FrancophonIA/ELRC3.0 huggingface dataset:
English: For the suspension to be lifted the marketing authorisation holders should provide the national competent authorities with scientific evidence to demonstrate that the administration of the vaccine to dams, according to the recommendations of the summary of product characteristics, does not lead to an increased risk of bovine neonatal pancytopenia or propose management measures to mitigate this risk and to demonstrate a favourable benefit-risk balance for the product.
Slovenian: Za preklic začasnega umika morajo imetniki dovoljenja za promet z zdravilom nacionalnim pristojnim organom predložiti znanstvene dokaze za to, da dajanje cepiva materam v skladu s priporočili iz povzetka glavnih značilnosti zdravila ne povzroča povečanega tveganja neonatalne pancitopenije pri govedu, ali predlagati ukrepe za obvladovanje tveganja, da se tveganje zmanjša in dokaže ugodno razmerje med koristmi in tveganji za zdravilo.
English: The Committee reviewed the list of ongoing or planned research studies supported by the marketing authorisation holder to investigate bovine neonatal pancytopenia and the potential relation with Pregsure BVD.
Slovenian: Odbor je pregledal seznam potekajočih ali načrtovanih raziskovalnih študij, ki jih je podprl imetnik dovoljenja za promet z zdravilom, za proučitev neonatalne pancitopenije pri govedu in morebitne povezave z zdravilom Pregsure BVD.
English: • no specific measures could be recommended to ensure that the product is not associated with an unacceptable risk of bovine neonatal pancytopenia under the authorised conditions of use;
Slovenian: • Ni bilo mogoče priporočiti specifičnih ukrepov za zagotovitev, da pri odobrenih pogojih uporabe zdravilo ni povezano z nesprejemljivim tveganjem neonatalne pancitopenije pri govedu.
English: Pribinova 25
Slovenian: Pfizer AH Pribinova 25
English: The CVMP concluded that the overall benefit-risk balance of the product is unfavourable under the authorised conditions of use.
Slovenian: CVMP je sklenil, da celokupno razmerje med koristmi in tveganji za zdravilo pri odobrenih pogojih uporabe ni ugodno.
English: The data evaluated suggest that Pregsure BVD may be one of the contributing factors for bovine neonatal pancytopenia although investigations are currently ongoing to determine all the factors associated with the disorder and the underlying cause.
Slovenian: Proučevani podatki kažejo, da je zdravilo Pregsure BVD eden izmed dejavnikov, ki prispevajo k neonatalni pancitopeniji pri govedu, čeprav trenutno potekajo preiskave za ugotovitev vseh dejavnikov, povezanih z boleznijo in temeljnim vzrokom.
English: In addition to the pharmacovigilance data, the CVMP also took into account epidemiological and experimental studies that provided further evidence to suggest an association between Pregsure BVD and bovine neonatal pancytopenia.
Slovenian: Poleg podatkov o farmakovigilanci je CVMP upošteval tudi epidemiološke in izkustvene študije, ki so podale nadaljnje dokaze glede povezave med zdravilom Pregsure BVD in neonatalno pancitopenijo pri govedu.
English: Pregsure BVD is an inactivated vaccine for the immunisation of female cattle to prevent bovine viral diarrhoea virus (BVDV) type 1 (cytopathogenic strain 5960) transplacental infection and the birth of BVDV type 1 persistently infected calves.
Slovenian: Pregsure BVD je inaktivirano cepivo za imunizacijo samic goveda, s čimer se prepreči okužba z virusom goveje virusne diareje (BVDV) tipa 1 (citopatogeni sev 5960) prek posteljice in skotitev telet, trajno okuženih z BVDV tipa 1.
English: Although the definitive aetiology of bovine neonatal pancytopenia is at present unknown, it appears to be a multi-factorial disorder and the possibility that it may be immune-mediated is consistent with available epidemiological data and is becoming a focus of research efforts to identify the causal factor(s) for calves developing bovine neonatal pancytopenia.
Slovenian: Čeprav dokončna etiologija neonatalne pancitopenije pri govedu trenutno ni znana, se zdi, da gre za multifaktorsko bolezen; poleg tega je možnost, da utegne biti imunsko povzročena, skladna z razpoložljivimi epidemiološkimi podatki in postaja osrednja točka raziskovalnih prizadevanj za opredelitev vzročnih dejavnikov za razvoj neonatalne pancitopenije pri govedu pri teletih.
English: • the CVMP concluded that the benefit-risk balance for Pregsure BVD is unfavourable under the authorised conditions of use;
Slovenian: • CVMP je sklenil, da razmerje med koristmi in tveganji za zdravilo Pregsure BVD pri odobrenih pogojih uporabe ni ugodno.
English: Slovak republic Pfizer Luxembourg SARL o.z.
Slovenian: Pfizer Luxembourg SARL o.z.
English: Whilst acknowledging the limitations of the pharmacovigilance data and the lack of appropriate control animals in some of laboratory studies, having evaluated the data available, the CVMP concluded the above-mentioned findings provide evidence to suggest a potential association between the occurrence of bovine neonatal pancytopenia and Pregsure BVD.
Slovenian: Ob priznavanju omejitev podatkov o farmakovigilanci in pomanjkanja ustreznih kontrolnih živali v nekaterih laboratorijskih študijah je CVMP po ovrednotenju razpoložljivih podatkov zaključil, da zgoraj navedeni izsledki dokazujejo morebitno povezavo med primeri neonatalne pancitopenije pri govedu in zdravilom Pregsure BVD.
English: A number of laboratory studies identified the ingestion of colostral antibodies from vaccinated dams as a potential risk factor.
Slovenian: Iz številnih laboratorijskih študij je bilo razvidno, da je zaužitje protiteles iz mleziva cepljenih mater možen dejavnik tveganja.
English: Following the evaluation of adverse event reports of bovine neonatal pancytopenia after the use of Pregsure BVD, and epidemiological data and findings from research projects on bovine neonatal pancytopenia, the German authority (Paul-Ehrlich Institut (PEI)) questioned the benefit-risk balance for the product.
Slovenian: Po ovrednotenju poročil o neželenih primerih neonatalne pancitopenije pri govedu po uporabi zdravila Pregsure BVD, epidemioloških podatkov in izsledkov raziskovalnih projektov v zvezi z neonatalno pancitopenijo pri govedu je nemški organ (Paul-Ehrlich Institut (PEI)) izrazil pomisleke glede razmerja med koristmi in tveganji za zdravilo.
English: The overall incidence for bovine neonatal pancytopenia events reported following use of the product was estimated to be over 0.016% across the EU, based on a single dose, between 2004 and 2009.
Slovenian: Splošna pojavnost poročanih primerov neonatalne pancitopenije pri govedu po uporabi zdravila je bila med leti 2004 in 2009 ocenjena na več kot 0,016 % v EU, pri čemer je ocena temeljila na posameznem odmerku.
English: The aetiology of bovine neonatal pancytopenia is unknown at present and the potential association with Pregsure BVD is the focus of ongoing research.
Slovenian: Etiologija neonatalne pancitopenije pri govedu trenutno še ni znana, morebitna povezava z zdravilom Pregsure BVD pa je osrednja točka trenutne raziskave.
English: In addition, unpublished data from a study involving negative control farms to investigate management factors potentially associated with bovine neonatal pancytopenia identified a history of Pregsure BVD vaccination at the herd level as a potential risk factor for bovine neonatal pancytopenia.
Slovenian: Poleg tega neobjavljeni podatki iz študije, ki je vključevala negativne kontrolne farme za proučevanje dejavnikov upravljanja, ki utegnejo biti povezani z neonatalno pancitopenijo pri govedu, kažejo, da je anamneza cepljenja z zdravilom Pregsure BVD na ravni črede možen dejavnik tveganja neonatalne pancitopenije pri govedu.
English: It was noted that in Member States where Pregsure BVD was not marketed or in herds where Pregsure BVD had not been used, bovine neonatal pancytopenia appears to be reported as isolated events and may be compatible with so-called idiopathic bovine neonatal pancytopenia.
Slovenian: Ugotovili so, da so v državah članicah, v katerih zdravilo Pregsure BVD ni bilo na trgu, oz. v čredah, v katerih se zdravilo BVD ni uporabljalo, v zvezi z neonatalno pancitopenijo pri govedu poročali o posameznih primerih, ki so skladni s tako imenovano idiopatsko neonatalno pancitopenijo pri govedu.
English: Evaluation of the potential association between the occurrence of bovine neonatal pancytopenia in calves and vaccination of dams using Pregsure BVD and associated names
Slovenian: Ovrednotenje morebitne povezave med primeri neonatalne pancitopenije pri govedu pri teletih in cepljenjem mater z zdravilom Pregsure BVD in povezanimi imeni
English: Although considered by the marketing authorisation holder, an association between the occurrence of bovine neonatal pancytopenia and the release of particular batch(es) of the product has not been found nor any indication for circovirus contamination of the product.
Slovenian: Kljub pomisleku imetnika dovoljenja za promet z zdravilom povezava med primeri neonatalne pancitopenije pri govedu in sproščanjem določenih serij zdravila ni bila ugotovljena, kot tudi ne indikacija kontaminacije zdravila s cirkovirusom.
English: • adverse events of bovine neonatal pancytopenia reported after the use of Pregsure BVD appear to indicate an association with the product.
Slovenian: • Neželeni primeri neonatalne pancitopenije pri govedu, o katerih so poročali po uporabi zdravila Pregsure BVD, kažejo povezavo z zdravilom.
English: Preliminary epidemiological findings report an association between bovine neonatal pancytopenia calves and a vaccination history, at the herd level, involving Pregsure BVD.
Slovenian: Uvodni epidemiološki izsledki poročajo o povezavi med teleti z neonatalno pancitopenijo pri govedu in anamnezo cepljenja na ravni črede, ki vključuje zdravilo Pregsure BVD.
English: Member State Marketing Authorisation Holder
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: From the data evaluated to date, there is evidence to suggest a potential association between vaccination of dams using Pregsure BVD and the occurrence of bovine neonatal pancytopenia in calves.
Slovenian: Podatki, ki so bili doslej ovrednoteni, kažejo morebitno povezavo med cepljenjem mater z zdravilom Pregsure BVD in pojavom neonatalne pancitopenije pri govedu pri teletih.
English: Germany is the Member State where most adverse events of bovine neonatal pancytopenia have been reported.
Slovenian: O največ neželenih primerih neonatalne pancitopenije pri govedu so poročali iz Nemčije.
English: 150 00 Praha
Slovenian: Stroupežnického 17 150 00 Praha CZECH REPUBLIC
English: Administration of Pregsure BVD to female cattle allows prevention of BVDV type 1 transplacental infection and the birth of BVDV type 1 persistently infected calves and laboratory scale investigations have also demonstrated that vaccination can reduce fertility losses due to BVDV type 1 infection in the early stage of gestation.
Slovenian: Dajanje zdravila Pregsure BVD samicam goveda omogoča preprečevanje okužbe z BVDV tipa 1 prek posteljice in skotitev telet, trajno okuženih z BVDV tipa 1.
English: Pfizer Animal Health BV Rivium Westlaan 142 2909 LD Capelle a/d Ijssel
Slovenian: Nizozemska Pfizer Animal Health BV Rivium Westlaan 142
English: (Invented) name Strength Pharmaceutical form
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
English: Therefore, concerns about heterogeneity of the studied population remain.
Slovenian: Zato zaskrbljenost glede heterogenosti proučevane populacije ostaja.
English: The publications on clinical data are old (from 1971 up to 1995).
Slovenian: Publikacije, ki obravnavajo klinične podatke, so stare (iz obdobja med letoma 1971 in 1995).
English: Therefore, the CHMP maintained its opinion of 27 June 2013 and therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Slovenian: Zato je CHMP potrdil mnenje z dne 27. junija 2013 in v skladu s členom 116 Direktive 2001/83/ES priporočil naslednje:
English: All these old studies suffered from methodological flaws.
Slovenian: Vse te stare študije so imele metodološke pomanjkljivosti.
English: The scales used were largely based on subjective assessment rather than formal testing.
Slovenian: Uporabljene lestvice so večinoma temeljile na subjektivnem ocenjevanju, in ne na formalnih testiranjih.
English: In addition, the CHMP convened another meeting of the scientific advisory group (SAG) that took place on 16 October 2013.
Slovenian: Poleg tega je CHMP sklical še en sestanek znanstveno svetovalne skupine, ki je potekal 16. oktobra 2013.
English: In others, only certain points of the scale to assess efficacy were significantly improved.
Slovenian: V drugih so se pomembno izboljšali samo nekateri rezultati na lestvici za oceno učinkovitosti.
English: Thus the demonstrated benefit for patients in the proposed indication does not outweigh the above identified risk.
Slovenian: Zato opažena korist za bolnike pri predlagani indikaciji ne odtehta zgoraj opredeljenega tveganja.
English: It therefore remains uncertain whether the studied population in the selected clinical studies is representative of the proposed indication.
Slovenian: Zaradi tega še vedno ni jasno, ali je populacija, ki so jo proučevali v izbranih kliničnih študijah, reprezentativna za predlagano indikacijo.
English: Overall summary of the scientific evaluation of dihydroergotoxine containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergotoksin (glejte Prilogo I)
English: Indeed, the heterogeneity of the studies submitted is such that no firm conclusions can be drawn.
Slovenian: Dejansko je heterogenost predloženih študij tako velika, da ni mogoče podati nobenih trdnih zaključkov.
English: The primary mechanism of action of dihydroergotoxine and other ergoloids is unclear at the present time.
Slovenian: Glavni mehanizem delovanja dihidroergotoksina in drugih ergoloidov trenutno še ni povsem pojasnjen.
English: Diagnostic and determination of the origin of cognitive impairments are difficult tasks for the modern medicine.
Slovenian: Diagnosticiranje in opredelitev vzroka za kognitivne okvare sta težki nalogi za sodobno medicino.
English: No reports of ergotism were stated, however, the CHMP questioned the appropriateness of the data collection method (i.e. non exhaustive and thus inconclusive).
Slovenian: Navedena niso bila nobena poročila o ergotizmu, vendar je CHMP podvomil o ustreznosti načina zbiranja podatkov (tj. podatki so premalo izčrpni in zato neprepričljivi).
English: In addition, both included a small number of patients (n=48 and n=62), both were short-term studies (1-5 months and 8 months, respectively) which short term duration is considered inappropriate to evaluate the outcome of slow progressing diseases.
Slovenian: Poleg tega je v obeh študijah sodelovalo majhno število bolnikov (n = 48 oziroma n = 62) in obe sta trajali kratek čas (od 1-5 mesecev oziroma 8 mesecev), kar ni primerno za vrednotenje izida bolezni, ki napredujejo počasi.
English: In general, a drug investigated in the prodromal stages of dementia would need to demonstrate improvement in cognitive function, and additionally, delay of progression to dementia.
Slovenian: Na splošno bi zdravilo, raziskovano v prodromalnih fazah demence, moralo izboljšati kognitivno funkcijo, poleg tega pa tudi upočasniti napredovanje v demenco.
English: The MAH submitted a number of papers with efficacy clinical studies, 2 reviews (the medical letter, 1974, Mc Donald, 1979) and one Cochrane review (2009).
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil številne članke, ki obravnavajo klinične študije učinkovitosti, 2 pregleda (zdravniško pismo, 1974, Mc Donald, 1979) in en pregled skupine Cochrane (2009).
English: Moreover, three out of the nine cases were reported during the French Pharmacovigilance survey that was conducted in 2011 which shows that the risk minimisation measures that are currently in place are not sufficient to prevent the risk of fibrotic reactions.
Slovenian: Poleg tega so tri od devetih primerov odkrili v francoski raziskavi farmakovigilance, ki so jo opravili leta 2011, kar kaže, da trenutni ukrepi za zmanjšanje tveganja ne zadostujejo za preprečitev tveganja za fibrotične reakcije.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Slovenian: Odbor je izpostavil resnost teh neželenih učinkov in njihov možni smrtni izid;
English: 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.
Slovenian: Poleg tega je treba izpostaviti resnost teh neželenih učinkov, njihov možen smrtni izid in povečano tveganje za razvoj fibrotične motnje pri dolgotrajni uporabi, skladni z odobrenimi indikacijami.
English: The two comparative studies described by the MAH (Orma, 1958 and Vannas, 1958) were of poor methodological quality; moreover no information is available about the exact design or randomisation in the different groups tested.
Slovenian: Dve primerjalni študiji, ki ju je opisal imetnik dovoljenja za promet z zdravilom (Orma, 1958 in Vannas, 1958), je zaznamovala slaba metodološka kakovost; poleg tega ni na voljo nobenih podatkov o točni zasnovi ali randomizaciji v različne skupine.
English: The majority of the papers are not relevant (publications not submitted, studies were open-label, not placebo-controlled and/or with intravenous use of dihydroergotoxine mesilate).
Slovenian: Večina člankov ni relevantna (publikacije niso bile predložene, študije so bile odprtega tipa in so bile izvedene brez kontrole s placebom in/ali z intravensko uporabo dihidroergotoksinijevega mesilata).
English: Furthermore, those reporting positive results are claiming improvement in different parameters in scales intended to capture important aspects of impaired cognition.
Slovenian: Poleg tega študije, ki so poročale o pozitivnih rezultatih, navajajo izboljšanje različnih parametrov na lestvicah, ki naj bi zajele pomembne vidike motenj kognitivnih funkcij.
English: Dementia and dementia related indications, as well as the acute treatment of migraine, are outside the scope of this referral procedure.
Slovenian: Demenca in z demenco povezane indikacije ter akutno zdravljenje migrene ne spadajo v sklop tega napotitvenega postopka.
English: The Cochrane review is not relevant for the assessment as it focuses on dementia and symptoms consistent with dementia.
Slovenian: Pregled skupine Cochrane ni pomemben za ta postopek ocenjevanja, saj se osredotoča na demenco in simptome, značilne za demenco.
English: With the current patient evaluation tools, the distinction between mild or moderate cognitive impairment and early stage of Alzheimer or of other dementia is difficult.
Slovenian: S trenutno razpoložljivimi orodji za vrednotenje bolnikov je težko razlikovati med blago ali zmerno kognitivno okvaro in zgodnjo fazo Alzheimerjeve bolezni ali drugih oblik demence.
English: In the 19 clinical studies that are argued to be supportive of this restricted indication, and which included heterogeneous populations, some did not show significant effects of dihydroergotoxine.
Slovenian: Med 19 kliničnimi študijami, ki naj bi podpirale to omejeno indikacijo in v katere so bile vključene heterogene populacije, je bilo nekaj takih, ki niso pokazale pomembnih učinkov dihidroergotoksina.
English: Issues such as a high dropout level, unclear or subjective evaluation criterions and low number of patients also preclude a conclusion on efficacy based on these data.
Slovenian: Pomanjkljivosti, kot so veliko število bolnikov, ki so izstopili iz študije, nejasni ali subjektivni kriteriji vrednotenja in majhno število bolnikov, prav tako onemogočajo, da bi na podlagi teh podatkov podali zaključke o učinkovitosti.
English: Furthermore, the fact that these studies have been performed many years ago raises methodological concerns given advances in clinical research methods and the changes in the definition of dementia/ pre-dementia conditions over time.
Slovenian: Poleg tega je bil zaradi dejstva, da so bile te študije opravljene pred mnogimi leti, odbor zaskrbljen zaradi metodoloških pomanjkljivosti, ki so posledica napredka kliničnih raziskovalnih metod in sprememb definicije demence/bolezenskih stanj, ki vodijo v demenco.
English: Although some of the proposed measures could help identify patients with preexisting fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
Slovenian: Čeprav lahko nekateri od predlaganih ukrepov pomagajo odkriti bolnike z obstoječo fibrozo, zadevna sočasna zdravila in povečano tveganje, je odbor izpostavil, da ukrepi ne zadoščajo za to, da bi preprečili razvoj fibroze in ergotizma med zdravljenjem pri nekaterih bolnikih.
English: • The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergotoxine cannot be excluded.
Slovenian: • odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in dihidroergotoksinom ni mogoče izključiti.
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Slovenian: Če je bilo mogoče, so predložili tudi pregled vseh drugih razpoložljivih podatkov (tj. podatkov iz literature, predkliničnih podatkov in drugih kliničnih podatkov, vključno z epidemiološkimi študijami), primernih za oceno tveganja za fibrozo.
English: 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.
Slovenian: Skupina je izpostavila, da se zahtevana indikacija v klinični praksi ne uporablja več, zato s kliničnega vidika trenutno ni dokazov, da obstaja terapevtska potreba po tej zdravilni učinkovini za zdravljenje kognitivne in nevrosenzorične okvare pri starejših.
English: The outcome in the different components included in these assessment tools vary considerably between the studies and no general conclusions can be drawn neither on the size of possible effects nor on the clinical relevance.
Slovenian: Končne ocene parametrov, vključenih v ta orodja za vrednotenje, se zelo razlikujejo med posameznimi študijami, zato ni mogoče podati nobenih splošnih zaključkov niti o obsegu morebitnih učinkov niti o kliničnem pomenu.
English: In addition, severe cases of peripheral vasoconstrictive symptoms were reported in the literature.
Slovenian: Poleg tega so v literaturi navedeni hudi primeri simptomov periferne vazokonstrikcije.
English: In such cases, administration of dihydroergotoxine may delay the administration of an appropriate treatment for dementia.
Slovenian: V takih primerih lahko dajanje dihidroergotoksina zakasni dajanje ustreznega zdravila za demenco.
English: • The Committee considered the overall submitted data and grounds provided by the MAHs and the outcome of the scientific advisory groups.
Slovenian: • odbor je upošteval vse predložene podatke in utemeljitve, ki so jih podali imetniki dovoljenj za promet z zdravili, ter ugotovitve znanstveno svetovalnih skupin;
English: From the approved indications of the dihydroergotoxine 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):
Slovenian: Od odobrenih indikacij za zdravila, ki vsebujejo dihidroergotoksin, 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):