FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies transient elevations of liver enzymes have been seen.
Croatian: U kliničkim ispitivanjima zabilježena su prolazna povećanja razine jetrenih enzima.
English: Physicians should exercise caution when administering Kineret to patients with a history of recurring infections or with underlying conditions which may predispose them to infections.
Croatian: Liječnici trebaju biti oprezni prilikom primjene Kinereta u bolesnika koji u anamnezi imaju ponavljajuće infekcije ili osnovnu bolest zbog koje mogu biti podložni infekcijama.
English: Side effects with frequency not known (frequency cannot be estimated from the available data): - Signs of liver disorders such as yellow skin and eyes, nausea, loss of appetite, dark-coloured urine and light-coloured stools.
Croatian: Nuspojave čija je učestalost nepoznata (učestalost se ne može ocijeniti iz raspoloživih podataka): - Znakovi poremećaja rada jetre poput žute kože i očiju, mučnine, gubitka apetita, mokraće tamne boje i stolice svijetle boje.
English: - Serious infections such as pneumonia (a chest infection) or infections of the skin.
Croatian: - Ozbiljne infekcije poput upale pluća (infekcija prsnog koša) ili infekcije kože.
English: Symptoms of infection might include a fever or a sore throat.
Croatian: Simptomi infekcije mogu uključivati vrućicu ili grlobolju.
English: For the purpose of ambulatory use, Kineret may be removed from the refrigerator for 12 hours at temperature not above 25 °C, without exceeding the expiry date.
Croatian: U svrhu kućne primjene, Kineret se može izvaditi iz hladnjaka i čuvati na temperaturi ne višoj od 25°C kroz 12 sati, unutar roka valjanosti.
English: Adverse events data in patients with Still's disease is based on a partially open-label and partially blinded, placebo-controlled study of 15 SJIA patients, treated for up to 1.5 years.
Croatian: Podaci o štetnim događajima u bolesnika sa Stillovom bolešću dobiveni su u djelomično otvorenom, a djelomično slijepom placebom kontroliranom ispitivanju u 15 bolesnika sa SJIA, liječenih do 1,5 godine.
English: - Elevated levels of liver enzymes determined after a blood test.
Croatian: - Povišene razine jetrenih enzima utvrđene krvnim pretragama.
English: Put your thumb on the plunger rod and push slowly until the plunger front has reached the scale mark of your Kineret dose.
Croatian: Palcem polako gurajte klip dok prednji dio klipa ne dosegne odmjernu oznaku Vaše doze Kinereta.
English: Pharmacokinetic data are lacking in older CAPS patients.
Croatian: Nema dovoljno farmakokinetičkih podataka za starije bolesnike s CAPS-om.
English: In subjects with RA, maximum plasma concentrations of anakinra occurred at 3 to 7 hours after subcutaneous administration of anakinra at clinically relevant doses (1 to 2 mg/kg; n = 18).
Croatian: U ispitanika s RA maksimalne koncentracije anakinre u plazmi pojavile su se 3 do 7 sati nakon supkutane primjene anakinre u dozama od kliničkog značaja (1 do 2 mg/kg; n = 18).
English: 16 patients completed the subsequent open label phase and among 7 responders at month 12, 6 had stopped glucocorticoid treatment and 5 of them had inactive disease.
Croatian: Sljedeću, otvorenu fazu ispitivanja završilo je 16 bolesnika, a od 7 bolesnika s odgovorom u 12. mjesecu liječenja, njih 6 prekinulo je liječenje glukokortikoidima i u njih 5 bolest je bila inaktivna.
English: The thrombocytopenias have been mild, i.e. platelet counts have been > 75 x109/l.
Croatian: Slučajevi trombocitopenije bili su blagi, tj. s brojem trombocita > 75 x109/l.
English: In addition, in a clinical trial 6% of 86 paediatric patients with JIA, whereof none of the 15 SJIA subtype patients, tested seropositive at least once during the study for neutralizing anti-anakinra antibodies.
Croatian: u kliničkom se ispitivanju 6% od 86 pedijatrijskih bolesnika s JIA, od kojih nijedan od 15 bolesnika s podvrstom SJIA, pokazalo seropozitivno najmanje jednom tijekom ispitivanja na neutralizirajuća protutijela na anakinru.
English: Use of Kineret is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Primjena Kinereta ne preporučuje se u trudnoći niti u žena koje mogu zatrudnjeti, a ne koriste kontracepciju.
English: Neutropenia (ANC < 1.5 x 109/l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
Croatian: Neutropenija (ABN < 1,5 x 109/l) je bila prijavljena u 2,4% bolesnika koji su primali Kineret u usporedbi s 0,4% bolesnika koji su primali placebo.
English: No data are available on the effects of vaccination with other inactivated antigens in patients receiving Kineret.
Croatian: Nema dostupnih podataka o učincima cijepljenja drugim inaktiviranim antigenima u bolesnika koji primaju Kineret.
English: Clinical efficacy and safety in CAPS
Croatian: Klinička djelotvornost i sigurnost u CAPS
English: The adverse event profile from these studies show no overall difference from that seen in the rheumatoid arthritis studies.
Croatian: Profil nuspojava iz ovih ispitivanja ne odudara od onog primijećenog u ispitivanjima reumatoidnog artritisa.
English: Adult
Croatian: Odrasla osoba
English: 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.
Croatian: 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.
English: Breast-feeding should be discontinued during treatment with Kineret.
Croatian: Dojenje treba prekinuti za vrijeme liječenja Kineretom.
English: 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.
Croatian: Dodatno objavljeni podaci o Stillovoj bolesti pokazuju da Kineret inducira brzo povlačenje sistemskih znakova kao što su vrućica, osip i povišenje reaktanata akutne faze.
English: 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.
Croatian: 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.
English: In 15 SJIA patients followed for up to 1.5 years, one patient developed a serious hepatitis in connection with a cytomegalovirus infection.
Croatian: Od 15 bolesnika sa SJIA praćenih do 1,5 godine, jedan je bolesnik razvio ozbiljan hepatitis povezan s infekcijom citomegalovirusom.
English: 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.
Croatian: 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.
English: Kineret treatment should not be initiated in patients with active infections.
Croatian: Liječenje Kineretom ne smije se započinjati u bolesnika s aktivnim infekcijama.
English: • That it is not recommended to start treatment with Kineret in patients with an ongoing infection
Croatian: • Da nije preporučljivo započinjati liječenje Kineretom u bolesnika s prisutnom infekcijom
English: At a dose of 100 mg/day, 71% of RA patients developed an ISR compared to 28% of the placebo treated patients.
Croatian: Pri dozi od 100 mg/dnevno, 71% bolesnika s RA imalo je ISR u usporedbi s 28% bolesnika koji su primali placebo.
English: 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.
Croatian: 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.
English: Kineret contains the active substance anakinra.
Croatian: Kineret sadrži djelatnu tvar anakinra.
English: • Patient identification
Croatian: • Identifikacijske podatke o bolesniku
English: Allergic reactions, including anaphylactic reactions and angioedema have been reported uncommonly.
Croatian: Alergijske reakcije, uključujući anafilaktičke reakcije i angioedem prijavljene su manje često.
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Croatian: 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).
English: The majority of patients have been treated for Still's disease or have had predisposing factors, e.g. a history of transaminase elevations.
Croatian: Većina bolesnika bila je liječena zbog Stillove bolesti ili je imala predisponirajuće čimbenike, npr. povišenja transaminaza u anamnezi.
English: The concurrent use of Kineret with etanercept or any other TNF-α antagonist is not recommended (see section 4.4).
Croatian: Istodobna primjena Kinereta s etanerceptom ili bilo kojim drugim antagonistom TNF-α se ne preporučuje (vidjeti dio 4.4).
English: Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
Croatian: Ako ste zdravi, Vaše tijelo stvara bjelančevinu koja blokira štetne učinke interleukina-1.
English: 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.
Croatian: Kineret je indiciran u odraslih za liječenje znakova i simptoma RA u kombinaciji s metotreksatom, u osoba s neodgovarajućim odgovorom na sam metotreksat.
English: In general the pharmacokinetics in CAPS patients is similar to that in RA patients.
Croatian: Farmakokinetika u bolesnika s CAPS-om općenito je slična onoj u bolesnika s RA.
English: 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.
Croatian: 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.
English: The estimated anakinra clearance increased with increasing creatinine clearance and body weight.
Croatian: Procijenjeni klirens anakinre povećao se s povećanjem klirensa kreatinina i tjelesne težine.
English: Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).
Croatian: Svaka kalibrirana napunjena štrcaljka sadrži 100 mg anakinre* u 0,67 ml (150 mg/ml).
English: • The importance of providing patients and/or caregivers with the educational material
Croatian: • Zašto je važno bolesnicima/njegovateljima uručiti edukacijske materijale
English: Therefore the use of Kineret in patients with pre-existing malignancy is not recommended.
Croatian: Stoga se primjena Kinereta u bolesnika s prethodnim malignitetima ne preporučuje.
English: Possible side effects are similar regardless if you are treated with Kineret for RA, CAPS or Still's disease.
Croatian: Moguće nuspojave slične su neovisno o tome primate li Kineret za RA, CAPS ili Stillovu bolest.
English: During post-marketing use isolated case reports indicating non-infectious hepatitis have been received.
Croatian: Tijekom postmarketinške primjene prijavljeni su pojedinačni slučajevi neinfektivnog hepatitisa.
English: - Serious infections such as pneumonia (a chest infection) or infections of the skin can occur during Kineret treatment.
Croatian: - Ozbiljne infekcije poput upale pluća (pneumonija) ili infekcija kože mogu se javiti tijekom liječenja Kineretom.
English: The role of IL-1 in the pathogenesis of Still's disease has been demonstrated by ex vivo and gene expression studies.
Croatian: Uloga IL-1 u patogenezi Stillove bolesti dokazana je ispitivanjim ex vivo te ispitivanjima genske ekspresije.
English: 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.
Croatian: 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.
English: • If your doctor has prescribed a lower dose you should continue to the “How to prepare a 20 to 90 mg dose” section.
Croatian: • Ako Vam je liječnik propisao nižu dozu, idite na odjeljak „Kako pripremiti dozu od 20 do
English: The recommended starting dose in all CAPS subtypes is 1-2 mg/kg/day by subcutaneous injection.
Croatian: Preporučena početna doza za sve podvrste CAPS-a iznosi 1-2 mg/kg/dan primijenjena supkutanom injekcijom.
English: The safety and efficacy of Kineret have been demonstrated in CAPS patients with varying degrees of disease severity.
Croatian: Sigurnost i djelotvornost Kinereta dokazana je u bolesnika s CAPS-om s različitim stupnjevima težine bolesti.
English: These data support that no dose adjustment is needed for patients with mild renal impairment (CLcr 50 to 80 ml/minute).
Croatian: Ovi podaci potvrđuju da nije potrebna prilagodba doze za bolesnike s blagim oštećenjem bubrega (CLcr 50 do 80 ml/minuti).
English: Still's disease - Patients with Still's disease may develop a condition called macrophage activation syndrome (MAS), which can be life-threatening.
Croatian: Stillova bolest - U bolesnika sa Stillovom bolešću može se pojaviti stanje pod nazivom sindrom aktivacije makrofaga (MAS), koji može ugroziti život bolesnika.
English: In 15 SJIA patients followed for up to 1.5 years, no allergic event was serious and no event required discontinuation of Kineret.
Croatian: 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.
English: It is unknown whether anakinra/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se anakinra/metaboliti u majčino mlijeko.
English: A clinical response to anakinra generally appeared within 2 weeks of initiation of treatment and was sustained with continued administration of anakinra.
Croatian: Klinički odgovor na anakinru općenito javio se unutar 2 tjedna nakon početka liječenja te se održao uz kontinuiranu primjenu anakinre.
English: 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.
Croatian: 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.
English: After your injection discard the wet gauze or tissue with your syringe and clean the surface with a fresh tissue.
Croatian: Nakon primjene lijeka zbrinite mokru gazu ili maramicu zajedno sa štrcaljkom i površinu očistite čistom maramicom.
English: 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.
Croatian: 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.
English: In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed.
Croatian: U kliničkim ispitivanjima nisu primijećene interakcije između Kinereta i drugih lijekova (uključujući nesteroidne protuupalne lijekove, glukokortikoide i lijekove koji modificiraju tijek bolesti).
English: If you develop signs of lung disease you should contact your health care provider as soon as possible.
Croatian: Ako Vam se pojave znakovi bolesti pluća, trebate se što prije obratiti liječniku.
English: 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).
Croatian: 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).
English: In clinical trials in RA, up to 3% of adult patients tested seropositive at least once during the study for neutralizing anti-anakinra antibodies.
Croatian: U kliničkim ispitivanjima u bolesnika s RA do 3% testiranih odraslih bolesnika bilo je seropozitivno najmanje jednom tijekom ispitivanja na neutralizirajuća protutijela na anakinru.
English: 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).
Croatian: 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).
English: Disposing of used syringes and supplies
Croatian: Odlaganje korištenih štrcaljki i pribora
English: Still's disease: Data in elderly patients are limited.
Croatian: Stillova bolest: Podaci za starije osobe su ograničeni.
English: 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.
Croatian: 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.
English: No dose-limiting toxicities were observed during clinical studies.
Croatian: Tijekom kliničkih ispitivanja nije primijećena dozno-limitirajuća toksičnost.
English: 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.
Croatian: U 15 bolesnika sa SJIA koji su praćeni do 1,5 godine, najčešće i dosljedno prijavljivane nuspojave povezane s liječenjem Kineretom bile su ISR.
English: Administration of Kineret results in a decrease in the acute phase reactants and a decrease in IL-6 expression level has been observed.
Croatian: Primjena Kinereta dovodi do smanjenja reaktanata akutne faze te je primijećeno da dolazi do smanjenja razine ekspresije IL-6.
English: Therefore, live vaccines should not be given concurrently with Kineret.
Croatian: Stoga se živa cjepiva ne smiju primjenjivati istodobno s Kineretom.
English: This might increase the risk of you getting an infection.
Croatian: Vaš rizik od infekcije.
English: • the upper outer areas of the buttocks; and
Croatian: • gornji vanjski dijelovi stražnjice i
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (CONTAINS BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S NAPUNJENOM ŠTRCALJKOM (S PLAVIM OKVIROM)
English: The activated inflammasome results in proteolytic maturation and secretion of IL-1β, which has a broad range of effects including systemic inflammation.
Croatian: Aktivirani inflamasom uzrokuje proteolitično dozrijevanje i lučenje interleukina-1β koji ima širok raspon učinaka, uključujući izazivanje sustavne upale.
English: Symptoms might be persistent high fever, shivers, cough, headache, and redness and tenderness of the skin.
Croatian: Simptomi mogu biti stalno visoka tjelesna temperatura, tresavica, kašalj, glavobolja i crvenilo i osjetljivost kože.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava prema MedDRA-i i kategoriji učestalosti.
English: A subset of these patients continued open-label treatment with Kineret for up to 1 year in a companion extension study.
Croatian: Jedna je podskupina tih bolesnika nastavila sudjelovati u otvorenom liječenju Kineretom do godine dana u popratnom nastavku ispitivanja.
English: The risk may be increased in patients with Down's syndrome (trisomy 21).
Croatian: Downovim sindromom (trisomijom 21).
English: 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.
Croatian: 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.
English: A similar pattern was seen after 24 weeks Kineret treatment.
Croatian: Slična pojava uočena je nakon 24 tjedna primjene Kinereta.
English: How to use Kineret
Croatian: Kako primjenjivati Kineret
English: • Instructions on correct injection procedures and disposal of used syringes
Croatian: • Upute za uporabu štrcaljke • Upute o ispravnom postupku injiciranja i zbrinjavanju korištenih štrcaljki
English: The patient and caregiver guide shall contain the following key elements:
Croatian: Vodič za bolesnike i njegovatelje sadržavat će sljedeće ključne elemente:
English: Systemically, IL-1 is known to cause the hypothalamic fever response and promote hyperalgesia.
Croatian: Poznato je da IL-1 sistemskim djelovanjem uzrokuje vrućicu preko hipotalamusa te potiče hiperalgeziju.
English: The ejected liquid will be absorbed by the gauze or tissue as shown in Figure C.
Croatian: Gaza ili maramica će upiti izbačenu tekućinu kako je prikazano na slici C.
English: Kineret treatment must not be initiated in patients with neutropenia (ANC <1.5 x 109/l) (see section 4.4).
Croatian: Liječenje Kineretom ne smije se započeti u bolesnika s neutropenijom (ABN < 1,5 x 109/l) (vidjeti dio 4.4).
English: The most common reason for withdrawal from study in Kineret-treated RA patients was injection site reaction.
Croatian: Najčešći razlog za povlačenje iz ispitivanja u bolesnika s RA liječenih Kineretom bila je reakcija na mjestu primjene.
English: The incidence of serious infection was higher in Kineret-treated patients compared to patients receiving placebo (1.8% vs. 0.7%).
Croatian: Incidencija ozbiljnih infekcija bila je viša u bolesnika liječenih Kineretom u usporedbi s bolesnicima koji su primali placebo (1,8% naspram 0,7%).
English: Hepatic events in patients with Still's disease predominantly occur during the first month of Kineret treatment.
Croatian: Hepatički događaji u bolesnika sa Stillovom bolešću uglavnom se javljaju tijekom prvog mjeseca liječenja Kineretom.
English: 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.
Croatian: 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.