FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients had mean DAS28 at baseline of 6.7 on subcutaneous and 6.6 on placebo arms.
Croatian: Srednja početna vrijednost DAS28 iznosila je 6,7 u bolesnika liječenih supkutanom formulacijom lijeka te 6,6 u bolesnika koji su primali placebo.
English: Chugai Pharma Europe Zweigniederlassung Deutschland Tel: +49 (0) 69 663000 0
Croatian: Zweigniederlassung Deutschland Tel: +49 (0) 69 663000 0
English: RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.
Croatian: Temeljem radioloških snimaka zglobova pokazano je da RoActemra u kombinaciji s metotreksatom usporava progresiju oštećenja zglobova i poboljšava fizičku funkciju.
English: Higher scores signal improvement in both FACIT-Fatigue and EQ5D.
Croatian: Veće promjene FACIT rezultata za umor i EQ-5D rezultata ukazuju na poboljšanje.
English: Numerically greater responses compared with MTX alone were observed in the tocilizumab 8 mg/kg monotherapy group in all secondary endpoints, including radiographic endpoints.
Croatian: U usporedbi s monoterapijom MTX-om, skupina koja je primala monoterapiju tocilizumabom u dozi od 8 mg/kg postigla je brojčano veće odgovore za sve sekundarne mjere ishoda, uključujući radiološke mjere ishoda.
English: An elevation in AST > 3 ULN occurred in 1% of patients in the RoActemra subcutaneous weekly group, compared to no patients in either of the placebo plus prednisone taper groups.
Croatian: Porast vrijednosti AST-a > 3 x GGN zabilježen je u 1% bolesnika koji su primali lijek RoActemra supkutano jednom tjedno, u odnosu na niti jednog bolesnika u skupinama koje su primale placebo plus prednizon čija se doza postupno smanjivala.
English: Action
Croatian: Postupak
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on RoActemra clearance in RA patients.
Croatian: Populacijske farmakokinetičke analize nisu ukazale ni na kakav učinak MTX-a, nesteroidnih protuupalnih lijekova ili kortikosteroida na klirens lijeka RoActemra u bolesnika s RA.
English: If you forget to use RoActemra
Croatian: Ako ste zaboravili primijeniti lijek RoActemra
English: Concentrate for solution for infusion 400 mg/20 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 400 mg/20 ml
English: Part I consisted of a 16-week active tocilizumab treatment lead-in period (n=188) followed by Part II, a 24-week randomized double-blind placebo-controlled withdrawal period (n=163), followed by Part III, a 64-week open-label period.
Croatian: 24-tjedno randomizirano, dvostruko slijepo, placebom kontrolirano razdoblje izuzimanja lijeka iz liječenja (n=163) i na kraju dio III, 64-tjedno razdoblje otvorenog ispitivanja.
English: There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA 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.
English: • Slowly inject all of the medicine by gently pushing the plunger all the way down.
Croatian: · Polako injicirajte sav lijek nježno pritišćući klip sve do kraja (vidjeti Sliku F).
English: Cholesterol increased sJIA
Croatian: povišene vrijednosti kolesterola sJIA pJIA
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® 4 pre-filled pens.
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici, ACTPen® 4 napunjene brizgalice.
English: If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of RoActemra should be stopped immediately, appropriate therapy initiated and RoActemra should be permanently discontinued.
Croatian: Ako se pojavi anafilaktička reakcija ili druga ozbiljna reakcija preosjetljivosti, potrebno je odmah zaustaviti primjenu lijeka RoActemra, uvesti odgovarajuće liječenje i trajno prekinuti liječenje lijekom
English: At Week 52, the mean change in HAQ-DI was -0.58 in the tocilizumab 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 tocilizumab 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: • RoActemra can also be used to treat adults who have not had previous methotrexate treatment if they have severe, active and progressive rheumatoid arthritis.
Croatian: · RoActemra se može koristiti i za liječenje teškog oblika aktivnog i progresivnog reumatoidnog artritisa u odraslih bolesnika koji prethodno nisu bili liječeni metotreksatom.
English: During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg tocilizumab + DMARD.
Croatian: Tijekom dvostruko slijepog kontroliranog razdoblja incidencija povećanja indirektnog bilirubina iznad gornje granice normale, zabilježenog kao rutinski laboratorijski parametar, jest 6,2% kod bolesnika liječenih tocilizumabom u dozi od 8 mg/kg i DMARD-om.
English: In sJIA, pJIA and RA patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Croatian: Kod bolesnika sa sJIA, pJIA i RA vrijednosti lipida moraju se odrediti 4 do 8 tjedana nakon početka liječenja lijekom RoActemra.
English: • Hold the syringe comfortably in your hand.
Croatian: 6. korak: Injicirajte lijek · Štrcaljku držite opušteno u jednoj ruci.
English: Platelets During routine laboratory monitoring in the RoActemra 6 month clinical trial SC-I, none of the patients on the SC weekly dose had a decrease in platelet count to ≤50 × 103 / μL.
Croatian: Prilikom rutinskog laboratorijskog praćenja u 6-mjesečnom kliničkom ispitivanju lijeka RoActemra SC-I, niti u jednoga bolesnika koji je primao supkutanu dozu jedanput tjedno nije primijećeno smanjenje broja trombocita na ≤ 50 x 103/µl.
English: In GCA clinical study WA28119, similar rapid decreases in CRP and ESR were observed along with slight increases in mean corpuscular haemoglobin concentration.
Croatian: U kliničkom ispitivanju primjene kod GCA (WA28119) opažena su slična nagla smanjenja vrijednosti
English: In Study IV, RoActemra was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
Croatian: U Ispitivanju IV RoActemra se primjenjivala intravenski svaka četiri tjedna u kombinaciji s drugim DMARD-ovima i uspoređivao se s placebom u kombinaciji s drugim DMARD-ovima.
English: Step 2.
Croatian: PRILOG II.
English: RoActemra is supplied as a 0.9 mL pre-filled pen containing 162 mg tocilizumab solution for injection.
Croatian: RoActemra je dostupna u napunjenoj brizgalici od 0,9 ml koja sadrži 162 mg tocilizumaba u otopini za injekciju.
English: In SCII, 656 patients were randomized 2:1 to RoActemra subcutaneous 162 mg every other week or placebo, in combination with non-biologic DMARD(s).
Croatian: U ispitivanju SC-II, 656 bolesnika randomizirano je u omjeru 2:1 u skupinu koja je primala lijek RoActemra u supkutanoj dozi od 162 mg jedanput svaka dva tjedna ili placebo, u kombinaciji s nebiološkim DMARD-ovima.
English: Four (2.5%) patients in the tocilizumab arm and two (1.2%) patients in the adalimumab arm experienced CTC grade 3 or 4 neutrophil count decreases.
Croatian: Kod četiri (2,5%) bolesnika u skupini koja je primala tocilizumab te kod dva (1,2%) bolesnika koja su primala adalimumab primijećen je smanjen broj neutrofila stupnja 3 ili 4 prema CTC-u.
English: • adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Croatian: · odraslih bolesnika s umjerenim do teškim aktivnim oblikom autoimune bolesti koja se zove reumatoidni artritis (RA) u slučaju da prethodna liječenja nisu bila dovoljno učinkovita.
English: The key secondary efficacy endpoint also based on the proportion of patients achieving sustained remission at week 52, comparing tocilizumab plus 26 weeks prednisone taper with placebo plus 52 weeks prednisone taper, was also met (Table 4).
Croatian: Postignuta je i ključna sekundarna mjera ishoda za djelotvornost, koja se također temeljila na udjelu bolesnika koji su postigli održanu remisiju u 52. tjednu, pri čemu su se uspoređivale skupina koja je primala tocilizumab plus 26-tjedni režim postupnog smanjivanja doze prednizona i skupina koja je primala placebo plus 52-tjedni režim postupnog smanjivanja doze prednizona (Tablica 4).
English: Approximately half of the patients who developed an ANC < 1 x 109/ l did so within 8
Croatian: U približno polovice bolesnika koji su imali apsolutni broj neutrofila < 1 x 109/ l smanjenje broja nastupilo je u roku od 8
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA and/or GCA.
Croatian: Liječenje trebaju započeti liječnici s iskustvom u dijagnosticiranju i liječenju RA i/ili GCA.
English: Reduction of tocilizumab dosing frequency due to laboratory abnormalities has not been studied in sJIA or pJIA patients.
Croatian: Smanjenje učestalosti doziranja tocilizumaba zbog poremećaja laboratorijskih nalaza nije ispitano kod bolesnika sa sJIA ili pJIA.
English: Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with RoActemra during the controlled and open label clinical studies.
Croatian: Tijekom kontroliranih i otvorenih kliničkih ispitivanja, klinički značajne reakcije preosjetljivosti povezane s primjenom lijeka RoActemra koje zahtijevaju prestanak liječenja prijavljene su u ukupno 56 od 4009 bolesnika (1,4%) liječenih lijekom RoActemra.
English: • upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache,
Croatian: · infekcije gornjih dišnih putova s tipičnim simptomima poput kašlja, začepljenog nosa, curenja iz nosa, grlobolje ili glavobolje · povišena razina masnoće (kolesterola) u krvi
English: respectively.
Croatian: rezultata.
English: After IV dosing, approximately 90% of the steady-state was reached by week 12 for the 10 mg/kg (BW < 30 kg), and by week 16 for the 8 mg/kg (BW ≥ 30 kg) dose.
Croatian: Nakon intravenske primjene lijeka približno 90% stanja dinamičke ravnoteže postignuto je do 12. tjedna uz dozu od 10 mg/kg (TT < 30 kg), odnosno do 16. tjedna uz dozu od 8 mg/kg (TT ≥ 30 kg).
English: The risk of malignancy is increased in patients with RA.
Croatian: Kod bolesnika s RA povećan je rizik od razvoja maligne bolesti.
English: During routine laboratory monitoring in the RoActemra all exposure population, a decrease in neutrophil count below 1 × 109/L occurred in 15.4% of patients treated with SC RoActemra.
Croatian: Tijekom rutinskog laboratorijskog praćenja u cjelokupnoj populaciji izloženoj lijeku RoActemra, pad broja neutrofila na vrijednost ispod 1 × 109/l nastupio je kod 15,4% bolesnika liječenih lijekom
English: How to store RoActemra
Croatian: Kako čuvati lijek RoActemra
English: Immune system disorders
Croatian: Perforacije u probavnom sustavu
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION RoActemra 20 mg/mL sterile concentrate
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA RoActemra 20 mg/ml sterilni koncentrat tocilizumab i.v.
English: If you stop using RoActemra
Croatian: Ako prestanete primati lijek RoActemra
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 mL.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 162 mg tocilizumaba u 0,9 ml.
English: NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/mL concentrate for solution for infusion.
Croatian: NAZIV LIJEKA RoActemra 20 mg/ml koncentrat za otopinu za infuziju
English: In all studies, patients treated with tocilizumab 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 3).
Croatian: Klinički odgovor U svim su ispitivanjima bolesnici liječeni tocilizumabom u dozi od 8 mg/kg imali statistički značajno više stope odgovora prema kriterijima ACR 20, 50 i 70 nakon 6 mjeseci u usporedbi s kontrolnim ispitanicima (Tablica 3).
English: Endocrine disorders
Croatian: Endokrini poremećaji hipotireoza
English: The safety observed in the tocilizumab arm was consistent with the known safety profile of tocilizumab and no new or unexpected adverse drug reactions were observed (see Table 1).
Croatian: Sigurnost primijećena u skupini koja je primala tocilizumab bila je u skladu s poznatim sigurnosnim profilom tocilizumaba pa nisu primijećene nove niti neočekivane nuspojave na primjenu lijeka (vidjeti tablicu 1).
English: At week 24, a significant reduction in DAS28 from baseline of 3.1 was observed on subcutaneous and 1.7 on placebo arm, and for DAS28 < 2.6, 32.0% was observed on subcutaneous and 4.0% on placebo arm.
Croatian: Nakon 24 tjedna u bolesnika liječenih supkutanom formulacijom zabilježeno je značajno smanjenje vrijednosti DAS28 za 3,1 u odnosu na početnu vrijednost, a za 1,7 u bolesnika koji su primali placebo, dok je vrijednost DAS28 < 2,6 primijećena u 32,0% bolesnika liječenih supkutanom formulacijom te u 4,0% bolesnika koji su primali placebo.
English: The most common events occurring during infusion were headache, nausea and hypotension and within 24 hours of infusion were dizziness and hypotension.
Croatian: mučnina i hipotenzija, a unutar 24 sata nakon infuzije omaglica i hipotenzija.
English: The total content (0.9 mL) of the pre-filled pen should be administered as a subcutaneous injection.
Croatian: Potrebno je primijeniti ukupan sadržaj (0,9 ml) napunjene brizgalice supkutanom injekcijom.
English: At steady-state, predicted AUC and Cmin were 3.2 and 30 fold higher at 8 mg/kg as compared to 4 mg/kg, respectively.
Croatian: U stanju dinamičke ravnoteže, očekivani AUC bio je 3,2 puta veći pri dozi od 8 mg/kg nego pri dozi od 4 mg/kg, dok je Cmin bio 30 puta veći.
English: In general, side effects in sJIA patients were of a similar type to those in adults with RA.
Croatian: Nuspojave kod bolesnika sa sJIA u načelu su slična onima kod odraslih s RA.
English: Children and adolescents RoActemra subcutaneous injection is not recommended for use in children under 18 years of age.
Croatian: Ne preporučuje se primjena lijeka RoActemra za supkutanu injekciju u djece mlađe od 18 godina.
English: RoActemra will be given to you as a drip into a vein, by a doctor or a nurse.
Croatian: Lijek RoActemra dat će Vam liječnik ili medicinska sestra kapanjem (dripom) u venu.
English: In the open label extension phase, decreases in neutrophil counts below 1 x 109/l, occurred in 15% of the tocilizumab group.
Croatian: Tijekom otvorene faze produžetka ispitivanja smanjenje broja neutrofila na razinu manju od 1 x 109/l zabilježeno je u 15% bolesnika iz skupine koja je primala tocilizumab.
English: (See Fig.
Croatian: (engl.
English: • Pre-filled Syringe
Croatian: · napunjena štrcaljka
English: The mean change in HAQ-DI was maintained at Week 104 in the RoActemra 8 mg/kg plus MTX group (-0.61).
Croatian: Srednja promjena prema HAQ-DI održana je u 104. tjednu u skupini koja je primala lijek RoActemra u dozi od 8 mg/kg u kombinaciji s MTX-om (-0,61).
English: In GCA patients, the central volume of distribution was 4.09 L, the peripheral volume of distribution was 3.37 L, resulting in a volume of distribution at steady state of 7.46 L.
Croatian: U bolesnika s GCA središnji volumen distribucije iznosio je 4,09 l, a periferni volumen distribucije 3,37 l, što je dovelo do volumena distribucije u stanju dinamičke ravnoteže od 7,46 l.
English: At body weight ≥ 100 kg, the predicted mean (± SD) steadystate AUC, Cmin and Cmax of tocilizumab were 50000 ± 16800 μg•h/mL, 24.4 ± 17.5 μg/mL, and 226 ± 50.3 μg/mL, respectively, which are higher than mean exposure values for the patient population (i.e. all body weights) reported above.
Croatian: Uz tjelesnu težinu ≥ 100 kg predviđene srednje vrijednosti (± SD) AUC-a, Cmin odnosno Cmax tocilizumaba u stanju dinamičke ravnoteže bile su 50000 ± 16800 μg•sat/ml, 24,4 ± 17,5 μg/ml odnosno 226 ± 50,3 μg/ml, što je veće od srednjih vrijednosti izloženosti za populaciju bolesnika (tj sve tjelesne težine) gore navedenih.
English: In SC-II, a total of 434 patients treated with RoActemra 162mg every other week were tested for antiRoActemra antibodies in the 6 month controlled period.
Croatian: Tijekom 6-mjesečnog kontroliranog razdoblja u ispitivanju SC-II, ukupno su 434 bolesnika liječena lijekom RoActemra u dozi od 162 mg jedanput svaka dva tjedna testirana na protutijela na lijek RoActemra.
English: Do not use RoActemra
Croatian: Nemojte primijeniti lijek RoActemra
English: (See Fig. E).
Croatian: i 90°. (Vidjeti sliku E)
English: In Part 1, eligible patients ≥ 30 kg received tocilizumab at 8 mg/kg IV every 4 weeks for 4 doses.
Croatian: U dijelu I su bolesnici tjelesne težine ≥ 30 kg prikladni za liječenje primali intravenski tocilizumab u dozi od 8 mg/kg svaka 4 tjedna tijekom 4 doze.
English: The incidence of infections leading to dose interruptions was also numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (21.4%)
Croatian: Incidencija infekcija koje su dovele do prekida liječenja također je bila brojčano viša kod bolesnika tjelesne težine < 30 kg liječenih tocilizumabom u dozi od 10 mg/kg (21,4%) nego kod bolesnika tjelesne težine ≥ 30 kg liječenih tocilizumabom u dozi od 8 mg/kg (7,6%).
English: At body weight ≥ 100 kg, the predicted mean (± SD) steady state AUC, Cmin and Cmax of RoActemra were 50000 ± 16800 μg•h/mL, 24.4 ± 17.5 μg/mL, and 226 ± 50.3 μg/mL, respectively, which are higher than mean exposure values for the patient population (i.e. all body weights) reported above.
Croatian: Uz tjelesnu težinu ≥ 100 kg predviđene srednje vrijednosti (± SD) AUC-a, Cmin odnosno Cmax lijeka RoActemra u stanju dinamičke ravnoteže bile su 50000± 16800 μg•sat/ml, 24,4 ± 17,5 μg/ml odnosno 226 ± 50,3 μg/ml, što je veće od srednjih vrijednosti izloženosti za populaciju bolesnika (tj sve tjelesne težine) gore navedenih.
English: In the SC RoActemra study, the rate of infection in pJIA patients treated with SC RoActemra was comparable with pJIA patients treated with IV RoActemra.
Croatian: U ispitivanju supkutane primjene lijeka RoActemra stopa infekcija kod bolesnika s pJIA liječenih supkutanom formulacijom lijeka RoActemra bila je usporediva s onom kod bolesnika s pJIA liječenih intravenskom formulacijom lijeka RoActemra.
English: Tocilizumab-treated patients reported an improvement in all patient-reported outcomes (Health Assessment Questionnaire Disability Index - HAQ-DI), Short Form-36 and Functional Assessment of Chronic Illness Therapy questionnaires.
Croatian: Health Assessment Questionnaire Disability Index, HAQ-DI), Kratki oblik „Upitnika-36“ (SF-36 -Short form-36), i Prosudba funkcionalnog statusa liječenja kronične bolesti (engl.
English: • Throw away the needle-cap in the puncture resistant container or sharps container.
Croatian: · Zatvarač igle odložite u neprobojan spremnik ili spremnik za oštre predmete.
English: Vigilance for the timely detection of serious infection is recommended for patients receiving biological treatments for moderate to severe RA, sJIA or pJIA as signs and symptoms of acute inflammation may be lessened, associated with suppression of the acute phase reaction.
Croatian: Kod bolesnika koji primaju biološke lijekove za liječenje umjerenog do teškog oblika RA, sJIA ili pJIA preporučuje se povećan oprez kako bi se na vrijeme otkrila prisutnost ozbiljne infekcije, budući da znakovi i simptomi akutne upale mogu biti ublaženi zbog supresije reakcije akutne faze.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® Multipack: 12 (3 packs of 4) pre-filled pens.
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici, ACTPen® Višestruko pakiranje: 12 (3 pakiranja od 4) napunjenih brizgalica 162 mg/0,9 ml
English: The mean change from baseline at week 104 in total Sharp-Genant score was significantly lower for patients randomised to tocilizumab 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 tocilizumab 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: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 200 mg/10 ml
English: During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg RoActemra + DMARD.
Croatian: Tijekom dvostruko slijepog kontroliranog razdoblja incidencija povećanja indirektnog bilirubina iznad gornje granice normale, zabilježenog kao rutinski laboratorijski parametar, jest 6,2% kod bolesnika liječenih lijekom RoActemra u dozi od 8 mg/kg i DMARD-om.
English: If you are given more RoActemra than you should Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much.
Croatian: Ako primijenite više lijeka RoActemra nego što ste trebali Budući da se lijek RoActemra primjenjuje jednom napunjenom štrcaljkom, mala je vjerojatnost da ćete primiti preveliku količinu lijeka.
English: • The recommended injection sites are the front and middle of your thighs and the lower part of the abdomen below the navel (belly button) except for the five centimeter area directly around the navel.
Croatian: 4. korak: Odaberite i pripremite mjesto za injiciranje · Preporučena mjesta za injiciranje su prednji i središnji dio bedara te donji dio trbuha ispod pupka, osim područja pet centimetara oko pupka. (Vidjeti Sliku B)
English: In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Croatian: U kliničkim ispitivanjima tocilizumaba primijećena su nagla smanjenja vrijednosti C-reaktivnog proteina (CRP), brzine sedimentacije eritrocita (SE), serumskog amiloida A (SAA) i fibrinogena.
English: Once the nonlinear clearance pathway is saturated, at higher tocilizumab concentrations, clearance is mainly determined by the linear clearance.
Croatian: Kad nastupi zasićenje nelinearnog puta klirensa, što se događa pri višim koncentracijama tocilizumaba, onda je klirens uglavnom određen linearnim klirensom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION RoActemra 162 mg injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA RoActemra 162 mg injekcija tocilizumab s.c.
English: If you miss a dose of RoActemra
Croatian: Ako ste zaboravili primiti dozu lijeka RoActemra
English: After subcutaneous administration, the effective t1/2 of RoActemra in pJIA patients is up to 10 days for patients < 30 kg (162 mg SC Q3W) and up to 7 days for patients >= 30 kg (162 mg SC Q2W) during a dosing interval at steady state.
Croatian: Nakon supkutane primjene efektivni t1/2 lijeka RoActemra kod bolesnika s pJIA iznosi do 10 dana za bolesnike tjelesne težine < 30 kg (162 mg supkutano svaka 3 tjedna) te do 7 dana za bolesnike tjelesne težine ≥ 30 kg (162 mg supkutano svaka 2 tjedna) tijekom intervala doziranja u stanju dinamičke ravnoteže.
English: • If a caregiver is giving the injection, the outer area of the upper arms may also be used.
Croatian: · Ako injekciju daje skrbnik, lijek se može injicirati i u vanjski dio nadlaktice. (Vidjeti Sliku B)
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and / or GCA.
Croatian: Liječenje trebaju započeti liječnici s iskustvom u dijagnosticiranju i liječenju RA, sJIA, pJIA i/ili GCA.