FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment was continued until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression or deterioration in performance status) or unacceptable toxicity.
Croatian: Liječenje je nastavljeno do zatajenja liječenja (definirano kao progresija bolesti temeljena na povećanju simptoma, radiološkoj progresiji ili pogoršanju funkcionalnog stanja) ili neprihvatljive toksičnosti.
English: • The recommended dose is 11 milligrams per kilogram of body weight, given once every
Croatian: • Preporučena doza je 11 miligrama po kilogramu tjelesne težine, primijenjeno jedanput svaka
English: What SYLVANT looks like and contents of the pack
Croatian: Kako SYLVANT izgleda i sadržaj pakiranja
English: The results showed no significant difference in the PK of siltuximab in patients older than 65 years compared to patients age 65 years or younger.
Croatian: Rezultati nisu pokazali značajnu razliku u farmakokinetici siltuksimaba u bolesnika starijih od 65 godina u usporedbi s bolesnicima u dobi od 65 godina ili mlađih.
English: Therefore, prescribers should diligently monitor patients receiving treatment in order to detect serious infections.
Croatian: Stoga, liječnici koji su propisali lijek moraju pažljivo pratiti bolesnike koji primaju liječenje kako bi uočili ozbiljne infekcije.
English: It is not known if SYLVANT may affect the baby or a pregnant or breast-feeding woman.
Croatian: Nije poznato može li SYLVANT utjecati na dijete, trudnicu ili dojilju.
English: Siltuximab should be given to a pregnant woman only if the benefit clearly outweighs the risk.
Croatian: Siltuksimab se smije primijeniti u trudnica samo ako dobrobit jasno prevladava rizik.
English: Paediatric population No interaction studies have been performed in this population.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja interakcija u ovoj populaciji.
English: This leaflet was last revised in MM/YYYY Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u MM/YYYY
English: However, there is also evidence to suggest that IL-6 inhibition may suppress immune responses, immune surveillance and lower defense against established tumours.
Croatian: Međutim, postoje i dokazi koji ukazuju da inhibicija IL-6 može suprimirati imunološke odgovore, imunološki nadzor i oslabjeti obranu protiv ustanovljenih tumora.
English: The overall tumour response rate was evaluated based on modified Cheson criteria both by independent review and investigator assessment.
Croatian: Ukupna stopa odgovora tumora bila je procijenjena temeljeno na modificiranim Chesonovim kriterijima, i nezavisnom procjenom, i procjenom ispitivača.
English: Use aseptic technique.
Croatian: Koristite aseptičku tehniku.
English: • You must not become pregnant while you are being treated with SYLVANT and for 3 months after your treatment has finished.
Croatian: • Ne smijete zatrudniti tijekom liječenja lijekom SYLVANT i 3 mjeseca nakon završetka liječenja.
English: The management of severe infusion reactions should be dictated by the signs and symptoms of the reaction.
Croatian: Zbrinjavanje teških reakcija povezanih s infuzijom mora biti određeno znakovima i simptomima reakcije.
English: Biomarkers
Croatian: Biomarkeri
English: MCD-related signs and symptoms were prospectively collected.
Croatian: Znakovi i simptomi povezani s MCD-om bili su prikupljeni prospektivno.
English: Histological subtype was similar in both treatment arms, with 33% hyaline vascular subtype, 23% plasmacytic subtype and 44% mixed subtype.
Croatian: Histološki podtipovi bili su slični u obje skupine liječenja, s 33% hijalinsko vaskularnog podtipa, 23% plazmocitnog podtipa i 44% miješanog podtipa.
English: • warfarin, a blood thinner
Croatian: • varfarin, za razrjeđivanje krvi
English: The following factors had no clinical effect on the clearance of siltuximab: gender, age, and ethnicity.
Croatian: Sljedeći faktori nisu imali klinički učinak na klirens siltuksimaba: spol, dob i etnička pripadnost.
English: • theophylline, used to treat asthma
Croatian: • teofilin, koristi se za liječenje astme
English: • Use aseptic technique.
Croatian: • Koristite aseptičku tehniku.
English: Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every third dosing cycle thereafter.
Croatian: Laboratorijska hematološka ispitivanja moraju se provesti prije svake doze liječenja lijekom SYLVANT tijekom prvih 12 mjeseci, a nakon toga svaki treći 3 ciklus doziranja.
English: Women of childbearing potential must use effective contraception during and up to 3 months after treatment (see section 4.5).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja, i do 3 mjeseca nakon liječenja (vidjeti dio 4.5).
English: This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision.
Croatian: Ovaj lijek mora primijeniti kvalificirani zdravstveni radnik, te se mora primijeniti uz prikladan medicinski nadzor.
English: The product is a freeze-dried white powder.
Croatian: Proizvod je bijeli prašak osušen smrzavanjem.
English: You are severely allergic to siltuximab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Imate tešku alergiju na siltuksimab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • you have liver disease or changes that show up in blood tests of the liver.
Croatian: • ako imate bolest jetre ili promjene koje se vide u krvnim pretragama jetre.
English: Patients should be managed according to current clinical guidelines for management of hyperlipidaemia.
Croatian: Bolesnike se mora zbrinuti prema trenutnim kliničkim smjernicama za zbrinjavanje hiperlipidemije.
English: On the basis of limited experience with siltuximab the present data do not suggest any increased risk of malignancy.
Croatian: Na temelju ograničenog iskustva sa siltuksimabom, sadašnji podaci ne ukazuju na povišen rizik za zloćudne bolesti.
English: • drop in the number of white blood cells (neutropenia)
Croatian: • pad broja bijelih krvnih stanica (neutropenija)
English: • weight gain.
Croatian: • dobivanje na težini
English: Pharmacotherapeutic group: Immunosuppresants, interleukin inhibitors, ATC code: L04AC11.
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC11.
English: No case of overdose has been reported in clinical trials.
Croatian: Nisu prijavljeni slučajevi predoziranja u kliničkim ispitivanjima.
English: Tell your doctor straight away if you get any signs of infection during treatment with SYLVANT.
Croatian: Odmah obavijestite svog liječnika ako razvijete bilo koji simptom infekcije tijekom liječenja lijekom SYLVANT.
English: Infections, including localised infections, should be treated prior to administration of SYLVANT.
Croatian: Infekcije, uključujući lokalizirane infekcije, moraju se liječiti prije primjene lijeka SYLVANT.
English: Infusion related reactions and hypersensitivity
Croatian: Reakcije povezane s infuzijom i preosjetljivost
English: • severe allergic reaction - the signs may include: difficulty breathing, chest tightness, wheezing,
Croatian: • teška alergijska reakcija - znakovi mogu uključiti: poteškoće s disanjem, stezanje u prsima,
English: Lipid parameters
Croatian: Parametri lipida
English: SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute-phase reactants, such as C-reactive protein (CRP).
Croatian: SYLVANT može prikriti znakove i simptome akutne upale uključujući supresiju vrućice i reaktanata akutne faze, poput C-reaktivnog proteina (CRP).
English: Intravenous infusion after reconstitution and dilution.
Croatian: Intravenska infuzija nakon rekonstitucije i razrjeđivanja.
English: In non-clinical studies, interleukin-6 (IL-6) is known to decrease the activity of cytochrome P450 (CYP450).
Croatian: Iz nekliničkih ispitivanja poznato je da interleukin-6 (IL-6) snižava aktivnost citokroma P450 (CYP450).
English: In this study 37 patients with CD (35 MCD patients) were treated with siltuximab.
Croatian: U ovom ispitivanju 37 bolesnika s CD-om (35 bolesnika s MCD-om) bilo je liječeno siltuksimabom.
English: SYLVANT does not contain preservatives; therefore do not store any unused portion of the infusion solution for re-use.
Croatian: SYLVANT ne sadrži konzervanse, stoga bilo koju preostalu količinu infuzijske otopine nemojte ponovno upotrebljavati.
English: After reconstitution and dilution
Croatian: Nakon rekonstitucije i razrjeđivanja
English: A decision must be made whether to discontinue breast-feeding or discontinue/abstain from siltuximab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja siltuksimabom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: In this study, 16 of the 35 MCD patients were hyaline vascular subtype; 31% of these patients had a radiologic response based on independent review and 88% showed clinical benefit response as defined in the protocol.
Croatian: U ovom ispitivanju, 16 od 35 bolesnika s MCD imalo je hijalinsko vaskularni histološki podtip; 31% tih bolesnika imalo je radiološki odgovor temeljen na nezavisnoj procjeni i 88% pokazalo je koristan klinički odgovor koji je definiran protokolom.
English: Siltuximab clearance increased with increasing body weight; however, no dose adjustment is required for body weight since administration is on an mg/kg basis.
Croatian: Klirens siltuksimaba povećao se s povećanjem tjelesne težine; međutim, nije potrebna prilagodba doze prema tjelesnoj težini budući da se primjena temelji na mg/kg.
English: If you think you have been given too much SYLVANT, tell your doctor or nurse straight away.
Croatian: Ako mislite da Vam je primijenjeno previše lijeka SYLVANT, odmah to recite liječniku ili medicinskoj sestri.
English: Analyses for both primary and secondary endpoints on various subgroups including age (< 65 years and ≥ 65 years); race (White and Non-White); region (North America, Europe, Middle East and Africa, and Asia Pacific); baseline corticosteroid use (yes and no); prior therapy (yes and no); and MCD histology (plasmatic and mixed histology) consistently showed that the treatment effect favoured the siltuximab arm except for the hyaline vascular subgroup in which no patient achieved the definition of the primary endpoint.
Croatian: Analiza i primarnih mjera ishoda i sekundarnih mjera ishoda za različite podskupine uključujući dob (< 65 godina i ≥ 65 godina); rasu (bijelu i ostale); regiju (Sjeverna Amerika, Europa, Bliski istok i Afrika, te azijsko-pacifička regija); primjenu kortikosteroida na početku (da ili ne); prethodnu terapiju (da ili ne); i MCD histologiju (plazmocitni i miješani histološki podtip) dosljedno je pokazala da je učinak liječenja u korist skupine liječene siltuksimabom osim za podskupinu hijalinsko vaskularnog histološkog podtipa u kojoj niti jedan bolesnik nije postigao definiranu primarnu mjeru ishoda.
English: Requirements before first SYLVANT administration
Croatian: Zahtjevi prije prve primjene lijeka SYLVANT
English: • respiratory infections - such as of the nose, sinuses or throat
Croatian: • infekcije dišnog sustava - poput nosa, sinusa ili grla
English: The SYLVANT therapy should be withheld if the patient has a severe infection or any severe non-haematological toxicity and can be restarted at the same dose after recovery.
Croatian: Liječenje lijekom SYLVANT mora se uskratiti ako bolesnik ima tešku infekciju ili bilo koju tešku nehematološku toksičnost i može se ponovno započeti u istoj dozi nakon oporavka.
English: Histopathological examination of lymphoid tissues from GD140 fetuses showed no morphological abnormalities in the development of the immune system.
Croatian: Histopatološki pregled limfoidnih tkiva od GD140 fetusa nije pokazao morfološke abnormalnosti u razvoju imunološkog sustava.
English: Data from all patients treated with siltuximab monotherapy (n = 370) form the overall basis of the safety evaluation.
Croatian: Podaci za sve bolesnike liječene siltuksimabom u monoterapiji (n = 370) čine ukupnu osnovu za sigurnosnu procjenu.
English: Median duration of siltuximab treatment was 5.52 years (range: 0.8 to 10.8 years); more than 50% of patients received siltuximab treatment for ≥5 years.
Croatian: Medijan trajanja liječenja siltuksimabom bio je 5,52 godine (raspon: 0,8 do 10,8 godina); više od 50% bolesnika primalo je liječenje siltuksimabom tijekom ≥5 godina.
English: In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately.
Croatian: U slučaju predoziranja, bolesnika je potrebno nadzirati radi znakova ili simptoma nuspojava i odmah započeti odgovarajuće simptomatsko liječenje.
English: The European Medicines Agency has waived the obligation to submit the results of studies with siltuximab in all subsets of the paediatric population in CD (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja siltuksimaba u svim podskupinama pedijatrijske populacije s CD-om (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: All clinical studies with SYLVANT excluded patients with clinically significant infections, including those known to be hepatitis B surface antigen positive.
Croatian: U svim kliničkim ispitivanjima s lijekom SYLVANT isključeni su bolesnici s klinički značajnim infekcijama, uključujući one za koje je poznato da su pozitivni na površinski antigen hepatitisa B.
English: Consequently, infants born to women treated with siltuximab may be at increased risk of infection, and caution is advised in the administration of live vaccines to these infants (see section 4.4).
Croatian: Posljedično, dojenčad žena koje su liječene siltuksimabom može imati povećan rizik za infekciju, te se savjetuje oprez pri primjeni živih cjepiva u te dojenčadi (vidjeti dio 4.4).
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Croatian: Imunomodulatori mogu povećati rizik za zloćudne bolesti.
English: You and your doctor should decide if you will continue to take SYLVANT, or breast-feed and discontinue SYLVANT.
Croatian: Vi i Vaš liječnik morate odlučiti hoćete li nastaviti uzimati SYLVANT ili ćete dojiti i prestati uzimati SYLVANT.
English: Serious infections, including pneumonia and sepsis, were observed during clinical studies (see section 4.8).
Croatian: Ozbiljne infekcije, uključujući pneumoniju i sepsu, bile su uočene tijekom kliničkih ispitivanja (vidjeti dio 4.8).
English: A total score of all symptoms (referred to as the MCD-related Overall Symptom Score) is the sum of the severity grades (NCI-CTCAE grade) of the MCD-related signs and symptoms [general MCD-related (fatigue, malaise, hyperhidrosis, night sweats, fever, weight loss, anorexia, tumour pain, dyspnea, and pruritus), autoimmune phenomena, fluid retention, neuropathy, and skin disorders].
Croatian: Ukupni rezultat svih simptoma (odnosi se na rezultat ukupnih simptoma povezanih s MCD-om) bio je zbroj stupnjeva težine (NCI-CTCAE stupanj) znakova i simptoma povezanih s MCD [općenito povezano s MCD-om (umor, malaksalost, hiperhidroza, noćna znojenja, vrućica, gubitak težine, anoreksija, tumorska bol, dispneja i pruritus), autoimuni fenomen, zadržavanje tekućine, neuropatija i kožni poremećaji].
English: Siltuximab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Siltuksimab se ne preporučuje tijekom trudnoće i u žena reproduktivne dobi koje ne koriste kontracepciju.
English: The MAH should provide tabulated data to the CHMP every 12 months in line with the periodic safety update report (PSUR) cycle including data for only those patients who are candidates for treatment with siltuximab.
Croatian: Nositelj odobrenja mora dostaviti tablične podatke CHMP-u svakih 12 mjeseci u skladu s ciklusom periodičkih izvješća o neškodljivosti (PSUR) uključujući podatke samo za one bolesnike koji su kandidati za liječenje siltuksimabom.
English: The highest total amount of siltuximab administered in any clinical trial so far per dose was 2,190 mg (11 mg/kg).
Croatian: Najviša ukupna količina siltuksimaba koja je primijenjena u bilo kojem kliničkom ispitivanju do sada, po dozi bila je 2190 mg (11 mg/kg).
English: A registry should be conducted to collect information on patients with Castleman's disease, who are candidates to receive Sylvant or are currently receiving treatment with Sylvant.
Croatian: Potrebno je provesti registar kako bi se prikupili podaci o bolesnicima s Castlemanovom bolešću, kandidatima za primanje lijeka Sylvant ili onima koji trenutno primaju liječenje lijekom Sylvant.
English: • you are due to have a vaccination or may need to have one in the near future - this is because some vaccines should not be given with SYLVANT.
Croatian: • ako se trebate cijepiti ili ćete se trebati cijepiti u bliskoj budućnosti - zbog toga što se neka cjepiva ne smiju primjenjivati s lijekom SYLVANT.
English: • SYLVANT is supplied as a glass vial containing a white powder for concentrate for solution for infusion (powder for concentrate).
Croatian: • SYLVANT se isporučuje u staklenoj bočici koja sadrži bijeli prašak za koncentrat za otopinu za infuziju (prašak za koncentrat).
English: Gastrointestinal (GI) perforation has been reported in siltuximab clinical trials although not in MCD trials.
Croatian: Gastrointestinalna (GI) perforacija bila je prijavljena u kliničkim ispitivanjima sa siltuksimabom, iako ne i u MCD ispitivanjima.
English: It is well established that IL-6 stimulates the acute-phase expression of C-reactive protein (CRP).
Croatian: Dobro je ustanovljeno da IL-6 stimulira ekpresiju C-reaktivnog proteina (CRP) u akutnoj fazi.
English: Further immunogenicity analyses were conducted for all positive samples from the 4 patients with detectable anti-siltuximab antibodies.
Croatian: Daljnje analize imunogenosti bile su provedene za sve pozitivne uzorke od 4 bolesnika s detektabilnim anti-siltuksimab protutijelima.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Naročito obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od slijedećih lijekova:
English: Within the system organ class, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to
Croatian: Unutar klase organskih sustava, nuspojave su navedene ispod naslova učestalosti uz korištenje sljedećih kategorija: vrlo često (≥ 1/10); često
English: Tell your doctor straight away if you notice the following side effects, as he or she may need to stop your treatment:
Croatian: Odmah recite svom liječniku ako primijetite bilo koju od sljedećih nuspojava jer možda će morati odmah prekinuti Vaše liječenje:
English: Time to treatment failure
Croatian: Vrijeme do zatajenja liječenja
English: Name and address of the manufacturers of the biological active substances
Croatian: Nazivi i adrese proizvođača biološke djelatne tvari
English: Siltuximab+BSC* Placebo+BSC 95% CIa
Croatian: Siltuksimab+BSC* Placebo+BSC 95% CI
English: Signs of such a tear developing include stomach pain getting worse, feeling sick (nausea), change in bowel habits and fever - if you get any of these, contact your doctor right away.
Croatian: Znakovi koji upućuju na takav razvoj pukotine uključuju bol u želucu koja se pojačava, mučninu, promjenu navika crijeva i vrućicu - ako razvijete bilo što od navedenog, odmah se obratite svom liječniku.
English: Treatment criteria
Croatian: Kriteriji za liječenje
English: Siltuximab must be administered as an intravenous infusion.
Croatian: Siltuksimab se mora primijeniti intravenskom infuzijom.
English: Two cases of reactivated hepatitis B have been reported when SYLVANT was administered concomitantly with high dose dexamethasone, and bortezomib, melphalan and prednisone in multiple myeloma patients.
Croatian: Dva slučaja reaktiviranog hepatitisa B bila su prijavljena kada je SYLVANT bio primijenjen istodobno s visokom dozom deksametazona i bortezomiba, melfalana i prednizona u bolesnika s multiplim mijelomom.
English: The effect of siltuximab on CYP450 enzyme activity can persist for several weeks after stopping therapy.
Croatian: Učinak siltuksimaba na aktivnost CYP450 enzima može potrajati nekoliko tjedana nakon prestanka liječenja.
English: Signs include: cough, flu-like symptoms, feeling unwell, red or hot skin, fever.
Croatian: Znakovi uključuju: kašalj, simptome slične gripi, loše osjećanje, crvenu ili vruću kožu, vrućicu.
English: Paediatric population The safety and efficacy of siltuximab have not been established in paediatric patients.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost siltuksimaba nisu bile ustanovljene u pedijatrijskih bolesnika.
English: Promptly evaluate patients presenting with symptoms that may be associated with or suggestive of GI perforation.
Croatian: Potrebna je brza procjena bolesnika koji pokazuju simptome koji mogu biti povezani ili ukazuju na GI perforaciju.
English: • you have high level of fats in your blood (hypertriglyceridaemia) - this is because SYLVANT may increase these levels.
Croatian: • ako imate visoku razinu masnoća u krvi (hipertrigliceridemija) -zbog toga što SYLVANT može povisiti te vrijednosti.
English: Janssen Sciences Ireland UC
Croatian: Janssen Sciences Ireland UC Barnahely
English: Siltuximab is a monoclonal antibody (a specialised type of protein) that binds selectively to an antigen (a target protein) in the body called interleukin-6 (IL-6).
Croatian: Siltuksimab je monoklonsko protutijelo (specijalizirana vrsta proteina) koje se selektivno veže na antigen (ciljni protein) u tijelu koji se zove interleukin-6 (IL-6).
English: The dose of the concomitant medicinal products should be adjusted as needed.
Croatian: Dozu lijeka koji se istodobno primjenjuje mora se po potrebi prilagođavati.
English: The mechanism of action of siltuximab is neutralisation of IL-6 bioactivity, which can be measured indirectly by suppression of CRP.
Croatian: Mehanizam djelovanja siltuksimaba je neutralizacija IL-6 bioaktivnosti, koja se indirektno može mjeriti supresijom CRP-a.
English: Best tumour response (investigator assessment)
Croatian: Najbolji tumorski odgovor (procjena ispitivača)
English: The population PK of siltuximab were analysed to evaluate the effects of demographic characteristics.
Croatian: Populacijska farmakokinetika siltuksimaba bila je analizirana radi procjene učinaka demografskih karakteristika.
English: • you have a condition such as stomach ulcer or diverticulitis that may increase the risk of getting a tear in the stomach or gut (gastrointestinal perforation).
Croatian: • ako imate stanje kao što je čir na želucu ili divertikulitis, koje može povećati rizik za nastajanje pukotine na želucu ili crijevima (perforacija probavnog sustava).
English: IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation.
Croatian: Pokazalo se da je IL-6 uključen u različite normalne fiziološke procese kao što je indukcija sekrecije imunoglobulina, inicijacija sinteze jetrenih proteina akutne faze i stimulacija proliferacije i diferencijacije hematopoetske prekursorske stanice.
English: Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).
Croatian: Kemijska i fizikalna stabilnost tijekom primjene bila je dokazana do 8 sati pri sobnoj temperaturi
English: Binding bioactive IL-6 by siltuximab may result in increased metabolism of CYP450 substrates, because CYP450 enzyme activity will normalise.
Croatian: Vezanje bioaktivnog IL-6 sa siltuksimabom može dovesti do povećanog metabolizma supstrata CYP450, jer će se aktivnost enzima CYP450 normalizirati.