natgillin/translations-raw huggingface dataset:
Nicergoline is a semisynthetic ergoline derivative that seems to have an action: (i) as an α1adrenoceptor antagonist, it induces vasodilation and increases arterial blood flow; (ii) it enhances cholinergic and catecholaminergic neurotransmitter function; (iii) it inhibits platelet aggregation; (iv) it promotes metabolic activity, resulting in increased utilization of oxygen and glucose; and (v) it has neurotrophic and antioxidant properties. 
Nicergolin je polsintetični derivat ergolina, ki domnevno deluje: kot antagonist α1-adrenoreceptorjev, povzroča vazodilatacijo in poveča arterijski krvni pretok, ii) poveča delovanje holinergičnih ter kateholaminergičnih nevrotransmitorjev, iii) zavira agregacijo trombocitov, iv) spodbuja delovanje presnove, s čimer poveča izkoristek kisika in glukoze ter v) ima nevrotropne in antioksidacijske lastnosti.
In conclusion, the CHMP was of the opinion that a couple of studies have some positive findings in the populations tested but considering the inadequate methodology, the reliability and the clinical relevance of the results is questionable. 
Odbor CHMP je zaključil, da imata dve študiji nekaj pozitivnih ugotovitev pri preiskovani populaciji, vendar sta zanesljivost in klinični pomen rezultatov zaradi pomanjkljive metodologije vprašljiva.
This Cochrane review on efficacy of nicergoline was performed in patients with mild to moderate dementia and is therefore also outside the scope of the procedure. 
Ta pregled učinkovitosti nicergolina je organizacija Cochrane opravila pri bolnikih z blago do zmerno demenco, zato je zunaj sklopa tega napotitvenega postopka.
• The variation to the terms of the marketing authorisation for nicergoline containing medicinal products referred to in Annex I, to delete the below indications (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, 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 nicergolin, 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:
Regarding ergotism, there were no cases identified in the MAH's safety database reporting the preferred term ergotism associated with nicergoline. 
V varnostni zbirki podatkov imetnika dovoljenja za promet z zdravilom ni bilo nobenih primerov, ki bi poročali o prednostnem izrazu ergotizem, povezan z nicergolinom.
For the indication “ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)” no data were submitted and as a result was considered as unsupported by the CHMP. 
Za indikacijo „dodatno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II)“niso bili predloženi nobeni podatki, zato je odbor CHMP menil, da ni utemeljena.
The MAHs considers that the most comprehensive review of nicergoline efficacy was completed in a meta-analysis performed in 2008 by Winblad et al. 
Imetniki dovoljenj za promet z zdravilom menijo, da je bil najobsežnejši pregled učinkovitosti nicergolina opravljen v metaanalizi, ki so jo leta 2008 izvedli Winblad in sodelavci.
The MAH further provided information on six clinical comparative studies in senile cerebral insufficiency and a short description of a non-comparative study and three observational studies in support of the efficacy of nicergoline in a specific indication “symptomatic treatment of mild cognitive impairment of vascular origin in the elderly”. 
Imetnik dovoljenja za promet z zdravilom je prav tako predložil podatke šestih kliničnih primerjalnih študij senilne cerebralne insuficience in kratek opis neprimerjalne študije ter treh opazovalnih študij, ki naj bi podprle učinkovitost nicergolina pri zadevni indikaciji „simptomatsko zdravljenje blage kognitivne okvare žilnega izvora pri starejših“.
The CHMP noted that none of the studies was designed to address the specific indication under question (symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)), and that the data is further weakened by publication biases and changes in the understanding of proper criteria for current diagnoses. 
CHMP je ugotovil, da nobena od teh študij ni bila načrtovana za obravnavo zadevne indikacije (simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)) in da je kredibilnost podatkov dodatno zmanjšana zaradi pristranskosti publikacij ter sprememb v razumevanju ustreznih meril za trenutne diagnoze.
In addition, a scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia). 
Znanstveno svetovalna skupina je na pobudo odbora CHMP decembra 2012 sklicala sestanek, na katerem so strokovnjaki na podlagi svojih kliničnih izkušenj razpravljali o tem, ali ima ta učinkovina vlogo pri simptomatskem zdravljenju kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence).
For the indications “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin” and “acute retinopathies of vascular origin” the CHMP noted that positive clinical results (in particular regarding the progression of visual acuity) were described mainly in one open long-term study in the context of an ambulatory ophthalmological practice that involved 213 patients with heterogeneous pathologies (e.g. retina degeneration, inflammatory diseases of the retina and of the optic nerve, venous and arterial vessels occlusions, glaucoma, etc) (Hasslinger, 1986). 
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 opazil, da so bili pozitivni klinični rezultati (predvsem glede izboljšanja ostrine vida) večinoma opisani v eni odprti dolgotrajni študiji v sklopu ambulantne oftalmološke prakse, ki je vključevala 213 bolnikov z različnimi patologijami (npr. degeneracija mrežnice, vnetne bolezni mrežnice in optičnega živca, venske ter arterijske okluzije, glavkom itd.) (Hasslinger 1986).
The Committee concluded that the benefit-risk balance of nicergoline 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 intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II), for ancillary treatment of Raynaud's syndrome, for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, for acute retinopathies of vascular origin and for prophylaxis of migraine headache. 
Odbor je zaključil, da skladno s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo nicergolin, ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence), dodatno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II), dodatno zdravljenje Raynaudovega sindroma, dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora, akutno retinopatijo žilnega izvora in preprečevanje migrenskega glavobola.
• Adverse drug reaction with a substance marketed for a long time is generally less reported 
• se o neželenem učinku pri učinkovini, ki je v prometu dolgo časa, navadno poroča redkeje;
These data were considered insufficient by the CHMP to conclude on a beneficial efficacy of nicergoline in the prophylaxis of migraine headache. 
Odbor CHMP je menil, da so ti podatki nezadostni, da bi lahko sklepali o koristni učinkovitosti nicergolina pri preprečevanju migrenskih glavobolov.
The CHMP was of the opinion that overall based on these data there is some evidence of positive effects of nicergoline on cognition and behaviour in patients with senile cerebral insufficiency of different origins. 
CHMP je menil, da je na splošno v teh podatkih nekaj dokazov za pozitivne učinke nicergolina na kognicijo in vedenje pri bolnikih s senilno cerebralno insuficienco različnega izvora, vendar klinični pomen ni znan.
• Symptomatic treatment of veno-lymphatic insufficiency 
• Simptomatsko zdravljene veno-limfatične insuficience.
This does not exactly reflect the indication supported by the MAH. 
To pa se ne nanaša natančno na indikacijo, za podporo katere je imetnik dovoljenja za promet z zdravilom predložil podatke.
The CHMP concluded that, as result, no conclusion on efficacy of nicergoline as “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)” can be drawn from the data provided. 
CHMP je zaključil, da posledično iz predloženih podatkov ni mogoče sklepati na učinkovitost nicergolina pri „simptomatskem zdravljenju kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“.
− Is not favourable for prophylaxis of migraine headache. 
− ni ugodno za preprečevanje migrenskega glavobola.
− Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia). 
− ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence),
To conclude, given the cases reported for a reaction difficult to early diagnose (delayed symptoms) and probably under reported, the use of the drug at an approved dosage, added to a plausible pharmacological profile, nicergoline is considered to be associated with a risk of fibrotic reactions. 
Glede na to, da so poleg verjetnega farmakološkega profila poročani primeri povezani z reakcijo, ki je težavna za pravočasno diagnosticiranje (zapozneli simptomi) in verjetno preredko poročana, lahko sklenemo, da je uporaba nicergolina v odobrenem odmerku povezana s tveganjem fibrotičnih reakcij.
− Is not favourable for ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II). 
− ni ugodno za dodatno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II),
Therefore, the CHMP was of the opinion that these substantial methodological deficiencies preclude any conclusion on the efficacy of nicergoline (oral or parenteral) on Raynaud's syndrome, and more largely in peripheral circulation disorders. 
Posledično sta zanesljivost in klinična pomembnost teh študij vprašljivi, zato je odbor CHMP menil, da te pomembne metodološke pomanjkljivosti onemogočajo zaključke glede učinkovitosti nicergolina (peroralnega ali parenteralnega) pri Raynaudovem sindromu in zlasti perifernih cirkulacijskih motnjah.
− Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II). 
− dodatno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II);
− Prophylaxis of migraine headache. 
− preprečevanje migrenskega glavobola.
Regarding peritoneal and cardiac fibrosis, the CHMP was of the view that the causal role of nicergoline cannot be excluded. 
Odbor CHMP je menil, da vzročne vloge nicergolina pri peritonealni in srčni fibrozi ni mogoče izključiti.
− Ancillary treatment of Raynaud's syndrome. 
• dodatno zdravljenje Raynaudovega sindroma.
− Is not favourable for acute retinopathies of vascular origin. 
− ni ugodno za akutno retinopatijo žilnega izvora,
− Acute retinopathies of vascular origin. 
• akutna retinopatija žilnega izvora.
− Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin. 
− dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora;
On the efficacy side for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, the efficacy data were mainly provided from study publications conducted in patients with dementia (Alzheimer disease, multi-infarct dementia, vascular dementia, Parkinson disease, etc), while dementia is excluded from the scope of this referral procedure. 
Za indikacijo „simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“ so bili podatki o učinkovitosti predloženi zlasti iz publikacij študij, opravljenih pri bolnikih z demenco (Alzheimerjevo boleznijo,
The full EPAR for Myfenax 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 Myfenax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Myfenax. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Myfenax.
The European Commission granted a marketing authorisation valid throughout the EU for Myfenax on 21 February 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Myfenax, veljavno po vsej Evropski uniji, odobrila dne 21. februarja 2008.
This means that Myfenax is similar to a ‘reference medicine' already authorised in the European Union (EU) called CellCept. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu CellCept.
In children aged between two and 18 years, the dose of Myfenax is calculated depending on height and weight. 
Pri otrocih, starih od 2 do 18 let, se odmerek zdravila Myfenax izračuna na podlagi telesne višine in mase.
The way that Myfenax should be given and the dose depend on the type of organ transplant and the patient's age and size. 
Način uporabe zdravila Myfenax in njegovo odmerjanje sta odvisna od vrste presajenega organa ter bolnikove starosti in velikosti.
What are the benefits and risks of Myfenax? 
Kakšne so koristi in tveganja, povezani z zdravilom Myfenax?
For more information about treatment with Myfenax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Mafenax preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Myfenax. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Myfenax, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Because Myfenax 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 Myfenax generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Myfenax is a ‘generic medicine'. 
Myfenax je „generično zdravilo“.
The CHMP concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to CellCept. 
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Myfenax primerljivo raven kakovosti kot zdravilo Cellcept ter da mu je biološko enakovredno.
Myfenax treatment should be initiated and maintained by a qualified transplant specialist. 
Zdravljenje z zdravilom Myfenax mora uvesti in voditi zdravnik specialist za presaditve.
The Committee recommended that Myfenax be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Myfenax odobri dovoljenje za promet.
Myfenax is used to prevent the body from rejecting a transplanted kidney, heart or liver. 
Zdravilo Myfenax se uporablja za preprečevanje zavrnitve ledvic, srca in jeter po presaditvi.
For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated. 
Pri odraslih bolnikih s presajenimi jetri se mofetilmikofenolat prve štiri dni po presaditvi daje kot infuzija (kapalna infuzija v veno), ko je bolnik sposoben požirati, pa preide na jemanje 1,5 g zdravila Myfenax dvakrat na dan.
Myfenax mycophenolate mofetil 
Myfenax mofetilmikofenolat
Other information about Myfenax 
Druge informacije o zdravilu Myfenax:
Because Myfenax is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, CellCept. 
Ker je zdravilo Myfenax generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu CellCept.
By preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply. 
Zdravilo Myfenax s preprečevanjem tvorbe nove DNK zmanjša hitrost razmnoževanja limfocitov.
Myfenax is a medicine containing the active substance mycophenolate mofetil. 
Myfenax je zdravilo, ki vsebuje zdravilno učinkovino mofetilmikofenolat.
Why has Myfenax been approved? 
Zakaj je bilo zdravilo Myfenax odobreno?
The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine. 
Zdravilna učinkovina v zdravilu Myfenax, mofetilmikofenolat, je zaviralec imunske odzivnosti.
What is Myfenax? 
Kaj je zdravilo Myfenax?
How has Myfenax been studied? 
Kako je bilo zdravilo Myfenax raziskano?
What is Myfenax used for? 
Za kaj se zdravilo Myfenax uporablja?
How does Myfenax work? 
Kako zdravilo Myfenax deluje?
How is Myfenax used? 
Kako se zdravilo Myfenax uporablja?
The referral started on 15 May 2013. 
Napotitveni postopek se je začel 15. maja 2013.
Written explanations were provided by some of the applicants and marketing authorisation holders by 30 September 2013 and 3 February 2014. 
Nekateri predlagatelji in imetniki dovoljenja za promet so pisna pojasnila predložili 30. septembra 2013 in 3. februarja 2014.
The Committee appointed C. Muñoz Madero as rapporteur and M. Holzhauser-Alberti as co-rapporteur. 
Odbor je imenoval Cristino Muñoz Madero za poročevalko in Michaela Holzhauser-Albertija za soporočevalca.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III. 
Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so navedeni v Prilogi II, skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Prilogi III.
The CVMP was requested to consider what indications, dosage regimens and durations of treatments should be applied for the products concerned in order to ensure efficacy and target animal safety and to minimise the development of antimicrobial resistance, taking into account the available data. 
Odbor CVMP so prosili, naj na podlagi razpoložljivih podatkov določi indikacije, režime odmerjanja in trajanje zdravljenja, ki naj se uporabljajo za zadevna zdravila, da bi zagotovili učinkovitost in varnost ciljnih živalskih vrst ter čim bolj zmanjšali razvoj odpornosti proti protimikrobnim zdravilom.
The CVMP was also requested to consider what withdrawal periods should be applied to the concerned products for each target species. 
Odbor so prosili tudi, naj preveri, kakšne karence naj se uporabljajo za zadevna zdravila pri posameznih ciljnih vrstah.
On 22 April 2013, Spain presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products. 
Španija je 22. aprila 2013 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za zdravila Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje, Baytril 10 % raztopina za injiciranje in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski medicini.
Opinion following an Article 351 referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products 
Mnenje v zvezi z napotitvijo v skladu s členom 351 za zdravilo Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje, Baytril 10 % raztopina za injiciranje in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski medicini
1 Article 35 of Directive 2001/82/EC, as amended 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom 
1 Člen 35 Direktive 2001/82/ES, kakor je bila spremenjena.
Opinion following an Article 350F referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products 
Mnenje v zvezi z napotitvijo v skladu s členom 350F za zdravilo Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje, Baytril 10 % raztopina za injiciranje in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski me EMA/597438/2014
8 May 2018 
8. maj 2018
Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/122) 
Izid postopka v skladu s členom 34 Direktive 2001/82/ES (EMEA/V/A/122)
The European Commission issued a decision on 8 May 2018. 
Evropska komisija je sklep izdala 8. maja 2018.
Girolan (and its associated name Apralan) is marketed in Denmark, France, Germany, Ireland, Italy, The Netherlands, Portugal, Spain and the United Kingdom. 
Zdravilo Girolan (in povezano ime Apralan) se trži na Danskem, v Franciji, Nemčiji, na Irskem, v Italiji, na Nizozemskem, Portugalskem, v Španiji in Združenem kraljestvu.
Girolan is authorised in the EU via national procedures. 
Zdravilo Girolan je bilo v EU odobreno po nacionalnih postopkih.
The amended product information is available on the 'All documents' tab. 
Popravljene informacije o zdravilu so na voljo pod zavihkom„Vsi dokumenti“.
Questions and answers on Girolan and its associated name Apralan EMA/295529/2018 
Vprašanja in odgovori v zvezi z zdravilom Girolan in povezanim imenom Apralan EMA/295529/2018
Spain noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Girolan (and its associated name Apralan) is marketed. 
Španija je opozorila, da med državami članicami obstajajo razlike v načinu, kako se zdravilo za uporabo v veterinarski medicini lahko uporablja, kar se odraža v razlikah med informacijami o zdravilu v državah, v katerih se zdravilo Girolan (in povezano ime Apralan) trži.
Why was Girolan and its associated name Apralan reviewed? 
Zakaj sta bila zdravilo Girolan in povezano ime Apralan pregledana?