FrancophonIA/ELRC3.0 huggingface dataset:
English: Onivyde can only be obtained with a prescription and treatment should only be prescribed and given by a doctor who has experience in the use of cancer medicines.
Croatian: Lijek Onivyde izdaje se samo na liječnički recept, a liječenje mora propisati i provoditi liječnik s iskustvom u primjeni lijekova protiv raka.
English: The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets).
Croatian: Najčešće ozbiljne nuspojave (koje se mogu javiti u više od 1 na 50 osoba) uključuju proljev, mučninu i povraćanje, neutropeniju i vrućicu, infekcije krvi ili pluća (sepsu, upalu pluća), šok, dehidraciju, otkazivanje bubrega i trombocitopeniju (niske razine krvnih pločica).
English: Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women.
Croatian: Onivyde se ne smije davati bolesnicima s prethodnim ozbiljnim reakcijama hipersenzitivnosti (alergijama) na irinotekan te dojiljama.
English: How does Onivyde work?
Croatian: Kako djeluje Onivyde?
English: In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes'.
Croatian: U lijeku Onivyde, irinotekan se nalazi u sićušnim česticama masti naziva „liposomi”.
English: Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination.
Croatian: Bolesnicima je davan lijek Onivyde ili 5-fluorouracil plus leukovorin, odnosno kombinacija sva tri lijeka.
English: The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth) and fever.
Croatian: Najčešće nuspojave lijeka Onivyde (koje se mogu javiti u više od 1 na 5 osoba) jesu proljev, mučnina, povraćanje, gubitak apetita, neutropenija (niske razine neutrofila, vrste bijeli krvnih stanica), umor, slabost, anemija (niske razine crvenih krvnih stanica), stomatitis (upala sluznice u usnoj šupljini) i vrućica.
English: What benefits of Onivyde have been shown in studies?
Croatian: Koje su koristi od lijeka Onivyde utvrđene u ispitivanjima?
English: Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.
Croatian: Onivyde se primjenjuje zajedno s 5-fluorouracilom i leukovorinom (druga dva lijeka protiv raka) u odraslih čiji je rak uznapredovao usprkos terapiji koja sadrži lijek protiv raka gemcitabin.
English: Onivyde was investigated in one main study involving 417 patients with metastatic adenocarcinoma of the pancreas whose cancer got worse despite cancer treatment that contained gemcitabine.
Croatian: Onivyde je ispitivan u jednom glavnom ispitivanju na 417 bolesnika s adenokarcinomom gušterače čiji se rak pogoršao unatoč terapiji protiv raka koja sadrži gemcitabin.
English: Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas.
Croatian: Onivyde je lijek protiv raka koji se primjenjuje za liječenje oblika raka gušterače naziva metastatski adenokarcinom gušterače.
English: Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Croatian: Onivyde je dostupan kao koncentrat od kojeg se priprema otopina za intravensku infuziju.
English: The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Croatian: Djelatna tvar u lijeku Onivyde, irinotekan, lijek je protiv raka koji se ubraja u skupinu „inhibitora topoizomeraze”.
English: How is Onivyde used?
Croatian: Kako se Onivyde primjenjuje?
English: The Agency considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.
Croatian: Agencija je smatrala da je produljenje života zabilježeno kad se Onivyde primjenjivao zajedno s 5-fluorouracilom i leukovorinom značajno u prethodno liječenih bolesnika s metastatskim adenokarcinomom gušterače, koji imaju ograničene mogućnosti liječenja.
English: For the full list of side effects of Onivyde, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Onivyde potražite u uputi o lijeku.
English: The full EPAR for Imatinib Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Imatinib Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Imatinib Accord is available as tablets (100 and 400 mg).
Croatian: Imatinib Accord dostupan je u obliku tableta (100 i 400 mg).
English: The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Croatian: Doza ovisi o bolesti koja se liječi, dobi i stanju bolesnika te o reakciji na terapiju, ali ne smije premašiti 800 mg dnevno.
English: This means that Imatinib Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Croatian: To znači da Imatinib Accord sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Glivec.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours.
Croatian: Izdaje se samo na liječnički recept, a liječenje mora započeti liječnik koji ima iskustva u liječenju osoba oboljelih od raka krvi ili solidnih tumora.
English: As for every medicine, the company provided studies on the quality of Imatinib Accord.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Imatinib Accord.
English: Imatinib Accord is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Croatian: Imatinib Accord uzima se kroz usta uz obrok i veliku čašu vode kako bi se smanjio rizik od iritacije želuca i crijeva.
English: These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Croatian: Ti se enzimi nalaze u nekim receptorima na površini stanica raka, uključujući i receptore koji sudjeluju u stimulaciji nekontrolirane diobe stanica.
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Croatian: Lijek se također koristi u odraslih i djece u „kroničnoj fazi” bolesti ako nije uspjela terapija interferonom-alfa (drugim lijekom protiv raka) te u uznapredovalim fazama bolesti („u fazi ubrzanja” ili „u blastičnoj krizi”).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Accord has been shown to have comparable quality and to be bioequivalent to Glivec.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Imatinib Accord posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Glivec.
English: This is a summary of the European public assessment report (EPAR) for Imatinib Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Imatinib Accord.
English: What is Imatinib Accord and what is it used for?
Croatian: Što je Imatinib Accord i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Imatinib Accord?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imatinib Accord?
English: By blocking these receptors, Imatinib Accord helps to control cell division.
Croatian: Blokiranjem tih receptora lijek Imatinib Accord pomaže u kontroli diobe stanica.
English: Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Imatinib Accord generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Accord.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenim uporabama već su provedena za referentni lijek Glivec te se ne trebaju ponavljati za lijek Imatinib Accord.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine, Glivec.
Croatian: Tvrtka je provela i ispitivanja koja su pokazala da je lijek „bioekvivalentan” referentnom lijeku Glivec.
English: Imatinib Accord is a cancer medicine used to treat the following diseases:
Croatian: Accord je lijek protiv raka koji se koristi za liječenje sljedećih bolesti:
English: Imatinib Accord is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Croatian: Imatinib Accord koristi se za liječenje odraslih bolesnika s DFSP-om koji se ne može kirurški ukloniti i odraslih bolesnika koji ne mogu biti podvrgnuti kirurškom zahvatu u slučaju kada se rak ponovo razvio nakon prethodnog liječenja ili se proširio na druge dijelove tijela.
English: What are the benefits and risks of Imatinib Accord?
Croatian: Koje su koristi i rizici od lijeka Imatinib Accord?
English: Therefore, the Agency's view was that, as for Glivec, the benefit outweighs the identified risk.
Croatian: Agencije da, kao i kod lijeka Glivec, koristi nadmašuju utvrđene rizike.
English: The active substance in Imatinib Accord, imatinib, is a protein-tyrosine kinase inhibitor.
Croatian: Djelatna tvar lijeka Imatinib Accord je imatinib, inhibitor protein-tirozin kinaze.
English: For more information about treatment with Imatinib Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Za više informacija o liječenju lijekom Imatinib Accord pročitajte uputu o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib 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 Imatinib Accord nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Accord on 1 July 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Imatinib Accord na snazi u Europskoj uniji od 1. srpnja 2013.
English: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Croatian: • mijelodisplastičnih ili mijeloproliferativnih bolesti (MD/MPD), skupine bolesti kod kojih tijelo proizvodi veliki broj abnormalnih krvnih stanica.
English: Imatinib Accord is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Croatian: Lijek Imatinib Accord koristi se za liječenje bolesnika „pozitivnih na Philadelphia kromosom” (Ph+).
English: The Agency recommended that Imatinib Accord be approved for use in the EU.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje u promet lijeka Imatinib Accord u EU-u.
English: Imatinib Accord is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Croatian: Imatinib Accord koristi se za liječenje odraslih bolesnika s HES-om ili KEL-om sa specifičnom preraspodjelom dvaju gena naziva FIP1L1 i PDGFRα;
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Croatian: • dermatofibrosarkoma protuberans (DFSP), vrste raka (sarkoma) kod koje se stanice u tkivu ispod kože nekontrolirano dijele.
English: It is not intended to provide practical advice on how to use Imatinib Accord.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Imatinib Accord.
English: Imatinib Accord is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Croatian: Imatinib Accord primjenjuje se zajedno s drugim lijekovima protiv raka u odraslih i djece s novodijagnosticiranim Ph+ ALL-om.
English: Other information about Imatinib Accord
Croatian: Ostale informacije o lijeku Imatinib Accord
English: Imatinib Accord is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Croatian: Imatinib Accord koristi se za liječenje odraslih bolesnika s MD/MPD-om s preraspodjelom gena za receptor faktora rasta koji potječe od trombocita (PDGFR);
English: For practical information about using Imatinib Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Imatinib Accord bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Croatian: ALL vratio nakon prethodnog liječenja ili u osoba koje ne reagiraju na druge lijekove;
English: Imatinib Accord contains the active substance imatinib.
Croatian: Imatinib Accord sadrži djelatnu tvar imatinib.
English: Why is Imatinib Accord approved?
Croatian: Zašto je Imatinib Accord odobren?
English: Imatinib Accord is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for bone marrow transplantation.
Croatian: Lijek Imatinib Accord primjenjuje se u odraslih i djece s novodijagnosticiranim Ph+ KML-om u koje nije moguća transplantacija koštane srži.
English: • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Croatian: • uznapredovalog hipereozinofilnog sindroma (HES) ili kronične eozinofilne leukemije (KEL), bolesti kod kojih eozinofili (druga vrsta bijelih krvnih stanica) počinju nekontrolirano rasti.
English: • chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
Croatian: • kronične mijeloične leukemije (KML-a), raka bijelih krvnih stanica kod kojega granulociti (vrsta bijelih krvnih stanica) počinju nekontrolirano rasti.
English: • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Croatian: • akutne limfoblastične leukemije s pozitivnim Philadelphia kromosomom (Ph+ ALL), vrste raka kod koje se limfociti (druga vrsta bijelih krvnih stanica) prebrzo umnožavaju.
English: How does Imatinib Accord work?
Croatian: Kako djeluje Imatinib Accord?
English: How has Imatinib Accord been studied?
Croatian: Kako je Imatinib Accord ispitivan?
English: How is Imatinib Accord used?
Croatian: Kako se Imatinib Accord koristi?
English: In such a case, treatment must be stopped immediately.
Croatian: U takvom se slučaju liječenje mora odmah prekinuti.
English: The review of testosterone was initiated on 27 March 2014 at the request of Estonia, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled testosterona započet je 27. ožujka 2014. na zahtjev Estonije, u skladu s člankom 31. Direktive 2001/83/EZ.
English: 1 The Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Croatian: 1 Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove
English: • Patients who have any concerns about their treatment should discuss them with their doctor or pharmacist.
Croatian: • Bolesnici koji imaju bilo kakvih razloga za zabrinutost u vezi s terapijom trebaju se obratiti svojem liječniku ili ljekarniku.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014 EMA/706140/2014
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21. studeni 2014. EMA/706140/2014
English: Available at: https://www.aace.com/files/late-breaking-abstracts2014.pdf
Croatian: Available at: https://www.aace.com/files/late-breakingabstracts-2014.pdf 7.
English: However, an in-depth review did not find any conclusive evidence that this was the case.
Croatian: No, dubinskim pregledom nije pronađen jednoznačan dokaz koji bi to potvrdio.
English: Possible signs and symptoms include incomplete sexual development, decreased sexual function, infertility, fatigue, depressed mood, mild anaemia, reduced muscle bulk and strength and increased body fat.
Croatian: Mogući znakovi i simptomi uključuju nepotpuni seksualni razvoj, smanjenu seksualnu funkciju, neplodnost, iscrpljenost, depresivno raspoloženje, blagu anemiju, smanjenu mišićnu masu i povećan udio masti u tijelu.
English: The PRAC recommendations were sent to the CMDh, which adopted a final position.
Croatian: Preporuke PRAC-a dostavljene su CMDh-u koji je donio konačnu odluku.
English: Testosterone levels should then be monitored regularly during treatment.
Croatian: Razine testosterona treba redovito pratiti tijekom liječenja.
English: Taking all the data into account, the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive.
Croatian: Uzimajući u obzir sve podatke, signali za povišen kardiovaskularan rizik povezan s primjenom testosterona ostaje slab i nekonkluzivan.
English: The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems.
Croatian: PRAC je također napomenuo da bi i manjak testosterona kao takav mogao također povećati rizik od srčanih problema.
English: The CMDh1, a regulatory body representing EU Member States, has agreed by consensus that there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone (a condition known as hypogonadism).
Croatian: CMDh1, regulatorno tijelo koje predstavlja države članice EU-a, odlučilo je konsenzusom da ne postoje konzistentni dokazi o povećanom riziku od srčanih problema povezani s lijekovima koji sadrže testosteron u muškaraca kojima nedostaje hormon (stanje poznato pod nazivom hipogonadizam).
English: A review of these data was first conducted by the PRAC, the EMA's Committee responsible for the evaluation of safety issues for human medicines.
Croatian: PRAC je prvi proveo pregled ovih podataka, a zatim je pregled proveo i Odbor pri EMA-i odgovoran za ocjenu pitanja sigurne primjene za humane lijekove.
English: Testosterone-containing medicines have been authorised in all EU Member States via national procedures under various trade names.
Croatian: Lijekovi koji sadrže testosteron odobreni su u svim državama članicama EU-a nacionalnim postupcima pod različitim trgovačkim nazivima.
English: They are available as various formulations such as oral capsules, implants to be injected under the skin and as patches, gels or solutions to be applied to the skin.
Croatian: Dostupni su kao različite formulacije, primjerice oralne kapsule, implantati za potkožne injekciju te flasteri, gelovi ili otopine koje se primjenjuju na kožu.
English: • Testosterone replacement therapy should only be given when deficiency of the hormone has been confirmed by clinical features and biochemical tests.
Croatian: • Zamjensku terapiju testosteronom treba primjenjivati samo u slučaju kada je deficit hormona potvrđen kliničkim značajkama i biokemijskim testovima.
English: • Patients who are prescribed testosterone should remind their doctors if they are being treated for high blood pressure, as testosterone can also increase blood pressure.
Croatian: • Bolesnici kojima se propisuje testosteron trebaju podsjetiti svoje liječnike da primaju terapiju za povišeni krvni tlak jer testosteron može također povisiti krvni tlak.
English: • In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Croatian: • U bolesnika koji pate od ozbiljne srčane, jetrene ili bubrežne insuficijencije ili ishemijske bolesti srca liječenje testosteronom može uzrokovati ozbiljne komplikacije karakterizirane edemom s kongestivnim zatajenjem srca ili bez njega.
English: Testosterone is a hormone, known as an androgen, responsible for the development and maintenance of reproductive function and sexual characteristics in men.
Croatian: Testosteron je hormon, poznat i kao androgen, odgovoran za razvoj i održavanje reproduktivne funkcije i spolnih obilježja u muškaraca.
English: Haemoglobin, haematocrit, liver function and blood lipid profile should also be monitored regularly.
Croatian: Redovito treba pratiti i razine hemoglobina, hematokrita, funkcije jetre i profil lipida u krvi.
English: The PRAC further considered that the risks of effects on the heart and circulation, and any potential mechanisms for such effects should continue to be monitored, and information from ongoing studies should be provided as part of the next regular safety review (to which these medicines, like all medicines in the EU, are subject).
Croatian: Nadalje, PRAC je zaključio kako se rizici djelovanja na srce i cirkulaciju, te mogući mehanizmi djelovanja trebaju i dalje pratiti, te da se informacije iz ispitivanja u tijeku trebaju dostaviti kao dio sljedećeg redovitog pregleda sigurne primjene (kojem podliježu ovi lijekovi, poput svih lijekova u EUu).
English: • As a precaution, the product information for these medicines will be updated with the latest information on the risks together with some additional warnings for safe use, and the safety of the medicines will continue to be closely monitored.
Croatian: • Kao mjera opreza, informacije o lijeku za ove lijekove treba ažurirati najnovijim informacijama o rizicima zajedno s pojedinim drugim dodatnim upozorenjima o sigurnoj primjeni, te se sigurnosna primjena lijekova i dalje treba pažljivo nadzirati.
English: The PRAC recommended updating the product information in line with the latest evidence and to provide warnings about those who might be at increased risk of heart problems.
Croatian: PRAC je preporučio ažuriranje informacija o lijeku u skladu s najnovijim dokazima te navođenje upozorenja za osobe koje bi mogle biti izložene povišenom riziku od srčanih problema.