FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Sivextro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Sivextro nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Sivextro pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: A list of bacteria against which Sivextro is active can be found in the summary of product characteristics (also part of the EPAR).
Croatian: Popis bakterija protiv kojih Sivextro djeluje dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: For practical information about using Sivextro, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Sivextro pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Sivextro have been shown in studies?
Croatian: Koje su koristi lijeka Sivextro utvrđene u ispitivanjima?
English: How does Sivextro work?
Croatian: Kako djeluje Sivextro?
English: How is Sivextro used?
Croatian: Kako se Sivextro koristi?
English: For the full list of all side effects and restrictions with Sivextro, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Sivextro potražite u uputi o lijeku.
English: The way it works in this disease is not completely understood.
Croatian: Način njegova djelovanja kod ove bolesti nije u potpunosti poznat.
English: Treatment is divided into 2 phases: induction and consolidation.
Croatian: Terapija je podijeljena u dvije faze: indukciju i konsolidaciju.
English: If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.
Croatian: Ako se to ne dogodi do 50. dana (u prethodno liječenih bolesnika) ili 60. dana (u novodijagnosticiranih bolesnika) terapiju je potrebno obustaviti.
English: The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects.
Croatian: Infuzija treba trajati između jednog i dva sata, ali se možda mora davati i dulje ako bolesnik iskusi određene nuspojave.
English: Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
Croatian: Više informacija o lijeku Arsenic trioxide Accord dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
English: It is given as an infusion (drip) into a vein.
Croatian: Daje se kao infuzija (ukapavanje) u venu.
English: • Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Croatian: • bolesnika s APL-om čija bolest nije reagirala na prethodnu terapiju retinoidima i lijekovima protiv raka, odnosno u kojih se bolest vratila nakon te vrste terapije.
English: Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Croatian: Arsenic trioxide Accord koristi se za liječenje odraslih (od 18 godina ili starijih) s akutnom promijelocitnom leukemijom (APL), rijetkim oblikom leukemije (raka bijelih krvnih stanica) uzrokovane genetskom „translokacijom” (kada dođe do zamjene gena između dva kromosoma).
English: It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.
Croatian: Smatra se da sprječava proizvodnju DNK-a koji je potreban stanicama leukemije za rast.
English: The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Croatian: Translokacija utječe na način na koji bijele krvne stanice rastu te zbog toga nemaju sposobnost korištenja retinolne kiseline (vitamina A).
English: During the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not.
Croatian: U fazi konsolidacije Arsenic trioxide Accord daje se tijekom pet dana svakoga tjedna, međutim trajanje pauze između svake terapije i trajanje ciklusa ovise o tome jesu li bolesnici prethodno primili terapiju ili ne.
English: Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Croatian: Bolesnike s APL-om obično se liječi retinoidima (tvarima dobivenima iz vitamina A).
English: Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Arsenic trioxide Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Croatian: U fazi indukcije Arsenic trioxide Accord daje se svakodnevno sve dok se ne pojave znakovi da terapija djeluje (kad koštana srž više ne sadrži nikakve stanice leukemije).
English: There was no need for ‘bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Arsenic trioxide Accord slično kao referentni lijek da bi postigao istu razinu djelatne tvari u krvi.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.
Croatian: Ispitivanja koristi i rizika od djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Trisenox i stoga ih nije potrebno ponavljati za lijek Arsenic trioxide Accord.
English: This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Trisenox.
Croatian: To znači da Arsenic trioxide Accord sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Trisenox.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je lijek Arsenic trioxide Accord usporediv s lijekom Trisenox.
English: Arsenic trioxide Accord can only be obtained with a prescription and its use should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Croatian: Arsenic trioxide Accord izdaje se samo na recept, a njegovo korištenje mora nadzirati liječnik s iskustvom u liječenju bolesnika s akutnim leukemijama.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Arsenic trioxide Accord nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia.
Croatian: Djelatna tvar lijeka, arsenov trioksid, u medicini se koristi dugi niz godina, uključujući za liječenje leukemije.
English: The recommended dose of Arsenic trioxide Accord depends on the patient's weight.
Croatian: Preporučena doza lijeka Arsenic trioxide Accord ovisi o tjelesnoj težini bolesnika.
English: Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Arsenic trioxide Accord pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid.
Croatian: • bolesnika s novodijagnosticiranim APL-om niskog do srednjeg rizika kad se koristi zajedno s lijekom naziva sve-trans-retinolna kiselina.
English: This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Croatian: To je zbog toga što se Arsenic trioxide Accord daje intravenskom infuzijom te tako djelatna tvar dospijeva izravno u krvotok.
English: What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Arsenic trioxide Accord?
English: For more information about using Arsenic trioxide Accord, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Arsenic trioxide Accord pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: An overview of Arsenic trioxide Accord and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Arsenic trioxide Accord i zašto je odobren u EU-u
English: Arsenic trioxide Accord (arsenic trioxide)
Croatian: Arsenic trioxide Accord (arsenov trioksid)
English: Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Accord outweigh the identified risks and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da, kao i kod lijeka Trisenox, koristi od lijeka Arsenic trioxide Accord nadmašuju identificirane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine'.
Croatian: Arsenic trioxide Accord sadrži djelatnu tvar arsenov trioksid te je „generički lijek”.
English: Other information about Arsenic trioxide Accord
Croatian: Ostale informacije o lijeku Arsenic trioxide Accord
English: As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord.
Croatian: Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće lijeka Arsenic trioxide Accord.
English: What is Arsenic trioxide Accord and what is it used for?
Croatian: Što je Arsenic trioxide Accord i za što se koristi?
English: What are the benefits and risks of Arsenic trioxide Accord?
Croatian: Koje su koristi i rizici od lijeka Arsenic trioxide Accord?
English: Why is Arsenic trioxide Accord authorised in the EU?
Croatian: Zašto je Arsenic trioxide Accord odobren u EU-u?
English: Arsenic trioxide Accord is used in:
Croatian: Arsenic trioxide Accord koristi se u:
English: As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Arsenic trioxide Accord kontinuirano se prate.
English: How does Arsenic trioxide Accord work?
Croatian: Kako djeluje Arsenic trioxide Accord?
English: How has Arsenic trioxide Accord been studied?
Croatian: Kako je Arsenic trioxide Accord ispitivan?
English: How is Arsenic trioxide Accord used?
Croatian: Kako se Arsenic trioxide Accord primjenjuje?
English: It is given by a drip (infusion) into a vein (intravenously).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: This can take 3 to 6 hours and may need to be repeated.
Croatian: Ovaj postupak može potrajati od 3 do 6 sati i možda će se trebati ponoviti.
English: In particular, you must not be given certain vaccines called live vaccines:
Croatian: Posebno ne smijete primiti određena cjepiva koja se nazivaju živim cjepivima:
English: • After treatment while the immune system is recovering.
Croatian: • nakon liječenja dok se imunosni sustav oporavlja.
English: Date of first authorisation: 23 August 2018
Croatian: Datum prvog odobrenja: 23. kolovoza 2018.
English: If not improving, manage as Grade 4 (below).
Croatian: Ako ne nastupi poboljšanje, postupiti kao u slučaju 4. stupnja (ispod).
English: It will not be given to you again.
Croatian: Nećete ga primiti ponovno.
English: •Final report of study results: December 2038
Croatian: • Konačno izvješće rezultata ispitivanja: prosinac 2038.
English: • Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
Croatian: • provjeriti jeste li primili cjepivo u posljednjih 6 tjedana ili planirate li primiti cjepivo u sljedećih nekoliko mjeseci.
English: • Check your lungs, heart and blood pressure.
Croatian: • provjeriti pluća, srce i krvni tlak
English: An impact of these antibodies on efficacy or safety was not discernible.
Croatian: Utjecaj tih protutijela na djelotvornost ili sigurnost nije bio zamjetan.
English: A clear to opaque, white to red dispersion.
Croatian: Bistra do neprozirna, bijela do crvena disperzija.
English: Do not try to treat your symptoms with other medicines on your own.
Croatian: Simptome nemojte liječiti sami drugim lijekovima.
English: One out of 111 patients did not receive the product due to manufacturing failure.
Croatian: Jedan od 111 bolesnika nije primio lijek zbog pogreške u proizvodnji.
English: • Check if your cancer is getting worse.
Croatian: • provjeriti da Vam se rak ne pogoršava
English: Thawing should take approximately 3 to 5 minutes.
Croatian: Odmrzavanje treba trajati otprilike 3 do 5 minuta.
English: If you think you may be allergic, ask your doctor for advice.
Croatian: Ako mislite da ste alergični, pitajte liječnika za savjet.
English: Response and survival after treatment with available standard-of-care therapy was evaluated.
Croatian: Procijenjen je odgovor i preživljenje nakon liječenja dostupnom standardnom terapijom.
English: Median duration of response and median overall survival have not been reached (Table 5).
Croatian: Medijan trajanja odgovora i medijan ukupnog preživljenja još nisu postignuti (tablica 5).
English: • Fever, which may be a symptom of an infection.
Croatian: • vrućicu, koja može biti simptom infekcije
English: Your doctor or nurse will check carefully that this medicine is yours.
Croatian: Liječnik ili medicinska sestra pažljivo će provjeriti pripada li lijek Vama.
English: Effects on male and female fertility have not been evaluated in animal studies.
Croatian: Učinci na mušku i žensku plodnost nisu ispitani u ispitivanjima na životinjama.
English: Ninety-eight percent (98%) of patients recovered from CRS.
Croatian: Devedeset osam posto (98%) bolesnika oporavilo se od CRS-a.
English: It usually takes about 3 to 4 weeks to receive your YESCARTA therapy but the time may vary.
Croatian: Obično je potrebno oko 3 do 4 tjedna da primite terapiju lijekom YESCARTA, ali se vrijeme može razlikovati.
English: If this happens to you, do not drive or use heavy machines until at least 8 weeks after infusion or until your doctor tells you that you have completely recovered.
Croatian: Ako se to dogodi i Vama, nemojte upravljati vozilima i strojevima najmanje 8 tjedana nakon infuzije ili dok Vam liječnik ne kaže da ste se potpuno oporavili.
English: If your temperature is high, see your doctor immediately.
Croatian: Ako Vam je temperatura povišena, odmah se obratite liječniku.
English: Five patients responded, including 4 CRs.
Croatian: Pet je bolesnika odgovorilo, uključujući 4 s CR-om.
English: Symptoms require and respond to aggressive intervention.
Croatian: Simptomi zahtijevaju i odgovaraju na agresivnu intervenciju.
English: Verify patient ID.
Croatian: Provjerite ID bolesnika.
English: CRS occurred in 93% of patients.
Croatian: CRS se pojavio u 93% bolesnika.
English: Patients relapsed within 1 year of ASCT Patients with International Prognostic Index 3/4 Patients with disease stage III/IV
Croatian: Bolesnici s relapsom unutar 1 godine od ASCT-a Bolesnici s međunarodnim prognostičkim indeksom 3/4 Bolesnici sa III./IV. stadijem bolesti
English: • Tocilizumab and emergency equipment should be available prior to infusion and during the monitoring period.
Croatian: • Tocilizumab i oprema za hitne slučajeve moraju biti dostupni prije infuzije i tijekom razdoblja praćenja.
English: One sterile infusion bag.
Croatian: Jedna sterilna vrećica za infuziju.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: not yet assigned
Croatian: Farmakoterapijska skupina: ostali antineoplastici, ATK oznaka: nije još dodijeljena
English: Your doctor will regularly check your blood counts as the number of blood cells and other blood components may decrease.
Croatian: Liječnik će Vam redovito provjeravati krvnu sliku jer može doći do smanjenja broja krvnih stanica i drugih sastojaka krvi.
English: The safety and efficacy of YESCARTA in children and adolescents below 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka YESCARTA u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: You should not be given YESCARTA if you are allergic to any of the ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primiti lijek YESCARTA ako ste alergični na neki sastojak ovog lijeka (naveden u dijelu 6.).
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane redoslijedom po padajućoj ozbiljnosti.
English: Repeat tocilizumab every 8 hours as needed if not responsive to intravenous fluids or increasing supplemental oxygen.
Croatian: Ponoviti tocilizumab svakih 8 sati prema potrebi, ako nema odgovora na tekućine primijenjene intravenski ili povećanje dodatnog kisika.
English: It is used to treat these conditions when other available medicines have stopped working for you.
Croatian: Lijek se primjenjuje za liječenje tih stanja ako su Vam drugi dostupni lijekovi prestali djelovati.
English: YESCARTA will always be given to you by a healthcare professional.
Croatian: Lijek YESCARTA će Vam uvijek davati zdravstveni radnik.
English: If the bag is compromised, follow the local guidelines (or immediately contact Kite).
Croatian: Ako na vrećici opazite nedostatke, slijedite nacionalne smjernice (ili se odmah obratite tvrtki Kite).
English: Do NOT use a leukodepleting filter.
Croatian: NEMOJTE koristiti leukodeplecijski filtar.
English: As this medicine will be given by qualified healthcare professionals, they are responsible for the correct disposal of the product.
Croatian: Budući da će Vam lijek dati za to osposobljeni zdravstveni radnici, oni su odgovorni za pravilno zbrinjavanje lijeka.
English: This is the equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 15% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including infection.
Croatian: Dijagnoza CRS-a zahtijeva isključivanje drugih uzroka sistemskog upalnog odgovora, uključujući infekciju.
English: 2132 NT Hoofddorp The Netherlands
Croatian: 2132 NT Hoofddorp Nizozemska
English: Due to the risks associated with YESCARTA treatment, infusion should be delayed if a patient has any of the following conditions:
Croatian: Zbog rizika povezanih s liječenjem lijekom YESCARTA, infuziju treba odgoditi ako bolesnik ima neko od sljedećih stanja:
English: The most common site of infection was in the respiratory tract.
Croatian: Najčešće mjesto infekcije bio je dišni sustav.
English: Efficacy was consistent with the overall treated patient population.
Croatian: Djelotvornost je u skladu s ukupnom populacijom liječenih bolesnika.
English: The primary endpoint was objective response rate (ORR).
Croatian: Primarna mjera ishoda bila je stopa objektivnog odgovora (engl. objective response rate, ORR).
English: What YESCARTA is and what it is used for
Croatian: Što je YESCARTA i za što se koristi
English: If visible cell clumps remain, continue to gently mix the contents of the bag.
Croatian: Ako vidljive nakupine staničnog materijala i dalje budu prisutne, nastavite pažljivo miješati sadržaj vrećice.
English: Limit to a maximum of 3 doses in a 24 hour period; maximum total of 4 doses if no clinical improvement in the signs and symptoms of CRS.
Croatian: Ograničiti na najviše 3 doze u razdoblju od 24 sata; ukupno najviše 4 doze ako ne nastupi kliničko poboljšanje znakova i simptoma CRS-a.
English: Active uncontrolled infection.
Croatian: • nekontroliranu aktivnu infekciju
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000).
English: Cumulatively, 33 (31%) of 108 subjects received intravenous immunoglobulin therapy at the time of the 24-month analysis.
Croatian: Kumulativno je 33 (31%) od 108 ispitanika primilo intravensku imunoglobulinsku terapiju u vrijeme analize provedene nakon 24 mjeseca.
English: Forty-seven patients were evaluable for MYC, BCL-2, and BCL-6 status.
Croatian: Četrdeset sedam bolesnika bilo je procjenjivo za status MYC-a, BCL-2 i BCL-6.
English: Too many of these abnormal white blood cells accumulate in your tissue and this is the cause of the symptoms you may have.
Croatian: Prevelik broj tih abnormalnih leukocita nakuplja se u Vašem tkivu i to uzrokuje simptome koje možda imate.
English: In the event that a secondary malignancy occurs, contact the company to obtain instructions on patient samples to collect for testing.
Croatian: U slučaju pojave sekundarnog maligniteta kontaktirajte s tvrtkom kako biste dobili upute o uzimanju bolesnikovih uzoraka za testiranje.
English: Of 111 patients who underwent leukapheresis, 101 received YESCARTA.
Croatian: Od 111 bolesnika podvrgnutih leukaferezi, 101 je primio lijek YESCARTA.
English: YESCARTA is a clear to opaque, white to red dispersion for infusion, supplied in an infusion bag individually packed in a metal cassette.
Croatian: YESCARTA je bistra do neprozirna, bijela do crvena disperzija za infuziju, a isporučuje se u vrećici za infuziju koja je zasebno pakirana u metalnoj kazeti.
English: Secondary malignancies
Croatian: Sekundarni maligniteti
English: The requirements for submission of PSUR for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: The analysis included patients who had not responded (SD or PD) to their last line of therapy, or had relapsed within 12 months after ASCT.
Croatian: Analiza je uključivala bolesnike koji nisu odgovorili (SD ili PD) na zadnju liniju terapije ili koji su imali relaps u 12 mjeseci nakon ASCT-a.
English: The number of anti-CD19 CAR T cells in the blood was positively associated with objective response (CR or PR).
Croatian: Broj anti-CD19 CAR T-stanica u krvi bio je pozitivno povezan s objektivnim odgovorom (CR ili PR).
English: What YESCARTA looks like and contents of the pack
Croatian: Kako YESCARTA izgleda i sadržaj pakiranja