FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of RoActemra in sJIA patients was characterized by a population pharmacokinetic analysis which included 140 patients who were treated with 8 mg/kg IV every 2
Croatian: Farmakokinetika lijeka RoActemra u bolesnika s GCA određivala se uz pomoć populacijskog farmakokinetičkog modela na temelju analize skupa podataka prikupljenih u 149 bolesnika s GCA
English: Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3296 for at least one year; 2806 received treatment for at least 2 years and 1222 for 3 years.
Croatian: 3296 najmanje jednu godinu, 2806 najmanje 2 godine, a njih 1222 tri godine.
English: Renal impairment: No formal study of the effect of renal impairment on the pharmacokinetics of RoActemra has been conducted.
Croatian: Oštećenje funkcije bubrega: Nisu provedena formalna ispitivanja učinka oštećenja bubrežne funkcije na farmakokinetiku lijeka RoActemra.
English: pJIA Patients < 30 kg
Croatian: Bolesnici s pJIA tjelesne težine < 30 kg
English: Predicted mean ± SD PK parameters at steady-state after IV dosing in pJIA RoActemra PK Parameter
Croatian: Tablica 11. Predviđena srednja vrijednost ± SD farmakokinetičkih parametara u stanju dinamičke ravnoteže nakon intravenske primjene kod bolesnika s pJIA Farmakokinetički parametri lijeka RoActemra
English: Exploratory efficacy results showed that RoActemra SC improved all exploratory efficacy parameters including Juvenile Arthritis Disease Activity Score (JADAS)-71, for TCZ naïve patients and maintained all exploratory efficacy parameters for patients who switched from RoActemra IV to RoActemra SC treatment over the entire course of the study for patients in both body weight groups
Croatian: Rezultati eksploracijskog ispitivanja djelotvornosti pokazali su da je RoActemra u supkutanoj formulaciji poboljšala sve eksploracijske parametre djelotvornosti, uključujući rezultat za aktivnost bolesti kod juvenilnog artritisa (engl.
English: Primary Endpoint - Mean Change from baseline at Week 24 DAS28 (adjusted mean) Difference in adjusted mean (95% CI) Secondary Endpoints - Percentage of Responders at Week 24
Croatian: Primarna mjera ishoda - srednja promjena u odnosu na početne vrijednosti u 24. tjednu DAS28 (prilagođena srednja promjena)
English: Upper respiratory tract infections
Croatian: Opis odabranih nuspojava Infekcije
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of decreases in neutrophil counts 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 smanjenja broja neutrofila u skladu su s onim što je uočeno u 6-mjesečnim kontroliranim kliničkim ispitivanjima.
English: The total clearance of tocilizumab was concentrationdependent and is the sum of the linear and non-linear clearance.
Croatian: Ukupni klirens tocilizumaba ovisio je o koncentraciji i bio je jednak zbroju linearnog i nelinearnog klirensa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (WITH BLUE BOX) - Multipack
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU ŠTRCALJKU (S PLAVIM OKVIROM) - Višestruko pakiranje
English: 8 mg/kg Q2W ≥ 30 kg
Croatian: 8 mg/kg svaka 2 tjedna (TT ≥ 30 kg).
English: - to address the risk that patients using RoActemra may develop complications of diverticulitis which can become serious if not treated.
Croatian: - radi opisa rizika od razvoja komplikacija divertikulitisa kod bolesnika liječenih lijekom
English: During routine laboratory monitoring in the intravenous RoActemra study WA19977 3.4% and 10.4% of patients experienced a post-baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during the study treatment, respectively.
Croatian: U ispitivanju supkutane primjene je kod 14,3% bolesnika nakon početka liječenja zabilježeno povišenje razine LDL kolesterola na ≥ 130 mg/dl, a kod njih 12,8% povišenje razine ukupnog kolesterola na ≥ 200 mg/dl u bilo kojem trenutku tijekom liječenja ispitivanim lijekom.
English: • Infusion rate
Croatian: i.v. infuzija
English: • adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate..
Croatian: · liječenje teškog oblika aktivnog i progresivnog reumatoidnog artritisa (RA) u odraslih bolesnika koji prethodno nisu liječeni MTX-om
English: If a patient misses a subcutaneous once every 2 week injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose immediately and the next dose on the next scheduled day.
Croatian: Ako bolesnik propusti supkutanu injekciju lijeka RoActemra koja se primjenjuje svaka 2 tjedna, a prošlo je manje od 7 dana od propuštene planirane doze, treba ga uputiti da propuštenu dozu primijeni odmah, a sljedeću dozu prema uobičajenom rasporedu.
English: • Patient Information Pack
Croatian: · informativni materijal za medicinske sestre · informativni materijal za bolesnike
English: DAS28 < 2.6, n (%) 17 (10.5)
Croatian: Bolesnici s odgovorom u 52. tjednu, n (%) 7 (14%)
English: Accumulation Cmax Accumulation Cmin Accumulation Cmean or AUCτ *
Croatian: Cmax akumulacije Cmin akumulacije Cmean ili AUCτ akumulacije*
English: Roche d.o.o Tel: +385 1 47 22 333
Croatian: Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
English: Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA or pJIA.
Croatian: Nema još dovoljno kliničkog iskustva o primjeni lijeka RoActemra s drugim biološkim lijekovima za liječenje RA, sJIA i pJIA pa se takva primjena ne preporučuje.
English: Store vials in a refrigerator (2°C-8°C).
Croatian: Bočice čuvati u hladnjaku (2°C-8°C).
English: Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Croatian: Lijek ne smijete injicirati u madeže, ožiljke, modrice, niti u područja na kojima je koža bolna na dodir,
English: A colourless to slightly yellowish solution.
Croatian: Bezbojna do blijedo žućkasta otopina.
English: If the needle is not covered proceed carefully, and place the syringe into the puncture resistant container to avoid injury with the needle.
Croatian: pažljivo odložite štrcaljku u neprobojan spremnik kako biste izbjegli ozljedu iglom.
English: Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with RoActemra.
Croatian: Zbog mogućnosti nastanka anafilaktičke reakcije tijekom liječenja lijekom RoActemra, potrebno je u pripremi imati odgovarajuće lijekove za liječenje anafilaktičke reakcije.
English: Doses of 4 or 8 mg/kg tocilizumab or placebo were given every four 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 u kombinaciji sa stabilnom dozom MTX-a (od 10 mg do 25 mg tjedno).
English: mTSS
Croatian: Ltd.
English: ANC > 1 Maintain dose ANC 0.5 to
Croatian: Održavati dozu ABN 0,5 do 1 Privremeno prekinuti primjenu lijeka RoActemra
English: The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving RoActemra (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 lijek
English: months).
Croatian: ispitivanja).
English: Clear to opalescent, colourless to pale yellow solution.
Croatian: Bistra do opalescentna, bezbojna do blijedožuta otopina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/492/010
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED PEN CARTON (WITH BLUE BOX) - Multipack
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU BRIZGALICU (S PLAVIM OKVIROM) - Višestruko pakiranje
English: The decision to discontinue RoActemra in 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 s pJIA u slučaju poremećaja laboratorijskih nalaza mora se temeljiti na medicinskoj procjeni svakog bolesnika pojedinačno.
English: Secondary Endpoints
Croatian: Sekundarne mjere ishoda
English: If a patient misses a subcutaneous weekly injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose on the next scheduled day.
Croatian: Ako bolesnik sa sJIA propusti supkutanu injekciju lijeka RoActemra koja se primjenjuje jednom tjedno, a prošlo je manje od 7 dana od propuštene planirane doze, bolesnika treba uputiti da propuštenu dozu primijeni na dan sljedeće planirane doze.
English: In the 6-month controlled trials decreases in platelet counts below 100 x 103/ μL occurred in 1.7% of patients on RoActemra 8 mg/kg plus DMARDs compared to < 1% on placebo plus DMARDs.
Croatian: 100 x 103/ μl nastalo je kod 1,7% bolesnika koji su primali lijek RoActemra u dozi od 8 mg/kg s DMARD-om, u usporedbi s < 1% bolesnika koji su primali placebo s DMARD-om.
English: Accumulation Cmax Accumulation Ctrough Accumulation Cmean or AUCτ *
Croatian: Cmax akumulacije Ctrough akumulacije Cmean ili AUCτ akumulacije*
English: It is recommended that all patients particularly elderly patients, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating RoActemra therapy.
Croatian: Prije uvođenja lijeka RoActemra, preporučuje se da svi bolesnici, osobito oni starije dobi, prime sva cjepiva predviđena trenutnim smjernicama za imunizaciju.
English: Pack sizes of 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes.
Croatian: Dostupna su pakiranja s 4 napunjene štrcaljke i višestruka pakiranja s 12 (3 pakiranja od 4) napunjenih štrcaljki.
English: RoActemra should not be used during pregnancy unless clearly necessary.
Croatian: Trudnoća, dojenje i plodnost RoActemra se ne smije primjenjivati tijekom trudnoće, osim ako to nije neophodno.
English: The dose is 12 mg for every kg of body weight if you weigh less than 30 kg. RoActemra can be given alone or in combination with corticosteroids.
Croatian: Doza iznosi 12 mg po svakom kilogramu tjelesne težine ako je tjelesna težina manja od 30 kg.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 200 mg tocilizumab.
Croatian: 1 bočica sadrži 200 mg tocilizumaba.
English: In the 6-month controlled studies the rate of all infections reported with RoActemra 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: RoActemra u dozi od 8 mg/kg u kombinaciji s DMARD-om iznosila je 127 infekcija na 100 bolesnikgodina u usporedbi sa 112 infekcija na 100 bolesnik-godina u skupini koja je primala placebo i
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: · Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Primary Endpoint ****Sustained remission (Tocilizumab groups vs Placebo+26) Responders at Week 52, n (%)
Croatian: ****Održana remisija (skupine liječene tocilizumabom naspram placeba+26)
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevations in lipid parameters remained consistent with what was seen in the 6-month controlled trials.
Croatian: Tijekom dvostruko slijepog kontroliranog razdoblja te tijekom dugotrajne izloženosti, obrazac i učestalost povećanja lipidnih parametara u skladu su s onim što je uočeno u 6-mjesečnim kontroliranim kliničkim ispitivanjima.
English: For subcutaneous administration, the concentration-dependent apparent t 1/2 is up to 12 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, prividan t1/2 ovisan o koncentraciji u stanju dinamičke ravnoteže iznosi najviše 12 dana za dozu od 162 mg jedanput tjedno te 5 dana za dozu od 162 mg jedanput svaka dva tjedna.
English: NAME OF THE MEDICINAL PRODUCT RoActemra 162 mg solution for injection in pre-filled syringe Tocilizumab
Croatian: Uputa o lijeku: Informacije za korisnika RoActemra 162 mg otopina za injekciju u napunjenoj štrcaljki tocilizumab
English: ALT ≥3 x ULN occurred in 3% of patients in the RoActemra subcutaneous weekly group compared to 2% in the placebo plus 52 week prednisone taper group and none in the placebo plus 26 week prednisone taper group.
Croatian: Tijekom rutinskog laboratorijskog praćenja u 12-mjesečnom kontroliranom kliničkom ispitivanju lijeka RoActemra, porast vrijednosti ALT-a ≥ 3 x GGN zabilježen je u 3% bolesnika koji su primali lijek RoActemra supkutano jednom tjedno u usporedbi s 2% bolesnika koji su primali placebo plus 52-tjedni režim postupnog smanjivanja doze prednizona i niti jednim bolesnikom u skupini koja je primala placebo plus 26-tjedni režim postupnog smanjivanja doze prednizona.
English: A more than dose-proportional increase in the AUC and Cmin was observed for doses of 4 and 8 mg/kg every 4 weeks.
Croatian: Pri dozama od 4 i 8 mg/kg svaka 4 tjedna primijećeno je povećanje AUC-a i Cmin nešto veće od onoga proporcionalnog dozi.
English: Anaphylaxis
Croatian: Cijepljenje
English: The decision to discontinue RoActemra in sJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.
Croatian: Odluka o prekidu primjene lijeka RoActemra kod bolesnika sa sJIA u slučaju poremećaja laboratorijskih nalaza mora se temeljiti na medicinskoj procjeni svakog bolesnika pojedinačno.
English: For ALT or AST elevations > 3-5 x ULN, confirmed by repeat testing, RoActemra treatment should be interrupted.
Croatian: uključujući prekid liječenja lijekom RoActemra, na temelju vrijednosti transaminaza vidjeti dio 4.2. U slučaju povišenja vrijednosti ALT-a ili AST-a > 3-5 x iznad gornje granice normale, što se mora potvrditi ponovljenim testiranjem, liječenje lijekom RoActemra treba privremeno prekinuti.
English: The concentration-dependent non-linear clearance plays a major role at low RoActemra concentrations.
Croatian: Nelinearni klirens ovisan o koncentraciji igra glavnu ulogu pri niskim koncentracijama lijeka
English: Predicted mean ± SD PK parameters at steady-state after IV dosing in sJIA RoActemra PK Parameter
Croatian: Predviđena srednja vrijednost ± SD farmakokinetičkih parametara u stanju dinamičke ravnoteže nakon intravenske primjene kod bolesnika sa sJIA Farmakokinetički parametri lijeka RoActemra
English: Hepatic impairment
Croatian: Maligne bolesti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/492/007
English: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including RoActemra (see section 4.8, Undesirable effects).
Croatian: Kod bolesnika koji se liječe imunosupresivima, uključujući lijek RoActemra, prijavljene su ozbiljne infekcije, ponekad sa smrtnim ishodom (vidjeti dio 4.8 Nuspojave).
English: Subcutaneous
Croatian: Imunogenost
English: RoActemra 162 mg solution for injection in pre-filled pen (ACTPen®) Tocilizumab
Croatian: Uputa o lijeku: Informacije za korisnika RoActemra 162 mg otopina za injekciju u napunjenoj brizgalici (ACTPen®) tocilizumab
English: The addition of potentially hepatotoxic drugs (e.g. MTX) to RoActemra monotherapy resulted in increased frequency of these elevations.
Croatian: Aktivna bolest jetre i oštećenje jetre Liječenje lijekom RoActemra, osobito kad se RoActemra primjenjuje zajedno s MTX-om, može biti povezano s povišenjem vrijednosti jetrenih transaminaza.
English: Each vial contains 200 mg of tocilizumab* in 10 mL (20 mg/mL).
Croatian: Jedna bočica od 10 ml sadrži 200 mg tocilizumaba* (20 mg/ml).
English: Study II, a two year study with planned analyses at week 24, week 52 and week 104, evaluated 1196 patients who had an inadequate clinical response to MTX.
Croatian: Ispitivanje II, u trajanju od dvije godine s planiranim analizama u 24., 52. i 104. tjednu, uključilo je
English: A statistically significant superior treatment effect was seen in favour of tocilizumab over adalimumab in control of disease activity from baseline to week 24 for the primary endpoint of change in DAS28 and for all secondary endpoints (Table 5).
Croatian: U usporedbi s adalimumabom, liječenje tocilizumabom imalo je statistički značajan superioran učinak na kontrolu aktivnosti bolesti od početka liječenja do 24. tjedna za primarnu mjeru ishoda - promjenu vrijednosti
English: In study SC-II, at week 24 there was ACR20 of 60.9%, ACR50 of 39.8% and ACR70 of 19.7% for patients treated with RoActemra subcutaneous every other week versus placebo ACR20 of 31.5%, ACR50 of 12.3% and ACR70 of 5.0%.
Croatian: zabilježen je u njih 31,5%, odgovor ACR50 u njih 12,3%, a odgovor ACR70 u 5,0% bolesnika.
English: During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, 19% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dl), with 9% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L(160 mg/dL) on the subcutaneous weekly dose.
Croatian: u 19% bolesnika koji su primali supkutanu dozu jedanput tjedno, pri čemu je u 9% bolesnika primijećeno trajno povišenje LDL-a na ≥ 4,1 mmol/l (160 mg/dl).
English: Each vial contains 80 mg of tocilizumab* in 4 mL (20 mg/mL).
Croatian: Jedna bočica od 4 ml sadrži 80 mg tocilizumaba* (20 mg/ml).
English: Doses of 4 or 8 mg/kg RoActemra or placebo were given every four 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 u kombinaciji sa stabilnom dozom MTX-a (od 10 mg do 25 mg tjedno).
English: Each pack contains 4 pre-filled pens with multipacks containing 12 (3 packs of 4) pre-filled pens.
Croatian: Jedno pakiranje sadrži 4 napunjene brizgalice, a višestruka pakiranja sadrže 12 (3 pakiranja od 4)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/492/005
English: If the pre-filled pen is not used within 3 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled pen.
Croatian: Ako se napunjena brizgalica ne upotrijebi unutar 3 minute nakon skidanja zatvarača, morate je odložiti u neprobojan spremnik za oštre predmete te upotrijebiti novu napunjenu brizgalicu.
English: MT X
Croatian: MTX.
English: Rare side effects:
Croatian: Pomoćne tvari s poznatim učinkom:
English: • Liver enzyme abnormalities
Croatian: · Poremećene vrijednosti jetrenih enzima
English: • If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe), once every 3 weeks
Croatian: · Ako bolesnik teži manje od 30 kg: doza iznosi 162 mg (sadržaj 1 napunjene štrcaljke), jedanput svaka 3 tjedna · Ako bolesnik teži 30 kg ili više: doza iznosi 162 mg (sadržaj 1 napunjene štrcaljke), jedanput svaka 2 tjedna
English: In the 6-month controlled trials decreases in neutrophil counts below 1 x 109/ l occurred in 3.4% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 0.1% of patients on placebo plus DMARDs.
Croatian: 1 × 109/ l nastupilo je u 3,4% bolesnika koji su primali tocilizumab u dozi od 8 mg/kg s DMARD-om, u usporedbi s < 0,1% bolesnika koji su primali placebo s DMARD-om.
English: Treatment with RoActemra, particularly when administered concomitantly with MTX, may be associated with elevations in hepatic transaminases, therefore, caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment (see sections 4.2 and 4.8).
Croatian: Stoga je potreban oprez kad se donosi odluka o liječenju bolesnika s aktivnom bolešću jetre ili oštećenjem jetre (vidjeti dijelove 4.2 i 4.8).
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the tocilizumab arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Croatian: Srednje povišenje vrijednosti LDL-a u odnosu na početnu vrijednost iznosilo je 0,64 mmol/l (25 mg/dl) kod bolesnika koji su primali tocilizumab te
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial contains 80 mg tocilizumab.
Croatian: 1 bočica sadrži 80 mg tocilizumaba.
English: In the 6-month controlled trials decreases in neutrophil counts below 1 x 109/ L occurred in 3.4% of patients on RoActemra 8 mg/kg plus DMARDs compared to < 0.1% of patients on placebo plus DMARDs.
Croatian: 1 × 109/ l nastupilo je u 3,4% bolesnika koji su primali lijek RoActemra u dozi od 8 mg/kg s DMARDom, u usporedbi s < 0,1% bolesnika koji su primali placebo s DMARD-om.
English: 162 mg QW ≥ 30 kg
Croatian: ≥ 30 kg
English: During routine laboratory monitoring in the 12 week controlled phase, elevation in ALT or AST ≥ 3 x
Croatian: Tablica 6: Radiološki utvrđene srednje promjene tijekom 52 tjedna u Ispitivanju II
English: Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.
Croatian: Napunjene brizgalice čuvati u vanjskom pakiranju radi zaštite od svjetlosti i vlage.
English: In sJIA and pJIA patients, neutrophils and platelets should be monitored at the time of the second administration and thereafter according to good clinical practice (see section 4.2).
Croatian: Za preporučene prilagodbe doze na temelju ukupnog broja neutrofila i broja trombocita, vidjeti dio 4.2. Kod bolesnika sa sJIA i pJIA broj neutrofila i trombocita treba pratiti prilikom primjene druge doze, a nakon toga u skladu s dobrom kliničkom praksom (vidjeti dio 4.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/008
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/492/008
English: The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.
Croatian: 4.2 Doziranje i način primjene Liječenje trebaju započeti liječnici s iskustvom u dijagnosticiranju i liječenju RA, sJIA, pJIA ili
English: • children and adolescents, aged 2 years and over, with active polyarticular juvenile idiopathic arthritis (pJIA).
Croatian: · djece i adolescenata 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: • If you get any side effects, talk to your doctor or nurse.
Croatian: · Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: Gastrointestinal perforation
Croatian: Tablični prikaz nuspojava
English: The median time from start of CRS to first dose of tocilizumab was 3 days (range, 0-18 days).
Croatian: Medijan vremena od početka CRS-a do primjene prve doze tocilizumaba iznosio je
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/492/009
English: Statistically significant improvements in HAQ-DI scores were observed in patients treated with RoActemra compared with patients treated with DMARDs.
Croatian: Kod bolesnika liječenih lijekom RoActemra u usporedbi s bolesnicima liječenima DMARD lijekovima opaženo je statistički značajno poboljšanje HAQ-DI
English: For persistent increases > 3 x ULN, discontinue RoActemra
Croatian: U slučaju da su vrijednosti trajno povišene > 3 × iznad gornje granice normale, potpuno prekinuti primjenu lijeka RoActemra.
English: Keep the pre-filled syringe in the outer carton in order to protect from light and moisture.
Croatian: Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti i vlage.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/492/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/492/001
English: United Kingdom Roche Products Ltd. Tel: +44 (0) 1707 366000 or
Croatian: Tel: +44 (0) 1707 366000 or