natgillin/translations-raw huggingface dataset:
An overview of Onivyde and why it is authorised in the EU 
Pregled zdravila Onivyde in zakaj je odobreno v EU
Side effects reported with Onivyde are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Onivyde, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Onivyde and what is it used for? 
Kaj je zdravilo Onivyde in za kaj se uporablja?
Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women. 
Zdravilo Onivyde se ne sme dajati bolnikom, ki so imeli v preteklosti hudo preobčutljivostno (alergijsko) reakcijo na irinotekan, in ženskam, ki dojijo.
For more information about using Onivyde, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Onivyde glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The dose may be adjusted by the doctor in patients who develop severe side effects and those with particular genetic characteristics that increase the risk of side effects. 
Zdravnik lahko prilagodi odmerek pri bolnikih, pri katerih se razvijejo hudi neželeni učinki, in tistih z določenimi genetskimi značilnostmi, ki povečajo tveganje za pojav neželenih učinkov.
What are the risks associated with Onivyde? 
Kakšna tveganja so povezana z zdravilom Onivyde?
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. 
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa lahko predpiše in daje le zdravnik z izkušnjami pri uporabi zdravil za zdravljenje raka.
It blocks an enzyme called topoisomerase I, which is involved in copying cell DNA, which is needed to make new cells. 
Ta zavira encim, imenovan topoizomeraza I, ki sodeluje pri podvajanju celične DNK, ki je potrebna za nastanek novih celic.
What benefits of Onivyde have been shown in studies? 
Kakšne koristi je zdravilo Onivyde izkazalo v študijah?
The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients' lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone. 
Študija je pokazala, da se je z dodajanjem zdravila Onivyde k režimu 5-fluorouracila in levkovorina podaljšalo življenje bolnikov: bolniki, ki so skupaj jemali tri zdravila, so živeli 6,1 meseca v primerjavi s 4,2 meseca pri bolnikih, ki so jemali 5-fluorouracil in levkovorin, in 4,9 meseca pri bolnikih, ki so jemali samo zdravilo Onivyde.
Pancreatic cancer is rare, and Onivyde was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 December 2011. 
Rak trebušne slinavke je redka bolezen, zato je bilo zdravilo Onivyde 9. decembra 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination. 
Bolniki so prejemali zdravilo Onivyde ali 5-fluorouracil in levkovorin ali vsa tri zdravila skupaj.
In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes'. 
V zdravilu Onivyde je irinotekan vključen v drobne maščobne delce, imenovane liposomi.
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. 
Najpogostejši neželeni učinki zdravila Onivyde (ki se lahko pojavijo pri več kot 1 bolniku od 5) so driska, navzeja (slabost), bruhanje, izguba teka, nevtropenija (nizke vrednosti nevtrofilcev, tj. vrste belih krvnih celic), utrujenost, oslabelost, anemija (nizka raven rdečih krvnih celic), stomatitis (vnetje ustne sluznice) in povišana telesna temperatura.
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. 
Zdravilo Onivyde so proučevali v eni glavni študiji s 417 bolniki z metastatskim adenokarcinomom trebušne slinavke, pri katerih se je rak poslabšal kljub zdravljenju z gemcitabinom, zdravilom proti raku.
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). 
Najpogostejši resni neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 50) so driska, navzeja in bruhanje, nevtropenija in povišana telesna temperatura, okužbe krvi ali pljuč (sepsa, pljučnica), šok, dehidracija, ledvična odpoved in trombocitopenija (nizka raven trombocitov).
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. 
Zdravilo Onivyde se uporablja skupaj s 5-fluorouracilom in levkovorinom (dvema drugima zdraviloma za zdravljenje raka) pri odraslih, pri katerih se je rak poslabšal kljub zdravljenju z gemcitabinom, tj. zdravilom za zdravljenje raka.
Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas. 
Onivyde je zdravilo proti raku, ki se uporablja za zdravljenje oblike raka na trebušni slinavki, ki se imenuje metastatski adenokarcinom trebušne slinavke.
Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein. 
Zdravilo Onivyde je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'. 
Učinkovina v zdravilu Onivyde, irinotekan, je zdravilo za zdravljenje raka, ki spada v skupino zaviralcev topoizomeraze.
How is Onivyde used? 
Kako se zdravilo Onivyde uporablja?
How does Onivyde work? 
Kako zdravilo Onivyde deluje?
For the full list of side effects of Onivyde, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Onivyde, glejte navodilo za uporabo.
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. 
Ocenila je, da je bilo podaljšanje preživetja, ki je bilo opaženo, ko se je zdravilo Onivyde uporabljalo skupaj s 5-fluorouracilom in levkovorinom, pomembno pri predhodno zdravljenih bolnikih z metastatskim adenokarcinomom trebušne slinavke, za katere so na voljo omejene možnosti zdravljenja.
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. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Imatinib Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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'); 
Uporablja se tudi pri odraslih in otrocih v kronični fazi bolezni, če se ta ne odziva na interferon alfa (drugo zdravilo za zdravljenje raka), ter v napredovalih fazah bolezni (pospešeni fazi in blastni krizi);
This is a summary of the European public assessment report (EPAR) for Imatinib Accord. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imatinib Accord.
Imatinib Accord is available as tablets (100 and 400 mg). 
Na voljo je v obliki tablet (100 mg in 400 mg).
What measures are being taken to ensure the safe and effective use of Imatinib Accord? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib Accord?
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. 
Ker je zdravilo Imatinib Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Accord on 1 July 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Imatinib Accord, veljavno po vsej Evropski uniji, izdala 1. julija 2013.
As for every medicine, the company provided studies on the quality of Imatinib Accord. 
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Imatinib Accord.
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. 
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Imatinib Accord, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
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. 
Odmerek je odvisen od zdravljene bolezni, starosti bolnika in njegovega bolezenskega stanja ter odziva na zdravljenje, vendar ne sme presegati 800 mg na dan. Za več informacij glejte navodilo za uporabo.
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. 
Ti encimi so v nekaterih receptorjih na površini rakavih celic, vključno z receptorji, ki spodbujajo celice, da se nenadzorovano delijo.
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. 
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Glivec, zato jih ni treba ponoviti za zdravilo Imatinib Accord.
Imatinib Accord is a cancer medicine used to treat the following diseases: 
Imatinib Accord je zdravilo za zdravljenje raka, ki se uporablja pri naslednjih obolenjih:
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome. 
To pomeni, da so se nekateri njihovi geni prerazporedili tako, da tvorijo poseben kromosom Philadephia.
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. 
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Glivec, ki je že odobreno v Evropski uniji (EU).
The Agency recommended that Imatinib Accord be approved for use in the EU. 
Priporočila je, da se zdravilo Imatinib Accord odobri za uporabo v EU.
What are the benefits and risks of Imatinib Accord? 
Kakšne so koristi in tveganja, povezani z zdravilom Imatinib Accord?
It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines; 
Uporablja se tudi kot samostojno zdravilo pri odraslih za zdravljenje Ph+ ALL, ki se je po predhodnih zdravljenjih ponovno pojavila ali se ne odziva na druga zdravila;
What is Imatinib Accord and what is it used for? 
Kaj je zdravilo Imatinib Accord in za kaj se uporablja?
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. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib Accord primerljivo raven kakovosti kot referenčno zdravilo Glivec ter da mu je biološko enakovredno.
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. 
Zdravilo Imatinib Accord se uporablja za zdravljenje odraslih z DFSP, ki ga ni mogoče odstraniti s kirurškim posegom, ter pri odraslih, ki niso primerni za kirurški poseg po ponovnem pojavu raka po zaključenem zdravljenju ali pri razširitvi na druge dele telesa.
For more information about treatment with Imatinib Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Imatinib Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Imatinib Accord is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα; 
Zdravilo Imatinib Accord se uporablja za zdravljenje odraslih s HES ali CEL, ki imajo posebno preureditev dveh genov, imenovanih FIP1L1 in PDGFRα;
The active substance in Imatinib Accord, imatinib, is a protein-tyrosine kinase inhibitor. 
Zdravilna učinkovina v zdravilu Imatinib Accord, imatinib, je zaviralec beljakovine tirozin kinaze.
Other information about Imatinib Accord 
Druge informacije o zdravilu Imatinib Accord
Therefore, the Agency's view was that, as for Glivec, the benefit outweighs the identified risk. 
Zato je menila, da njegove koristi enako kot pri zdravilu Glivec odtehtajo znana tveganja.
Imatinib Accord is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL. 
Zdravilo Imatinib Accord se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka pri odraslih in otrocih z na novo diagnosticirano Ph+ ALL.
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. 
Zdravilo Imatinib Accord se zaužije peroralno sočasno s hrano in velikim kozarcem vode, da se zmanjša tveganje za draženje želodca in črevesja.
Imatinib Accord is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR); 
Zdravilo Imatinib Accord se uporablja za zdravljenje odraslih z MDS/MPD, pri katerih je prisotna preureditev genov za receptor za rastni faktor iz trombocitov (PDGFR - platelet derived growth factor receptor);
For practical information about using Imatinib Accord, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Imatinib Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
By blocking these receptors, Imatinib Accord helps to control cell division. 
Zdravilo Imatinib Accord z zaviranjem teh receptorjev pomaga pri nadzoru deljenja celic.
• myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. 
• mielodisplastični ali mieloproliferativni bolezni (MDS/MPD), tj. skupini bolezni, pri katerih telo proizvaja velike količine nenormalnih krvnih celic.
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. 
Predpisovanje in izdaja zdravila Imatinib Accord je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem krvnega raka ali čvrstih tumorjev.
• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. 
• protuberantnem dermatofibrosarkomu (DFSP), tj. vrsti raka (sarkoma), pri kateri se celice pod kožo nenadzorovano delijo.
It is not intended to provide practical advice on how to use Imatinib Accord. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
• Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. 
• Ph+ akutni limfoblastni levkemiji (ALL), tj. vrsti raka, pri kateri se limfociti (druga vrsta belih krvnih celic) prehitro množijo.
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. 
Zdravilo Imatinib Accord se uporablja pri odraslih in otrocih, pri katerih je bila Ph+ KML na novo diagnosticirana in niso primerni za presaditev kostnega mozga.
Imatinib Accord is used when the patients are ‘Philadelphia chromosome positive' (Ph+). 
Zdravilo Imatinib Accord se uporablja pri bolnikih s prisotnim kromosomom Philadelphia (Ph+).
The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine, Glivec. 
Opravila je tudi študije, ki so pokazale, da je zdravilo Imatinib Accord biološko enakovredno referenčnemu zdravilu Glivec.
Why is Imatinib Accord approved? 
Zakaj je bilo zdravilo Imatinib Accord odobreno?
• advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control. 
• napredovalem hipereozinofilnem sindromu (HES) ali kronični eozinofilni levkemiji (CEL), tj. bolezni, pri katerih eozinofilci (druga vrsta belih krvnih celic) začnejo nenadzorovano rasti.
• 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. 
• kronični mieloidni levkemiji (KML), tj. raku belih krvnih celic, pri katerem začnejo granulociti (vrsta belih krvnih celic) nenadzorovano rasti.
How is Imatinib Accord used? 
Kako se zdravilo Imatinib Accord uporablja?
Imatinib Accord contains the active substance imatinib. 
Zdravilo Imatinib Accord vsebuje zdravilno učinkovino imatinib.
How has Imatinib Accord been studied? 
Kako je bilo zdravilo Imatinib Accord raziskano?
How does Imatinib Accord work? 
Kako zdravilo Imatinib Accord deluje?
In such a case, treatment must be stopped immediately. 
V takih primerih je treba zdravljenje takoj prekiniti.
However, an in-depth review did not find any conclusive evidence that this was the case. 
Vendar v podrobnem pregledu niso bili odkriti prepričljivi dokazi, da je temu res tako.
The review of testosterone was initiated on 27 March 2014 at the request of Estonia, under Article 31 of Directive 2001/83/EC. 
Pregled zdravil, ki vsebujejo testosteron, se je pričel 27. marca 2014 na zahtevo Estonije v skladu s členom 31 Direktive 2001/83/ES.
Available at: https://www.aace.com/files/late-breaking-abstracts2014.pdf 
Na voljo na: https://www.aace.com/files/late-breakingabstracts-2014.pdf.
1 The Coordination Group for Mutual Recognition and Decentralised Procedures - Human 
1 Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini
The PRAC recommendations were sent to the CMDh, which adopted a final position. 
Priporočila odbora PRAC so bila posredovana skupini CMDh, ki je sprejela končno stališče.
• Patients who have any concerns about their treatment should discuss them with their doctor or pharmacist. 
• Bolniki, ki imajo kakršne koli skrbi v zvezi z zdravljenjem, naj se posvetujejo z zdravnikom ali farmacevtom.
Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), p. 238, abstract #1353. 
Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), str. 238, izvleček #1353.
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. 
Možni znaki in simptomi hipogonadizma vključujejo nepopoln spolni razvoj, zmanjšano spolno funkcijo, neplodnost, utrujenost, depresivno razpoloženje, blago anemijo, zmanjšano mišično maso in moč ter povečano telesno maščobo.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU. 
Skupina CMDh, organ, ki predstavlja vse države članice EU, je odgovorna za zagotavljanje usklajenih varnostnih standardov po vsej EU za zdravila, odobrena z nacionalnimi postopki.
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. 
Pregled teh podatkov je najprej opravil odbor PRAC, odbor Evropske agencije za zdravila, zadolžen za ocenjevanje vprašanj v zvezi z varnostjo zdravil za uporabo v humani medicini.
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. 
Na voljo so v različnih farmacevtskih oblikah, kot so peroralne kapsule, implantati, ki se injicirajo pod kožo, ter obliži, geli ali raztopine, ki se nanašajo na kožo.
• There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age. 
• Izkušnje glede varnosti in učinkovitosti uporabe teh zdravil pri bolnikih, starejših od 65 let, so omejene.
It follows concerns over reports about side effects of these medicines on the heart. 
Sprožen je bil zaradi pomislekov glede poročil o neželenih učinkih teh zdravil na srce.
• 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. 
• Iz previdnosti bodo informacije o zdravilu za ta zdravila posodobljene v skladu z najnovejšimi informacijami o tveganju, skupaj z določenimi dodatnimi opozorili za varno uporabo, varnost zdravil pa se bo še naprej skrbno spremljala.
• Relevant safety and efficacy data in patients with age-related hypogonadism and established physiological reference values in older patients are lacking, and further studies are needed. 
• Ustreznih podatkov o varnosti in učinkovitosti pri bolnikih s hipogonadizmom, povezanim s starostjo, in opredeljenih referenčnih vrednosti za starejše bolnike ni; potrebne so nadaljnje študije.
• 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. 
• Pri bolnikih s hudo srčno, jetrno ali ledvično insuficienco ali ishemično srčno boleznijo lahko zdravljenje s testosteronom povzroči hude zaplete, za katere je značilen edem s kongestivnim srčnim popuščanjem ali brez njega.
• Testosterone replacement therapy should only be given when deficiency of the hormone has been confirmed by clinical features and biochemical tests. 
• Nadomestno testosteronsko zdravljenje se lahko uvede le, če je bilo pomanjkanje hormona potrjeno s kliničnimi značilnostmi in biokemičnimi preiskavami.
Haemoglobin, haematocrit, liver function and blood lipid profile should also be monitored regularly. 
Redno je treba spremljati tudi hemoglobin, hematokrit, jetrno funkcijo in profil lipidov v krvi.
Testosterone-containing medicines have been authorised in all EU Member States via national procedures under various trade names. 
Zdravila, ki vsebujejo testosteron, so bila z nacionalnimi postopki pod različnimi tržnimi imeni odobrena v vseh državah članicah EU.