FrancophonIA/ELRC3.0 huggingface dataset:
English: Exploratory Endpoints Week 24: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%) Week 52: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%)
Slovenian: 24. teden: ACR/EULAR remisija (Boolean), n (%) ACR/EULAR remisija (Index), n (%) 52. teden: ACR/EULAR remisija (Boolean), n (%) ACR/EULAR remisija (Index), n (%) mTSS - ocena po prirejeni Sharpovi lestvici (mTSS, modified Total Sharp Score)
English: > 3 x ULN to 5x ULN
Slovenian: > 3- do 5-kratna ZMN
English: Such reactions may be more severe, and potentially fatal in patients who have experienced hypersensitivity reactions during previous treatment with RoActemra even if they have received premedication with steroids and antihistamines.
Slovenian: Tovrstne reakcije so lahko hujše in morebiti tudi smrtne pri bolnikih, pri katerih so se preobčutljivostne reakcije pojavile med predhodnim zdravljenjem z zdravilom RoActemra, tudi če so le-ti prejeli premedikacijo s steroidi in antihistaminiki.
English: • After you remove the green cap, the pre-filled pen is ready for use.
Slovenian: • Ko odstranite zelen pokrovček, je napolnjeni injekcijski peresnik pripravljen za uporabo.
English: • Do not remove the needle-cap on your syringe until Step 5.
Slovenian: • Ne odstranjujte pokrovčka za injekcijsko iglo na napolnjeni injekcijski brizgi do koraka 5.
English: • Continue to pinch the skin while you keep the pre-filled pen in place.
Slovenian: • Še naprej držite kožno gubo, medtem ko držite napolnjeni injekcijski peresnik na mestu.
English: Hepatic transaminases increased, Weight increased, Total bilirubin increased*
Slovenian: Preiskave zvišanje jetrnih transaminaz, zvečanje telesne mase, zvišanje celotnega bilirubina*
English: RoActemra is usually given in combination with another medicine for RA called methotrexate.
Slovenian: Zdravilo RoActemra se po navadi uporablja v kombinaciji z drugim zdravilom za zdravljenje revmatoidnega artritisa, imenovanim metotreksat.
English: The primary endpoint was the proportion of patients achieving DAS28 remission (DAS28 < 2.6) at week 24.
Slovenian: Primarni cilj je bil delež bolnikov, ki so dosegli remisijo glede na DAS28 (DAS28 < 2,6) v 24. tednu.
English: RoActemra subcutaneous formulation is not intended for intravenous administration.
Slovenian: Subkutana oblika zdravila RoActemra ni namenjena intravenski aplikaciji.
English: Patients should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Slovenian: Bolnikom morate naročiti, naj se nemudoma posvetujejo z zdravnikom, če se pojavi kakršen koli simptom okužbe, da bodo deležni hitre ocene stanja in ustreznega zdravljenja.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: čas običajno ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če je bilo razredčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
English: The efficacy of tocilizumab was assessed in a three-part study WA19977 including an open-label extension in children with active pJIA.
Slovenian: Učinkovitost tocilizumaba pri otrocih z aktivnim pJIA so ocenili v študiji WA19977, sestavljeni iz treh delov, vključno z odprtim, podaljšanim spremljanjem.
English: Do not use it if the expiration date has passed because it may not be safe to use.
Slovenian: Če je rok uporabnosti potekel, ga ne uporabljajte, ker morda ni varen za uporabo.
English: • Do not inject into areas that could be bothered by a belt or waistband.
Slovenian: • Ne injicirajte v mesta, kjer bi lahko prišlo do draženja s pasom.
English: The most common events occurring during infusion were headache, nausea and hypotension and within 24 hours of infusion were dizziness and hypotension.
Slovenian: Najbolj pogosti neželeni učinki med infundiranjem so bili glavobol, navzea in hipotenzija, v 24 urah po infundiranju pa omotica in hipotenzija.
English: Most of the patients in the population pharmacokinetic analysis had normal renal function or mild renal impairment.
Slovenian: Večina bolnikov v analizi populacijske farmakokinetike je imela normalno delovanje ledvic ali blago okvaro ledvic.
English: • Do not remove the pre-filled pen cap until you are ready to inject RoACTEMRA.
Slovenian: • Ne odstranjujte pokrovčka napolnjenega injekcijskega peresnika, dokler niste pripravljeni na injiciranje zdravila RoACTEMRA.
English: In the 12 week double-blind, controlled phase, 75 patients received treatment with tocilizumab (8 mg/kg or 12 mg/kg based upon body weight).
Slovenian: V 12-tedenski, dvojno slepi, kontrolirani fazi je 75 bolnikov prejelo zdravljenje s tocilizumabom (8 mg/kg ali 12 mg/kg telesne mase).
English: • Do not use the syringe if it appears to be damaged
Slovenian: • Ne uporabljajte napolnjene injekcijske brizge, če se vam zdi poškodovana.
English: For persistent increases in this range, reduce RoActemra dose frequency to every other week injection or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised.
Slovenian: V primeru dolgotrajnih zvišanj v tem razponu zmanjšajte pogostnost odmerjanja injekcij zdravila RoActemra na enkrat na dva tedna ali prekinite njegovo uporabo, dokler se alanin-aminotransferaza (ALT) ali aspartat-aminotransferaza (AST) ne normalizira.
English: Ask your healthcare provider or pharmacist for information about where you can get a "sharps" container or what other types of puncture-resistant containers you can use to safely dispose of your used syringes, if you do not have one.
Slovenian: Posvetujte se z zdravstvenim delavcem ali farmacevtom o tem, kje bi lahko dobili tak zabojnik oziroma kakšen zabojnik lahko uporabite za varno odstranitev uporabljenih napolnjenih injekcijskih brizg (glejte sliko I).
English: You will need the following to give your injection: Included in the box:
Slovenian: Za dajanje injekcije boste potrebovali:
English: In the 12 week controlled phase, the rate of serious infections in the intravenous RoActemra group was 11.5 per 100 patient years.
Slovenian: V 12-tedenski, kontrolirani fazi je bil delež resnih okužb v skupini, ki je prejemala intravensko obliko zdravila RoActemra, 11,5 na 100 bolnik-let.
English: Do not repeat the injection with another pre-filled pen.
Slovenian: Injiciranja ne ponavljajte z drugim napolnjenim injekcijskim peresnikom.
English: All patients treated with RoActemra should be given the Patient Alert Card.
Slovenian: Vsi bolniki, ki se zdravijo z zdravilom RoActemra, morajo dobiti opozorilno kartico za bolnika.
English: • The recommended injection sites are the front and middle of your thighs and the lower part of the abdomen below the navel (belly button) except for the five centimeter area directly around the navel.
Slovenian: • Priporočena mesta injiciranja so sredinska sprednja stran stegen in spodnji del trebuha pod popkom, razen petcentimetrskega območja neposredno okoli popka (glejte sliko B).
English: A decrease in platelet count below 100 × 103 / μL was not observed in either of the placebo plus prednisone taper groups.
Slovenian: Zmanjšanja števila trombocitov pod 100 × 103/µl niso opažali v nobeni od skupin, ki sta prejemali placebo in prednizon v zmanjšujočem se odmerku.
English: The steady-state profile following the RoActemra weekly dose was almost flat, with very little fluctuations between trough and peak values, while there were substantial fluctuations for the RoActemra every other weekly dose.
Slovenian: Profil v stanju dinamičnega ravnovesja je bil po uporabi zdravila RoActemra vsak teden skoraj raven, z zelo majhnimi nihanji med najnižjimi in najvišjimi vrednostmi, medtem ko so bila nihanja pri uporabi zdravila RoActemra vsak drugi teden občutna.
English: Caution should be exercised when considering initiation of RoActemra treatment in patients with elevated ALT or AST > 1.5 x ULN.
Slovenian: Previdnost je potrebna, če razmišljate o uvedbi zdravila RoActemra pri bolnikih, ki imajo ALT ali AST zvišano na > 1,5-kratno ZMN.
English: • To use the pre-filled pen, you first have to unlock the green Activation button.
Slovenian: • Pred uporabo napolnjenega injekcijskega peresnika morate najprej odkleniti zelen gumb za aktivacijo.
English: Thirty patients (1.1%) developed neutralising antibodies.
Slovenian: Pri 30 bolnikih (1,1 %) so se pojavila nevtralizacijska protitelesa.
English: The tocilizumab 8 mg/kg + MTX group also showed statistically significant results across the key secondary endpoints.
Slovenian: V skupini s tocilizumabom 8 mg/kg in metotreksatom so bili statistično značilni tudi rezultati za ključne sekundarne cilje.
English: This leaflet was last revised
Slovenian: Navodilo je bilo nazadnje revidirano Drugi viri informacij
English: Diarrhea pJIA, sJIA
Slovenian: diareja pJIA, sJIA
English: • Do not touch the needle or let it touch any surface.
Slovenian: • Ne prijemajte injekcijske igle in se z njo ne dotikajte nobenih površin.
English: • if you or a child patient you look after are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični ali je bolnik otrok, za katerega skrbite, alergičen na tocilizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: The total patient exposure to RoActemra in the pJIA all exposure population was 184.4 patient years for IV and 50.4 patient years for SC tocilizumab.
Slovenian: Skupna izpostavljenost bolnikov s pJIA zdravilu RoActemra je bila pri vsej izpostavljeni populaciji 184,4 bolnik-let za intravenski in 50,4 bolnik-let za subkutani tocilizumab.
English: Following SC dosing in sJIA patients, the absorption half-life was around 2 days, and the bioavailability for the SC formulation in sJIA patients was 95%.
Slovenian: Po subkutanem odmerjanju pri bolnikih s sJIA je razpolovni čas absorpcije znašal približno 2 dneva; biološka uporabnost za subkutano obliko pri bolnikih s sJIA je bila 95 %.
English: RoActemra normalises expression of these enzymes.
Slovenian: Zdravilo RoActemra normalizira ekspresijo teh encimov.
English: Four patients were tested positive for IgE isotype (0.9%).
Slovenian: Pri štirih bolnikih se je pojavil izotip IgE (0,9 %).
English: In the 12 week controlled phase, 16% of patients in the tocilizumab group and 5.4% of patients in the placebo group experienced an event within 24 hours of infusion.
Slovenian: V 12-tedenski, kontrolirani fazi je 16 % bolnikov v skupini, ki je prejemala tocilizumab in 5,4 % bolnikov v skupini, ki je prejemala placebo, doživelo neželeni učinek v 24 urah po infundiranju.
English: The dose should be calculated based on the patient's body weight at each administration.
Slovenian: Odmerek je treba izračunati glede na bolnikovo telesno maso pred vsakim dajanjem.
English: Injection into muscle could result in an uncomfortable injection.
Slovenian: Injiciranje v mišico lahko povzroči neugodje.
English: Caution should be exercised when considering initiation of RoActemra treatment in patients with a low platelet count (i.e. platelet count below 100 x 103/ μL).
Slovenian: Previdnost je potrebna, če razmišljate o uvedbi zdravila RoActemra pri bolnikih z majhnim številom trombocitov (tj. številom trombocitov pod 100 x 103/µl).
English: • tiredness,
Slovenian: • utrujenost,
English: Given its long elimination half-life (t1/2), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Slovenian: Glede na dolg eliminacijski razpolovni čas (t1/2) tocilizumaba lahko njegov učinek na aktivnost encima CYP450 traja še več tednov po koncu zdravljenja.
English: Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra.
Slovenian: Zdravnik vas bo preiskal glede znakov in simptomov tuberkuloze, preden vas bo začel zdraviti z zdravilom RoActemra.
English: Very rare side effects: These may affect up to 1 in every 10,000 patients
Slovenian: Zelo redki neželeni učinki: Ti se lahko pojavijo pri največ 1 od 10.000 bolnikov.
English: After 2 years of treatment with RoActemra plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Slovenian: Po 2 letih zdravljenja z zdravilom RoActemra v kombinaciji z metotreksatom je 14 % bolnikov doseglo pomembnejšo klinično odzivnost (vzdrževanje odziva ACR 70 24 tednov ali več).
English: Radiographic response
Slovenian: Radiološka ocena
English: The pharmacokinetics of RoActemra is characterized by nonlinear elimination which is a combination of linear clearance and Michaelis-Menten elimination.
Slovenian: Značilnost farmakokinetike zdravila RoActemra je nelinearno izločanje, ki je kombinacija linearnega očistka in Michaelis-Mentenovega izločanja.
English: followed by a 104-week open-label extension (Part 2).
Slovenian: 104-tedensko podaljšanje z odprtim načrtom zdravljenja (2. del).
English: How do I dispose of used pre-filled pens?
Slovenian: Kako naj odstranim uporabljene napolnjene injekcijske peresnike?
English: Dose modify concomitant DMARDs (RA) or immunomodulatory agents (GCA) if appropriate.
Slovenian: Prilagodite odmerek sočasnih imunomodulirajočih antirevmatičnih zdravil (revmatoidni artritis) ali imunomodulirajočih zdravil (GCA), če je primerno.
English: A median of 1 dose of tocilizumab (range, 1-4 doses) was administered.
Slovenian: Mediano so prejeli 1 odmerek tocilizumaba (razpon: 1 - 4 odmerki).
English: • The purple indicator will move along the Window area during the injection (See Figure K).
Slovenian: • Med injiciranjem se bo vijolični indikator premaknil vzdolž območja okenca (glejte sliko K).
English: • lung infection (pneumonia)
Slovenian: • okužba pljuč (pljučnica),
English: Numerically greater responses compared with MTX alone were observed in the tocilizumab 8 mg/kg monotherapy group in all secondary endpoints, including radiographic endpoints.
Slovenian: Številčno večje odzive v primerjavi s samim metotreksatom so opazili v skupini s tocilizumabom 8 mg/kg v monoterapiji pri vseh sekudarnih ciljih, vključno z radiološkimi.
English: In GCA clinical study WA28119, similar rapid decreases in CRP and ESR were observed along with slight increases in mean corpuscular haemoglobin concentration.
Slovenian: V klinični študiji GCA (WA28119) so skupaj z rahlimi zvečanji povprečne koncentracije hemoglobina v eritrocitih opažali podobno hitro znižanje CRP in hitrosti sedimentacije eritrocitov.
English: One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg.
Slovenian: Opisan je en primer naključnega prevelikega odmerjanja, pri katerem je bolnik z multiplim mielomom dobil 40 mg/kg v enem odmerku.
English: Limited data are available regarding exposures following subcutaneous administration of RoActemra in sJIA patients below 2 years of age with a body weight less than 10 kg.
Slovenian: Razpoložljivih podatkov o izpostavljenosti po subkutanem dajanju zdravila RoActemra pri bolnikih s sJIA, mlajših od 2 let, s telesno maso manj kot 10 kg, je malo.
English: Consistent with the effect on acute phase reactants, treatment with tocilizumab was associated with reduction in platelet count within the normal range.
Slovenian: Skladno z vplivom na reaktante akutne faze je bilo zdravljenje s tocilizumabom povezano z zmanjšanjem števila trombocitov znotraj normalnega območja.
English: If you cannot start the injection you should ask for help from a caregiver or contact your healthcare provider.
Slovenian: Če ne morete začeti z injiciranjem, za pomoč prosite skrbnika ali se obrnite na zdravstvenega delavca.
English: Do not use the pre-filled pen if the expiration date has passed because it may not be safe to use.
Slovenian: Napolnjenega injekcijskega peresnika ne uporabite, če je rok uporabnosti potekel, ker morda ni varen za uporabo.
English: The physician's global assessment of disease activity, as measured on a 0-100 mm scale, showed a greater reduction in disease activity for tocilizumab compared to placebo (adjusted mean changes of -45.2 mm vs -35.2 mm, p=0.0031).
Slovenian: Zdravnikova celokupna ocena aktivnosti bolezni izmerjena po lestvici 0-100 mm je pokazala večje zmanjšanje aktivnosti bolezni za tocilizumab v primerjavi s placebom (prilagojeni povprečni spremembi: -45,2 mm v primerjavi z35,2 mm; p = 0,0031).
English: - Methotrexate
Slovenian: - metotreksat
English: Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°C.
Slovenian: Ko zdravilo RoActemra vzamemo iz hladilnika, ga je treba uporabiti v 8 urah, pri čemer ga ne smemo hraniti nad 30 °C
English: RoActemra is not recommended for use with other biological agents.
Slovenian: Zdravila RoActemra ni priporočljivo uporabljati z drugimi biološkimi zdravili.
English: Study IV evaluated 1,220 patients who had an inadequate response to their existing rheumatologic therapy, including one or more DMARDs.
Slovenian: Študija IV je ocenila 1220 bolnikov, ki se niso zadostno odzvali na svoje obstoječe revmatološko zdravljenje, vključno z enim ali več imunomodulirajočimi antirevmatičnimi zdravili.
English: uncommon (≥ 1/1,000 to < 1/100) rare, (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Slovenian: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000) ali zelo redki (< 1/10.000).
English: • if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na tocilizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: The recommended posology is 8 mg/kg body weight, given once every four weeks.
Slovenian: Priporočeno odmerjanje je 8 mg/kg telesne mase enkrat na 4 tedne.
English: • Use your other hand to gently pinch the area of skin you cleaned, to prepare a firm injection site (See Figure G).
Slovenian: • Na mestu, ki ste ga očistili, s pomočjo druge roke naredite kožno gubo, da pripravite čvrsto mesto injiciranja (glejte sliko G).
English: • upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache,
Slovenian: • okužbe zgornjih dihal s tipičnimi simptomi, kot so kašelj, zamašen nos, izcedek iz nosu, boleče žrelo in glavobol,
English: Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with RoActemra.
Slovenian: Med zdravljenjem z zdravilom RoActemra mora biti na voljo ustrezno zdravljenje za takojšnjo uporabo v primeru anafilaktične reakcije.
English: • If you have had intestinal ulcers or diverticulitis, tell your doctor.
Slovenian: • Če ste kdaj imeli razjede na črevesu ali divertikulitis, morate to povedati zdravniku.
English: In the all exposure population the overall rate of serious infections was 4.7 events per 100 pt years.
Slovenian: V celotni izpostavljeni populaciji je bil celokupni delež resnih okužb 4,7 dogodka na 100 bolnik-let.
English: After 2 years of treatment with tocilizumab plus MTX, 14% of patients achieved a major clinical response (maintenance of an ACR70 response for 24 weeks or more).
Slovenian: Po 2 letih zdravljenja s tocilizumabom v kombinaciji z metotreksatom je 14 % bolnikov doseglo pomembnejšo klinično odzivnost (vzdrževanje odziva ACR 70 24 tednov ali več).
English: The safety of RoActemra has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Slovenian: Varnost zdravila RoActemra so preučevali v štirih s placebom kontroliranih študijah (študije II, III, IV in V), eni z metotreksatom kontrolirani študiji (študija I) ter v njihovih podaljšanih fazah (glejte poglavje 5.1).
English: The usual dose of RoActemra depends on your weight.
Slovenian: Običajni odmerek zdravila RoActemra je odvisen od vaše telesne mase.
English: Do not use RoActemra.
Slovenian: Ne uporabite zdravila RoActemra.
English: In GCA patients, no effect of cumulative corticosteroid dose on RoActemra exposure was observed.
Slovenian: Pri bolnikih z GCA niso opazili učinka kumulativnega odmerka kortikosteroida na izpostavljenost zdravilu RoActemra.
English: A total of 5.8% of patients experienced an elevation of indirect bilirubin of > 1 to 2 x ULN and 0.4% had an elevation of > 2 x ULN.
Slovenian: Pri 5,8 % bolnikov se je indirektni bilirubin zvišal na vrednost med 1-kratno in 2-kratno ZMN; pri 0,4 % bolnikov pa se je zvišal nad 2-kratno ZMN.
English: The total content (0.9 mL) of the pre-filled syringe should be administered as a subcutaneous injection.
Slovenian: Celotno vsebino (0,9 ml) napolnjene injekcijske brizge je treba dati kot subkutano injekcijo.
English: Live and live attenuated vaccines should not be given concurrently with RoActemra as clinical safety has not been established.
Slovenian: Med zdravljenjem z zdravilom RoActemra ne smete uporabljati živih in živih oslabljenih cepiv, ker klinična varnost ni ugotovljena.
English: Children and adolescents RoActemra is not recommended for use in children under 2 years of age.
Slovenian: Otroci in mladostniki Zdravila RoActemra ni priporočljivo uporabljati pri otrocih, mlajših od 2 let.
English: This study evaluated the efficacy of IV tocilizumab 4 or 8 mg/kg every 4 weeks/MTX combination therapy, IV tocilizumab 8 mg/kg monotherapy and MTX monotherapy in reducing the signs and symptoms and rate of progression of joint damage for 104 weeks.
Slovenian: Ta študija je ocenjevala učinkovitost intravensko danega tocilizumaba 4 mg/kg ali 8 mg/kg vsake 4 tedne v kombinaciji z metotreksatom, intravensko danega tocilizumaba 8 mg/kg v monoterapiji in metotreksata v monoterapiji na zmanjšanje znakov in simptomov ter hitrosti napredovanja okvare sklepov v 104 tednih.
English: Some side effects are seen more often in children and adolescents: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Slovenian: Nekateri neželeni učinki so pogostejši pri otrocih in mladostnikih: vnetje nosu in grla, glavobol, občutek slabosti (navzea) in manjše število belih krvnih celic.
English: Following subcutaneous dosing in GCA patients, the absorption t½ was around 4 days.
Slovenian: Po subkutani uporabi pri bolnikih z GCA je bil t1/2 absorpcije približno 4 dni.
English: In sJIA and pJIA patients, neutrophils and platelets should be monitored at the time of the second administration and thereafter according to good clinical practice (see section 4.2).
Slovenian: Pri bolnikih s sJIA in pJIA je treba nevtrofilce in trombocite kontrolirati v času druge aplikacije, pozneje pa v skladu z dobro klinično prakso (glejte poglavje 4.2).
English: • Be sure not to touch the cleaned area prior to the injection.
Slovenian: • Ne dotikajte se očiščenega mesta, preden si daste injekcijo.
English: The developed model had the same structure as the population PK model developed earlier based on data from RA patients (see Table 8).
Slovenian: Razviti model je imel enako zgradbo kot model populacijske farmakokinetike, oblikovan pred tem na podlagi podatkov bolnikov z revmatoidnim artritisom (glejte preglednico 8).
English: Children with pJIA (aged 2 and over)
Slovenian: Otroci s pJIA (stari 2 leti ali več)
English: DAS28 ≤ 3.2, n (%) 32 (19.8) ACR20 response, n (%) 80 (49.4) ACR50 response, n (%) 45 (27.8) ACR70 response, n (%) 29 (17.9)
Slovenian: DAS28 ≤ 3,2, n (%) 32 (19,8) odziv ACR20, n (%) 80 (49,4) odziv ACR50, n (%) 45 (27,8) odziv ACR70, n (%) 29 (17,9)
English: The excretion of RoActemra in milk has not been studied in animals.
Slovenian: Izločanje zdravila RoActemra v mleko pri živalih ni raziskano.
English: • Serious injection/infusion reaction and their management
Slovenian: • resne reakcije, povezane z injiciranjem/infundiranjem in njihovo obvladovanje,
English: Multiplicity controlled using Bonferroni-Holm Procedure
Slovenian: Za nadzor multiplicitete so uporabili Holm-Bonferronijevo korekcijo.