FrancophonIA/ELRC3.0 huggingface dataset:
English: RoActemra is used to improve the symptoms of pJIA and can be given in combination with methotrexate or alone.
Slovenian: Zdravilo RoActemra se uporablja za izboljšanje simptomov pJIA in se lahko daje v kombinaciji z metotreksatom ali samostojno.
English: Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS.
Slovenian: Bolniki s hudim ali življenje ogrožajočim CRS imajo pogosto citopenije ali zvišane vrednosti ALT ali
English: List of ADRs occurring in patients treated with RoActemra MedDRA System Organ Class
Slovenian: Seznam neželenih učinkov pri bolnikih, zdravljenih z zdravilom RoActemra Organski sistem po MedDRA
English: What RoActemra looks like and contents of the pack RoActemra is a solution for injection.
Slovenian: Izgled zdravila RoActemra in vsebina pakiranja Zdravilo RoActemra je v obliki raztopine za injiciranje.
English: The safety and efficacy of intravenous RoActemra in children below 2 years of age has not been established.
Slovenian: Varnost in učinkovitost intravenske oblike zdravila RoActemra pri otrocih, mlajših od 2 let, ni dokazana.
English: As recommended for other biological treatments, RA, sJIA and pJIA patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Slovenian: Kot velja za druga biološka zdravila, je treba bolnike z revmatoidnim artritisom, sJIA in pJIA pred začetkom zdravljenja z zdravilom RoActemra presejalno pregledati glede latentne tuberkuloze.
English: • If you cannot remove the green cap you should ask a caregiver for help or contact your healthcare provider.
Slovenian: • Če zelenega pokrovčka ne morete odstraniti, se za pomoč obrnite na skrbnika ali zdravstvenega delavca.
English: Steady state was reached after 12 weeks for AUC and Cmin, and after 10 weeks for Cmax.
Slovenian: Stanje dinamičnega ravnovesja je bilo za AUC in Cmin doseženo po 12 tednih, za Cmax pa po 10 tednih.
English: Dose adjustments due to laboratory abnormalities (see section 4.4).
Slovenian: Prilagoditev odmerka zaradi nenormalnih laboratorijskih vrednosti (glejte poglavje 4.4).
English: At week 24, inhibition of structural damage was shown, with significantly less radiographic progression in patients receiving RoActemra subcutaneous compared to placebo (mean mTSS of 0.62 vs. 1.23, p=0.0149 (van Elteren).
Slovenian: Po 24. tednih so potrdili zavrtje strukturne okvare, na rentgenskih posnetkih je bilo značilno manj znakov napredovanja bolezni v skupini, ki je subkutano prejemala zdravilo RoActemra, v primerjavi s placebom (povprečna mTSS 0,62 v primerjavi z 1,23; p = 0,0149 (van Elteren)).
English: Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
Slovenian: Ena 400-mg viala vsebuje 0,39 mmol (8,85 mg) natrija.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: In pJIA patients, infusion related reactions are defined as all events occurring during or within 24 hours of an infusion.
Slovenian: Reakcije, povezane z infundiranjem, so pri bolnikih s pJIA definirane kot vsi neželeni učinki, ki se pojavijo med infundiranjem ali v 24 urah po njem.
English: Please also read the Patient Leaflet that comes with the RoActemra syringe for the most important information you need to know about the medicine.
Slovenian: Prosimo, preberite tudi navodilo za uporabo, ki je priloženo napolnjeni injekcijski brizgi, da se seznanite z najbolj pomembnimi informacijami o zdravilu.
English: mTSS Erosion Score JSN 0.03 Radiographic Non-Progression n (%) (change from baseline in mTSS of ≤0)
Slovenian: 52. teden mTSS 0,08*** ocena erozij ocena zožitve sklepne špranje Ne-napredovanje, merjeno radiološko n (%) (sprememba od izhodišča v mTSS ≤ 0)
English: Neurological disorders
Slovenian: Nevrološke motnje
English: At week 24, a significant reduction in DAS28 from baseline of 3.1 was observed on subcutaneous and 1.7 on placebo arm, and for DAS28 < 2.6, 32.0% was observed on subcutaneous and 4.0% on placebo arm.
Slovenian: V 24. tednu so opazili značilno znižanje DAS28 za 3,1 od izhodišča v subkutani skupini in 1,7 v skupini na placebu, DAS28 < 2,6 pa so opazili pri 32 % v subkutani skupini in 4,0 % v skupini na placebu.
English: The clinical data are insufficient to assess the potential incidence of malignancy following exposure to tocilizumab.
Slovenian: Kliničnih podatkov za oceno možne incidence malignomov po izpostavljenosti tocilizumabu ni dovolj.
English: The most common ISRs were erythema, pruritus, pain, and swelling at the injection site.
Slovenian: Najpogostejše reakcije na mestu injiciranja so bile eritem, srbenje, bolečina in oteklina na mestu injiciranja.
English: The primary endpoint for each of the five studies was the proportion of patients who achieved an ACR 20 response at week 24.
Slovenian: Primarni cilj vsake od petih študij je bil delež bolnikov, ki so po 24 tednih dosegli odziv ACR 20.
English: These factors need to be monitored while receiving RoActemra.
Slovenian: Te dejavnike je treba med zdravljenjem z zdravilom RoActemra kontrolirati.
English: No injection site reaction was reported as a serious adverse event or required treatment discontinuation.
Slovenian: Nobena reakcija na mestu injiciranja ni bila zabeležena kot resen neželen učinek in nobena ni zahtevala prekinitve zdravljenja.
English: Comprehensive instructions for the administration of RoActemra in a pre-filled syringe are given in the package leaflet, see section 6.6.
Slovenian: Celotna navodila za dajanje zdravila RoActemra v napolnjeni injekcijski brizgi so navedena v navodilu za uporabo, glejte poglavje 6.6.
English: • RoActemra is used to treat children with pJIA.
Slovenian: • Zdravilo RoActemra se uporablja tudi za zdravljenje otrok s pJIA.
English: • Check the expiration date on the RoACTEMRA pre-filled pen (See Figure A).
Slovenian: • Preverite datum izteka roka uporabnosti na napolnjenem injekcijskem peresniku z zdravilom RoACTEMRA (glejte sliko A).
English: Lipid parameters
Slovenian: Vrednosti lipidov
English: In healthy subjects administered RoActemra in doses from 2 to 28 mg/kg intravenously and 81 to 162 mg subcutaneously, absolute neutrophil counts decreased to their lowest 2 to 5 days following administration.
Slovenian: Pri zdravih preiskovancih, ki so dobili tocilizumab v odmerkih od 2 do 28 mg/kg intravensko in 81 do 162 mg subkutano, je bilo absolutno število nevtrofilcev najmanjše 2 do 5 dni po prejemu zdravila.
English: Do not touch the needle-shield of the prefilled pen, because you may stick yourself with the needle.
Slovenian: Ne dotikajte se zaščite za iglo napolnjenega injekcijskega peresnika, ker se lahko z iglo zbodete.
English: After week 52, all patients could receive open-label treatment with RoActemra 8 mg/kg.
Slovenian: Po 52. tednu so imeli vsi bolniki možnost prejemati odprto zdravljenje z zdravilom RoActemra v odmerku 8 mg/kg.
English: The t1/2 of RoActemra was concentration-dependent.
Slovenian: Razpolovni čas (t1/2) zdravila RoActemra je odvisen od koncentracije.
English: RoActemra is for subcutaneous use.
Slovenian: Zdravilo RoActemra je namenjeno subkutani uporabi.
English: • Press the green Activation button to start the injection.
Slovenian: • Za začetek injiciranja pritisnite zeleni gumb za aktivacijo.
English: Interrupt RoActemra dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN
Slovenian: Prekinite uporabo zdravila RoActemra, dokler ni dosežena < 3-kratna ZMN in upoštevajte zgoraj navedena priporočila pri > 1- do 3-kratni ZMN.
English: Increases in haemoglobin levels were observed, through tocilizumab decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Slovenian: Opažali so povečanje koncentracije hemoglobina, ker tocilizumab zmanjša učinke IL-6 na nastajanje hepcidina in tako poveča razpoložljivost železa.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Allow the pre-filled pen to sit at room temperature outside the box for 45 minutes before use
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Vzemite napolnjeni injekcijski peresnik iz škatle in ga pustite na sobni temperaturi 45 minut pred uporabo
English: At the start, your doctor or nurse may inject RoActemra (ACTPen®).
Slovenian: Na začetku zdravljenja vam bo zdravnik ali medicinska sestra injicirala zdravilo RoActemra (ACTPen®).
English: What you need to know before you use RoActemra
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo RoActemra
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as tocilizumab, is introduced.
Slovenian: Zato se lahko ekspresija CYP450 po uvedbi močnih zaviralcev citokinov, kakršen je tocilizumab, spremeni.
English: • Do not use if medicine is cloudy, hazy, discolored or contains particles
Slovenian: • Ne uporabljajte napolnjene injekcijske brizge, če je zdravilo motno, nejasno, obarvano ali vsebuje delce.
English: Symptoms include headache, fatigue and jaw pain.
Slovenian: Med simptomi se pojavljajo glavobol, utrujenost in bolečina v žvečnih mišicah.
English: SC-Ia
Slovenian: SC-I
English: • jaundice (yellow discoloration of skin or eyes)
Slovenian: • bolečine v trebuhu, • zlatenica (rumeno obarvanje kože in oči).
English: • Do not remove the needle-cap until you are ready to inject
Slovenian: • Ne odstranite pokrovčka za injekcijsko iglo, dokler niste pripravljeni za injiciranje.
English: The primary endpoint in the study was the difference in the proportion of patients who achieved an ACR20 response at week 24.
Slovenian: Primarni cilj študije je bila razlika v deležu bolnikov, ki so v 24. tednu dosegli odziv ACR 20.
English: However, your doctor may decide that you may inject RoActemra yourself.
Slovenian: Vaš zdravnik se lahko nato odloči, da si boste zdravilo RoActemra injicirali sami.
English: After removing the pre-filled pen from the refrigerator the pre-filled pen should be allowed to reach room temperature (18°C to 28°C) by waiting for 45 minutes, before injecting RoActemra.
Slovenian: Po tem, ko vzamemo napolnjeni injekcijski peresnik iz hladilnika, ga pustimo 45 minut, da doseže sobno temperaturo (18 °C do 28 °C), preden zdravilo RoActemra injiciramo.
English: Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice.
Slovenian: študiji kroničnih toksičnih učinkov pri opicah cynomolgus niso opazili učinkov na endokrino aktivnih in reproduktivnih organih in reproduktivna sposobnost miši s pomanjkanjem IL-6 ni bila prizadeta.
English: This was not observed in either of the placebo plus prednisone taper groups.
Slovenian: Tega niso opažali v nobeni od skupin, ki sta prejemali placebo in prednizon v zmanjšujočem se odmerku.
English: • If you have had tuberculosis, tell your doctor.
Slovenian: • Če ste kdaj imeli tuberkulozo, morate to povedati zdravniku.
English: One of these events, urticaria, was considered serious.
Slovenian: Enega izmed teh neželenih učinkov, urtikarijo,so šteli za resnega.
English: If you miss a dose of RoActemra
Slovenian: Če ste izpustili odmerek zdravila RoActemra
English: RoActemra AUC, Cmin and Cmax increased with increase of body weight.
Slovenian: AUC, Cmin in Cmax zdravila RoActemra so se zvečale s povečanjem telesne mase.
English: Approximately 90% of the steady-state (AUCτ) was reached by week 14 in the every other weekly and week 17 in the weekly dose groups.
Slovenian: Približno 90-% stanje dinamičnega ravnovesja (AUCτ) je bilo pri uporabi vsak drugi teden doseženo do 14. tedna in pri uporabi vsak teden do
English: RoActemra monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established.
Slovenian: Za zdravljenje akutnih relapsov se zdravila RoActemra v monoterapiji ne sme uporabljati, saj učinkovitost za zdravljenje le-teh ni bila dokazana.
English: After week 52, all patients could receive open-label treatment with tocilizumab 8 mg/kg.
Slovenian: Po 52. tednu so imeli vsi bolniki možnost prejemati odprto zdravljenje s tocilizumabom v odmerku 8 mg/kg.
English: Patients with sJIA must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously (see section 4.2).
Slovenian: Bolniki s sJIA morajo ob prejemu subkutane oblike zdravila RoActemra tehtati najmanj 10 kg (glejte poglavje 4.2).
English: Choose and prepare an injection site
Slovenian: Izberite in pripravite mesto vboda
English: The long-term exposure population includes all patients who received at least one dose of tocilizumab either in the double-blind control period or open label extension phase in the studies.
Slovenian: Dolgoročno izpostavljena populacija vključuje vse bolnike, ki so dobili vsaj en odmerek tocilizumaba v obdobju dvojno slepe kontrole ali pa v odprti, podaljšani fazi študij.
English: What you need to know before you are given RoActemra
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo RoActemra
English: RoActemra is for single-use only.
Slovenian: Zdravilo RoActemra je namenjeno samo za enkratno uporabo.
English: Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (Relapsing patients; Tocilizumab groups vs Placebo + 52) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo +26) HR (99% CI) Time to first GCA flare¹ (New-onset patients; Tocilizumab groups vs Placebo + 52) HR (99% CI)
Slovenian: Čas do prvega poslabšanja GCA¹ (bolniki z novonastalo boleznijo; skupini s tocilizumabom v primerjavi s placebom + 26) RO (99-% IZ) Čas do prvega poslabšanja GCA¹ (bolniki z novonastalo boleznijo; skupini s tocilizumabom v primerjavi s placebom + 52) RO (99-% IZ)
English: No impact on RoActemra exposure was noted in these patients.
Slovenian: Pri teh bolnikih niso ugotovili vpliva na izpostavljenost zdravilu RoActemra.
English: The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids.
Slovenian: Priporočeno odmerjanje je 162 mg subkutano enkrat na teden skupaj z glukokortikoidom, katerega odmerek postopoma zmanjšujemo.
English: At the start, your doctor or nurse may inject RoActemra.
Slovenian: Na začetku zdravljenja vam bo zdravnik ali medicinska sestra injicirala zdravilo RoActemra.
English: Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
Slovenian: V primeru pojava simptomov resne alergijske reakcije morajo bolniki nemudoma poiskati zdravniško pomoč (glejte poglavje 4.4).
English: For ALT or AST elevations > 3-5 x ULN, RoActemra treatment should be interrupted.
Slovenian: V primeru zvišanja ALT ali AST na > 3- do 5-kratno ZMN je treba zdravljenje z zdravilom RoActemra prekiniti.
English: • cold sores (oral herpes simplex), blisters
Slovenian: • pasovec (herpes zoster), • herpes (oralni herpes simpleks), mehurji,
English: The primary endpoint at week 24 was the proportion of patients who achieved an ACR 20 response.
Slovenian: Primarni cilj v 24. tednu je bil delež bolnikov, ki so dosegli odziv ACR 20.
English: Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Slovenian: Bolnike s simptomi, ki lahko nakazujejo zaplete divertikulitisa (npr. z bolečinami v trebuhu, krvavitvijo in/ali nepojasnjeno spremembo v razporedu iztrebljanja in zvišano telesno temperaturo), je treba takoj pregledati, da bi zgodaj odkrili divertikulitis, ki ga lahko spremlja perforacija v prebavilih.
English: RA patients have an increased risk for cardiovascular disorders and should have risk factors (e.g. hypertension, hyperlipidaemia) managed as part of usual standard of care.
Slovenian: Bolniki z revmatoidnim artritisom imajo večje tveganje za srčno-žilne bolezni, zato mora njihova običajna standardna obravnava vključevati obvladanje dejavnikov tveganja (npr. hipertenzije,
English: If you stop using RoActemra You should not stop using RoActemra without discussing with your doctor first.
Slovenian: Če ste prenehali uporabljati zdravilo RoActemra Zdravila RoActemra ne smete nehati uporabljati, ne da bi se pred tem posvetovali z zdravnikom.
English: Patients included in the trial had a total disease duration of at least 6 months and active disease but were not experiencing an acute flare requiring corticosteroid doses of more than 0.5 mg/kg prednisone equivalent.
Slovenian: Pri bolnikih, vključenih v študijo, je bolezen trajala vsaj 6 mesecev, bila je aktivna, vendar ob vključitvi bolniki niso doživljali nenadnega poslabšanja bolezni, za katerega bi potrebovali odmerke kortikosteroida,
English: A statistically significant superior treatment effect was seen in favour of tocilizumab over adalimumab in control of disease activity from baseline to week 24 for the primary endpoint of change in DAS28 and for all secondary endpoints (Table 5).
Slovenian: Učinek zdravljenja s tocilizumabom je bil statistično značilno boljši kot z adalimumabom v kontroli aktivnosti bolezni od začetka zdravljenja do 24. tedna za primarni cilj študije, spremembo DAS28, in za vse sekundarne cilje (preglednica 5).
English: After the Injection
Slovenian: Po injiciranju
English: What do I need to know to use my RoActemra pre-filled syringe safely?
Slovenian: Kaj morate vedeti za varno uporabo vaše napolnjene injekcijske brizge RoActemra
English: • Once the needle is removed completely from the skin, you can release the plunger, allowing the needle-shield to protect the needle.
Slovenian: • Ko injekcijsko iglo popolnoma odstranite iz kože, lahko izpustite bat, kar omogoči, da varovalo igle zaščiti iglo (glejte sliko H).
English: Concomitant administration of a single dose of 10 mg/kg RoActemra with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Slovenian: Sočasna uporaba posamičnega odmerka 10 mg/kg zdravila RoActemra in 10 do 25 mg metotreksata enkrat na teden ni klinično pomembno vplivala na izpostavljenost metotreksatu.
English: RA The recommended posology is subcutaneous 162 mg once every week.
Slovenian: Priporočeno odmerjanje je 162 mg subkutano enkrat na teden.
English: Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble and membrane-bound interleukin 6 receptors.
Slovenian: Tocilizumab je rekombinantno humanizirano antihumano monoklonsko protitelo podskupine imunoglobulinov G1 (IgG1) proti topnim in membranskim receptorjem za interlevkin-6.
English: The safety profile of intravenous RoActemra in sJIA has been studied in 112 patients from 2 to 17 years of age.
Slovenian: Varnostni profil intravenske oblike zdravila RoActemra pri bolnikih s sJIA so preučevali pri 112 bolnikih, starih od 2 do 17 let.
English: For recommended modifications, including RoActemra discontinuation, based on transaminases levels see section 4.2.
Slovenian: Za priporočene prilagoditve odmerjanja, vključno z ukinitvijo zdravila RoActemra, na podlagi vrednosti transaminaz glejte poglavje 4.2.
English: What RoActemra is and what it is used for What you need to know before you use RoActemra How to use RoActemra
Slovenian: Kaj je zdravilo RoActemra in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo RoActemra Kako boste prejeli zdravilo RoActemra
English: • RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Slovenian: • Zdravilo RoActemra se uporablja za zdravljenje odraslih bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom (avtoimunsko boleznijo), če predhodna zdravljenja niso učinkovala dovolj dobro.
English: RoActemra is used to improve the symptoms of sJIA and can be given in combination with methotrexate or alone.
Slovenian: Zdravilo RoActemra se uporablja za izboljšanje simptomov sJIA in se lahko daje v kombinaciji z metotreksatom ali samostojno.
English: If the needle cap is removed for more than 5 minutes, it may be more difficult to perform an injection as the medicine can dry out and block the needle.
Slovenian: Če bi napolnjeno injekcijsko brizgo brez pokrovčka pustili več kot 5 minut, bi lahko bilo injiciranje težje, saj se lahko zdravilo izsuši in zamaši injekcijsko iglo.
English: The proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was also comparable on the subcutaneous (65.2%) versus intravenous (67.4%) arms, with a weighted difference in proportions of - 2.3% (95% CI - 8.1, 3.4).
Slovenian: Prav tako je bil primerljiv delež bolnikov, ki so v 24. tednu dosegli klinično pomembno izboljšanje po HAQ-DI (sprememba od izhodišča ≥ 0,3 enote) v subkutani (65,2 %) v primerjavi z intravensko skupino (67,4 %) z uravnoteženo razliko v deležih -2,3 % (95-% interval zaupanja, -8,1; 3,4).
English: Each of the RoActemra-treated groups and one of the placebo-treated groups followed a pre-specified prednisone-taper regimen over 26 weeks, while the second placebo-treated group followed a pre-specified prednisone-taper regimen over 52 weeks, designed to be more in keeping with standard practice.
Slovenian: V obeh skupinah z zdravilom RoActemra in v eni skupini s placebom je bila uporabljena vnaprej določena shema 26-tedenskega zmanjševanja prednizona, druga skupina s placebom pa je prejemala vnaprej določeno shemo 52-tedenskega zmanjševanja prednizona, ki predstavlja boljši približek standardni praksi.
English: The safety profile of tocilizumab 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: Varnostni profil tocilizumaba so preučevali v štirih s placebom kontroliranih študijah (študije II, III, IV in V), eni z metotreksatom kontrolirani študiji (študija I) ter v njihovih odprtih, podaljšanih fazah
English: • mouth or skin blisters
Slovenian: • mehurji na ustih ali koži,
English: How to use RoActemra
Slovenian: Kako uporabljati zdravilo RoActemra
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as RoActemra, is introduced.
Slovenian: Zato se lahko ekspresija CYP450 po uvedbi močnih zaviralcev citokinov, kakršno je zdravilo RoActemra,
English: RA and CRS adult patients (≥ 30 kg)
Slovenian: Odrasli bolniki z RA in CRS (≥ 30 kg)
English: Concentrate for solution for infusion 200 mg/10 mL
Slovenian: Koncentrat za raztopino za infundiranje 200 mg/10 ml
English: Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Slovenian: Ne injicirajte v bradavice, brazgotine, modrice ali področja, kjer je koža občutljiva, rdeča, trda ali poškodovana.
English: Although IL-6 does not seem to be a critical cytokine for foetal growth or the immunological control of the maternal/foetal interface, a relation of this finding to RoActemra cannot be excluded.
Slovenian: Čeprav ne kaže, da bi bil citokin IL-6 ključen za rast ploda ali imunološki nadzor stika mati-plod, povezanosti tega izsledka z zdravilom RoActemra ni mogoče izključiti.
English: Radiographic mean changes over 52 weeks in Study II PBO + MTX (+ TCZ from week 24) N = 393
Slovenian: Povprečne radiološke spremembe v 52 tednih študije II Placebo + MTX (+ TCZ od 24. tedna)
English: The concentrationdependent non-linear clearance plays a major role at low tocilizumab concentrations.
Slovenian: Od koncentracije odvisni nelinearni očistek igra pomembno vlogo pri nizkih koncentracijah tocilizumaba.
English: After proper training in injection technique, patients may self-inject with RoActemra if their physician determines that it is appropriate.
Slovenian: Po primernem usposabljanju o tehniki injiciranja si lahko bolniki sami injicirajo zdravilo RoActemra,
English: Each 200 mg vial contains 0.20 mmol (4.43 mg) sodium.
Slovenian: Ena 200-mg viala vsebuje 0,20 mmol (4,43 mg) natrija.