natgillin/translations-raw huggingface dataset:
Blurred vision, scleritis and orbital inflammation Uveitis 
Zamegljen vid, skleritis in vnetje očnice
The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003). 
29,8%, v skupini s placebom pa 49,6% (p=0,003).
BPI mean change from baseline 
Povprečna sprememba BPI od izhodišča
Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia. 
Po pregledu podatkov kliničnih preskušanj in primerov, ki so jih opažali po prihodu zdravila na trg, je na voljo dovolj dokazov, ki povezujejo zdravljenje z zoledronsko kislino,
- Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis. 
- Pri bolnicah, ki so dobivale zoledronsko kislino zaradi postmenopavzalne osteoporoze, so opažali neredno bitje srca (atrijsko fibrilacijo).
Convulsions, hypoaesthesia and tetany (secondary to hypocalcaemia) 
- Zaradi nizke vrednosti kalcija: napadi krčev, otrplost in tetanija (zaradi hipokalciemije).
After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose. 
8°C in pri temperaturi 25°C po redčenju s 100 ml 0,9% m/v raztopine natrijevega klorida ali 100 ml
Bradycardia, cardiac arrhythmia (secondary to hypocalcaemia) 
- Zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
OTHER 
Uveitis
The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively. 
I, III in IV (starih od 1 do 17 let), so primerjali z intravenskim pamidronatom v eni mednarodni,
Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia. 
Poročali so o razvoju aritmij in nevroloških neželenih dogodkov (vključno s konvulzijami, hipestezijo in tetanijo),
Zoledronic acid Actavis can be given to people aged 65 years and over. 
Bolniki, stari 65 let ali več, lahko dobivajo zdravilo Zoledronska kislina Actavis.
This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment. 
Če ste dobili več zdravila Zoledronska kislina Actavis, kot bi ga smeli Če ste dobili odmerek, večji od priporočenega, vas mora zdravnik natančno kontrolirati, ker se lahko pojavijo nepravilnosti elektrolitov v serumu (npr. nenormalna koncentracija kalcija, fosforja in magnezija) in/ali spremenjeno delovanje ledvic, vključno z odpovedjo ledvic.
The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate. 
16% zmanjšanje tveganja pri prejemnikih zoledronske kisline v primerjavi s prejemniki pamidronata.
How to store Zoledronic acid Actavis 
Kako se daje zdravilo Zoledronska kislina Actavis
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid. 
O osteonekrozi čeljustnic (ONČ) so občasno poročali pri bolnikih, ki so prejemali zdravilo
In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively. 
V 3-letnem randomiziranem dvojno slepem kontroliranem preskušanju so ocenjevali učinkovitost in varnost 5 mg zoledronske kisline enkrat na leto v primerjavi s placebom pri zdravljenju postmenopavzalne osteoporoze (PMO).
Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid Actavis or after stopping treatment. 
Če se med zdravljenjem ali po zaključku zdravljenja z zdravilom Zoledronska kislina Actavis pojavijo simptomi kot so pojav bolečine, ki je prej ni bilo, poslabšanje obstoječe bolečine ali okornost, takoj obvestite zdravnika.
Respiratory, thoracic and mediastinal disorders Common: 
Bolezni dihal, prsnega koša in mediastinalnega prostora
Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid 
Navodilo za uporabo Zoledronska kislina Actavis 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
Ref.: EMEA/503246/2009 EMEA/H/C/1054 
: EMEA/503244/2009 EMEA/H/C/1054
This means that Clopidogrel 1A Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix. 
To pomeni, da je zdravilo Clopidogrel 1A Pharma podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
The standard dose of Clopidogrel 1A Pharma is one 75 mg tablet once a day, taken with or without food. 
Običajni odmerek zdravila Clopidogrel 1A Pharma je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel 1A Pharma to Acino Pharma GmbH on 28 July 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel 1A Pharma, veljavno po vsej Evropski uniji, odobrila družbi Acino Pharma GmbH dne 28. julija 2009.
Clopidogrel 1A Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). 
Zdravilo Clopidogrel 1A Pharma se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
Clopidogrel 1A Pharma can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment. 
Zdravilo Clopidogrel 1A Pharma se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG), če zdravnik meni, da bi jim zdravilo lahko pomagalo.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel 1A Pharma has been shown to have comparable quality and to be bioequivalent to Plavix. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel 1A Pharma primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
Because Clopidogrel 1A Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine. 
Ker je zdravilo Clopidogrel 1A Pharma generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel 1A Pharma can be given to the following groups of patients: 
Zdravilo Clopidogrel 1A Pharma se lahko daje naslednjim skupinam bolnikov:
Clopidogrel 1A Pharma can be started between a few days and 35 days after the attack; 
Zdravilo Clopidogrel 1A Pharma se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
In acute coronary syndrome, Clopidogrel 1A Pharma is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets. 
Pri akutnem koronarnem sindromu se zdravilo Clopidogrel 1A Pharma uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih
Because Clopidogrel 1A Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. 
Ker je zdravilo Clopidogrel 1A Pharma generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
Clopidogrel 1A Pharma clopidogrel EPAR summary for the public 
Clopidogrel 1A Pharma klopidogrel Povzetek EPAR za javnost
Other information about Clopidogrel 1A Pharma: 
Druge informacije o zdravilu Clopidogrel 1A Pharma:
Clopidogrel 1A Pharma can be started between seven days and six months after 
Zdravilo Clopidogrel 1A Pharma se lahko začne jemati od sedem dni po napadu in do šest mesecev po njem;
The Committee recommended that Clopidogrel 1A Pharma be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Clopidogrel 1A Pharma odobri dovoljenje za promet.
What are the benefit and risk of Clopidogrel 1A Pharma? 
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel 1A Pharma?
Clopidogrel 1A Pharma is a ‘generic medicine'. 
Clopidogrel 1A Pharma je „generično zdravilo“.
Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel. 
Clopidogrel 1A Pharma je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Clopidogrel 1A Pharma, klopidogrel, je zaviralec agregacije trombocitov.
The full EPAR for Clopidogrel 1A Pharma can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel 1A Pharma je na voljo tukaj.
Why has Clopidogrel 1A Pharma been approved? 
Zakaj je bilo zdravilo Clopidogrel 1A Pharma odobreno?
How has Clopidogrel 1A Pharma been studied? 
Kako je bilo zdravilo Clopidogrel 1A Pharma raziskano?
What is Clopidogrel 1A Pharma? 
Kaj je zdravilo Clopidogrel 1A Pharma?
What is Clopidogrel 1A Pharma used for? 
Za kaj se zdravilo Clopidogrel 1A Pharma uporablja?
How does Clopidogrel 1A Pharma work? 
Kako zdravilo Clopidogrel 1A Pharma deluje?
How is Clopidogrel 1A Pharma used? 
Kako se zdravilo Clopidogrel 1A Pharma uporablja?
Results are heterogeneous and inconsistent. 
Rezultati so heterogeni in nedosledni.
In six of the evaluable studies with population under 100 patients there were similar findings. 
V šestih ocenljivih študijah s populacijo, manjšo od 100 bolnikov, so bile ugotovitve podobne.
It produces a decrease in blood pressure and an increase in peripheral blood flow. 
Povzroča znižanje krvnega tlaka in poveča periferni krvni pretok.
In Europe, dihydroergocristine is also available in combination with etofyllinum. 
V Evropi je dihidroergokristin na voljo tudi v kombinaciji z etofilinom.
Overall summary of the scientific evaluation of dihydroergocristine containing medicinal products (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergokristin (glejte Prilogo I)
The CHMP was of the opinion that no efficacy conclusion could be drawn based on these studies. 
Odbor CHMP je menil, da na podlagi teh študij ni mogoče sklepati o učinkovitosti.
The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocristine. 
CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti dihidroergokristina.
There were 3 placebo controlled studies with a study population of 200-240 patients. 
Opravljene so bile 3 s placebom nadzorovane študije, ki so vključile populacijo od 200 do 240 bolnikov.
Of the 6 randomised, double blind, placebo-controlled studies, 5 studies were not considered relevant by the CHMP because the definition of the diagnosis was not standardised, no primary efficacy criterion was selected among the multi-dimensional assessment, the number of patients per group was small (from 47 to 65), and the treatment duration was short (2 and 3 months). 
Od 6 randomiziranih, dvojno slepih, s placebom nadzorovanih študij jih 5 po mnenju odbora CHMP ni bilo ustreznih, saj opredelitev diagnoze ni bila standardizirana, med večrazsežnostno oceno ni bilo izbrano nobeno primarno merilo za učinkovitost, število bolnikov na skupino je bilo majhno (od 47 do 65), zdravljenje pa je bilo kratko (2 in 3 mesece).
• The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocristine 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 dihidroergokristina v zvezi s trenutno ocenjenimi indikacijami izredno omejeni, zato je zgoraj omenjeno tveganje večje od morebitne koristi za bolnike v zvezi s temi indikacijami;
Moreover the severity of such adverse effects, their possible fatal outcome and the raised risk for patient to develop a fibrotic disorder with long term use according to the authorised indications should be underlined. 
Poleg tega je treba izpostaviti resnost teh neželenih učinkov, njihov morebitni smrtni izid in povečano tveganje za razvoj fibrotične motnje pri dolgotrajni uporabi, skladni z odobrenimi indikacijami.
Under-reporting can also be suspected because the substance has been on the market for a long time and because fibrosis is already mentioned as an undesirable effect 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.
Of these, 18 concerned placebocontrolled trials, 2 concerned actively-controlled trials and 7 concerned open label studies. 
Od teh se jih je 18 nanašalo na s placebom nadzorovana preskušanja, 2 na z zdravilno učinkovino nadzorovani preskušanji, 7 pa na odprte študije.
Although some of the proposed measures could help identify patients with pre-existing 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 nekateri od predlaganih ukrepov 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.
Dihydroergocristine is a partial agonist of α-adrenoreceptors that decreases the activity of sympathetic centres and is responsible for a peripheral adrenolytic effect with an increased venous wall tone. 
Dihidroergokristin je delni agonist alfa-adrenoreceptorjev, ki zmanjša dejavnost simpatičnih centrov in je odgovoren za periferni adrenolitični učinek s povečanim tonusom venskih sten.
From the approved indications of the dihydroergocristine 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 dihidroergokristin, 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):
While it is agreed that the medical terminology used nowdays and in the past differs and that the data needs to be assessed bearing this aspect in mind, the clinical symptom of dementia is a result of various pathophysiological processes which makes pooling and comparison of the data difficult, especially when the individual studies used slightly different inclusion criteria. 
Medtem ko je jasno, da se današnja medicinska terminologija razlikuje od tiste v preteklosti in da je treba to upoštevati pri ocenjevanju podatkov, je klinični simptom demence rezultat različnih patofizioloških procesov, zaradi česar je združevanje in primerjanje podatkov oteženo, predvsem ker so posamezne študije uporabljale rahlo različna merila za vključevanje preskušancev.
In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the identified risk. 
Za preklic začasnega umika morajo imetniki dovoljenja za promet z zdravilom ugotoviti specifično populacijo bolnikov, pri kateri so koristi zdravila večje od ugotovljenega tveganja.
The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation. 
Imetniki dovoljenj za promet z zdravilom so predložili vse razpoložljive podatke o učinkovitosti iz kliničnih preskušanj in opazovalnih študij, vključno s podatki, ki so se pridobili po odobritvi prvotnega dovoljenja za promet z zdravilom.
Among these 3 studies, the publications by Lazzaroni et al and Aranda et al indicated superiority over placebo, while the study by Vellas et al demonstrated similar efficacy to placebo. 
Pri teh 3 študijah sta objavi Lazzaronija in sodelavcev ter Arande in sodelavcev pokazali superiornost v primerjavi s placebom, študija Vellasa in sodelavcev pa je pokazala učinkovitost, podobno placebu.
However, in this study with adequate methodological quality standard, non-significant difference between dihydroergocristine + raubasine and placebo groups was observed. 
Vendar v tej študiji z zadostnim standardom metodološke kakovosti niso opazili pomembne razlike med skupinami s kombinacijo dihidroergokristina ter ravbazina in placebom.
• The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocristine cannot be excluded. 
• odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in dihidroergokristinom ni mogoče izključiti.
In addition, on the basis of the reported cases, vasoconstriction induced by dihydroergocristine cannot be excluded. 
Poleg tega na podlagi poročanih primerov ni mogoče izključiti vazokonstrikcije, ki jo povzroča dihidroergokristin.
This is indicative of a causal relationship between fibrosis and dihydroergocristine. 
To kaže na vzročno povezavo med fibrozo in dihidroergokristinom.
All the data submitted were reviewed and considered, and though it can be interpreted as suggestive of mild efficacy of dihydroergocristine in the”treatment of chronic cognitive impairment in the elderly”, efficacy cannot be considered as sufficiently demonstrated namely due to the inconsistency of the data generated in the larger trials. 
Pregledali in upoštevali so se vsi predloženi podatki in čeprav kažejo na blago učinkovitost dihidroergokristina pri „zdravljenju kronične kognitivne okvare pri starejših“, učinkovitosti ni mogoče obravnavati kot zadostno dokazane zaradi nedoslednosti podatkov, pridobljenih v večjih preskušanjih.
The data from the reported cases of fibrosis (n=12) are indicative of the capacity of dihydroergocristine to induce fibrotic reactions, mostly localised in the pulmonary area considering also the improvement of some patients following discontinuation of the product. 
Podatki o poročanih primerih fibroze (n = 12) kažejo na zmožnost dihidroergokristina za povzročanje fibrotičnih reakcij, predvsem lokaliziranih v pljučnem območju, kar se je pokazalo tudi z izboljšanjem pri nekaterih bolnikih po prekinitvi uporabe zdravila.
The CHMP also noted the position of one of the MAHs that due to the limitations of the data available, the ocular indicaton cannot be upheld. 
Odbor CHMP je prav tako upošteval mnenje enega od imetnikov dovoljenj za promet z zdravilom, da zaradi omejitev razpoložljivih podatkov očesne indikacije ni mogoče ohraniti.
Moreover, it was pointed out that topical instillations of dihydroergocristine are out of the scope of this procedure. 
Poleg tega je izpostavil, da je topično vkapavanje dihidroergokristina zunaj sklopa tega postopka.
It is available in combination with raubasine that is an adrenolytic and sympatholytic agent with an inhibitory effect on sympathetic centres. 
Na voljo je v kombinaciji z ravbazinom, adrenolitično in simpatikolitično učinkovino z zaviralnim učinkom na simpatične centre.
It should also be underlined that reports of reduction of the extension of the fibrotic plaque a long time after dihydroergocristine withdrawal, improvements after dihydroergocristine discontinuation and positive rechallenge (symptoms re-occurring on readministration) have been reported. 
Prav tako je treba izpostaviti, da so poročali o zmanjšanju obsežnosti fibrotičnega plaka dolgo po prekinitvi uporabe dihidroergokristina, izboljšanju po prekinitvi dihidroergokristina in pozitivni provokaciji (ponovnem pojavu simptomov po ponovni uporabi).
Based on these data and based on the pharmacological plausibility, dihydroergocristine is considered to be associated with fibrotic reactions. 
Na podlagi teh podatkov in farmakološke verjetnosti menijo, da je dihidroergokristin povezan s fibrotičnimi reakcijami.
These included 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 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.
In addition it has a pharmacological action on the serotoninergic and dopaminergic receptors leading to interesting effects on cerebral metabolism. 
Poleg tega ima farmakološki učinek na serotoninergične in dopaminergične receptorje, kar povzroča zanimive učinke na presnovo v možganih.
• The Committee considered that the benefit-risk balance of dihydroergocristine containing products: 
• odbor je menil, da razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokristin:
• The suspension of the marketing authorisation for dihydroergocristine 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 dihidroergokristin, če se kot del njihovega dovoljenja za promet z zdravilom ne odobrijo nobene druge indikacije.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications. 
• odbor je v skladu s členom 31 Direktive 2001/83/ES obravnaval napotitveni postopek za zdravila, ki vsebujejo dihidroergokristin, pri zadevnih indikacijah;
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).
− Is not favourable for acute retinopathies of vascular origin. 
− ni ugodno za akutno retinopatijo žilnega izvora;
• Symptomatic treatment of veno-lymphatic insufficiency 
• simptomatsko zdravljenje veno-limfatične insuficience.