natgillin/translations-raw huggingface dataset:
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). 
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).
Radiographic response 
Radiološka ocena
The pharmacokinetics of RoActemra is characterized by nonlinear elimination which is a combination of linear clearance and Michaelis-Menten elimination. 
Značilnost farmakokinetike zdravila RoActemra je nelinearno izločanje, ki je kombinacija linearnega očistka in Michaelis-Mentenovega izločanja.
followed by a 104-week open-label extension (Part 2). 
104-tedensko podaljšanje z odprtim načrtom zdravljenja (2. del).
How do I dispose of used pre-filled pens? 
Kako naj odstranim uporabljene napolnjene injekcijske peresnike?
Dose modify concomitant DMARDs (RA) or immunomodulatory agents (GCA) if appropriate. 
Prilagodite odmerek sočasnih imunomodulirajočih antirevmatičnih zdravil (revmatoidni artritis) ali imunomodulirajočih zdravil (GCA), če je primerno.
A median of 1 dose of tocilizumab (range, 1-4 doses) was administered. 
Mediano so prejeli 1 odmerek tocilizumaba (razpon: 1 - 4 odmerki).
• The purple indicator will move along the Window area during the injection (See Figure K). 
• Med injiciranjem se bo vijolični indikator premaknil vzdolž območja okenca (glejte sliko K).
• lung infection (pneumonia) 
• okužba pljuč (pljučnica),
Numerically greater responses compared with MTX alone were observed in the tocilizumab 8 mg/kg monotherapy group in all secondary endpoints, including radiographic endpoints. 
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.
In GCA clinical study WA28119, similar rapid decreases in CRP and ESR were observed along with slight increases in mean corpuscular haemoglobin concentration. 
V klinični študiji GCA (WA28119) so skupaj z rahlimi zvečanji povprečne koncentracije hemoglobina v eritrocitih opažali podobno hitro znižanje CRP in hitrosti sedimentacije eritrocitov.
One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg. 
Opisan je en primer naključnega prevelikega odmerjanja, pri katerem je bolnik z multiplim mielomom dobil 40 mg/kg v enem odmerku.
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. 
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.
Consistent with the effect on acute phase reactants, treatment with tocilizumab was associated with reduction in platelet count within the normal range. 
Skladno z vplivom na reaktante akutne faze je bilo zdravljenje s tocilizumabom povezano z zmanjšanjem števila trombocitov znotraj normalnega območja.
If you cannot start the injection you should ask for help from a caregiver or contact your healthcare provider. 
Če ne morete začeti z injiciranjem, za pomoč prosite skrbnika ali se obrnite na zdravstvenega delavca.
Do not use the pre-filled pen if the expiration date has passed because it may not be safe to use. 
Napolnjenega injekcijskega peresnika ne uporabite, če je rok uporabnosti potekel, ker morda ni varen za uporabo.
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). 
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).
- Methotrexate 
- metotreksat
Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°C. 
Ko zdravilo RoActemra vzamemo iz hladilnika, ga je treba uporabiti v 8 urah, pri čemer ga ne smemo hraniti nad 30 °C
RoActemra is not recommended for use with other biological agents. 
Zdravila RoActemra ni priporočljivo uporabljati z drugimi biološkimi zdravili.
Study IV evaluated 1,220 patients who had an inadequate response to their existing rheumatologic therapy, including one or more DMARDs. 
Študija IV je ocenila 1220 bolnikov, ki se niso zadostno odzvali na svoje obstoječe revmatološko zdravljenje, vključno z enim ali več imunomodulirajočimi antirevmatičnimi zdravili.
uncommon (≥ 1/1,000 to < 1/100) rare, (≥1/10,000 to <1/1,000) or very rare (<1/10,000). 
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).
• if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na tocilizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
The recommended posology is 8 mg/kg body weight, given once every four weeks. 
Priporočeno odmerjanje je 8 mg/kg telesne mase enkrat na 4 tedne.
• Use your other hand to gently pinch the area of skin you cleaned, to prepare a firm injection site (See Figure G). 
• Na mestu, ki ste ga očistili, s pomočjo druge roke naredite kožno gubo, da pripravite čvrsto mesto injiciranja (glejte sliko G).
• upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache, 
• okužbe zgornjih dihal s tipičnimi simptomi, kot so kašelj, zamašen nos, izcedek iz nosu, boleče žrelo in glavobol,
Appropriate treatment should be available for immediate use in the event of an anaphylactic reaction during treatment with RoActemra. 
Med zdravljenjem z zdravilom RoActemra mora biti na voljo ustrezno zdravljenje za takojšnjo uporabo v primeru anafilaktične reakcije.
• If you have had intestinal ulcers or diverticulitis, tell your doctor. 
• Če ste kdaj imeli razjede na črevesu ali divertikulitis, morate to povedati zdravniku.
In the all exposure population the overall rate of serious infections was 4.7 events per 100 pt years. 
V celotni izpostavljeni populaciji je bil celokupni delež resnih okužb 4,7 dogodka na 100 bolnik-let.
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). 
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).
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). 
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).
The usual dose of RoActemra depends on your weight. 
Običajni odmerek zdravila RoActemra je odvisen od vaše telesne mase.
Do not use RoActemra. 
Ne uporabite zdravila RoActemra.
In GCA patients, no effect of cumulative corticosteroid dose on RoActemra exposure was observed. 
Pri bolnikih z GCA niso opazili učinka kumulativnega odmerka kortikosteroida na izpostavljenost zdravilu RoActemra.
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. 
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.
The total content (0.9 mL) of the pre-filled syringe should be administered as a subcutaneous injection. 
Celotno vsebino (0,9 ml) napolnjene injekcijske brizge je treba dati kot subkutano injekcijo.
Live and live attenuated vaccines should not be given concurrently with RoActemra as clinical safety has not been established. 
Med zdravljenjem z zdravilom RoActemra ne smete uporabljati živih in živih oslabljenih cepiv, ker klinična varnost ni ugotovljena.
Children and adolescents RoActemra is not recommended for use in children under 2 years of age. 
Otroci in mladostniki Zdravila RoActemra ni priporočljivo uporabljati pri otrocih, mlajših od 2 let.
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. 
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.
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. 
Nekateri neželeni učinki so pogostejši pri otrocih in mladostnikih: vnetje nosu in grla, glavobol, občutek slabosti (navzea) in manjše število belih krvnih celic.
Following subcutaneous dosing in GCA patients, the absorption t½ was around 4 days. 
Po subkutani uporabi pri bolnikih z GCA je bil t1/2 absorpcije približno 4 dni.
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). 
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).
• Be sure not to touch the cleaned area prior to the injection. 
• Ne dotikajte se očiščenega mesta, preden si daste injekcijo.
The developed model had the same structure as the population PK model developed earlier based on data from RA patients (see Table 8). 
Razviti model je imel enako zgradbo kot model populacijske farmakokinetike, oblikovan pred tem na podlagi podatkov bolnikov z revmatoidnim artritisom (glejte preglednico 8).
Children with pJIA (aged 2 and over) 
Otroci s pJIA (stari 2 leti ali več)
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) 
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)
The excretion of RoActemra in milk has not been studied in animals. 
Izločanje zdravila RoActemra v mleko pri živalih ni raziskano.
• Serious injection/infusion reaction and their management 
• resne reakcije, povezane z injiciranjem/infundiranjem in njihovo obvladovanje,
Multiplicity controlled using Bonferroni-Holm Procedure 
Za nadzor multiplicitete so uporabili Holm-Bonferronijevo korekcijo.
Drug-induced liver injury, Hepatitis, Jaundice, Very rare: Hepatic failure 
žolčnika in žolčevodov z zdravili povzročena okvara jeter, hepatitis, zlatenica; zelo redko: odpoved jeter
Age, gender and ethnicity: Population pharmacokinetic analyses in RA and GCA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of RoActemra. 
Starost, spol in etnična pripadnost: analize populacijske farmakokinetike pri bolnikih z revmatoidnim artritisom in GCA so pokazale, da starost, spol in etnična pripadnost ne vplivajo na farmakokinetiko zdravila RoActemra.
• RoActemra is used to treat children with sJIA. 
• Zdravilo RoActemra se uporablja za zdravljenje otrok s sJIA.
No correlation between antibody development and clinical response or adverse events was observed 
Povezave med tvorbo protiteles in kliničnim odzivom ali neželenimi dogodki ni bilo.
Resolution of CRS was defined as lack of fever and off vasopressors for at least 24 hours. 
Opredelili so, da je CRS izzvenel, če vsaj 24 ur ni bilo zvišane telesne temperature in uporabe vazopresorjev.
RoActemra treatment must not be initiated in patients with active infections (see section 4.3). 
Zdravljenja z zdravilom RoActemra ne smete uvesti pri bolnikih z aktivnimi okužbami (glejte poglavje 4.3).
• Check the pre-filled pen to make sure it is not damaged. 
• Preverite napolnjeni injekcijski peresnik in se prepričajte, da ni poškodovan.
In the long-term exposure population, the overall rate of serious infections (bacterial, viral and fungal) was 4.7 events per 100 patient years. 
V dolgoročno izpostavljeni populaciji je bil celokupni delež resnih okužb (bakterijskih, virusnih in glivičnih) 4,7 dogodka na 100 bolnik-let.
• Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). 
• Kožno gubo je pomembno pripraviti, da zagotovite injiciranje zdravila pod kožo (v maščobno tkivo), ne pa globlje (v mišico).
*τ = 4 weeks for IV regimens 
*τ = 4 tedne za intravenska režima
Not allowing the syringe to come to room temperature could result in an uncomfortable injection and it may be difficult to depress the plunger. 
Če ne pustite injekcijske brizge, da se ogreje do sobne temperature, lahko to povzroči neudobno injiciranje in morda bo težko pritisniti na bat.
Adding RoActemra to the treatment means that steroids can be used for a shorter time, while still controlling GCA. 
Z dodajanjem zdravila RoActemra k zdravljenju boste lahko kortikosteroide prejemali krajši čas, kljub temu pa bo gigantocelični arteriitis ostal pod nadzorom.
For ALT or AST elevations > 3-5 x ULN, confirmed by repeat testing, RoActemra treatment should be interrupted. 
V primeru zvišanja ALT ali AST na > 3- do 5-kratno ZMN, ki je potrjeno s ponovnim testiranjem, je treba zdravljenje z zdravilom RoActemra prekiniti.
The median values of Tmax were 3 days after the RoActemra weekly dose and 4.5 days after the tocilizumab every other week dose. 
Mediani Tmax je bil 3 dni po uporabi zdravila RoActemra vsak teden in 4,5 dni po uporabi vsak drugi teden.
Reported serious infections, some with fatal outcome, included pneumonia, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis, bacterial arthritis. 
Med opisanimi resnimi okužbami, od katerih so se nekatere končale tudi s smrtnim izidom, so bile pljučnica, celulitis, herpes zoster, gastroenteritis, divertikulitis, sepsa in bakterijski artritis.
At week 12, the proportion of tocilizumab treated patients showing a minimally clinically important improvement in the Childhood Health Assessment Questionnaire - Disability Index (defined as an individual total score decrease of ≥ 0.13) was significantly higher than in placebo treated patients, 77% versus 19% (p<0.0001). 
Izidi, povezani s splošnim zdravstvenim stanjem in kakovostjo življenja V 12. tednu je bil delež bolnikov, zdravljenih s tocilizumabom, pri katerih je bilo vsaj minimalno klinično pomembno izboljšanje glede na vprašalnik Childhood Health Assessment QuestionaireDisability Index (definirano kot individualno zmanjšanje celokupne ocene ≥ 0,13) signifikantno večji kot pri bolnikih, ki so prejemali placebo (77 % v primerjavi z 19 %) (p < 0,0001).
If you are given more RoActemra than you should Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much. 
Če ste dobili večji odmerek zdravila RoActemra, kot bi smeli Ker vam bo zdravilo RoActemra dal zdravnik ali medicinska sestra, ni verjetno, da bi ga dobili preveč.
Supplies needed for an injection using your RoACTEMRA pre-filled pen (See Figure B): 
Pripomočki, potrebni za injiciranje zdravila RoACTEMRA z uporabo napolnjenega injekcijskega peresnika (glejte sliko B):
The number of active joints was significantly reduced compared to baseline in patients receiving tocilizumab compared to placebo (adjusted mean changes of -14.3 vs -11.4, p=0.0435). 
Število aktivnih sklepov se je signifikantno zmanjšalo v primerjavi z izhodiščno vrednostjo pri bolnikih, ki so prejemali tocilizumab v primerjavi z bolniki, ki so prejemali placebo (prilagojeni povprečni spremembi: -14,3 v primerjavi z -11,4; p = 0,0435).
The pre-filled pen requires a firm injection site to properly activate. 
Za pravilno aktivacijo napolnjenega injekcijskega peresnika je potrebno čvrsto mesto injiciranja.
In the 12 week controlled phase, 4% of patients from the tocilizumab group experienced events occurring during infusion. 
V 12-tedenski, kontrolirani fazi je 4 % bolnikov iz skupine, ki je jemala tocilizumab, imelo neželene učinke, ki so se pojavili med infundiranjem.
The safety profile of intravenous RoActemra in pJIA has been studied in 188 patients from 2 to 17 years of age. 
Varnostni profil intravenske oblike zdravila RoActemra pri bolnikih s pJIA so proučevali pri 188 bolnikih, starih od 2 do 17 let.
pJIA Patients: 
Bolniki s pJIA:
A higher incidence of infections and infestations was reported in the tocilizumab arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%). 
O večji incidenci infekcijskih in parazitskih bolezni so poročali v skupini s tocilizumabom (48 % v primerjavi z 42 %), razlik v incidenci resnih okužb pa ni bilo (3,1 %).
Complications of diverticulitis 
Zapleti divertikulitisa
Clinical Efficacy 
Klinična učinkovitost
Children with pJIA 
Otroci s pJIA
• The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, LArginine, L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections. 
• Druge sestavine zdravila so L-histidin, L-histidinijev monoklorid monohidrat, L-arginin, Largininijev klorid, L-metionin, polisorbat 80 in voda za injekcije.
In healthy subjects administered tocilizumab in doses from 2 to 28 mg/kg, absolute neutrophil counts decreased to their lowest 3 to 5 days following administration. 
Pri zdravih preiskovancih, ki so dobili tocilizumab v odmerkih od 2 do 28 mg/kg, je bilo absolutno število nevtrofilcev najmanjše 3 do 5 dni po prejemu zdravila.
A higher incidence of infections and infestations was reported in the RoActemra arm (48% vs. 42%), with no difference in the incidence of serious infections (3.1%). 
O večji incidenci infekcijskih in parazitskih bolezni so poročali v skupini z zdravilom RoActemra (48 % v primerjavi z 42 %), razlik v incidenci resnih okužb pa ni bilo (3,1 %).
Infusion related reactions are defined as all events occurring during or within 24 hours of an infusion. 
Reakcije, povezane z infundiranjem, so definirane kot vsi neželeni učinki, ki se pojavijo med infundiranjem ali v 24 urah po njem.
Visually check the syringe 
Vizualno preglejte napolnjeno injekcijsko brizgo
In Part II, patients were randomized to tocilizumab (same dose received in Part I) or placebo in a 1:1 ratio, stratified by concurrent MTX use and concurrent corticosteroid use. 
delu so bili bolniki randomizirani v skupino, ki je prejemala tocilizumab (enak odmerek kot v I. fazi) ali placebo v razmerju 1:1, stratifikacijo so naredili glede na sočasno uporabo metotreksata in kortikosteroidov.
Most of the patients in the RA and GCA studies population pharmacokinetic analysis had normal renal function or mild renal impairment. 
Večina bolnikov v študijah revmatoidnega artritisa in GCA iz analize populacijske farmakokinetike je imela normalno delovanje ledvic ali blago okvaro ledvic.
Given its long elimination half-life (t1/2), the effect of RoActemra on CYP450 enzyme activity may persist for several weeks after stopping therapy. 
Glede na dolg eliminacijski razpolovni čas (t1/2) zdravila RoActemra lahko njegov učinek na aktivnost encima CYP450 traja še več tednov po koncu zdravljenja.
In the SC Study (WA28118), 46 of the 51 (90.2%) patients tested for anti-tocilizumab antibodies at baseline had at least one post-baseline screening assay result. 
V študiji s subkutano obliko (WA28118) so pri 46 od 51 bolnikov (90,2 %), pri katerih so preverili protitelesa proti tocilizumabu v izhodišču, opravili vsaj en presejalni test po izhodišču.
After dilution, RoActemra for RA, sJIA, pJIA, and CRS patients should be administered as an intravenous infusion over 1 hour. 
Po razredčenju je treba zdravilo RoActemra bolnikom z revmatoidnim artritisom, sJIA, pJIA in CRS dati v 1-urni intravenski infuziji.
Injection into muscle could cause the injection to feel uncomfortable. 
Injiciranje v mišico lahko povzroči, da je le-to neprijetno.
Thereafter, neutrophils recovered towards baseline in a dose dependent manner. 
Potem se je število nevtrofilcev povečevalo nazaj proti izhodiščni vrednosti v odvisnosti od odmerka.
Study III OPTION 
Študija III
• low counts for white blood cells, red blood cells and platelets in blood tests. 
• nizke vrednosti belih krvnih celic, rdečih krvnih celic in trombocitov v krvi, • odpoved jeter.
For individuals whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended (see section 5.2). 
Za posameznike, ki tehtajo več kot 100 kg, odmerki, ki presegajo 800 mg na infuzijo, niso priporočljivi (glejte poglavje 5.2).
Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label RoActemra 8 mg/kg in year 2. 
Od bolnikov, ki so zaključili študijo, in ki so bili na začetku randomizirani v skupino s placebom ter metotreksatom, jih je 86 % prejemalo odprto zdravljenje z zdravilom RoActemra 8 mg/kg v 2. letu.
• Keep out of the reach of children. 
• Shranjujte nedosegljivo otrokom.
Age, gender and ethnicity: Population pharmacokinetic analyses in RA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of tocilizumab. 
Starost, spol in etnična pripadnost: analize populacijske farmakokinetike pri bolnikih z revmatoidnim artritisom so pokazale, da starost, spol in etnična pripadnost ne vplivajo na farmakokinetiko tocilizumaba.
You should not stop using RoActemra without discussing with your doctor first. 
Zdravila RoActemra ne smete nehati uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. 
Zdravilo RoActemra je v kombinaciji z metotreksatom indicirano za zdravljenje juvenilnega idiopatskega poliartritisa (pJIA; s pozitivnim ali negativnim revmatoidnim faktorjem in razširjenim oligoartritisom) pri bolnikih, starih 2 leti ali več, ki se niso zadostno odzvali na predhodno zdravljenje z metotreksatom.
• Open the box, and remove 1 single-use RoACTEMRA pre-filled pen from the box. 
• Odprite škatlo in vzemite iz nje en napolnjeni injekcijski peresnik z zdravilom RoACTEMRA za enkratno uporabo.
RoActemra subcutaneous formulation is not intended to be given to children with sJIA weighing less than 10 kg. 
Subkutana oblika zdravila RoActemra ni namenjena dajanju otrokom s sJIA, ki tehtajo manj kot 10 kg.
The safety profile of subcutaneous RoActemra was evaluated in 51 paediatric patients (1 to 17 years of age) with sJIA. 
Varnostni profil subkutane oblike zdravila RoActemra je bil ovrednoten pri 51 pediatričnih bolnikih (starih od 1 do 17 let) s sJIA.
The excretion of tocilizumab in milk has not been studied in animals. 
Izločanje tocilizumaba v mleko pri živalih ni raziskano.
Based on the current characterization of PK, RoActemra trough concentration at steady state are 50% higher in this population relative to average concentrations in a large dataset from the RA population. 
Na podlagi trenutno opredeljene farmakokinetike je v tej populaciji v stanju dinamičnega ravnovesja opazna za 50 % večja najmanjša koncentracija zdravila RoActemra pred naslednjim odmerkom v primerjavi s povprečno koncentracijo v velikem naboru podatkov populacije z revmatoidnim artritisom.
The Patient Information Pack should contain the following key elements: 
Izobraževalno gradivo za bolnike mora vključevati naslednje ključne elemente:
The usual dose of RoActemra is 8 mg per kg of body weight. 
Običajni odmerek zdravila RoActemra je 8 mg na kg telesne mase.