FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 185 patients aged 28 days and above were enrolled and a total of 181 patients aged 2 years and above were randomised in part II of the study.
Slovenian: Skupno so v študijo vključili 185 bolnikov, ki so bili stari 28 dni ali več, v 2. obdobje študije pa so randomizirali skupno 181 bolnikov, ki so bili stari 2 leti ali več.
English: Based on the population pharmacokinetic modelling analysis, the expected exposures after a dose of 2 mg/kg were comparable across the CAPS paediatric age groups, but were approximately 40% lower in paediatric patients of very low body weight (e.g. 10 kg) than in adult patients (150 mg dose).
Slovenian: Na podlagi analize populacijskega farmakokinetičnega modeliranja so bile pričakovane izpostavljenosti po odmerjanju 2 mg/kg primerljive med vsemi starostnimi skupinami pediatričnih bolnikov s CAPS, pri tem pa so bile pri pediatričnih bolnikih z zelo majhno telesno maso (na primer 10 kg) približno za 40 % manjše kot pri odraslih bolnikih (z odmerkom 150 mg).
English: Ilaris is available in packs containing one vial.
Slovenian: Zdravilo Ilaris je na voljo v pakiranjih, ki vsebujejo po eno vialo.
English: It is recommended to select a different injection site each time the product is injected to avoid soreness.
Slovenian: Priporočeno je, da vsakokrat, ko injicirate zdravilo, izberete drugo mesto injiciranja, s čimer lahko preprečite bolečino.
English: During clinical development of Ilaris in over 2,600 patients, no anaphylactoid or anaphylactic reactions were reported.
Slovenian: V času kliničnega razvoja zdravila Ilaris pri več kot 2.600 bolnikih o primerih anafilaktoidnih ali anafilaktičnih reakcij niso poročali.
English: You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while being treated with Ilaris (see also “Other medicines and Ilaris”).
Slovenian: Priporočeno je, da se v času zdravljenja z zdravilom Ilaris izogibate cepljenju z določenimi vrstami cepiv, ki jih imenujemo živa cepiva (glejte tudi "Druga zdravila in zdravilo Ilaris").
English: For children given a starting dose of 4 mg/kg who have not responded well enough after 7 days, the doctor may give a second dose of 4 mg/kg.
Slovenian: Otrokom, ki so prejeli začetni odmerek 4 mg/kg, vendar pri njih po 7 dneh ni prišlo do dovolj dobrega odziva, lahko zdravnik da drugi odmerek 4 mg/kg.
English: - The solution should be used immediately after first piercing the vial stopper to prepare the injection.
Slovenian: - Raztopino je treba uporabiti takoj po tem, ko predrete zamašek na viali, da bi pripravili zdravilo za injiciranje.
English: Treatment with canakinumab induced a reduction of pain and reduced the risk of subsequent attacks in patients using ULT and unable to use both NSAIDs and colchicine, although the observed treatment difference compared to triamcinolone acetonide was less pronounced than with the overall study population.
Slovenian: Zdravljenje s kanakinumabom je olajšalo bolečine in zmanjšalo tveganje za nadaljnje napade pri bolnikih, ki so uporabljali zdravila za zmanjševanje količine urata, niso pa mogli uporabljati niti nesteroidnih protivnetnih zdravil niti kolhicina, vendar je bila pri njih razlika v primerjavi z uporabo triamcinolon acetonida manj izrazita kot pri celotni študijski populaciji.
English: On initiation of canakinumab in patients being treated with this type of medicinal product, therapeutic monitoring of the effect or of the active substance concentration should be performed and the individual dose of the medicinal product adjusted as necessary.
Slovenian: Pri bolnikih, ki se zdravijo s to vrsto zdravil, je treba ob začetku zdravljenja s kanakinumabom spremljati terapevtski učinek ali koncentracijo zdravilne učinkovine in, če je treba, posameznemu bolniku ustrezno prilagoditi odmerek zdravila.
English: Treatment with Ilaris may result in dizziness/vertigo or asthenia (see section 4.8).
Slovenian: Zdravljenje ze zdravilom Ilaris lahko povzroča omotičnost/vrtoglavico ali splošno oslabelost (glejte poglavje 4.8).
English: 9/l were reported in 2% of patients in the comparative trials.
Slovenian: 9/l pri 2 % bolnikov.
English: The results of a 56-week, open label study in CAPS patients aged 4 years and younger demonstrated that all patients who received non-live, standard of care childhood vaccinations developed protective antibody levels.
Slovenian: Rezultati 56-tedenske odprte študije pri bolnikih s CAPS, ki so bili stari 4 leta ali manj, so pokazali, da se je pri vseh bolnikih, ki so bili cepljeni z neživimi cepivi po standardnem programu cepljenja v otroški dobi, razvila zaščitna raven protiteles.
English: No neutralising antibodies were detected.
Slovenian: Pri nobenem bolniku niso odkrili nevtralizirajočih protiteles.
English: In the event of conversion from a negative to a positive PPD test, especially in high-risk patients, alternative means of screening for a tuberculosis infection should be considered.
Slovenian: Če pri bolniku pride do konverzije iz negativnega v pozitivni rezultat testa s PDD, je treba zlasti pri bolnikih s povečanim tveganjem razmisliti o presejalnem pregledu glede okužbe z bacilom tuberkuloze.
English: Transient and asymptomatic cases of elevations of serum transaminases or bilirubin have been reported in clinical trials (see section 4.8).
Slovenian: V kliničnih preskušanjih so poročali o prehodnih in asimptomatskih zvišanjih koncentracij aminotransferaz ali bilirubina v serumu (glejte poglavje 4.8).
English: Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by canakinumab.
Slovenian: Študija G2301 je bila randomizirana, dvojno slepa, s placebom kontrolirana študija opuščanja zdravljenja ob uporabi kanakinumaba za preprečevanje zagona bolezni.
English: - Part IV: All Part III patients treated with canakinumab were eligible to enter into a 72-week open-label treatment extension period.
Slovenian: - 4. obdobje: vsi bolniki, ki so v 3. obdobju prejemali kanakinumab, so bili primerni za vstop v 72-tedensko obdobje podaljšanja z odprtim zdravljenjem.
English: Sixty-three of the 100 patients entering Part II, whether assigned to placebo or canakinumab, did not experience a flare over the observation period (up to a maximum of 80 weeks).
Slovenian: Pri triinšestdesetih od 100 bolnikov, ki so vstopili v 2. obdobje in so prejemali placebo ali kanakinumab, ni prišlo do zagona v opazovanem obdobju (največ 80 tednov).
English: For gouty arthritis, the physician should be experienced in the use of biologics and Ilaris should be administered by a healthcare professional.
Slovenian: Pri uričnem artritisu mora imeti zdravnik izkušnje z uporabo bioloških zdravil, zdravilo Ilaris pa naj bolniku aplicira usposobljen zdravstveni delavec.
English: They should not be used with Ilaris because this may increase the risk of infections.
Slovenian: Navedenih zdravil ne smete uporabljati sočasno z zdravilom Ilaris, saj to lahko poveča tveganje za okužbe.
English: The patient or caregiver and the doctor should decide together who will administer the Ilaris injections.
Slovenian: Bolnik oziroma skrbnik naj se skupaj z zdravnikom odloči, kdo bo bolniku injiciral zdravilo Ilaris.
English: Immediately proceed to administering the injection.
Slovenian: Takoj nadaljujte z injiciranjem zdravila.
English: Elderly No dose adjustment is required.
Slovenian: Prilagajanje odmerkov ni potrebno.
English: Canakinumab had no effect on male fertility parameters in marmosets (C. jacchus).
Slovenian: Kanakinumab pri marmozetkah (C. jacchus) ni vplival na parametre moške plodnosti.
English: Patients who experience such symptoms during Ilaris treatment should wait for this to resolve completely before driving or operating machines.
Slovenian: Bolniki, pri katerih med zdravljenjem z zdravilom Ilaris prihaja do tovrstnih simptomov, ne smejo voziti ali upravljati s stroji, dokler ta simptom popolnoma ne izzveni.
English: Make sure the tip of the transfer needle is covered by the water and slowly pull the syringe plunger down to slightly past the 1.0 ml mark.
Slovenian: Ko se prepričate, da je konica igle pod vodno gladino, počasi potegnite bat navzdol, da nekoliko preseže oznako 1,0 ml.
English: Still's disease (AOSD and SJIA)
Slovenian: Stillova bolezen (AOSD in SJIA)
English: The most frequent adverse drug reactions were infections predominantly of the upper respiratory tract.
Slovenian: Najbolj pogosti neželeni učinki zdravila so bile okužbe zlasti zgornjih dihal.
English: Based on clinical trial experience, canakinumab does not appear to increase the incidence of MAS in SJIA patients, but no definitive conclusion can be made.
Slovenian: Po izkušnjah iz kliničnih študij ne kaže, da bi kanakinumab povečal pogostnost sindroma aktivacije makrofagov pri bolnikih s SJIA, vendar dokončnega zaključka ni mogoče podati.
English: Slowly inject the water into the vial containing the Ilaris powder.
Slovenian: Počasi vbrizgajte vodo v vialo s praškom Ilaris.
English: Activation of macrophages and concomitant over-production of IL-1 beta results in an acute painful inflammatory response.
Slovenian: Aktivacija makrofagov in spremljajoče prekomerno nastajanje IL-1 beta povzročita boleč akutni vnetni odziv.
English: Clean the injection site with a new alcohol swab.
Slovenian: Mesto za injiciranje očistite z novo alkoholno blazinico.
English: Concomitant use of canakinumab with tumour necrosis factor (TNF) inhibitors is not recommended because this may increase the risk of serious infections (see section 4.5).
Slovenian: Sočasna uporaba kanakinumaba in zaviralcev tumor nekrotizirajočega faktorja (TNF - tumor necrosis factor) ni priporočljiva ker lahko poveča tveganje za resne okužbe (glejte poglavje 4.5).
English: - Do not use this medicine if you notice that the solution is not clear to opalescent or contains particles.
Slovenian: - Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra ali opalescentna ali če vsebuje delce.
English: Periodic fever syndromes Ilaris is used in adults and children aged 2 years and older to treat the following: - Cryopyrin-associated periodic syndromes (CAPS) - this is a group of auto-inflammatory diseases, which include:
Slovenian: Periodični vročinski sindromi Zdravilo Ilaris uporabljamo pri odraslih in otrocih, ki so stari 2 leti ali več za zdravljenje naslednjih bolezni: - s kriopirinom povezani periodični sindromi s kratico CAPS - gre za skupino avtoinflamatornih (avtovnetnih) bolezni, med katerimi so:
English: Ilaris should be injected by a healthcare professional only.
Slovenian: Zdravilo Ilaris vam sme injicirati samo usposobljen zdravstveni delavec.
English: The median improvement from baseline to end of Part I of study G2301 was 0.88 (79%).
Slovenian: V študiji G2301 je znašala mediana vrednost izboljšanja od izhodišča do konca 1. obdobja 0,88 (79 %).
English: In patients who respond and require re-treatment, there should be an interval of at least 12 weeks before a new dose of canakinumab may be administered (see section 5.2).
Slovenian: Bolniki, ki se odzovejo in potrebujejo ponovno zdravljenje, lahko prejmejo naslednji odmerek kanakinumaba šele po preteku najmanj 12 tednov (glejte poglavje 5.2).
English: In an exploratory analysis of the primary endpoint, it was observed that in patients with an inadequate response after the first dose, an up-titration within the first month to a dose of 300 mg (or 4 mg/kg) every 4 weeks further improved flare control, reduced disease activity and normalised CRP and SAA levels.
Slovenian: V raziskovalni analizi primarnega cilja študije so opazili, da je pri bolnikih z nezadostnim odzivom po prvem odmerku, zvišanje odmerjanja v prvem mesecu na 300 mg (oziroma na 4 mg/kg) vsake 4 tedne dodatno izboljšalo obvladovanje zagonov, zmanjšalo aktivnost bolezni in omogočilo normalizacijo vrednosti CRP in SAA.
English: If bleeding occurs, apply a clean, dry cotton swab over the area, and press gently for 1 to 2 minutes, or until bleeding stops.
Slovenian: Če pride do krvavitve na tem mestu, ga pokrijte s čistim suhim bombažnim zložencem in nežno pritiskajte 1 do 2 minuti oziroma dokler se krvavitev ne ustavi, nato mesto prelepite z adhezivnim obližem.
English: Your doctor will discuss with you the need to start or adjust a urate lowering therapy to lower the uric acid level in your blood.
Slovenian: Zdravnik vam bo povedal, da morate začeti oziroma ustrezno spremeniti zdravljenje z zdravili za zmanjševanje količine urata, ki omogočajo znižanje koncentracije sečne kisline v krvi.
English: It is recommended that white blood cell (WBC) counts including neutrophil counts be assessed prior to initiating treatment and again after 1 to 2 months.
Slovenian: Določanje števila levkocitov vključno s številom nevtrofilcev je priporočeno pred začetkom zdravljenja in nato spet 1 do 2 meseca po začetku zdravljenja.
English: Check the expiry dates on the vial and syringes.
Slovenian: Preverite datum izteka roka uporabnosti zdravila na viali in na brizgah.
English: Patients who maintained inactive disease status for 6 additional months at this lowest dose regimen were allowed to discontinue canakinumab.
Slovenian: Bolnikom, ki so uspeli ohraniti status neaktivne bolezni dodatnih 6 mesecev, so dovolili, da prekinejo zdravljenje s kanakinumabom.
English: Formal carcinogenicity studies have not been conducted with canakinumab.
Slovenian: Formalnih študij kancerogenosti s kanakinumabom niso opravili.
English: Of the patients in clinical remission who continued with further dose reduction (1 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 12 weeks), 93% (26/28) and 91% (30/33) of patients, respectively, were able to maintain inactive disease status for 6 months.
Slovenian: Med bolniki, ki so bili v klinični remisiji in so nadaljevali zdravljenje z nadaljnjim znižanjem odmerka (1 mg/kg vsake 4 tedne) ali podaljšanjem odmernega intervala (4 mg/kg vsakih 12 tednov), jih je 93 % (26/28) oziroma 91 % (30/33) uspelo še 6 mesecev ohraniti status neaktivne bolezni.
English: After 24 weeks, 71% (27/38) of patients who received the reduced dose (2 mg/kg every 4 weeks) and 84% (31/37) of patients who received the prolonged dosing interval (4 mg/kg every 8 weeks) were able to maintain inactive disease status for 6 months.
Slovenian: Po 24 tednih je 71 % (27/38) bolnikov, ki so prejemali znižan odmerek (2 mg/kg vsake 4 tedne), in 84 % (31/37) tistih bolnikov, ki so zdravilo prejemali s podaljšanim intervalom (4 mg/kg vsakih 8 tednov), uspelo 6 mesecev ohranjati status neaktivne bolezni.
English: Find a clean place in which to prepare and give yourself the injection.
Slovenian: Poiščite čist prostor, v katerem boste pripravljali in si injicirali zdravilo.
English: For the primary efficacy endpoint, canakinumab was superior to placebo for all three disease cohorts.
Slovenian: Pri primarnem cilju študije je bil kanakinumab boljši od placeba v vseh treh kohortah.
English: Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype.
Slovenian: Kanakinumab je humano monoklonsko protitelo proti humanemu interlevkinu-1 beta (IL-1 beta) izotipa IgG1/κ.
English: Significant improvements were seen in physician's clinical assessment of autoinflammatory disease activity: global assessment of autoinflammatory disease activity, assessment of skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, assessment of other related symptoms, and patient's assessment of symptoms.
Slovenian: Pomembno izboljšanje so opažali pri zdravnikovi klinični oceni aktivnosti avotimunske bolezni: pri celotni oceni aktivnosti avtoimunske bolezni, pri oceni kožne bolezni (urtikarijski izpuščaj), artralgije, mialgije, glavobola/migrene, konjunktivitisa, utrujenosti/splošnega slabega počutja, pri oceni drugih povezanih simptomov in pri bolnikovi oceni simptomov.
English: What Ilaris is and what it is used for What you need to know before you use Ilaris How to use Ilaris
Slovenian: Kaj je zdravilo Ilaris in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ilaris Kako uporabljati zdravilo Ilaris Možni neželeni učinki
English: Although ≥ Grade 2 reductions in neutrophil count occurred in 6.5% of patients (common) and Grade 1 reductions occurred in 9.5% of patients, the reductions are generally transient and neutropenia-associated infection has not been identified as an adverse reaction.
Slovenian: Do znižanja števila nevtrofilcev stopnje ≥2 je prišlo pri 6,5 % bolnikov (pogosto), do znižanja stopnje 1 pa pri 9,5 % bolnikov, vendar so bila ta znižanja večinoma prehodna, med neželenimi učinki pa niso opažali z nevtropenijo povezanih okužb.
English: See also section 3, “Injecting Ilaris yourself or injecting a patient with Ilaris”.
Slovenian: Glejte tudi poglavje 3 "Samoinjiciranje zdravila Ilaris ali injiciranje zdravila Ilaris bolniku".
English: Corticosteroid dose tapering:
Slovenian: Postopno zniževanje odmerkov kortikosteroidov:
English: The risk for the development of malignancies with anti-interleukin (IL)-1 therapy is unknown.
Slovenian: Obseg tveganja za razvoj malignih bolezni pri zdravljenju z antagonisti interlevkina 1 (IL-1) ni znan.
English: Animal studies have shown that a murine anti-murine IL-1 beta antibody had no undesirable effects on development in nursing mouse pups and that the antibody was transferred to them (see section 5.3).
Slovenian: Študije na živalih so pokazale, da glodalsko protitelo proti glodalskemu IL-1 beta ni imelo neželenih učinkov na razvoj dojenih mišjih mladičev in da je to protitelo prehajalo k mladičem (glejte poglavje 5.3).
English: Overall, 33% (25/75) of patients randomised to dose reduction or dose interval prolongation arms were able to discontinue treatment with canakinumab and maintain inactive disease status for 6 months.
Slovenian: Skupno je 33 % (25/75) bolnikov, ki so jih randomizirali v skupini z znižanim odmerkom oziroma podaljšanim intervalom odmerjanja, uspelo prekiniti zdravljenje s kanakinumabom in 6 mesecev ohraniti status neaktivne bolezni.
English: Other medicines and Ilaris
Slovenian: Druga zdravila in zdravilo Ilaris
English: Never re-use the leftover solution.
Slovenian: Nikoli ne poskušajte ponovno uporabiti preostanka raztopine.
English: This patient presented at study entry with a history of immune thrombocytopenic purpura and an active medical condition of abnormal hepatic function.
Slovenian: Ob vstopu v študijo so pri temu bolniku zabeležili anamnezo imunske trombocitopenične purpure in aktivno bolezen z nepravilnim delovanjem jeter.
English: Canakinumab binds to serum IL-1 beta.
Slovenian: Kanakinumab se veže na IL-1 beta v serumu.
English: Long-term data and laboratory abnormalities in CAPS patients During clinical trials with canakinumab in CAPS patients mean values for haemoglobin increased and those for white blood cell, neutrophils and platelets decreased.
Slovenian: Dolgoročni podatki in patološki laboratorijski izvidi pri bolnikih s CAPS V kliničnih preskušanjih s kanakinumabom pri bolnikih s CAPS so se njihove vrednosti hemoglobina zvišale, vrednosti levkocitov, nevtrofilcev in trombocitov pa znižale.
English: Women who received canakinumab during pregnancy should be instructed to inform the baby's healthcare professional before any vaccinations are given to their newborn infant.
Slovenian: Ženske, ki v času nosečnosti prejemajo kanakinumab, morajo o tem obvestiti otrokovega zdravnika, preden novorojenček prejme katerokoli cepivo.
English: CAPS in children 2-< 4 years of age or children  4 years of age  7.5 kg and < 15 kg
Slovenian: CAPS pri otrocih, starih 2-< 4 leta, ali pri otrocih, starih  4 leta in z  7,5 kg ter < 15 kg
English: Packs containing 1 vial or multipacks containing 4 (4x1) vials.
Slovenian: Pakiranja vsebujejo 1 vialo, skupna pakiranja pa vsebujejo 4 viale (4x1 vialo).
English: Patients taking canakinumab in Part II had a 64% reduced risk of a flare event as compared to the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75; p=0.0032).
Slovenian: Pri bolnikih, ki so v 2. obdobju prejemali kanakinumab, je bilo tveganje za dogodke, ki pomenijo zagon bolezni, nižje za 64 % v primerjavi z bolniki v skupini s placebom (razmerje ogroženosti je bilo 0,36; 95-odstotni IZ: 0,17 do 0,75; p=0,0032).
English: The mean change in patient pain score (0-100 mm visual analogue scale) at day 15 was -50.0 mm for canakinumab (N=43), as compared to +4.5 mm for placebo (N=25).
Slovenian: Povprečna sprememba bolnikove ocene bolečine (0-100 mm na vizualni analogni lestvici) na 15. dan je bila -50,0 mm pri uporabi kanakinumaba (N=43) v primerjavi s +4,5 mm pri uporabi placeba (N=25).
English: A new flare was defined as a PGA score ≥ 2 (“mild, moderate, or severe disease”) and CRP ≥ 30 mg/l.
Slovenian: Nov zagon je bil opredeljen z oceno ≥ 2 na lestvici PGA (kar pomeni “blaga, zmerna ali huda aktivnost bolezni”) in vrednostjo CRP ≥ 30 mg/l.
English: Your doctor may want to check your vaccination history and give you any vaccinations that you have missed before you start treatment with Ilaris.
Slovenian: Vaš zdravnik bo morda hotel preveriti, proti čemu ste že bili cepljeni, in vas v primeru, da niste bili cepljeni po programu, dodatno cepiti še pred začetkom zdravljenja z zdravilom Ilaris.
English: Physicians should be attentive to symptoms of infection or worsening of Still's disease, as these are known triggers for MAS.
Slovenian: Zdravniki morajo biti pozorni na simptome okužbe ali poslabšanja Stillove bolezni, saj so to znani sprožilci sindroma aktivacije makrofagov.
English: The AUCss4w in each age group was 692, 615, 707 and 742 µg*d/ml for 2-3, 4-5, 6-11, and 12-19 years old, respectively.
Slovenian: Vrednosti AUCss v starostnih skupinah 2-3, 4-5, 6-11 in 12-19 let so znašale 692, 615, 707 in 742 µg*d/ml.
English: Study G2306
Slovenian: Študija G2306
English: If a patient becomes neutropenic or leukopenic, the WBC counts should be monitored closely and treatment discontinuation should be considered.
Slovenian: Če pride do nevtropenije ali levkopenije, je treba pri bolniku skrbno spremljati število levkocitov in razmisliti o prekinitvi zdravljenja.
English: Without touching the rubber stopper, swirl (do not shake) the vial slowly at an angle of about 45 degrees for about 1 minute.
Slovenian: Ne da bi se dotikali gumijastega zamaška, počasi vrtite vialo pod kotom približno 45 stopinj približno 1 minuto (viale pri tem ne stresajte).
English: What Ilaris is used for Ilaris is used for treatment of the following inflammatory diseases: - Periodic fever syndromes:
Slovenian: Za kaj uporabljamo zdravilo Ilaris Zdravilo Ilaris uporabljamo za zdravljenje naslednjih vnetnih bolezni: - periodični vročinski sindromi:
English: It is unknown whether canakinumab is excreted in human milk.
Slovenian: Ni znano, ali se kanakinumab izloča v materino mleko.
English: This may cause fever, headache, fatigue, skin rash, or painful joints and muscles.
Slovenian: To lahko povzroča simptome, kot so zvišana telesna temperatura, glavobol, utrujenost, kožni izpuščaj ter bolečine v sklepih in mišicah.
English: Resolution of disease flare was achieved by week 5 and the patient had not experienced any new flare at the end of Part II of the study (week 16).
Slovenian: Zagon bolezni je pri tem bolniku izzvenel do konca 5. tedna, nato pa pri bolniku ni prišlo do novega zagona do konca 2. obdobja v študiji (do konca 16. tedna).
English: Adverse reactions are listed according to MedDRA system organ class.
Slovenian: Neželeni učinki so navedeni glede na organski sistem po MedDRA klasifikaciji.
English: Insert the transfer needle through the centre of the stopper of the vial of Ilaris powder, taking care not to touch the needle or the stopper.
Slovenian: Iglo za prenos vstavite skozi osrednji del gumijastega zamaška viale s praškom Ilaris, pri tem pa pazite, da se ne dotaknete niti igle niti zamaška.
English: These data showed similar improvements from baseline to week 12 in the adapted paediatric ACR responses and its components to those observed in the placebo controlled study (G2305).
Slovenian: Ti podatki kažejo podobno izboljšanje po prirejenih pediatričnih kriterijih odziva ACR in po posameznih ocenah ACR kot pri rezultatih s placebom kontrolirane študije (G2305).