FrancophonIA/ELRC3.0 huggingface dataset:
English: Drug-induced liver injury, Hepatitis, Jaundice, Very rare: Hepatic failure
Slovenian: žolčnika in žolčevodov z zdravili povzročena okvara jeter, hepatitis, zlatenica; zelo redko: odpoved jeter
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.
Slovenian: Starost, spol in etnična pripadnost: analize populacijske farmakokinetike pri bolnikih z revmatoidnim artritisom in GCA so pokazale, da starost, spol in etnična pripadnost ne vplivajo na farmakokinetiko zdravila RoActemra.
English: • RoActemra is used to treat children with sJIA.
Slovenian: • Zdravilo RoActemra se uporablja za zdravljenje otrok s sJIA.
English: No correlation between antibody development and clinical response or adverse events was observed
Slovenian: Povezave med tvorbo protiteles in kliničnim odzivom ali neželenimi dogodki ni bilo.
English: Resolution of CRS was defined as lack of fever and off vasopressors for at least 24 hours.
Slovenian: Opredelili so, da je CRS izzvenel, če vsaj 24 ur ni bilo zvišane telesne temperature in uporabe vazopresorjev.
English: RoActemra treatment must not be initiated in patients with active infections (see section 4.3).
Slovenian: Zdravljenja z zdravilom RoActemra ne smete uvesti pri bolnikih z aktivnimi okužbami (glejte poglavje 4.3).
English: • Check the pre-filled pen to make sure it is not damaged.
Slovenian: • Preverite napolnjeni injekcijski peresnik in se prepričajte, da ni poškodovan.
English: In the long-term exposure population, the overall rate of serious infections (bacterial, viral and fungal) was 4.7 events per 100 patient years.
Slovenian: V dolgoročno izpostavljeni populaciji je bil celokupni delež resnih okužb (bakterijskih, virusnih in glivičnih) 4,7 dogodka na 100 bolnik-let.
English: • Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Slovenian: • Kožno gubo je pomembno pripraviti, da zagotovite injiciranje zdravila pod kožo (v maščobno tkivo), ne pa globlje (v mišico).
English: *τ = 4 weeks for IV regimens
Slovenian: *τ = 4 tedne za intravenska režima
English: Not allowing the syringe to come to room temperature could result in an uncomfortable injection and it may be difficult to depress the plunger.
Slovenian: Če ne pustite injekcijske brizge, da se ogreje do sobne temperature, lahko to povzroči neudobno injiciranje in morda bo težko pritisniti na bat.
English: Adding RoActemra to the treatment means that steroids can be used for a shorter time, while still controlling GCA.
Slovenian: Z dodajanjem zdravila RoActemra k zdravljenju boste lahko kortikosteroide prejemali krajši čas, kljub temu pa bo gigantocelični arteriitis ostal pod nadzorom.
English: For ALT or AST elevations > 3-5 x ULN, confirmed by repeat testing, RoActemra treatment should be interrupted.
Slovenian: V primeru zvišanja ALT ali AST na > 3- do 5-kratno ZMN, ki je potrjeno s ponovnim testiranjem, je treba zdravljenje z zdravilom RoActemra prekiniti.
English: The median values of Tmax were 3 days after the RoActemra weekly dose and 4.5 days after the tocilizumab every other week dose.
Slovenian: Mediani Tmax je bil 3 dni po uporabi zdravila RoActemra vsak teden in 4,5 dni po uporabi vsak drugi teden.
English: Reported serious infections, some with fatal outcome, included pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis, bacterial arthritis.
Slovenian: Med opisanimi resnimi okužbami, od katerih so se nekatere končale tudi s smrtnim izidom, so bile pljučnica, celulitis, herpes zoster, gastroenteritis, divertikulitis, sepsa in bakterijski artritis.
English: At week 12, the proportion of tocilizumab treated patients showing a minimally clinically important improvement in the Childhood Health Assessment Questionnaire - Disability Index (defined as an individual total score decrease of ≥ 0.13) was significantly higher than in placebo treated patients, 77% versus 19% (p<0.0001).
Slovenian: Izidi, povezani s splošnim zdravstvenim stanjem in kakovostjo življenja V 12. tednu je bil delež bolnikov, zdravljenih s tocilizumabom, pri katerih je bilo vsaj minimalno klinično pomembno izboljšanje glede na vprašalnik Childhood Health Assessment QuestionaireDisability Index (definirano kot individualno zmanjšanje celokupne ocene ≥ 0,13) signifikantno večji kot pri bolnikih, ki so prejemali placebo (77 % v primerjavi z 19 %) (p < 0,0001).
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.
Slovenian: Če ste dobili večji odmerek zdravila RoActemra, kot bi smeli Ker vam bo zdravilo RoActemra dal zdravnik ali medicinska sestra, ni verjetno, da bi ga dobili preveč.
English: Supplies needed for an injection using your RoACTEMRA pre-filled pen (See Figure B):
Slovenian: Pripomočki, potrebni za injiciranje zdravila RoACTEMRA z uporabo napolnjenega injekcijskega peresnika (glejte sliko B):
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).
Slovenian: Število aktivnih sklepov se je signifikantno zmanjšalo v primerjavi z izhodiščno vrednostjo pri bolnikih, ki so prejemali tocilizumab v primerjavi z bolniki, ki so prejemali placebo (prilagojeni povprečni spremembi: -14,3 v primerjavi z -11,4; p = 0,0435).
English: The pre-filled pen requires a firm injection site to properly activate.
Slovenian: Za pravilno aktivacijo napolnjenega injekcijskega peresnika je potrebno čvrsto mesto injiciranja.
English: In the 12 week controlled phase, 4% of patients from the tocilizumab group experienced events occurring during infusion.
Slovenian: V 12-tedenski, kontrolirani fazi je 4 % bolnikov iz skupine, ki je jemala tocilizumab, imelo neželene učinke, ki so se pojavili med infundiranjem.
English: The safety profile of intravenous RoActemra in pJIA has been studied in 188 patients from 2 to 17 years of age.
Slovenian: Varnostni profil intravenske oblike zdravila RoActemra pri bolnikih s pJIA so proučevali pri 188 bolnikih, starih od 2 do 17 let.
English: pJIA Patients:
Slovenian: Bolniki s pJIA:
English: A higher incidence of infections and infestations was reported in the tocilizumab arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%).
Slovenian: O večji incidenci infekcijskih in parazitskih bolezni so poročali v skupini s tocilizumabom (48 % v primerjavi z 42 %), razlik v incidenci resnih okužb pa ni bilo (3,1 %).
English: Complications of diverticulitis
Slovenian: Zapleti divertikulitisa
English: Clinical Efficacy
Slovenian: Klinična učinkovitost
English: Children with pJIA
Slovenian: Otroci s pJIA
English: • The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, LArginine, L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections.
Slovenian: • Druge sestavine zdravila so L-histidin, L-histidinijev monoklorid monohidrat, L-arginin, Largininijev klorid, L-metionin, polisorbat 80 in voda za injekcije.
English: In healthy subjects administered tocilizumab in doses from 2 to 28 mg/kg, absolute neutrophil counts decreased to their lowest 3 to 5 days following administration.
Slovenian: Pri zdravih preiskovancih, ki so dobili tocilizumab v odmerkih od 2 do 28 mg/kg, je bilo absolutno število nevtrofilcev najmanjše 3 do 5 dni po prejemu zdravila.
English: A higher incidence of infections and infestations was reported in the RoActemra arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%).
Slovenian: O večji incidenci infekcijskih in parazitskih bolezni so poročali v skupini z zdravilom RoActemra (48 % v primerjavi z 42 %), razlik v incidenci resnih okužb pa ni bilo (3,1 %).
English: Infusion related reactions are defined as all events occurring during or within 24 hours of an infusion.
Slovenian: Reakcije, povezane z infundiranjem, so definirane kot vsi neželeni učinki, ki se pojavijo med infundiranjem ali v 24 urah po njem.
English: Visually check the syringe
Slovenian: Vizualno preglejte napolnjeno injekcijsko brizgo
English: In Part II, patients were randomized to tocilizumab (same dose received in Part I) or placebo in a 1:1 ratio, stratified by concurrent MTX use and concurrent corticosteroid use.
Slovenian: delu so bili bolniki randomizirani v skupino, ki je prejemala tocilizumab (enak odmerek kot v I. fazi) ali placebo v razmerju 1:1, stratifikacijo so naredili glede na sočasno uporabo metotreksata in kortikosteroidov.
English: Most of the patients in the RA and GCA studies population pharmacokinetic analysis had normal renal function or mild renal impairment.
Slovenian: Večina bolnikov v študijah revmatoidnega artritisa in GCA iz analize populacijske farmakokinetike je imela normalno delovanje ledvic ali blago okvaro ledvic.
English: Given its long elimination half-life (t1/2), the effect of RoActemra on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Slovenian: Glede na dolg eliminacijski razpolovni čas (t1/2) zdravila RoActemra lahko njegov učinek na aktivnost encima CYP450 traja še več tednov po koncu zdravljenja.
English: In the SC Study (WA28118), 46 of the 51 (90.2%) patients tested for anti-tocilizumab antibodies at baseline had at least one post-baseline screening assay result.
Slovenian: V študiji s subkutano obliko (WA28118) so pri 46 od 51 bolnikov (90,2 %), pri katerih so preverili protitelesa proti tocilizumabu v izhodišču, opravili vsaj en presejalni test po izhodišču.
English: After dilution, RoActemra for RA, sJIA, pJIA, and CRS patients should be administered as an intravenous infusion over 1 hour.
Slovenian: Po razredčenju je treba zdravilo RoActemra bolnikom z revmatoidnim artritisom, sJIA, pJIA in CRS dati v 1-urni intravenski infuziji.
English: Injection into muscle could cause the injection to feel uncomfortable.
Slovenian: Injiciranje v mišico lahko povzroči, da je le-to neprijetno.
English: Thereafter, neutrophils recovered towards baseline in a dose dependent manner.
Slovenian: Potem se je število nevtrofilcev povečevalo nazaj proti izhodiščni vrednosti v odvisnosti od odmerka.
English: Manufacturer Roche Pharma AG Emil-Barell-Str. 1
Slovenian: Roche Pharma AG Emil-Barell-Str. 1
English: Study III OPTION
Slovenian: Študija III
English: • low counts for white blood cells, red blood cells and platelets in blood tests.
Slovenian: • nizke vrednosti belih krvnih celic, rdečih krvnih celic in trombocitov v krvi, • odpoved jeter.
English: For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended (see section 5.2).
Slovenian: Za posameznike, ki tehtajo več kot 100 kg, odmerki, ki presegajo 800 mg na infuzijo, niso priporočljivi (glejte poglavje 5.2).
English: Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label RoActemra 8 mg/kg in year 2.
Slovenian: Od bolnikov, ki so zaključili študijo, in ki so bili na začetku randomizirani v skupino s placebom ter metotreksatom, jih je 86 % prejemalo odprto zdravljenje z zdravilom RoActemra 8 mg/kg v 2. letu.
English: • Keep out of the reach of children.
Slovenian: • Shranjujte nedosegljivo otrokom.
English: Age, gender and ethnicity: Population pharmacokinetic analyses in RA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of tocilizumab.
Slovenian: Starost, spol in etnična pripadnost: analize populacijske farmakokinetike pri bolnikih z revmatoidnim artritisom so pokazale, da starost, spol in etnična pripadnost ne vplivajo na farmakokinetiko tocilizumaba.
English: You should not stop using RoActemra without discussing with your doctor first.
Slovenian: Zdravila RoActemra ne smete nehati uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
English: RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Slovenian: Zdravilo RoActemra je v kombinaciji z metotreksatom indicirano za zdravljenje juvenilnega idiopatskega poliartritisa (pJIA; s pozitivnim ali negativnim revmatoidnim faktorjem in razširjenim oligoartritisom) pri bolnikih, starih 2 leti ali več, ki se niso zadostno odzvali na predhodno zdravljenje z metotreksatom.
English: • Open the box, and remove 1 single-use RoACTEMRA pre-filled pen from the box.
Slovenian: • Odprite škatlo in vzemite iz nje en napolnjeni injekcijski peresnik z zdravilom RoACTEMRA za enkratno uporabo.
English: RoActemra subcutaneous formulation is not intended to be given to children with sJIA weighing less than 10 kg.
Slovenian: Subkutana oblika zdravila RoActemra ni namenjena dajanju otrokom s sJIA, ki tehtajo manj kot 10 kg.
English: The safety profile of subcutaneous RoActemra was evaluated in 51 paediatric patients (1 to 17 years of age) with sJIA.
Slovenian: Varnostni profil subkutane oblike zdravila RoActemra je bil ovrednoten pri 51 pediatričnih bolnikih (starih od 1 do 17 let) s sJIA.
English: The excretion of tocilizumab in milk has not been studied in animals.
Slovenian: Izločanje tocilizumaba v mleko pri živalih ni raziskano.
English: Based on the current characterization of PK, RoActemra trough concentration at steady state are 50% higher in this population relative to average concentrations in a large dataset from the RA population.
Slovenian: Na podlagi trenutno opredeljene farmakokinetike je v tej populaciji v stanju dinamičnega ravnovesja opazna za 50 % večja najmanjša koncentracija zdravila RoActemra pred naslednjim odmerkom v primerjavi s povprečno koncentracijo v velikem naboru podatkov populacije z revmatoidnim artritisom.
English: The Patient Information Pack should contain the following key elements:
Slovenian: Izobraževalno gradivo za bolnike mora vključevati naslednje ključne elemente:
English: The usual dose of RoActemra is 8 mg per kg of body weight.
Slovenian: Običajni odmerek zdravila RoActemra je 8 mg na kg telesne mase.
English: Both study treatments induced the same pattern of changes in laboratory safety parameters (decreases in neutrophil and platelet counts, increases in ALT, AST and lipids), however, the magnitude of change and the frequency of marked abnormalities was higher with tocilizumab compared with adalimumab.
Slovenian: Pri obeh študijskih zdravljenjih so se pojavili enaki vzorci sprememb laboratorijskih varnostnih parametrov (zmanjšanje števila nevtrofilcev in trombocitov, zvišanje ALT, AST in lipidov), vendar pa je bila pri tocilizumabu v primerjavi z adalimumabom magnituda spremembe in pogostnost izraženih nepravilnosti večja.
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%.
Slovenian: V študiji SC-II je bil ACR 20 60,9 %, ACR 50 39,8 % in ACR 70 19,7 % za bolnike, zdravljene z zdravilom RoActemra subkutano vsak drug teden v primerjavi s placebom ACR 20 31,5 %, ACR 50
English: List of ADRs occurring in patients with RA receiving tocilizumab as monotherapy or in combination with MTX or other DMARDs in the double-blind controlled period or during postmarketing experience
Slovenian: Seznam neželenih učinkov pri bolnikih z revmatoidnim artritisom, zdravljenih s tocilizumabom v monoterapiji ali v kombinaciji z metotreksatom ali drugimi imunomodulirajočimi antirevmatičnimi zdravili v obdobju dvojno slepe kontrole ali v obdobju po prihodu zdravila na trg
English: Reducing the steroid dose can also lead to a flare-up of the GCA.
Slovenian: Prav tako lahko zmanjšanje odmerka kortikosteroida povzroči poslabšanje gigantoceličnega arteriitisa.
English: Tocilizumab versus adalimumab in monotherapy
Slovenian: Tocilizumab v primerjavi z adalimumabom v monoterapiji
English: Tocilizumab AUC, Cmin and Cmax increased with increase of body weight.
Slovenian: AUC, Cmin in Cmax tocilizumaba so se zvečale s povečanjem telesne mase.
English: This medicine contains 26.55 mg sodium per maximum dose of 1200 mg. Take this into account if you are on a low-sodium diet.
Slovenian: Zdravilo RoActemra vsebuje natrij To zdravilo vsebuje 26,55 mg natrija na največji odmerek 1200 mg. Upoštevajte ta podatek, če potrebujete prehrano z nizko količino natrija.
English: L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, LMethionine, Polysorbate 80, Water for injections.
Slovenian: L-histidin, L-histidinijev monoklorid monohidrat, L-arginin, L-argininijev klorid, L-metionin, polisorbat 80, voda za injekcije.
English: Diluted product: After dilution, the prepared solution for infusion is physically and chemically stable in sodium chloride 9 mg/mL (0.9%) solution for injection at 30ºC for 24 hours.
Slovenian: Razredčeno zdravilo: Pripravljena raztopina za infundiranje je po razredčenju v raztopini natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, pri 30 °C fizikalno in kemično stabilna 24 ur.
English: In study SC-II, mean decrease in HAQ-DI from baseline to week 24 was significantly greater for patients treated with RoActemra subcutaneous every other week (0.4) versus placebo (0.3).
Slovenian: V študiji SC-II je bilo povprečno zmanjšanje po HAQ-DI od izhodišča do 24. tedna značilno večje pri bolnikih, zdravljenih z zdravilom RoActemra subkutano vsak drugi teden (0,4) v primerjavi s placebom (0,3).
English: • benzodiazepines (e.g. temazepam), used to relieve anxiety.
Slovenian: • benzodiazepine (npr. temazepam), ki se uporabljajo za odpravljanje tesnobnosti.
English: Skin Reactions Rare reports of Stevens-Johnson Syndrome have occurred in the post marketing setting.
Slovenian: Po prihodu zdravila na trg so redko poročali o Stevens-Johnsonovem sindromu.
English: GCA is often treated with medicines called steroids.
Slovenian: Gigantocelični arteriitis se običajno zdravi z zdravili, imenovanimi kortikosteroidi.
English: Although IL-6 does not seem to be a critical cytokine for foetal growth or the immunological control of the maternal/foetal interface, a relation of this finding to tocilizumab cannot be excluded.
Slovenian: Čeprav ne kaže, da bi bil citokin IL-6 ključen za rast ploda ali imunološki nadzor stika mati-plod, povezanosti tega izsledka s tocilizumabom ni mogoče izključiti.
English: All 112 patients were tested for anti-tocilizumab antibodies at baseline.
Slovenian: Vseh 112 bolnikov so pred začetkom zdravljenja testirali na protitelesa proti tocilizumabu.
English: Consistent with the effect on acute phase reactants, treatment with RoActemra was associated with reduction in platelet count within the normal range.
Slovenian: Skladno z vplivom na reaktante akutne faze je bilo zdravljenje z zdravilom RoActemra povezano z zmanjšanjem števila trombocitov znotraj normalnega območja.
English: This data does not suggest a relevant risk for cancer initiation and progression under tocilizumab treatment.
Slovenian: Ti podatki ne kažejo, da bi med zdravljenjem s tocilizumabom obstajalo pomembno tveganje za nastanek in napredovanje raka.
English: Early removal of the needle-cap can cause the medication to dry out and block the needle.
Slovenian: Zgodnja odstranitev pokrovčka lahko povzroči izsušitev zdravila in s tem zaporo injekcijske igle.
English: • cough, chest discomfort/tightness, shortness of breath
Slovenian: • kašelj, neugoden občutek v prsnem košu/stiskanje, pomanjkanje sape,
English: Tlf: +45 - 36 39 99 99
Slovenian: Roche a/s Tlf: +45 - 36 39 99 99
English: > 5x ULN Discontinue RoActemra.
Slovenian: > 5-kratna ZMN Ukinite zdravilo RoActemra.
English: • To unlock it, press the pre-filled pen firmly against your pinched skin until the needle-shield is completely pushed in (See Figure I).
Slovenian: • Za odklepanje gumba napolnjeni injekcijski peresnik trdno pritisnite na kožno gubo, dokler zaščita za iglo ni popolnoma potisnjena na kožno gubo (glejte sliko I).
English: Table 11.
Slovenian: Preglednica 11.
English: In RA patients, neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice.
Slovenian: Pri bolnikih z revmatoidnim artritisom je treba nevtrofilce in trombocite kontrolirati od 4 do 8 tednov po začetku zdravljenja, pozneje pa v skladu s standardno klinično prakso.
English: Both study treatments induced the same pattern of changes in laboratory safety parameters (decreases in neutrophil and platelet counts, increases in ALT, AST and lipids), however, the magnitude of change and the frequency of marked abnormalities was higher with RoActemra compared with adalimumab.
Slovenian: Pri obeh študijskih zdravljenjih so se pojavili enaki vzorci sprememb laboratorijskih varnostnih parametrov (zmanjšanje števila nevtrofilcev in trombocitov, zvišanje ALT, AST in lipidov), vendar pa je bila pri zdravilu RoActemra v primerjavi z adalimumabom magnituda spremembe in pogostnost izraženih nepravilnosti večja.
English: Do not use RoActemra pre-filled pen if the box looks damaged.
Slovenian: Ne uporabljajte napolnjenega injekcijskega peresnika zdravila RoActemra, če je škatla poškodovana.
English: • Check the expiration date on the box and syringe (See Fig. A) to make sure that it has not passed (expired).
Slovenian: • Preverite rok uporabnosti na škatli in na napolnjeni injekcijski brizgi (glejte sliko A), da se prepričate, da rok uporabnosti ni pretečen.
English: One patient was tested positive for IgE isotype (0.2%).
Slovenian: Pri enem bolniku se je pojavil izotip IgE (0,2 %).
English: • children and adolescents, aged 1 year and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Slovenian: • otrok, starih 1 leto in več, in mladostnikov, ki imajo aktivni sistemski juvenilni idiopatski artritis (sJIA), vnetno bolezen, ki povzroči bolečino in otekanje enega ali več sklepov, kot tudi povišano telesno temperaturo in izpuščaj.
English: Keep track of the next dose.
Slovenian: Zabeležite naslednji odmerek.
English: • Put your used RoACTEMRA pre-filled pen and green cap in a sharps disposal container right away after use (See Figure M).
Slovenian: • Napolnjeni injekcijski peresnik zdravila RoACTEMRA in zelen pokrovček takoj po uporabi odložite v zabojnik za ostre predmete (glejte sliko M).
English: These reactions were generally observed during the second to fifth infusions of tocilizumab (see section 4.4).
Slovenian: Te reakcije so se praviloma pojavile med drugim do petim infundiranjem tocilizumaba (glejte poglavje 4.4).
English: However, a slight increase in abortion/embryonal-foetal death was observed with high systemic exposure (> 100 x human exposure) in the 50 mg/kg/day high-dose group compared to placebo and other low-dose groups.
Slovenian: Vendar pa so pri veliki sistemski izpostavljenosti (> 100-kratna izpostavljenost kot pri človeku) v visokoodmerni skupini 50 mg/kg/dan opažali rahel porast splavov oz. embrio-fetalnih smrti v primerjavi s skupino, ki je prejemala placebo in drugimi nizkoodmernimi skupinami.
English: Two hundred and fifty one (251) patients with new-onset or relapsing GCA were enrolled and assigned to one of four treatment arms.
Slovenian: Vključila je 251 bolnikov z novonastalim GCA ali ponovitvijo GCA; bolniki so bili razvrščeni v eno od štirih terapevtskih skupin.
English: In the 12 week controlled phase, the rate of all infections in the intravenous RoActemra group was 344.7 per 100 patient years and 287.0 per 100 patient years in the placebo group.
Slovenian: Okužbe V 12-tedenski, kontrolirani fazi je bil delež vseh okužb v skupini, ki je prejemala intravensko obliko zdravila RoActemra, 344,7 na 100 bolnik-let in 287,0 na 100 bolnik-let v skupini, ki je prejemala placebo.
English: HR (99% CI)
Slovenian: RO (99-% IZ)
English: • difficulty with breathing, chest tightness or light-headedness
Slovenian: • težave z dihanjem, tiščanje v prsih ali rahla vrtoglavica,