natgillin/translations-raw huggingface dataset:
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. 
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.
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%. 
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
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 
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
Reducing the steroid dose can also lead to a flare-up of the GCA. 
Prav tako lahko zmanjšanje odmerka kortikosteroida povzroči poslabšanje gigantoceličnega arteriitisa.
Tocilizumab versus adalimumab in monotherapy 
Tocilizumab v primerjavi z adalimumabom v monoterapiji
Tocilizumab AUC, Cmin and Cmax increased with increase of body weight. 
AUC, Cmin in Cmax tocilizumaba so se zvečale s povečanjem telesne mase.
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. 
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.
L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, LMethionine, Polysorbate 80, Water for injections. 
L-histidin, L-histidinijev monoklorid monohidrat, L-arginin, L-argininijev klorid, L-metionin, polisorbat 80, voda za injekcije.
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. 
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.
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). 
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).
• benzodiazepines (e.g. temazepam), used to relieve anxiety. 
• benzodiazepine (npr. temazepam), ki se uporabljajo za odpravljanje tesnobnosti.
Skin Reactions Rare reports of Stevens-Johnson Syndrome have occurred in the post marketing setting. 
Po prihodu zdravila na trg so redko poročali o Stevens-Johnsonovem sindromu.
GCA is often treated with medicines called steroids. 
Gigantocelični arteriitis se običajno zdravi z zdravili, imenovanimi kortikosteroidi.
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. 
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.
All 112 patients were tested for anti-tocilizumab antibodies at baseline. 
Vseh 112 bolnikov so pred začetkom zdravljenja testirali na protitelesa proti tocilizumabu.
Consistent with the effect on acute phase reactants, treatment with RoActemra was associated with reduction in platelet count within the normal range. 
Skladno z vplivom na reaktante akutne faze je bilo zdravljenje z zdravilom RoActemra povezano z zmanjšanjem števila trombocitov znotraj normalnega območja.
This data does not suggest a relevant risk for cancer initiation and progression under tocilizumab treatment. 
Ti podatki ne kažejo, da bi med zdravljenjem s tocilizumabom obstajalo pomembno tveganje za nastanek in napredovanje raka.
Early removal of the needle-cap can cause the medication to dry out and block the needle. 
Zgodnja odstranitev pokrovčka lahko povzroči izsušitev zdravila in s tem zaporo injekcijske igle.
• cough, chest discomfort/tightness, shortness of breath 
• kašelj, neugoden občutek v prsnem košu/stiskanje, pomanjkanje sape,
> 5x ULN Discontinue RoActemra. 
> 5-kratna ZMN Ukinite zdravilo RoActemra.
• To unlock it, press the pre-filled pen firmly against your pinched skin until the needle-shield is completely pushed in (See Figure I). 
• Za odklepanje gumba napolnjeni injekcijski peresnik trdno pritisnite na kožno gubo, dokler zaščita za iglo ni popolnoma potisnjena na kožno gubo (glejte sliko I).
Table 11. 
Preglednica 11.
In RA patients, neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice. 
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.
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. 
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.
Do not use RoActemra pre-filled pen if the box looks damaged. 
Ne uporabljajte napolnjenega injekcijskega peresnika zdravila RoActemra, če je škatla poškodovana.
• Check the expiration date on the box and syringe (See Fig. A) to make sure that it has not passed (expired). 
• Preverite rok uporabnosti na škatli in na napolnjeni injekcijski brizgi (glejte sliko A), da se prepričate, da rok uporabnosti ni pretečen.
One patient was tested positive for IgE isotype (0.2%). 
Pri enem bolniku se je pojavil izotip IgE (0,2 %).
• 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. 
• 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.
Keep track of the next dose. 
Zabeležite naslednji odmerek.
• Put your used RoACTEMRA pre-filled pen and green cap in a sharps disposal container right away after use (See Figure M). 
• Napolnjeni injekcijski peresnik zdravila RoACTEMRA in zelen pokrovček takoj po uporabi odložite v zabojnik za ostre predmete (glejte sliko M).
These reactions were generally observed during the second to fifth infusions of tocilizumab (see section 4.4). 
Te reakcije so se praviloma pojavile med drugim do petim infundiranjem tocilizumaba (glejte poglavje 4.4).
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. 
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.
Two hundred and fifty one (251) patients with new-onset or relapsing GCA were enrolled and assigned to one of four treatment arms. 
Vključila je 251 bolnikov z novonastalim GCA ali ponovitvijo GCA; bolniki so bili razvrščeni v eno od štirih terapevtskih skupin.
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. 
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.
HR (99% CI) 
RO (99-% IZ)
• difficulty with breathing, chest tightness or light-headedness 
• težave z dihanjem, tiščanje v prsih ali rahla vrtoglavica,
RoActemra is used to improve the symptoms of pJIA and can be given in combination with methotrexate or alone. 
Zdravilo RoActemra se uporablja za izboljšanje simptomov pJIA in se lahko daje v kombinaciji z metotreksatom ali samostojno.
Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS. 
Bolniki s hudim ali življenje ogrožajočim CRS imajo pogosto citopenije ali zvišane vrednosti ALT ali
List of ADRs occurring in patients treated with RoActemra MedDRA System Organ Class 
Seznam neželenih učinkov pri bolnikih, zdravljenih z zdravilom RoActemra Organski sistem po MedDRA
What RoActemra looks like and contents of the pack RoActemra is a solution for injection. 
Izgled zdravila RoActemra in vsebina pakiranja Zdravilo RoActemra je v obliki raztopine za injiciranje.
The safety and efficacy of intravenous RoActemra in children below 2 years of age has not been established. 
Varnost in učinkovitost intravenske oblike zdravila RoActemra pri otrocih, mlajših od 2 let, ni dokazana.
As recommended for other biological treatments, RA, sJIA and pJIA patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy. 
Kot velja za druga biološka zdravila, je treba bolnike z revmatoidnim artritisom, sJIA in pJIA pred začetkom zdravljenja z zdravilom RoActemra presejalno pregledati glede latentne tuberkuloze.
• If you cannot remove the green cap you should ask a caregiver for help or contact your healthcare provider. 
• Če zelenega pokrovčka ne morete odstraniti, se za pomoč obrnite na skrbnika ali zdravstvenega delavca.
Steady state was reached after 12 weeks for AUC and Cmin, and after 10 weeks for Cmax. 
Stanje dinamičnega ravnovesja je bilo za AUC in Cmin doseženo po 12 tednih, za Cmax pa po 10 tednih.
Dose adjustments due to laboratory abnormalities (see section 4.4). 
Prilagoditev odmerka zaradi nenormalnih laboratorijskih vrednosti (glejte poglavje 4.4).
At week 24, inhibition of structural damage was shown, with significantly less radiographic progression in patients receiving RoActemra subcutaneous compared to placebo (mean mTSS of 0.62 vs. 1.23, p=0.0149 (van Elteren). 
Po 24. tednih so potrdili zavrtje strukturne okvare, na rentgenskih posnetkih je bilo značilno manj znakov napredovanja bolezni v skupini, ki je subkutano prejemala zdravilo RoActemra, v primerjavi s placebom (povprečna mTSS 0,62 v primerjavi z 1,23; p = 0,0149 (van Elteren)).
Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium. 
Ena 400-mg viala vsebuje 0,39 mmol (8,85 mg) natrija.
INFORMATION IN BRAILLE Justification for not including Braille accepted 
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
In pJIA patients, infusion related reactions are defined as all events occurring during or within 24 hours of an infusion. 
Reakcije, povezane z infundiranjem, so pri bolnikih s pJIA definirane kot vsi neželeni učinki, ki se pojavijo med infundiranjem ali v 24 urah po njem.
Please also read the Patient Leaflet that comes with the RoActemra syringe for the most important information you need to know about the medicine. 
Prosimo, preberite tudi navodilo za uporabo, ki je priloženo napolnjeni injekcijski brizgi, da se seznanite z najbolj pomembnimi informacijami o zdravilu.
mTSS Erosion Score JSN 0.03 Radiographic Non-Progression n (%) (change from baseline in mTSS of ≤0) 
52. teden mTSS 0,08*** ocena erozij ocena zožitve sklepne špranje Ne-napredovanje, merjeno radiološko n (%) (sprememba od izhodišča v mTSS ≤ 0)
Neurological disorders 
Nevrološke motnje
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. 
V 24. tednu so opazili značilno znižanje DAS28 za 3,1 od izhodišča v subkutani skupini in 1,7 v skupini na placebu, DAS28 < 2,6 pa so opazili pri 32 % v subkutani skupini in 4,0 % v skupini na placebu.
The clinical data are insufficient to assess the potential incidence of malignancy following exposure to tocilizumab. 
Kliničnih podatkov za oceno možne incidence malignomov po izpostavljenosti tocilizumabu ni dovolj.
The most common ISRs were erythema, pruritus, pain, and swelling at the injection site. 
Najpogostejše reakcije na mestu injiciranja so bile eritem, srbenje, bolečina in oteklina na mestu injiciranja.
The primary endpoint for each of the five studies was the proportion of patients who achieved an ACR 20 response at week 24. 
Primarni cilj vsake od petih študij je bil delež bolnikov, ki so po 24 tednih dosegli odziv ACR 20.
These factors need to be monitored while receiving RoActemra. 
Te dejavnike je treba med zdravljenjem z zdravilom RoActemra kontrolirati.
No injection site reaction was reported as a serious adverse event or required treatment discontinuation. 
Nobena reakcija na mestu injiciranja ni bila zabeležena kot resen neželen učinek in nobena ni zahtevala prekinitve zdravljenja.
Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet, see section 6.6. 
Celotna navodila za dajanje zdravila RoActemra v napolnjeni injekcijski brizgi so navedena v navodilu za uporabo, glejte poglavje 6.6.
• RoActemra is used to treat children with pJIA. 
• Zdravilo RoActemra se uporablja tudi za zdravljenje otrok s pJIA.
• Check the expiration date on the RoACTEMRA pre-filled pen (See Figure A). 
• Preverite datum izteka roka uporabnosti na napolnjenem injekcijskem peresniku z zdravilom RoACTEMRA (glejte sliko A).
Lipid parameters 
Vrednosti lipidov
In healthy subjects administered RoActemra in doses from 2 to 28 mg/kg intravenously and 81 to 162 mg subcutaneously, absolute neutrophil counts decreased to their lowest 2 to 5 days following administration. 
Pri zdravih preiskovancih, ki so dobili tocilizumab v odmerkih od 2 do 28 mg/kg intravensko in 81 do 162 mg subkutano, je bilo absolutno število nevtrofilcev najmanjše 2 do 5 dni po prejemu zdravila.
Do not touch the needle-shield of the prefilled pen, because you may stick yourself with the needle. 
Ne dotikajte se zaščite za iglo napolnjenega injekcijskega peresnika, ker se lahko z iglo zbodete.
After week 52, all patients could receive open-label treatment with RoActemra 8 mg/kg. 
Po 52. tednu so imeli vsi bolniki možnost prejemati odprto zdravljenje z zdravilom RoActemra v odmerku 8 mg/kg.
The t1/2 of RoActemra was concentration-dependent. 
Razpolovni čas (t1/2) zdravila RoActemra je odvisen od koncentracije.
RoActemra is for subcutaneous use. 
Zdravilo RoActemra je namenjeno subkutani uporabi.
• Press the green Activation button to start the injection. 
• Za začetek injiciranja pritisnite zeleni gumb za aktivacijo.
Interrupt RoActemra dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN 
Prekinite uporabo zdravila RoActemra, dokler ni dosežena < 3-kratna ZMN in upoštevajte zgoraj navedena priporočila pri > 1- do 3-kratni ZMN.
Increases in haemoglobin levels were observed, through tocilizumab decreasing the IL-6 driven effects on hepcidin production to increase iron availability. 
Opažali so povečanje koncentracije hemoglobina, ker tocilizumab zmanjša učinke IL-6 na nastajanje hepcidina in tako poveča razpoložljivost železa.
OTHER SPECIAL WARNING(S), IF NECESSARY Allow the pre-filled pen to sit at room temperature outside the box for 45 minutes before use 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vzemite napolnjeni injekcijski peresnik iz škatle in ga pustite na sobni temperaturi 45 minut pred uporabo
At the start, your doctor or nurse may inject RoActemra (ACTPen®). 
Na začetku zdravljenja vam bo zdravnik ali medicinska sestra injicirala zdravilo RoActemra (ACTPen®).
What you need to know before you use RoActemra 
Kaj morate vedeti, preden boste uporabili zdravilo RoActemra
Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as tocilizumab, is introduced. 
Zato se lahko ekspresija CYP450 po uvedbi močnih zaviralcev citokinov, kakršen je tocilizumab, spremeni.
• Do not use if medicine is cloudy, hazy, discolored or contains particles 
• Ne uporabljajte napolnjene injekcijske brizge, če je zdravilo motno, nejasno, obarvano ali vsebuje delce.
Symptoms include headache, fatigue and jaw pain. 
Med simptomi se pojavljajo glavobol, utrujenost in bolečina v žvečnih mišicah.
• jaundice (yellow discoloration of skin or eyes) 
• bolečine v trebuhu, • zlatenica (rumeno obarvanje kože in oči).
• Do not remove the needle-cap until you are ready to inject 
• Ne odstranite pokrovčka za injekcijsko iglo, dokler niste pripravljeni za injiciranje.
The primary endpoint in the study was the difference in the proportion of patients who achieved an ACR20 response at week 24. 
Primarni cilj študije je bila razlika v deležu bolnikov, ki so v 24. tednu dosegli odziv ACR 20.
However, your doctor may decide that you may inject RoActemra yourself. 
Vaš zdravnik se lahko nato odloči, da si boste zdravilo RoActemra injicirali sami.
After removing the pre-filled pen from the refrigerator the pre-filled pen should be allowed to reach room temperature (18°C to 28°C) by waiting for 45 minutes, before injecting RoActemra. 
Po tem, ko vzamemo napolnjeni injekcijski peresnik iz hladilnika, ga pustimo 45 minut, da doseže sobno temperaturo (18 °C do 28 °C), preden zdravilo RoActemra injiciramo.
Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice. 
študiji kroničnih toksičnih učinkov pri opicah cynomolgus niso opazili učinkov na endokrino aktivnih in reproduktivnih organih in reproduktivna sposobnost miši s pomanjkanjem IL-6 ni bila prizadeta.
This was not observed in either of the placebo plus prednisone taper groups. 
Tega niso opažali v nobeni od skupin, ki sta prejemali placebo in prednizon v zmanjšujočem se odmerku.
• If you have had tuberculosis, tell your doctor. 
• Če ste kdaj imeli tuberkulozo, morate to povedati zdravniku.
One of these events, urticaria, was considered serious. 
Enega izmed teh neželenih učinkov, urtikarijo,so šteli za resnega.
If you miss a dose of RoActemra 
Če ste izpustili odmerek zdravila RoActemra
RoActemra AUC, Cmin and Cmax increased with increase of body weight. 
AUC, Cmin in Cmax zdravila RoActemra so se zvečale s povečanjem telesne mase.
Approximately 90% of the steady-state (AUCτ) was reached by week 14 in the every other weekly and week 17 in the weekly dose groups. 
Približno 90-% stanje dinamičnega ravnovesja (AUCτ) je bilo pri uporabi vsak drugi teden doseženo do 14. tedna in pri uporabi vsak teden do
RoActemra monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. 
Za zdravljenje akutnih relapsov se zdravila RoActemra v monoterapiji ne sme uporabljati, saj učinkovitost za zdravljenje le-teh ni bila dokazana.
After week 52, all patients could receive open-label treatment with tocilizumab 8 mg/kg. 
Po 52. tednu so imeli vsi bolniki možnost prejemati odprto zdravljenje s tocilizumabom v odmerku 8 mg/kg.
Patients with sJIA must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously (see section 4.2). 
Bolniki s sJIA morajo ob prejemu subkutane oblike zdravila RoActemra tehtati najmanj 10 kg (glejte poglavje 4.2).
Choose and prepare an injection site 
Izberite in pripravite mesto vboda
The long-term exposure population includes all patients who received at least one dose of tocilizumab either in the double-blind control period or open label extension phase in the studies. 
Dolgoročno izpostavljena populacija vključuje vse bolnike, ki so dobili vsaj en odmerek tocilizumaba v obdobju dvojno slepe kontrole ali pa v odprti, podaljšani fazi študij.
What you need to know before you are given RoActemra 
Kaj morate vedeti, preden boste prejeli zdravilo RoActemra
RoActemra is for single-use only. 
Zdravilo RoActemra je namenjeno samo za enkratno uporabo.
Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo + 52) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo + 52) HR (99% CI) 
Čas do prvega poslabšanja GCA¹ (bolniki z novonastalo boleznijo; skupini s tocilizumabom v primerjavi s placebom + 26) RO (99-% IZ) Čas do prvega poslabšanja GCA¹ (bolniki z novonastalo boleznijo; skupini s tocilizumabom v primerjavi s placebom + 52) RO (99-% IZ)
No impact on RoActemra exposure was noted in these patients. 
Pri teh bolnikih niso ugotovili vpliva na izpostavljenost zdravilu RoActemra.
The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids. 
Priporočeno odmerjanje je 162 mg subkutano enkrat na teden skupaj z glukokortikoidom, katerega odmerek postopoma zmanjšujemo.
At the start, your doctor or nurse may inject RoActemra. 
Na začetku zdravljenja vam bo zdravnik ali medicinska sestra injicirala zdravilo RoActemra.
Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4). 
V primeru pojava simptomov resne alergijske reakcije morajo bolniki nemudoma poiskati zdravniško pomoč (glejte poglavje 4.4).
For ALT or AST elevations > 3-5 x ULN, RoActemra treatment should be interrupted. 
V primeru zvišanja ALT ali AST na > 3- do 5-kratno ZMN je treba zdravljenje z zdravilom RoActemra prekiniti.
• cold sores (oral herpes simplex), blisters 
• pasovec (herpes zoster), • herpes (oralni herpes simpleks), mehurji,
The primary endpoint at week 24 was the proportion of patients who achieved an ACR 20 response. 
Primarni cilj v 24. tednu je bil delež bolnikov, ki so dosegli odziv ACR 20.
Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation. 
Bolnike s simptomi, ki lahko nakazujejo zaplete divertikulitisa (npr. z bolečinami v trebuhu, krvavitvijo in/ali nepojasnjeno spremembo v razporedu iztrebljanja in zvišano telesno temperaturo), je treba takoj pregledati, da bi zgodaj odkrili divertikulitis, ki ga lahko spremlja perforacija v prebavilih.
RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidaemia) managed as part of usual standard of care. 
Bolniki z revmatoidnim artritisom imajo večje tveganje za srčno-žilne bolezni, zato mora njihova običajna standardna obravnava vključevati obvladanje dejavnikov tveganja (npr. hipertenzije,