FrancophonIA/ELRC3.0 huggingface dataset:
English: During the 6-month controlled trials transient elevations in ALT/AST > 3 x ULN were observed in 2.1% of patients on tocilizumab 8 mg/kg compared to 4.9% of patients on MTX and in 6.5% of patients who received 8 mg/kg tocilizumab plus DMARDs compared to 1.5% of patients on placebo plus DMARDs.
Croatian: > 3 x iznad gornje granice normale kod 2,1% bolesnika koji su primali tocilizumab u dozi od 8 mg/kg u usporedbi s 4,9% bolesnika koji su primali MTX te u 6,5% bolesnika koji su primali tocilizumab u dozi od 8 mg/kg s DMARD-om u usporedbi s 1,5% bolesnika koji su dobivali placebo s DMARD-om.
English: In the double-blind controlled studies, 774 patients received RoActemra 4 mg/kg in combination with MTX, 1870 patients received RoActemra 8 mg/kg in combination with MTX or other DMARDs and 288 patients received RoActemra 8 mg/kg monotherapy.
Croatian: U dvostruko slijepim kontroliranim kliničkim ispitivanjima, 774 bolesnika primala su lijek RoActemra u dozi od 4 mg/kg u kombinaciji s MTX-om, 1870 bolesnika primalo je lijek RoActemra u dozi od 8 mg/kg u kombinaciji s MTX-om ili nekim drugim DMARD-om, dok je 288 bolesnika primalo lijek RoActemra u dozi od 8 mg/kg kao monoterapiju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED PEN CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA NAPUNJENU BRIZGALICU
English: During the 6-month controlled trials transient elevations in ALT/AST > 3 x ULN were observed in 2.1% of patients on RoActemra 8 mg/kg compared to 4.9% of patients on MTX and in 6.5% of patients who received 8 mg/kg RoActemra plus DMARDs compared to 1.5% of patients on placebo plus DMARDs.
Croatian: > 3 x iznad gornje granice normale kod 2,1% bolesnika koji su primali lijek RoActemra u dozi od 8 mg/kg u usporedbi s 4,9% bolesnika koji su primali MTX te u 6,5% bolesnika koji su primali lijek RoActemra u dozi od 8 mg/kg s DMARD-om u usporedbi s 1,5% bolesnika koji su dobivali placebo s DMARD-om.
English: Haemoglobin levels
Croatian: Vrijednost hemoglobina
English: 12 mg/kg Q2W below 30 kg
Croatian: 12 mg/kg svaka 2 tjedna manje od 30 kg
English: If you miss your once every other weekly 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 dva tjedna i ako je od propuštanja prošlo manje od 7 dana, injicirajte lijek čim se sjetite, a sljedeću dozu primijenite prema uobičajenom rasporedu.
English: Leukopenia, Neutropenia, Hypofibrinogenae mia
Croatian: Poremećaji krvi i limfnog sustava leukopenija, neutropenija, hipofibrinogenemija
English: The required amount of RoActemra concentrate (0.5 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 (0,5 ml/kg) i ubrizga u infuzijsku vrećicu od 50 ml.
English: Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in pJIA patients.
Croatian: Smanjenje doze tocilizumaba zbog poremećaja laboratorijskih nalaza nije ispitivano kod bolesnika s pJIA.
English: In RA patients the central volume of distribution was 3.72, the peripheral volume of distribution was 3.35 resulting in a volume of distribution at steady state of 7.07.
Croatian: Kod bolesnika s RA središnji volumen distribucije iznosio je 3,72, dok je periferni volumen distribucije iznosio 3,35, što je rezultiralo volumenom distribucije od 7,07 u stanju dinamičke ravnoteže.
English: ANC 0.5 to 1 Interrupt RoActemra dosing When ANC increases > 1 x 109/ l resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
Croatian: Privremeno prekinuti primjenu lijeka RoActemra Kad se ABN poveća > 1 x 109/ l, treba nastaviti s primjenom lijeka RoActemra u dozi od 4 mg/kg te povećavati dozu na
English: In general, the ADRs in pJIA and sJIA patients were similar in type to those seen in RA patients, see section 4.8.
Croatian: Nuspojave kod bolesnika sa pJIA i sJIA općenito su bile slične onima zabilježenima kod bolesnika s RA, vidjeti dio 4.8.
English: • Package leaflet (with instructions for use for SC)
Croatian: · Uputu za bolesnike (s uputama za primjenu supkutane formulacije lijeka) · karticu s upozorenjima za bolesnike
English: Available non-clinical data do not suggest an effect on fertility under RoActemra treatment.
Croatian: Dostupni neklinički podaci ne ukazuju ni na kakve učinke liječenja lijekom RoActemra na plodnost.
English: Interrupt RoActemra dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN
Croatian: Privremeno prekinuti primjenu lijeka RoActemra sve dok vrijednosti ne budu < 3 x iznad GGN i slijediti gore navedene preporuke za vrijednosti > 1 do 3 x iznad GGN.
English: Rash, Pruritus, Urticaria
Croatian: Poremećaji kože i potkožnog tkiva osip, pruritus, urtikarija
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 9.5 mL/h.
Croatian: Linearni klirens mjerio se kao parametar u ispitivanju populacijske farmakokinetike i iznosio je 9,5 ml/sat.
English: 4 vials of 10 mL
Croatian: 1 bočica s 10 ml 4 bočice s 10 ml
English: MTX naïve, Early RA Study VII (WA19926), a 2 year study with the planned primary analysis at week 52 evaluated 1162
Croatian: U ispitivanju VII (WA19926), 2-godišnjem ispitivanju s planiranom primarnom analizom u 52. tjednu, ocijenjena su 1162 odrasla bolesnika s umjerenim do teškim oblikom aktivnog RA u ranoj fazi
English: In paediatric patients with sJIA, the central volume of distribution was 1.87 L, the peripheral volume of distribution was 2.14 L resulting in a volume of distribution at steady state of 4.01 L
Croatian: Kod bolesnika sa sJIA centralni je volumen distribucije bio 1,87 l, a periferni volumen distribucije 2,14 l, što je rezultiralo volumenom distribucije u stanju dinamičke ravnoteže od 4,01 l.
English: Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in sJIA patients.
Croatian: Smanjenje doze tocilizumaba zbog poremećaja laboratorijskih nalaza nije ispitano kod bolesnika sa sJIA.
English: (See Fig. F).
Croatian: (vidjeti Tablicu 1).
English: During routine laboratory monitoring in the 12 week controlled phase (study WA18221), 13.4% and 33.3% of patients experienced a post-baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL
Croatian: Prilikom rutinskog laboratorijskog praćenja bolesnika tijekom 12-tjedne kontrolirane faze ispitivanja (ispitivanje WA18221), kod 13,4% bolesnika je nakon početka liječenja zabilježeno povišenje razine
English: Eligible patients received tocilizumab dosed according to body weight (BW), with patients weighing ≥30 kg (n = 25) dosed with 162 mg of RoActemra every 2 weeks (Q2W) and patients weighing below 30 kg (n = 27) dosed with 162 mg of RoActemra every 3 weeks (Q3W) for 52 weeks.
Croatian: Bolesnici tjelesne težine ≥ 30 kg (n=25) primali su 162 mg lijeka RoActemra svaka 2 tjedna, dok su bolesnici tjelesne težine manje od 30 kg (n=27) primali 162 mg lijeka RoActemra svaka 3 tjedna tijekom 52 tjedna.
English: Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation, were reported in 1 out of 112 patients (< 1%) treated with tocilizumab during the controlled and up to and including the open label clinical trial.
Croatian: Tijekom kontroliranog ispitivanja i u otvorenom dijelu kliničkog ispitivanja u 1 od 112 bolesnika (< 1%) liječenih tocilizumabom prijavljene su klinički značajne reakcije preosjetljivosti povezane s tocilizumabom, koje su zahtijevale prekid liječenja.
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of RoActemra monotherapy patients and 1.4% of RoActemra plus DMARD patients, the majority of whom were discontinued permanently from RoActemra treatment.
Croatian: Povišenje vrijednosti ALT/AST > 5 x iznad gornje granice normale bilo je primijećeno u 0,7% bolesnika na monoterapiji lijekom RoActemra i 1,4% bolesnika na terapiji lijekom RoActemra i DMARD-om; u većine tih bolesnika liječenje lijekom RoActemra trajno je prekinuto.
English: Serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, have been observed with RoActemra (see section 4.8).
Croatian: Kod liječenja lijekom RoActemra opaženo je ozbiljno oštećenje jetre uzrokovano djelovanjem lijeka, uključujući akutno zatajenje jetre, hepatitis i žuticu (vidjeti dio 4.8).
English: • If you weigh 30 kg or more: the dose is 8 mg for every kilogram of body weight The dose is calculated based on your body weight at each administration.
Croatian: · ako je tjelesna težina manja od 30 kg: doza iznosi 10 mg po svakom kilogramu tjelesne težine · ako je tjelesna težina 30 kg ili više: doza iznosi 8 mg po svakom kilogramu tjelesne težine
English: Once the non-linear clearance pathway is saturated, at higher RoActemra concentrations, clearance is mainly determined by the linear clearance.
Croatian: Kad nastupi zasićenje puta nelinearnog klirensa, što se događa pri višim koncentracijama lijeka RoActemra, onda klirens uglavnom ovisi o linearnom klirensu.
English: An elevation in ALT or AST ≥3 x ULN occurred in 9.6% and 3.8% patients treated with RoActemra SC,
Croatian: 9,6% odnosno 3,8% bolesnika liječenih supkutanom formulacijom lijeka RoActemra.
English: Certain types of vaccines should not be used while receiving RoActemra.
Croatian: Za vrijeme liječenja lijekom RoActemra ne smiju se primijeniti određene vrste cjepiva.
English: In patients with elevated ALT or AST above 5x ULN treatment is not recommended.
Croatian: Liječenje se ne preporučuje kod bolesnika kojima su vrijednosti ALT-a ili AST-a više od 5 x GGN.
English: 162 mg Q3W below 30 kg
Croatian: 162 mg svaka 3 tjedna manje od 30 kg
English: Patients should be instructed to seek medical advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with RoActemra.
Croatian: Bolesnike treba uputiti da se jave liječniku ako se tijekom ili nakon liječenja lijekom RoActemra pojave znakovi/simptomi koji bi mogli ukazivati na tuberkulozu (npr. uporan kašalj, gubitak tjelesne težine, subfebrilnost).
English: (See Fig. D) If you cannot remove the needle cap you should request the help of a caregiver or contact your healthcare provider.
Croatian: Ako ne možete skinuti zatvarač igle, zatražite pomoć skrbnika ili se obratite svom zdravstvenom radniku.
English: Results of the population PK analysis for sJIA and pJIA patients confirmed that body size is the only covariate which has an appreciable impact on the pharmacokinetics of RoActemra including elimination and absorption so that body-weight based dosing should be taken into consideration (see Tables 8 and 9).
Croatian: Rezultati populacijske farmakokinetičke analize podataka prikupljenih u bolesnika sa sJIA i pJIA potvrdili su da je veličina tijela jedina varijabla koja osjetno utječe na farmakokinetiku lijeka
English: Peripheral oedema, Hypersensitivity reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene periferni edem, reakcije preosjetljivosti
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj, dispneja
English: JIA ACR30 Response
Croatian: Pogoršanje upale na razini JIA ACR30
English: Each 10 mL vial contains 200 mg tocilizumab (20 mg/mL).
Croatian: Jedna bočica od 10 ml sadrži 200 mg tocilizumaba (20 mg/ml).
English: • Do not take the next dose until you have informed your doctor AND your doctor has told you to take the next dose if you have experienced any allergic reaction symptoms after RoActemra administration.
Croatian: nemojte primijeniti sljedeću dozu dok o tome ne obavijestite liječnika i dok Vam on ne kaže da možete primijeniti sljedeću dozu.
English: Signs and symptoms of liver toxicity These may affect up to 1 in every 1000 users
Croatian: Znakovi i simptomi toksičnosti za jetru Mogu se javiti u do 1 na 1000 bolesnika · umor · bol u trbuhu · žutica (promjena boje kože ili očiju u žuto)
English: elevation in ALT or AST ≥3 x ULN occurred in 6.5% and 1.4% of patients, respectively on the subcutaneous weekly dose.
Croatian: RoActemra SC-I, došlo je do povišenja razine ALT-a odnosno AST-a ≥ 3 x iznad gornje granice normale (GGN) u 6,5% odnosno 1,4% bolesnika koji su primali supkutanu dozu jedanput tjedno.
English: In patients not previously treated with RoActemra, initiation is not recommended in patients with an ANC below 2 x 109/L.
Croatian: Kod bolesnika koji prije nisu bili liječeni lijekom RoActemra, uvođenje lijeka RoActemra se ne preporučuje kod onih bolesnika koji imaju ABN manji od 2 x 109/l.
English: 162 mg Q2W below 30 kg
Croatian: 162 mg svaka 2 tjedna manje od 30 kg
English: Steady state was reached after 12 weeks for AUC, Cmin, and Cmax.
Croatian: Stanje dinamičke ravnoteže za AUC, Cmin i Cmax postignuto je nakon 12 tjedana.
English: RoActemra can be used alone following discontinuation of glucocorticoids.
Croatian: RoActemra se nakon prekida primjene glukokortikoida može primjenjivati u monoterapiji.
English: These decreases occurred without associated bleeding events.
Croatian: Smanjenja broja trombocita nisu bila praćena epizodama krvarenja.
English: Infusion related reaction events in sJIA patients included but were not limited to rash, urticaria, diarrhoea, epigastric discomfort, arthralgia and headache pJIA Patients
Croatian: Reakcije povezane s infuzijom kod bolesnika sa sJIA obuhvaćale su, uz ostalo, osip, urtikariju, proljev, nelagodu u epigastriju, artralgiju i glavobolju
English: Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sJIA patients in the tables below.
Croatian: Kod bolesnika sa sJIA, privremeni prekid primjene tocilizumaba preporučuje se pri poremećajima laboratorijskih nalaza prikazanima u tablicama u nastavku.
English: RoActemra should be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.
Croatian: Bolesnici s RA, sJIA, pJIA i CRS-om tjelesne težine ≥ 30 kg RoActemra se treba razrijediti sterilnom, apirogenom otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%) u aseptičkom postupku, tako da razrijeđeni lijek ima konačni volumen od 100 ml.
English: The pharmacokinetics of tocilizumab 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 tocilizumab 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 tocilizumaba odredila se populacijskom farmakokinetičkom analizom iz baze podataka koja se sastojala od 3552 bolesnika s RA liječenih jednosatnom infuzijom tocilizumaba 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: • Continue to pinch the skin while you keep the pre-filled pen in place.
Croatian: · Nemojte otpustiti nabor kože i držite brizgalicu na mjestu.
English: The safety observed in the RoActemra arm was consistent with the known safety profile of RoActemra and no new or unexpected adverse drug reactions were observed (see Table 1).
Croatian: Sigurnost primijećena u skupini koja je primala lijek RoActemra bila je u skladu s poznatim sigurnosnim profilom lijeka RoActemra pa nisu primijećene nove niti neočekivane nuspojave na primjenu lijeka (vidjeti Tablicu 1).
English: In patients not previously treated with RoActemra, initiation is not recommended in patients with an absolute neutrophil count (ANC) below 2 x 109/l.
Croatian: Kod bolesnika koji prije nisu bili liječeni lijekom RoActemra, uvođenje lijeka RoActemra se ne preporučuje kod onih bolesnika koji imaju apsolutni broj neutrofila (ABN) manji od 2 x 109/l.
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of RoActemra monotherapy patients and 1.4% of RoActemra 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 lijekom RoActemra i 1,4% bolesnika na terapiji lijekom RoActemra i DMARD-om; u većine tih bolesnika liječenje tocilizumabom je trajno prekinuto.
English: After removing the cap the injection must be started within 5 minutes to prevent the medicine from drying out and blocking the needle.
Croatian: Kada se skine zatvarač, primjena injekcije mora započeti unutar 5 minuta kako bi se spriječilo sušenje lijeka te začepljenje igle.
English: Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
Croatian: 9 mg/ml (0,9%) iz infuzijske vrećice od 100 ml, koji je jednak volumenu koncentrata lijeka RoActemra potrebnom za dozu koja se daje bolesniku.
English: Very rare: Hepatic failure
Croatian: Vrlo rijetke nuspojave
English: It is recommended that all patients, particularly sJIA and pJIA 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, a osobito bolesnici sa sJIA i pJIA, prime sva cjepiva predviđena trenutnim smjernicama za imunizaciju.
English: • Do not try to take apart the syringe at any time
Croatian: · Nikada nemojte pokušavati rastaviti štrcaljku.
English: These may affect more than 1 in every 10 users
Croatian: Mogu se javiti u više od 1 na 10 bolesnika
English: Do not fan or blow on the clean area.
Croatian: Očišćeno područje ne smijete sušiti vrućim zrakom niti puhanjem.
English: The pharmacokinetic parameters of RoActemra do not change with time.
Croatian: Farmakokinetički parametri lijeka RoActemra ne mijenjaju se s vremenom.
English: The corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000
Croatian: Odgovarajuća učestalost za svaku nuspojavu definira se sljedećim kategorijama: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10) ili manje često (≥ 1/1000 i
English: > 3 to 5 x ULN (confirmed by repeat testing, see section 4.4).
Croatian: (potvrđeno ponovljenim testiranjem, vidjeti dio 4.4).
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe Multipack: 12 (3 packs of 4) pre-filled syringes.
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj štrcaljki Višestruko pakiranje: 12 (3 pakiranja od 4) napunjenih štrcaljki 162 mg/0,9 ml
English: RoActemra has minor influence on the ability to drive and use machines (see section 4.8, dizziness).
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima RoActemra malo utječe na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8, omaglica)
English: NAME OF THE MEDICINAL PRODUCT RoActemra 162 mg solution for injection in pre-filled syringe.
Croatian: NAZIV LIJEKA RoActemra 162 mg otopina za injekciju u napunjenoj štrcaljki.
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as RoActemra, is introduced.
Croatian: Stoga, kad se primjenjuju lijekovi koji su snažni inhibitori citokina, kao što je RoActemra, može doći do ponovnog porasta ekspresije CYP450.
English: After removing the cap the injection must be started within 3 minutes to prevent the medicine from drying out and blocking the needle.
Croatian: Kada se skine zatvarač, primjena injekcije mora započeti unutar 3 minute kako bi se spriječilo sušenje lijeka te začepljenje igle.
English: Hepatobiliary disorders
Croatian: Hematološki poremećaji
English: The number of active joints was significantly reduced compared to baseline in patients receiving tocilizumab compared to placebo (adjusted mean changes of -14.3 vs -11.4, p=0.0435).
Croatian: Broj zglobova s aktivnom upalom bio je značajno manji u odnosu na početak liječenja u bolesnika liječenih tocilizumabom nego u onih koji su primali placebo (prilagođene srednje promjene -14,3
English: After removing the cap the injection must be started within 3 minutes, to prevent the medicine from drying out and blocking the needle.
Croatian: Kada se skine zatvarač, primjena injekcije mora započeti unutar 3 minute, kako bi se spriječilo sušenje lijeka te začepljenje igle.
English: Hepatic transaminase elevations
Croatian: Povišenje razine jetrenih transaminaza
English: When ANC increases > 1 x 109/ L resume RoActemra dosing every other week and increase to every week injection, as clinically appropriate.
Croatian: Privremeno prekinuti primjenu lijeka RoActemra Kad se ABN poveća > 1 x 109/ l, treba nastaviti s primjenom lijeka RoActemra jedanput svaka dva tjedna, a zatim povećati učestalost na jedanput tjedno, prema kliničkoj potrebi.
English: Read the package leaflet before use
Croatian: Prije uporabe pročitajte uputu o lijeku
English: The recommended posology in patients above 2 years of age is 8 mg/kg once every 2 weeks in patients weighing greater than or equal to 30 kg or 12 mg/kg once every 2 weeks in patients weighing less than 30 kg.
Croatian: Preporučena doza u bolesnika starijih od 2 godine je 8 mg/kg jedanput svaka 2 tjedna za bolesnike tjelesne težine 30 kg ili veće, odnosno 12 mg/kg jedanput svaka 2 tjedna za bolesnike tjelesne težine manje od 30 kg.
English: Events of diverticular perforations as complications of diverticulitis have been reported uncommonly in patients treated with RoActemra (see section 4.8).
Croatian: U bolesnika liječenih lijekom RoActemra manje su često prijavljeni slučajevi perforacija divertikula kao komplikacija divertikulitisa (vidjeti dio 4.8).
English: During routine laboratory monitoring in the Roactemra 12 month controlled clinical trial, a decrease in neutrophil count below 1 × 109/L occurred in 4% of patients in the RoActemra subcutaneous weekly group.
Croatian: Tijekom rutinskog laboratorijskog praćenja u 12-mjesečnom kontroliranom kliničkom ispitivanju lijeka RoActemra, u 4% bolesnika koji su primali lijek RoActemra supkutano jednom tjedno primijećeno je smanjenje broja neutrofila na manje od 1 x 109/l.
English: Allergic reactions during or after infusion:
Croatian: Česte: mogu se javiti u do 1 na 10 bolesnika Alergijske reakcije tijekom ili nakon infuzije:
English: The primary endpoint was the proportion of patients achieving DAS28 remission (DAS28 < 2.6) at week 24.
Croatian: Sekundarne mjere ishoda - postotak bolesnika s odgovorom u 24. tjednu (b) DAS28 < 2,6, n (%)
English: The rate of infection in sJIA patients treated with SC RoActemra was comparable to sJIA patients treated with IV RoActemra.
Croatian: Stopa infekcija kod bolesnika sa sJIA liječenih supkutanom formulacijom lijeka RoActemra bila je usporediva s onom kod bolesnika sa sJIA liječenih intravenskom formulacijom lijeka RoActemra.
English: This medicinal product contains 1.17 mmol (or 26.55 mg) sodium per maximum dose of 1200 mg. To be taken into consideration by patients on a controlled sodium diet. Doses below 1025 mg of this medicinal product contain less than 1 mmol sodium (23 mg), i.e. essentially ‘sodium free'.
Croatian: Ovaj lijek sadrži 1,17 mmol (ili 26,55 mg) natrija u maksimalnoj dozi od 1200 mg.
English: In RA patients the central volume of distribution was 3.72 L, the peripheral volume of distribution was 3.35 L resulting in a volume of distribution at steady state of 7.07 L.
Croatian: Kod bolesnika s RA središnji volumen distribucije iznosio je 3,72 l, dok je periferni volumen distribucije iznosio 3,35 l što je rezultiralo volumenom distribucije od 7,07 l u stanju dinamičke ravnoteže.