FrancophonIA/ELRC3.0 huggingface dataset:
English: Macrophage activation syndrome in patients with Still's disease
Slovenian: Sindrom aktivacije makrofagov pri bolnikih s Stillovo boleznijo
English: Tip the vial to ensure that the required amount of solution can be drawn into the syringe.
Slovenian: Nagnite vialo, da boste lahko iz nje potegnili potrebno količino raztopine v brizgo.
English: No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving canakinumab.
Slovenian: O vplivu na cepljenje z živimi cepivi ali na sekundarni prenos okužb z živimi cepivi pri bolnikih, ki so prejemali kanakinumab, ni podatkov.
English: The Marketing Authorisation Holder has completed four Paediatric Investigation Plans for Ilaris (for CAPS, SJIA, FMF - HIDS/MKD and TRAPS respectively).
Slovenian: Imetnik dovoljenja za promet z zdravilom je izvedel štiri načrte pediatričnih raziskav za zdravilo Ilaris (in sicer za sindrome CAPS, SJIA, FMF - HIDS/MKD in TRAPS).
English: In approximately 12% of CAPS patients tested with a PPD (purified protein derivative) skin test in clinical trials, follow-up testing yielded a positive test result while treated with canakinumab without clinical evidence of a latent or active tuberculosis infection.
Slovenian: Pri približno 12 % bolnikov, ki imajo katerega od s kriopirinom povezanih periodičnih sindromov in so jim v kliničnih preskušanjih izvedli kožni test s PPD (s prečiščenim proteinskim derivatom), je pri kontrolnem testiranju v času zdravljenja s kanakinumabom prišlo do pozitivnih rezultatov, ne da bi imeli bolniki klinične znake latentne ali aktivne tuberkuloze.
English: Keep the needle all the way in the skin while slowly pushing the syringe plunger down until the barrel is empty.
Slovenian: Medtem ko je igla še vedno v celoti v kožni gubi, počasi potiskajte bat brizge navzdol, dokler brizge povsem ne izpraznite.
English: Allergic reactions with rash and itching and possibly also hives, difficulty breathing or swallowing, dizziness, unusual awareness of your heart beat (palpitations) or low blood pressure.
Slovenian: alergijske reakcije z izpuščajem in srbenjem, lahko tudi z urtikarijo, z oteženim dihanjem ali požiranjem, z omotičnostjo, z neprijetnim občutkom razbijanja srca (s palpitacijami) ali z nizkim krvnim tlakom.
English: All patients should be instructed to seek medical advice if signs or symptoms suggestive of tuberculosis (e.g. persistent cough, weight loss, subfebrile temperature) appear during canakinumab therapy.
Slovenian: Vsem bolnikom je treba naročiti, naj obiščejo zdravnika, če v času zdravljenja s kanakinumabom opazijo znake ali simptome, ki bi kazali na tuberkulozo (na primer trdovraten kašelj, zmanjševanje telesne mase, subfebrilne temperature).
English: Using an 18 G or 21 G x 2 inch needle (or similar as available on the market) and a 1 ml syringe, carefully withdraw the required volume depending on the dose to be administered.
Slovenian: Z uporabo igle 18 G ali 21 G x 2 palca (ali podobne igle, ki je na voljo na trgu) in 1-mililitrske injekcijske brizge previdno izvlecite toliko raztopine, kolikor je potrebno za injiciranje predpisanega odmerka.
English: For the overall study population, pain intensity was statistically significantly lower for canakinumab 150 mg compared with triamcinolone acetonide at 72 hours.
Slovenian: V celotni populaciji je bila intenzivnost bolečine 72 ur po odmerjanju statistično značilno manjša po uporabi kanakinumaba 150 mg v primerjavi z uporabo triamcinolon acetonida.
English: Prior to initiation of canakinumab therapy it is recommended that adult and paediatric patients receive all vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine (see section 4.5).
Slovenian: Priporočeno je, da odrasli in pediatrični bolniki že pred začetkom zdravljenja s kanakinumabom opravijo vsa cepljenja, ki jih potrebujejo, tudi cepljenje proti pnevmokoku in cepljenje z inaktiviranim virusom gripe (glejte poglavje 4.5).
English: Phase III trial, pivotal placebo-controlled withdrawal period (Part II) Canakinumab N=15 n(%)
Slovenian: Preskušanja faze III: obdobje s placebom kontroliranega opuščanja zdravila (2. obdobje) kanakinumab N=15 n(%)
English: Patients enrolled were aged 2 to < 20 years (mean age of 8.5 years and mean disease duration of 3.5 years at baseline) and had active disease defined as ≥ 2 joints with active arthritis, fever and elevated CRP.
Slovenian: Vključeni bolniki so bili stari od 2 do < 20 let (povprečna starost je znašala 8,5 let, povprečno trajanje bolezni ob izhodišču pa 3,5 let) in so imeli aktivno bolezen, opredeljeno z aktivnim artritisom v najmanj 2 sklepih, zvišano telesno temperaturo in zvišano vrednostjo C-reaktivnega proteina (CRP).
English: After proper training in the correct injection technique, patients or their caregivers may inject Ilaris if the physician determines that it is appropriate and with medical follow-up as necessary (see section 6.6).
Slovenian: Bolniki ali njihovi skrbniki smejo sami injicirati zdravilo Ilaris, če so se naučili pravilne tehnike injiciranja in če zdravnik presodi, da je to za njih primerno, in kasneje na ustrezen način preveri, če tako zdravljenje pri bolnikih pravilno poteka (glejte poglavje 6.6).
English: Canakinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators.
Slovenian: Kanakinumab se z veliko afiniteto specifično veže na humani interlevkin-1 beta in onemogoča njegovo biološko delovanje tako, da zavira njegovo interakcijo z receptorji za IL-1, s tem pa prepreči z IL-1 beta sproženo aktivacijo genov in tvorbo vnetnih mediatorjev.
English: Do not use after the expiry date which is stated on the label and carton.
Slovenian: Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: In clinical studies, CAPS, TRAPS, HIDS/MKD and FMF patients who have uncontrolled overproduction of IL-1 beta show a rapid and sustained response to therapy with canakinumab, i.e. laboratory parameters such as high C-reactive protein (CRP) and serum amyloid A (SAA), high neutrophil and platelet counts, and leukocytosis rapidly returned to normal.
Slovenian: V kliničnih študijah je pri bolnikih, ki so imeli katerega od sindromov CAPS, TRAPS, HIDS/MKD ali FMF in nenadzorovano prekomerno tvorbo IL-1 beta, prišlo do hitrega in dolgotrajnega odziva na zdravljenje s kanakinumabom, kar pomeni, da so se pri njih laboratorijski parametri, kot so koncentracije C-reaktivnega proteina (CRP), serumskega amiloida A (SAA) in zvišano število nevtrofilcev ter trombocitov in levkocitoza hitro vrnili na normalne vrednosti.
English: Preparing the injection
Slovenian: Pripravljanje injekcije
English: For maximum effect, canakinumab should be administered as soon as possible after the onset of a gouty arthritis attack.
Slovenian: Za doseganje največjega učinka mora bolnik prejeti kanakinumab čimprej po začetku napada uričnega artritisa.
English: It was estimated to be 6.2 litres in a CAPS patient of body weight 70 kg.
Slovenian: Ocenjujejo, da pri bolniku s CAPS, ki ima telesno maso 70 kg, znaša 6,2 litra.
English: The needle should not be in the liquid at this point.
Slovenian: Tokrat konica igle ne sme biti pokrita s tekočino.
English: After repeated subcutaneous administration of 150 mg every 4 weeks, canakinumab minimal concentration at week 16 (Cmin) was estimated to be 15.4 ± 6.6 g/ml.
Slovenian: Pri ponavljanju subkutanega odmerjanja 150 mg vsake 4 tedne je po 16 tednih ocenjena najnižja koncentracija kanakinumaba (Cmin) 15,4 ± 6,6 g/ml.
English: Secondary endpoints, all based on week 16 results (end of Part II), included the proportion of patients who achieved a PGA score of < 2, the proportion of patients with serological remission (defined as CRP ≤ 10 mg/l), and the proportion of patients with a normalised SAA level (defined as SAA ≤ 10 mg/l).
Slovenian: Vsi sekundarni cilji študije so izhajali iz rezultatov 16 tednov zdravljenja (ob zaključku 2. obdobja) in so vključevali delež bolnikov, ki so dosegli oceno < 2 na lestvici PGA, delež bolnikov s serološko remisijo (opredeljeno z vrednostjo CRP ≤ 10 mg/l) in delež bolnikov z normalizacijo vrednosti SAA (opredeljeno z vrednostjo SAA ≤ 10 mg/l).
English: Stopping your treatment with Ilaris may cause your condition to get worse.
Slovenian: Če prenehate uporabljati zdravilo Ilaris, se lahko vaša bolezen poslabša.
English: Time to flare:
Slovenian: Čas do zagona bolezni:
English: Study G2301
Slovenian: Študija G2301
English: Carefully withdraw the required volume depending on the dose to be administered (0.1 ml to 1 ml) and subcutaneously inject using a 27 G x 0.5 inch (13 mm) needle.
Slovenian: Previdno izvlecite toliko raztopine, kolikor je potrebno za injiciranje predpisanega odmerka (od 0,1 ml do 1 ml), in subkutano injicirajte raztopino z uporabo igle 27 G x 0,5 palca (13 mm).
English: • Patient Reminder Card
Slovenian: • opozorilno kartico za bolnika.
English: The efficacy of canakinumab for the treatment of acute gouty arthritis attacks was demonstrated in two multicentre, randomised, double-blind, active-controlled studies in patients with frequent gouty arthritis (≥ 3 attacks in the previous 12 months) unable to use NSAIDs or colchicine (due to contraindication, intolerance or lack of efficacy).
Slovenian: Učinkovitost kanakinumaba pri zdravljenju akutnih napadov uričnega artritisa so dokazali v dveh multicentričnih, randomiziranih, dvojno slepih, aktivno kontroliranih študijah z bolniki, ki so imeli pogoste napade uričnega artritisa (3 ali več napade v predhodnih 12 mesecih) in niso mogli uporabljati nesteroidnih protivnetnih zdravil ali kolhicina (zaradi kontraindikacij, neprenašanja ali nezadostnega učinka).
English: Women should use effective contraceptives during treatment with canakinumab and for up to 3 months after the last dose.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Ženske morajo med zdravljenjem s kanakinumabom in do 3 mesece po zadnjem odmerku uporabljati učinkovita kontracepcijska sredstva.
English: Safety results showed an increased incidence of adverse events for canakinumab compared to triamcinolone acetonide, with 66% vs 53% of patients reporting any adverse event and 20% vs 10% of patients reporting an infection adverse event over 24 weeks.
Slovenian: Rezultati glede varnosti kažejo večjo pogostnost neželenih dogodkov pri uporabi kanakinumaba v primerjavi z uporabo triamcinolon acetonida, saj je v 24 tednih o neželenem dogodku poročalo 66 % bolnikov s kanakinumabom v primerjavi s 53 % bolnikov s triamcinolon acetonidom, o okužbi kot o neželenem dogodku pa je poročalo 20 % bolnikov s kanakinumabom v primerjavi z 10 % bolnikov s triamcinolon acetonidom.
English: Read these instructions all the way through before beginning.
Slovenian: Preden začnete, preberite ta navodila v celoti.
English: Ilaris is also indicated for the treatment of:
Slovenian: Zdravilo Ilaris je indicirano tudi za zdravljenje naslednjih dveh bolezni:
English: TRAPS, HIDS/MKD and FMF: Adults, adolescents and children aged 2 years and older The recommended starting dose of canakinumab in TRAPS, HIDS/MKD and FMF patients is:
Slovenian: Sindromi TRAPS, HIDS/MKD in FMF: odrasli, mladostniki in otroci, stari 2 leti ali več Priporočeni začetni odmerek kanakinumaba za bolnike, ki imajo sindrome TRAPS, HIDS/MKD ali FMF je:
English: The pivotal study consisted of a 48-week three-part multicentre study, i.e. an 8-week open-label period (Part I), a 24-week randomised, double-blind, placebo-controlled withdrawal period (Part II), followed by a 16-week open-label period (Part III).
Slovenian: Ena ključnih študij je bila multicentrična in je obsegala 48-tedensko zdravljenje v treh različnih obdobjih: 8-tedensko odprto zdravljenje (1. obdobje), 24-tedensko randomizirano dvojno slepo, s placebom kontrolirano obdobje opuščanja zdravila (2. obdobje), temu pa je sledilo 16-tedensko odprto zdravljenje (3. obdobje).
English: Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors.
Slovenian: Zdravilo Ilaris vsebuje učinkovino kanakinumab, ki je monoklonsko protitelo in sodi v skupino zdravil, ki jih imenujemo zaviralci interlevkina.
English: Allow to stand for about 15 minutes at room temperature to obtain a clear to opalescent solution.
Slovenian: Vialo spet pustite, da stoji približno 15 minut pri sobni temperaturi, da dobite bistro ali opalescentno raztopino.
English: Do not turn the vial and syringe upside down, the vial should stay upright.
Slovenian: Viale z brizgo ne obračajte na glavo, viala mora stati pokonci.
English: Appropriate screening tests (e.g. tuberculin skin test, interferon gamma release assay or chest X-ray) should be performed in all patients (local recommendations may apply).
Slovenian: Pri vseh bolnikih je treba izvesti ustrezne presejalne teste (na primer tuberkulinski kožni test, gama interferonske teste ali rentgensko slikanje pljuč; v skladu z lokalnimi priporočili).
English: Accordingly, Tmax was shorter (3.6 days) in younger SJIA patients (2-3 years) compared to older SJIA patients (12-19 years; Tmax 6 days).
Slovenian: V skladu s tem je pri mlajših bolnikih s SJIA (starih 2-3 leta) koncentracija hitreje dosegla najvišje vrednosti (Tmax je bil 3,6 dneva) kot pri starejših bolnikih s SJIA (starih 12-19 let, pri katerih je Tmax znašal 6 dni).
English: Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall CAPS population (comprised of adult and paediatric patients, N=211), including the overall frequency and severity of infectious episodes.
Slovenian: Klinično pomembnih razlik glede varnostnih lastnosti in učinkovitosti kanakinumaba pri pediatrični populaciji v primerjavi s celotno populacijo bolnikov s CAPS (ki jo sestavljajo odrasli in pediatrični bolniki, N=211) ni bilo, kar velja tudi za pogostnost vseh okužb in njihovo resnost.
English: Treatment with canakinumab resulted in a rapid and sustained improvement of both the articular and the systemic features of SJIA with significant reduction of the number of inflamed joints, prompt resolution of fever and reduction of acute phase reactants in the majority of patients (see Clinical efficacy and safety).
Slovenian: Zdravljenje s kanakinumabom je omogočilo hitro in trajno izboljšanje tako sklepnih kot sistemskih znakov SJIA, in sicer se je pri večini bolnikov bistveno zmanjšalo število vnetih sklepov, prišlo je do hitrega znižanja zvišane telesne temperature in znižanja vrednosti beljakovin akutne faze (glejte Klinična učinkovitost in varnost).
English: Infections of the upper respiratory tract were the most frequently reported infection events.
Slovenian: Od okužb so najbolj pogosto poročali o okužbah zgornjih dihal.
English: This is consistent with the observations of higher exposure in higher body weight groups in CAPS patients.
Slovenian: Navedeno se ujema z ugotovitvijo, da je v skupinah bolnikov s CAPS z večjo telesno maso tudi izpostavljenost zdravilu večja.
English: Ilaris can be used alone or in combination with methotrexate.
Slovenian: Zdravilo Ilaris je mogoče uporabljati samostojno ali v kombinaciji z metotreksatom.
English: Study G2306 was an open-label study to assess maintenance of treatment response with canakinumab dose reduction (2 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 8 weeks) in SJIA patients who were receiving canakinumab 4 mg/kg every 4 weeks.
Slovenian: Študija G2306 je bila odprta študija za oceno ohranjanja odziva na zdravljenje ob znižanem odmerku kanakinumaba (2 mg/kg vsake 4 tedne) ali ob podaljšanem intervalu odmerjanja (4 mg/kg vsakih 8 tednov) pri bolnikih s SJIA, ki so prej prejemali kanakinumab v odmerku 4 mg/kg vsake 4 tedne.
English: Patients with Still's disease may develop a condition called macrophage activation syndrome (MAS), which can be life-threatening.
Slovenian: Pri bolnikih s Stillovo boleznijo lahko pride do motnje, ki jo imenujemo sindrom aktivacije makrofagov in je lahko življenjsko nevarna.
English: The safety and efficacy of Ilaris in SJIA patients under 2 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Ilaris pri bolnikih, ki imajo SJIA in so stari manj kot 2 leti, nista bili dokazani.
English: Not included in the pack one vial (or ampoule) of sterile water for injections (“water”) (at room temperature) one 1.0 ml syringe one 18 G x 2 inch (50 mm) needle for reconstituting the powder (“transfer needle”) one 27 G x 0.5 inch (13 mm) needle for injecting (“injection needle”) alcohol swabs clean, dry cotton swabs an adhesive plaster a proper disposal container for used needles, syringe and vials (sharps container)
Slovenian: Kar ni priloženo pakiranju eno vialo (ali ampulo), ki vsebuje sterilno vodo za injekcije ("vodo"), (sobne temperature) eno brizgo 1,0 ml eno iglo 18 G x 2 palca (50 mm) za rekonstituiranje praška ("iglo za prenos") eno iglo 27 G x 0,5 palca (13 mm) za injiciranje ("injekcijsko iglo") alkoholne blazinice čiste suhe bombažne zložence adhezivni obliž ustrezen zabojnik za uporabljene igle, brizge in viale (zbiralnik za ostre predmete)
English: Seventy five patients aged 2 to 22 years who maintained inactive disease status for at least 6 consecutive months (clinical remission) with canakinumab monotherapy, including patients who were able to maintain inactive disease status with discontinuation of concomitant corticosteroid and/or methotrexate use for at least 4 weeks, were randomised to receive canakinumab 2 mg/kg every 4 weeks (N=38) or canakinumab 4 mg/kg every 8 weeks (N=37).
Slovenian: Petinsedemdeset bolnikov, ki so bili stari od 2 do 22 let in so ohranjali status neaktivne bolezni najmanj 6 zaporednih mesecev (klinično remisijo) ob prejemanju samo kanakinumaba, vključno z bolniki, ki so uspeli najmanj 4 tedne ohranjati status neaktivne bolezni kljub prekinitvi sočasne uporabe kortikosteroidov in/ali metotreksata, je bilo randomiziranih tako, da so prejemali bodisi kanakinumab 2 mg/kg vsake 4 tedne (N=38) ali kanakinumab 4 mg/kg vsakih 8 tednov (N=37).
English: Open the wrapper containing the injection needle and attach the needle to the syringe.
Slovenian: Odprite zavoj z injekcijsko iglo in iglo namestite na brizgo.
English: This is administered every eight weeks as a single dose via subcutaneous injection.
Slovenian: Bolniki vsakih osem tednov prejmejo en odmerek s subkutano injekcijo.
English: The rate of adverse events in both treatment arms was similar to the rate seen in patients treated with canakinumab 4 mg/kg every 4 weeks.
Slovenian: Pogostnost neželenih dogodkov je bila v obeh zdravljenih skupinah podobna kot pri bolnikih, ki so prejemali kanakinumab v odmerku 4 mg/kg vsake 4 tedne.
English: Talk to your doctor before using Ilaris if any of the following applies to you: if you currently have an infection or if you have had repeated infections or a condition such as a known low level of white blood cells which makes you more likely to get infections.
Slovenian: Pred začetkom uporabe zdravila Ilaris se posvetujte z zdravnikom, če za vas velja karkoli od spodaj navedenega: če imate trenutno katero od okužb ali če so se vam kdaj ponavljale okužbe ali stanja, kot je ugotovljeno znižano število levkocitov, zaradi česar je možnost za razvoj okužbe pri vas večja; če imate ali ste imeli kdaj prej tuberkulozo ali ste prišli v neposreden stik z osebo z aktivno tuberkulozo.
English: Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).
Slovenian: Zdravilo Ilaris je indicirano za simptomatsko zdravljenje odraslih bolnikov s pogostimi napadi uričnega artritisa (z najmanj 3 napadi v predhodnih 12 mesecih), pri katerih je uporaba nesteroidnih protivnetnih zdravil in kolhicina kontraindicirana, jih bolnik ne prenaša ali ne povzročajo zadostnega odziva, in pri katerih ponavljajoči se ciklusi zdravljenja s kortikosteroidi niso primerni (glejte poglavje 5.1).
English: Hepatic function
Slovenian: Jetrna funkcija
English: The other was an open-label study with canakinumab to evaluate the efficacy and safety in Japanese CAPS patients for 24 weeks, with an extension phase up to 48 weeks.
Slovenian: Druga študija je bila odprta, v njej pa so ocenjevali učinkovitost in varnost uporabe kanakinumaba pri japonskih bolnikih s CAPS najprej 24 tednov, nato pa še v podaljšanju študije do skupaj 48 tednov.
English: Hold the syringe at a 90-degree angle and in a single, smooth motion, push the needle straight down completely into the skin.
Slovenian: Brizgo držite pod kotom 90 stopinj in jo z enim samim enakomernim gibom potisnite navzdol, tako da bo cela igla v kožni gubi.
English: The second patient received a starting dose of canakinumab 2 mg/kg and an add-on dose of 2 mg/kg at week 3, and was up-titrated at week 5 to receive a dose of 4 mg/kg administered every 4 weeks until the end of Part II of the study.
Slovenian: Drugi bolnik je prejel začetni odmerek kanakinumaba 2 mg/kg, po 3 tednih je prejel dodatni odmerek 2 mg/kg, po koncu 5. tedna pa so mu zvišali odmerek na 4 mg/kg vsake 4 tedne, kar je prejemal do konca 2. obdobja v študiji.
English: Patients must be monitored closely for signs and symptoms of tuberculosis during and after treatment with canakinumab.
Slovenian: Bolnike je treba med zdravljenjem s kanakinumabom in po njem natačno spremljati glede znakov in simptomov tuberkuloze.
English: Injecting Ilaris yourself or injecting a patient with Ilaris If you are a patient with CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA), or a caregiver of a patient with one of these conditions, you may administer Ilaris injections yourself after proper training in the correct injection technique.
Slovenian: Samoinjiciranje zdravila Ilaris ali injiciranje zdravila Ilaris bolniku Če ste bolnik s katerim od sindromov CAPS, TRAPS, HIDS/MKD ali FMF ali s Stillovo boleznijo (AOSD ali SJIA) ali če ste skrbnik bolnika s katero od navedenih bolezni, lahko sami injicirate zdravilo Ilaris, če ste se ustrezno izurili v pravilni tehniki injiciranja.
English: In study G2305, the Childhood Health Assessment Questionnaire Least Squares means improvement was 0.69 for canakinumab vs placebo representing 3.6 times the minimal clinically important difference of 0.19 (p=0.0002).
Slovenian: V študiji G2305 so bili rezultati Vprašalnika za oceno zdravja v otroštvu (Childhood Health Assessment Questionnaire) po metodi najmanjših kvadratov pri uporabi kanakinumaba za 0,69 točke boljši kot pri uporabi placeba, kar predstavlja 3,6-kratnik minimalne klinično pomembne spremembe 0,19 (p=0,0002).
English: Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).
Slovenian: Periodični sindrom povezan z receptorjem za tumor nekrotizirajoči factor (TNF) (TRAPS-tumour necrosis factor receptor associated periodic syndrome) Zdravilo Ilaris je indicirano za zdravljenje periodičnega sindroma, ki je povezan z receptorjem za TNF (TRAPS).
English: Study G2305
Slovenian: Študija G2305
English: Using aseptic technique, reconstitute each vial of canakinumab at room temperature (typically 15°C to 25°C) by slowly injecting 1 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 mm) needle.
Slovenian: Kanakinumab v viali z aseptično tehniko rekonstituirajte pri sobni temperaturi (običajno pri 15°C do 25°C), in sicer tako, da v vialo počasi injicirate 1 ml vode za injekcije z 1-mililitrsko injekcijsko brizgo in iglo 18 G x 2 palca (50 mm).