natgillin/translations-raw huggingface dataset:
The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies. 
Profil nuspojava iz ovih ispitivanja ne odudara od onog primijećenog u ispitivanjima reumatoidnog artritisa.
Adult 
Odrasla osoba
Hepatic events during post-marketing use have mainly been reported in patients that have been treated for Still's disease and in patients with predisposing factors, e.g. a history of transaminase elevations before start of Kineret treatment. 
Hepatički događaji tijekom postmarketinške primjene zabilježeni su uglavnom u bolesnika koji su bili liječeni zbog Stillove bolesti i u bolesnika s predispozicijom, npr. s anamnezom povišene transaminaze prije početka liječenja Kineretom.
Breast-feeding should be discontinued during treatment with Kineret. 
Dojenje treba prekinuti za vrijeme liječenja Kineretom.
Additional published data in Still's disease indicate that Kineret induces a rapid resolution of systemic features such as fever, rash, and elevation of acute phase reactants. 
Dodatno objavljeni podaci o Stillovoj bolesti pokazuju da Kineret inducira brzo povlačenje sistemskih znakova kao što su vrućica, osip i povišenje reaktanata akutne faze.
There are no indications either from this study or from post-marketing adverse reaction reports that the overall safety profile in patients with CAPS or Still's disease is different from that in patients with RA, with the exception of the risk for development of MAS in patients with Still's disease. 
Nema naznaka, ni iz ovog ispitivanja, niti iz postmarketinški prijavljenih nuspojava, da se općeniti sigurnosni profil u bolesnika s CAPS-om ili Stillovom bolešću razlikuje od onog u bolesnika s RA, osim u riziku za razvoj MAS-a u bolesnika sa Stillovom bolešću.
In 15 SJIA patients followed for up to 1.5 years, one patient developed a serious hepatitis in connection with a cytomegalovirus infection. 
Od 15 bolesnika sa SJIA praćenih do 1,5 godine, jedan je bolesnik razvio ozbiljan hepatitis povezan s infekcijom citomegalovirusom.
IL-1 is found in the plasma and synovial fluid of patients with rheumatoid arthritis, and a correlation has been reported between IL-1 concentrations in the plasma and the activity of the disease. 
Farmakodinamički učinci IL-1 je otkriven u plazmi i sinovijalnoj tekućini bolesnika s reumatoidnim artritisom i prijavljena je veza između koncentracija IL-1 u plazmi i aktivnosti bolesti.
Kineret treatment should not be initiated in patients with active infections. 
Liječenje Kineretom ne smije se započinjati u bolesnika s aktivnim infekcijama.
• That it is not recommended to start treatment with Kineret in patients with an ongoing infection 
• Da nije preporučljivo započinjati liječenje Kineretom u bolesnika s prisutnom infekcijom
At a dose of 100 mg/day, 71% of RA patients developed an ISR compared to 28% of the placebo treated patients. 
Pri dozi od 100 mg/dnevno, 71% bolesnika s RA imalo je ISR u usporedbi s 28% bolesnika koji su primali placebo.
During post-marketing use events of interstitial lung disease, pulmonary alveolar proteinosis and pulmonary hypertension have been reported mainly in paediatric patients with Still's disease treated with IL-6 and IL-1 inhibitors, including Kineret. 
Tijekom postmarketinške primjene zabilježeni su događaji intersticijske bolesti pluća, plućne alveolarne proteinoze te plućne hipertenzije, uglavnom u pedijatrijskih bolesnika sa Stillovom bolešću liječenih inhibitorima IL-6 i IL-1, uključujući Kineret.
Kineret contains the active substance anakinra. 
Kineret sadrži djelatnu tvar anakinra.
• Patient identification 
• Identifikacijske podatke o bolesniku
Allergic reactions, including anaphylactic reactions and angioedema have been reported uncommonly. 
Alergijske reakcije, uključujući anafilaktičke reakcije i angioedem prijavljene su manje često.
During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l). 
Nakon stavljanja lijeka u promet prijavljeni su slučajevi trombocitopenije, uključujući povremene prijave slučajeva koji su upućivali na tešku trombocitopeniju (tj. broj trombocita < 10 x109/l).
The majority of patients have been treated for Still's disease or have had predisposing factors, e.g. a history of transaminase elevations. 
Većina bolesnika bila je liječena zbog Stillove bolesti ili je imala predisponirajuće čimbenike, npr. povišenja transaminaza u anamnezi.
The concurrent use of Kineret with etanercept or any other TNF-α antagonist is not recommended (see section 4.4). 
Istodobna primjena Kinereta s etanerceptom ili bilo kojim drugim antagonistom TNF-α se ne preporučuje (vidjeti dio 4.4).
Normally, your body produces a protein that blocks the harmful effects of interleukin-1. 
Ako ste zdravi, Vaše tijelo stvara bjelančevinu koja blokira štetne učinke interleukina-1.
Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. 
Kineret je indiciran u odraslih za liječenje znakova i simptoma RA u kombinaciji s metotreksatom, u osoba s neodgovarajućim odgovorom na sam metotreksat.
In general the pharmacokinetics in CAPS patients is similar to that in RA patients. 
Farmakokinetika u bolesnika s CAPS-om općenito je slična onoj u bolesnika s RA.
In patients with severe renal impairment (CLcr < 30 ml/min) or end stage renal disease, including dialysis, administration of the prescribed dose of Kineret every other day should be considered. 
U bolesnika s teškim oštećenjem bubrega (CLcr < 30 ml/min) ili u završnom stadiju bubrežne bolesti, uključujući one na dijalizi, treba razmotriti primjenu propisane doze Kinereta svaki drugi dan.
The estimated anakinra clearance increased with increasing creatinine clearance and body weight. 
Procijenjeni klirens anakinre povećao se s povećanjem klirensa kreatinina i tjelesne težine.
Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml). 
Svaka kalibrirana napunjena štrcaljka sadrži 100 mg anakinre* u 0,67 ml (150 mg/ml).
• The importance of providing patients and/or caregivers with the educational material 
• Zašto je važno bolesnicima/njegovateljima uručiti edukacijske materijale
Therefore the use of Kineret in patients with pre-existing malignancy is not recommended. 
Stoga se primjena Kinereta u bolesnika s prethodnim malignitetima ne preporučuje.
Possible side effects are similar regardless if you are treated with Kineret for RA, CAPS or Still's disease. 
Moguće nuspojave slične su neovisno o tome primate li Kineret za RA, CAPS ili Stillovu bolest.
During post-marketing use isolated case reports indicating non-infectious hepatitis have been received. 
Tijekom postmarketinške primjene prijavljeni su pojedinačni slučajevi neinfektivnog hepatitisa.
- Serious infections such as pneumonia (a chest infection) or infections of the skin can occur during Kineret treatment. 
- Ozbiljne infekcije poput upale pluća (pneumonija) ili infekcija kože mogu se javiti tijekom liječenja Kineretom.
The role of IL-1 in the pathogenesis of Still's disease has been demonstrated by ex vivo and gene expression studies. 
Uloga IL-1 u patogenezi Stillove bolesti dokazana je ispitivanjim ex vivo te ispitivanjima genske ekspresije.
There are no indications from post-marketing experience that types and severity of infections in patients with Still's disease differ from those in RA or CAPS patients. 
U postmarketinškom iskustvu nema naznaka da se vrste i težina infekcija u bolesnika sa Stillovom bolešću razlikuju od onih u bolesnika s RA ili CAPS-om.
• If your doctor has prescribed a lower dose you should continue to the “How to prepare a 20 to 90 mg dose” section. 
• Ako Vam je liječnik propisao nižu dozu, idite na odjeljak „Kako pripremiti dozu od 20 do
The recommended starting dose in all CAPS subtypes is 1-2 mg/kg/day by subcutaneous injection. 
Preporučena početna doza za sve podvrste CAPS-a iznosi 1-2 mg/kg/dan primijenjena supkutanom injekcijom.
The safety and efficacy of Kineret have been demonstrated in CAPS patients with varying degrees of disease severity. 
Sigurnost i djelotvornost Kinereta dokazana je u bolesnika s CAPS-om s različitim stupnjevima težine bolesti.
These data support that no dose adjustment is needed for patients with mild renal impairment (CLcr 50 to 80 ml/minute). 
Ovi podaci potvrđuju da nije potrebna prilagodba doze za bolesnike s blagim oštećenjem bubrega (CLcr 50 do 80 ml/minuti).
Still's disease - Patients with Still's disease may develop a condition called macrophage activation syndrome (MAS), which can be life-threatening. 
Stillova bolest - U bolesnika sa Stillovom bolešću može se pojaviti stanje pod nazivom sindrom aktivacije makrofaga (MAS), koji može ugroziti život bolesnika.
In 15 SJIA patients followed for up to 1.5 years, no allergic event was serious and no event required discontinuation of Kineret. 
U 15 bolesnika sa SJIA koji su praćeni do 1,5 godine, nijedan događaj alergije nije bio ozbiljan i nijedan događaj nije zahtijevao prekid primjene Kinereta.
It is unknown whether anakinra/metabolites are excreted in human milk. 
Nije poznato izlučuju li se anakinra/metaboliti u majčino mlijeko.
A clinical response to anakinra generally appeared within 2 weeks of initiation of treatment and was sustained with continued administration of anakinra. 
Klinički odgovor na anakinru općenito javio se unutar 2 tjedna nakon početka liječenja te se održao uz kontinuiranu primjenu anakinre.
In clinical trials, whilst patients treated with Kineret had a higher incidence of lymphoma than the expected rate in the general population, this rate is consistent with rates reported in general for RA patients. 
U kliničkim ispitivanjima su bolesnici liječeni Kineretom imali veću incidenciju limfoma od očekivane stope u općoj populaciji, ova stopa odgovara stopama općenito prijavljenim u bolesnika s RA.
After your injection discard the wet gauze or tissue with your syringe and clean the surface with a fresh tissue. 
Nakon primjene lijeka zbrinite mokru gazu ili maramicu zajedno sa štrcaljkom i površinu očistite čistom maramicom.
The safety and efficacy of Kineret versus DMARD have been reported in a published 24-week multicenter, randomized, open-label study of 22 patients with glucocorticoid-dependent refractory AOSD. 
Sigurnost i djelotvornost Kinereta u usporedbi s DMARD-ovima zabilježene su u objavljenom multicentričnom, randomiziranom, otvorenom ispitivanju u 22 bolesnika s refraktornim AOSD-om ovisnim o glukokortikoidima koje je trajalo 24 tjedna.
In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed. 
U kliničkim ispitivanjima nisu primijećene interakcije između Kinereta i drugih lijekova (uključujući nesteroidne protuupalne lijekove, glukokortikoide i lijekove koji modificiraju tijek bolesti).
If you develop signs of lung disease you should contact your health care provider as soon as possible. 
Ako Vam se pojave znakovi bolesti pluća, trebate se što prije obratiti liječniku.
Anakinra had no observed effect on the fertility, early development, embryo-foetal development, or peri- and postnatal development in the rat at doses up to 100 times the human dose (2 mg/kg/day). 
Učinak anakinre na plodnost, rani razvoj, embriofetalni razvoj ili peri- i postnatalni razvoj u štakora nije primijećen pri dozama do 100 puta većim od doze za ljude (2 mg/kg/dan).
In clinical trials in RA, up to 3% of adult patients tested seropositive at least once during the study for neutralizing anti-anakinra antibodies. 
U kliničkim ispitivanjima u bolesnika s RA do 3% testiranih odraslih bolesnika bilo je seropozitivno najmanje jednom tijekom ispitivanja na neutralizirajuća protutijela na anakinru.
For CAPS, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain, fever, headache and fatigue in adults and children (age 8 months and older). 
U slučaju CAPS-a, Kineret se koristi za ublažavanje znakova i simptoma upala povezanih s bolesti kao što su osip, bol u zglobovima, vrućica, glavobolja i umor u odraslih i djece (stare 8 i više mjeseci).
Disposing of used syringes and supplies 
Odlaganje korištenih štrcaljki i pribora
Still's disease: Data in elderly patients are limited. 
Stillova bolest: Podaci za starije osobe su ograničeni.
In clinical trials, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population. 
U kliničkim ispitivanjima gruba stopa incidencije malignih bolesti bila je ista kao i u bolesnika liječenih Kineretom te u bolesnika koji su primali placebo i nije se razlikovala od one u općoj populaciji.
No dose-limiting toxicities were observed during clinical studies. 
Tijekom kliničkih ispitivanja nije primijećena dozno-limitirajuća toksičnost.
In 15 SJIA patients followed for up to 1.5 years, the most common and consistently reported treatment-related adverse reactions associated with Kineret treatment were ISRs. 
U 15 bolesnika sa SJIA koji su praćeni do 1,5 godine, najčešće i dosljedno prijavljivane nuspojave povezane s liječenjem Kineretom bile su ISR.
Administration of Kineret results in a decrease in the acute phase reactants and a decrease in IL-6 expression level has been observed. 
Primjena Kinereta dovodi do smanjenja reaktanata akutne faze te je primijećeno da dolazi do smanjenja razine ekspresije IL-6.
Therefore, live vaccines should not be given concurrently with Kineret. 
Stoga se živa cjepiva ne smiju primjenjivati istodobno s Kineretom.
This might increase the risk of you getting an infection. 
Vaš rizik od infekcije.
• the upper outer areas of the buttocks; and 
• gornji vanjski dijelovi stražnjice i
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (CONTAINS BLUE BOX) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S NAPUNJENOM ŠTRCALJKOM (S PLAVIM OKVIROM)
The activated inflammasome results in proteolytic maturation and secretion of IL-1β, which has a broad range of effects including systemic inflammation. 
Aktivirani inflamasom uzrokuje proteolitično dozrijevanje i lučenje interleukina-1β koji ima širok raspon učinaka, uključujući izazivanje sustavne upale.
Symptoms might be persistent high fever, shivers, cough, headache, and redness and tenderness of the skin. 
Simptomi mogu biti stalno visoka tjelesna temperatura, tresavica, kašalj, glavobolja i crvenilo i osjetljivost kože.
Adverse reactions are listed according to MedDRA system organ class and frequency category. 
Nuspojave su navedene prema klasifikaciji organskih sustava prema MedDRA-i i kategoriji učestalosti.
A subset of these patients continued open-label treatment with Kineret for up to 1 year in a companion extension study. 
Jedna je podskupina tih bolesnika nastavila sudjelovati u otvorenom liječenju Kineretom do godine dana u popratnom nastavku ispitivanja.
The risk may be increased in patients with Down's syndrome (trisomy 21). 
Downovim sindromom (trisomijom 21).
Concurrent Kineret and TNF-α antagonist treatment In a clinical trial with RA patients receiving background methotrexate, patients treated with Kineret and etanercept were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept alone and higher than observed in previous trials where Kineret was used alone. 
Istodobno liječenje Kineretom i antagonistima TNF-α U kliničkom ispitivanju s bolesnicima s RA koji primaju osnovno liječenje metotreksatom, primijećeno je da bolesnici liječeni Kineretom i etanerceptom imaju višu stopu ozbiljnih infekcija (7%) i neutropenije od bolesnika liječenih samo etanerceptom te višu u odnosu na prethodna ispitivanja u kojima se Kineret primjenjivao sam.
A similar pattern was seen after 24 weeks Kineret treatment. 
Slična pojava uočena je nakon 24 tjedna primjene Kinereta.
How to use Kineret 
Kako primjenjivati Kineret
• Instructions on correct injection procedures and disposal of used syringes 
• Upute za uporabu štrcaljke • Upute o ispravnom postupku injiciranja i zbrinjavanju korištenih štrcaljki
The patient and caregiver guide shall contain the following key elements: 
Vodič za bolesnike i njegovatelje sadržavat će sljedeće ključne elemente:
Systemically, IL-1 is known to cause the hypothalamic fever response and promote hyperalgesia. 
Poznato je da IL-1 sistemskim djelovanjem uzrokuje vrućicu preko hipotalamusa te potiče hiperalgeziju.
The ejected liquid will be absorbed by the gauze or tissue as shown in Figure C. 
Gaza ili maramica će upiti izbačenu tekućinu kako je prikazano na slici C.
Kineret treatment must not be initiated in patients with neutropenia (ANC <1.5 x 109/l) (see section 4.4). 
Liječenje Kineretom ne smije se započeti u bolesnika s neutropenijom (ABN < 1,5 x 109/l) (vidjeti dio 4.4).
The most common reason for withdrawal from study in Kineret-treated RA patients was injection site reaction. 
Najčešći razlog za povlačenje iz ispitivanja u bolesnika s RA liječenih Kineretom bila je reakcija na mjestu primjene.
The incidence of serious infection was higher in Kineret-treated patients compared to patients receiving placebo (1.8% vs. 0.7%). 
Incidencija ozbiljnih infekcija bila je viša u bolesnika liječenih Kineretom u usporedbi s bolesnicima koji su primali placebo (1,8% naspram 0,7%).
Hepatic events in patients with Still's disease predominantly occur during the first month of Kineret treatment. 
Hepatički događaji u bolesnika sa Stillovom bolešću uglavnom se javljaju tijekom prvog mjeseca liječenja Kineretom.
17 patients completed the open-label extension phase (Week 52), of which 7 of 14 Kineret-treated patients, and 2 of 3 patients on DMARDs, were in remission at that time point. 
Fazu otvorenog nastavka ispitivanja (do 52. tjedna) završilo je 17 bolesnika od kojih je u to vrijeme 7 od 14 bolesnika liječenih Kineretom te 2 od 3 bolesnika liječena DMARD-ovima bilo u remisiji.
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 
Otopina za injekciju u napunjenoj štrcaljki 1 KALIBRIRANA napunjena štrcaljka 7 KALIBRIRANIH napunjenih štrcaljki Višestruko pakiranje: 28 (4 x 7) KALIBRIRANIH napunjenih štrcaljki
It is not known whether anakinra is excreted in human milk. 
Nije poznato izlučuje li se anakinra u majčino mlijeko.
The concurrent administration of Kineret and etanercept or other TNF-α antagonists is not recommended (see section 4.5). 
Istodobna primjena Kinereta i etanercepta ili drugih antagonista TNF-α se ne preporučuje (vidjeti dio 4.5).
The Guide for healthcare professionals shall contain the following key elements: 
• Vodič za zdravstvene djelatnike Vodič za zdravstvene djelatnike sadržavat će sljedeće ključne elemente:
Blood cholesterol increased 
Povišen kolesterol u krvi
The safety and efficacy of Kineret treatment in patients with chronic and serious infections have not been evaluated. 
Sigurnost i djelotvornost Kinereta u bolesnika s kroničnim i teškim infekcijama nije procjenjivana.
Concurrent Kineret and etanercept treatment has not demonstrated increased clinical benefit. 
Istodobna primjena Kinereta i etanercepta nije pokazala povećanu kliničku korist.
A study including 12 patients with hepatic dysfunction (Child-Pugh Class B) given a single 1mg/kg intravenous dose has been performed. 
Provedeno je ispitivanje u 12 ispitanika s poremećajem jetrene funkcije (Child-Pughov stadij B) koji su primili jednokratnu dozu od 1 mg/kg intravenski.
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). 
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).
Cytokines are proteins made by your body that co-ordinate communication between cells and help control cell activity. 
Vaše tijelo koji usklađuju komunikaciju između stanica i pomažu u kontroli stanične aktivnosti.
• Keep used syringes out of reach and sight of children. 
• Čuvajte korištene štrcaljke izvan dohvata i pogleda djece.
Kineret may worsen these conditions; - if you have cancer. 
Kineret može pogoršati ova stanja;
Human and animal data demonstrated that the kidney is the major organ responsible for elimination of anakinra. 
Podaci dobiveni u ispitivanjima na ljudima i životinjama pokazuju da se anakinra prvenstveno izlučuje putem bubrega.
Kineret treatment should be discontinued in RA patients if a serious infection develops. 
Liječenje Kineretom treba prekinuti u bolesnika s RA ako dođe do ozbiljne infekcije.
Patients weighing less than 50 kg should be dosed by body weight with a starting dose of 1-2 mg/kg/day. 
U bolesnika s tjelesnom težinom manjom od 50 kg dozu treba odrediti prema tjelesnoj težini s početnom dozom od 1-2 mg/kg/dan.
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. 
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.
Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation. 
(IL-1) je glavni proupalni citokin koji posreduje u mnogim staničnim odgovorima uključujući one važne u upali sinovije.
Kineret is supplied ready for use in a graduated pre-filled syringe. 
Kineret se isporučuje spreman za uporabu u kalibriranoj napunjenoj štrcaljki.
Kineret should be used with caution in patients with severe hepatic impairment. 
Kineret treba primjenjivati uz oprez u bolesnika s teškim oštećenjem jetre.
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. 
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.
These were typically characterised by 1 or more of the following: erythaema, ecchymosis, 
Reakcije su tipično bile obilježene jednom ili više sljedećih pojava: eritem,
No patient withdrew from Kineret treatment due to adverse reactions. 
Nijedan se od bolesnika nije povukao iz liječenja Kineretom zbog nuspojava.
No dose adjustment is required for patients with moderate hepatic impairment (Child-Pugh Class B). 
Nije potrebna prilagodba doze u bolesnika s umjerenim oštećenjem jetre (Child-Pughov stadij B).
A causal relationship between Kineret and MAS has not been established. 
Uzročna povezanost između Kinereta i MAS-a nije ustanovljena.
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. 
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.
When patients are clinically well-controlled, CNS and ophthalmological monitoring may be conducted yearly. 
Ako je bolest klinički dobro kontrolirana, praćenje središnjeg živčanog sustava i očiju može se provoditi jednom godišnje.
A total of 752 RA patients ≥ 65 years of age, including 163 patients ≥ 75 years of age, were studied in clinical trials. 
U kliničkim ispitivanjima proučavana su 752 bolesnika s RA u dobi od ≥ 65 godina, uključujući 163 bolesnika u dobi od ≥ 75 godina.