FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving tocilizumab compared to control (Table 4).
Slovenian: Pri bolnikih, ki so dobivali tocilizumab, so potrdili zavrtje strukturne okvare sklepov, saj je bilo na rentgenskih posnetkih značilno manj znakov napredovanja bolezni kot pri bolnikih v kontrolni skupini (preglednica 4).
English: Your doctor will have to decide if they can still be given RoActemra.
Slovenian: Zdravnik se bo odločil, ali bo otrok vseeno prejemal zdravilo RoActemra.
English: Do not use the pre-filled pen if it appears to be damaged or if you have accidentally dropped the pre-filled pen.
Slovenian: Napolnjenega injekcijskega peresnika ne uporabljajte, če je poškodovan ali če vam je po nesreči padel.
English: RoActemra can be used alone or in combination with MTX.
Slovenian: Zdravilo RoActemra se lahko uporablja samostojno ali v kombinaciji z metotreksatom.
English: 12 mg/kg Q2W below 30 kg
Slovenian: 12 mg/kg na 2 tedna pod 30 kg
English: After SC dosing, approximately 90% of the steady-state was reached by week 12 for both the 162 mg QW and Q2W regimens.
Slovenian: Po subkutanem odmerjanju je bilo približno 90 % stanja dinamičnega ravnovesja doseženega do 12. tedna za oba 162-mg subkutana režima, vsaka 2 tedna in vsake 3 tedne.
English: A significantly higher proportion of patients in the tocilizumab 8 mg/kg + MTX and tocilizumab monotherapy groups met the primary endpoint compared with MTX alone.
Slovenian: V skupini s tocilizumabom 8 mg/kg in metotreksatom ter skupini s tocilizumabom v monoterapiji je primarni cilj dosegel signifikantno večji delež bolnikov v primerjavi s samim metotreksatom.
English: A total of 28.8% (15/52) pJIA patients experienced ISRs to RoActemra SC.
Slovenian: Reakcije na mestu injiciranja je imelo pri subkutanem injiciranju zdravila RoActemra skupno 28,8 % (15/52) bolnikov s pJIA.
English: The recommended posology in patients above 1 year of age is subcutaneous 162 mg once every week in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 2 weeks in patients weighing less than 30 kg.
Slovenian: Priporočeno odmerjanje za bolnike, starejše od 1 leta, je 162 mg subkutano enkrat na teden pri bolnikih, ki tehtajo 30 kg ali več, ali 162 mg subkutano vsaka 2 tedna pri bolnikih, ki tehtajo manj kot 30 kg.
English: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with tocilizumab (see section 4.8).
Slovenian: Pri bolnikih, ki so dobivali tocilizumab, so opazili zvišanje vrednosti lipidov, vključno z zvišanjem celotnega holesterola, lipoproteina majhne gostote (LDL), lipoproteina velike gostote (HDL) in trigliceridov (glejte poglavje 4.8).
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.25 mL/h.
Slovenian: Linearni očistek so ocenili kot parameter v analizi populacijske farmakokinetike, znašal je 6,25 ml/h.
English: Patients should be advised to seek medical advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade (fever) suggestive of a tuberculosis infection occur during or after therapy with RoActemra.
Slovenian: Bolnikom je treba svetovati, da poiščejo medicinsko pomoč, če se med zdravljenjem z zdravilom RoActemra pojavijo znaki ali simptomi (npr. vztrajen kašelj, hujšanje oziroma izguba telesne mase, blago zvišana telesna temperatura), ki nakazujejo na okužbo s tuberkulozo.
English: • Throw away used syringes in a puncture-resistant container or sharps container.
Slovenian: • Uporabljene injekcijske brizge zavrzite v zabojnik za ostre predmete, odporen proti vbodom.
English: Events of diverticular perforations as complications of diverticulitis have been reported uncommonly in patients treated with RoActemra (see section 4.8).
Slovenian: Zapleti divertikulitisa Občasno so pri bolnikih, zdravljenih z zdravilom RoActemra, poročali o perforaciji divertiklov kot zapletu divertikulitisa (glejte poglavje 4.8).
English: Available non-clinical data do not suggest an effect on fertility under tocilizumab treatment.
Slovenian: Razpoložljivi neklinični podatki ne kažejo, da bi zdravljenje s tocilizumabom vplivalo na plodnost.
English: The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg.
Slovenian: Priporočeno odmerjanje za bolnike, starejše od 2 let, je 8 mg/kg telesne mase enkrat na 4 tedne pri bolnikih, ki tehtajo 30 kg ali več, in 10 mg/kg enkrat na 4 tedne pri bolnikih, ki tehtajo manj kot 30 kg.
English: • If a caregiver is giving the injection, the outer area of the upper arms may also be used.
Slovenian: • Če daje injekcijo skrbnik, potem lahko uporabi tudi zunanji del zgornjega dela rok (glejte sliko B).
English: Steady state was reached after 12 weeks for AUC, Cmin, and Cmax.
Slovenian: Stanje dinamičnega ravnovesja je bilo za AUC, Cmin in Cmax doseženo po 12
English: In SC-I, 1262 patients were randomized 1:1 to receive RoActemra subcutaneous 162 mg every week or RoActemra intravenous 8 mg/kg every four weeks in combination with non-biologic DMARD(s).
Slovenian: V SC-I so 1262 bolnikov randomizirali v razmerju 1:1, da so prejeli 162 mg zdravila RoActemra subkutano vsak teden ali 8 mg/kg zdravila
English: Decreases below 0.5 x 109/ l were reported in 0.3% patients receiving tocilizumab 8 mg/kg plus DMARDs.
Slovenian: O zmanjšanju pod 0,5 x 109/l so poročali pri 0,3 % bolnikov, ki so dobivali 8 mg/kg tocilizumaba v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili.
English: After removing the cap the injection must be started within 5 minutes, to prevent the medicine from drying out and blocking the needle.
Slovenian: Po odstranitvi pokrovčka je treba z injiciranjem pričeti v 5 minutah, da preprečimo, da bi se zdravilo izsušilo in zaprlo injekcijsko iglo.
English: Step 3.
Slovenian: Korak 3.
English: RoActemra 162mg SC weekly + 26 weeks prednisone taper N=100
Slovenian: RoActemra 162 mg s.c. tedensko + 26 tednov zmanjševanja prednizona n = 100
English: RoActemra 162 mg SC every other weekly + 26 weeks prednisone taper N=49
Slovenian: RoActemra 162 mg s.c. vsak drugi teden + 26 tednov zmanjševanja prednizona n = 49
English: *humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Slovenian: *Humanizirano monoklonsko protitelo IgG1 proti človeškemu receptorju za interlevkin-6 (IL-6),
English: The half life of tocilizumab in sJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 12 mg/kg for body weight < 30 kg) at week 12.
Slovenian: Razpolovni čas tocilizumaba pri bolnikih s sJIA je v 12. tednu do 16 dni za obe skupini, ločeni glede na telesno maso (8 mg/kg tocilizumaba za bolnike s telesno maso ≥ 30 kg ali 12 mg/kg za bolnike s telesno maso < 30 kg).
English: ACR20 Week 24 Weighted difference (95% CI) ACR50 Week 24 Weighted difference (95% CI) ACR70 Week 24 Weighted difference (95% CI)
Slovenian: ACR 20 24. teden uravnotežena razlika (95-%
English: calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Slovenian: fenitoin, ciklosporin ali benzodiazepini), morate po uvedbi ali prenehanju dajanja tocilizumaba nadzorovati, ker utegnejo za ohranitev terapevtskega učinka potrebovati večje odmerke.
English: During routine laboratory monitoring in the 12 week controlled phase (study WA18221), 13.4% and 33.3% of patients experienced a post-baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL
Slovenian: Med rutinskim laboratorijskim spremljanjem v 12-tedenski, kontrolirani fazi (študija WA18221) je imelo v katerem koli času med študijskim zdravljenjem (ne v izhodišču) 13,4 % bolnikov zvišano vrednost holesterola LDL na ≥ 130 mg/dl in 33,3 % bolnikov zvišano vrednost celokupnega holesterola na ≥ 200 mg/dl.
English: IV
Slovenian: V
English: - Joint space narrowing - p≤ 0.0001, TCZ vs. PBO + MTX - p< 0.005, TCZ vs. PBO + MTX
Slovenian: TCZ - tocilizumab * - p ≤ 0,0001, tocilizumab v primerjavi s placebom + metotreksatom ** - p < 0,005, tocilizumab v primerjavi s placebom + metotreksatom
English: 1 vial of 10 mL
Slovenian: 1 viala z 10 ml
English: Eligible patients received tocilizumab dosed according to body weight (BW), with patients weighing ≥30 kg (n = 25) dosed with 162 mg of RoActemra every 2 weeks (Q2W) and patients weighing below 30 kg (n = 27) dosed with 162 mg of RoActemra every 3 weeks (Q3W) for 52 weeks.
Slovenian: Bolniki, primerni za vključitev v študijo, so prejemali tocilizumab glede na telesno maso; bolniki s telesno maso ≥ 30 kg (n = 25) so prejemali odmerek 162 mg zdravila RoActemra vsaka 2 tedna, bolniki s telesno maso manj kot 30 kg (n = 27) pa so prejemali 162 mg zdravila RoActemra vsake 3 tedne 52 tednov.
English: methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Slovenian: 2C9 (npr. metilprednizolon, deksametazon (z možnim odtegnitvenim sindromom peroralnih glukokortikoidov), atorvastatin, zaviralci kalcijevih kanalčkov, teofilin, varfarin, fenprokumon,
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with RoActemra (see section 4.8).
Slovenian: Opisane so bile hude preobčutljivostne reakcije, vključno z anafilaksijo, povezane z zdravilom RoActemra (glejte poglavje 4.8).
English: The mean change from baseline at week 104 in total Sharp-Genant score was significantly lower for patients randomised to RoActemra 8 mg/kg plus MTX (p<0.0001) compared with patients who were randomised to placebo plus MTX.
Slovenian: Povprečna sprememba celotne ocene po Sharp-Genant od izhodišča po 104 tednih je bila signifikantno nižja pri bolnikih, ki so bili randomizirani v skupino z zdravilom RoActemra 8 mg/kg ter metotreksatom (p < 0,0001), v primerjavi s tistimi, ki so bili randomizirani v skupino s placebo ter metotreksatom.
English: In all studies, patients treated with RoActemra 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 5).
Slovenian: Klinični odziv V vseh študijah so bili deleži odzivov ACR 20, 50 in 70 po 6 mesecih statistično značilno večji med bolniki, ki so dobivali 8 mg/kg zdravila RoActemra kot med bolniki v kontrolnih skupinah (preglednica 5).
English: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with RoActemra (see section 4.8).
Slovenian: Pri bolnikih, ki so dobivali zdravilo RoActemra, so opazili zvišanje vrednosti lipidov, vključno z zvišanjem celotnega holesterola, lipoproteina majhne gostote (LDL), lipoproteina velike gostote (HDL) in trigliceridov (glejte poglavje 4.8).
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of RoActemra monotherapy patients and 1.4% of RoActemra plus DMARD patients, the majority of whom were discontinued permanently from tocilizumab treatment.
Slovenian: Zvišanje ALT/AST na > 5-kratno ZMN so opažali pri 0,7 % bolnikov, ki so dobivali zdravilo RoActemra v monoterapiji, in pri 1,4 % bolnikov, ki so zdravilo RoActemra dobivali v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili; pri večini teh so zdravljenje s tocilizumabom ukinili.
English: For the 162 mg every week dose, the predicted mean (±SD) steady-state AUC1week, Cmin and Cmax of RoActemra were 7970 ± 3432 µg•h/mL, 43.0 ± 19.8 µg/mL, and 49.8 ± 21.0 µg/mL, respectively.
Slovenian: Za odmerek 162 mg vsak teden je bila pričakovana povprečna (± SD) površina pod krivuljo AUC1 teden v stanju dinamičnega ravnovesja = 7970 ± 3432 µg•h/ml, najmanjša koncentracija (Cmin) = 43,0 ± 19,8 µg/ml in največja koncentracija (Cmax) = 49,8 ± 21,0 µg/ml.
English: Stop breast-feeding if you are to be given RoActemra, and talk to your doctor.
Slovenian: Če boste prejeli zdravilo RoActemra, prenehajte dojiti in se posvetujte s svojim zdravnikom.
English: For persistent increases > 3 x ULN (confirmed by repeat testing, see 4.4.
Slovenian: V primeru dolgotrajnih zvišanj > 3-kratno ZMN (potrjenih s ponovnim testiranjem, glejte poglavje 4.4) ukinite zdravilo RoActemra.
English: Infusion related reaction events in pJIA patients included but were not limited to headache, nausea and hypotension 2.
Slovenian: 1Reakcije, povezane z infundiranjem, so pri bolnikih s pJIA med drugimi vključevale glavobol, navzeo in hipotenzijo.
English: The primary endpoint was the proportion of patients with a JIA ACR30 flare at week 40 relative to week 16.
Slovenian: Primarni cilj je bil ugotoviti delež bolnikov pri katerih se je bolezen v 40. tednu nenadno poslabšala glede na 16. teden, ocenjeno z merilom JIA ACR 30.
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on RoActemra clearance in RA patients.
Slovenian: Analize populacijske farmakokinetike niso odkrile, da bi metotreksat, nesteroidna protivnetna zdravila ali kortikosteroidi pri bolnikih z revmatoidnim artritisom vplivali na očistek zdravila RoActemra.
English: 4 vials of 10 mL
Slovenian: 4 viale z 10 ml
English: Study VI (WA19924), a 24 week double-blinded study that compared RoActemra monotherapy with adalimumab monotherapy, evaluated 326 patients with RA who were intolerant of MTX or where continued treatment with MTX was considered inappropriate (including MTX inadequate responders).
Slovenian: Tocilizumab v primerjavi z adalimumabom v monoterapiji V 24-tedenski dvojno slepi študiji VI (WA19924) so pri 326 bolnikih z revmatoidnim artritisom, ki niso prenašali metotreksata ali za katere so smatrali, da nadaljevanje zdravljenja z metotreksatom ni primerno (vključno s tistimi, ki se niso zadostno odzvali na zdravljenje z metotreksatom) primerjali zdravljenje z zdravilom RoActemra v monoterapiji z zdravljenjem z adalimumabom v monoterapiji.
English: The mean change from baseline at week 104 in total Sharp-Genant score was significantly lower for patients randomised to tocilizumab 8 mg/kg plus MTX (p<0.0001) compared with patients who were randomised to placebo plus MTX.
Slovenian: Povprečna sprememba celotne ocene po Sharp-Genant od izhodišča po 104 tednih je bila signifikantno nižja pri bolnikih, ki so bili randomizirani v skupino s tocilizumabom 8 mg/kg ter metotreksatom (p < 0,0001), v primerjavi s tistimi, ki so bili randomizirani v skupino s placebo ter metotreksatom.
English: If a pJIA patient misses a subcutaneous injection of RoActemra within 7 days of the scheduled dose, he/she should take the missed dose as soon as they remember and take the next dose at the regular scheduled time.
Slovenian: Če je od izpuščenega odmerka subkutane injekcije zdravila RoActemra pri bolniku s pJIA minilo manj kot 7 dni, mora dobiti izpuščeni odmerek, takoj ko se spomni, naslednji odmerek pa po običajnem razporedu.
English: • If a dose is missed by more than 7 days, or you are not sure when to inject RoActemra, call the doctor or pharmacist.
Slovenian: • Če je od izpuščenega odmerka minilo 7 dni ali več ali niste gotovi, kdaj morate spet injicirati zdravilo RoActemra, se posvetujte z zdravnikom ali farmacevtom.
English: RA and GCA patients demonstrate a comparable (to healthy subjects) decrease of absolute neutrophil counts following RoActemra administration (see section 4.8).
Slovenian: Pri bolnikih z revmatoidnim artritisom in GCA se je po prejemu zdravila RoActemra absolutno število nevtrofilcev zmanjšalo primerljivo z zdravimi prostovoljci (glejte poglavje 4.8).
English: *τ = 2 weeks for IV regimens
Slovenian: *τ = 2 tedna za intravenska režima
English: 4 vials of 20 mL
Slovenian: 4 viale z 20 ml
English: A total of 2,876 patients have been tested for anti-RoActemra antibodies in the 6-month controlled clinical trials.
Slovenian: Imunogenost V šestmesečnih kontroliranih kliničnih preskušanjih so protitelesa proti zdravilu RoActemra preverili pri skupaj 2876 bolnikih.
English: Patients should be instructed to seek medical advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with RoActemra.
Slovenian: Bolnikom je treba naročiti, da poiščejo medicinsko pomoč, če se med zdravljenjem z zdravilom RoActemra pojavijo znaki ali simptomi (npr. vztrajen kašelj, hujšanje oziroma izguba telesne mase, blago zvišana telesna temperatura), ki nakazujejo na okužbo s tuberkulozo.
English: In the open label extension phase (study WA18221), 13.2% and 27.7% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200
Slovenian: V odprti, podaljšani fazi (študija WA18221) je imelo v katerem koli času med študijskim zdravljenjem (ne v izhodišču) 13,2 % bolnikov zvišano vrednost holesterola LDL na ≥ 130 mg/dl in 27,7 %
English: These may affect up to 1 in every 10,000 patients
Slovenian: Ti se lahko pojavijo pri največ 1 od 10.000 bolnikov.
English: Following intravenous administration, RoActemra undergoes biphasic elimination from the circulation.
Slovenian: Po intravenski uporabi se zdravilo RoActemra iz obtoka odstrani v dveh fazah.
English: In paediatric patients with sJIA, the central volume of distribution was 1.87 L, the peripheral volume of distribution was 2.14 L resulting in a volume of distribution at steady state of 4.01 L
Slovenian: Pri pediatričnih bolnikih je bil centralni volumen porazdelitve 1,87 l in periferni volumen porazdelitve 2,14 l, tako da je volumen porazdelitve v stanju dinamičnega ravnovesja 4,01 l.
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving RoActemra compared to control (Table 6).
Slovenian: RoActemra, so potrdili zavrtje strukturne okvare sklepov, saj je bilo na rentgenskih posnetkih značilno manj znakov napredovanja bolezni kot pri bolnikih v kontrolni skupini (preglednica 6).
English: During routine laboratory monitoring in the tocilizumab all exposure population, 1% of patients had a decrease in platelet count to ≤ 50 × 103/µL without associated bleeding events.
Slovenian: Med rutinskim laboratorijskim spremljanjem se je število trombocitov zmanjšalo na ≤ 50 x 103/µl pri 1 % bolnikov v celotni populaciji, ki je prejemala tocilizumab, brez sočasnih krvavitev.
English: (See Fig. D) If you cannot remove the needle cap you should request the help of a caregiver or contact your healthcare provider.
Slovenian: Če ne morete odstraniti pokrovčka injekcijske igle, prosite za pomoč skrbnika ali zdravstvenega delavca.
English: A more than dose-proportional increase in the AUC and Cmin was observed for doses of 4 and 8 mg/kg every 4 weeks.
Slovenian: Z odmerkoma 4 in 8 mg/kg na 4 tedne so ugotovili več kot odmerku sorazmerno povečanje AUC in Cmin.
English: At Week 52, the mean change in HAQ-DI was -0.58 in the RoActemra 8 mg/kg plus MTX group compared with -0.39 in the placebo + MTX group.
Slovenian: - 0,58 v skupini z zdravilom RoActemra 8 mg/kg in metotreksatom v primerjavi z - 0,39 v skupini s placebom in metotreksatom.
English: • 1 RoACTEMRA pre-filled pen
Slovenian: • 1 napolnjeni injekcijski peresnik z zdravilom RoACTEMRA • 1 alkoholni zloženec
English: • If you miss your once every 2 weeks dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time.
Slovenian: • Če prejemate zdravilo RoActemra enkrat na dva tedna in je od izpuščenega odmerka minilo manj kot 7 dni, si injicirajte odmerek takoj, ko se spomnite, in naslednji odmerek vzemite po načrtu.
English: • Low absolute neutrophil count (ANC) Laboratory Value (cells x 109/ l )
Slovenian: • Majhno absolutno število nevtrofilcev (ANC) Laboratorijska vrednost
English: In all studies, patients treated with tocilizumab 8 mg/kg had statistically significant higher ACR 20, 50, 70 response rates at 6 months compared to control (Table 3).
Slovenian: Klinični odziv V vseh študijah so bili deleži odzivov ACR 20, 50 in 70 po 6 mesecih statistično značilno večji med bolniki, ki so dobivali 8 mg/kg tocilizumaba kot med bolniki v kontrolnih skupinah (preglednica 3).
English: Each pre-filled syringe contains 162 mg tocilizumab in 0.9 mL.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 162 mg tocilizumaba v 0,9 ml.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Slovenian: Če imate kakršna koli vprašanja o tem, kako si lahko sami daste injekcijo, se pogovorite s svojim zdravnikom.
English: Tell your doctor if you are taking any other medicines, or have recently taken any.
Slovenian: Druga zdravila in zdravilo RoActemra Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
English: The safety observed in the RoActemra arm was consistent with the known safety profile of RoActemra and no new or unexpected adverse drug reactions were observed (see Table 1).
Slovenian: Varnost, ki so jo opazili v skupini z zdravilom RoActemra, je bila v skladu z znanimi varnostnimi značilnostmi zdravila RoActemra, novih ali nepričakovanih neželenih učinkov niso opazili (glejte preglednico 1).
English: In Part 1, eligible patients ≥ 30 kg received tocilizumab at 8 mg/kg IV every 4 weeks for 4 doses.
Slovenian: V I. delu so primerni bolniki s telesno maso ≥ 30 kg prejeli 4 odmerke po 8 mg/kg tocilizumaba i.v.
English: The total patient years duration in the RoActemra all exposure population was 138.5 patient years during the 12 month double blind, placebo controlled phase of the study.
Slovenian: Med 12-mesečno dvojno slepo, s placebom kontrolirano fazo študije je celotna izpostavljenost zdravilu RoActemra v vsej izpostavljeni populaciji trajala 138,5 bolnik-let.
English: For the 162 mg every week dosing regimen, the steady-state Cavg was 51% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg. For the 162 mg every other week regimen, the steady-state Cavg was 129% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg.
Slovenian: Pri odmernem režimu 162 mg enkrat na dva tedna je bila pri bolnikih s telesno maso, manjšo od 60 kg, Csrednja v stanju dinamičnega ravnovesja 129 % večja kot pri bolnikih s telesno maso od 60 do 100 kg.
English: The following parameters (predicted mean ± SD) were estimated for a dose of 8 mg/kg tocilizumab given every 4 weeks: steady-state area under curve (AUC) = 38000 ± 13000 h µg/mL, trough concentration (Cmin) = 15.9 ± 13.1 µg/mL and maximum concentration (Cmax) = 182 ± 50.4 µg/mL, and the accumulation ratios for AUC and Cmax were small, 1.32 and 1.09, respectively.
Slovenian: Za zdravilo RoActemra, uporabljenov odmerku 8 mg/kg vsake 4 tedne, so bili ocenjeni naslednji parametri (napovedano povprečje ± standardni odklon): površina pod krivuljo (AUC) v stanju dinamičnega ravnovesja = 38.000 ± 13.000 h•µg/ml, najmanjša koncentracija (Cmin) = 15,9 ± 13,1 µg/ml in največja koncentracija (Cmax) = 182 ± 50,4 µg/ml; deleža kopičenja sta bila majhna (1,32 za AUC in 1,09 za Cmax).
English: Rash, Pruritus, Urticaria
Slovenian: • izpuščaj in srbenje, koprivnica,
English: The radiographic response of subcutaneous administered RoActemra was assessed in a double-blind, controlled, multicenter study in patients with active RA (SC-II).
Slovenian: V dvojno slepi, kontrolirani, multicentrični študiji pri bolnikih z aktivnim revmatoidnim artritisom (SC-II) so radiološko ocenjevali subkutano dano zdravilo RoActemra.
English: Maintain dose
Slovenian: Priporočeni odmerek
English: Figure I
Slovenian: PRILOGA I