FrancophonIA/ELRC3.0 huggingface dataset:
English: The way it works in this disease is not completely understood.
Croatian: Način djelovanja kod ove bolesti nije u potpunosti poznat.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 10 August 2010.
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” prestale su vrijediti 10. kolovoza
English: This summary was last updated in 11-2016.
Croatian: Sažetak je posljednji put ažuriran: 11.2016.
English: The infusion should last one to two hours, but it may last longer if the patient has certain side effects.
Croatian: Infuzija treba trajati jedan do dva sata, ali može trajati dulje ako bolesnik ima određene nuspojave.
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 do 60. dana (u novodijagnosticiranih bolesnika), liječenje se treba prekinuti.
English: The full EPAR for Trisenox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Trisenox nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Forty-five of the patients in the studies were adults.
Croatian: Četrdeset i pet bolesnika u ispitivanjima bili su odrasle osobe.
English: The main measure of effectiveness was the number of patients who had complete remission.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika s potpunom remisijom.
English: On average, it took 57 days for the patients to reach complete remission.
Croatian: Bolesnicima je u prosjeku trebalo 57 dana za postizanje potpune remisije.
English: The treatment is divided into 2 phases: induction and consolidation.
Croatian: Liječenje je podijeljeno u dvije faze: fazu indukcije i fazu konsolidacije.
English: Trisenox was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Croatian: Lijek Trisenox prvobitno je odobren u „iznimnim okolnostima” zbog toga što su, uzevši u obzir da je bolest rijetka, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
English: The number of times these cycles are repeated depends on whether patients have received previous treatment or not.
Croatian: Broj ponavljanja ciklusa ovisi o tome jesu li bolesnici prethodno liječeni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trisenox on 5 March 2002.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Trisenox na snazi u Europskoj uniji od 5. ožujka 2002.
English: The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes).
Croatian: Najčešće nuspojave lijeka Trisenox (uočene u 1 na 10 bolesnika) jesu hiperglikemija (povišena razina glukoze u krvi), hipomagnezijemija (niske razine magnezija u krvi), hipokalemija (niske razine kalija u krvi), parestezija (neuobičajeni osjeti poput bockanja iglama), omaglica, glavobolja, tahikardija (ubrzani otkucaji srca), dispneja (poteškoće u disanju), sindrom diferencijacije (potencijalno smrtonosna komplikacija kemoterapije u bolesnika s APL-om), proljev, povraćanje, mučnina, pruritus (svrbež), osip, mialgija (bol u mišićima), pireksija (vrućica), bol, umor (malaksalost), edem (oticanje), produljeni QT interval na elektrokardiogramu (promjena električne aktivnosti srca) i povišene razine alanin aminotransferaze i aspartat aminotransferaze (jetreni enzimi).
English: This is a summary of the European public assessment report (EPAR) for Trisenox.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Trisenox.
English: Looking at the results of these two studies together, 87% of the patients had complete remission (45 out of 52).
Croatian: Uzevši u obzir rezultate obaju ispitivanja zajedno, u 87 % bolesnika (45 od 52) zabilježena je potpuna remisija.
English: During the consolidation phase, Trisenox is given once a day for five days, followed by a two-day break, repeated for four or five weeks.
Croatian: Tijekom faze konsolidacije lijek Trisenox daje se jedanput dnevno tijekom pet dana nakon čega slijedi pauza od dva dana, a cijeli se postupak ponavlja četiri ili pet tjedana.
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: • u bolesnika s APL-om čija bolest nije reagirala na prethodno liječenje retinoidnim lijekovima i lijekovima za liječenje raka ili čija se bolest ponovno javila nakon takvog liječenja.
English: 97% (72 out of 74) of patients treated with Trisenox did not have any event, compared with 86% (65 out of 76) of those treated with anthracyclines.
Croatian: U 97 % bolesnika (72 od 74) liječenih lijekom Trisenox nije zabilježen nikakav događaj, u usporedbi s 86 % bolesnika (65 od 76) liječenih antraciklinima.
English: It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.
Croatian: Smatra se da sprečava stvaranje DNK koja je neophodna za rast stanica leukemije.
English: The recommended dose of Trisenox depends on the body weight of the patient.
Croatian: Preporučena doza lijeka Trisenox ovisi o tjelesnoj težini bolesnika.
English: What measures are being taken to ensure the safe and effective use of Trisenox?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Trisenox?
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 rast bijelih krvnih stanica, koje kao rezultat toga nisu sposobne upotrebljavati retinoatnu kiselinu (vitamin A).
English: During the induction phase, Trisenox is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Croatian: Tijekom faze indukcije lijek Trisenox daje se svakog dana do pojave znakova da liječenje djeluje (kada u koštanoj srži nema stanica leukemije).
English: It is not intended to provide practical advice on how to use Trisenox.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Trisenox.
English: Why is Trisenox approved?
Croatian: Zašto je Trisenox odobren?
English: This is when there are no more leukaemia cells in the bone marrow and the levels of platelets and white blood cells in the blood have recovered.
Croatian: To je stanje kada u koštanoj srži više nema stanica leukemije, a razine trombocita i bijelih krvnih stanica vraćene su na uobičajene razine.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trisenox 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 Trisenox nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What is Trisenox and what is it used for?
Croatian: Što je Trisenox i za što se koristi?
English: Other information about Trisenox
Croatian: Ostale informacije o lijeku Trisenox
English: The CHMP decided that Trisenox's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za primjenu kod ljudi odlučio je da koristi lijeka Trisenox nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Trisenox 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: Lijek Trisenox primjenjuje se u liječenju odraslih osoba (u dobi od 18 godina ili više) s akutnom promijelocitnom leukemijom (APL), rijetkim oblikom leukemije (rak bijelih krvnih stanica) izazvanom translokacijom gena (zamjena gena između dvaju kromosoma).
English: Trisenox has also been investigated in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline and a retinoid.
Croatian: Lijek Trisenox također je ispitivan u dvama ispitivanjima koja su obuhvatila ukupno 52 bolesnika s APL-om koji su prethodno liječeni antraciklinom i retinoidom.
English: Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Croatian: Bolesnici s APL-om uglavnom se liječe retinoidima (derivati vitamina A).
English: Trisenox can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Croatian: Lijek Trisenox izdaje se samo na recept, a liječenje mora nadzirati liječnik s iskustvom u liječenju bolesnika s akutnim leukemijama.
English: What are the risks associated with Trisenox?
Croatian: Koji su rizici povezani s lijekom Trisenox?
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA).
Croatian: • u bolesnika s novodijagnosticiranim APL-om niskog do srednjeg rizika u kombinaciji sa svetrans-retinoatnom kiselinom (ATRA);
English: For more information about treatment with Trisenox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Trisenox pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Trisenox was not compared with any other medicine in either study.
Croatian: Ni u jednom ispitivanju Lijek Trisenox nije uspoređivan s drugim lijekom.
English: The active substance in Trisenox, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia.
Croatian: Djelatna tvar u lijeku Trisenox, arsenov trioksid, kemijski je spoj koji se niz godina upotrebljava u lijekovima, među ostalim za liječenje leukemije.
English: Trisenox arsenic trioxide
Croatian: Trisenox arsenov trioksid
English: Trisenox is used in:
Croatian: Lijek Trisenox primjenjuje se:
English: For practical information about using Trisenox, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Trisenox bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: What benefits of Trisenox have been shown in studies?
Croatian: Koje su koristi lijeka Trisenox dokazane u ispitivanjima?
English: How does Trisenox work?
Croatian: Kako djeluje Trisenox?
English: Trisenox contains the active substance arsenic trioxide.
Croatian: Lijek Trisenox sadrži djelatnu tvar arsenov trioksid.
English: For the full list of all side effects and restrictions with Trisenox, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Trisenox potražite u uputi o lijeku.
English: How is Trisenox used?
Croatian: Kako se Trisenox koristi?
English: Trisenox has been investigated in 159 newly diagnosed patients who had not yet received any treatment for APL. Trisenox was compared with an anthracycline (a type of cancer medicine), both taken in combination with ATRA, and the measure of effectiveness was the number of patients who did not experience any event (such as worsening of their disease or death) 2 years after diagnosis.
Croatian: Oba su lijeka bila uzimana u kombinaciji s ATRA-om, a mjera djelotvornosti bio je broj bolesnika kod kojih dvije godine nakon dijagnoze nije došlo do nikakvih događaja (pogoršanja bolesti ili smrti).
English: Centaury should only be used in adults and elderly.
Croatian: Kičicina zelen se smije koristiti samo u odraslih i starijih osoba.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2. veljače 2016.
English: Studies in laboratory tests indicate an effect as appetite and digestion stimulant, although the data available are very limited.
Croatian: Ispitivanja provedena u laboratoriju kao učinak naznačuju stimulaciju apetita i probave, iako su dostupni podatci vrlo ograničeni.
English: If symptoms last longer than 2 weeks during use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
Croatian: Ako simptomi tijekom primjene traju dulje od 2 tjedna, potrebno se obratiti liječniku ili kvalificiranom zdravstvenom radniku.
English: In some cases the solvent is partially evaporated to obtain a soft extract.
Croatian: U nekim se slučajevima otapalo djelomično isparava kako bi se dobio meki ekstrakt.
English: What are the HMPC conclusions on its medicinal uses?
Croatian: Koji su zaključci HMPC-a o njezinoj medicinskoj primjeni?
English: Centaury medicines should not be taken by people with ulcers in the stomach.
Croatian: Lijekove koji sadrže kičicinu zelen ne bi trebali uzimati ljudi s čirom na želucu.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Croatian: U vrijeme kad je HPMC procjenjivao lijek, nisu prijavljene nikakve nuspojave prilikom primjene ovih lijekova.
English: This summary is not intended to provide practical advice on how to use medicines containing centaury.
Croatian: Svrha ovog sažetka nije davati praktične savjete o načinu primjene lijekova koji sadrže kičicinu zelen.
English: What is centaury?
Croatian: Što je kičicina zelen?
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Croatian: Za detaljnije informacije o ispitivanjima koje je procijenio HMPC pogledajte izvješće HMPC-a o procjeni lijeka.
English: Any applications for the licensing of medicines containing centaury have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže kičicinu zelen moraju se podnijeti nacionalnim tijelima nadležnima za lijekove koja procjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: Further information on the risks associated with centaury medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više o rizicima povezanim s lijekovima koji sadrže kičicinu zelen, uključujući odgovarajuće mjere opreza za njihovu sigurnu primjenu, možete pronaći u monografiji pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the HMPC assessment of centaury medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Daljnje informacije o HMPC-ovoj procjeni lijekova koji sadrže kičicinu zelen, uključujući pojedinosti zaključaka Odbora, nalaze se pod karticom „All documents” na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions on the use of centaury medicines for indigestion or other stomach and gut disorders, and in temporary loss of appetite are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže kičicinu zelen za lošu probavu ili druge želučane i crijevne poremećaje te za privremeni gubitak apetita temelje se na njihovoj „tradicionalnoj primjeni”.
English: The HMPC noted the lack of clinical studies with centaury.
Croatian: HMPC je istaknuo nedostatak kliničkih istraživanja kičicine zeleni.
English: Centaury can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Kičicina zelen može postojati također i u kombinaciji s drugim biljnim tvarima u nekim biljnim lijekovima.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing centaury.
Croatian: Države članice EU-a uzimaju u obzir zaključke HMPC-a prilikom procjene zahtjeva za davanje odobrenja za biljne lijekove koji sadrže kičicinu zelen.
English: Information on the use and licensing of centaury medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o primjeni i davanju odobrenja za lijekove koji sadrže kičicinu zelen u državama članicama EU-a mogu se dobiti od nadležnih nacionalnih tijela.
English: Other information about centaury medicines
Croatian: Ostale informacije o lijekovima koji sadrže kičicinu zelen
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of centaury.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Odbora za biljne lijekove (HMPC) u pogledu medicinske primjene kičicine zeleni.
English: Detailed instructions on how to take centaury medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o načinu uzimanja lijekova koji sadrže kičicinu zelen i o tome tko ih smije uzimati navedene su u uputi koja je priložena uz lijek.
English: Herbal medicines containing centaury are usually available as herbal teas to be drunk, or in liquid or solid forms to be taken by mouth.
Croatian: Biljni lijekovi koji sadrže kičicinu zelen najčešće su dostupni kao biljni čaj koji se pije i u krutom obliku koji se uzima na usta.
English: The HMPC conclusions are therefore based on the long-standing use of centaury.
Croatian: Zaključci HMPC-a temelje se stoga na dugotrajnoj primjeni kičicine zeleni.
English: s.l., herba
Croatian: Centaurium erythraea Rafn. s. l., herba
English: What are the risks associated with centaury medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže kičicinu zelen?
English: The HMPC concluded that, on the basis of its long-standing use, centaury can be used for mild indigestion or other stomach and gut disorders as well as for temporary loss of appetite.
Croatian: Na temelju dugotrajne primjene, HMPC je zaključio da se kičicina zelen može koristiti za blagi poremećaj probave ili druge želučane, odnosno crijevne poremećaje te za privremeni gubitak apetita.
English: For more information about treatment with centaury medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekovima koji sadrže kičicinu zelen pročitajte uputu o lijeku priloženu uz lijek, odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using centaury medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni lijekova koji sadrže kičicinu zelen bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: How are centaury medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže kičicinu zelen?
English: What evidence supports the use of centaury medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže kičicinu zelen?
English: Centaury preparations are obtained by drying and comminuting (reducing into tiny pieces) or powdering the aerial parts.
Croatian: Kičicina zelen je uobičajeni naziv za nadzemne dijelove biljke Centaurium erythraea Rafn. s. l. Pripravci od kičicine zeleni dobivaju se sušenjem i usitnjavanjem (smanjivanjem na manje komadiće) ili usitnjavanjem nadzemnih dijelova u prah.
English: Packaging Package size bottle (HDPE) 168 (4 x 42) tablets bottle (HDPE) 42 tablets
Croatian: Za primjenu kroz usta Bočica (HDPE) 168 (4 x 42) tableta
English: Route of Administration
Croatian: Doza Farmaceutski oblik Put primjene
English: - you are planning to have a baby.
Croatian: - ako planirate imati dijete.
English: This applies to both men and women.
Croatian: To se odnosi i na muškarce i na žene.
English: However, the choice of method should be consistent from day to day.
Croatian: Međutim, izbor metode treba biti dosljedan iz dana u dan.
English: No specific studies have been carried out in the elderly.
Croatian: Nisu provedena specifična ispitivanja na starijim osobama.
English: After first opening: 56 days.
Croatian: Nakon prvog otvaranja: 56 dana.
English: Ask your doctor if you would like more explanation about this disease.
Croatian: Pitajte svog liječnika ako trebate više objašnjenja o ovoj bolesti.
English: May be harmful to the teeth.
Croatian: Lijek može biti štetan za zube.
English: - After first opening of the bottle, discard any unused contents after 56 days.
Croatian: Nakon prvog otvaranja bočice, bacite sav neiskorišteni sadržaj nakon 56 dana.
English: It is possible that the levels of other anti-epileptic medicinal products may also be altered.
Croatian: Moguće je da se razine drugih antiepileptičkih lijekova također promijene.
English: Date of latest renewal: 18 November 2016
Croatian: Datum posljednje obnove odobrenja: 18. studeni 2016.
English: • Risk Management Plan (RMP) Not applicable
Croatian: • Plan upravljanja rizikom (RMP) Nije primjenjivo.
English: Administration in the evening compared to morning administration may lower the risk of relapse.
Croatian: Primjena navečer u usporedbi s onom ujutro može smanjiti rizik od relapsa.
English: They therefore cannot fight infections and may cause bleeding.
Croatian: Stoga se ne mogu boriti protiv infekcija i mogu uzrokovati krvarenje.
English: The frequency of NUDT15 c.415C>T has an ethnic variability of approximately 10 % in East Asians, 4 % in Hispanics, 0.2 % in Europeans and 0 % in Africans.
Croatian: Učestalost NUDT15 c.415C>T ima etničku varijabilnost od otprilike 10 % u istočnih Azijata, 4 % u Latinoamerikanaca, 0,2 % u Europljana i 0 % u Afrikanaca.
English: This is to check the number and type of cells in your blood and to ensure your liver is working correctly.
Croatian: To je stoga da bi se provjerio broj i vrstu stanica u Vašoj krvi i da bi se osiguralo da Vaša jetra radi ispravno.
English: Talk to your doctor if you have any of the following side effects which may also happen with this medicine:
Croatian: Razgovarajte sa svojim liječnikom ako imate bilo koju od sljedećih nuspojava koje se također mogu dogoditi s ovim lijekom:
English: These new white blood cells are immature (not fully formed) and unable to grow and work properly.
Croatian: Te nove bijele krvne stanice su nezrele (nisu potpuno oblikovane) te ne mogu rasti i ispravno djelovati.
English: Keep the bottle tightly closed (see section 6.6).
Croatian: Bočicu čuvati čvrsto zatvorenu (vidjeti dio 6.6).
English: The suspension is pink to brown in colour.
Croatian: Suspenzija je ružičaste do smeđe boje.
English: Remove the syringe from your mouth.
Croatian: Izvadite štrcaljku iz usta.
English: - tumours, including skin cancer.
Croatian: - tumora, uključujući rak kože.