natgillin/translations-raw huggingface dataset:
There seemed to be a benefit of treatment in approximately 5575% of patients but the CHMP concluded that these results are in fact difficult to interpret from a clinical point of view and not reliable due to the methodological limitations of the studies. 
Videti je, da je imelo korist od zdravljenja približno 55-75 % bolnikov, vendar je odbor CHMP zaključil, da je te rezultate težko interpretirati s kliničnega vidika in da niso zanesljivi zaradi metodoloških omejitev teh študij.
The studies included young and old patients (1878 years old) with idiopathic acrosyndrome. 
Študije so vključevale mlade in stare bolnike (od 18 do 78 let) z idiopatičnim akrosindromom.
Results were heterogeneous and there was no consistency across studies. 
Rezultati so bili heterogeni, med študijami pa je bila prisotna nedoslednost.
The reliability and the clinical relevance of the study results was therefore questionable and preclude any conclusion on the efficacy of the product. 
Zanesljivost in klinična pomembnost rezultatov študij sta bili zato vprašljivi, kar onemogoča zaključke glede učinkovitosti zdravila.
As a note, one of the above mentioned three cases of fibrosis was reported in 2009 (i.e. after finalisation of the previous referral) which shows that the risk minimisation measures that were imposed at that point in time are not sufficient to exclude the risk. 
Opomba: o enem od zgoraj omenjenih primerov fibroze so poročali leta 2009 (tj. po koncu prejšnjega napotitvenega postopka), kar kaže, da takrat uvedeni ukrepi za zmanjševanje tveganja niso zadostni za izključitev tega tveganja.
• The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocryptine/caffeine cannot be excluded. 
• odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in dihidroergokriptinom/kofeinom ni mogoče izključiti.
In general the CHMP was of the opinion that the methodological flaws and the absence of primary efficacy endpoint do not allow to draw conclusions on clinical efficacy or to support an indication with standardised diagnosis. 
Na splošno je odbor CHMP menil, da metodološke napake in odsotnost primarnega opazovanega dogodka za učinkovitost ne omogočajo zaključkov glede klinične učinkovitosti ali podpore indikacije s standardizirano diagnozo.
It is available in combination with caffeine that may improve the digestive absorption of this ergot alkaloid. 
Na voljo je v kombinaciji s kofeinom, ki lahko izboljša prebavno absorpcijo tega ergot-alkaloida.
The studies mainly assessed functional symptoms, capillaroscopic parameters and plethysmographic parameters whose clinical relevance was considered questionable by the CHMP. 
Študije so večinoma ocenjevale funkcionalne simptome, parametre kapilaroskopije in parametre pletizmografije, pri katerih je odbor CHMP menil, da je njihova klinična pomembnost vprašljiva.
The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocryptine/caffeine. 
CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti dihidroergokriptina/kofeina.
Although some of the proposed measures could help identify patients with preexisting fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment. 
Čeprav lahko nekatera od predlaganih meril pomagajo odkriti bolnike z obstoječo fibrozo, zadevna sočasna zdravila in povečano tveganje, je odbor izpostavil, da to ni zadostno za preprečevanje razvoja fibroze in ergotizma med zdravljenjem pri nekaterih bolnikih.
Overall summary of the scientific evaluation of dihydroergocryptine/caffeine containing medicinal products (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergokriptin/kofein (glejte Prilogo I)
• The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocryptine/caffeine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk. 
• odbor meni, da so dokazi o klinično pomembni učinkovitosti dihidroergokriptina/kofeina v zvezi s trenutno ocenjenimi indikacijami izredno omejeni, zato je zgoraj omenjeno tveganje večje od morebitne koristi za bolnike v zvezi s temi indikacijami;
In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the risk. 
Za preklic začasnega umika morajo imetniki dovoljenja za promet z zdravilom ugotoviti specifično populacijo bolnikov, pri kateri so koristi zdravila večje od tveganj.
Considering the several reported cases of vasoconstriction and the pharmacological structure of this ergot alkaloid derivative product, ergotism cannot be ruled out. 
Glede na mnogo poročanih primerov vazokonstrikcije in farmakološko strukturo tega derivata ergot-alkaloidov ni mogoče izključiti ergotizma.
In 2 studies patients presented a clinical diagnosis of mild organic brain syndrome (stage 2-3 on the Global Deterioration Scale) (Scarzella study) and an early stage senile cerebral deterioration without dementia or major dependence with respect to the environment, based on DSM-III criteria (Babeau study). 
V 2 študijah so imeli bolniki postavljeno klinično diagnozo blagega organskega možganskega sindroma (stadija 2-3 na globalni lestvici za ocenjevanje deterioracije) (študija Scarzella) in senilno možgansko deterioracijo zgodnjega stadija brez demence ali velike odvisnosti od okolice, kar je temeljilo na merilih priročnika DSM-III (študija Babeau).
In rats, dihydroergocryptine showed to activate antioxidant enzymatic systems physiologically alterated during aging. 
Pri podganah so pokazali, da dihidroergokriptin aktivira sisteme antioksidantnih encimov, ki se med staranjem fiziološko spremenijo.
Dihydroergocryptine only containing products are approved in other EU Member States but their indications were not in the scope of this referral procedure (e.g. Parkinson's disease) and were excluded from this review. 
Zdravila, ki vsebujejo samo dihidroergokriptin, so odobrena v drugih državah članicah, vendar njihove indikacije ne spadajo v sklop tega napotitvenega postopka (npr. Parkinsonova bolezen), zato so bile iz tega pregleda izključene.
Overall, the CHMP was of the opinion that no situation could justify exposing a patient to risk of fibrosis and ergotism considering the very limited data on efficacy. 
Na splošno je odbor CHMP menil, da nobene okoliščine ne upravičijo izpostavitve bolnika tveganju za fibrozo in ergotizem, še zlasti ker so podatki o učinkovitosti zelo omejeni.
The CHMP considered the MAHs proposals for risk minimisation measures. 
Odbor CHMP je obravnaval predloge imetnikov dovoljenj za promet z zdravilom glede ukrepov za zmanjšanje tveganja.
Based on these data and based on the pharmacological plausibility, dihydroergocryptine is considered to be associated with fibrotic reactions. 
Na podlagi teh podatkov in farmakološke verjetnost menijo, da je dihidroergokriptin povezan s fibrotičnimi reakcijami.
Under-reporting can also be suspected because the substance is marketed for a long time as well as because fibrosis is already mentioned as an adverse drug reaction in the product information. 
Prav tako obstaja sum na preredko poročanje, saj je učinkovina v prometu že dolgo časa in je fibroza že omenjena kot neželeni učinek v informacijah o zdravilu.
The clinical efficacy endpoints were numerous and heterogeneous with no defined primary efficacy endpoint. 
Klinični opazovani dogodki za učinkovitost so bili številni in heterogeni, primarni opazovani dogodek za učinkovitost pa sploh ni bil opredeljen.
From the approved indications of the dihydroergocryptine containing medicinal products the ones that are in the scope of this referral procedure and are approved in at least one Member State are the following (specific wording of the indication may vary from product to product): 
Od odobrenih indikacij za zdravila, ki vsebujejo dihidroergokriptin, so indikacije, ki spadajo v sklop tega napotitvenega postopka in so odobrene v vsaj eni državi članici, naslednje (natančno besedilo za indikacijo se lahko med zdravili razlikuje):
These included changing the prescription status, limiting treatment duration in certain conditions, contraindicating the product in patients with pre-existing fibrosis or in association with other drugs, the issuing of a DHPC highlighting the risk, a checklist for prescribers, and a pharmacological in vitro study for 5-HT subclass receptors affinity to the product. 
Ti so vključevali spremembo statusa za predpisovanje, omejitev trajanja zdravljenja pri nekaterih pogojih, kontraindikacijo zdravila pri bolnikih z obstoječo fibrozo ali kontraindikacijo za kombinacije z drugimi zdravili, izdajo neposrednega obvestila zdravstvenim delavcem, ki izpostavlja tveganje, kontrolni seznam za predpisovalce ter izvedbo farmakološke študije in vitro za afiniteto podrazreda receptorjev 5-HT za zdravilo.
Dihydroergocryptine is an ergot alkaloid that has an agonist activity on D2 dopaminergic receptors and a partial agonist activity on D1 receptors. 
Dihidroergokriptin je ergot-alkaloid, ki agonistično deluje na D2-dopaminergične receptorje in delno agonistično deluje na D1-receptorje.
In fact, dihydroergocryptine being part of the class of ergot derivatives containing medicinal products covered by this procedure is only approved in the above mentioned indications in France and only in combination with caffeine since 1979. 
Ker dihidroergokriptin spada v razred zdravil, ki vsebujejo derivate ergot-alkaloidov in jih vključuje ta postopek, je v Franciji odobren samo za zgoraj navedene indikacije in od leta 1979 samo v kombinaciji s kofeinom.
Overall, for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, the MAHs provided 6 publications (dated from 1983 to 1998) with an adequate design (randomised, double-blind, placebo controlled) to support the claim for efficacy, plus one study in vascular cognitive impairment which wasnot further discussed. 
Za indikacijo „simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“ so imetniki dovoljenj za promet z zdravilom predložili 6 publikacij (z datumom od 1983 do 1998) z zadostnim načrtom (randomiziranim, dvojno slepim, s placebom nadzorovanim), da bi s tem podprli trditve o učinkovitosti, ter eno študijo žilne kognitivne okvare, ki se ni nadalje obravnavala.
Data provided during a referral under Article 31 in 2007-2008 (EMEA/H/A-31/881) including dihydroergocryptine showed that several cases of fibrosis either pulmonary or cardiac or retroperitoneal were suspected to be associated to the treatment with dihydroergocryptine use for Parkinson's disease treatment (involving dosage five times higher). 
Podatki, predloženi med napotitvenim postopkom v skladu s členom 31 med letoma 2007-2008 (EMEA/H/A-31/881), ki vključuje dihidroergokriptin, so pokazali, da pri mnogih primerih pljučne, srčne ali retroperitonealne fibroze obstaja sum na povezavo z zdravljenjem Parkinsonove bolezni z dihidroergokriptinom (ki je vključevalo petkrat večje odmerjanje).
The data from the reported cases of fibrosis (n=3) are limited in order to draw any firm conclusions, however, the risk cannot be excluded considering the improvement observed when dihydroergocryptine/caffeine was discontinued in one of the three reported cases of pulmonary fibrosis occurring with recommended daily dose. 
Podatki o poročanih primerih fibroze (n = 3) so omejeni, kar ne omogoča prepričljivih zaključkov, vendar tveganja ni mogoče izključiti, saj so pri enem od treh poročanih primerih pljučne fibroze, ki so se pojavili ob uporabi priporočenega dnevnega odmerka, opazili izboljšanje po prekinitvi uporabe dihidroergokriptina/kofeina.
Therefore, other mechanisms inducing fibrosis cannot be excluded, which suggests a causal link between fibrosis and agonism of 5-HT2A and 5-HT1B receptors and also plausible effect on serotonin transporter. 
Zato ni mogoče izključiti drugih mehanizmov, ki povzročajo fibrozo, kar kaže na vzročno povezavo med fibrozo in agonizmom receptorjev 5-HT2A ter 5-HT1B in tudi na verjetni učinek na transmitorje serotonina.
• The suspension of the marketing authorisation for dihydroergocryptine /caffeine containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation. 
• začasni umik dovoljenj za promet z zdravili, navedenimi v Prilogi I, ki vsebujejo dihidroergokriptin/kofein, če v sklopu njihovega dovoljenja za promet z zdravilom ni drugih odobrenih indikacij.
The duration of these studies was short (2 or 3 months) considering the chronic indication approved. 
Upoštevajoč odobreno kronično indikacijo so bile te študije kratkotrajne (2 ali 3 mesece).
For the indication “ancillary treatment of Raynaud's syndrome”, all the studies submitted in support of this indication were considered by the CHMP of poor methodological quality (i.e. uncontrolled, open designed, with a low number of patients (n=20-37)). 
Za vse študije, predložene kot podpora indikaciji „dodatno zdravljenje Raynaudovega sindroma“, je odbor CHMP menil, da je njihova metodološka kakovost slaba (tj. nenadzorovano, z odprtim načrtom in majhnim številom bolnikov (n = 20-37)).
• Acute retinopathies of vascular origin 
• akutna retinopatija žilnega izvora.
Scientific conclusions and grounds for variation to the terms of the marketing authorisations or suspension of the marketing authorisations, as applicable, taking into consideration the approved indications for each product 
Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom ali začasni umik dovoljenj za promet z zdravilom, kot je primerno, ob upoštevanju odobrenih indikacij za posamezno zdravilo
Regarding ergotism, there were several cases reported in the French Pharmacovigilance database where dihydroergocryptine/caffeine was the suspected drug for symptoms related to ergotism. 
V francoski farmakovigilančni zbirki podatkov so poročali o mnogih primerih ergotizma, pri čemer je bil domnevno povzročitelj simptomov dihidroergokriptin/kofein.
The Committee concluded that the benefit-risk balance of dihydroergocryptine/caffeine 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) and for ancillary treatment of Raynaud's syndrome. 
Odbor je zaključil, da skladno s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokriptin/kofein, ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence) ter dodatno zdravljenje Raynaudovega sindroma.
The absence of such reports claimed from the MAH, raised questions to the CHMP with regard to the way that the data collection was performed. 
Imetnik dovoljenja za promet z zdravilom je trdil, da takih poročil ni, kar je odbor CHMP opozorilo na način zbiranja podatkov.
Agonism to 5-HT2B receptors induces a proliferative response and mitogenicity of the cells expressing this receptor leading to fibrogenesis. 
sproži proliferativni odziv in mitogenost celic, ki izražajo ta receptor, kar povzroči fibrogenezo.
• The variation to the terms of the marketing authorisation for dihydroergocryptine/caffeine 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 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 dovoljenj za promet z zdravili, navedenimi v Prilogi I, ki vsebujejo dihidroergokriptin/kofein, tako da se iz informacij o zdravilu izbrišejo spodaj navedene indikacije (natančno besedilo za indikacijo se lahko med zdravili in državami razlikuje) ter druga zadevna sklicevanja na te indikacije, kadar so v sklopu dovoljenja za promet z zdravilom druge odobrene terapevtske indikacije: simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence), dodatno zdravljenje Raynaudovega sindroma;
Is not favourable for ancillary treatment of Raynaud's syndrome. 
• dodatno zdravljenje Raynaudovega sindroma.
• The Committee considered that the benefit-risk balance of dihydroergocryptine/caffeine containing products: Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia). 
• odbor je menil, da razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokriptin/kofein: ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence), ni ugodno za dodatno zdravljenje Raynaudovega sindroma; zato odbor CHMP skladno s členom 116 Direktive 2001/83/ES priporoča:
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 Ob upoštevanju naslednjega:
To help avoid possible infections and to ensure that you use the medicine correctly, it is important that you follow these instructions. 
Da bi preprečili morebitne okužbe in zagotovili, da zdravilo pravilno uporabljate, je pomembno, da upoštevate ta navodila.
Kolodvorska Cesta 27 1234 Menges Slovenia 
Kolodvorska cesta 27 1234 Mengeš Slovenija
The pre-filled syringe cannot be re-used. 
Napolnjene brizge ni mogoče ponovno uporabiti.
• if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na pegfilgrastim, filgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Your doctor may decide that it would be more convenient for you to inject Ziextenzo yourself. 
Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si zdravilo Ziextenzo injicirate sami.
Device ACTIVATED - DO NOT USE 
Pripomoček AKTIVIRAN - NE
If it has expired, return the entire pack to the pharmacy. 
Če je rok uporabe potekel, vrnite celoten paket v lekarno.
• The recommended site is the front of your thighs. 
• Priporočeno mesto je na sprednji strani stegen.
Ziextenzo is for use in adults aged 18 and over. 
Zdravilo Ziextenzo je namenjeno uporabi pri odraslih, starih 18 ali več let.
Its colour may vary from colourless to slightly yellowish. 
Njena barva lahko variira od brezbarvne do rahlo rumenkaste.
Do not open the carton until you are ready to use the pre-filled syringe. 
Ne odprite škatle, dokler niste pripravljeni uporabiti napolnjene brizge.
By touching them, the needle guard may be activated too early. 
Če se jih dotaknete, se lahko ščitnik igle aktivira prezgodaj.
Be careful not to touch the needle guard wings before use. 
Pazite, da se pred uporabo ne dotaknete krilc ščitnika igle.
The trade name of the administered product should be clearly recorded in the patient file. 
Zaščiteno ime uporabljenega zdravila je treba jasno zabeležiti v bolnikovi dokumentaciji.
Healthcare providers only 
Samo za zdravstveno osebje
Do not use the pre-filled syringe if the seal of the blister is broken, as it may not be safe for you to use. 
Napolnjene brizge ne uporabite, če je pečat pretisnega omota poškodovan, saj mogoče ni varna za uporabo.
When you are ready to use the pre-filled syringe, open the blister and wash your hands thoroughly with soap and water. 
Ko ste napolnjeno brizgo pripravljeni uporabiti, odprite pretisni omot in si z milom in vodo temeljito umijte roke.
Your doctor has given you Ziextenzo to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection. 
Vaš zdravnik vam je predpisal zdravilo Ziextenzo, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
What Ziextenzo is and what it is used for 
Kaj je zdravilo Ziextenzo in za kaj ga uporabljamo
The needle guard is intended to protect healthcare professionals, caregivers and patients from accidental needle sticks after the injection. 
Ščitnik igle je namenjen za zaščito zdravstvenih delavcev, negovalcev in bolnikov pred naključnimi vbodi po injiciranju.
Ziextenzo therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. 
Zdravljenje z zdravilom Ziextenzo morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
Do not use if the syringe is broken or activated. 
Ne uporabite, če je injekcijska brizga poškodovana ali aktivirana.
What Ziextenzo is and what it is used for What you need to know before you use Ziextenzo How to use Ziextenzo 
Kaj je zdravilo Ziextenzo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ziextenzo Kako uporabljati zdravilo Ziextenzo
• Choose a different site each time you give yourself an injection. 
• Vsakič ko si daste injekcijo, izberite drugo mesto.
You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds. 
Na mesto injiciranja lahko pritisnete vatiran tampon ali gazo in jo držite 10 sekund.
Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/L) have been reported (see section 4.4). 
Pogosto so poročali o primerih levkocitoze (število belih krvničk > 100 x 109/l) (glejte poglavje 4.4).
In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file. 
Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev (G-CSF) je treba v bolnikovi kartoteki jasno zabeležiti zaščiteno ime uporabljenega zdravila.
Do not use the pre-filled syringe if any other particulates and/or discolouration are observed. 
Napolnjene brizge ne uporabite, če opazite katere koli druge delce in/ali obarvanje.
Contents of the pack and other information What Ziextenzo contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ziextenzo
• inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2. 
• vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
Rates of generation of antibodies against pegfilgrastim are generally low. 
Stopnje nastajanja protiteles proti pegfilgrastimu so na splošno nizke.
Slowly release the plunger and allow the syringe needle guard to automatically cover the exposed needle. 
Počasi sprostite bat in pustite, da ščitnik igle samodejno pokrije izpostavljeno iglo.
Ziextenzo left at room temperature for more than 120 hours should be discarded. 
Zdravilo Ziextenzo, ki je bilo na sobni temperaturi več kot 120 ur, je treba zavreči.
Allow the pre-filled syringe to reach room temperature before injecting. 
Pustite napolnjeno injekcijsko brizgo, da pred injiciranjem doseže sobno temperaturo.
There may be a small amount of blood at the injection site. 
Na mestu injiciranja je lahko vidna majhna količina krvi.
If you use more Ziextenzo than you should 
Če ste uporabili večji odmerek zdravila Ziextenzo, kot bi smeli
Other medicines and Ziextenzo 
Druga zdravila in zdravilo Ziextenzo
You may see a small air bubble in the liquid. 
V tekočini lahko vidite majhen mehurček zraka.
Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds. 
Bat držite v celoti pritisnjen, iglo pa držite na mestu 5 sekund.