FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Ilaris for patients with Still's disease (AOSD or SJIA) with body weight of 7.5 kg and above is 4 mg/kg (up to a maximum of 300 mg).
Slovenian: Priporočeni odmerek zdravila Ilaris za bolnike s Stillovo boleznijo (AOSD ali SJIA) in telesno maso najmanj 7,5 kg je 4 mg/kg (do največ 300 mg).
English: Disease activity was rated as absent or mild/moderate in more than 90% of patients at all post-baseline time points in the study, and median serological markers of inflammation (CRP and SAA) were normal (< 10 mg/litre) at all post-baseline time points.
Slovenian: Pri več kot 90 % bolnikov so v študiji, pri vseh časovnih točkah opazovanja po izhodiščnem, ocenili aktivnost bolezni kot odsotno ali blago/zmerno, mediane vrednosti seroloških označevalcev vnetja (CRP in SAA) pa so bile normalne (< 10 mg/liter) pri vseh časovnih točkah opazovanja po izhodiščnem.
English: All up-titrated patients remained at the increased dose of 300 mg (or 4 mg/kg for patients ≤ 40 kg) every 4 weeks.
Slovenian: Vsi bolniki, ki so jim tako zvišali odmerjanje, so še naprej prejemali zvišan odmerek 300 mg (oziroma 4 mg/kg pri bolnikih s telesno maso ≤ 40 kg) vsake 4 tedne.
English: If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible.
Slovenian: Če pride do razvoja sindroma aktivacije makrofagov ali je postavljen sum nanj, je treba čimprej začeti s preiskavami in zdravljenjem.
English: At day 15, the median change from baseline in the number of joints with active arthritis and limited range of motion were -67% and -73% for canakinumab (N=43), respectively, compared to a median change of 0% and 0% for placebo (N=41).
Slovenian: Na 15. dan je bila v skupini s kanakinumabom (N=43) mediana sprememba od izhodišča glede števila sklepov z aktivnim artritisom -67 %, glede števila sklepov z omejeno gibljivostjo pa -73 % v primerjavi s tovrstnima medianima spremembama 0 % oziroma 0 % v skupini s placebom (N=41).
English: The recommended dose of canakinumab for patients with Still's disease (AOSD and SJIA) with body weight ≥ 7.5 kg is 4 mg/kg (up to a maximum of 300 mg) administered every four weeks via subcutaneous injection.
Slovenian: Priporočeni odmerek kanakinumaba za bolnike s Stillovo boleznijo (AOSD ali SJIA) s telesno maso ≥ 7,5 kg je 4 mg/kg (do največ 300 mg), ki jih bolnik dobi vsake štiri tedne s subkutano injekcijo.
English: 9/l) and transient decreases in platelet counts were observed at a higher incidence (12.7%) with canakinumab in the active-controlled clinical studies versus the comparator (7.7%) in gouty arthritis patients.
Slovenian: 9/l) in prehodna znižanja števila trombocitov opažali z večjo pogostnostjo (12,7 %) pri bolnikih, ki so prejemali kanakinumab, kot pri tistih, ki so prejemali primerjalno zdravilo (7,7 %).
English: Patients in Part II (double-blind) received either canakinumab 4 mg/kg or placebo every 4 weeks until 37 flare events occurred.
Slovenian: V 2. obdobju (dvojno slepo zdravljenje) so bolniki prejemali bodisi kanakinumab 4 mg/kg ali placebo vsake 4 tedne, dokler ni prišlo do 37 dogodkov, ki pomenijo zagon bolezni.
English: In Part I (open label) 177 patients were enrolled and received 4 mg/kg (up to 300 mg) canakinumab administered every 4 weeks for up to 32 weeks.
Slovenian: V 1. obdobju (odprto zdravljenje) je bilo vključenih 177 bolnikov, ki so prejemali odmerke 4 mg/kg (največ 300 mg) kanakinumaba vsake 4 tedne do 32 tednov.
English: Set the syringe aside.
Slovenian: Odložite brizgo.
English: Overall, there were no clinically meaningful differences in the efficacy, safety and tolerability profile of canakinumab in paediatric patients compared to the overall CAPS population.
Slovenian: Skupno ni bilo klinično pomembnih razlik glede učinkovitosti, varnosti in prenašanja kanakinumaba pri pediatričnih bolnikih v primerjavi s celotno populacijo bolnikov s CAPS.
English: - Keep the vial in the outer carton in order to protect from light.
Slovenian: - Shranjujte vialo v zunanji škatli za zagotovitev zaščite pred svetlobo.
English: A total of 225 patients were treated with subcutaneous canakinumab 150 mg and 229 patients were treated with intramuscular triamcinolone acetonide (TA) 40 mg at study entry, and when experiencing a new attack thereafter.
Slovenian: Ob vstopu v študijo je skupno 225 bolnikov subkutano prejemalo kanakinumab 150 mg, 229 bolnikov pa intramuskularno triamcinolon acetonid (TA) 40 mg.
English: Bioavailability in gouty arthritis patients has not been determined independently.
Slovenian: Biološke uporabnosti zdravila pri bolnikih z uričnim artritisom niso določali posebej.
English: The recommended dose of canakinumab for adult patients with gouty arthritis is 150 mg administered subcutaneously as a single dose during an attack.
Slovenian: Priporočeni odmerek kanakinumaba za odrasle bolnike z uričnim artritisom je 150 mg, ki ga prejmejo subkutano kot enkraten odmerek v času napada.
English: A gouty arthritis attack is caused by urate (monosodium urate monohydrate) crystals in the joint and surrounding tissue, which trigger resident macrophages to produce IL-1 beta via the “NALP3 inflammasome” complex.
Slovenian: Napad uričnega artritisa sprožijo uratni kristali (natrijev urat monohidrat) v sklepih in okolnem tkivu, ki aktivirajo tamkajšnje makrofage, da začno s pomočjo kompleksa "imflamasom NALP3" izdelovati IL-1 beta.
English: Laboratory abnormalities in gouty arthritis patients Haematology
Slovenian: Patološki laboratorijski izvidi pri bolnikih z uričnim artritisom Hematološki izvidi
English: Injection into scar tissue should be avoided as this may result in insufficient exposure to canakinumab.
Slovenian: Injiciranje zdravila v brazgotino ni primerno, ker bi lahko prišlo do prenizke koncentracije kanakinumaba v telesu.
English: Choose an injection site on the upper thigh, abdomen, upper arm or buttocks.
Slovenian: Izberite mesto za injiciranje na zgornjem delu stegna, na trebuhu, na nadlakti ali na zadnjici.
English: Mild and transient Grade 1 reduction in platelets occurred in 15.9% of patients without any associated bleeding adverse events.
Slovenian: Pri 15,9 % bolnikov je prišlo do blagega in prehodnega znižanja števila trombocitov stopnje 1 brez neželenih krvavitev, ki bi bile povezane s tem.
English: The efficacy and safety profile in AOSD patients are expected to be similar to SJIA patients based on literature reports.
Slovenian: Po podatkih poročil iz literature je pri bolnikih z AOSD mogoče pričakovati podobna profila učinkovitosti in varnosti kot pri bolnikih s SJIA.
English: Open the wrappers containing the syringe and the transfer needle (the 50 mm needle) and attach the needle to the syringe.
Slovenian: Odprite zavoja z brizgo in z iglo za prenos (dolžine 50 mm) in iglo namestite na brizgo.
English: Efficacy results for a more stringent subgroup limited to current users of ULT (N=62) are presented in Table 5.
Slovenian: Rezultati učinkovitosti za ožjo podskupino bolnikov, ki so tedaj uporabljali zdravila za zmanjševanje količine urata, (N=62), so prikazani v preglednici 5.
English: • Cryopyrin-associated periodic syndromes (CAPS),
Slovenian: • s kriopirinom povezani periodični sindromi (angl. cryopyrin-associated periodic syndromes, s kratico CAPS),
English: All indications: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, gouty arthritis
Slovenian: Vse indikacije: sindromi CAPS, TRAPS, HIDS/MKD in FMF, SJIA, urični artritis
English: If a satisfactory clinical response has not been achieved 7 days after this increased dose, a third dose of canakinumab at 300 mg or 4 mg/kg can be considered.
Slovenian: Če ne pride do zadovoljivega kliničnega odziva 7 dni po tem zvišanju odmerka, je mogoče razmisliti o uporabi tretjega odmerka 300 mg oziroma 4 mg/kg kanakinumaba.
English: Treatment difference for all ACR scores was significant (p ≤ 0.0001)
Slovenian: ACR100 neaktivna bolezen razlika med ocenami ACR pri obeh načinih zdravljenja je bila v vseh primerih statistično značilna (p ≤ 0,0001)
English: The primary efficacy endpoint of the randomised treatment period (Part II) was the proportion of responders within each cohort who had resolution of their index disease flare at day 15 and did not experience a new flare during the remainder of the 16-week treatment period (defined as complete response).
Slovenian: Primarni cilj študije za oceno učinkovitosti v obdobju randomiziranega zdravljenja (v 2. obdobju) je bil za vsako od kohort delež bolnikov z odzivom, pri katerih so do 15. dne izzveneli njihovi značilni znaki in simptomi zagona, v preostanku 16-tedenskega obdobja zdravljenja pa ni prišlo do novega zagona (kar je bilo opredeljeno kot popolni odziv).
English: Ilaris has not been studied in patients with hepatic impairment.
Slovenian: Uporabe zdravila Ilaris pri bolnikih z okvaro jeter niso proučevali.
English: A total of 243 CAPS patients (85 paediatric patients aged ≥ 2 to ≤ 17 years and 158 adult patients aged ≥ 18 years) were treated with canakinumab in routine clinical practice in a long-term registry study (mean of 3.8 years of canakinumab exposure).
Slovenian: V dolgoročni registrski študiji so v okviru rutinske klinične prakse s kanakinumabom zdravili skupno 243 bolnikov s CAPS (85 pediatričnih bolnikov v starosti od ≥ 2 do ≤ 17 let in 158 odraslih bolnikov, starih ≥ 18 let) s povprečno 3,8 let izpostavljenosti kanakinumabu.
English: Inflammatory markers* C-reactive protein, mg/l Serum amyloid A, mg/l * mean (median) change from beginning of Part II
Slovenian: vrednost p primarni cilj opazovanja (zagon bolezni) delež bolnikov z zagonom bolezni v 2. obdobju vnetni označevalci* C-reaktivni protein, mg/l serumski amiloid A, mg/l * povprečje (mediana) spremembe od začetka 2. obdobja
English: - Part III: Patients who completed 16 weeks of treatment and were classified as responders were re-randomised into a 24-week, double-blind withdrawal period during which they received canakinumab 150 mg (2 mg/kg for patients ≤ 40 kg) s.c. or placebo every 8 weeks.
Slovenian: - 3. obdobje: bolnike, ki so zaključili 16 tednov zdravljenja in so bili opredeljeni kot odzivni bolniki, so randomizirali v 24-tedensko dvojno slepo obdobje opuščanja zdravila, v katerem so subkutano prejemali kanakinumab v odmerku 150 mg (oziroma 2 mg/kg pri bolnikih s telesno maso ≤ 40 kg) ali placebo vsakih 8 tednov.
English: In TRAPS, HIDS/MKD and FMF, exposure parameters (trough concentrations) were comparable across age groups from 2 to < 20 years old following subcutaneous administration of canakinumab 2 mg/kg every 4 weeks.
Slovenian: Pri bolnikih s sindromi TRAPS, HIDS/MKD in FMF so bili parametri izpostavljenosti (najnižje koncentracije pred naslednjim odmerkom) po subkutanem odmerjanju kanakinumaba 2 mg/kg vsake 4 tedne primerljivi med vsemi starostnimi skupinami pri bolnikih, ki so bili stari od 2 leti do < 20 let.
English: The recommended dose of Ilaris for adult gouty arthritis patients is 150 mg given as a single dose at the time of a gouty arthritis attack.
Slovenian: Priporočeni odmerek zdravila za odrasle bolnike z uričnim artritisom je 150 mg v enkratnem odmerku v času napada uričnega artritisa.
English: Gastrointestinal disorders Very common Upper abdominal pain Uncommon Gastro-oesophageal reflux disease Skin and subcutaneous tissue disorders Very common Injection site reaction Musculoskeletal and connective tissue disorders Very common Arthralgia Common
Slovenian: Bolezni prebavil zelo pogosti bolečine v zgornjem delu trebuha občasni gastro-ezofagealna refluksna bolezen Bolezni kože in podkožja zelo pogosti reakcija na mestu injiciranja
English: Predicted steady-state exposure values (Cmin,ss, Cmax,ss, AUC,ss,8w) after 150 mg subcutaneous administration (or 2 mg/kg, respectively) every 8 weeks were slightly higher in the weight category 40-70 kg (6.6 µg/ml, 24.3 µg/ml, 767 µg*d/ml) compared to the weight categories < 40 kg (4.0 µg/ml, 19.9 µg/ml, 566 µg*d/ml) and > 70 kg (4.6 µg/ml, 17.8 µg/ml, 545 µg*d/ml).
Slovenian: Predvidene vrednosti izpostavljenosti v stanju dinamičnega ravnovesja (najnižje koncentracije v stanju dinamičnega ravnovesja (Cmin,ss), najvišje koncentracije v stanju dinamičnega ravnovesja (Cmax,ss), površina pod krivuljo v stanju dinamičnega ravnovesja pri odmerjanju vsakih 8 tednov (AUC,ss,8w)) po subkutanem odmerjanju 150 mg (oziroma 2 mg/kg) vsakih 8 tednov so bile nekoliko višje v kategoriji bolnikov s telesno maso 40-70 kg (6,6 µg/ml, 24,3 µg/ml, 767 µg*d/ml) v primerjavi s kategorijama < 40 kg (4,0 µg/ml, 19,9 µg/ml, 566 µg*d/ml) in > 70 kg (4,6 µg/ml, 17,8 µg/ml, 545 µg*d/ml).
English: Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall population.
Slovenian: V celoti niso opažali klinično pomembnih razlik glede varnostnih lastnosti in prenosljivosti kanakinumaba pri pediatričnih bolnikih v primerjavi s celotno populacijo.
English: Instructions for use of Ilaris solution for injection
Slovenian: Navodila za uporabo raztopine za injiciranje zdravila Ilaris
English: The safety profile of canakinumab appeared similar to that in patients aged 2 years and above.
Slovenian: Pokazalo se je, da so bile varnostne lastnosti kanakinumaba podobne kot pri bolnikih, ki so stari 2 leti ali več.
English: Ilaris is injected every 8 weeks as a single dose.
Slovenian: Bolnik prejme zdravilo Ilaris v obliki injekcije, in sicer vsakih 8 tednov en odmerek.
English: In the overall SJIA programme, transient decreased white blood cell (WBC) counts ≤ 0.8 x LLN were reported in 33 patients (16.5%).
Slovenian: V celotnem programu študij SJIA so o prehodno znižanem številu levkocitov na ≤ 0,8-kratnik spodnje meje normalnih vrednosti poročali pri 33 bolnikih (16,5 %).
English: - If you have not responded well enough to the treatment after 7 days, your doctor may give you another dose of 150 mg or 2 mg/kg.
Slovenian: - Če 7 dni po začetku zdravljenja ne pride do dovolj dobrega odziva na zdravljenje, vam bo zdravnik morda dal še en odmerek 150 mg oziroma 2 mg/kg.
English: Hypersensitivity reactions have been reported in patients treated with canakinumab (see sections 4.3 and 4.4).
Slovenian: Pri bolnikih, ki so prejemali kanakinumab, so poročali o preobčutljivostnih reakcijah (glejte poglavji 4.3 in 4.4).
English: Do not touch the vial stoppers.
Slovenian: Ne dotikajte se zamaška na viali.
English: Canakinumab should be used as an on-demand therapy to treat gouty arthritis attacks.
Slovenian: Kanakinumab je treba uporabljati le po potrebi za zdravljenje napadov uričnega artritisa.
English: Data from the first 12 weeks of canakinumab treatment from studies G2305, G2301 and the extension study were pooled to assess maintenance of efficacy.
Slovenian: Analiza združenih podatkov za oceno učinkovitosti Za oceno ohranjanja učinkovitosti so združili podatke prvih 12 tednov zdravljenja s kanakinumabom iz študij G2305, G2301 in iz podaljšanja študije.
English: Dispose of the needle and syringe in the sharps container without recapping or removing the needle.
Slovenian: Iglo in brizgo zavrzite v zbiralnik za ostre predmete, ne da bi prej pokrili iglo s pokrovčkom ali iglo odstranjevali z brizge.
English: Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment.
Slovenian: V času zdravljenja s kanakinumabom so poročali o posameznih primerih neobičajnih ali oportunističnih okužb (kar vključuje aspergilozo, atipične okužbe z mikobakterijami, herpes zoster).
English: Do not touch the needles or the top of the vial.
Slovenian: Pri rokovanju se ne dotikajte igle in vrha vial.
English: Resolution of the index disease flare was defined as having a Physician's Global Assessment (PGA) of Disease Activity score < 2 (“minimal or no disease”) and CRP within normal range (≤ 10 mg/l) or reduction ≥ 70% from baseline.
Slovenian: Prenehanje značilnih znakov in simptomov zagona je bilo opredeljeno z oceno < 2 na lestvici zdravnikove splošne ocene (PGA-Physician's Global Assessment) na lestvici aktivnosti bolezni (kar pomeni “minimalna aktivnost ali odsotnost bolezni”) in vrednostjo CRP v okviru normalnih vrednosti (≤ 10 mg/l) ali znižanjem vrednosti CRP za ≥ 70 % od izhodiščne.
English: Mean exposure in a typical gouty arthritis patient (93 kg) after a single subcutaneous 150 mg dose (Cmax: 10.8 µg/ml and AUCinf: 495 µg*d/ml) was lower than in a typical 70 kg CAPS patient (15.9 µg/ml and 708 µg*d/ml).
Slovenian: Pri značilnem bolniku z uričnim artritisom (93 kg) sta bili po enkratnem subkutanem odmerku 150 mg povprečni vrednosti izpostavljenosti zdravilu (Cmax: 10,8 µg/ml in AUCinf: 495 µg*d/ml) nižji kot pri značilnem bolniku s CAPS s 70 kilogrami (15,9 µg/ml in 708 µg*d/ml).
English: No impact on the type or frequency of adverse drug reactions was seen with longer-term treatment.
Slovenian: Pri dologotrajnejšem zdravljenju niso opažali bistvenih razlik glede vrste in pogostnosti neželenih učinkov zdravila.
English: The incidence of patients with triglyceride elevations > 5 x upper limit of normal (ULN) was 2.4% with canakinumab and 0.7% with triamcinolone acetonide.
Slovenian: Pri bolnikih s kanakinumabom je bila pogostnost zvišanja na več kot 5-kratnik zgornje meje normalnih vrednosti 2,4 %, pri bolnikih s triamcinolon acetonidom pa 0,7 %.
English: Ilaris is indicated for the treatment of active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.
Slovenian: Zdravilo Ilaris je indicirano za zdravljenje aktivne Stillove bolezni, ki vključuje Stillovo bolezen z začetkom v odrasli dobi (adult-onset Still's disease - AOSD) in sistemski juvenilni idiopatski artritis (systemic juvenile idiopathic arthritis - SJIA), pri bolnikih, ki so stari 2 leti ali več in pri katerih ni prišlo do zadostnega odziva na predhodno zdravljenje z nesteroidnimi protivnetnimi zdravili (NSAID) in sistemskimi kortikosteroidi.
English: If the child responds well enough to this, treatment may be continued with a dose of 8 mg/kg every 8 weeks.
Slovenian: Če pri otroku po tem odmerku pride do dovolj dobrega odziva, se zdravljenje lahko nadaljuje z odmerjanjem 8 mg/kg vsakih 8 tednov.
English: One patient had resolution of index flare by day 15 after receiving one single dose of canakinumab 2 mg/kg, but discontinued treatment after this first dose due to serious adverse events (pancytopenia and hepatic failure).
Slovenian: Pri enem od teh bolnikov so po enkratnem odmerku kanakinumaba 2 mg/kg značilni znaki in simptomi zagona izzveneli do 15. dne, vendar bolnik po prvem odmerku ni več prejemal zdravila zaradi resnih neželenih dogodkov (pancitopenije in odpovedi jeter).
English: In Part II of the study, patients treated with canakinumab who had persistent disease activity received an additional dose of 150 mg (or 2 mg/kg for patients ≤ 40 kg) within the first month.
Slovenian: V 2. obdobju študije so bolniki, ki so prejemali kanakinumab, aktivnost bolezni pa se jim pri tem ni zmanjšala, prejeli dodatni odmerek 150 mg (oziroma 2 mg/kg pri bolnikih s telesno maso ≤ 40 kg) v prvem mesecu zdravljenja.
English: Statistically significant improvements in the Child Health Questionnaire-PF50 scores were reported for canakinumab vs placebo in study G2305 (physical p=0.0012; psychosocial well-being p=0.0017).
Slovenian: V študiji G2305 so navajali statistično značilno razliko med ocenami pri Zdravstvenem vprašalniku za otroke -PF50 (Child Health Questionnaire - PF50) pri uporabi kanakinumaba v primerjavi z uporabo placeba (na telesnem področju p=0,0012; na psihosocialnem področju p=0,0017).
English: NOTE: The required amount depends on the dose to be administered.
Slovenian: POZOR: Koliko raztopine morate potegniti v brizgo, je odvisno od odmerka, ki ga morate injicirati.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Slovenian: S stališča mikrobiološke varnosti je treba zdravilo uporabiti takoj po rekonstituciji.
English: Following canakinumab treatment, the inflammatory markers CRP or SAA and signs of acute inflammation (e.g. pain, swelling, redness) in the affected joint subside rapidly.
Slovenian: Po zdravljenju s kanakinumabom so se vrednosti označevalcev vnetja C-reaktivnega proteina (CRP) oziroma serumskega amiloida (SAA) v kratkem času znižale, znaki akutnega vnetja (na primer bolečina, oteklina in rdečina) v prizadetih sklepih pa so se hitro umirili.
English: Remove the withdrawal needle from the syringe and place it in the sharps container.
Slovenian: Iglo za izvlek odstranite z brizge in jo zavrzite v zbiralnik za ostre predmete.
English: TRAPS, HIDS/MKD and FMF patients with body weight  7.5 kg and ≤ 40 kg
Slovenian: Bolniki s sindromom TRAPS, HIDS/MKD ali FMF in z 7,5 kg ter ≤ 40 kg
English: Ilaris can be given as monotherapy or in combination with methotrexate.
Slovenian: Zdravilo Ilaris je mogoče dajati samostojno ali v kombinaciji z metotreksatom.
English: Based on the population pharmacokinetic modelling analysis, the pharmacokinetics of canakinumab in children aged 2 to < 4 years were similar to those in patients 4 years of age and older.
Slovenian: Na podlagi analize populacijskega farmakokinetičnega modeliranja so bile farmakokinetične lastnosti kanakinumaba pri otrocih, ki so bili stari od 2 do < 4 leta, podobne kot pri bolnikih, ki so bili stari 4 leta ali več.
English: • 2 mg/kg for patients with body weight ≥ 7.5 kg and ≤ 40 kg
Slovenian: 2 mg/kg za bolnike s telesno maso ≥ 7,5 kg in ≤ 40 kg
English: The peak serum canakinumab concentration (Cmax) occurred approximately 7 days following single subcutaneous administration of 150 mg in adult CAPS patients.
Slovenian: Kanakinumab je dosegel najvišje koncentracije (Cmax) približno 7 dni po enkratnem subkutanem odmerku 150 mg pri odraslih bolnikih s periodičnimi sindromi, povezanimi s kriopirinom (CAPS).
English: Elevations of transaminases have been observed rarely in CAPS patients.
Slovenian: Pri bolnikih s CAPS so redko opažali zvišanje koncentracij aminotransferaz.
English: Opportunistic infections have been reported in patients treated with canakinumab (see section 4.4).
Slovenian: Pri bolnikih, ki so prejemali kanakinumaba, so poročali o oportunističnih okužbah (glejte poglavje 4.4).
English: Maintenance dose 2 mg/kg every 4 weeks
Slovenian: Vzdrževalni odmerek 2 mg/kg vsake 4 tedne
English: Predicted canakinumab steady state exposures at a dose level of 4 mg/kg (maximum 300 mg) in patients over the age of 20 years were comparable to those in SJIA patients younger than 20 years of age.
Slovenian: Pri bolnikih, ki so bili stari več kot 20 let, je pričakovana izpostavljenost kanakinumabu v stanju dinamičnega ravnovesja pri odmerni stopnji 4 mg/kg (največ 300 mg) podobna kot pri bolnikih s SJIA, ki so stari manj kot 20 let.
English: There were no antibodies against Ilaris observed in TRAPS, HIDS/MKD and FMF patients treated with doses of 150 mg and 300 mg over 16 weeks of treatment.
Slovenian: Pri bolnikih, ki so imeli katerega od sindromov TRAPS, HIDS/MKD ali FMF in so v obdobju 16 tednov zdravljenja prejemali odmerke 150 mg ali 300 mg, niso opažali protiteles proti zdravilu Ilaris.
English: Carefully remove the transfer needle from the vial and recap the needle as instructed by your healthcare provider or pharmacist.
Slovenian: Previdno odstranite iglo za prenos iz viale in jo spet pokrijte s pokrovčkom, kot vas je naučil zdravstveni delavec ali farmacevt.
English: Table 2 Tabulated summary of efficacy in Phase III trial, pivotal placebo-controlled withdrawal period (Part II)
Slovenian: Preglednica 2 Tabelaričen povzetek učinkovitosti v preskušanjih faze III: v obdobju s placebom kontroliranega opuščanja zdravila (v 2. obdobju)
English: Therefore patients should be monitored carefully for signs and symptoms of infections during and after treatment with canakinumab.
Slovenian: Iz tega razloga je treba bolnike med zdravljenjem s kanakinumabom in po njem skrbno spremljati glede znakov in simptomov okužb.
English: The active substance is canakinumab.
Slovenian: Učinkovina je kanakinumab.