FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of subcutaneous administered RoActemra in alleviating the signs and symptoms of RA and radiographic response, was assessed in two randomised, double-blind, controlled, multi-center studies.
Slovenian: Učinkovitost subkutano danega zdravila RoActemra za ublažitev znakov in simptomov revmatoidnega artritisa in radiološki odziv so ocenili v dveh randomiziranih, dvojno slepih, kontroliranih multicentričnih študijah.
English: Step 5.
Slovenian: Korak 5.
English: Seven patients (1.6%) developed positive anti-RoActemra antibodies; of these, six (1.4%) developed neutralizing anti-RoActemra antibodies.
Slovenian: Pri sedmih bolnikih (1,6 %) so se pojavila protitelesa proti zdravilu RoActemra, od teh pri šestih (1,4 %) nevtralizacijska.
English: Table 6: Efficacy Results for Study VII (WA19926) on MTX-naïve, early RA patients
Slovenian: Rezultati učinkovitosti za študijo VII (WA19926) pri bolnikih z zgodnjim revmatoidnim artritisom, ki se še niso zdravili z metotreksatom
English: Study SC-I 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-I so ocenjevali bolnike z zmerno 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: * p<0.01, tocilizumab vs. placebo
Slovenian: *p < 0,01, tocilizumab v primerjavi s placebom
English: Corticosteroid Tapering
Slovenian: Prilagoditev odmerka kortikosteroida
English: Healthcare professionals should exercise caution when considering the use of RoActemra in patients with a history of recurring or chronic infections or with underlying conditions (e.g. diverticulitis, diabetes and interstitial lung disease which may predispose patients to infections.
Slovenian: Zdravniki morajo biti previdni pri odločanju za uporabo zdravila RoActemra pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb ali z drugimi boleznimi (npr. divertikulitisom, sladkorno boleznijo in intersticijsko boleznijo pljuč), ki lahko povečajo nagnjenost k okužbam.
English: RoActemra monotherapy should not be used for the treatment of acute relapses (see 4.4).
Slovenian: Za zdravljenje akutnih relapsov se zdravila RoActemra samostojno ne sme uporabljati (glejte poglavje 4.4).
English: • phenytoin, used to treat convulsions
Slovenian: • fenitoin, ki se uporablja za zdravljenje epileptičnih napadov (konvulzij),
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih se odmerkov, genotoksičnosti in toksičnosti za razmnoževanje in razvoj ne kažejo posebnega tveganja za človeka.
English: Therefore, tocilizumab doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Slovenian: Odmerki tocilizumaba, večji od 800 mg na infuzijo, torej niso priporočljivi (glejte poglavje 4.2).
English: Viral reactivation
Slovenian: Reaktivacija virusov
English: Pharmacokinetic parameters of tocilizumab did not change with time.
Slovenian: Farmakokinetični parametri tocilizumaba se s časom niso spreminjali.
English: • Throw away the green cap in a sharps container.
Slovenian: • Zelen pokrovček odstranite v zabojnik za ostre predmete.
English: Step 1.
Slovenian: Korak 1.
English: All ISRs reported were non-serious Grade 1 events, and none of the ISRs required patient withdrawal from treatment or dose interruption.
Slovenian: Vse reakcije na mestu injiciranja, o katerih so poročali, so bile zabeležene kot neresni dogodki 1. stopnje in nobena od njih ni zahtevala prenehanja zdravljenja ali prekinitve odmerjanja.
English: An increased frequency of these elevations was observed when potentially hepatotoxic drugs (e.g. MTX) were used in combination with RoActemra.
Slovenian: Zvišanje je bilo pogostejše med kombinirano uporabo zdravila RoActemra s potencialno hepatotoksičnimi zdravili (npr. z metotreksatom).
English: There are limited data available on overdose with RoActemra.
Slovenian: Podatkov o prevelikem odmerjanju zdravila RoActemra je malo.
English: Study V evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies.
Slovenian: Študija V je ocenila 499 bolnikov, ki se niso dovolj odzvali na zdravljenje z enim ali več zaviralci TNF ali takšnega zdravljenja niso prenesli.
English: • If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.
Slovenian: • Če se vam med injiciranjem ali po njem pojavi alergijska reakcija, npr. tiščanje v prsih, piskajoče dihanje, huda omotica ali vrtoglavost, otekanje ustnic, jezika, obraza ali srbenje kože, koprivnica ali kožni izpuščaj, morate to nemudoma povedati zdravniku.
English: The Physician Information pack should contain the following key elements:
Slovenian: Izobraževalno gradivo za zdravnike mora vključevati naslednje ključne elemente:
English: In general, the adverse drug reactions observed during or within 24 hours of an infusion were similar in nature to those seen in RA and sJIA patients, see section 4.8.
Slovenian: V splošnem so neželeni učinki, povezani z infundiranjem, opaženi med njim ali v 24 urah po njem, podobnega tipa kot tisti, opaženi pri bolnikih z revmatoidnim artritisom in sJIA (glejte poglavje 4.8).
English: Available data suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Slovenian: Razpoložljivi podatki kažejo, da je klinično izboljšanje opaženo v 12 tednih od začetka zdravljenja z zdravilom RoActemra.
English: You can press a cotton ball or gauze over the injection site.
Slovenian: Nanj lahko položite bombažno kroglico ali gazo.
English: RoActemra is used for children aged 2 years and over with active polyarticular juvenile idiopathic arthritis (pJIA), an inflammatory disease that causes pain and swelling in one or more joints.
Slovenian: Zdravilo RoActemra se uporablja tudi za zdravljenje otrok, starih 2 leti in več, ki imajo aktivni poliartikularni juvenilni idiopatski artritis (pJIA), vnetno bolezen, ki povzroči bolečino in otekanje enega ali več sklepov.
English: • If you weigh less than 30 kg: the dose is 12 mg for every kilogram of body weight
Slovenian: • Če tehtate manj kot 30 kg: odmerek je 12 mg na kg telesne mase.
English: INFORMATION IN BRAILLE roactemra 162 mg
Slovenian: roactemra 162 mg
English: (See Fig. G)
Slovenian: (glejte sliko G).
English: The addition of potentially hepatotoxic drugs (e.g. MTX) to tocilizumab monotherapy resulted in increased frequency of these elevations.
Slovenian: Če so monoterapiji s tocilizumabom dodali potencialno hepatotoksična zdravila (npr. metotreksat), se je pogostnost teh zvišanj povečala.
English: Peripheral oedema Hypersensitivity reaction, Injection site reaction
Slovenian: preobčutljivostna reakcija, reakcija na mestu injiciranja
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® 4 pre-filled pens
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku, ACTPen® 4 napolnjeni injekcijski peresniki
English: • Always keep the puncture-resistant container out of the sight and reach of children.
Slovenian: • Vedno shranjujte zabojnik za ostre predmete nedosegljivo otrokom.
English: The overall clinical adverse event profile was similar between RoActemra and adalimumab.
Slovenian: Celokupne klinične značilnosti neželenih učinkov so bile pri zdravilu RoActemra in adalimumabu podoben.
English: • mouth ulceration, stomach pain
Slovenian: • razjeda v ustih, bolečine v trebuhu,
English: • Hold the pre-filled pen comfortably in 1 hand by the upper part, so that you can see the Window area of the pre-filled pen (See Figure F).
Slovenian: • Z eno roko držite zgornji del napolnjenega injekcijskega peresnika, tako da vidite območje okenca (glejte sliko F).
English: RoActemra has not been studied in patients with moderate to severe renal impairment (see section 5.2).
Slovenian: Uporaba zdravila RoActemra ni raziskana pri bolnikih z zmerno do hudo okvaro ledvic (glejte poglavje 5.2).
English: The rate of infection in sJIA patients treated with SC RoActemra was comparable to sJIA patients treated with IV RoActemra.
Slovenian: Delež okužb pri bolnikih s sJIA, zdravljenih s subkutano obliko zdravila RoActemra, je bil primerljiv s tistim pri bolnikih s sJIA, zdravljenih z intravensko obliko zdravila RoActemra.
English: There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA, sJIA or pJIA patients.
Slovenian: Ni izkušenj z uporabo zdravila RoActemra z zaviralci TNF ali drugimi biološkimi zdravili za revmatoidni artritis, sJIA ali pJIA.
English: PBO + DMARD
Slovenian: placebo DMARD
English: FACIT-Fatigue change from baseline to week 52 scores were calculated for all groups.
Slovenian: Za vse skupine so izračunali spremembo ocene utrujenosti po FACIT-Fatigue od izhodišča do 52. tedna.
English: Figure C
Slovenian: Slika C
English: The addition of potentially hepatotoxic drugs (e.g. MTX) to RoActemra monotherapy resulted in increased frequency of these elevations.
Slovenian: Če so monoterapiji z zdravilom RoActemra dodali potencialno hepatotoksična zdravila (npr. metotreksat), se je pogostnost teh zvišanj povečala.
English: Always store the syringe in a refrigerator at a temperature of 2°C - 8°C.
Slovenian: Napolnjeno injekcijsko brizgo vedno shranjujte v hladilniku pri temperaturi 2 ºC - 8 ºC.
English: Side effects could occur 3 months or more after your last dose of RoActemra.
Slovenian: Neželeni učinki se lahko pojavijo tudi še 3 mesece ali več po zadnjem odmerku zdravila
English: Do not use the syringe if the expiration date has passed.
Slovenian: Ne uporabite injekcijske brizge, če je rok uporabnosti pretečen.
English: Important: Keep your unused pre-filled pens in the original carton and keep in the refrigerator at 2˚C
Slovenian: Pomembno: Neuporabljene napolnjene injekcijske peresnike shranjujte v originalni ovojnini (škatli) v hladilniku pri temperaturi od 2 °C in 8 °C (36 °F do 46 °F).
English: • adults with a disease of the arteries called giant cell arteritis (GCA), caused by inflammation of the body's largest arteries, especially those that supply blood to the head and neck.
Slovenian: Gre za vnetje največjih arterij v telesu, zlasti tistih, ki s krvjo oskrbujejo glavo in vrat.
English: Placebo + 52 weeks prednisone taper N=51
Slovenian: Placebo + 52 tednov zmanjševanja prednizona n = 51
English: Major clinical response
Slovenian: Pomembnejša klinična odzivnost
English: Reported serious infections were similar to those seen in RA patients with the addition of varicella and otitis media.
Slovenian: Resne okužbe, o katerih so poročali, so bile podobne opaženim pri bolnikih z revmatoidnim artritisom z dodatkom noric in vnetjem srednjega ušesa.
English: In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with RoActemra.
Slovenian: Na njej so zapisane pomembne informacije o varnosti, ki jih morate poznati pred zdravljenjem z zdravilom RoActemra in med zdravljenjem z njim.
English: RoActemra has not been studied in patients with severe renal impairment (see section 5.2).
Slovenian: Uporaba zdravila RoActemra ni raziskana pri bolnikih s hudo okvaro ledvic (glejte poglavje 5.2).
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Slovenian: Zdravilo RoActemra je indicirano za zdravljenje aktivnega sistemskega juvenilnega idiopatskega artritisa (sJIA) pri bolnikih, starih 1 leto ali več, ki se niso zadostno odzvali na predhodno zdravljenje z nesteroidnimi protivnetnimi zdravili ali sistemskimi kortikosteroidi.
English: In study I, superiority of RoActemra 8 mg/kg was demonstrated against the active comparator MTX.
Slovenian: V študiji I so dokazali superiornost 8 mg/kg zdravila RoActemra nad primerjalno učinkovino metotreksatom.
English: SF-36 (mean change in mental and physical component scores) was significantly greater with RoActemra subcutaneous group (6.5 and 5.3) versus placebo (3.8 and 2.9).
Slovenian: RoActemra (6,5 in 5,3) v primerjavi s placebom (3,8 in 2,9).
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the tocilizumab arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Slovenian: 0,64 mmol/l (25 mg/dl) pri bolnikih v skupini s tocilizumabom in 0,19 mmol/l (7 mg/dl) pri bolnikih v skupini z adalimumabom.
English: The types of adverse drug reactions in the RoActemra arm were consistent with the known safety profile of RoActemra and adverse drug reactions were reported at a similar frequency compared with Table 1.
Slovenian: Tipi neželenih učinkov v skupini z zdravilom RoActemra so bili skladni z znanimi varnostnimi značilnostmi zdravila RoActemra, o neželenih učinkih so poročali s podobno pogostnostjo v primerjavi s preglednico 1.
English: Other sources of information
Slovenian: DRUGI PODATKI
English: In clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Slovenian: Farmakodinamični učinki V kliničnih študijah z zdravilom RoActemra so opažali hitro znižanje CRP, hitrosti sedimentacije eritrocitov (SR), serumskega amiloida A (SAA) in fibrinogena.
English: pJIA Patients
Slovenian: Bolniki s pJIA
English: • injection site reactions.
Slovenian: • reakcije na mestu injiciranja.
English: The concentrate is a clear to opalescent, colourless to pale yellow liquid.
Slovenian: Koncentrat je bistra do opalescentna, brezbarvna do bledorumena raztopina.
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on tocilizumab clearance.
Slovenian: Analize populacijske farmakokinetike niso odkrile, da bi metotreksat, nesteroidna protivnetna zdravila ali kortikosteroidi vplivali na očistek tocilizumaba.
English: When compared to the adult RA population, patients with sJIA experienced a higher frequency of nasopharyngitis, decrease in neutrophil counts, hepatic transaminases increased, and diarrhea.
Slovenian: V primerjavi z odraslo populacijo z revmatoidnim artritisom so o naslednjih neželenih učinkih poročali pogosteje pri populaciji s sJIA: nazofaringitisu, zmanjšanem številu nevtrofilcev, zvišanju jetrnih transaminaz in diareji.
English: • The front of your thigh or your abdomen except for the 2-inch (5cm) area around your navel are the recommended injection sites (See Figure D).
Slovenian: • Priporočena mesta injiciranja so sprednji del stegna ali trebuha, razen območja okoli popka, ki meri približno 2 palca (5 cm) (glejte sliko D).
English: The solution is colourless to slightly yellowish.
Slovenian: Raztopina je brezbarvna do rahlo rumenkasta.
English: • If you weigh less than 30 kg: the dose is 10mg for every kilogram of body weight
Slovenian: • Če tehtate manj kot 30 kg: odmerek je 10 mg na kg telesne mase.
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, one patient (1%, 1/100) in the RoActemra subcutaneous weekly group had a single transient occurence of decrease in platelet count to <100 × 103 / μL without associated bleeding events.
Slovenian: Trombociti Med rednim laboratorijskim spremljanjem v 12-mesečnem kontroliranem kliničnem preskušanju zdravila RoActemra se je pri enem bolniku (1 %, 1/100), ki je prejemal zdravilo RoActemra subkutano vsak teden, pojavilo prehodno zmanjšanje števila trombocitov na < 100 × 103/µl brez spremljajočih krvavitev.
English: Hypertriglyceridae mia
Slovenian: hipertrigliceridemija
English: A 52-week, open-label, multi-centre, PK/PD and safety study (WA28118) was conducted in paediatric patients with sJIA, aged 1 to 17 years, to determine the appropriate SC dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Slovenian: Pri pediatričnih bolnikih s sJIA, starih od 1 do 17 let, so izvedli 52-tedensko, odprto, multicentrično študijo farmakokinetike/farmakodinamike in varnosti (WA28118) za določitev ustreznega subkutanega odmerka zdravila RoActemra, ki bi imel primerljiv farmakokinetični/farmakodinamični in varnostni profil v primerjavi z intravenskim režimom.
English: Hepatic transaminases increased pJIA
Slovenian: Preiskave zvišanje jetrnih transaminaz pJIA
English: The efficacy of tocilizumab in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Slovenian: Učinkovitost tocilizumaba za ublažitev znakov in simptomov revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih multicentričnih študijah.
English: Placebo + MTX N=287
Slovenian: MTX n = 287
English: The total clearance of RoActemra was concentration-dependent and is the sum of the linear and non-linear clearance.
Slovenian: Celotni očistek zdravila RoActemra je odvisen od koncentracije in je vsota linearnega in nelinearnega očistka.
English: In the open label extension phase, elevation in ALT or AST ≥ 3 x ULN occurred in 12% and 4% of patients, respectively, in the tocilizumab group.
Slovenian: V odprti, podaljšani fazi se je dvig ALT na ≥ 3-kratno ZMN pojavil pri 12 % bolnikov, dvig AST na ≥ 3-kratno ZMN pa pri 4 % bolnikov v skupini, ki je prejemala tocilizumab.
English: The total clearance of tocilizumab was concentrationdependent and is the sum of the linear and non-linear clearance.
Slovenian: Celotni očistek tocilizumaba je odvisen od koncentracije in je vsota linearnega in nelinearnega očistka.
English: During routine laboratory monitoring in the 12 week controlled phase, a decrease in neutrophil counts below 1 x 109/l occurred in 7% of patients in the tocilizumab group, and no decreases in the placebo group.
Slovenian: Med rutinskim laboratorijskim spremljanjem v 12-tedenski, kontrolirani fazi se je zmanjšanje števila nevtrofilcev pod 1 x 109/l pojavilo pri 7 % bolnikov v skupini, ki je prejemala tocilizumab, v skupini, ki je prejemala placebo, pa ni bilo zmanjšanja.
English: Fatal anaphylaxis has been reported after marketing authorisation during treatment with intravenous RoActemra (see section 4.4).
Slovenian: V obdobju po prihodu zdravila na trg so poročali o primeru smrtne anafilaksije med zdravljenjem z intravensko obliko zdravila RoActemra (glejte poglavje 4.4).
English: The median doses for escape patients in the RoActemra weekly and every other weekly groups were 3129.75 mg and 3847 mg, respectively.
Slovenian: RoActemra vsak teden 3129,75 mg in v skupini z zdravilom RoActemra vsak drugi teden 3847 mg.
English: Systemic Effects In the tocilizumab treated patients, 85% who had fever due to sJIA at baseline were free of fever (no temperature recording ≥ 37.5°C in the preceding 14 days) at week 12 versus 21% of placebo patients
Slovenian: Od bolnikov, ki so imeli pred začetkom zdravljenja povišano telesno temperaturo zaradi sJIA, jih 85 % v skupini, ki je prejemala tocilizumab, po 12 tednih ni imelo povišane telesne temperature (brez povišane telesne temperature ≥ 37,5 °C v preteklih 14 dneh), v primerjavi z 21 % bolnikov, ki so prejemali placebo (p < 0,0001).
English: • high blood fat (cholesterol) levels
Slovenian: • zvišana raven maščob v krvi (holesterola),
English: Side effects could occur at least up to 3 months after your last dose of RoActemra.
Slovenian: Neželeni učinki se lahko pojavijo vsaj še 3 mesece po zadnjem odmerku zdravila
English: In study I, superiority of tocilizumab 8 mg/kg was demonstrated against the active comparator MTX.
Slovenian: študiji I so dokazali superiornost 8 mg/kg tocilizumaba nad primerjalno učinkovino metotreksatom.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Slovenian: Zdravilo RoActemra je indicirano za zdravljenje aktivnega sistemskega juvenilnega idiopatskega artritisa (sJIA) pri bolnikih, starih 2 leti ali več, ki se niso zadostno odzvali na predhodno zdravljenje z nesteroidnimi protivnetnimi zdravili ali sistemskimi kortikosteroidi.
English: Only solutions which are clear to opalescent, colourless to pale yellow and free of visible particles should be diluted.
Slovenian: Razredčiti smete le raztopine, ki so bistre do opalescentne, brezbarvne do bledorumene in ne vsebujejo vidnih delcev.
English: Restart with weekly or every other week injection, as clinically appropriate.
Slovenian: Ponovno začnite z dajanjem injekcij zdravila RoActemra enkrat na teden ali enkrat na dva tedna, kot je klinično ustrezno.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: In the SC Study (WA28118), a total of 41.2% (21/51) sJIA patients experienced ISRs to RoActemra SC.
Slovenian: V študiji s subkutano obliko (WA28118) je imelo reakcije na mestu injiciranja pri subkutanem injiciranju zdravila RoActemra skupno 41,2 % (21/51) bolnikov s sJIA.
English: The most commonly reported Adverse Drug Reactions (ADRs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Slovenian: Najpogosteje opisani neželeni učinki so bili okužbe zgornjih dihal, nazofaringitis, glavobol, hipertenzija in zvišanje ALT.
English: During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg RoActemra + DMARD.
Slovenian: V obdobju dvojno slepe kontrole je incidenca zvišanja indirektnega bilirubina (parameter rutinskih laboratorijskih preiskav) nad ZMN pri bolnikih, zdravljenih z 8 mg/kg zdravila RoActemra in DMARD, znašala 6,2 %.
English: An elevation in ALT or AST ≥3 x ULN occurred in 9.6% and 3.8% patients treated with RoActemra SC,
Slovenian: Zvišanje vrednosti ALT ≥ 3 x ZMN se je pojavilo pri 9,6 % in zvišanje vrednosti AST ≥ 3 x ZMN pri 3,8 % bolnikov, zdravljenih s subkutano obliko zdravila RoActemra.
English: Other Secondary Endpoints Time to first GCA flare¹ (Tocilizumab groups vs Placebo+26)
Slovenian: Drugi sekundarni opazovani dogodki Čas do prvega poslabšanja GCA¹ (skupini s tocilizumabom v primerjavi s placebom + 26)
English: All patients received background non-biologic DMARD(s).
Slovenian: Vsi bolniki so prejeli osnovno zdravljenje z nebiološkimi imunomodulirajočimi antirevmatičnimi zdravili.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle.
Slovenian: 0,9 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) z vstavljeno iglo.
English: If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid any injury with the needle.
Slovenian: Če igla ni pokrita, napolnjeni injekcijski peresnik previdno odložite v zabojnik za ostre predmete, da se izognete morebitni poškodbi z iglo.