FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with RoActemra, particularly when administered concomitantly with MTX, may be associated with elevations in hepatic transaminases, therefore, caution should be exercised when considering treatment of patients with active hepatic disease or hepatic impairment (see sections 4.2 and 4.8).
Slovenian: Zdravljenje z zdravilom RoActemra lahko spremlja zvišanje jetrnih transaminaz, zlasti če se uporablja z metotreksatom, zato morate biti pri odločanju za uporabo zdravila RoActemra pri bolnikih z aktivno boleznijo jeter ali okvaro jeter previdni (glejte poglavji 4.2 ter 4.8).
English: Signs and symptoms of liver toxicity These may affect up to 1 in every 1000 users
Slovenian: Znaki jetrne toksičnosti: Ti se lahko pojavijo pri največ 1 od 1000 bolnikov.
English: Nervous system disorders Headache pJIA
Slovenian: Bolezni živčevja glavobol pJIA
English: The pre-filled syringe should not be shaken.
Slovenian: Napolnjene injekcijske brizge se ne sme stresati.
English: A patient or parent/guardian can self-inject RoActemra only if the physician determines that it is appropriate and the patient or parent/guardian agrees to medical follow-up as necessary and has been trained in proper injection technique.
Slovenian: Po ustreznem usposabljanju o primerni tehniki injiciranja si lahko bolnik (ali njegovi starši/skrbniki) zdravilo RoActemra aplicira sam, če zdravnik potrdi, da je to primerno in se bolnik (ali njegovi starši/skrbniki) strinja z zdravniškim spremljanjem po potrebi.
English: The overall safety profile observed in the RoActemra treatment groups was consistent with the known safety profile of RoActemra (see Table 1).
Slovenian: celoti so se varnostne značilnosti, opažene v terapevtskih skupinah z zdravilom RoActemra, ujemale z znanimi varnostnimi značilnostmi zdravila RoActemra (glejte preglednico 1).
English: If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of RoActemra should be stopped immediately, appropriate therapy initiated and tocilizumab should be permanently discontinued.
Slovenian: Če pride do anafilaktične ali druge hude preobčutljivostne reakcije, je treba dajanje zdravila RoActemra nemudoma prekiniti, pričeti s primernim zdravljenjem in uporabo tocilizumaba trajno ukiniti.
English: Subcutaneous
Slovenian: Subkutano
English: Once the non-linear clearance pathway is saturated, at higher RoActemra concentrations, clearance is mainly determined by the linear clearance.
Slovenian: Ko je pot nelinearnega očistka nasičena, očistek pri višjih koncentracijah zdravila RoActemra določa predvsem linearni očistek.
English: Active hepatic disease and hepatic impairment
Slovenian: Aktivna bolezen jeter in okvara jeter
English: In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of RoActemra, to the level similar to, or slightly higher than, those observed in healthy subjects.
Slovenian: V študiji pri bolnikih z revmatoidnim artritisom so se koncentracije simvastatina (CYP3A4) en teden po enkratnem odmerku zdravila RoActemra znižale za 57 % in dosegle podobne ali malo višje koncentracije od teh, ki so jih izmerili pri zdravih ljudeh.
English: Administration of RoActemra should be interrupted if a patient develops a serious infection until the infection is controlled (see section 4.8).
Slovenian: Če se pojavi resna okužba, je treba uporabo zdravila RoActemra prekiniti, dokler okužba ni obvladana (glejte poglavje 4.8).
English: There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA patients.
Slovenian: Ni izkušenj z uporabo zdravila RoActemra z zaviralci TNF ali drugimi biološkimi zdravili za revmatoidni artritis.
English: Study SC-II evaluated patients with moderate to severe active RA who had an inadequate clinical response to their existing rheumatologic therapy, including one or more DMARD(s) where approximately 20% had a history of inadequate response to at least one TNF inhibitor.
Slovenian: V študiji SC-II so ocenjevali bolnike z zmernim do hudo aktivnim revmatoidnim artritisom, ki se niso zadostno klinično odzvali na svoje obstoječe revmatološko zdravljenje, vključno z enim ali več imunomodulirajočimi antirevmatičnimi zdravili, pri čemer jih približno 20 % v preteklosti ni imelo zadostnega odziva na najmanj enega zaviralca TNF.
English: Elderly No dose adjustment is required in elderly patients >65 years of age.
Slovenian: Starejši Starejšim bolnikom (> 65 let) odmerka ni treba prilagoditi.
English: The rate of infection/serious infection events was balanced between the RoActemra weekly group (200.2/9.7 events per 100 patient years) vs. placebo plus 26 weeks prednisone taper (156.0/4.2 events per 100 patient years) and placebo plus 52 weeks taper (210.2/12.5 events per 100 patient years) groups.
Slovenian: RoActemra (200,2/9,7 dogodkov na 100 bolnik-let), s placebom in 26-tedenskim zmanjševanjem prednizona (156,0/4,2 dogodkov na 100 bolnik-let) in s placebom in 52-tedenskim zmanjševanjem (210,2/12,5 dogodkov na 100 bolnik-let).
English: The frequency of ADRs in pJIA patients can be found in Table 2.
Slovenian: Pogostnost neželenih učinkov pri bolnikih s pJIA je navedena v preglednici 2.
English: Check the liquid in the RoACTEMRA pre-filled pen (See Figure C).
Slovenian: Preverite raztopino v napolnjenem injekcijskem peresniku zdravila RoACTEMRA (glejte sliko C).
English: • Do not throw away (dispose of) the pre-filled pen and the green cap in your household trash and do not recycle them.
Slovenian: • Napolnjenega injekcijskega peresnika in zelenega pokrovčka ne smete odvreči (odložiti) med gospodinjske odpadke; prav tako ju ni mogoče reciklirati.
English: Available data suggest that clinical improvement is observed within 6 weeks of initiation of treatment with RoActemra.
Slovenian: Razpoložljivi podatki kažejo, da je klinično izboljšanje opaženo v 6 tednih po začetku zdravljenja z zdravilom RoActemra.
English: • Insert the needle all the way into the pinched skin at an angle between 45° to 90° with a quick,
Slovenian: • Injekcijsko iglo popolnoma vstavite v kožno gubo pod kotom 45° do 90° hitro in odločno (glejte sliko E).
English: When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Slovenian: Bolnike, zdravljene z individualno prilagojenimi zdravili, ki se presnavljajo s CYP450 3A4, 1A2 ali 2C9 (npr. metilprednizolon, deksametazon (z možnim odtegnitvenim sindromom peroralnih glukokortikoidov), atorvastatin, zaviralci kalcijevih kanalčkov, teofilin, varfarin, fenprokumon,
English: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including RoActemra (see section 4.8, Undesirable effects).
Slovenian: Pri bolnikih, ki so prejemali imunosupresivna zdravila, vključno z zdravilom RoActemra, so poročali o resnih in včasih smrtnih okužbah (glejte poglavje 4.8, Neželeni učinki).
English: The purpose of Part 2 was to describe the long-term safety and maintenance of efficacy after 52 weeks of RoActemra therapy, to explore the rate of relapse and the requirement for RoActemra therapy beyond 52 weeks, and to gain insight into the potential long-term steroid-sparing effect of RoActemra.
Slovenian: deleža ponovitev in potrebe po več kakor 52-tedenskem zdravljenju z zdravilom RoActemra ter pridobitev vpogleda v možen dolgoročni učinek zdravila RoActemra na varčevanje z glukokortikoidi.
English: In general, the safety profile observed in patients with pJIA was consistent with the known safety profile of RoActemra with the exception of ISRs (see Table 1).
Slovenian: Na splošno se je varnostni profil, opažen pri bolnikih s pJIA, skladal z znanim varnostnim profilom zdravila RoActemra, z izjemo reakcij na mestu injiciranja (glejte preglednico 1).
English: Therefore, RoActemra doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Slovenian: Odmerki zdravila RoActemra, večji od 800 mg na infuzijo, torej niso priporočljivi (glejte poglavje 4.2).
English: The long-term exposure population includes all patients who received at least one dose of RoActemra either in the double-blind control period or open label extension phase in the studies.
Slovenian: Dolgoročno izpostavljena populacija vključuje vse bolnike, ki so dobili vsaj en odmerek zdravila RoActemra v obdobju dvojno slepe kontrole ali pa v odprti, podaljšani fazi študije.
English: The dose-response curve for RoActemra flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in RoActemra concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with > 800 mg of RoActemra.
Slovenian: Krivulja odmerek-odziv za zdravilo RoActemra je pri večji izpostavljenosti bolj položna, kar pomeni manjše poraste učinkovitosti pri vsakem nadaljnjem povečanju koncentracije zdravila RoActemra; tako pri bolnikih, zdravljenih z več kot 800 mg zdravila RoActemra, niso dokazali klinično pomembnih porastov učikovitosti.
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in tocilizumab plus MTX-treated patients was maintained in the second year of treatment.
Slovenian: V odprti, podaljšani fazi študije II se je zaviranje strukturne okvare sklepov pri bolnikih, ki so prejemali tocilizumab in metotreksat, ohranilo v drugem letu zdravljenja.
English: The accumulation ratios for AUC, Cmin, and Cmax were 6.32, 6.30, and 5.27, respectively.
Slovenian: Deleži kopičenja so bili 6,32 za AUC, 6,30 za Cmin in 5,27 za Cmax.
English: 1p<0.0001, tocilizumab vs. placebo
Slovenian: 1p < 0,0001, tocilizumab v primerjavi s placebom
English: If you stop being given RoActemra
Slovenian: Če so vam prenehali dajati zdravilo RoActemra
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.
Slovenian: Če se simptomi tuberkuloze (vztrajen kašelj, izguba telesne mase, ravnodušnost, blago zvišana telesna temperatura) ali katere koli druge okužbe pojavijo med zdravljenjem ali po njem, to nemudoma povejte svojemu zdravniku.
English: The majority of ISRs reported were Grade 1 events and all ISRs reported were non-serious and none required patient withdrawal from treatment or dose interruption.
Slovenian: Večina reakcij na mestu injiciranja, o katerih so poročali, je bila 1. stopnje, vse so bile neresne in nobena od njih ni zahtevala prenehanja zdravljenja ali prekinitve odmerjanja.
English: Patients who transition from tocilizumab IV therapy to SC administration should administer the first SC dose at the time of the next scheduled IV dose under the supervision of a qualified health care professional.
Slovenian: Bolniki, ki prehajajo z zdravljenja z intravenskim tocilizumabom na subkutano dajanje, si morajo v času naslednjega načrtovanega intravenskega odmerka prvi subkutani odmerek aplicirati pod nadzorom usposobljenega zdravstvenega delavca.
English: The adjusted mean change in the pain VAS after 40 weeks of tocilizumab treatment was 32.4 mm on a 0-100 mm scale compared to a reduction of 22.3 mm for placebo patients (highly statistically significant; p=0.0076).
Slovenian: 32,4 mm na lestvici 0-100 mm v primerjavi z zmanjšanjem za 22,3 mm za bolnike na placebu (zelo statistično signifikantno; p = 0,0076).
English: One patient in the 10 mg/kg < 30kg group developed positive anti-tocilizumab antibodies without developing a hypersensitivity reaction and subsequently withdrew from the study.
Slovenian: Pri enem bolniku, ki se je zdravil z 10 mg/kg v skupini s telesno maso < 30 kg, so se pojavila protitelesa proti tocilizumabu brez preobčutljivostne reakcije.
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the RoActemra arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Slovenian: Povprečno povišanje LDL od pričetka zdravljenja je bilo 0,64 mmol/l (25 mg/dl) pri bolnikih v skupini z zdravilom RoActemra in 0,19 mmol/l (7 mg/dl) pri bolnikih v skupini z adalimumabom.
English: There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist.
Slovenian: Bolniki, ki so že bili zdravljeni z antagonistom TNF, imajo lahko večje tveganje za nevtropenijo.
English: When platelet count is > 100 x 103/µl resume RoActemra
Slovenian: Ko je število trombocitov > 100 x 103/μl, znova uvedite zdravilo RoActemra.
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and / or GCA.
Slovenian: Zdravljenje mora vpeljati zdravnik, ki ima izkušnje s prepoznavanjem in zdravljenjem revmatoidnega artritisa, sJIA, pJIA in/ali GCA.
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.
Slovenian: • Zdravilo RoActemra se lahko uporablja tudi za zdravljenje odraslih bolnikov s hudim, aktivnim in napredujočim revmatoidnim artritisom brez predhodnega zdravljenja z metotreksatom.
English: All TCZ
Slovenian: teden TCZ
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).
Slovenian: V SC-II so 656 bolnikov randomizirali v razmerju 2:1, da so prejeli 162 mg zdravila RoActemra subkutano vsak drugi teden ali placebo v kombinaciji z nebiološkimi imunomodulirajočimi antirevmatičnimi zdravili.
English: The frequency of ADRs in sJIA patients can be found in Table 2.
Slovenian: Pogostnost neželenih učinkov pri bolnikih s sJIA je prikazana v preglednici 2.
English: RoActemra subcutaneous weekly dose also showed a clinically meaningful decrease in the risk for flare compared to placebo plus 26 weeks prednisone in patients who entered the trial with relapsing GCA as well as those with new-onset disease (Table 4).
Slovenian: Subkutana uporaba zdravila RoActemra vsak teden je v primerjavi s placebom skupaj s 26-tedenskim prednizonom tudi klinično pomembno zmanjšala tveganje za poslabšanje tako pri bolnikih, ki so bili vključeni v preskušanje s ponovitvijo GCA kot pri tistih z novonastalo boleznijo (preglednica 4).
English: Children and adolescents RoActemra subcutaneous injection is not recommended for use in children under 18 years of age.
Slovenian: Zdravila RoActemra v podkožni injekciji ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: • cough, shortness of breath
Slovenian: • kašelj, oteženo dihanje,
English: • Package leaflet (with instructions for use for SC)
Slovenian: • navodilo za uporabo (z navodili za uporabo subkutane oblike), • opozorilno kartico za bolnika
English: • Then keep the syringe in position and let go of the pinch of skin.
Slovenian: • Nato napolnjeno injekcijsko brizgo držite in spustite kožno gubo.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle containing 162 mg RoActemra assembled into a pre-filled pen.
Slovenian: 0,9 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) z vstavljeno iglo, ki vsebuje 162 mg zdravila RoActemra v napolnjenem injekcijskem peresniku.
English: Following 1 year of treatment with RoActemra plus MTX, 85% of patients(n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients(n=290) (p ≤ 0.001).
Slovenian: Po 1 letu zdravljenja z zdravilom RoActemra in metotreksatom pri 85 % bolnikov (n = 348) ni bilo napredovanja strukturne okvare sklepov, opredeljene kot spremembe v celotni oceni po Sharpu 0 ali manj, v primerjavi s 67 % bolnikov, ki so prejemali placebo in metotreksat (n = 290) (p ≤ 0,001).
English: However, if you are worried, talk to your doctor or nurse.
Slovenian: A če vas skrbi, se posvetujte z zdravnikom ali medicinsko sestro.
English: Patients in study SC-I had a mean Disease Activity Score (DAS28) at baseline of 6.6 and 6.7 on the subcutaneous and intravenous arms, respectively.
Slovenian: Bolniki v študiji SC-I so imeli povprečno izhodiščno oceno aktivnosti bolezni DAS28 (Disease Activity Score) v subkutani skupini 6,6, v intravenski pa 6,7.
English: • high blood fat (triglycerides)
Slovenian: • zvišane maščobe v krvi (trigliceridi),
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Slovenian: Če se simptomi tuberkuloze (vztrajen kašelj, izguba telesne mase, ravnodušnost, blago zvišana telesna temperatura) ali katerekoli druge okužbe pojavijo med zdravljenjem ali po njem, to nemudoma povejte svojemu zdravniku.
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.
Slovenian: V študiji s subkutano obliko zdravila RoActemra je bil delež okužb pri bolnikih s pJIA, zdravljenih z zdravilom RoActemra subkutano, primerljiv s tistim pri bolnikih s pJIA, zdravljenih z zdravilom RoActemra intravensko.
English: In the RoActemra subcutaneous weekly group, a total of 6% (6/100) patients reported an adverse reaction occurring at the site of a subcutaneous injection.
Slovenian: Reakcije na mestu injiciranja V skupini, zdravljeni z zdravilom RoActemra subkutano vsak teden je neželeni učinek na mestu subkutanega injiciranja navedlo skupno 6 % (6/100) bolnikov.
English: Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 13 out of 3778 patients (0.3%) treated with RoActemra during the controlled and open label clinical studies.
Slovenian: Klinično pomembne preobčutljivostne reakcije, ki so bile povezane z uporabo zdravila RoActemra in so zahtevale prekinitev zdravljenja, so zabeležili pri skupaj 13 od 3778 bolnikov (0,3 %), ki so v kontroliranih in odprtih kliničnih študijah dobivali zdravilo RoActemra.
English: Upper Respiratory Tract Infections pJIA, sJIA
Slovenian: Občasni okužbe zgornjih dihal pJIA, sJIA
English: sJIA and pJIA Patients
Slovenian: Bolniki s sJIA in pJIA
English: Your doctor will have to decide if you can still be given RoActemra.
Slovenian: Zdravnik bo presodil, ali lahko dobite zdravilo RoActemra.
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in RoActemra plus MTX-treated patients was maintained in the second year of treatment.
Slovenian: V odprti, podaljšani fazi študije II se je zaviranje strukturne okvare sklepov pri bolnikih, ki so prejemali zdravilo RoActemra in metotreksat, ohranilo v drugem letu zdravljenja.
English: Concentrate for solution for infusion 400 mg/20 mL
Slovenian: Koncentrat za raztopino za infundiranje 400 mg/20 ml
English: If you are using medicines containing any of the following active substances, tell your doctor:
Slovenian: Zdravniku morate povedati, če uporabljate zdravila, ki vsebujejo katero od naslednjih učinkovin:
English: Some side effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.
Slovenian: Nekatere neželene učinke so opazili pogosteje: vnet nos in žrelo, drisko, majhno število belih krvnih celic in zvišanje jetrnih transaminaz.
English: What RoActemra contains
Slovenian: Kaj vsebuje zdravilo RoActemra
English: To mix the solution, gently invert the infusion bag to avoid foaming.
Slovenian: Za premešanje raztopine infuzijsko vrečko previdno obračajte, da boste preprečili penjenje.
English: A 52-week, open-label, multicenter, PK-PD and safety study was conducted in paediatric patients with pJIA, aged 1 to 17 years old, to determine the appropriate subcutaneous dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Slovenian: Pri pediatričnih bolnikih s pJIA, starimi od 1 do 17 let, so izvedli 52-tedensko, odprto, multicentrično, študijo farmakokinetike/farmakodinamike in varnosti za določitev ustreznega subkutanega odmerka zdravila RoActemra, ki bi imel primerljiv farmakokinetični/farmakodinamični in varnostni profil v primerjavi z intravenskim režimom.
English: The types of adverse drug reactions in the tocilizumab arm were consistent with the known safety profile of tocilizumab and adverse drug reactions were reported at a similar frequency compared with Table 1.
Slovenian: Tipi neželenih učinkov v skupini s tocilizumabom so bili skladni z znanim varnostnim profilom tocilizumaba, o neželenih učinkih so poročali s podobno pogostnostjo v primerjavi s preglednico 1.
English: Cumulative glucocorticoid dose (mg) median at Week 52 (Tocilizumab groups vs Placebo+262) median at Week 52 (Tocilizumab groups vs Placebo +522)
Slovenian: Kumulativni odmerek glukokortikoida (mg) mediana po 52 tednih (skupini s tocilizumabom v primerjavi s placebom + 262)
English: Five patients (0.8%) developed positive anti-RoActemra antibodies; of these, all developed neutralizing anti-RoActemra antibodies.
Slovenian: Pri petih bolnikih (0,8 %) so se pojavila protitelesa proti zdravilu RoActemra, od teh pri vseh nevtralizacijska.
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.
Slovenian: Če pride do anafilaktične ali druge hude preobčutljivostne reakcije, je treba dajanje zdravila RoActemra nemudoma prekiniti, pričeti s primernim zdravljenjem in uporabo zdravila RoActemra trajno ukiniti.
English: RoActemra is supplied in a single use pre-filled syringe fitted into a needle safety device.
Slovenian: Zdravilo RoActemra je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo z varnostnim pripomočkom za injekcijsko iglo.
English: The PK of RoActemra in GCA patients were determined using a population PK model from an analysis dataset composed of 149 GCA patients treated with 162 mg subcutaneous every week or 162 mg subcutaneous every other week.
Slovenian: Farmakokinetiko zdravila RoActemra so pri bolnikih z GCA ugotavljali z modelom populacijske farmakokinetike na podlagi podatkov za 149 bolnikov z GCA, zdravljenih s 162 mg subkutano vsak teden ali 162 mg subkutano vsak drugi teden.
English: Following 1 year of treatment with tocilizumab plus MTX, 85% of patients (n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients (n=290) (p ≤ 0.001).
Slovenian: Po 1 letu zdravljenja s tocilizumabom in metotreksatom pri 85 % bolnikov (n = 348) ni bilo napredovanja strukturne okvare sklepov, opredeljene kot spremembe v celotni oceni po Sharpu 0 ali manj, v primerjavi s 67 % bolnikov, ki so prejemali placebo in metotreksat (n = 290) (p ≤ 0,001).
English: OTHER
Slovenian: oder
English: The safety and immunogenicity observed for RoActemra administered subcutaneous was consistent with the known safety profile of intravenous RoActemra and no new or unexpected adverse drug reactions were observed (see Table 1).
Slovenian: Varnost in imunogenost, opažena pri subkutano danem zdravilu RoActemra, je bila skladna z znanimi varnostnimi značilnostmi intravensko danega zdravila RoActemra, novih ali nepričakovanih neželenih učinkov niso opazili (glejte preglednico 1).