FrancophonIA/ELRC3.0 huggingface dataset:
English: Solution for injection in pre-filled syringe 1 GRADUATED pre-filled syringe 7 GRADUATED pre-filled syringes Multipack: 28 (4 x 7) GRADUATED pre-filled syringes
Croatian: Otopina za injekciju u napunjenoj štrcaljki 1 KALIBRIRANA napunjena štrcaljka 7 KALIBRIRANIH napunjenih štrcaljki Višestruko pakiranje: 28 (4 x 7) KALIBRIRANIH napunjenih štrcaljki
English: It is not known whether anakinra is excreted in human milk.
Croatian: Nije poznato izlučuje li se anakinra u majčino mlijeko.
English: The concurrent administration of Kineret and etanercept or other TNF-α antagonists is not recommended (see section 4.5).
Croatian: Istodobna primjena Kinereta i etanercepta ili drugih antagonista TNF-α se ne preporučuje (vidjeti dio 4.5).
English: The Guide for healthcare professionals shall contain the following key elements:
Croatian: • Vodič za zdravstvene djelatnike Vodič za zdravstvene djelatnike sadržavat će sljedeće ključne elemente:
English: Blood cholesterol increased
Croatian: Povišen kolesterol u krvi
English: The safety and efficacy of Kineret treatment in patients with chronic and serious infections have not been evaluated.
Croatian: Sigurnost i djelotvornost Kinereta u bolesnika s kroničnim i teškim infekcijama nije procjenjivana.
English: Concurrent Kineret and etanercept treatment has not demonstrated increased clinical benefit.
Croatian: Istodobna primjena Kinereta i etanercepta nije pokazala povećanu kliničku korist.
English: A study including 12 patients with hepatic dysfunction (Child-Pugh Class B) given a single 1mg/kg intravenous dose has been performed.
Croatian: Provedeno je ispitivanje u 12 ispitanika s poremećajem jetrene funkcije (Child-Pughov stadij B) koji su primili jednokratnu dozu od 1 mg/kg intravenski.
English: The subject incidence of serious adverse reactions in RA studies at the recommended dose of Kineret (100 mg/day) was comparable with placebo (7.1% compared with 6.5% in the placebo group).
Croatian: Incidencija ispitanika s ozbiljnim nuspojavama u ispitivanjima s bolesnicima s reumatoidnim artritisom pri preporučenoj dozi Kinereta (100 mg/dan) bila je usporediva s placebom (7,1% u usporedbi sa 6,5% u skupini s placebom).
English: Cytokines are proteins made by your body that co-ordinate communication between cells and help control cell activity.
Croatian: Vaše tijelo koji usklađuju komunikaciju između stanica i pomažu u kontroli stanične aktivnosti.
English: • Keep used syringes out of reach and sight of children.
Croatian: • Čuvajte korištene štrcaljke izvan dohvata i pogleda djece.
English: Kineret may worsen these conditions; - if you have cancer.
Croatian: Kineret može pogoršati ova stanja;
English: Human and animal data demonstrated that the kidney is the major organ responsible for elimination of anakinra.
Croatian: Podaci dobiveni u ispitivanjima na ljudima i životinjama pokazuju da se anakinra prvenstveno izlučuje putem bubrega.
English: Kineret treatment should be discontinued in RA patients if a serious infection develops.
Croatian: Liječenje Kineretom treba prekinuti u bolesnika s RA ako dođe do ozbiljne infekcije.
English: Patients weighing less than 50 kg should be dosed by body weight with a starting dose of 1-2 mg/kg/day.
Croatian: U bolesnika s tjelesnom težinom manjom od 50 kg dozu treba odrediti prema tjelesnoj težini s početnom dozom od 1-2 mg/kg/dan.
English: In placebo-controlled studies in RA patients, the most frequently reported adverse reactions with Kineret were injection site reactions (ISRs), which were mild to moderate in the majority of patients.
Croatian: Sažetak sigurnosnog profila U placebom kontroliranim ispitivanjima s bolesnicima s RA najčešće prijavljene nuspojave s Kineretom bile su reakcije na mjestu primjene (ISR), koje su bile blage do umjerene u većine bolesnika.
English: Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation.
Croatian: (IL-1) je glavni proupalni citokin koji posreduje u mnogim staničnim odgovorima uključujući one važne u upali sinovije.
English: Kineret is supplied ready for use in a graduated pre-filled syringe.
Croatian: Kineret se isporučuje spreman za uporabu u kalibriranoj napunjenoj štrcaljki.
English: Kineret should be used with caution in patients with severe hepatic impairment.
Croatian: Kineret treba primjenjivati uz oprez u bolesnika s teškim oštećenjem jetre.
English: These elevations have not been associated with signs or symptoms of hepatocellular damage, except for one patient with SJIA that developed serious hepatitis in connection with a cytomegalovirus infection.
Croatian: Povećanja nisu bila povezana sa znakovima ili simptomima hepatocelularnog oštećenja, osim u jednog bolesnika sa SJIA u kojeg se razvio ozbiljan hepatitis povezan s citomegalovirusnom infekcijom.
English: These were typically characterised by 1 or more of the following: erythaema, ecchymosis,
Croatian: Reakcije su tipično bile obilježene jednom ili više sljedećih pojava: eritem,
English: No patient withdrew from Kineret treatment due to adverse reactions.
Croatian: Nijedan se od bolesnika nije povukao iz liječenja Kineretom zbog nuspojava.
English: No dose adjustment is required for patients with moderate hepatic impairment (Child-Pugh Class B).
Croatian: Nije potrebna prilagodba doze u bolesnika s umjerenim oštećenjem jetre (Child-Pughov stadij B).
English: A causal relationship between Kineret and MAS has not been established.
Croatian: Uzročna povezanost između Kinereta i MAS-a nije ustanovljena.
English: These elevations have not been associated with signs or symptoms of hepatocellular damage, except for one patient with SJIA that developed a serious hepatitis in connection with a cytomegalovirus infection.
Croatian: Povećanja nisu bila povezana sa znakovima ili simptomima hepatocelularnog oštećenja, osim u jednog bolesnika sa SJIA u kojeg se razvio ozbiljan hepatitis povezan s infekcijom citomegalovirusom.
English: When patients are clinically well-controlled, CNS and ophthalmological monitoring may be conducted yearly.
Croatian: Ako je bolest klinički dobro kontrolirana, praćenje središnjeg živčanog sustava i očiju može se provoditi jednom godišnje.
English: A total of 752 RA patients ≥ 65 years of age, including 163 patients ≥ 75 years of age, were studied in clinical trials.
Croatian: U kliničkim ispitivanjima proučavana su 752 bolesnika s RA u dobi od ≥ 65 godina, uključujući 163 bolesnika u dobi od ≥ 75 godina.
English: The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation.
Croatian: Tijekom kronične upale stvaranje enzima CYP450 je potisnuto zbog povećanih razina citokina (npr. IL-1).
English: The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection.
Croatian: Preporučena doza Kinereta je 100 mg primijenjena jednom dnevno supkutanom injekcijom.
English: Kineret contains sodium
Croatian: Kineret sadrži natrij
English: Pharmacokinetic data in children < 4 years are lacking, but clinical experience is available from 8 months of age, and when started at the recommended daily dose of 1-2 mg/kg, no safety concerns have been identified.
Croatian: Nema dovoljno farmakokinetičkih podataka za djecu mlađu od 4 godine, ali postoji kliničko iskustvo s djecom od 8 mjeseci u koje se lijek pokazao sigurnim ako se liječenje započne pri preporučenoj dnevnoj dozi od 1-2 mg/kg.
English: You must not breast-feed if you use Kineret.
Croatian: Ne smijete dojiti ako primjenjujete Kineret.
English: Kineret has been associated with an increased incidence of serious infections (1.8%) vs. placebo (0.7%) in RA patients.
Croatian: Kineret je povezan s povećanom incidencijom ozbiljnih infekcija (1,8%) naspram placeba (0,7%) u bolesnika s RA.
English: Therefore, screening for viral hepatitis should be performed in accordance with published guidelines also before starting therapy with Kineret.
Croatian: Stoga prije početka terapije Kineretom treba napraviti i pretragu za virusni hepatitis u skladu s objavljenim smjernicama.
English: The graduated pre-filled syringe allows for doses between 20 and 100 mg. As the minimum dose is 20 mg the syringe is not suitable for paediatric patients with a body weight below 10 kg.
Croatian: Budući da je minimalna doza 20 mg, štrcaljka nije prikladna za pedijatrijske bolesnike s tjelesnom težinom manjom od 10 kg.
English: In a placebo-controlled clinical trial (n = 126), no difference was detected in anti-tetanus antibody response between the Kineret and placebo treatment groups when a tetanus/diphtheria toxoid vaccine was administered concurrently with Kineret.
Croatian: U placebom kontroliranom kliničkom ispitivanju (n = 126) u kojem je cjepivo s toksoidom tetanusa/difterije primjenjivano istodobno s Kineretom nije uočena razlika u odgovoru protutijela protiv tetanusa između skupine koja je primala Kineret i skupine koje je primala placebo.
English: Overall, the efficacy and safety profile of Kineret is comparable in adult and paediatric patients with CAPS or Still's disease.
Croatian: Pedijatrijska populacija Djelotvornost i sigurnost Kinereta usporediva je u odraslih i pedijatrijskih bolesnika s CAPS-om ili
English: Glucocorticoid doses can in many cases be reduced after initiation of Kineret therapy.
Croatian: U mnogim se slučajevima nakon uvođenja Kinereta doze glukokortikoida mogu smanjiti.
English: The recommended dose for patients weighing 50 kg or more is 100 mg/ day by subcutaneous injection.
Croatian: Preporučena doza za bolesnike s tjelesnom težinom od 50 kg ili većom iznosi 100 mg/dan primijenjeno supkutanom injekcijom.
English: • The patient and caregiver guide
Croatian: • Vodič za bolesnike i njegovatelje
English: Injecting Kineret yourself
Croatian: Kako sami sebi injicirati Kineret
English: Available data is limited regarding whether Kineret can be continued during serious infections in patients with Still's disease.
Croatian: Dostupni podaci o tome može li se liječenje Kineretom nastaviti tijekom ozbiljnih infekcija u bolesnika koji imaju Stillovu bolest su ograničeni.
English: Kineret treatment significantly decreases the manifestations of CAPS, including a reduction in frequently occurring symptoms as fever, rash, joint pain, headache, fatigue, and eye redness.
Croatian: Liječenje Kineretom značajno smanjuje manifestacije CAPS-a, uključujući smanjenje učestalosti čestih simptoma kao što su vrućica, osip, bol u zglobovima, glavobolja, umor i crvenilo oka.
English: Consequently plasma clearance of Kineret decreases with decreasing renal function.
Croatian: Kinereta iz plazme opada sa smanjenjem bubrežne funkcije.
English: Prior to launch of the new indication Still's disease for Kineret in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme,
Croatian: Prije uključivanja nove indikacije za Kineret, Stillove bolesti, u svakoj državi članici nositelj odobrenja mora dogovoriti sadržaj i oblik edukacijskih programa, uključujući komunikacijske medije, načine distribucije te sve druge aspekte programa s nacionalnim nadležnim tijelom.
English: Kineret is a clear, colourless-to-white solution for injection and is supplied ready for use in a pre-filled syringe.
Croatian: Kineret je bistra, bezbojna do bijela otopina za injekciju te se isporučuje spremna za primjenu u napunjenoj štrcaljki.
English: - Swelling of the face, tongue or throat - Trouble swallowing or breathing - Suddenly feeling fast pulse or sweating - Itchy skin or rash
Croatian: - Poteškoće u gutanju ili disanju - Iznenadni osjećaj ubrzanog pulsa ili znojenje
English: For information on vaccinations see section 4.4.
Croatian: Za informacije o cijepljenju vidjeti dio 4.4.
English: In severe renal insufficiency and end stage renal disease (creatinine clearance < 30 ml/min), mean plasma clearance declined by 70% and 75%, respectively.
Croatian: Kod teške insuficijencije bubrega i završne faze bubrežne bolesti (klirens kreatinina < 30 ml/min), srednji klirens kreatinina bio je manji za 70% odnosno 75%.
English: In 43 CAPS patients followed for up to 5 years, no allergic event was serious and no event required discontinuation of Kineret treatment.
Croatian: U 43 bolesnika s CAPS-om koji su praćeni do najdulje 5 godina, nijedna alergijska reakcija nije bila ozbiljna i nijedna reakcija nije zahtjevala prekid liječenja Kineretom.
English: The clearance of anakinra in RA patients increased with increasing creatinine clearance.
Croatian: Klirens anakinre u bolesnika s RA povećao se s povećanjem klirensa kreatinina.
English: Kineret treatment should not be initiated in patients with neutropenia (ANC < 1.5 x 109/l).
Croatian: Liječenje Kineretom ne smije se započeti u bolesnika s neutropenijom (ABN < 1,5 x 109/l).
English: Excipients: anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polysorbate 80, sodium hydroxide, water for injections.
Croatian: Pomoćne tvari: citratna kiselina, bezvodna, natrijev klorid, dinatrijev edetat dihidrat, polisorbat 80, natrijev hidroksid, voda za injekcije.
English: Place a sterile gauze or tissue on a flat surface and hold the syringe above it with the needle pointing towards the gauze or tissue, as shown in Figure C. Make sure the needle does not touch the gauze or tissue.
Croatian: Na ravnu površinu položite sterilnu gazu ili maramicu i iznad toga držite štrcaljku, s iglom usmjerenom prema gazi ili maramici, kako je prikazano na slici C.
English: The mean plasma clearance of Kineret in subjects with mild (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-49 ml/min) renal insufficiency was reduced by 16% and 50%, respectively.
Croatian: Srednji klirens Kinereta u plazmi u bolesnika s blagom insuficijencijom bubrega (klirens kreatinina 50-80 ml/min) bio je manji za 16%, a u onih s umjerenom insuficijencom bubrega (klirens kreatinina 30-49 ml/min) 50% manji.
English: For a small number of patients with asthma, the incidence of serious infection was higher in Kineret-treated patients (4.5%) vs. placebo-treated patients (0%), these infections were mainly related to the respiratory tract.
Croatian: U manjeg broja bolesnika s astmom, incidencija ozbiljne infekcije bila je viša u bolesnika liječenih Kineretom (4,5%) naspram bolesnika liječenih placebom (0%).
English: CAPS: Posology and administration in children and infants aged 8 months and older with a body weight of 10 kg or above are the same as for adult CAPS patients, based on body weight.
Croatian: CAPS: Doziranje i način primjene u djece i dojenčadi u dobi od 8 mjeseci i starijih s tjelesnom težinom od najmanje 10 kg isti su kao i u odraslih bolesnika s CAPS-om, razmjerno tjelesnoj težini.
English: Do not inject more Kineret.
Croatian: Ne injicirajte više Kinereta nego što je potrebno.
English: - Thrombocytopenia (low level of blood platelets).
Croatian: - Trombocitopenija (niske razine trombocita u krvi)
English: The patient and caregiver information pack should contain:
Croatian: Informacijski paket za bolesnike i njegovatelje treba sadržavati:
English: - In rare cases patients with Still's disease, mainly children, may develop lung disease, also during Kineret treatment.
Croatian: U rijetkim slučajevima, uključujući i tijekom liječenja lijekom Kineret, bolesnici sa Stillovom bolešću, uglavnom djeca, mogu razviti bolest pluća.
English: You must not be given live vaccines while being treated with
Croatian: Ne smijete primati živa cjepiva dok se liječite Kineretom.
English: Kineret.
Croatian: Kineretom.
English: No dose adjustment is needed for patients with mild renal impairment (CLcr 60 to 89 ml/min).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem bubrega (CLcr 60 do 89 ml/min).
English: MedDRA Organ System Frequency
Croatian: MedDRA organski sustav Učestalost
English: Clear, colourless-to-white solution for injection that may contain some product-related translucentto-white amorphous particles.
Croatian: Bistra, bezbojna do bijela otopina za injekciju koja može sadržavati neke prozirne do bijele amorfne čestice porijeklom od lijeka.
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 100 mg, tj. zanemarive količine natrija.
English: Discard any unused medicinal product.
Croatian: Bacite neiskorišteni lijek.
English: Neutropenia Thrombocytopenia
Croatian: Neutropenija Trombocitopenija
English: An adverse event profile similar to that seen in adult RA patients was observed in these studies.
Croatian: U tim su ispitivanjima zabilježeni štetni događaji slični onima u odraslih bolesnika s RA.
English: • The early signs indicative of MAS
Croatian: • Rane znakove koji upućuju na MAS
English: Kineret was commonly associated with neutropenia (ANC < 1.5 x 109/l) in placebo-controlled studies in RA and cases of neutropenia have been observed in patients with CAPS and Still's disease.
Croatian: U ispitivanjima kontroliranim placebom Kineret je često bio povezan s neutropenijom (ABN < 1,5 x 109/l) u bolesnika s RA, a primijećeni su i slučajevi neutropenije u bolesnika s CAPS-om i Stillovom bolešću.
English: Accordingly, the decrease in clearance is most likely explained by a decrease in renal function in this population.
Croatian: Iz toga se može zaključiti da je smanjenje klirensa posljedica smanjene bubrežne funkcije u toj populaciji.
English: In CAPS patients approximate dose linearity with a slight tendency to higher than proportional increase has been noted.
Croatian: CAPS-om utvrđeno je da je približna linearnost doze blago povišena, a ne proporcionalna dozi.
English: To give yourself or your child a subcutaneous injection you will need:
Croatian: Da biste sebi ili svom djetetu dali potkožnu injekciju potrebna Vam je: • napunjena štrcaljka Kinereta
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGES
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENE ŠTRCALJKE
English: After a 1-month blinded phase, 8 of 12 patients in the Kineret treated group were identified as modified ACRpedi30 responders compared to 1 of 12 in the placebo group.
Croatian: 12 bolesnika u skupini liječenoj Kineretom identificirani su kao bolesnici s modificiranim odgovorom ACRpedi30 u usporedbi s 1 od 12 bolesnika u skupini koja je primala placebo.
English: Concurrent Kineret and TNF-α antagonist treatment Concurrent administration of Kineret and etanercept has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone in RA patients.
Croatian: Istodobna primjena Kinereta i etanercepta u bolesnika s RA povezana je s povećanim rizikom od ozbiljnih infekcija i neutropenije u usporedbi sa samim etanerceptom.
English: The impact of treatment with Kineret on pre-existing malignancy has not been studied.
Croatian: Utjecaj liječenja Kineretom na prethodna maligna stanja nije ispitivan.
English: Remember
Croatian: Ne zaboravite
English: • The importance of explaining the use of the syringe and correct injection technique to patients and/or caregivers
Croatian: • Zašto je važno bolesnicima i/ili njegovateljima objasniti način uporabe štrcaljke i ispravne tehnike ubrizgavanja
English: Before administration, visually inspect the solution for particulate matter and discolouration.
Croatian: Prije primjene vizualno pregledati otopinu na prisutnost čestica i promjenu boje.
English: Patients should be screened for latent tuberculosis prior to initiating Kineret.
Croatian: Prije početka liječenja Kineretom bolesnici trebaju napraviti pretragu za otkrivanje latentne tuberkuloze.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Kineret Lijek čuvajte izvan pogleda i dohvata djece.
English: There is limited experience in treating elderly CAPS and Still's disease patients.
Croatian: Iskustva u liječenju starijih osoba s CAPS-om i Stillovom bolešću su ograničena.
English: • a sterile gauze or tissue
Croatian: • sterilna gaza ili maramica
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free'.
Croatian: Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 100 mg, tj. zanemarive količine natrija.
English: For Still´s disease, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain and fever.
Croatian: U slučaju Stillove bolesti, Kineret se koristi za ublažavanje znakova i simptoma upale povezanih s bolesti, kao što su osip, bol u zglobovima i vrućica.
English: Injection site reactions
Croatian: Reakcija na mjestu primjene
English: It must be a clear, colourless-to-white solution.
Croatian: Mora biti prozirna, bezbojna do bijela otopina.
English: In patients who become neutropenic (ANC < 1.5 x 109/l) the ANC should be monitored closely and Kineret treatment should be discontinued.
Croatian: U bolesnika u kojih se pojavi neutropenija (ABN < 1,5 x 109/l) treba pomno nadzirati apsolutni broj neutrofila te prekinuti liječenje Kineretom.
English: 100 mg dose” section.
Croatian: 100 mg“.
English: Method of administration Kineret is administered by subcutaneous injection.
Croatian: Kineret se primjenjuje supkutanom injekcijom.
English: These data support that no dose adjustment is required for patients with hepatic dysfunction of Child-Pugh Class B. See section 4.2.
Croatian: Ti podaci potvrđuju da nije potrebna prilagodba doze za bolesnike s poremećajem jetrene funkcije Child-Pughovog stadija B.
English: Allergic reactions including anaphylactic reactions, angioedema, urticaria, rash, and pruritus have been reported uncommonly with Kineret.
Croatian: Alergijske reakcije, uključujući anafilaktičke reakcije, angioedem, urtikariju, osip i pruritus, prijavljuju se manje često u liječenju Kineretom.
English: In 15 SJIA patients followed for up to 1.5 years, one event of transient neutropenia was reported.
Croatian: U 15 bolesnika sa SJIA koji su praćeni do 1,5 godine prijavljen je jedan slučaj prolazne neutropenije.
English: X-ray examinations have been undertaken in one clinical study with anakinra.
Croatian: U jednom kliničkom ispitivanju anakinre obavljeni su rendgenski pregledi.
English: In placebo-controlled RA studies with Kineret, treatment was associated with small reductions in the mean values for total white blood count and absolute neutrophil count (ANC).
Croatian: U placebom kontroliranim kliničkim ispitivanjima u bolesnika s RA liječenje Kineretom bilo je povezano s malim sniženjem prosječnih vrijednosti za ukupni broj leukocita i apsolutni broj neutrofila
English: Still's disease: Children weighing less than 50 kg are dosed by body weight with a starting dose of 1-2 mg/kg/day, patients weighing 50 kg or more are dosed with 100 mg/day.
Croatian: Stillova bolest: U djece s tjelesnom težinom manjom od 50 kg doza se određuje prema tjelesnoj težini s početnom dozom od 1-2 mg/kg/dan, a u bolesnika tjelesne težine 50 kg ili više primjenjuje se doza od
English: In 43 CAPS patients followed for up to 5 years neutropenia was reported in 2 patients.
Croatian: U 43 bolesnika s CAPS-om koji su praćeni najdulje do 5 godina neutropenija je prijavljenja u
English: In 43 CAPS patients followed for up to 5 years no patient permanently or temporarily discontinued Kineret treatment due to injection site reactions.
Croatian: U 43 bolesnika s CAPS-om koji su praćeni najdulje do 5 godina, nijedan bolesnik nije trajno ili privremeno prekinuo liječenje Kineretom zbog ISR.
English: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of CAPS, including: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological,
Croatian: Kineret je indiciran u odraslih, adolescenata, djece i dojenčadi u dobi od 8 mjeseci i starije s tjelesnom težinom od najmanje 10 kg ili više za liječenje CAPS-a, uključujući: - neonatalnu multisistemsku upalnu bolest (engl.