FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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).
English: How is Retaane expected to work?
Slovenian: Kako naj bi zdravilo Retaane delovalo?
English: 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).
Slovenian: 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).
English: London, 23 March 2006 Doc.Ref.
Slovenian: London, 23 March 2006 EMEA/H/C/635
English: The study was well conducted and according to current scientific standards.
Slovenian: Študija je bila dobro izvedena in v skladu s trenutnimi znanstvenimi standardi.
English: On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place.
Slovenian: 27. septembra 2012 je potekalo plenarno zasedanje stalnega odbora za zdravila za uporabo v veterinarski medicini.
English: 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.
Slovenian: 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.
English: Seven sites in three countries have been investigated.
Slovenian: Pod drobnogled so vzeli sedem lokacij v treh državah.
English: 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.
Slovenian: Zadevne države članice niso uspele doseči dogovora v zvezi z zdravilom, zato je bila zadeva 19. decembra 2011 predložena odboru CVMP.
English: 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.
Slovenian: Omenjeni večji odmerki in trajanje zdravljenja so odobreni v več državah članicah EU, na primer na Danskem, Nizozemskem in v Združenem kraljestvu.
English: Strength Animal species
Slovenian: Ciljna živalska vrsta
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtska oblika, jakost zdravila za uporabo v veterinarski medicini, ciljna živalska vrsta, način uporabe , predlagatelj v državi članici
English: As the activity of florfenicol is time dependent, the active concentration has to be above MIC for a certain time.
Slovenian: Ker je delovanje florfenikola odvisno od časa, mora biti aktivna koncentracija določen čas nad MIK.
English: 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.
Slovenian: V študijo mora vključiti zadostno število ciljnih živali, da zagotovi veljavne rezultate, tako v smislu klinične kot tudi statistične pomembnosti.
English: 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.
Slovenian: 31. avgusta 2012, med pisnim delom postopka stalnega odbora, je Nizozemska vložila ugovor zoper mnenje, ki ga je 13. junija 2012 sprejel CVMP.
English: 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.
Slovenian: Terensko študijo mora zasnovati po vzorcu terenske študije V-0049-0059, tj. vključiti mora podobne vključitvene/izključitvene kriterije in klinične končne točke.
English: 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.
Slovenian: 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.
English: Relevance of the choice of positive control product
Slovenian: Relevantnost izbire zdravila za pozitivno kontrolo
English: On 13 June 2012 the CVMP adopted an opinion regarding this referral.
Slovenian: 13. junija 2012 je CVMP sprejel mnenje v zvezi z omenjeno napotitvijo.
English: On 3 October 2012 the European Commission sent a letter to the CVMP requesting a reconsideration of the opinion adopted on 13 June 2012.
Slovenian: Evropska komisija je 3. oktobra 2012 v dopisu pozvala CVMP, naj ponovno preuči mnenje, ki ga je sprejel dne 13. junija 2012.
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za zavrnitev odobritve dovoljenj za promet z zdravilom
English: No robust information is available about the distribution of florfenicol to the site of infection.
Slovenian: O porazdelitvi florfenikola na mestu okužbe ni na voljo nobenih zanesljivih podatkov.
English: For approximately 36 hours 1 µg/ml may be covered, whereas 2 µg/ml is covered only for a very short time.
Slovenian: Približno 36 ur je lahko vrednost 1 µg/ml, medtem ko koncentracija 2 µg/ml obstane zelo kratek čas.
English: 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.
Slovenian: V praksi je vloga postantibiotičnega učinka pri učinkovitosti zdravila sporna, tako da ni mogoče podati nobenih trdnih zaključkov glede trajanja učinka.
English: 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.
Slovenian: 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.
English: Enrofloxacin 5% solution for injection was used for control.
Slovenian: Za kontrolo so uporabili 5-odstotno raztopino enrofloksacina za injiciranje.
English: Correlation between plasma concentrations and pulmonary concentrations or high failure rate
Slovenian: Korelacija med plazemskimi koncentracijami in pljučnimi koncentracijami oziroma visoko stopnjo neuspešnosti zdravljenja
English: 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.
Slovenian: 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.
English: Florfenicol is bacteriostatic and exerts time-dependent activity.
Slovenian: Florfenikol deluje bakteriostatično in v odvisnosti od časa.
English: The official clinical break point for florfenicol sensitivity is ≤2 µg/ml.
Slovenian: Uradna klinična mejna vrednost za občutljivost za florfenikol je ≤ 2 µg/ml.
English: 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.
Slovenian: 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.
English: One explanation for the high failure rate of Nuflor Swine Once may be the short duration of active concentration at the infection sites.
Slovenian: Eden od možnih vzrokov za visoko stopnjo neuspešnosti zdravljenja z zdravilom Nuflor Swine Once bi lahko bila kratkotrajna prisotnost aktivnih koncentracij na mestih okužbe.
English: 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.
Slovenian: 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.
English: Such high variations in failure rates reveal the risk of insufficient clinical efficacy and thus, represent an animal welfare concern.
Slovenian: Tako spremenljive stopnje neuspešnosti zdravljenja kažejo na možnost pomanjkanja klinične učinkovitosti, zaradi česar je lahko ogroženo dobro počutje živali.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Slovenian: Po preučitvi predloženih podatkov je CVMP glede vprašanj, ki jih je v sporočilu poslala Nemčija, podal zaključke, ki so navedeni v nadaljevanju.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Kljub temu je bil Odbor izjemno zaskrbljen zaradi zelo spremenljivih stopenj neuspešnosti zdravljenja, zabeleženih v klinični terenski študiji 11. dan po zdravljenju (primarni cilj).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Razlogi za opažena odstopanja niso znani in jih je nemogoče ugotoviti na podlagi študije ali drugih podatkov, ki so bili predloženi med napotitvenim postopkom.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Clinical efficacy was assessed based on mean cumulative failure rates on Day 5 and Day 11 post-treatment.
Slovenian: Klinično učinkovitost zdravila so ocenili na podlagi povprečne kumulativne stopnje neuspešnosti 5. in 11. dan po končanem zdravljenju.
English: 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.
Slovenian: 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.
English: The choice of the selected positive control product and its dosing regimen were considered by the Committee, as well as whether it is appropriate to compare a time-dependent antimicrobial (florfenicol) and a concentration-dependent antimicrobial (enrofloxacin).
Slovenian: CVMP je preučil izbiro uporabljenega zdravila za pozitivno kontrolo in način njegovega odmerjanja ter tudi primernost primerjave časovno odvisnega antimikrobnega zdravila (florfenikola) in od koncentracije odvisnega antimikrobnega zdravila (enrofloksacina).
English: In view of the uncertainties and lack of data, the Standing Committee concluded that the CVMP should reconsider the opinion and evaluate again the benefit-risk balance of Nuflor Swine Once 450 mg/kg solution for injection.
Slovenian: Ob upoštevanju nejasnosti in pomanjkanja podatkov je stalni odbor zaključil, da bi moral CVMP ponovno preučiti mnenje in še enkrat oceniti razmerje med tveganji in koristmi za zdravilo Nuflor Swine Once 450 mg/kg raztopina za injiciranje.
English: The Standing Committee noted that the CVMP recommended the granting of the marketing authorisation of the product subject to a condition requesting further clinical data on the efficacy of the veterinary medicinal product.
Slovenian: Upošteval je, da je CVMP priporočil odobritev vloge za pridobitev dovoljenja za promet z zdravilom pod pogojem, da se zagotovijo dodatni klinični podatki o učinkovitosti tega zdravila za uporabo v veterinarski medicini.
English: This control should preferably belong to a different class of antimicrobials for which sufficient efficacy has been demonstrated, e.g. tulathromycin.
Slovenian: Priporočeno je, da uporabi kontrolno zdravilo iz druge skupine antimikrobnih zdravil, katerega učinkovitost je že bila dokazana, npr. tulatromicin.
English: The persistence of A. pleuropneumoniae in alveolar macrophages might be one possible explanation for these results, but is not verified by clinical data.
Slovenian: Eden od možnih vzrokov za odstopanja bi lahko bila vztrajna prisotnost A. pleuropneumoniae v alveolarnih makrofagih, vendar pa tega ni mogoče potrditi s kliničnimi podatki.
English: The proposed dose is 30 mg florfenicol/kg bodyweight given by intramuscular administration as a single injection.
Slovenian: Predlagani odmerek je 30 mg florfenikola/kg telesne mase, ki se ga daje intramuskularno z enkratnim injiciranjem.
English: The failure rate for Nuflor Swine Once varied from 0 to 56% at Day 11 and was similar to the comparator enrofloxacin with 0 to 42%.
Slovenian: Stopnja neuspešnosti zdravljenja z zdravilom Nuflor Swine Once, zabeležena 11. dan, je znašala od 0 do 56 % in je bila podobna stopnji za primerjalno zdravilo enrofloksacin, ki se je gibala od 0 do 42 %.
English: The marketing authorisation holder should provide a GCP-compliant clinical field study.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izvesti klinično terensko študijo v skladu z dobro klinično prakso.
English: Based on the available pharmacokinetic data in swine and limited experiments in other species it is reasonable to predict that florfenicol concentrations may be equal at the level as in plasma.
Slovenian: Na podlagi razpoložljivih farmakokinetičnih podatkov za prašiče in nekaterih poskusov pri drugih živalskih vrstah pa je mogoče utemeljeno sklepati, da je koncentracija florfenikola na teh mestih enaka kot v plazmi.
English: The reasons for the observed large variation of failure rates in the clinical field study are not known and cannot be determined from this study, nor on basis of other data presented during this referral procedure.
Slovenian: Razlogi za zelo spremenljive stopnje neuspešnosti zdravljenja, opažene v klinični terenski študiji, niso znani in jih je nemogoče ugotoviti iz študije ali na podlagi drugih podatkov, ki so bili predloženi med napotitvenim postopkom.
English: Concerns have been raised about the high failure rate observed in the pivotal field study and the choice and dose of the positive control product used in that field study.
Slovenian: Zadržki so se pojavili zaradi visoke stopnje neuspešnosti zdravljenja, zabeležene med ključno terensko študijo, in izbire zdravila za pozitivno kontrolo ter njegovih odmerkov , uporabljenih v tej terenski študiji.
English: The Committee considered whether the proposed dose of 30 mg/kg bw intramuscularly once may lead to a long sub-therapeutic period (e.g. below the MIC) and thus to development of florfenicol resistance.
Slovenian: Odbor je preučil, ali lahko predlagani enkratni intramuskularni odmerek 30 mg/kg telesne mase povzroči dolgotrajne koncentracije pod terapevtsko ravnijo (npr. pod MIK) in s tem razvoj odpornosti na florfenikol.
English: Also, the principle of singledose administration had been questioned in terms of the sustained concentration above the Minimum Inhibitory Concentration (MIC) and the increased potential for development of antimicrobial resistance.
Slovenian: Vprašanja so se pojavila tudi glede dajanja enkratnega odmerka, in sicer glede vzdrževanja koncentracije nad minimalno inhibitorno koncentracijo (MIK) ter povečanega tveganja za razvoj odpornosti na antimikrobna zdravila.
English: The mean cumulative failure rate for Nuflor Swine Once 450 mg/ml solution for injection in this field study was 8.9% on Day 5 and 20.7% on Day 11.
Slovenian: Povprečna kumulativna stopnja neuspešnosti zdravljenja z zdravilom Nuflor Swine Once 450 mg/ml raztopina za injiciranje, zabeležena v terenski študiji, je 5. dan znašala 8,9 %, 11. dan pa 20,7 %.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the clinical efficacy of Nuflor Swine Once 450 mg/ml solution for injection at a single intramuscular dose of 30 mg/kg bw in the treatment of swine respiratory disease.
Slovenian: Napotitveni postopek v skladu s členom 33(4) Direktive 2001/82/ES je bil sprožen zaradi pomislekov, da predlagatelj ni v zadovoljivi meri dokazal klinične učinkovitosti zdravila Nuflor Swine Once 450 mg/ml raztopina za injiciranje pri enkratnem intramuskularnem odmerku 30 mg/kg telesne mase za zdravljenje bolezni dihal pri prašičih.
English: However, the efficacy could not be clearly confirmed in the pivotal multicentre randomised controlled field study.
Slovenian: Vendar pa v ključni multicentrični, randomizirani, nadzorovani terenski študiji ni bilo mogoče jasno potrditi njegove učinkovitosti.
English: This is a ‘hybrid application' according to Article 13(3) Directive 2001/82/EC, as amended, referring to the reference product, Nuflor Swine 300 mg/ml solution for injection (FR/V/0118/001).
Slovenian: V skladu s členom 13(3) dopolnjene Direktive 2001/82/ES gre za „hibridno vlogo‟, ki se nanaša na referenčno zdravilo Nuflor Swine Once 300 mg/ml raztopina za injiciranje (FR/V/0118/001).
English: The marketing authorisation holder should reconsider the selection of the treatment dose and should provide further clinical data to confirm the efficacy of the intended dosage in the treatment of Swine Respiratory Disease associated with the target pathogens A. pleuropneumoniae, P. multocida and H. parasuis under field conditions.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora ponovno preučiti predlagani odmerek in predložiti dodatne klinične dokaze, pridobljene v dejanskih razmerah na terenu, s katerimi bi potrdili, da je predlagani odmerek učinkovit pri zdravljenju bolezni dihal pri prašičih, ki so povezane s ciljnimi patogeni A. pleuropneumoniae, P. multocida in H. parasuis.