FrancophonIA/ELRC3.0 huggingface dataset:
English: Slowly pull the syringe plunger up to the correct mark (amount to be given as per healthcare provider's instructions), filling the syringe with Ilaris solution.
Slovenian: Počasi potegnite bat brizge navzgor do pravilne oznake (do oznake za količino, ki jo morate odmeriti po navodilu usposobljenega zdravstvenega delavca) in tako napolnite brizgo z raztopino Ilaris.
English: Clean the rubber stopper of the vial containing the Ilaris solution with a new alcohol swab.
Slovenian: Gumijast zamašek na viali, ki vsebuje zdravilo Ilaris, očistite z novo alkoholno blazinico.
English: It blocks the activity of a substance called interleukin-1 beta (IL-1 beta) in the body, which is present at increased levels in inflammatory diseases.
Slovenian: Zavira delovanje snovi, ki jo imenujemo interlevkin-1 beta (IL-1 beta) in jo najdemo v telesu, pri vnetnih boleznih pa je njena koncentracija zvišana.
English: These include shivering, chills, malaise, loss of appetite, body aches, typically in connection with a sudden onset of illness, sore throat or mouth ulcers, cough, phlegm, chest pain, difficulty breathing, ear pain, prolonged headache or localised redness, warmth or swelling of your skin or inflammation of connective tissue (cellulitis).
Slovenian: Ti simptomi vključujejo drgetanje, mrzlico, splošno slabo počutje, izgubo apetita, bolečine po telesu, ki so navadno povezane z nenadnim nastopom bolezni, vneto grlo oziroma žrelo ali razjede v ustih, kašelj, izkašljevanje sluzi, bolečine v prsih, oteženo dihanje, bolečine v ušesu, dolgotrajen glavobol ali rdečino, toploto ali oteklino na omejenem predelu kože ali vnetje vezivnega tkiva (flegmona).
English: Experience from individual patients who achieved a complete response following dose escalation to 600 mg (8 mg/kg) every 8 weeks suggests that a higher dose may be beneficial in patients not achieving complete response or not maintaining complete response with the recommended doses (150 mg or 2 mg/kg for patients ≥ 15 kg and ≤ 40 kg).
Slovenian: Izkušnje pri posameznih bolnikih, pri katerih je prišlo do popolnega odziva po zvišanju odmerka na 600 mg (8 mg/kg) vsakih 8 tednov, kažejo, da višji odmerki lahko koristijo bolnikom, pri katerih pri uporabi priporočenih odmerkov (150 mg oziroma 2 mg/kg za bolnike s telesno maso ≥ 15 kg in ≤ 40 kg) ni prišlo do popolnega odziva ali pa se ta ni ohranil.
English: Part III: Patients treated with placebo in Part II who flared regained and maintained clinical and serological response following entry into the open-label canakinumab extension.
Slovenian: 3. obdobje: Pri bolnikih, ki so v 2. obdobju prejemali placebo in pri katerih je prišlo do zagona bolezni, je po vključitvi v podaljšanje z odprtim zdravljenjem s kanakinumabom ponovno prišlo do kliničnega in serološkega odziva, ki se je tudi ohranil.
English: Although limited, evidence from the clinical trials suggests that patients not responding to tocilizumab or anakinra may respond to canakinumab.
Slovenian: Podatki iz kliničnih študij, čeprav omejenega obsega, kažejo, da pri bolnikih, ki se ne odzivajo na zdravljenje s tocilizumabom oziroma anakinro, lahko pride do odziva na zdravljenje s kanakinumabom.
English: Animal studies indicate that canakinumab crosses the placenta and is detectable in the foetus.
Slovenian: Rezultati študij na živalih kažejo, da kanakinumab prehaja preko placente in pri plodu doseže merljivo koncentracijo.
English: • Neonatal-onset multisystem inflammatory disease (NOMID), also called chronic infantile neurological, cutaneous, articular syndrome (CINCA),
Slovenian: • multisistemska vnetna bolezen z začetkom pri novorojenčku (angleško neonatal-onset multisystem inflammatory disease - NOMID), ki se imenuje tudi kronični vnetni nevrološki, kožni in sklepni sindrom pri dojenčku (angleško chronic infantile neurological, cutaneous, articular syndrome - CINCA),
English: Ensure that the correct amount of solution is in the syringe.
Slovenian: Preverite, če je v brizgi res ustrezna količina raztopine.
English: In this study, 25 patients who had a strong ACR response for a minimum of 5 months reduced their canakinumab dose to 2 mg/kg every 4 weeks and maintained a paediatric ACR100 response throughout the time the reduced dose was given (median 32 weeks, 8-124 weeks).
Slovenian: V tem podaljšanju je 25 bolnikov z močnim odzivom po kriterijih ACR za najmanj 5 mesecev znižalo odmerjanje kanakinumaba na 2 mg/kg vsake 4 tedne in ves čas prejemanja znižanih odmerkov ohranilo odziv po pediatričnih kriterijih ACR100 (mediano 32 tednov, od 8 do 124 tednov).
English: The safety and efficacy of Ilaris in CAPS, TRAPS, HIDS/MKD and FMF patients under 2 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Ilaris pri bolnikih, ki imajo CAPS ali katerega od sindromov TRAPS, HIDS/MKD ali FMF in so stari manj kot 2 leti, nista bili dokazani.
English: Study G2305 was a randomised, double-blind, placebo-controlled, 4-week study assessing the shortterm efficacy of canakinumab in 84 patients randomised to receive a single dose of 4 mg/kg (up to 300 mg) canakinumab or placebo.
Slovenian: Študija G2305 je bila randomizirana, dvojno slepa, s placebom kontrolirana 4-tedenska študija, v kateri so ocenjevali kratkoročno učinkovitost kanakinumaba pri 84 bolnikih, ki so jih randomizirali tako, da so prejeli enkraten odmerek 4 mg/kg (največ 300 mg) kanakinumaba ali placebo.
English: Canakinumab also demonstrated superior efficacy compared to placebo on the secondary endpoints of PGA < 2 and CRP ≤ 10 mg/l in all three cohorts.
Slovenian: Kanakinumab je bil v vseh treh kohortah bolj učinkovit od placeba tudi pri sekundarnih ciljih študije: pri doseganju ocene < 2 na lestvici PGA in vrednosti CRP ≤ 10 mg/l.
English: Antibodies against Ilaris were observed in approximately 1.5%, 3% and 2% of the patients treated with Ilaris for CAPS, SJIA and gouty arthritis, respectively.
Slovenian: Protitelesa proti zdravilu Ilaris so opažali pri približno 1,5 % bolnikov, ki so prejemali zdravilo Ilaris zaradi CAPS, pri 3 % bolnikov, ki so prejemali zdravilo zaradi SJIA, in pri 2 % bolnikov, ki so prejemali zdravilo zaradi uričnega artritisa.
English: In active-controlled gouty arthritis trials, there was a mean increase in triglycerides of 33.5 mg/dl in canakinumab-treated patients compared with a modest decrease of -3.1 mg/dl with triamcinolone acetonide.
Slovenian: V aktivno kontroliranih preskušanjih pri bolnikih z uričnim artritisom je pri bolnikih, ki so prejemali kanakinumab, prišlo do povprečnega zvišanja vrednosti trigliceridov za 33,5 mg/dl v primerjavi z zmernim znižanjem za -3,1 mg/dl pri bolnikih, ki so prejemali triamcinolon acetonid.
English: If you forget to use Ilaris
Slovenian: Če ste pozabili uporabiti zdravilo Ilaris
English: Live vaccines: You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while you are being treated with Ilaris.
Slovenian: Živa cepiva: Priporočeno je, da se v času zdravljenja z zdravilom Ilaris izogibate cepljenju z vrsto cepiv, ki jih imenujemo "živa cepiva".
English: In a subset of young adult SJIA patients aged 16 to 20 years (n=31), the safety profile of canakinumab was consistent with what was observed in SJIA patients less than 16 years of age.
Slovenian: V podskupini mladih odraslih bolnikov s SJIA, ki so bili stari od 16 do 20 let (n=31), je bil varnostni profil kanakinumaba podoben kot pri tistih bolnikih s SJIA, ki so bili stari manj kot 16 let.
English: The efficacy and safety of canakinumab have been demonstrated in a total of 211 adult and paediatric patients with varying degrees of disease severity and different CAPS phenotypes (including FCAS/FCU, MWS, and NOMID/CINCA).
Slovenian: S kriopirinom povezani periodični sindromi (CAPS) Varnost in učinkovitost kanakinumaba so dokazali pri skupno 211 odraslih in pediatričnih bolnikih z različnimi stopnjami izraženosti in z različnimi fenotipskimi oblikami bolezni s kriopirinom povezanih periodičnih sindromov (CAPS), vključno s sindromi FCAS/FCU, MWS in NOMID/CINCA.
English: Efficacy results in a subgroup of patients unable to use both NSAIDs and colchicine and who were on ULT, failed ULT or had a contraindication to ULT (N=101) were consistent with the overall study population with a statistically significant difference compared to triamcinolone acetonide in pain intensity at 72 hours (-10.2 mm, p=0.0208) and in reduction of risk of subsequent attacks (Hazard ratio 0.39, p=0.0047 at 24 weeks).
Slovenian: V skupini bolnikov, ki niso mogli uporabljati niti nesteroidnih protivnetnih zdravil niti kolhicina in so uporabljali zdravila, ki znižujejo količino urata, ali pa je bilo pri njih zdravljenje z njimi neuspešno ali kontraindicirano (N=101), so bili rezultati glede učinkovitosti skladni z rezultati celotne študijske populacije s statistično značilno razliko v primerjavi z uporabo triamcinolon acetonida, in sicer glede intenzivnosti bolečine po 72 urah (-10,2 mm, p=0,0208) in glede tveganja za nadaljnje napade (razmerje ogroženosti (HR) 0,39, p=0,0047 po 24 tednih).
English: TRAPS n=number of responders; N=number of evaluable patients * indicates statistical significance (one-sided) at the 0.025 level based on Fisher exact test **Indicates statistical significance (one-sided) at the 0.025 level based on the logistic regression model with treatment group and baseline PGA, CRP or SAA respectively, as explanatory variables for each cohort
Slovenian: TRAPS n=število bolnikov z odzivom; N=število bolnikov, ki so bili primerni za vrednotenje * pomeni statistično značilnost (enosmerno) za raven verjetnosti 0,025 na osnovi Fisherejevega eksaktnega testa ** pomeni statistično značilnost (enosmerno) za raven verjetnosti 0,025 na osnovi modela logistične regresije, v katerem so način zdravljenja in izhodiščne vrednosti ocene PGA, CRP ter SAA pojasnjevalne spremenljivke v posamezni kohorti
English: Therefore, live vaccines should not be given concurrently with canakinumab unless the benefits clearly outweigh the risks.
Slovenian: Iz tega razloga v času zdravljenja s kanakinumabom bolniki ne smejo biti cepljeni z živimi cepivi, razen če koristi nedvomno odtehtajo tveganja.
English: This is administered every four weeks as a single dose via subcutaneous injection.
Slovenian: Bolniki vsake štiri tedne prejmejo en odmerek s subkutano injekcijo.
English: If you stop using Ilaris
Slovenian: Če ste prenehali uporabljati zdravilo Ilaris
English: Ilaris is used in adults, adolescents and children to treat active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older if other treatments have not worked well enough.
Slovenian: Zdravilo Ilaris uporabljamo pri odraslih, mladostnikih in otrocih za zdravljenje aktivne Stillove bolezni, ki vključuje Stillovo bolezen z začetkom v odrasli dobi (AOSD) in sistemski juvenilni idiopatski artritis (SJIA), pri bolnikih, ki so stari 2 leti ali več, če druga zdravila pri njih niso dovolj dobro delovala.
English: - Do not use this medicine after the expiry date which is stated on the label and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: Maintenance dose: 150 mg every 4 weeks
Slovenian: Vzdrževalni odmerek: 150 mg vsake 4 tedne
English: In the pooled efficacy analysis for these two studies, 65.6% of patients who had not previously been treated with canakinumab achieved complete response at 150 mg or 2 mg/kg, while 85.2% of patients achieved complete response at any dose.
Slovenian: Rezultati analize podatkov o učinkovitosti iz obeh navedenih študij, kažejo, da je pri odmerjanju 150 mg oziroma 2 mg/kg prišlo do popolnega odziva pri 65,6 % bolnikov, ki predhodno niso bili zdravljeni s kanakinumabom, pri kateremkoli odmerku pa je do popolnega odziva prišlo pri 85,2 % bolnikov.
English: If not used immediately, the solution should be stored in the refrigerator (2°C - 8°C) and used within 24 hours.
Slovenian: Če raztopine ne uporabite takoj, jo morate hraniti v hladilniku (pri temperaturi 2 °C do 8 °C) in uporabiti v roku 24 ur.
English: Ilaris blocks the activity of IL-1 beta, which may improve the signs and symptoms of Still's disease.
Slovenian: Zdravilo Ilaris zavira delovanje IL-1-beta, kar lahko izboljša znake in simptome Stillove bolezni.
English: Do not use Ilaris - if you are allergic to canakinumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Ilaris - če ste alergični na kanakinumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če imate ali domnevate, da imate hudo okužbo, ki je aktivna.
English: Gouty arthritis There is no relevant use of Ilaris in the paediatric population in the indication gouty arthritis.
Slovenian: Zdravilo Ilaris ni primerno za uporabo pri pediatrični populaciji za indikacijo uričnega artritisa.
English: For instructions on how to administer Ilaris injections, please read the section “Instructions for use” at the end of this leaflet.
Slovenian: Navodila glede injiciranja zdravila Ilaris lahko preberete v poglavju "Navodila za uporabo praška za raztopino za injiciranje zdravila Ilaris" na koncu teh navodil.
English: 150 mg or 2 mg/kg
Slovenian: 150 mg oziroma 2 mg/kg
English: Triglycerides
Slovenian: Trigliceridi
English: Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF).
Slovenian: Družinska mediteranska vročica (FMF-familial Mediterranean fever) Zdravilo Ilaris je indicirano za zdravljenje družinske mediteranske vročice (FMF).
English: An additional pharmacokinetics analysis showed that the pharmacokinetics of canakinumab in 6 paediatric CAPS patients under the age of 2 years were similar to the pharmacokinetics in paediatric patients 2-4 years of age.
Slovenian: Dodatna farmakokinetična analiza je pokazala, da je bila farmakokinetika kanakinumaba pri 6 pediatričnih bolnikih s CAPS, ki so bili stari manj kot 2 leti, podobna farmakokinetiki pri pediatričnih bolnikih, ki so bili stari od 2 do 4 leta.
English: Additional dose of 150 mg can be considered
Slovenian: Razmislite o uporabi dodatnega odmerka 150 mg
English: In another study, among patients who were starting on ULT, increases in uric acid were not observed.
Slovenian: V drugi študiji pri bolnikih, ki so začeli zdravljenje z zdravili, ki znižujejo količino urata, niso opažali zvišanja koncentracije sečne kisline.
English: Additionally, 6 paediatric patients under the age of 2 years were evaluated in a small open-label clinical study.
Slovenian: Poleg tega so v majhni odprti klinični študiji ocenjevali tudi uporabo pri 6 pediatričnih bolnikih, ki so bili stari manj kot 2 leti.
English: Once the required volume is withdrawn, recap and remove the withdrawal needle from the syringe and attach a 27 G x 0.5 inch needle (or similar as available on the market) to immediately inject the solution subcutaneously.
Slovenian: Ko v brizgo potegnete ustrezno količino raztopine, iglo za izvlek pokrijte s pokrovčkom in jo odstranite z brizge, nato pa na brizgo namestite iglo 27 G x 0,5 palca (ali podobno iglo, ki je na voljo na trgu) in raztopino takoj subkutano injicirajte.
English: 2 In gouty arthritis
Slovenian: 2 pri uričnem artritisu
English: If not used immediately after reconstitution, the solution should be kept at 2°C to 8°C and used within 24 hours.
Slovenian: Če raztopine ne uporabite takoj po rekonstituciji, jo shranite pri temperaturi od 2 °C do 8 °C in uporabite v roku 24 ur.
English: Apparent clearance (CL/F) in the TRAPS, HIDS/MKD and FMF population at body weight of 55 kg (0.14 l/d) was comparable to CAPS population at body weight of 70 kg (0.17 l/d).
Slovenian: Vrednost navideznega očistka (CL/F) v populaciji bolnikov s sindromi TRAPS, HIDS/MKD ali FMF s telesno maso 55 kg (0,14 l/dan) je podobna kot v populaciji bolnikov s CAPS s telesno maso 70 kg (0,17 l/dan).
English: A 6-year observational registry study was conducted to provide data on the long-term safety and effectiveness of canakinumab treatment in paediatric and adult CAPS patients in routine clinical practice.
Slovenian: Za pridobitev podatkov o dolgoročni varnosti in učinkovitosti zdravljenja s kanakinumabom pri pediatričnih in odraslih bolnikih s CAPS v okviru rutinske klinične prakse so izvedli 6-letno opazovalno registrsko študijo.
English: p=0.2798 Risk reduction of subsequent gouty arthritis attacks as measured by time to first new flare (24 weeks)
Slovenian: zmanjševanje tveganja za nadaljnje napade uričnega artritisa: čas do prvega novega napada (v 24 tednih)
English: The CAPS interventional trials with canakinumab included a total of 80 paediatric patients with an age range from 2 to 17 years (approximately half of them treated on an mg/kg basis).
Slovenian: Intervencijska preskušanja zdravljenja periodičnih sindromov, povezanih s kriopirinom (CAPS), s kanakinumabom so vključevala skupno 80 pediatričnih bolnikov v starosti od 2 do 17 let (približno polovica teh bolnikov je prejemala odmerke zdravila na osnovi mg/kg telesne mase).
English: Adult-onset Still's disease and systemic juvenile idiopathic arthritis are severe autoinflammatory diseases, driven by innate immunity by means of pro-inflammatory cytokines, a key one being IL-1beta.
Slovenian: Stillova bolezen z začetkom v odrasli dobi in sistemski juvenilni idiopatski artritis sta hudi avtovnetni bolezni, pri katerih ima poglavitno vlogo prirojena imunost, in sicer provnetni citokini, med katerimi je najbolj pomemben IL-1-beta.
English: In the overall study population, patients on ULT had a less pronounced treatment difference in both pain reduction and reduction in the risk of subsequent gouty arthritis attacks compared to patients not on ULT.
Slovenian: V celotni študijski populaciji je bila pri bolnikih, ki so uporabljali zdravila za zmanjševanje količine urata, razlika med načinoma zdravljenja glede zmanjševanja bolečine in tveganja za nadaljnje napade uričnega artritisa manj izrazita kot pri bolnikih, ki niso jemali zdravil za zmanjševanje količine urata.
English: This is consistent with the observed increase in CL/F with body weight.
Slovenian: To se ujema z ugotovitvijo, da se navidezni očistek (Cl/F) povečuje z večanjem telesne mase.
English: Allow the vial to warm to room temperature before injection.
Slovenian: Vialo z zdravilom pred injiciranjem ogrejte na sobno temperaturo.
English: The decision whether to breast-feed during canakinumab therapy should therefore only be taken after a thorough benefit-risk evaluation.
Slovenian: Za dojenje v času zdravljenja s kanakinumabom se je zato smiselno odločiti šele po temeljitem razmisleku o razmerju med tveganji in koristmi.
English: Very common Respiratory tract infections (including pneumonia, bronchitis, influenza, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper respiratory tract infection)
Slovenian: Infekcijske in parazitske bolezni zelo pogosti okužbe dihal (kar vključuje pljučnico, bronhitis, gripo, virusno okužbo, sinusitis, rinitis, faringitis, tonzilitis, nazofaringitis, okužbo zgornjih dihal) okužba ušesa flegmona gastroenteritis okužba sečil pogosti vulvovaginalna kandidoza
English: Higher proportions of patients had normalised SAA (≤ 10 mg/l) at week 16 with canakinumab treatment compared to placebo in all three cohorts, with a statistically significant difference observed in TRAPS patients (see Table 3 with study results below).
Slovenian: V vseh treh kohortah je do konca 16. tedna prišlo do normalizacije vrednosti SAA (≤ 10 mg/l) pri večjem deležu bolnikov s kanakinumabom kot pri tistih s placebom, pri čemer so statistično značilno razliko opažali pri bolnikih s sindromom TRAPS (glejte spodaj rezultate v preglednici 3).
English: Overall, the efficacy, safety and tolerability profile of canakinumab in elderly patients ≥ 65 years of age was comparable to patients < 65 years of age.
Slovenian: V celoti so bile učinkovitost, varnost in prenašanje kanakinumaba pri bolnikih, starih 65 let ali več, primerljive s tistimi pri bolnikih, mlajših od 65 let.
English: Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Slovenian: Zdravila ne uporabljajte, če tekočina vsebuje vidne delce, je motna ali izrazito rjave barve.
English: canakinumab treatment improved all paediatric ACR response scores as compared to placebo at days 15 and 29 (Table 4).
Slovenian: Zdravljenje s kanakinumabom je v primerjavi s placebom izboljšalo vse ocene pediatričnih kriterijev odziva ACR na 15. in 29. dan (preglednica 4).
English: Part I: A complete clinical and biomarker response to canakinumab (defined as composite of physician's global assessment on autoinflammatory and on skin disease ≤ minimal and CRP or SAA values < 10 mg/litre) was observed in 97% of patients and appeared within 7 days of initiation of treatment.
Slovenian: 1. obdobje: Popoln klinični odziv na kanakinumab in odziv z biološkimi označevalci (opredeljen kot malo aktivna ali neaktivna tako avtoimunska kot kožna bolezen glede na zdravnikovo celotno oceno hkrati s koncentracijami CRP ali SAA, nižjimi od 10 mg/liter) so opažali pri 97 % bolnikov, do takega odziva pa je prišlo v 7 dneh od začetka zdravljenja.
English: The apparent volume of distribution per kg (V/F per kg) was 0.14 l/kg.
Slovenian: Navidezni volumen porazdelitve na kilogram telesne mase (V/F na kg) je znašal 0,14 l/kg.
English: Your healthcare provider will instruct you on the right amount for you.
Slovenian: Usposobljen zdravstveni delavec vam bo povedal, koliko raztopine morate uporabiti vi.
English: Laboratory abnormalities in SJIA patients
Slovenian: Patološki laboratorijski izvidi pri bolnikih s SJIA
English: For CAPS, TRAPS, HIDS/MKD, FMF and Still's disease, the treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication.
Slovenian: Pri sindromih CAPS, TRAPS, HIDS/MKD in FMF ter Stillovi bolezni sme zdravljenje uvesti in nadzirati zdravnik specialist, ki ima izkušnje z odkrivanjem in zdravljenjem omenjenih indikacij.
English: Multipack: 4 (4x1) vials.
Slovenian: prašek za raztopino za injiciranje Skupno pakiranje: 4 (4x1) viale.
English: There was no indication of accelerated clearance or time-dependent change in the pharmacokinetic properties of canakinumab following repeated administration.
Slovenian: Po večkratnem odmerjanju ni bilo znakov za pospešeno izločanje ali za spremenjen časovni potek farmakokinetičnih lastnosti kanakinumaba.
English: Decreased white blood cell counts (WBC) ≤ 0.8 x lower limit of normal (LLN) were reported in 6.7% of patients treated with canakinumab compared to 1.4% treated with triamcinolone acetonide.
Slovenian: O znižanem številu levkocitov (vrednostih, ki so bile enake ali nižje kot 0,8-kratnik spodnje meje normalnih vrednosti) so poročali pri 6,7 % bolnikov, ki so prejemali kanakinumab, v primerjavi z 1,4 % bolnikov, ki so prejemali triamcinolon acetonid.
English: Instructions for use of Ilaris powder for solution for injection
Slovenian: Navodila za uporabo zdravila Ilaris prašek za raztopino za injiciranje
English: A murine antimurine IL-1 beta antibody had no undesirable effects on fertility in male or female mice (see section 5.3).
Slovenian: Glodalsko protitelo proti glodalskemu IL-1 beta ni škodljivo vplivalo na plodnost niti pri mišjih samcih niti pri samicah (glejte poglavje 5.3).
English: What Ilaris looks like and contents of the pack Ilaris is supplied as a powder for solution for injection (150 mg in a 6 ml glass vial).
Slovenian: Zdravilo Ilaris je na voljo v obliki praška za raztopino za injiciranje v (150 mg v 6-mililitrski stekleni viali).
English: • 150 mg for patients with body weight > 40 kg
Slovenian: 150 mg za bolnike s telesno maso > 40 kg
English: Slowly pull the syringe plunger up to the correct mark (amount to be given), filling the syringe with Ilaris solution.
Slovenian: Počasi potegnite bat brizge navzgor do pravilne oznake (do oznake za količino, ki jo morate injicirati) in tako napolnite brizgo z raztopino Ilaris.