natgillin/translations-raw huggingface dataset:
Dizziness and blurred vision have been reported during treatment with CRIXIVAN. 
Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom CRIXIVAN so poročali o omotici in zamegljenem vidu.
Rosuvastatin AUC  2.08-fold Rosuvastatin Cmax  4.66-fold (Mechanism unknown) 
Cmax rosuvastatina  4,66-krat.
HISTAMINE H2 ANTAGONIST Cimetidine 600 mg BID (Indinavir 400 mg SD) 
Cimetidin 600 mg BID (indinavir 400 mg SD)
Careful monitoring of therapeutic and adverse effects is recommended when fexofenadine is concomitantly administered with indinavir/ritonavir. 
Kadar se takrolimus uporablja sočasno z indinavirjem/ritonavirjem, se priporoča skrbno spremljanje terapevtskih in neželenih učinkov.
Antifungals 
Mutagenost
International Non-proprietary Name (INN): anecortave 
Mednarodno nelastniško ime (INN): anecortave
The two main clinical studies were carried out in patients aged between 51 and 96 years of age, and lasted up to two years. 
Dve glavni klinični raziskavi sta bili opravljeni na bolnikih, starih od 51 do 96 let, in sta trajali do dve leti.
The Company has informed the CHMP that there are clinical trials currently running in Europe. 
Podjetje je CHMP obvestilo, da v Evropi trenutno potekajo klinične raziskave.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you. 
Če sodelujete v klinični raziskavi ali programu sočutne pomoči in potrebujete več informacij o vašem zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
The Company also plans to continue their compassionate use programme on a case-by-case basis. 
Podjetje tudi namerava nadaljevati s programom sočutne uporabe na podlagi presoje posameznih primerov.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for RETAANE 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA ODOBRITEV DOVOLJENJA ZA PROMET za zdravilo RETAANE
After the CHMP had assessed the responses from the Company to a list of questions, there were still unresolved outstanding issues. 
Po tem, ko je CHMP ocenil odgovore podjetja na seznam vprašanj, so še vedno ostala nekatera nerešena vprašanja.
The letter from the Company notifying the EMEA of the withdrawal of Retaane is available here. 
Dopis podjetja, s katerim EMEA obvešča o umiku, je na voljo tukaj.
Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company. 
Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (dan 120), ki ga pošlje podjetju.
Compared to photodynamic therapy, Retaane was not as effective. 
V primerjavi s fotodinamičnim zdravljenjem zdravilo Retaane ni bilo tako učinkovito.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks. 
Posledično je CHMP v času umika menil, da korist ni bila dokazana v zadostni meri in ni večja od znanih tveganj.
The CHMP had concerns that the effectiveness of Retaane was less than what they expected to see: Compared to placebo, Retaane has some effectiveness, but many patients were ‘lost' (exited the study) before the end of the study; and this affects the reliability of the results. 
CHMP je imel pomisleke, da je učinkovitost zdravila Retaane manjša od pričakovane: v primerjavi s placebom je zdravilo Retaane izkazalo določeno učinkovitost, vendar je bilo veliko bolnikov »izgubljenih« (izstopili so iz raziskave) pred zaključkom raziskave, kar vpliva na zanesljivost rezultatov.
The studies measured visual acuity (the results of an eye test) to see how the patients had responded to treatment. 
V raziskavi so merili ostrino vida (rezultati očesnega testa), da bi ugotovili, kako so se bolniki odzvali na zdravljenje.
It is able to stop or slow down the development of new blood vessels by interfering with the production of the proteins needed to build the vessels, and of the growth factors needed for the blood vessels to spread. 
Lahko zavre ali upočasni razvoj novih krvnih žil tako, da vpliva na tvorbo beljakovin, potrebnih za oblikovanje žil, in rastnih faktorjev, potrebnih za širjenje žil.
Retaane was to be injected every 6 months directly into the space behind the eye, as a ‘depot' injection (a type of injection where the medicine is prepared in such a way that it is absorbed by the body very slowly). 
Zdravilo Retaane bi se naj vsakih 6 mesecev injiciralo neposredno v prostor za očesom kot depo injekcija (vrsta injekcije, pri kateri je zdravilo pripravljeno tako, da ga telo zelo počasi absorbira).
The effects of Retaane were first tested in experimental models before being studied in humans. 
Učinki zdravila Retaane so bili najprej preizkušeni s pomočjo izkustvenih modelov, šele nato pa so jih raziskali na ljudeh.
The CHMP normally takes up to 210 days to evaluate a new application. 
CHMP za oceno nove vloge navadno potrebuje do 210 dni.
How far into the evaluation was the application when it was withdrawn? 
Kako daleč je bil postopek ocenjevanja vloge ob umaknitvi vloge?
Retaane was expected to be used to stop or slow down the development of these new blood vessels (neovascularisation) in the eye. 
Zdravilo Retaane bi se naj uporabljalo za zaustavitev ali upočasnitev razvoja teh novih žil (neovaskularizacije) v očeh.
What is Retaane? 
Kaj je zdravilo Retaane?
This disease affects the central part of the retina (called the macula), at the back of the eye and causes loss of vision. 
Ta bolezen prizadene osrednji del mrežnice (imenovan makula), ki leži na zadnji strani očesa, ter povzroči poslabšanje vida.
What documentation has been presented by the Company to support the application to the CHMP? 
Katero dokumentacijo je podjetje predložilo CHMP za podkrepitev svoje vloge?
Following CHMP opinion, it usually takes around 2 months for the European Commission to give a licence. 
Evropska komisija navadno potrebuje za izdajo dovoljenja na podlagi mnenja CHMP še dva meseca.
Anecortave, the active substance in Retaane, is similar in structure to cortisol, a natural hormone in the body. 
Anekortav, zdravilna učinkovina v zdravilu Retaane, je po strukturi podobna kortizolu, naravnemu hormonu v telesu.
Based on the review of the data submitted and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that Retaane could not be approved for the treatment of subfoveal choroidal neovascularisation with classic component due to age-related macular degeneration. 
Na podlagi pregleda predloženih podatkov in odgovorov podjetja na seznam vprašanj, ki ga je poslal CHMP, je imel CHMP v času umika vloge zadržke in se je nagibal k predhodnemu mnenju, da zdravila Retaane ni mogoče odobriti za uporabo pri zdravljenju subfovealne horoidalne neovaskularizacije (CNV) s klasično komponento, povezane s starostno degeneracijo makule (ADM).
The application was at Day 180 when the Company withdrew. 
Ko je podjetje zahtevalo umik vloge, je bila vloga v postopku 180. dan.
The wet form of the disease is caused by abnormal blood vessels under the retina and the macula, which may bleed and leak fluid. 
Vlažno obliko te bolezni povzročajo nenormalne žile pod mrežnico in makulo, ki lahko krvavijo in prepuščajo tekočino.
Retaane is a suspension for injection onto the outer part of the eye ball. 
Zdravilo Retaane je suspenzija za injiciranje, ki se daje v zunanji del zrkla.
Retaane was expected to be used to treat patients with the wet form of age-related macular degeneration. 
Zdravilo Retaane naj bi se uporabljalo za zdravljenje bolnikov z vlažno obliko starostne degeneracije makule.
One compared Retaane at various strengths (3 mg, 15 mg or 30 mg) with a dummy treatment (placebo) in 128 patients. 
V prvi raziskavi so pri 128 bolnikih primerjali zdravilo Retaane v različnih jakostih (3 mg, 15 mg ali 30 mg) s placebom.
It contains 30 mg/ml of the active substance anecortave acetate. 
Zdravilo Retaane vsebuje 30 mg/ml zdravilne učinkovine anekortavov acetat.
What was Retaane expected to be used for? 
Za kaj naj bi se zdravilo Retaane uporabljalo?
The Company plans to continue the two clinical trials in wet AMD patients, as well as the clinical trial in dry AMD patients at risk of developing wet AMD. 
Podjetje namerava nadaljevati z dvema kliničnima raziskavama pri bolnikih z vlažno obliko ADM in s klinično raziskavo pri bolnikih s suho obliko ADM, pri katerih obstaja tveganje, da se razvije v vlažno obliko ADM.
may, before giving an opinion, ask any remaining question(s) (at day 180). 
odgovore na vprašanja, jih CHMP pregleda in pred objavo mnenja zastavi še morebitno/a novo/a vprašanje/a (dan 180).
What are the consequences of the withdrawal for patients undergoing clinical trials / 
Kakšne so posledice umika za bolnike, vključene v klinična preizkušanja /programe sočutne uporabe zdravila Retaane?
The second compared the effect of Retaane 15 mg to photodynamic therapy (the standard treatment for the wet form of AMD, where laser treatment is used to destroy the newly formed blood vessels) in 530 patients. 
V drugi raziskavi so pri 530 bolnikih primerjali učinek zdravila Retaane v jakosti 15 mg s fotodinamičnim zdravljenjem (standardno zdravljenje vlažne oblike starostne degeneracije makule, pri katerem se uporablja laserski postopek za uničevanje novo nastalih žil).
How is Retaane expected to work? 
Kako naj bi zdravilo Retaane delovalo?
have officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Retaane, for the treatment of subfoveal choroidal neovascularisation (CNV) with classic component due to age-related macular degeneration (AMD). 
Dne 28. februarja 2006 je podjetje Alcon Laboratories (Združeno kraljestvo) Limited uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želijo umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Retaane, namenjenim za zdravljenje subfovealne horoidalne neovaskularizacije (CNV) s klasično komponento, povezane s starostno degeneracijo makule (ADM).
The study was well conducted and according to current scientific standards. 
Študija je bila dobro izvedena in v skladu s trenutnimi znanstvenimi standardi.
On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place. 
27. septembra 2012 je potekalo plenarno zasedanje stalnega odbora za zdravila za uporabo v veterinarski medicini.
The application was submitted to Germany as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States. 
Predlagatelj je vlogo predložil Nemčiji kot referenčni državi članici ter zadevnim državam članicam Avstriji, Belgiji, Bolgariji, Cipru, Češki republiki, Danski, Estoniji, Franciji, Grčiji, Madžarski, Irski, Italiji, Latviji, Litvi, Luksemburgu, Malti, Nizozemski, Poljski, Portugalski, Romuniji, Slovaški, Sloveniji, Španiji in Združenemu kraljestvu.
Seven sites in three countries have been investigated. 
Pod drobnogled so vzeli sedem lokacij v treh državah.
The Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 19 December 2011. 
Zadevne države članice niso uspele doseči dogovora v zvezi z zdravilom, zato je bila zadeva 19. decembra 2011 predložena odboru CVMP.
These higher doses and duration of treatment are authorised in a number of EU Member States, e.g. Denmark, the Netherlands and the United Kingdom. 
Omenjeni večji odmerki in trajanje zdravljenja so odobreni v več državah članicah EU, na primer na Danskem, Nizozemskem in v Združenem kraljestvu.
Strength Animal species 
Ciljna živalska vrsta
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States 
Seznam imen, farmacevtska oblika, jakost zdravila za uporabo v veterinarski medicini, ciljna živalska vrsta, način uporabe , predlagatelj v državi članici
As the activity of florfenicol is time dependent, the active concentration has to be above MIC for a certain time. 
Ker je delovanje florfenikola odvisno od časa, mora biti aktivna koncentracija določen čas nad MIK.
This should include sufficiently large number of target animals to ensure the validity of the results in terms of both clinical relevance and statistical significance. 
V študijo mora vključiti zadostno število ciljnih živali, da zagotovi veljavne rezultate, tako v smislu klinične kot tudi statistične pomembnosti.
On 31 August 2012, during the written phase of the Standing Committee procedure, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012. 
31. avgusta 2012, med pisnim delom postopka stalnega odbora, je Nizozemska vložila ugovor zoper mnenje, ki ga je 13. junija 2012 sprejel CVMP.
The design of the field study should follow the design of the field study V-0049-0059 in terms of the inclusion/exclusion criteria and clinical endpoints. 
Terensko študijo mora zasnovati po vzorcu terenske študije V-0049-0059, tj. vključiti mora podobne vključitvene/izključitvene kriterije in klinične končne točke.
According to the legal provisions set out in Annex I of Directive 2001/82/EC a positive control product should be an authorised product according to current European legislation. 
Glede na zakonske določbe iz Priloge I Direktive 2001/82/ES mora biti zdravilo za pozitivno kontrolo odobreno zdravilo, ki je skladno z veljavno evropsko zakonodajo.
Relevance of the choice of positive control product 
Relevantnost izbire zdravila za pozitivno kontrolo
On 13 June 2012 the CVMP adopted an opinion regarding this referral. 
13. junija 2012 je CVMP sprejel mnenje v zvezi z omenjeno napotitvijo.
On 3 October 2012 the European Commission sent a letter to the CVMP requesting a reconsideration of the opinion adopted on 13 June 2012. 
Evropska komisija je 3. oktobra 2012 v dopisu pozvala CVMP, naj ponovno preuči mnenje, ki ga je sprejel dne 13. junija 2012.
Scientific conclusions and grounds for refusal of the granting of the marketing authorisations 
Znanstveni zaključki in podlaga za zavrnitev odobritve dovoljenj za promet z zdravilom
No robust information is available about the distribution of florfenicol to the site of infection. 
O porazdelitvi florfenikola na mestu okužbe ni na voljo nobenih zanesljivih podatkov.
For approximately 36 hours 1 µg/ml may be covered, whereas 2 µg/ml is covered only for a very short time. 
Približno 36 ur je lahko vrednost 1 µg/ml, medtem ko koncentracija 2 µg/ml obstane zelo kratek čas.
However, the role of post-antibiotic effect in terms of efficacy is disputable and no firm conclusions with regard to effect duration can be drawn. 
V praksi je vloga postantibiotičnega učinka pri učinkovitosti zdravila sporna, tako da ni mogoče podati nobenih trdnih zaključkov glede trajanja učinka.
No further guidance on the selection of an appropriate control product, e.g. time-dependent versus concentration-dependent antimicrobials is included in the relevant guideline EMEA/CVMP/627/01-FINAL. 
Drugih navodil glede izbire ustreznega zdravila za kontrolo, na primer glede primerjave časovno odvisnega antimikrobnega zdravila z od koncentracije odvisnim antimikrobnim zdravilom, zadevna smernica EMEA/CVMP/627/01FINAL ne vsebuje.
Enrofloxacin 5% solution for injection was used for control. 
Za kontrolo so uporabili 5-odstotno raztopino enrofloksacina za injiciranje.
Correlation between plasma concentrations and pulmonary concentrations or high failure rate 
Korelacija med plazemskimi koncentracijami in pljučnimi koncentracijami oziroma visoko stopnjo neuspešnosti zdravljenja
It should be noted that since the commencement of this referral procedure, marketing authorisations for Nuflor Swine Once 450 mg/ml solution for injection have been granted in Austria, Bulgaria, France, Germany and Romania. 
Treba je omeniti, da so od začetka napotitvenega postopka dovoljenje za promet z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje odobrile Avstrija, Bolgarija, Francija, Nemčija in Romunija.
Florfenicol is bacteriostatic and exerts time-dependent activity. 
Florfenikol deluje bakteriostatično in v odvisnosti od časa.
The official clinical break point for florfenicol sensitivity is ≤2 µg/ml. 
Uradna klinična mejna vrednost za občutljivost za florfenikol je ≤ 2 µg/ml.
The CVMP noted that the reference product (Enrofloxacin 5% solution for injection) is an authorised product according to the relevant European legislation, and the dosage regimen used in the field study was in accordance with the label claim in the countries of the field studies. 
CVMP je presodil, da je referenčno zdravilo (5-odstotna raztopina enrofloksacina za injiciranje) odobreno zdravilo, ki je v skladu z ustrezno evropsko zakonodajo, in da je bil način odmerjanja, uporabljen v terenski študiji, skladen z vsemi označbami glede zdravila v državah, zajetih v terenske študije.
One explanation for the high failure rate of Nuflor Swine Once may be the short duration of active concentration at the infection sites. 
Eden od možnih vzrokov za visoko stopnjo neuspešnosti zdravljenja z zdravilom Nuflor Swine Once bi lahko bila kratkotrajna prisotnost aktivnih koncentracij na mestih okužbe.
The CVMP therefore considers that Nuflor Swine Once cannot fulfil the principles of responsible use of antimicrobials and concludes that the benefit-risk balance is negative. 
Zato je CVMP menil, da zdravilo Nuflor Swine Once ne izpolnjuje načel o preudarni rabi antimikrobnih zdravil, in je zaključil, da je razmerje med tveganji in koristmi negativno.
Such high variations in failure rates reveal the risk of insufficient clinical efficacy and thus, represent an animal welfare concern. 
Tako spremenljive stopnje neuspešnosti zdravljenja kažejo na možnost pomanjkanja klinične učinkovitosti, zaradi česar je lahko ogroženo dobro počutje živali.
Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany. 
Po preučitvi predloženih podatkov je CVMP glede vprašanj, ki jih je v sporočilu poslala Nemčija, podal zaključke, ki so navedeni v nadaljevanju.
The active substance is included in veterinary medicinal products currently licensed in several countries in the European Union for use in cattle and pigs for the treatment of respiratory diseases. 
Zdravilno učinkovino vsebujejo zdravila za uporabo v veterinarski medicini, ki so odobrena v več državah Evropske unije za zdravljenje bolezni dihal pri govedu in prašičih.
A. pleuropneumoniae is the only organism out of the three target pathogens which is taken up by alveolar macrophages and stored intracellularly in vesicles and possibly gives rise to a re-infection when the macrophages die. 
A. pleuropneumoniae je edini organizem od treh ciljnih patogenov, ki se veže na alveolarne makrofage in se naseli znotraj celic v veziklih ter lahko povzroči ponovno okužbo, ko makrofagi propadejo.
No information is available about the florfenicol distribution to these sites in pigs but limited experiments in other species indicate that the concentration may be approximately similar to the concentration in plasma. 
Podatki o porazdelitvi florfenikola na teh mestih pri prašičih niso na voljo, vendar pa nekateri poskusi pri drugih živalskih vrstah kažejo na to, da bi bila lahko koncentracija približno podobna koncentraciji v plazmi.
Nevertheless, the major concern of the Committee is the high variability of the failure rates in the clinical field study on Day 11 after treatment (primary endpoint). 
Kljub temu je bil Odbor izjemno zaskrbljen zaradi zelo spremenljivih stopenj neuspešnosti zdravljenja, zabeleženih v klinični terenski študiji 11. dan po zdravljenju (primarni cilj).
Theoretically, the ability of an antibiotic to induce a post-antibiotic effect is an attractive property since antibiotic concentrations could fall below the MIC for the bacterium and yet retain their effectiveness in their ability to suppress bacterial growth. 
Teoretično gledano je sposobnost antibiotika, da sproži postantibiotični učinek, dobrodošla lastnost, saj lahko tako koncentracije antibiotika padejo pod MIK, ki veljajo za bakterijo, in kljub temu še vedno učinkovito zavirajo rast bakterij.
The reasons for these observations are not known and cannot be determined from this study, nor on basis of other data presented during this referral procedure. 
Razlogi za opažena odstopanja niso znani in jih je nemogoče ugotoviti na podlagi študije ali drugih podatkov, ki so bili predloženi med napotitvenim postopkom.
Potential serious risks were identified during the decentralised procedure by Denmark regarding the high failure rate observed in the pivotal clinical field trial and potential for development of antimicrobial resistance to florfenicol. 
Med decentraliziranim postopkom je Danska ugotovila morebitna resna tveganja, povezana z visoko stopnjo neuspešnosti zdravljenja, ki so jo zabeležili med ključno klinično terensko študijo, ter z obstoječo nevarnostjo za razvoj odpornosti mikrobov proti florfenikolu.
Having considered all the data submitted in writing and in the oral explanations the CVMP concluded that the observed high and variable clinical failure rates in the clinical field study on Day 11 posttreatment are considered unacceptable. 
Na podlagi predložene pisne dokumentacije in ustnih obrazložitev je CVMP zaključil, da visoke in spremenljive stopnje klinične neuspešnosti zdravljenja, opažene v klinični terenski študiji 11. dan po zdravljenju, niso sprejemljive.
This would mean that an efficient antibiotic either has to penetrate to the site of A. pleuropneumoniae storage (i.e. macrophages vesicles) or to be maintained in a sufficient concentration in the extracellular environment until the A. pleuropneumoniae is liberated from the vesicles when the macrophages die. 
To pomeni, da mora učinkoviti antibiotik bodisi doseči mesto, kjer se nahaja A. pleuropneumoniae (tj. v makrofagih), bodisi v zadostni koncentraciji obstati v zunajceličnem prostoru, dokler se A. pleuropneumoniae ne sprosti iz veziklov, ko makrofagi propadejo.
Several studies reveal that the MIC value for A. pleuropneumoniae and P. multocida vary from 0.25 to 1 µg/ml with MIC90 of 0.5 µg/ml. 
Več študij je pokazalo, da se vrednosti MIK za A. pleuropneumoniae in P. multocida gibljejo med 0,25 in 1 µg/ml z MIK90 0,5 µg/ml.
It is well known that a dose of enrofloxacin of 2.5 mg/kg does not follow the current knowledge of the optimal dosing for a fluoroquinolone, which requires high doses of 5 mg/kg for a treatment period of 3-5 days. 
Kot je znano, odmerek enrofloksacina 2,5 mg/kg ni v skladu s trenutnimi spoznanji o optimalnem odmerjanju fluorokinolona, ki zahteva večje odmerke 5 mg/kg v obdobju zdravljenja, ki traja od 3 do 5 dni.
Pharmacokinetic/pharmacodynamic models using the raw data provided by the applicant could give another explanation for the different treatment failure rates in the clinical field study. 
Farmakokinetični/farmakodinamični modeli na podlagi neobdelanih podatkov, ki jih je predložil predlagatelj, bi prav tako lahko pojasnili različne stopnje neuspešnosti zdravljenja, opažene v klinični terenski študiji.
Clinical efficacy was assessed based on mean cumulative failure rates on Day 5 and Day 11 post-treatment. 
Klinično učinkovitost zdravila so ocenili na podlagi povprečne kumulativne stopnje neuspešnosti 5. in 11. dan po končanem zdravljenju.
It is important to confirm the aetiology of the disease by sampling a sufficient number of study animals at each study site prior to treatment, preferably by trans-tracheal lavage, and present susceptibility data of both Nuflor Swine Once and the control product. 
Pomembno je tudi, da potrdi vzrok bolezni, tako da pred začetkom zdravljenja odvzame vzorce zadostnega števila opazovanih živali na vsaki izmed lokacij študije, najbolje s transtrahealno aspiracijo, in predloži podatke o občutljivosti za zdravilo Nuflor Swine Once in za kontrolno zdravilo.