natgillin/translations-raw huggingface dataset:
The Committee concluded that the benefit-risk balance of dihydroergocristine containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia), for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin and for acute retinopathies of vascular origin. 
Odbor je zaključil, da skladno s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokristin, ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence), dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora, ter akutno retinopatijo žilnega izvora.
Even if in some cases, confounding treatment (known to induce fibrotic reaction) have been coadministrated, the relationship between fibrotic reactions observed and treatment with dihydroergocristine cannot be excluded. 
Čeprav se je v nekaterih primerih sočasno uporabila dodatna oblika zdravljenja (za katero je znano, da povzroča fibrotično reakcijo), povezave med opaženimi fibrotičnimi reakcijami in zdravljenjem z dihidroergokristinom ni mogoče izključiti.
Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions. 
Na splošno lahko spreminjajoča afiniteta za serotoninergične receptorje pri različnih derivatih ergotalkaloidov in terapevtskih odmerkih pojasni razlike, opažene pri poročanih deležih fibrotičnih reakcij.
The relationship between fibrosis and serotininergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature. 
Povezava med fibrozo in aktivacijo serotoninergičnih receptorjev, predvsem receptorjev 5-HT2B, ki jo povzročajo derivati ergot-alkaloidov, je obširno opisana v literaturi.
• The variation to the terms of the marketing authorisation for dihydroergocristine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and from country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation: 
• spremembo pogojev dovoljenja za promet z zdravili iz Priloge I, ki vsebujejo dihidroergokristin, tako da se iz informacij o zdravilu izbrišejo spodaj navedene indikacije (natančno besedilo za indikacijo se lahko med zdravili in državami razlikuje) ter druge zadevne reference na te indikacije, kadar so kot del dovoljenja za promet z zdravilom odobrene druge terapevtske indikacije:
For the indications “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin” and “acute retinopathies of vascular origin”, the few preclinical findings submitted reporting the effects of topical doses of dihydroergocristine were considered by the CHMP insufficient to support the use of dihydroergocristine as intraocular pressure (IOP) lowering agent in human or for other ocular conditions presumably of vascular origin. 
Pri indikacijah „dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora“ in „akutna retinopatija žilnega izvora“ je odbor CHMP glede na nekaj predloženih predkliničnih ugotovitev, ki poročajo o učinkih topičnih odmerkov dihidroergokristina, menil, da so te nezadostne, da bi podprle uporabo dihidroergokristina kot učinkovine za zniževanje očesnega tlaka pri ljudeh ali druga očesna stanja, za katere se domneva, da so žilnega izvora.
The MAHs submitted 27 literature references to support the efficacy of dihydroergocristine on the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”. 
Imetniki dovoljenj za promet z zdravilom so predložili 27 referenc iz literature za podporo učinkovitosti dihidroergokristina pri indikaciji „simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“.
There are 2 further studies by Hugonot et al with population of 114-127 patients, both showing superiority over placebo. 
Hugonot in sodelavci so opravili 2 študiji s populacijo od 114 do 127 bolnikov.
Grounds for the variation/suspension to the terms of the marketing authorisations 
Razlogi za spremembo pogojev dovoljenj za promet z zdravilom ali njihov začasni umik
The most recent study (Vellas 1998 - Not published) that became available after the granting of the initial marketing autohrisation, uses a standardised definition of diagnosis (patients had to present a moderate memory deficit, with a Mini-Mental Sate Examination MMSE > 25 and a score total > 38 and < 70 on the Mac Nair and Kahn auto-questionnaire assessing the difficulties in daily activities) and defines the primary efficacy criterion a priori (the Mac Nair and Kahn auto-questionnaire and the Gröber and Buschke test). 
MMSE) > 25 ter skupnim rezultatom > 38 in < 70 pri samostojnem vprašalniku Mac Nair in Kahn, ki ocenjuje težave pri vsakdanjih dejavnostih) in a priori opredeljuje primarno merilo za učinkovitost (samostojni vprašalnik Mac Nair in Kahn ter Gröber-Buschkejev test).
− Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia). 
− simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence),
Its effect results mainly from its α1-blocking properties. 
Njegovi učinki so večinoma posledica značilnosti zaviranja alfa-adrenergičnih receptorjev 1.
Additionally one case of retroperitoneal fibrosis was reported in the literature (concerning fibrotic plaque), and a scan performed one year after the discontinuation of dihydroergocristine revealed a marked reduction of the fibrotic plaque which was considered by the CHMP in favour of a causal relationship between the retroperitoneal fibrosis observed and dihydroergocristine. 
Slikanje, opravljeno eno leto po prekinitvi dihidroergokristina, je pokazalo znatno zmanjšanje fibrotičnega plaka, kar je odbor CHMP obravnaval kot vzročno povezavo med opaženo retroperitonealno fibrozo in dihidroergokristinom.
It is available as capsules (50 and 100 mg) and tablets (100 and 400 mg). 
Na voljo je v obliki kapsul (50 in 100 mg) in tablet (100 in 400 mg).
It has also been examined in a fourth main study involving 160 children and young people aged 1 to 22 years. 
Proučevali so ga tudi v četrti glavni študiji, v katero je bilo vključenih 160 otrok in mladih, starih od 1 do 22 let.
The European Commission granted a marketing authorisation valid throughout the European Union for Glivec on 7 November 2001. 
Evropska komisija je dovoljenje za promet z zdravilom Glivec, veljavno po vsej Evropski uniji, odobrila dne 7. novembra 2001.
The full EPAR for Glivec 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 Glivec je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
These studies examined whether blood cell counts returned to normal levels, or whether the number of cancerous blood cells or the size of tumours fell. 
S temi študijami so proučevali ali se je število krvnih celic vrnilo na normalno raven oziroma ali sta se število rakavih krvnih celic ali velikost tumorjev zmanjšala.
This is a summary of the European public assessment report (EPAR) for Glivec. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Glivec.
Due to their rarity, limited data were available for the other diseases, but around two thirds of the patients showed at least a partial response to Glivec. 
Zaradi redkosti so bili za te bolezni na voljo le omejeni podatki, vendar pa je približno dve tretjini bolnikov izkazalo vsaj delen odziv na zdravilo Glivec.
The most common side effects with Glivec (seen in more than 1 in 10 patients) are weight increase, neutropenia (low levels of the white blood cells that fight infection), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, periorbital oedema (swelling around the eyes), rash, muscle spasm and cramps, muscle, bone and joint pain, fluid retention and fatigue (tiredness). 
Najpogostejši neželeni učinki zdravila Glivec (opaženi pri več kot 1 bolniku od 10), so zvišanje telesne mase, nevtropenija (nizko število belih krvnih celic, ki se borijo proti okužbi), trombocitopenija (nizko število trombocitov), anemija (nizko število rdečih krvnih celic), glavobol, navzeja (slabost), bruhanje, driska, dispepsija (slaba prebava), bolečine v trebuhu, periorbitalni edemi (otekanje okrog oči), izpuščaji, mišični spazem in krči, bolečine v mišicah, kosteh in sklepih, zastajanje tekočine in utrujenost.
For more information about treatment with Glivec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Glivec preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Glivec 
Druge informacije o zdravilu Glivec
By blocking these receptors, Glivec helps to control cell division. 
Z zaviranjem teh receptorjev zdravilo Glivec pomaga pri nadzoru nad delitvijo celic.
It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another anticancer 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 zdravljenje z interferonom alfa (drugim zdravilom proti raku) ter v napredovalih fazah bolezni („pospešeni fazi“ in „blastni krizi“).
The CHMP decided that Glivec's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Glivec večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Glivec shown during the studies? 
Kakšne koristi je zdravilo Glivec izkazalo med študijami?
For GIST, Glivec has been examined in two main studies. 
Pri GIST je bilo zdravilo Glivec raziskano v dveh glavnih študijah.
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. 
Odmerjanje je odvisno od zdravljene bolezni, starosti in stanja bolnika ter odziva na zdravljenje, vendar pa ne sme preseči 800 mg na dan. Za več informacij glejte navodilo za uporabo.
For CML, Glivec has been examined in four main studies involving 2,133 adults and one study of 54 children. 
Za KML so zdravilo Glivec proučevali v štirih glavnih študijah, v katere je bilo vključenih 2 133 odraslih, in eni študiji s 54 otroki.
Glivec was more effective than the comparator medicines. 
Zdravilo Glivec je bilo učinkovitejše od primerjalnih zdravil.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Glivec. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Glivec, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Glivec is an anticancer medicine. 
Glivec je zdravilo proti raku.
What is the risk associated with Glivec? 
Kakšna tveganja so povezana z zdravilom Glivec?
This study did not compare Glivec with any other medicines. 
V tej študiji zdravila Glivec niso primerjali z drugimi zdravili.
Glivec must not be used in people who are hypersensitive (allergic) to imatinib or any of the other ingredients. 
Zdravila Glivec ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) imatinib ali katero koli drugo sestavino zdravila.
For MD/MPD (31 patients), HES and CEL (176 patients), and DFSP (18 patients), Glivec was not compared with any other medicines. 
Pri MD/MPD (31 bolnikov), HES in KEL (176 bolnikov) in DFSP (18 bolnikov) zdravila Glivec niso primerjali z nobenim drugim zdravilom.
Glivec 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 Glivec se zaužije peroralno z obrokom hrane in velikim kozarcem vode, da bi tako zmanjšali tveganje za draženje želodca in črevesja.
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 se nahajajo na nekaterih receptorjih na površini rakavih celic, med drugim tudi na receptorjih, ki pospešujejo nenadzorovano deljenje celic.
In the non-comparative studies of CML, Ph+ ALL and GIST, between 26 and 96% of patients showed a response to Glivec. 
Pri neprimerjalnih študijah KML, Ph+ ALL in GIST je odziv na zdravljenje izkazalo med 26 in 96 % bolnikov.
In patients with CML, the cancer had got worse in 16% of the patients taking Glivec after five years, compared with 28% of those taking interferon alpha plus cytarabine. 
Pri bolnikih s KML se je rak poslabšal pri 16 % bolnikov, ki so jemali zdravilo Glivec pet let, v primerjavi s 28 % tistih, ki so jemali kombinacijo interferona alfa in citarabina.
It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or is not responding to other medicines. 
Uporablja se tudi samostojno za zdravljenje odraslih s Ph+ ALL, ki se je po predhodnem zdravljenju ponovila, ali če ni odziva na druga zdravila.
Glivec treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours. 
Zdravljenje z zdravilom Glivec lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z krvnim rakom ali trdnimi tumorji.
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome. 
To pomeni, da je pri njih prišlo do prerazporeditve nekaterih genov, s čimer je nastal poseben kromosom, imenovan kromosom Philadelphia.
This study measured how long the patients lived without their cancer getting worse. 
V študiji so opazovali, kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala.
Glivec was also better than standard chemotherapy in patients with Ph+ ALL. 
Zdravilo Glivec je bilo tudi boljše od standardne kemoterapije pri bolnikih s Ph+ ALL.
The active substance in Glivec, imatinib, is a protein-tyrosine kinase inhibitor. 
Zdravilna učinkovina zdravila Glivec, imatinib, je zaviralec protein-tirozin-kinaze.
These included a study involving 1,106 adults that compared Glivec with the combination of interferon alpha plus cytarabine (other anticancer medicines). 
Te študije so vključevale študijo s 1 106 odraslimi, v kateri so zdravilo Glivec primerjali s kombinacijo interferona alfa in citarabina (drugih zdravil proti raku).
For Ph+ ALL, Glivec has been examined in three studies involving 456 adults, including one study comparing Glivec with standard chemotherapy (medicines used to kill cancer cells) in 55 newly diagnosed patients. 
Pri Ph+ ALL so zdravilo Glivec proučevali v treh študijah, ki so vključevale 456 odraslih, vključno z eno študijo, v kateri so ga primerjali s standardno kemoterapijo (zdravili, ki se uporabljajo za uničevanje rakavih celic) pri 55 bolnikih z na novo ugotovljeno boleznijo.
Glivec is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα; 
Zdravilo Glivec se uporablja za zdravljenje odraslih s HES ali KEL, ki imajo specifično preureditev dveh genov, imenovanih FIP1L1 in PDGFRα.
Why has Glivec been approved? 
Zakaj je bilo zdravilo Glivec odobreno?
Glivec is used in combination with other anticancer medicines in adults and children who have been newly diagnosed with Ph+ ALL. 
Zdravilo Glivec se uporablja v kombinaciji z drugimi zdravili proti raku pri odraslih in otrocih, pri katerih je bila na novo ugotovljena Ph+ ALL.
In the study of patients aged 1 to 22 years who had Ph+ ALL, Glivec was shown to increase how long the patients lived without any major events (such as a relapse). 
V študiji bolnikov s Ph+ ALL, starih od 1 so 22 let, se je izkazalo, da je zdravilo Glivec podaljšalo obdobje, v katerem pri bolnikih ni prišlo do večjih dogodkov (kot je recidiv).
For the full list of all side effects reported with Glivec, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Glivec, glejte navodilo za uporabo.
Glivec is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR); 
Zdravilo Glivec se uporablja za zdravljenje odraslih z MD/MPD, pri katerih se pojavljajo preureditve gena za receptor za rastni faktor iz trombocitov (PDGFR).
Glivec is a medicine that contains the active substance imatinib. 
Glivec je zdravilo, ki vsebuje zdravilno učinkovino imatinib.
This study measured how long the patients lived without their cancer coming back. 
V študiji so opazovali, kako dolgo so bolniki živeli, ne da bi se bolezen ponovila.
• myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells. 
• mielodisplastične ali mieloproliferativne bolezni (MD/MPD), tj. skupine bolezni, pri katerih telo proizvaja veliko število nenormalnih krvnih celic.
The other study compared Glivec with placebo (a dummy treatment) in 713 patients whose cancer had been removed with surgery. 
V drugi študiji so primerjali zdravilo Glivec s placebom (zdravilom brez zdravilne učinkovine) pri 713 bolnikih, pri katerih je bil tumor kirurško odstranjen.
Glivec 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 Glivec se uporablja za zdravljenje odraslih z DFSP, ki ga ni mogoče kirurško odstraniti, in odraslih, ki niso primerni za operacijo, če se je rak po zdravljenju ponovil ali razširil v druge dele telesa.
• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably. 
• protuberantnega dermatofibrosarkoma (DFSP), tj. vrste raka (sarkoma), pri katerem se celice v tkivu pod kožo nenadzorovano delijo.
Glivec is used when the patients are ‘Philadelphia chromosome positive' (Ph+). 
Zdravilo Glivec se uporablja pri bolnikih s kromosomom Philadelphia (Ph+).
In patients with GIST that had been removed with surgery, patients taking Glivec lived for longer than those taking placebo without their cancer coming back. 
Pri bolnikih z GIST, ki je bil kirurško odstranjen, je pri tistih, ki so jemali zdravilo Glivec, trajalo dlje, da se je bolezen ponovila, kot pri tistih, ki so jemali placebo.
One involved 147 patients whose GIST could not be surgically removed or had spread to other parts of the body, and looked at whether the tumours shrank in size. 
Ena je vključevala bolnike, pri katerih gastrointestinalnega stromalnega tumorja ni bilo mogoče kirurško odstraniti ali se je razširil na druge dele telesa, in je proučevala, ali se je tumor zmanjšal.
What is Glivec used for? 
Za kaj se zdravilo Glivec uporablja?
• advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control. 
• napredovalega hipereozinofilnega sindroma (HES) ali kronične eozinofilne levkemije (KEL), tj. bolezni, pri katerih eozinofili (druga vrsta belih krvničk) začnejo nenadzorovano rasti.
How does Glivec work? 
Kako zdravilo Glivec deluje?
Glivec is used to treat adults with GIST that cannot be removed with surgery or have spread to other parts of the body, and adults who are at risk of GIST coming back after surgical removal; 
Zdravilo Glivec se uporablja za zdravljenje odraslih z GIST, ki ga ni mogoče kirurško odstraniti ali ki se je razširil v druge dele telesa, in odraslih, pri katerih obstaja tveganje za ponovitev GIST po kirurški odstranitvi.
• gastrointestinal stromal tumours (GIST), a type of cancer (sarcoma) of the stomach and bowel, when there is uncontrolled growth of cells in the supporting tissues of these organs. 
• gastrointestinalnega stromalnega tumorja (GIST), vrste raka (sarkom) želodca in črevesja, kadar celice v opornem tkivu teh organov nenadzorovano rastejo.
• Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly. 
• akutne limfoblastne levkemije (ALL) s prisotnim kromosomom Philadelphia (Ph+), tj. vrste raka, pri kateri se limfociti (druga vrsta belih krvničk) množijo prehitro.
What is Glivec? 
Kaj je zdravilo Glivec?
Glivec is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant. 
Zdravilo Glivec se uporablja pri odraslih in otrocih z na novo ugotovljeno KML s kromosomom Philadelphia, pri katerih presaditev kostnega mozga ne pride v poštev.
• 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. 
• kronične mieloidne levkemije (KML), tj. raka belih krvnih telesc, pri katerem granulociti (vrsta belih krvnih telesc) začnejo nenadzorovano rasti.
How has Glivec been studied? 
Kako je bilo zdravilo Glivec raziskano?
How is Glivec used? 
Kako se zdravilo Glivec uporablja?
Treatment cycles may be repeated for as long as the patient benefits. 
Cikluse zdravljenja je mogoče ponavljati, dokler ima bolnik od njih koristi.
In both studies, the majority of patients were adults. 
V obeh študijah so v glavnem sodelovali odrasli bolniki.
Systemic formulations of levofloxacin (such as tablets and solutions for infusion) have been authorised in the EU since the 1990s. 
Formulacije levofloksacina za sistemsko uporabo (kot so tablete in raztopine za infundiranje) so v EU odobrene od devetdesetih let prejšnjega stoletja.
It must not be used in pregnant or breastfeeding women. 
Zdravila ne smejo uporabljati nosečnice ali ženske, ki dojijo.
The European Commission granted a marketing authorisation valid throughout the European Union for Quinsair on 26 March 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Quinsair, veljavno po vsej Evropski uniji, izdala 26. marca 2015.
After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment. 
Po 28 dneh zdravljenja bolnik to za 28 dni prekine, čemur ponovno sledi 28-dnevno zdravljenje.
This is a summary of the European public assessment report (EPAR) for Quinsair. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Quinsair.
The full EPAR and risk management plan summary for Quinsair 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) in povzetek načrta obvladovanja tveganj za zdravilo Quinsair sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Quinsair? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Quinsair?