natgillin/translations-raw huggingface dataset:
The kit may be kept for up to 4 weeks below 30°C prior to use. 
Set je lahko pred uporabo do 4 tedne shranjen na temperaturi do 30 ºC.
Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI) 
Sprememba od izhodišča (± SE) Povprečna razlika v spremembi od izhodišča v primerjavi s sitagliptinom (95 % IZ)
Abdominal distension Abdominal pain 
navzea bruhanje driska dispepsija bolečine v trebuhu
Change from baseline (± SE) Mean difference in change from baseline versus sitagliptin (95% CI) Mean difference in change from baseline versus placebo (95% CI) 
ROg = razmerje ogroženosti, IZ = interval zaupanja eksenatid placebo eksenatid v primerjavi s placebom: ROg (95 % IZ)
Dose Line 
Lipidi na tešče
The pre-filled pens may be kept for up to 4 weeks below 30°C prior to use. 
Peresniki so lahko pred uporabo do 4 tedne shranjeni na temperaturi do 30 ºC.
It is normal for air bubbles to be in the syringe. 
Zračni mehurčki so normalno prisotni v injekcijski brizgi.
Pick up the syringe. 
Vzemite injekcijsko brizgo.
Injection site erythema 
Mesta injiciranja
Immediate-release exenatide 10 mcg BID 
Eksenatid v obliki s takojšnjim sproščanjem 10 µg 2x/dan
Bydureon 2 mg powder and solvent for prolonged-release suspension for injection exenatide 
Bydureon 2 mg prašek in vehikel za suspenzijo s podaljšanim sproščanjem za injiciranje eksenatid
Nervous system disorders Headache 
Bolezni živčevja glavobol omotica dizgevzija somnolenca
Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen exenatide 
Bydureon 2 mg suspenzija s podaljšanim sproščanjem za injiciranje v napolnjenem injekcijskem peresniku eksenatid
− Comes in the locked position before you use it. Do not unlock the pen until you are ready to inject it. 
Peresnika ne odklepajte, dokler niste pripravljeni, da zdravilo injicirate.
Air bubbles in syringe 
Zračni mehurčki v injekcijski brizgi Pritrjevanje igle
Change from baseline (± SE) Mean difference in change from baseline versus sitagliptin (95% CI) Mean difference in change from baseline versus placebo (95% CI) Patients (%) achieving HbA1c < 7% Mean body weight (kg) 
Sprememba od izhodišča (± SE) Povprečna razlika v spremembi od izhodišča v primerjavi z eksenatidom v obliki s takojšnjim sproščanjem (95 % IZ) Bolniki (%), ki so dosegli HbA1c < 7 % Povprečna telesna masa (kg) Izhodišče
Patients (%) achieving HbA1c 7% 
Bolniki (%), ki so dosegli HbA1c ≤ 7 % 73
Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen 
Bydureon 2 mg prašek in vehikel za suspenzijo s podaljšanim sproščanjem za injiciranje v napolnjenem injekcijskem peresniku
Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen. 
Bydureon 2 mg suspenzija s podaljšanim sproščanjem za injiciranje v napolnjenem injekcijskem peresniku
Orange Cap 
Oranžni pokrovček
Mean difference in change from baseline between treatments (95% CI) 
Povprečna vrednost spremembe od začetne vrednosti med zdravljenji (95 %
Change from baseline (± SE) Mean difference change from baseline between treatments (95% CI) 
Sprememba v HbA1c glede na izhodišče (±SE) Povprečna vrednost spremembe od izhodiščne vrednosti med zdravljenji (95 % IZ)
Solvent: carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections sodium hydroxide 
Vehikel natrijev karmelozat natrijev klorid polisorbat 20 natrijev dihidrogen fosfat monohidrat natrijev hidrogen fosfat heptahidrat voda za injekcije natrijev hidroksid
Glycaemic control 
Glikemična kontrola
Cloudy 
Okence
Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen exenatide 
Bydureon 2 mg prašek in vehikel za suspenzijo s podaljšanim sproščanjem za injiciranje v napolnjenem injekcijskem peresniku eksenatid
Dysgeusia 
• riganje
To get your full dose the medicine must be mixed well. 
Zdravilo mora biti dobro premešano, da boste dobili celoten odmerek.
The pen may be kept for up to 4 weeks below 30°C prior to use. 
Peresnik je lahko pred uporabo do 4 tedne shranjen na temperaturi do 30 ºC.
Hold upright & firmly unscrew 
Držite pokonci in odločno odvijte
Each pen can only be used by one person and is for single use. 
Eksenatid v obliki s podaljšanim sproščanjem si bolnik da sam. Vsak peresnik lahko uporablja samo en bolnik in je za enkratno uporabo.
A reduction in body weight compared to baseline has been observed in all prolonged-release exenatide studies. 
Pri vseh študijah z eksenatidom v obliki s podaljšanim sproščanjem je prišlo do znižanja telesne mase v primerjavi z izhodiščem.
Pack size of 4 single-dose pre-filled pens and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens. 
Velikosti pakiranj sta pakiranje s 4 napolnjenimi injekcijskimi peresniki z enkratnim odmerkom in veliko pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov z enkratnim odmerkom.
In patients with end stage renal disease receiving dialysis, single doses of immediate release exenatide increased frequency and severity of gastrointestinal adverse reactions; therefore, prolonged release exenatide formulations are not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance <30 ml/min). 
Uporabe eksenatida v oblikah s podaljšanim sproščanjem bolnikom s končno stopnjo bolezni ledvic ali hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ne priporočamo.
The pre-filled pens may be kept for up to 4 weeks below 30 ºC prior to use. 
Napolnjeni injekcijski peresniki so lahko pred uporabo do 4 tedne shranjeni na temperaturi do 30 ºC.
Gastroesophageal reflux disease 
navzea bruhanje driska dispepsija bolečine v trebuhu gastroezofagealna refluksna bolezen napihnjenost trebuha spahovanje zaprtost flatulenca
Mean change from baseline in fasting plasma glucose (mmol/l) (±SE) 
Povprečna sprememba glukoze v plazmi na tešče v primerjavi z izhodiščem (mmol/l) (± SE)
Bydureon 2 mg prolonged-release suspension for injection exenatide 
Bydureon 2 mg suspenzija s podaljšanim sproščanjem za injiciranje eksenatid s.c.
4 single-dose pre-filled pens. 
4 napolnjeni injekcijski peresniki z enkratnim odmerkom.
Pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise). 
Velikost pakiranja je pakiranje s 4 napolnjenimi injekcijskimi peresniki (BCise) z enkratnim odmerkom in skupno pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov (BCise) z enkratnim odmerkom.
In 6 cases the treatment was ineffective. 
V šestih primerih je bilo zdravljenje neučinkovito.
The population was old and suffered from intermittent claudication. 
Populacija je bila stara in je imela intermitentno klavdikacijo.
In 8 cases full remission was achieved and in 3 cases the frequency and intensity of the attacks were significantly reduced. 
V osmih primerih je prišlo do popolne remisije, v treh primerih pa sta se pogostnost in intenzivnost napadov pomembno zmanjšali.
A complete relief of migraine attacks was achieved in 45% of patients, while a reduction of migraine attacks by at least 50% occurred in 18% patients. 
Popolno olajšanje migrenskih napadov je doseglo 45 % bolnikov, medtem ko je zmanjšanje migrenskih napadov za vsaj 50 % doseglo 18 % bolnikov.
On admission to the study, patients were suffering from 1-3 attacks per week. 
Ob vključitvi v študijo so imeli bolniki od 1 do 3 napade na teden.
Therefore, none of the studies can be considered as conclusively supporting the evidence of efficacy in the indications under assessment. 
Torej se ne more nobena od teh študij obravnavati kot dokončna podpora za dokaze učinkovitosti pri ocenjevanih indikacijah.
Overall summary of the scientific evaluation of nicergoline containing medicinal products (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo nicergolin (glejte Prilogo I)
Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends: 
zato odbor CHMP skladno s členom 116 Direktive 2001/83/ES priporoča:
When documented, the reactions occurred with recommended daily dose. 
V času dokumentiranja so se reakcije pojavile ob priporočenem dnevnem odmerku.
The seriousness of such adverse effects and their possible fatal outcome is underlined. 
Odbor je izpostavil resnost teh neželenih učinkov in njihov morebitni smrtni izid;
In these cases, the event occurred after 5 months to 30 years of nicergoline treatment and in patients aged between 59 and 90 years. 
V teh primerih se je dogodek pojavil od 5 mesecev do 30 let po zdravljenju z nicergolinom in pri bolnikih, starih med 59 in 90 let.
A total of 30 cases related to fibrotic events have been reported. 
Poročali so o skupno 30 primerih, povezanih s fibrotičnimi dogodki.
Results show statistically significant difference between nicergoline and placebo in favour of nicergoline. 
Rezultati kažejo na statistično pomembno razliko med nicergolinom in placebom v korist nicergolina.
Improvements in visual acuity were also reported in Ganescu study (46 patients of various eye conditions) but this study was not comparative. 
O izboljšanju ostrine vida so poročali tudi v študiji Ganescu (46 bolnikov z različnimi očesnimi obolenji), vendar ta študija ni bila primerjalna.
Insufficient information was reported in five cases precluding any meaningful assessment. 
Pri poročanju petih primerov so bili podatki nezadostni, kar je onemogočilo smiselno oceno.
Nevertheless, the MAH also provided an analysis regarding all spontaneous reports for the last 40 years (n=390, including 205 medically-confirmed cases). 
Imetnik dovoljenja za promet z zdravilom pa je priložil tudi analizo vseh spontanih poročil v zadnjih 40 letih (n = 390, vključno z 205 medicinsko potrjenimi primeri).
Patients were given 10 mg of nicergoline three times daily for the first 10 days followed by 5 mg three times daily for 3-5 weeks. 
Bolniki so prvih 10 dni prejemali 10 mg nicergolina trikrat na dan, potem pa od 3 do 5 tednov 5 mg trikrat na dan.
Dementia and dementia related indications are excluded from the scope of this referral procedure. 
Demenca in z demenco povezane indikacije so izključene iz sklopa tega napotitvenega postopka.
Taking into account the limited information presented from these studies (only summary of these studies were provided), the unclear inclusion/exclusion criteria and statistical analyses employed, no conclusion can be drawn from the data provided. 
Glede na omejene podatke iz teh študij (predloženi so bili samo povzetki teh študij), nejasna merila za vključitev/izključitev in uporabljene statistične metode ni mogoče podati zaključkov.
Moreover, recent cases were identified during the French survey conducted in 2011, which show that the risk minimisation measures currently in place are not sufficient to prevent the development of fibrotic reactions. 
Poleg tega so v francoski raziskavi, opravljeni leta 2011, odkrili nove primere, kar kaže, da trenutni ukrepi za zmanjševanje tveganja niso zadostni za preprečevanje razvoja fibrotičnih reakcij.
Most of the studies that became available after the granting of the initial marketing authorisation were very old and of poor methodological quality, notably non-randomised and with a low number of patients. 
Večina teh študij, ki so bile objavljene po odobritvi prvotnega dovoljenja za promet z zdravilom, je bilo zelo starih in s slabo kakovostjo metodologije, večinoma nerandomizirane in z majhnim številom bolnikov.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products. 
• odbor je obravnaval napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo derivate ergot-alkaloidov;
Indeed, this publication described the metaanalysis of 13 double-blind, placebo-controlled, randomised studies performed by the Cochrane Collaboration in 2001. 
Ta publikacija je opisala metaanalizo 13 dvojno slepih, s placebom nadzorovanih, randomiziranih študij, ki jo je leta 2001 opravila organizacija Cochrane Collaboration.
However, provision of information on these events is insufficient to avoid that some patients develop fibrosis and ergotism during treatment. 
Vendar navedba informacij o teh dogodkih ni zadostna, da bi lahko med zdravljenjem preprečili razvoj fibroze in ergotizma pri nekaterih bolnikih.
The CHMP has considered the totality of the available data on the safety and efficacy of nicergoline. 
CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti nicergolina.
Nicergoline was also given to 17 patients with migraines for prevention of attacks (Prusinski, Wiad.Lek, 1984). 
Nicergolin so dajali tudi 17 bolnikom z migrenami za preprečevanje napadov (Prusinski, Wiad.Lek 1984).
• The Committee is of the opinion that the evidence for clinically significant efficacy of nicergoline in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the identified risk. 
• odbor meni, da so dokazi o klinično pomembni učinkovitosti nicergolina v zvezi s trenutno ocenjevanimi indikacijami izredno omejeni, zato je zgoraj omenjeno tveganje večje od morebitne koristi za bolnike v zvezi s temi indikacijami;
• The Committee considered that a potential causal association between fibrotic reactions or ergotism and nicergoline cannot be excluded. 
• odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in nicergolinom ni mogoče izključiti.
For the indication “prophylaxis of migraine headache” the available data in migraine headache are from open label studies in a small number of patients (40 and 17 patients). 
Pri indikaciji „preprečevanje migrenskega glavobola“ so na voljo podatki za migrenski glavobol iz odprtih študij z majhnim številom bolnikov (40 in 17 bolnikov).
The main localisation of fibrosis is preferentially pulmonary area and also retroperitoneal and cardiac area. 
Glavno mesto fibroze je večinoma pljučno območje, prav tako pa tudi retroperitonealno in srčno območje.
Therefore, the CHMP was of the opinion that it is not possible to rule out the possibility that these actually correspond to the development of ergotism. 
Odbor CHMP je zato sklenil, da ni mogoče izključiti možnosti, da so ti simptomi dejansko povezani z razvojem ergotizma.
Overall, the study designs were adequate (randomised, double-blind, placebo-controlled), diagnoses were established according classification criteria at the time of the studies, primary efficacy scales were defined a priori (MMSE, SCAG, ADAS-Cog). 
Na splošno so bile zasnove študij primerne (randomizirane, dvojno slepe, s placebom nadzorovane), diagnoze pa so bile postavljene skladno s klasifikacijskimi merili, veljavnimi v času študij, lestvice za primarno učinkovitost pa so bile opredeljene a priori (MMSE, SCAG, ADAS-Cog).
From the approved indications of the nicergoline 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 nicergolin, 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):
The improvement, when documented, was observed between 3 and 10 months after nicergoline discontinuation, without corticoid treatment in four cases. 
Dokumentirano izboljšanje so opazili od 3 do 10 mesecev po prekinitvi uporabe nicergolina, v štirih primerih brez zdravljenja s kortikosteroidi.
The studies submitted have assessed nicergoline for oral or parenteral use and had heterogeneous efficacy endpoints such as: sensitivity to cold, peripheral blood flow, walking distance, pain, quality of life. 
Predložene študije so ocenjevale peroralno ali parenteralno uporabo nicergolina in so uporabile heterogene opazovane dogodke za učinkovitost, kot so: občutljivost za mraz, periferni krvni pretok, prehojena razdalja, bolečina, kakovost življenja.
• Fibrosis is also a slow and insidious reaction that occurs after a long period of treatment and with delayed diagnosis 
• je fibroza počasna in zahrbtna reakcija, ki se pojavi dolgo časa po zdravljenju, diagnoza pa je navadno zapoznela.
The majority of them had been previously treated with various anti-migraine drugs like dihydroergotamine, pizotifen and propranolol with unsatisfactory effects. 
Večina od njih se je predhodno neuspešno zdravila z različnimi zdravili proti migreni, kot so dihidroergotamin, pizotifen in propranolol.
Therefore, the group was of the opinion that there is not a clearly defined population, which unsatisfactorily responds to standard migraine prophylaxis treatment, where there is a therapeutic need for this substance as alternative/last line treatment. 
Skupina je zato zaključila, da ni jasno opredeljene populacije, ki se nezadostno odziva na standardno preprečevanje migrene, kadar obstaja terapevtska potrebna po uporabi te učinkovine kot alternativnega/zadnjega zdravljenja.
The group highlighted that the claimed indication is not used anymore in the clinical practice and that from a clinical viewpoint there is no evidence at present that there is a therapeutic need for this active substance in the treatment of cognitive and neurosensorial impairment in the elderly. 
Skupina je izpostavila, da se navedena indikacija v klinični praksi ne uporablja več, zato s kliničnega vidika trenutno ni dokazov, da obstaja terapevtska potreba po tej zdravilni učinkovini pri zdravljenju kognitivne in nevrosenzorične okvare pri starejših.
• The Committee considered that the benefit-risk balance of nicergoline containing products: 
• odbor je menil, da razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo nicergolin:
The CHMP noted that an under-notification of the adverse events can also be suspected given that: 
Odbor CHMP je omenil, da je lahko prav tako prisoten sum na preredko poročanje neželenih dogodkov, saj:
Fourty (40) patients with migraine were assessed in an open clinical study that became available after the initial marketing authorisation was granted (Prusinski, Wiad.Lek, 1984). 
Štirideset (40) bolnikov z migreno so ocenili v odprti klinični študiji, ki je bila objavljena po odobritvi prvotnega dovoljenja za promet z zdravilom (Prusinski, Wiad.Lek 1984).
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 
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom ali začasni umik dovoljenj za promet z zdravilom, kot je ustrezno, pri čemer so se upoštevale odobrene indikacije za posamezno zdravilo
The CHMP considered the MAH's proposal for risk minimisation measures: the inclusion of information related to fibrosis and ergotism in section 4.4 of the Summary of Product Characteristics. 
Odbor CHMP je obravnaval predlog imetnika dovoljenja za promet z zdravilom glede ukrepov za zmanjšanje tveganja: vključitev informacij, povezanih s fibrozo in ergotizmom, v poglavje 4.4 Povzetka glavnih značilnosti zdravila.
Four cases of fibrotic events were excluded from the analysis. 
Iz analize so izključili štiri primere fibrotičnih dogodkov.
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, saj so podatki o učinkovitosti zelo omejeni.
• The suspension of the marketing authorisation for nicergoline 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 dovoljenja za promet z zdravili iz Priloge I, ki vsebujejo nicergolin, če se kot del njihovega dovoljenja za promet z zdravilom ne odobrijo druge indikacije.
Regarding cases of pulmonary reactions, the emerging number of cases and the improvement observed after nicergoline discontinuation in 10 cases with no confounding factor is in favour of a causal role of nicergoline, especially in 5 cases in which improvement was also confirmed by radiography or scanner. 
Vedno večje število primerov pljučnih reakcij in izboljšanje, opaženo po prekinitvi uporabe nicergolina pri 10 bolnikih brez sočasnih dejavnikov, podpirata vzročno vlogo nicergolina, predvsem pri 5 primerih, pri katerih se je izboljšanje potrdilo tudi z radiografijo ali slikanjem.
Ninety (90) cases were found to contain terms potentially indicative of symptoms or ergotism, such as paraesthesia, formication, tingling, intestinal/cerebrovascular/peripheral/tongue ischaemia, angina pectoris, coronaropathy, thoracic pain, nausea, vomiting, diarrhoea, abdominal pain, cold sensation, thrombosis, stroke, gangrene, necrosis, vasoconstriction/vasospasm, cyanosis, myalgia, muscular cramps, pain in extremities, vertigo, hypoaesthesia, numbness, headache, confusion, hallucinations. 
Devetdeset (90) primerov vsebuje izraze, ki lahko kažejo na simptome ergotizma, kot so parestezija, mravljinčenje, ščemenje, intestinalna/cerebrovaskularna/periferna ishemija, ishemija jezika, angina pektoris, koronaropatija, bolečina v prsnem košu, navzea, bruhanje, diareja, bolečina v trebuhu, občutek mrazenja, tromboza, kap, gangrena, nekroza, vazokonstrikcija/vazospazem, cianoza, mialgija, mišični krči, bolečina v okončinah, vertigo, hipoestezija, otopelost, glavobol, zmedenost, halucinacije.
Therefore, despite the positive conclusions of the authors regarding the progression of visual acuity under a treatment with nicergoline, the CHMP considered that, in the absence of a comparison to a placebo control, no reliable conclusion can be drawn from these clinical results which referred to heterogeneous data based on small series of patients of various eye conditions. 
Kljub pozitivnim zaključkom avtorjev glede izboljšanja ostrine vida pri zdravljenju z nicergolinom je odbor CHMP menil, da zaradi odsotnosti primerjave s kontrolo s placebom ni mogoče podati zanesljivih zaključkov na podlagi teh kliničnih rezultatov, ki so se nanašali na različne podatke in temeljili na majhnem številu bolnikov z različnimi očesnimi obolenji.
Among the 21 remaining cases, an association between nicergoline and the fibrotic event or potential fibrotic event could not be excluded. 
Pri preostalih 21 primerih ni bilo mogoče izključiti povezave med nicergolinom in fibrotičnim dogodkom ali morebitnim fibrotičnim dogodkom.
In addition, given that fibrosis is a serious life threatening reaction, observed after long duration of treatment with nicergoline (a drug used in indications requiring long duration of treatment), this has an impact on the benefit-risk profile of the products. 
Ker je fibroza resna, smrtno nevarna reakcija, ki se pojavi po dolgem času od zdravljenja z nicergolinom (zdravilom, ki se uporablja z indikacijami, ki zahtevajo dolgotrajnega zdravljenja), ima to vpliv na profil razmerja med tveganji in koristmi teh zdravil.
For the indication “ancillary treatment of Raynaud's syndrome”, the submitted studies did not really assess nicergoline in patients with this specific indication, but were rather conducted in patients with peripheral arteriopathy. 
Pri indikaciji „dodatno zdravljenje Raynaudovega sindroma“ predložene študije niso dejansko ocenile nicergolina pri bolnikih z zadevno indikacijo, ampak so bile opravljene pri bolnikih s periferno arteriopatijo.
However, the CHMP considered whether some of these studies could be used in support of the indication “ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)”. 
Kljub temu je odbor CHMP presodil, ali se lahko nekatere od teh študij uporabijo kot podpora za indikacijo „dodatno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II)“.