FrancophonIA/ELRC3.0 huggingface dataset:
English: Abnormal liver function test results (transaminases increased) or high level of bilirubin in the blood, with or without yellow skin and eyes (hyperbilirubinaemia).
Croatian: Poremećeni rezultati testa jetrene funkcije (povišene transaminaze) ili visoka razina bilirubina u krvi, sa žutilom kože i očiju ili bez njega (hiperbilirubinemija).
English: It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis.
Croatian: Nije poznato povećava li primjena inhibitora interleukina-1 (IL-1) kao što je kanakinumab rizik od reaktivacije tuberkuloze.
English: Tell your doctor immediately, if you notice any of the side effects below:
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koju od sljedećih nuspojava:
English: The apparent clearance (CL/F) of canakinumab increases with body weight.
Croatian: Prividni klirens (CL/F) kanakinumaba povećava se s tjelesnom težinom.
English: Inactive disease
Croatian: Neaktivna bolest
English: Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors.
Croatian: Ilaris sadrži djelatnu tvar kanakinumab, monoklonsko protutijelo koje pripada skupini lijekova koji se nazivaju inhibitori interleukina.
English: In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence of acute toxicity.
Croatian: U ranom stadiju kliničkih ispitivanja, bolesnici i zdravi dobrovljci primili su doze od najviše 10 mg/kg, primijenjene intravenski ili supkutano, bez znakova akutne toksičnosti.
English: On initiation of canakinumab in patients being treated with this type of medicinal product, therapeutic monitoring of the effect or of the active substance concentration should be performed and the individual dose of the medicinal product adjusted as necessary.
Croatian: Kod započinjanja terapije kanakinumabom kod bolesnika koji se liječe ovom vrstom lijeka potrebno je nadzirati učinke terapije ili koncentracije djelatne tvari te prema potrebi prilagoditi individualnu dozu lijeka.
English: During clinical development of Ilaris in over 2,600 patients, no anaphylactoid or anaphylactic reactions were reported.
Croatian: Tijekom kliničkog razvoja Ilarisa, kod više od 2600 bolesnika nisu bile zabilježene anafilaktoidne ili anafilaktičke reakcije.
English: Canakinumab should not be administered during an active infection.
Croatian: Kanakinumab se ne smije primjenjivati tijekom aktivne infekcije.
English: Treatment with canakinumab should not be initiated in patients with neutropenia or leukopenia.
Croatian: Liječenje kanakinumabom ne smije se započeti kod bolesnika s neutropenijom ili leukopenijom.
English: Then gently turn the vial upside down and back again ten times.
Croatian: Zatim lagano okrećite bočicu naopako pa natrag deset puta.
English: For maximum effect, canakinumab should be administered as soon as possible after the onset of a gouty arthritis attack.
Croatian: Za maksimalan učinak kanakinumab je potrebno primijeniti što je prije moguće nakon nastupa napada uričnog artritisa.
English: In patients who respond and require re-treatment, there should be an interval of at least 12 weeks before a new dose of canakinumab may be administered (see section 5.2).
Croatian: Kod bolesnika kod kojih se javi odgovor a kojima je potrebno ponovno liječenje treba proći najmanje 12 tjedana prije primjene nove doze kanakinumaba (vidjeti dio 5.2).
English: An increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors.
Croatian: Povećana incidencija ozbiljnih infekcija povezana je s primjenom drugog blokatora IL-a u kombinaciji s inhibitorima TNF-a.
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.
Croatian: U otprilike 12% oboljelih od CAPS-a koji su bili testirani PPD (purificirani proteinski derivat) kožnim testom u kliničkim ispitivanjima naknadno je testiranje dalo pozitivan rezultat tijekom liječenja kanakinumabom bez kliničkih dokaza latentne ili aktivne infekcije tuberkulozom.
English: Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:
Croatian: Ilaris je indiciran za liječenje sljedećih autoinflamatornih sindroma periodičnih vrućica u odraslih, adolescenata i djece u dobi od 2 i više godina:
English: This patient presented at study entry with a history of immune thrombocytopenic purpura and an active medical condition of abnormal hepatic function.
Croatian: Ovaj je bolesnik kod uključivanja u ispitivanje imao u anamnezi imunu trombocitopeničnu purpuru i aktivno medicinsko stanje poremećene jetrene funkcije.
English: The efficacy and safety of canakinumab have been demonstrated in a total of 211 adult and paediatric patients with varying degrees of disease severity and different CAPS phenotypes (including FCAS/FCU, MWS, and NOMID/CINCA).
Croatian: Djelotvornost i sigurnost kanakinumaba dokazani su kod ukupno 211 odraslih i pedijatrijskih bolesnika s različitim stupnjevima težine bolesti i različitim fenotipovima CAPS-a (uključujući FCAS/FCU, MWS i NOMID/CINCA).
English: - Do not use this medicine if you notice that the solution is not clear to opalescent or contains particles.
Croatian: - Nemojte upotrijebiti ovaj lijek ako primijetite da otopina nije bistra do opalescentna ili ako sadrži čestice.
English: 3 Based on estimated creatinine clearance, most were transient 4 Most represented transient trace to 1+ positive urinary protein by dipstick 5 See further information below
Croatian: 3 Na temelju procijenjenog klirensa kreatinina, većinom su bili prolazni 4 Većina slučajeva bila je prolazni trag do 1+ pozitivnih proteina u mokraći dobiven pomoću test trake 5 Vidjeti u nastavku za dodatne informacije
English: In case of overdose, it is recommended for the patient to be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Croatian: U slučaju predoziranja preporučuje se motriti bolesnika zbog moguće pojave znakova ili simptoma nuspojava te odmah započeti odgovarajuće simptomatsko liječenje.
English: The safety profile of canakinumab observed following long-term treatment in this setting was consistent with what has been observed in interventional studies in CAPS patients.
Croatian: Sigurnosni profil kanakinumaba promatran tijekom dugoročnog liječenja u ovom režimu bio je u skladu s onim zabilježenim u intervencijskim ispitivanjima u bolesnika s CAPS-om.
English: - See also section 3, “Injecting Ilaris yourself or injecting a patient with Ilaris”.
Croatian: Pogledajte također dio 3, „Ako sami sebi ili bolesniku dajete injekciju Ilarisa“.
English: The causal relationship of canakinumab to these events cannot be excluded.
Croatian: Uzročna veza između tih događaja i kanakinumaba ne može se isključiti.
English: Management of hyperuricaemia with appropriate urate lowering therapy (ULT) should be instituted or optimised.
Croatian: Potrebno je započeti ili optimizirati kontrolu hiperuricemije odgovarajućom terapijom za snižavanje urata (engl. urate lowering therapy, ULT).
English: Approximately one-third of the patients enrolled (76 [33.8%] in the canakinumab group and 84 [36.7%] in the triamcinolone acetonide group) had documented inability (intolerance, contraindication or lack of response) to use both NSAIDs and colchicine.
Croatian: Otprilike jedna trećina uključenih bolesnika (76 [33,8%] u skupini koja je primala kanakinumab i 84 [36,7%] u skupini koja je primala triamcinolon acetonid) imala je dokumentiranu nemogućnost (zbog intolerancije, kontraindikacija ili nedostatka odgovora) korištenja NSAIL-a i kolhicina.
English: It blocks the activity of a substance called interleukin-1 beta (IL-1 beta) in the body, which is present at increased levels in inflammatory diseases.
Croatian: Ono blokira aktivnost tvari koja se naziva interleukin-1 beta (IL-1 beta) u tijelu, a koja je prisutna u povećanim razinama kod upalnih bolesti.
English: Elevations of transaminases have been observed rarely in CAPS patients.
Croatian: Povišenja transaminaza rijetko su zabilježena kod bolesnika s CAPS-om.
English: For the primary efficacy endpoint, canakinumab was superior to placebo for all three disease cohorts.
Croatian: Kada se radi o primarnoj mjeri djelotvornosti, kanakinumab je bio superioran u odnosu na placebo za sve tri kohorte prema bolesti.
English: This may cause fever, headache, fatigue, skin rash, or painful joints and muscles.
Croatian: To može uzrokovati vrućicu, glavobolju, umor, kožni osip ili bol u zglobovima i mišićima.
English: If drops remain on the stopper, tap the side of the vial to remove them.
Croatian: Ako su na čepu ostale kapljice, kucnite bočicu sa strane kako biste ih uklonili.
English: Laboratory parameters such as high CRP and SAA, high neutrophils and platelet counts normalised rapidly within days of canakinumab injection.
Croatian: Laboratorijski parametri poput CRP-a i SAA, visokog broja neutrofila i trombocita brzo su se normalizirali u roku od nekoliko dana od injekcije kanakinumaba.
English: Ilaris is intended for subcutaneous use.
Croatian: Ilaris je namijenjen za supkutanu (potkožnu) primjenu.
English: These data showed similar improvements from baseline to week 12 in the adapted paediatric ACR responses and its components to those observed in the placebo controlled study (G2305).
Croatian: Ti su podaci pokazali poboljšanja od početne vrijednosti do 12. tjedna u prilagođenim pedijatrijskim ACR odgovorima i njegovim komponentama slična onima uočenima u placebom kontroliranom ispitivanju (G2305).
English: Physicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions which may predispose them to infections.
Croatian: Liječnici moraju oprezno postupati kad kanakinumab daju bolesnicima s infekcijama, rekurentnim infekcijama u anamnezi ili postojećim bolestima zbog kojih bi mogli biti podložniji infekcijama.
English: It was estimated to be 6.2 litres in a CAPS patient of body weight 70 kg.
Croatian: Procijenjeno je da iznosi 6,2 litre u bolesnika s CAPS-om tjelesne težine od 70 kg.
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.
Croatian: Sve bolesnike valja uputiti da zatraže liječničku pomoć ako se pojave znakovi i simptomi koji upućuju na tuberkulozu (npr. ustrajan kašalj, gubitak težine, subfebrilna temperatura) tijekom liječenja kanakinumabom.
English: Infections of the upper respiratory tract were the most frequently reported infection events.
Croatian: Infekcije gornjeg dijela dišnog sustava bile su najučestalije zabilježene infekcije.
English: Mild (< LLN and > 75 x 10
Croatian: Blaga (<DGN i >75 x 10
English: Packs containing 1 vial or multipacks containing 4 (4x1) vials.
Croatian: Pakiranja koja sadrže 1 bočicu ili višestruka pakiranja koja sadrže 4 (4x1) bočice.
English: The reconstituted solution should ideally be used immediately, but can still be used for up to 24 hours if stored in a refrigerator.
Croatian: Otopinu je najbolje upotrijebiti odmah nakon rekonstitucije, ali se može koristiti do najviše 24 sata ako se čuva u hladnjaku.
English: What you need to know before you use Ilaris
Croatian: Što morate znati prije nego počnete primjenjivati Ilaris
English: Ilaris can be used alone or in combination with methotrexate.
Croatian: Ilaris se može koristiti sam ili u kombinaciji s metotreksatom.
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.
Croatian: Uključeni bolesnici bili su u dobi od 2 do < 20 godine (srednja dob od 8,5 godina i srednje trajanje bolesti 3,5 godine na početku) te imali aktivnu bolest definiranu kao ≥ 2 zgloba s aktivnim artritisom, vrućicom i povišenim CRP-om.
English: Serum amyloid A ≤ 10 mg/l
Croatian: Serumski amiloid A ≤10 mg/l
English: Medicines called tumour necrosis factor (TNF) inhibitors, such as etanercept, adalimumab or infliximab.
Croatian: Lijekovi koji se nazivaju inhibitorima tumor nekrotizirajućeg faktora (TNF), kao što su etanercept, adalimumab ili infliksimab.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Croatian: Nakon rekonstitucije, s mikrobiološkog stajališta, lijek se mora odmah upotrijebiti.
English: There was no indication of accelerated clearance or time-dependent change in the pharmacokinetic properties of canakinumab following repeated administration.
Croatian: Nije bilo naznaka ubrzanog klirensa ili o vremenu ovisne promjene u farmakokinetičkim svojstvima kanakinumaba nakon ponovljene primjene.
English: Elderly No dose adjustment is required.
Croatian: Nije potrebno prilagođavanje doze.
English: No human data are available, but as canakinumab is an immunoglobulin of the G class (IgG1), human transplacental transfer is expected.
Croatian: Nema dostupnih podataka za ljude, ali kako je kanakinumab imunoglobulin G klase (IgG1), očekuje se prolaz kroz placentu u žena.
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.
Croatian: Alergijske reakcije s osipom i svrbežom te moguće i koprivnjačom, poteškoće s disanjem ili gutanjem, omaglica, neuobičajeno osjećanje otkucaja srca (palpitacije) ili niski krvni tlak.
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.
Croatian: Drugo je bilo otvoreno ispitivanje s kanakinumabom za ocjenjivanje djelotvornosti i sigurnosti kod bolesnika japanske nacionalnosti s CAPS-om tijekom 24 tjedna, s fazom produžetka u trajanju do 48 tjedana.
English: For the overall study population, pain intensity was statistically significantly lower for canakinumab 150 mg compared with triamcinolone acetonide at 72 hours.
Croatian: Za cjelokupnu ispitivanu populaciju intenzitet boli bio je statistički značajno niži za kanakinumab 150 mg u usporedbi s triamcinolon acetonidom nakon 72 sata.
English: Ilaris is available in packs containing one vial.
Croatian: Ilaris je dostupan u pakiranjima koja sadrže jednu bočicu.
English: Check the expiry dates on the vial and syringes.
Croatian: Provjerite rok valjanosti na bočici i štrcaljkama.
English: Part III: Patients treated with placebo in Part II who flared regained and maintained clinical and serological response following entry into the open-label canakinumab extension.
Croatian: III. dio: Bolesnici liječeni placebom u II. dijelu koji su imali razbuktavanje bolesti i održali klinički i serološki odgovor nakon ulaska u otvoreni produžetak liječenja kanakinumabom.
English: The results of a 56-week, open label study in CAPS patients aged 4 years and younger demonstrated that all patients who received non-live, standard of care childhood vaccinations developed protective antibody levels.
Croatian: Rezultati 56-tjednog, otvorenog ispitivanja u bolesnika s CAPS-om u dobi od 4 godine i mlađih pokazalo je da su se u svih bolesnika koji su primili neživa, standardna dječja cjepiva razvile zaštitne razine protutijela.
English: Heartburn (gastro-oesophageal reflux disease).
Croatian: Žgaravica (gastroezofagealna refluksna bolest).
English: Sixty-three of the 100 patients entering Part II, whether assigned to placebo or canakinumab, did not experience a flare over the observation period (up to a maximum of 80 weeks).
Croatian: Šezdeset tri od 100 bolesnika koji su se uključili u drugi dio, bez obzira na to je li im bio dodijeljen placebo ili kanakinumab, nije osjetilo naglo pogoršanje bolesti tijekom razdoblja promatranja (do najviše 80 tjedana).
English: Table 1 Tabulated list of adverse reactions
Croatian: Tablica 1 Tablični popis nuspojava
English: - Any unused medicine must be discarded after withdrawal of the dose.
Croatian: - Sav neiskorišteni lijek treba baciti nakon izvlačenja doze.
English: The decision whether to breast-feed during canakinumab therapy should therefore only be taken after a thorough benefit-risk evaluation.
Croatian: Odluku o tome može li se dojiti tijekom liječenja kanakinumabom treba donijeti tek nakon temeljite procjene koristi i rizika.
English: Make sure the tip of the transfer needle is covered by the water and slowly pull the syringe plunger down to slightly past the 1.0 ml mark.
Croatian: Provjerite da je vrh igle za prijenos pokriven vodom i polako povucite klip štrcaljke prema dolje tako da malo prijeđe oznaku za 1,0 ml.
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).
Croatian: Ključno ispitivanje sastojalo se od 48-dnevnog, trodjelnog multicentričnog ispitivanja, tj. 8-tjednog otvorenog razdoblja (I. dio), 24-tjednog randomiziranog, dvostruko slijepog, placebom kontroliranog razdoblja ustezanja (II. dio), nakon kojeg je uslijedilo 16-tjedno otvoreno razdoblje (III. dio).
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as canakinumab, is introduced.
Croatian: Stoga se ekspresija CYP450 može vratiti kada se uvede potentni lijek za inhibiranje citokina, kao što je kanakinumab.
English: Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Croatian: Nemojte koristiti tekućinu ako sadrži lako vidljive čestice, ako je zamućena ili izrazito smeđa.
English: Mild and transient Grade 1 reduction in platelets occurred in 15.9% of patients without any associated bleeding adverse events.
Croatian: Blaga i prolazna smanjenja broja trombocita stupnja 1 javila su se u 15,9% bolesnika bez bilo kakvih uz to vezanih štetnih događaja krvarenja.
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).
Croatian: Liječenje kanakinumabom rezultiralo je brzim i održanim poboljšanjem i artikularnih i sistemskih karakteristika SJIA-e uz značajno smanjenje broja upaljenih zglobova, brzo povlačenje vrućice i smanjenje reaktanata akutne faze u većine bolesnika (vidjeti Kliničku djelotvornost i sigurnost).
English: Within each system organ class, the adverse reactions are ranked by frequency category with the most common first.
Croatian: Unutar svake klasifikacije organskog sustava nuspojave su navedene prema kategoriji učestalosti, počevši od najčešćih.
English: Make sure 1.0 ml of water is in the syringe, then take the needle out of the vial.
Croatian: Provjerite da je u štrcaljki 1,0 ml vode, a zatim izvucite iglu iz bočice.
English: The AUCss4w in each age group was 692, 615, 707 and 742 µg*d/ml for 2-3, 4-5, 6-11, and 12-19 years old, respectively.
Croatian: AUCss u svakoj dobnoj skupini bio je 692, 615, 707 odnosno 742 µg*d/ml za dobne skupine 2-3, 4-5, 6-11, odnosno 12-19 godina.
English: Do not inject into scar tissue as this may mean you do not get all of your medicine.
Croatian: Ne ubrizgavajte u ožiljkasto tkivo budući da bi to moglo značiti da nećete dobiti sav svoj lijek.
English: Based on the population pharmacokinetic modelling analysis, the expected exposures after a dose of 2 mg/kg were comparable across the CAPS paediatric age groups, but were approximately 40% lower in paediatric patients of very low body weight (e.g. 10 kg) than in adult patients (150 mg dose).
Croatian: Na temelju analize populacijskog farmakokinetičkog modeliranja, očekivana izloženost nakon doze od 2 mg/kg bila je usporediva po pedijatrijskim skupinama s CAPS-om, no bila je otprilike 40% niža u pedijatrijskih bolesnika vrlo niske tjelesne težine (npr. 10 kg) u odnosu na odrasle bolesnike (doza od 150 mg).
English: These crystals cause excessive production of IL-1 beta, which in turn can lead to sudden, severe pain, redness, warmth and swelling in a joint (known as a gouty arthritis attack).
Croatian: Ti kristali uzrokuju prekomjerno stvaranje IL-1 beta, što pak može dovesti do iznenadne teške boli, crvenila, vrućine i oticanja zgloba (to se zove napad uričnog artritisa).
English: Part I: A complete clinical and biomarker response to canakinumab (defined as composite of physician's global assessment on autoinflammatory and on skin disease ≤ minimal and CRP or SAA values < 10 mg/litre) was observed in 97% of patients and appeared within 7 days of initiation of treatment.
Croatian: I. dio: Potpun klinički odgovor i odgovor biomarkera na kanakinumab (definiran kao spoj liječnikove ukupne procjene autoinflamatorne i kožne bolesti ≤ minimalnog i vrijednosti CRP-a ili SAA <10 mg/litra) zabilježen je kod 97% bolesnika i pojavio se u roku od 7 dana od početka liječenja.
English: However, administration of live vaccines to newborn infants exposed to canakinumab in utero is not recommended for 16 weeks following the mother's last dose of canakinumab before childbirth.
Croatian: Međutim, primjena živih cjepiva u novorođenčadi koja je bila izložena kanakinumabu in utero se ne preporučuje tijekom 16 tjedana nakon zadnje doze kanakinumaba koju je majka primila prije poroda.
English: Injection site reaction (such as redness, swelling, warmth and itching).
Croatian: Reakcije na mjestu primjene injekcije (kao što su crvenilo, oticanje, toplina i svrbež).
English: An increased dose was administered more frequently to patients aged 2 to < 4 years and to patients with NOMID/CINCA symptoms compared with FCAS or MWS.
Croatian: Povećana doza primjenjivala se učestalije kod bolesnika u dobi od 2 do <4 godine i kod bolesnika sa simptomima NOMID-a/CINCA-e u usporedbi sa FCAS-om ili MWS-om.
English: For children given a starting dose of 4 mg/kg who have not responded well enough after 7 days, the doctor may give a second dose of 4 mg/kg.
Croatian: Za djecu koja su dobila početnu dozu od 4 mg/kg i koja nisu imala dovoljno dobar odgovor nakon 7 dana, liječnik može dati drugu dozu od 4 mg/kg.
English: Asymptomatic and mild elevations of serum bilirubin have been observed in CAPS patients treated with canakinumab without concomitant elevations of transaminases.
Croatian: Asimptomatska i blaga povišenja serumskog bilirubina zabilježena su kod bolesnika s CAPS-om liječenih kanakinumabom bez istodobnih povišenja transaminaza.
English: - Part IV: All Part III patients treated with canakinumab were eligible to enter into a 72-week open-label treatment extension period.
Croatian: - IV. dio: svi bolesnici iz III. dijela liječeni kanakinumabom mogli su se uključiti u 72-tjedni otvoreni produžetak ispitivanja.
English: Do not inject into scar-tissue as this may mean you do not get all of your medicine.
Croatian: Ne ubrizgavajte u ožiljkasto tkivo jer bi to moglo značiti da nećete dobiti sav svoj lijek.
English: In the pooled efficacy analysis for these two studies, 65.6% of patients who had not previously been treated with canakinumab achieved complete response at 150 mg or 2 mg/kg, while 85.2% of patients achieved complete response at any dose.
Croatian: U objedinjenoj analizi djelotvornosti za ta dva ispitivanja 65,6% bolesnika koji prethodno nisu bili liječeni kanakinumabom postiglo je potpuni odgovor pri dozi od 150 mg ili 2 mg/kg, dok je 85,2% bolesnika postiglo potpuni odgovor pri bilo kojoj dozi.