postignuta je primarna mjera ishoda za djelotvornost, koja se ocjenjivala na temelju udjela bolesnika koji su postigli održanu remisiju bez primjene steroida u 52. tjednu uz lijek RoActemra plus 26-tjedni režim postupnog smanjivanja doze prednizona (Tablica 4).
English: Hepatic transaminase elevations During routine laboratory monitoring in the RoActemra 6-month controlled clinical trial SC-I,
Croatian: Vrijednosti lipida Prilikom rutinskog laboratorijskog praćenja u ispitivanju intravenske formulacije lijeka RoActemra
English: Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra.
Croatian: RoActemra, liječnik će provjeriti imate li znakove i simptome tuberkuloze.
English: Table 2: List of ADRs occurring in clinical trial patients with sJIA or pJIA receiving tocilizumab as monotherapy or in combination with MTX.
Croatian: Tablica 2: Popis nuspojava koje su se javile u kliničkim ispitivanjima bolesnika sa sJIA ili pJIA
English: The bioavailability for the subcutaneous formulation was 79%.
Croatian: Bioraspoloživost supkutane formulacije iznosila je
English: Hepatic impairment: No formal study of the effect of hepatic impairment on the pharmacokinetics of RoActemra has been conducted.
Croatian: Oštećenje funkcije jetre: Nisu provedena formalna ispitivanja učinka oštećenja jetrene funkcije na farmakokinetiku lijeka RoActemra.
English: See package leaflet for further information.
Croatian: Za dodatne informacije pročitati uputu o lijeku.
English: Each 4 mL vial contains 80 mg tocilizumab (20 mg/mL).
Croatian: Jedna bočica od 4 ml sadrži 80 mg tocilizumaba (20 mg/ml).
English: Following subcutaneous administration, the effective t1/2 of RoActemra in sJIA patients is up to 14 days for both the 162 mg QW and Q2W regimens during a dosing interval at steady state.
Croatian: Nakon supkutane primjene, efektivni t1/2 lijeka RoActemra kod bolesnika sa sJIA tijekom intervala doziranja u stanju dinamičke ravnoteže iznosi do 14 dana i uz režim liječenja dozom od 162 mg svaki tjedan i uz režim liječenja dozom od 162 mg svaka 2 tjedna.
English: For subcutaneous administration, the effective t1/2 is up to 13 days for 162 mg every week and 5 days for 162 mg every other week in patients with RA at steady-state.
Croatian: Nakon supkutane primjene u bolesnika s RA, efektivni t1/2 iznosi najviše 13 dana za dozu od 162 mg jedanput tjedno te 5 dana za dozu od 162 mg jedanput svaka dva tjedna.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji bubrega i mokraćnog sustava nefrolitijaza
English: In study SC-I, the mean decrease in HAQ-DI from baseline to week 24 was 0.6 on both the subcutaneous and intravenous arms.
Croatian: U ispitivanju SC-I srednja vrijednost smanjenja HAQ-DI rezultata nakon 24 tjedna u odnosu na početnu vrijednost iznosila je 0,6 i u skupini liječenoj supkutanom formulacijom i u onoj liječenoj intravenskom formulacijom.
English: NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/mL concentrate for solution for infusion Tocilizumab
Croatian: Uputa o lijeku: Informacije za korisnika RoActemra 20 mg/ml koncentrat za otopinu za infuziju tocilizumab
English: The pharmacokinetic parameters of RoActemra did not change with time.
Croatian: Farmakokinetički parametri lijeka RoActemra nisu se mijenjali s vremenom.
English: In general, the safety profile observed in patients with pJIA was consistent with the known safety profile of RoActemra with the exception of ISRs (see Table 1).
Croatian: Sigurnosni profil opažen kod bolesnika s pJIA u načelu je odgovarao poznatom sigurnosnom profilu lijeka RoActemra, uz izuzetak reakcija na mjestu injekcije
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, 34% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dL), with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L (160 mg/dL) in the RoActemra subcutaneous weekly group.
Croatian: Tijekom rutinskog laboratorijskog praćenja u 12-mjesečnom kontroliranom kliničkom ispitivanju lijeka RoActemra, u 34% bolesnika koji su primali lijek RoActemra supkutano jednom tjedno zabilježeno je trajno povišenje razine ukupnog kolesterola > 6,2 mmol/l (240 mg/dl), pri čemu je u
English: The pharmacokinetics of RoActemra were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg RoActemra every 4 weeks for 24 weeks or with 162 mg RoActemra given subcutaneously either once a week or every other week for 24 weeks.
Croatian: Farmakokinetika lijeka RoActemra odredila se populacijskom farmakokinetičkom analizom iz baze podataka koja se sastojala od 3552 bolesnika s RA liječenih jednosatnom infuzijom lijeka RoActemra u dozi od 4 ili 8 mg/kg svaka 4 tjedna tijekom razdoblja od 24 tjedna ili sa 162 mg lijeka RoActemra primijenjenog supkutano jednom tjedno ili svaki drugi tjedan tijekom razdoblja od 24 tjedna.
English: If a patient misses a subcutaneous injection of RoActemra by more than 7 days of the scheduled dose or is unsure when to inject RoActemra, call the doctor or pharmacist.
Croatian: RoActemra, a prošlo je više od 7 dana od propuštene planirane doze, ili ako bolesnik nije siguran kada treba injicirati lijek RoActemra, treba se obratiti liječniku ili ljekarniku.
English: In the tocilizumab group, the events included, but were not limited to rash, urticaria, diarrhea, epigastric discomfort, arthralgia and headache.
Croatian: Reakcije u skupini koja je primala tocilizumab obuhvaćale su, uz ostalo, osip, urtikariju, proljev, nelagodu u epigastriju, artralgiju i glavobolju.
English: Forty (80%) of these patients had an increase in their haemoglobin to within the normal range at week 12, in comparison to 2 out of 29 (7%) of placebo treated patients with haemoglobin < LLN at baseline (p<0.0001).
Croatian: 29 (7%) bolesnika s početnom razinom hemoglobina ispod donje granice normale koji su primali placebo (p<0,0001).
English: • Hold the RoACTEMRA pre-filled pen firmly with one hand.
Croatian: 3. korak: Injicirajte lijek RoACTEMRA · Čvrsto držite RoACTEMRA napunjenu brizgalicu u jednoj ruci.
English: Modify the dose of the concomitant MTX if appropriate Interrupt RoActemra dosing until < 3x ULN and follow recommendations above for >1 to 3x ULN
Croatian: Privremeno prekinuti primjenu lijeka RoActemra dok vrijednost ne padne na < 3 x GGN, a zatim slijediti gore navedene preporuke za vrijednost > 1 do 3 x GGN.
English: The effects of RoActemra 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 lijeka RoActemra na C-reaktivni protein (CRP), neutrofile te znakove i simptome infekcije.
English: The decision to discontinue RoActemra in sJIA or pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.
Croatian: Odluka o prekidu primjene lijeka RoActemra u bolesnika sa sJIA ili pJIA u slučaju poremećaja laboratorijskih nalaza mora se temeljiti na medicinskoj procjeni svakog bolesnika pojedinačno.
English: Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA, pJIA or GCA.
Croatian: Nema još dovoljno kliničkog iskustva o primjeni lijeka RoActemra s drugim biološkim lijekovima za liječenje RA, sJIA, pJIA ili GCA pa se takva primjena ne preporučuje.
English: In clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Croatian: reaktivnog proteina (CRP), brzine sedimentacije eritrocita (SE), serumskog amiloida A (SAA) i fibrinogena.
English: Four (2.5%) patients in the RoActemra arm and two (1.2%) patients in the adalimumab arm experienced CTC grade 3 or 4 neutrophil count decreases.
Croatian: bolesnika u skupini koja je primala lijek RoActemra te kod dva (1,2%) bolesnika koja su primala adalimumab primijećen je smanjen broj neutrofila stupnja 3 ili 4 prema CTC-u.
English: The total patient years duration in the RoActemra all exposure population was 138.5 patient years during the 12 month double blind, placebo controlled phase of the study.
Croatian: Ukupno trajanje izloženosti u cjelokupnoj populaciji izloženoj lijeku RoActemra iznosilo je 138,5 bolesnik-godina tijekom
English: Doses of 4 or 8 mg/kg of tocilizumab or placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Croatian: Doze od 4 ili 8 mg/kg tocilizumaba ili placeba davale su se svaka četiri tjedna kao maskirana terapija tijekom 52 tjedna u kombinaciji sa stabilnom terapijom MTX-om (od 10 mg do 25 mg tjedno).
English: Reported serious infections, some with fatal outcome, included active tuberculosis, which may present with intrapulmonary or extrapulmonary disease, invasive pulmonary infections, including candidiasis, aspergillosis, coccidioidomycosis and pneumocystis jirovecii, pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
Croatian: neke sa smrtnim ishodom, uključivale su aktivnu tuberkulozu, koja se manifestirala u plućnom i izvanplućnom obliku, invazivne plućne infekcije, uključujući kandidijazu, aspergilozu,
English: • if you or a child patient you look after are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primijeniti lijek RoActemra · ako ste Vi ili pedijatrijski bolesnik o kojem skrbite alergični na tocilizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) · ako Vi ili pedijatrijski bolesnik o kojem skrbite imate aktivnu, tešku infekciju.
English: Each 20 mL vial contains 400 mg tocilizumab (20 mg/mL).
Croatian: Jedna bočica od 20 ml sadrži 400 mg tocilizumaba (20 mg/ml).
English: For storage conditions of the diluted medicinal product see section 6.3.
Croatian: Uvjete čuvanja razrijeđenog lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
English: • Prevention of medical errors and injection/infusion reactions
Croatian: Informativni materijal za medicinske sestre mora sadržavati sljedeće ključne elemente: · upute za sprječavanje medicinskih pogrešaka i reakcija na injekciju/infuziju
English: The pharmacokinetics of RoActemra were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg RoActemra every 4 weeks for 24 weeks or with 162 mg tocilizumab given subcutaneously either once a week or every other week for 24 weeks.
Croatian: Farmakokinetika lijeka RoActemra odredila se populacijskom farmakokinetičkom analizom iz baze podataka koja se sastojala od 3552 bolesnika s RA liječenih jednosatnom infuzijom lijeka RoActemra u dozi od 4 ili 8 mg/kg svaka 4 tjedna tijekom razdoblja od 24 tjedna ili sa 162 mg tocilizumaba primijenjenog supkutano jednom tjedno ili svaki drugi tjedan tijekom razdoblja od 24 tjedna.
English: Inject RoACTEMRA
Croatian: RoACTEMRA.
English: The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving tocilizumab (28-34%) compared to 1-12% of control patients at 24 weeks.
Croatian: Udio bolesnika koji su postigli kliničku remisiju prema DAS28 (DAS28 < 2,6) bio je značajno viši u skupini koja je primala tocilizumab
English: Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA or GCA.
Croatian: Nema još dovoljno kliničkog iskustva o primjeni lijeka RoActemra s drugim biološkim lijekovima za liječenje RA ili GCA pa se takva primjena ne preporučuje.
English: No patient developed positive antitocilizumab antibodies post baseline.
Croatian: Nijedan bolesnik nije imao pozitivan nalaz na protutijela na tocilizumab nakon početka ispitivanja.
English: Age, gender and ethnicity: Population pharmacokinetic analyses in RA and GCA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of RoActemra.
Croatian: Dob, spol i etničko porijeklo: Ispitivanja populacijske farmakokinetike kod bolesnika s RA i GCA
English: The pharmacokinetics of RoActemra in pJIA patients was characterized by a population pharmacokinetic analysis which included 237 patients who were treated with 8 mg/kg IV every 4 weeks (patients weighing ≥ 30 kg), 10 mg/kg IV every 4 weeks (patients weighing below 30 kg), 162
Croatian: Farmakokinetika lijeka RoActemra kod bolesnika s pJIA opisana je u populacijskoj farmakokinetičkoj analizi koja je obuhvatila 237 bolesnika liječenih intravenskom dozom od 8 mg/kg svaka 4 tjedna (bolesnici tjelesne težine ≥ 30 kg), intravenskom dozom od 10 mg/kg svaka 4 tjedna (bolesnici tjelesne težine manje od 30 kg), supkutanom dozom od 162 mg svaka 2 tjedna (bolesnici tjelesne težine ≥ 30 kg) ili supkutanom dozom od 162 mg svaka 3 tjedna (bolesnici tjelesne težine manje od 30 kg).
English: Of these 52 patients, 37 (71%) were naive to RoActemra and 15 (29%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Croatian: prethodno nije bilo liječeno lijekom RoActemra, dok je njih 15 (29%) prethodno primalo lijek RoActemra za intravensku primjenu te je na početku ispitivanja prešlo na supkutanu formulaciju toga lijeka.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevation in ALT/AST remained consistent with what was seen in the 6-month controlled clinical trials.
Croatian: Tijekom dvostruko slijepog kontroliranog razdoblja te tijekom dugotrajne izloženosti, obrazac i incidencija povišenja vrijednosti ALT-a/AST-a u skladu su s onim što je uočeno u 6-mjesečnim kontroliranim kliničkim ispitivanjima.
English: After IV dosing, approximately 90% of the steady-state was reached by week 8 for both the 12 mg/kg (BW < 30 kg) and 8 mg/kg Q2W (BW ≥ 30 kg) regimens.
Croatian: Nakon intravenske primjene, približno 90% stanja dinamičke ravnoteže postignuto je do 8. tjedna i uz režim liječenja dozom od 12 mg/kg svaka 2 tjedna (TT < 30 kg) i uz režim liječenja dozom od
English: • Continue to keep the needle-shield pushed in.
Croatian: Slika I · Nastavite držati zaštitni pokrov igle tako pritisnutim.
English: If the pre-filled syringe is not used within 5 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.
Croatian: Ako se napunjena štrcaljka ne upotrijebi unutar 5 minuta nakon skidanja zatvarača, morate je odložiti u neprobojan spremnik za oštre predmete te upotrijebiti novu napunjenu štrcaljku.
English: Renal impairment: No formal study of the effect of renal impairment on the pharmacokinetics of tocilizumab has been conducted.
Croatian: Oštećenje funkcije bubrega: Nisu provedena formalna ispitivanja učinka oštećenja bubrežne funkcije na farmakokinetiku tocilizumaba.
English: kg (n=25) dosed with 162 mg of RoActemra every 10 days (Q10D; n=8) or every 2 weeks (Q2W; n=17) for 52 weeks.
Croatian: Bolesnici tjelesne težine ≥ 30 kg (n=26) primali su 162 mg lijeka RoActemra svaki tjedan, dok su bolesnici tjelesne težine manje od 30 kg (n=25) primali 162 mg lijeka RoActemra svakih 10 dana (n=8) ili svaka 2 tjedna (n=17) tijekom 52 tjedna.
English: JIA ACR90 Response
Croatian: Odgovor JIA ACR30 Odgovor JIA ACR50 Odgovor JIA ACR70 Odgovor JIA ACR90
English: • Stevens-Johnson Syndrome (skin rash, which may lead to severe blistering and peeling of the skin)
Croatian: Mogu se javiti u do 1 na 1000 bolesnika · Stevens-Johnsonov sindrom (kožni osip, koji može dovesti do teških plikova i ljuštenja kože) · smrtonosne alergijske reakcije (anafilaksija [sa smrtnim ishodom]) · upala jetre (hepatitis), žutica
English: DAS28 < 2.6, n (%)
Croatian: DAS28 (DAS28 < 2,6) u 24. tjednu.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 400 mg tocilizumab.
Croatian: 1 bočica sadrži 400 mg tocilizumaba.
English: A higher frequency of pJIA patients experienced ISRs following SC RoActemra injections compared to adult RA.
Croatian: Učestalost reakcija na mjestu injekcije nakon supkutane primjene lijeka RoActemra bila je veća kod bolesnika s pJIA nego kod odraslih bolesnika s RA.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Allow the syringe to sit at room temperature outside the box for 25 to 30 minutes before use
Croatian: Prije primjene izvadite štrcaljku iz kutije i pričekajte 25-30 minuta da se ugrije na sobnu temperaturu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (WITHOUT BLUE BOX) - Multipack
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU ŠTRCALJKU (BEZ PLAVOG OKVIRA) - Višestruko pakiranje
English: Store in a refrigerator (2°C - 8°C)
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2°C - 8°C)
English: The frequency of ADRs in sJIA patients can be found in Table 2.
Croatian: Učestalost nuspojava na lijek kod bolesnika sa sJIA prikazana je u tablici 2.
English: TCZ 8 mg/kg
Croatian: 8 mg/kg.
English: NAME OF THE MEDICINAL PRODUCT RoActemra 162 mg solution for injection in pre-filled pen.
Croatian: NAZIV LIJEKA RoActemra 162 mg otopina za injekciju u napunjenoj brizgalici.
English: After the Injection
Croatian: Za intravensku infuziju nakon razrjeđivanja
English: Doses of 4 or 8 mg/kg of RoActemraor placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Croatian: Doze od 4 ili 8 mg/kg lijeka RoActemra ili placeba davale su se svaka četiri tjedna kao maskirana terapija tijekom 52 tjedna u kombinaciji sa stabilnom terapijom MTX-om (od 10 mg do 25 mg tjedno).
English: Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in pJIA patients in the tables below.
Croatian: Kod bolesnika s pJIA preporučuje se privremeni prekid primjene tocilizumaba pri poremećajima laboratorijskih nalaza prikazanima u tablicama u nastavku.
English: Chugai Pharma UK Ltd. Tel: +44 (0) 208 987 5600
Croatian: Tel: +44 (0) 208 987 5600
English: • If you weigh less than 30 kg: the dose is 12 mg for every kilogram of body weight
Croatian: · ako je tjelesna težina manja od 30 kg: doza iznosi 12 mg po svakom kilogramu tjelesne težine · ako je tjelesna težina 30 kg ili više: doza iznosi 8 mg po svakom kilogramu tjelesne težine
English: Dispose of the pre-filled pen
Croatian: Poremećaji probavnog s ustava mučnina pJIA