FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: 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.
English: Imatinib Accord is a cancer medicine used to treat the following diseases:
Slovenian: Imatinib Accord je zdravilo za zdravljenje raka, ki se uporablja pri naslednjih obolenjih:
English: This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
Slovenian: To pomeni, da so se nekateri njihovi geni prerazporedili tako, da tvorijo poseben kromosom Philadephia.
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.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Glivec, ki je že odobreno v Evropski uniji (EU).
English: The Agency recommended that Imatinib Accord be approved for use in the EU.
Slovenian: Priporočila je, da se zdravilo Imatinib Accord odobri za uporabo v EU.
English: What are the benefits and risks of Imatinib Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Imatinib Accord?
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;
Slovenian: 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;
English: What is Imatinib Accord and what is it used for?
Slovenian: Kaj je zdravilo Imatinib Accord in za kaj se uporablja?
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.
Slovenian: 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.
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.
Slovenian: 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.
English: For more information about treatment with Imatinib Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
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;
Slovenian: Zdravilo Imatinib Accord se uporablja za zdravljenje odraslih s HES ali CEL, ki imajo posebno preureditev dveh genov, imenovanih FIP1L1 in PDGFRα;
English: The active substance in Imatinib Accord, imatinib, is a protein-tyrosine kinase inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Imatinib Accord, imatinib, je zaviralec beljakovine tirozin kinaze.
English: Other information about Imatinib Accord
Slovenian: Druge informacije o zdravilu Imatinib Accord
English: Therefore, the Agency's view was that, as for Glivec, the benefit outweighs the identified risk.
Slovenian: Zato je menila, da njegove koristi enako kot pri zdravilu Glivec odtehtajo znana tveganja.
English: Imatinib Accord is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Slovenian: Zdravilo Imatinib Accord se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka pri odraslih in otrocih z na novo diagnosticirano Ph+ ALL.
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.
Slovenian: Zdravilo Imatinib Accord se zaužije peroralno sočasno s hrano in velikim kozarcem vode, da se zmanjša tveganje za draženje želodca in črevesja.
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);
Slovenian: 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);
English: For practical information about using Imatinib Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Imatinib Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: By blocking these receptors, Imatinib Accord helps to control cell division.
Slovenian: Zdravilo Imatinib Accord z zaviranjem teh receptorjev pomaga pri nadzoru deljenja celic.
English: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Slovenian: • mielodisplastični ali mieloproliferativni bolezni (MDS/MPD), tj. skupini bolezni, pri katerih telo proizvaja velike količine nenormalnih krvnih celic.
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.
Slovenian: 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.
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Slovenian: • protuberantnem dermatofibrosarkomu (DFSP), tj. vrsti raka (sarkoma), pri kateri se celice pod kožo nenadzorovano delijo.
English: It is not intended to provide practical advice on how to use Imatinib Accord.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Slovenian: • Ph+ akutni limfoblastni levkemiji (ALL), tj. vrsti raka, pri kateri se limfociti (druga vrsta belih krvnih celic) prehitro množijo.
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.
Slovenian: 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.
English: Imatinib Accord is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Slovenian: Zdravilo Imatinib Accord se uporablja pri bolnikih s prisotnim kromosomom Philadelphia (Ph+).
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine, Glivec.
Slovenian: Opravila je tudi študije, ki so pokazale, da je zdravilo Imatinib Accord biološko enakovredno referenčnemu zdravilu Glivec.
English: Why is Imatinib Accord approved?
Slovenian: Zakaj je bilo zdravilo Imatinib Accord odobreno?
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.
Slovenian: • napredovalem hipereozinofilnem sindromu (HES) ali kronični eozinofilni levkemiji (CEL), tj. bolezni, pri katerih eozinofilci (druga vrsta belih krvnih celic) začnejo nenadzorovano 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.
Slovenian: • kronični mieloidni levkemiji (KML), tj. raku belih krvnih celic, pri katerem začnejo granulociti (vrsta belih krvnih celic) nenadzorovano rasti.
English: How is Imatinib Accord used?
Slovenian: Kako se zdravilo Imatinib Accord uporablja?
English: Imatinib Accord contains the active substance imatinib.
Slovenian: Zdravilo Imatinib Accord vsebuje zdravilno učinkovino imatinib.
English: How has Imatinib Accord been studied?
Slovenian: Kako je bilo zdravilo Imatinib Accord raziskano?
English: How does Imatinib Accord work?
Slovenian: Kako zdravilo Imatinib Accord deluje?
English: In such a case, treatment must be stopped immediately.
Slovenian: V takih primerih je treba zdravljenje takoj prekiniti.
English: However, an in-depth review did not find any conclusive evidence that this was the case.
Slovenian: Vendar v podrobnem pregledu niso bili odkriti prepričljivi dokazi, da je temu res tako.
English: The review of testosterone was initiated on 27 March 2014 at the request of Estonia, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo testosteron, se je pričel 27. marca 2014 na zahtevo Estonije v skladu s členom 31 Direktive 2001/83/ES.
English: Available at: https://www.aace.com/files/late-breaking-abstracts2014.pdf
Slovenian: Na voljo na: https://www.aace.com/files/late-breakingabstracts-2014.pdf.
English: 1 The Coordination Group for Mutual Recognition and Decentralised Procedures - Human
Slovenian: 1 Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini
English: The PRAC recommendations were sent to the CMDh, which adopted a final position.
Slovenian: Priporočila odbora PRAC so bila posredovana skupini CMDh, ki je sprejela končno stališče.
English: • Patients who have any concerns about their treatment should discuss them with their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršne koli skrbi v zvezi z zdravljenjem, naj se posvetujejo z zdravnikom ali farmacevtom.
English: Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), p. 238, abstract #1353.
Slovenian: Abstract Book of the 2014 Annual Meeting of the American Association of Clinical Endocrinologists (AACE), str. 238, izvleček #1353.
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.
Slovenian: 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.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: • There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age.
Slovenian: • Izkušnje glede varnosti in učinkovitosti uporabe teh zdravil pri bolnikih, starejših od 65 let, so omejene.
English: It follows concerns over reports about side effects of these medicines on the heart.
Slovenian: Sprožen je bil zaradi pomislekov glede poročil o neželenih učinkih teh zdravil na srce.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014 EMA/706140/2014
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
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.
Slovenian: • 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.
English: • 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.
Slovenian: • 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.
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.
Slovenian: • 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.
English: • Testosterone replacement therapy should only be given when deficiency of the hormone has been confirmed by clinical features and biochemical tests.
Slovenian: • Nadomestno testosteronsko zdravljenje se lahko uvede le, če je bilo pomanjkanje hormona potrjeno s kliničnimi značilnostmi in biokemičnimi preiskavami.
English: Haemoglobin, haematocrit, liver function and blood lipid profile should also be monitored regularly.
Slovenian: Redno je treba spremljati tudi hemoglobin, hematokrit, jetrno funkcijo in profil lipidov v krvi.
English: Testosterone-containing medicines have been authorised in all EU Member States via national procedures under various trade names.
Slovenian: Zdravila, ki vsebujejo testosteron, so bila z nacionalnimi postopki pod različnimi tržnimi imeni odobrena v vseh državah članicah EU.
English: The PRAC considered these studies along with available data from other studies and analyses, and information on safety collected since marketing, and found that the evidence regarding the risk of heart problems was inconsistent: some studies suggested increased risk, while others did not, and some of the studies had problems with the design that limited the conclusions that could be drawn from them.
Slovenian: Odbor PRAC je te študije obravnaval skupaj z razpoložljivimi podatki iz drugih študij in analiz ter informacijami o varnosti, zbranimi v obdobju trženja zdravil, in ugotovil, da so dokazi glede tveganja težav s srcem neskladni: nekatere študije so nakazovale povečano tveganje, nekatere ne, v nekaterih študijah pa so težave z zasnovo omejile veljavnost sklepov, ki bi jih lahko izpeljali iz njih.
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).
Slovenian: Odbor PRAC je nadalje menil, da bi morali še naprej spremljati tveganja učinkov na srce in krvni obtok in vsakršne morebitne mehanizme za nastanek takšnih učinkov ter da bi morali v okviru naslednjega rednega pregleda varnosti (ki se tako kot za vsa zdravila v EU izvaja za zadevna zdravila) zagotoviti informacije iz študij, ki še potekajo.
English: • Caution is also advised in patients with pre-existing hypertension, since testosterone may cause an increase in blood pressure.
Slovenian: • Previdnost je potrebna tudi pri bolnikih z obstoječo hipertenzijo, ker lahko testosteron povzroči povišanje krvnega tlaka.
English: Taking all the data into account, the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive.
Slovenian: Ob upoštevanju vseh podatkov so dokazi glede povečanega kardiovaskularnega tveganja, povezanega z uporabo testosterona, še vedno šibki in neprepričljivi.
English: Testosterone is a hormone, known as an androgen, responsible for the development and maintenance of reproductive function and sexual characteristics in men.
Slovenian: Testosteron je hormon, znan kot androgeni hormon, odgovoren za razvoj in vzdrževanje reproduktivne funkcije in spolnih značilnosti pri moških.
English: As the CMDh position was adopted by consensus, it will now be directly implemented according to an agreed timetable by the Member States where the medicines are authorised.
Slovenian: Ker je bilo stališče skupine CMDh sprejeto soglasno, bo zdaj uveljavljeno neposredno v skladu s sprejetim časovnim razporedom v državah članicah, v katerih so bila zdravila odobrena.
English: • Some recent studies have suggested that using testosterone may increase a man's risk of heart attacks or other serious effects on the heart and circulation.
Slovenian: • Rezultati nekaterih nedavnih študij so nakazali, da lahko uporaba testosterona pri bolniku poveča tveganje srčnih napadov ali drugih resnih učinkov na srce in krvni obtok.
English: Testosterone levels should then be monitored regularly during treatment.
Slovenian: Med zdravljenjem je nato treba redno spremljati ravni testosterona.
English: • However, other findings4-7 do not provide evidence of an association between testosterone and cardiovascular events, and data from a multinational observational registry study (RHYME) looking at prostate health outcomes in men treated with testosterone for over 2 years also indicate cardiovascular events within the anticipated range.
Slovenian: • Vendar pa druge ugotovitve4-7 ne dokazujejo povezave med testosteronom in kardiovaskularnimi dogodki, podatki iz večnacionalne opazovalne registrske študije (RHYME), ki je preučevala izide glede zdravja prostate pri moških, ki so se več kot dve leti zdravili s testosteronom, pa kažejo, da so bili kardiovaskularni dogodki v pričakovanem razponu.
English: • The product information will also be amended to make it clear that these medicines should only be given to men in whom both signs and symptoms and laboratory tests confirm abnormally low levels of testosterone.
Slovenian: • Spremenjene bodo tudi informacije o zdravilu, da bi bilo iz njih jasno razvidno, da se ta zdravila lahko dajejo le moškim, pri katerih tako simptomi in znaki kot laboratorijske preiskave potrjujejo nenormalno nizke ravni testosterona.
English: The changes to the product information for testosterone medicines are based on a PRAC review of data available from clinical trials, observational studies, meta-analyses, post-marketing data and further published data on the cardiovascular risks associated with testosterone therapy.
Slovenian: Spremembe informacij o zdravilu za zdravila, ki vsebujejo testosteron, temeljijo na pregledu razpoložljivih podatkov iz kliničnih preskušanj, opazovalnih študij, metaanaliz, podatkov iz obdobja trženja in dodatnih objavljenih podatkov o kardiovaskularnem tveganju, povezanem z zdravljenjem s testosteronom, ki ga je opravil odbor PRAC.
English: • Although some studies show an increased risk of cardiovascular events in men treated with testosterone, findings in the literature do not show this consistently.
Slovenian: • Čeprav nekatere študije kažejo povečano tveganje kardiovaskularnih dogodkov pri moških, zdravljenih s testosteronom, ugotovitve v literaturi tega ne kažejo dosledno.
English: • The cardiovascular safety of testosterone medicines will continue to be monitored and the findings of ongoing studies will be reflected in the next regular benefit-risk assessments when available.
Slovenian: • Kardiovaskularna varnost zdravil, ki vsebujejo testosteron, se bo še naprej spremljala, ugotovitve študij, ki še potekajo, pa bodo, ko bodo na voljo, zajete z naslednjo redno oceno razmerja med tveganji in koristmi.
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).
Slovenian: Skupina CMDh1, regulativni organ, ki predstavlja države članice EU, je soglasno sklenila, da dokazi o povečanem tveganju težav s srcem pri moških, ki jim primanjkuje testosterona (bolezen znana kot hipogonadizem), zdravljenih z zdravili, ki vsebujejo testosteron, niso zanesljivi.
English: The review was started because of some recent studies suggesting an increase in heart problems in men using testosterone, compared with men not using it.
Slovenian: Pregled je bil sprožen, ker so nekatere nedavne študije pokazale povečanje težav s srcem pri moških, ki so jemali testosteron, v primerjavi z moškimi, ki ga niso jemali.
English: However, the product information is to be updated in line with the most current available evidence on safety, and with warnings that the lack of testosterone should be confirmed by signs and symptoms and laboratory tests before treating men with these medicines.
Slovenian: Informacije o zdravilu je treba posodobiti v skladu z najnovejšimi dostopnimi dokazi o varnosti, skupaj z opozorilom, da mora biti pomanjkanje testosterona potrjeno z znaki in simptomi ter laboratorijskimi preiskavami, preden se pri moških uvede zdravljenje s temi zdravili.
English: In men with hypogonadism, testosterone levels are abnormally low, affecting normal sexual development and function.
Slovenian: Pri moških s hipogonadizmom so ravni testosterona nenormalno nizke, kar vpliva na normalen spolni razvoj in funkcijo.
English: • Some recent studies have shown an increased risk of cardiovascular events in men treated with testosterone.
Slovenian: • Nekatere nedavne študije so pokazale povečano tveganje kardiovaskularnih dogodkov pri moških, zdravljenih s testosteronom.
English: The CMDh position follows a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked at the risk of serious problems affecting the heart and circulation, particularly heart attacks, in men treated with these medicines.
Slovenian: Mnenje skupine CMDh je bilo oblikovano na podlagi pregleda, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila in ki je obravnaval tveganje resnih težav s srcem in krvnim obtokom, zlasti srčnih napadov, pri moških, zdravljenih s tovrstnimi zdravili.
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.
Slovenian: Odbor PRAC je predlagal posodobitev informacij o zdravilu v skladu z najnovejšimi dokazi in posredovanje opozoril o bolnikih, ki bi lahko bili izpostavljeni povečanemu tveganju težav s srcem.
English: The PRAC also noted that the lack of testosterone itself could increase the risk of heart problems.
Slovenian: Odbor PRAC je prav tako izpostavil, da bi tveganje težav s srcem lahko povečalo sámo pomanjkanje testosterona.
English: • Testosterone is a hormone responsible for normal sexual development and function in men.
Slovenian: • Testosteron je hormon, odgovoren za normalen spolni razvoj in spolno funkcijo pri moških.