FrancophonIA/ELRC3.0 huggingface dataset:
English: In particular, Italy considered that (i) the correlation between the reduction of lung lesions and the reduction of clinical signs has not been adequately demonstrated; (ii) the benefit of the vaccine under practical conditions of use (i.e. reduction of lung lesions and clinical signs resulting in reduced weight losses in vaccinated animals) has not been demonstrated and (iii) inconsistent results were obtained from duration of immunity studies.
Slovenian: Italija je izpostavila predvsem, da i) povezava med zmanjšanjem pljučnih lezij in zmanjšanjem kliničnih znakov ni bila zadostno dokazana, ii) korist cepiva pri praktičnih pogojih uporabe (tj. zmanjšanje pljučnih lezij in kliničnih znakov je povzročilo zmanjšanje izgube telesne mase pri cepljenih živalih) ni bila dokazana in iii) so med študijami imunosti pridobili neskladne rezultate.
English: Overall summary of the scientific evaluation of Coglapix suspension for injection for pigs (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Coglapix suspenzija za injiciranje za prašiče (glejte Prilogo I)
English: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Slovenian: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne Francija
English: The MAH was requested to confirm, in writing, that the statistical analysis was performed using the results of relevant studies and to provide assurance the data-analysis method used was adequate and submit, if possible, a meta-analysis of all the results obtained from the different studies.
Slovenian: Imetnika dovoljenja za promet z zdravilom so zaprosili za pisno potrditev, da je bila opravljena statistična analiza z rezultati zadevnih študij, in predložitev jamstva, da je bila uporabljena metoda za analizo podatkov ustrezna, ter metaanalize vseh rezultatov, pridobljenih iz različnih študijah, če je to mogoče.
English: Coglapix suspension for injection for pigs (hereafter called ‘Coglapix') is an inactivated bacterial vaccine against porcine actinobacillosis.
Slovenian: Zdravilo Coglapix suspenzija za injiciranje za prašiče (v nadaljevanju „Coglapix“) je inaktivirano bakterijsko cepivo proti prašičji aktinobacilozi.
English: The CVMP was asked to consider the available data supporting the efficacy of Coglapix and conclude whether the veterinary medicinal product may present a potential serious risk to the animal health.
Slovenian: Odbor CVMP so prosili, naj pretehta vse razpoložljive podatke, ki podpirajo učinkovitost zdravila Coglapix, in razsodi, ali lahko zdravilo predstavlja morebitno resno tveganje za zdravje živali.
English: A sentence is included in section 5 Immunological properties of the Summary of Product Characteristics to reflect the lack of data from field trials.
Slovenian: Poglavju 5 Imunološke lastnosti v povzetku glavnih značilnosti zdravila so dodali stavek, ki odraža pomanjkanje podatkov iz terenskih preskušanj.
English: Therefore the CVMP recommended the granting of the marketing authorisations for the veterinary medicinal products referred to in Annex I with amendments to the Summary of Product Characteristics and package leaflet of the reference Member State.
Slovenian: Odbor CVMP je zato priporočil izdajo dovoljenj za promet z zdravili za uporabo v veterinarski medicini, navedenimi v Prilogi I, skupaj s spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice.
English: Sweden Ceva Animal Health A.B.
Slovenian: Švedska Ceva Animal Health A.B.
English: The amended sections of the Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Slovenian: Spremenjeni poglavji povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice sta navedeni v Prilogi III.
English: Based on the assessment of the overall efficacy of Coglapix vaccine, duration of immunity was established for both serotypes (1 and 2) up to 16 weeks after vaccination according to the results of relevant challenge studies carried out at 16 and 24 weeks.
Slovenian: Na podlagi ocene splošne učinkovitosti cepiva Coglapix so dokazali, da imunost proti obema serotipoma (1 in 2) traja do 16 tednov po cepljenju, pri čemer so upoštevali rezultate zadevnih provokacijskih študij, izvedenih po 16 in 24 tednih.
English: The MAH was therefore requested to further support the conclusion that the efficacy of the vaccine under practical conditions of use has been adequately demonstrated.
Slovenian: Imetnika dovoljenja za promet z zdravilom so zato zaprosili za dodatno podporo sklepa, da je bila učinkovitost cepiva pri praktičnih pogojih uporabe zadostno dokazana.
English: The MAH confirmed that the statistical analyses aiming to establish the correlation between reduction of lung lesions and reduction of clinical signs were performed using the results of all relevant studies (i.e., 12 challenge studies, 6 for each serotype).
Slovenian: Imetnik dovoljenja za promet z zdravilom je potrdil, da je statistične analize za ugotavljanje povezave med zmanjšanjem pljučnih lezij in zmanjšanjem kliničnih znakov izvedel z rezultati vseh zadevnih študij (tj. 12 provokacijskih študij, 6 za vsak serotip).
English: In these studies vaccinated animals showed lower incidence of the typical clinical signs (dyspnoea, coughing and vomiting) and lung lesions of porcine pleuropneumonia associated with infection by the microorganism when compared with controls.
Slovenian: V teh študijah so pokazali, da so imele cepljene živali manjšo pojavnost značilnih kliničnih znakov (dispneje, kašlja in bruhanja) in pljučnih lezij zaradi prašičje plevropnevmonije, povezane z okužbo z mikroorganizmom, v primerjavi s kontrolnimi skupinami.
English: The MAH submitted data from 12 laboratory studies and 3 field studies to support the efficacy claim.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v podporo trditvam o učinkovitosti predložil podatke iz 12 laboratorijskih študij in 3 terenskih študij.
English: 03-715 Warszawa Poland
Slovenian: Okrzei 1A, 03-715 Warszawa Polska
English: To demonstrate the immunogenicity of the vaccine, six laboratory efficacy studies were conducted to an acceptable standard and design to establish the onset and duration of immunity and meet the criteria of the Ph. Eur.
Slovenian: Za dokazovanje imunogenosti cepiva so izvedli šest laboratorijskih študij učinkovitosti s sprejemljivim standardom in načrtom, ki so pokazale pojav in trajanje imunosti ter so bile skladne z merili monografije Ph.
English: The CVMP concluded that the concerns expressed by Italy should not prevent the granting of marketing authorisations for Coglapix and recommended amendments in the relevant sections of the Summary of Product Characteristics and package leaflet (see Annex III).
Slovenian: Odbor CVMP je menil, da pomisleki Italije ne bi smeli preprečiti izdaje dovoljenj za promet z zdravilom Coglapix, in priporočil spremembe v zadevnih poglavjih povzetka glavnih značilnosti zdravila in navodila za uporabo (glejte Prilogo III).
English: Although acknowledging the justifications provided by the MAH concerning the complexity of the topic and the technical difficulties encountered, a major question arose as to whether a parameter shown to be significant in one relevant study is sufficient to erase the non-significance of the same parameters in a “non-significant” study.
Slovenian: Čeprav so upoštevali utemeljitve, ki jih je glede kompleksnosti tematike in tehničnih težav predložil imetnik dovoljenja za promet z zdravilom, se je pojavilo veliko vprašanje, ali je parameter, za katerega so pokazali pomembnost v eni zadevni študiji, zadosten za izbris nepomembnosti istih parametrov v „nepomembni“ študiji.
English: Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Slovenian: Spremembe v ustreznih poglavjih Povzetka glavnih značilnostih zdravila in navodila za uporabo
English: From the available laboratory efficacy studies, there was little evidence, if any, concerning the measurement of the impact of the vaccination on weight gain.
Slovenian: V razpoložljivih laboratorijskih študijah učinkovitosti je bilo malo dokazov (če sploh) glede meritev vpliva cepiva na pridobivanje telesne mase.
English: In conclusion, the CVMP agreed that the MAH has provided satisfactory evidence that Coglapix is manufactured and tested to an acceptable quality standard regarding the batch potency test and consequently the appearance of clinical signs are correlated with the presence of lung lesions.
Slovenian: Na koncu se je odbor CVMP strinjal, da je imetnik dovoljenja za promet z zdravilom predložil zadovoljive dokaze, da se zdravilo Coglapix izdeluje in testira skladno s sprejemljivim kakovostnim standardom za test moči serije in da je pojav kliničnih znakov posledično povezan s prisotnostjo pljučnih lezij.
English: The MAH also provided clarification in relation to some discrepant data emerging from a comparative analysis of the batch protocols of the two vaccines.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil tudi pojasnitev nekaterih protislovnih podatkov, ki jih je pridobil pri primerjalni analizi protokolov za serije obeh cepiv.
English: An overview of the statistical analyses to demonstrate significant differences between vaccinated and control animals in terms of reduction of clinical signs and lung lesions was also provided.
Slovenian: Predložil je tudi pregled statističnih analiz za dokazovanje pomembnih razlik med cepljenimi in kontrolnimi živalmi glede na zmanjšanje kliničnih znakov in pljučnih lezij.
English: When assessing the results of efficacy studies an additional point for concern was raised in relation to the consistency of the vaccine batches used for these trials.
Slovenian: Pri ocenjevanju rezultatov študij učinkovitosti so odkrili novo vprašanje, povezano z doslednostjo serij cepiva, ki so jih uporabljali v teh preskušanjih.
English: As the correlation coefficient was highly significant in each case, the MAH concluded that it is very unlikely that the observed relationship between clinical and lung lesion scores is only due to chance.
Slovenian: Ker je bil v vseh primerih koeficient povezave zelo pomemben, je imetnik dovoljenja za promet z zdravilom sklenil, da je izjemno neverjetno, da je opažena povezava med kliničnimi rezultati in rezultati za pljučne lezije le naključna.
English: The strains belong to the serotype 1 or serotype 2 groups.
Slovenian: Sevi spadajo v skupini serotipov 1 ali 2.
English: The MAH clarified that inferential statistics was used for the data analysis and addressed the relevance of the method used.
Slovenian: Imetnik dovoljenja za promet z zdravilom je pojasnil, da je za analizo podatkov uporabil sklepno statistiko, in obravnaval pomembnost uporabljene metode.
English: Ceva Saúde Animal Produtos
Slovenian: Portugalska Ceva Saúde Animal Produtos
English: The MAH confirmed that future commercial batches for the EU market will be produced based on fixed formulation targets and will be controlled in line with the finished product specifications agreed during the MRP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je potrdil, da bo prihodnje komercialne serije za trg EU izdeloval na podlagi fiksnih formulacijskih ciljev in jih kontroliral skladno s specifikacijami za končno zdravilo, določenimi med postopkom z medsebojnim priznavanjem.
English: Therefore the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to clearly reflect this conclusion.
Slovenian: Zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo je treba zato spremeniti, tako da bodo jasno odražala to ugotovitev.
English: The variability of the results observed in the efficacy studies was suggested to be correlated with the quality of the vaccine batches administered in the trials, with sub-potent batches formulated with insufficient antigen content.
Slovenian: Predlagali so, da je spremenljivost opaženih rezultatov v študijah učinkovitosti povezana s kakovostjo serij cepiva, ki so bile uporabljene v preskušanjih, pri čemer so bile prešibke serije formulirane z nezadostno vsebnostjo antigena.
English: To complement the answer, the batch release protocols for two batches were provided revealing consistent germ-count-based target formulation.
Slovenian: Kot dodatek k odgovoru je predložil protokola sproščanja dveh serij, ki sta pokazala dosledno ciljno formulacijo na podlagi števila mikroorganizmov.
English: Following vaccination of pigs with Coglapix reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory efficacy studies, although some concerns on the statistical significance of the results still remain.
Slovenian: Po cepljenju prašičev z zdravilom Coglapix so v laboratorijskih študijah učinkovitosti dokazali zmanjšanje kliničnih znakov in pljučnih lezij, povezanih s to boleznijo, čeprav so še vedno prisotni pomisleki glede statistične pomembnosti rezultatov.
English: During the MRP the MAH reduced the initial indication from four clinical parameters (clinical signs, losses, lung lesions and infection associated with the disease) to only two i.e. reduction of clinical signs and lung lesions (both of which are included in the European Pharmacopoeia (Ph.
Slovenian: Med postopkom z medsebojnim priznavanjem je imetnik dovoljenja za promet z zdravilom zmanjšal prvotno indikacijo s štirih kliničnih parametrov (klinični znaki, izgube, pljučne lezije in okužba, povezana z boleznijo) na samo dva, tj. zmanjšanje kliničnih znakov in pljučnih lezij (ki sta vključena v Evropsko farmakopejo (Ph.
English: The MAH confirmed that the batches were produced according to a consistent manufacturing process under EU Good Manufacturing Practice (GMP) standards and of adequate quality for use in the efficacy trials.
Slovenian: Imetnik dovoljenja za promet z zdravilom je potrdil, da so bile serije izdelane skladno z doslednim procesom izdelave, ki je skladen s standardi dobre proizvodne prakse (DPP) EU, in da je njihova kakovost za uporabo v preskušanjih učinkovitosti zadostna.
English: This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Slovenian: Ta napotitveni postopek je bil sprožen zaradi zadržkov v zvezi s splošno učinkovitostjo cepiva.
English: Based on these considerations, the MAH was requested to demonstrate that the significance shown for clinical signs in some laboratory efficacy studies is sufficient to overcome the non-significance of the same parameter in ‘non-significant' laboratory efficacy studies.
Slovenian: Na podlagi teh opažanj so imetnika dovoljenja za promet z zdravilom zaprosili, če lahko dokaže, da je pomembnost, ki so jo pokazali za klinične znake pri nekaterih laboratorijskih študijah učinkovitosti, zadostna, da prevlada nad nepomembnostjo istega parametra v „nepomembnih“ laboratorijskih študijah učinkovitosti.
English: Ceva Sante Animale B.V.
Slovenian: Nizozemska Ceva Sante Animale B.V.
English: Non-significant results have been obtained in 3 out of 5 studies carried out for both serotypes 1 and 2.
Slovenian: V 3 študijah od 5, ki so jih izvedli za oba serotipa, 1 in 2, so pridobili nepomembne rezultate.
English: The MAH conducted 2 studies to evaluate the onset of immunity and 4 studies to evaluate the duration of immunity, using appropriate challenge strains for both A. pleuropneumoniae serotypes (1 and 2) included in the vaccine.
Slovenian: Imetnik dovoljenja za promet z zdravilom je izvedel 2 študiji, s katerima je ocenil pojav imunosti, in 4 študije, s katerimi je ocenil trajanje imunosti ter pri tem uporabil ustrezne provokacijske seve za serotipe (1 in 2) A. pleuropneumoniae, vključene v cepivo.
English: The MAH confirmed that a meta-analysis of all the results obtained from the different studies has been provided.
Slovenian: Imetnik dovoljenja za promet z zdravilom je potrdil, da je predložil metaanalizo vseh rezultatov, pridobljenih iz različnih študijah.
English: Belgium Ceva Santé Animale S.A/N.V.
Slovenian: Ceva Santé Animale S.A/N.V.
English: Vaccination of pigs reduces the clinical signs and lung lesions associated with the disease, thus reducing the need for antimicrobial treatment and increasing the range of available prophylactic treatment possibilities against pneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Slovenian: Cepljenje prašičev zmanjša klinične znake in pljučne lezije, povezane z boleznijo, kar posledično zmanjša potrebo po zdravljenju z antibiotiki in povečanju obsega razpoložljivih možnosti profilaktičnega zdravljenja proti pljučnici, ki jo povzročata serotipa 1 in 2 A. pleuropneumoniae.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Coglapix suspension for injection for pigs
Slovenian: Znanstveni zaključki in podlaga za izdajo dovoljenja za promet z zdravilom Coglapix suspenzija za injiciranje za prašiče
English: Duration of immunity is 16 weeks following second vaccination.
Slovenian: Trajanje imunosti je 16 dni po drugem cepljenju.
English: Therefore, the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to reflect this (see Annex III).
Slovenian: Zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo je treba zato spremeniti, tako da bodo odražala to ugotovitev (glejte Prilogo III).
English: Slovakia Ceva Animal Health Slovakia, s.r.o.
Slovenian: Slovaška Ceva Animal Health Slovakia, s.r.o.
English: In particular, the MAH was requested to provide evidence that the reduction of lung lesions and clinical signs would result in reduced weight losses in vaccinated animals as compared to controls.
Slovenian: Imetnika dovoljenja za promet z zdravilom so zaprosili predvsem za dokaze, da bo zmanjšanje pljučnih lezij in kliničnih znakov povzročilo manjšo izgubo telesne mase pri cepljenih živalih v primerjavi s kontrolnimi skupinami.
English: The MAH explained that the positive effect on clinical signs and lung lesions would lead to at least partial protection of the losses in weight gain due to A. pleuropneumaniae infections.
Slovenian: Imetnik dovoljenja za promet z zdravilom je razložil, da pozitivni učinek na klinične znake in pljučne lezije vsaj delno ščiti pred izgubo pridobljene telesne mase zaradi okužb z A. pleuropneumaniae.
English: Tiendweg 8 c, 2670 AB Naaldwijk The Netherlands
Slovenian: Tiendweg 8 c, 2670
English: It is also considered that the indication is acceptable taking account of the intended use of the vaccine and the existing data from the laboratory studies.
Slovenian: „Učinkovitost so dokazali pri laboratorijskih pogojih, vendar ne tudi na terenu.“ Prav tako menijo, da je indikacija sprejemljiva, če se upoštevajo predvidena uporaba cepiva in obstoječi podatki iz laboratorijskih študij.
English: The vaccine contains inactivated Actinobacillus pleuropneumoniae bacteria.
Slovenian: Cepivo vsebuje inaktivirano bakterijo Actinobacillus pleuropneumoniae.
English: However, the MAH confirmed that a re-test was carried out according to the finished product specifications agreed during the MRP and the vaccine batches were found to conform to them.
Slovenian: Vendar je imetnik dovoljenja za promet z zdravilom potrdil, da je izvedel ponovno testiranje skladno s specifikacijami za končno zdravilo, ki so jih odobrili med postopkom z medsebojnim priznavanjem, in da je ugotovil, da so bile serije cepiva skladne z njimi.
English: The vaccine contains five, formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae.
Slovenian: Cepivo vsebuje pet s formaldehidom inaktiviranih sevov bacila Actinobacillus pleuropneumoniae.
English: The MAH presented the results of all the laboratory studies to support the efficacy claims.
Slovenian: Imetnik dovoljenja za promet z zdravilom je kot podporo trditvam o učinkovitosti predstavil rezultate vseh laboratorijskih študij.
English: Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae.
Slovenian: Cepljeni prašiči razvijejo aktivno imunost proti boleznim povzročenim s serotipi 1 ali 2 Actinobacillus pleuropneumoniae.
English: Onset of immunity is 21 days following second vaccination.
Slovenian: Imunost se razvije 21 dni po drugem cepljenju.
English: Grounds for the granting of the marketing authorisations for Coglapix suspension for injection for pigs
Slovenian: Podlaga za izdajo dovoljenja za promet z zdravilom Coglapix suspenzija za injiciranje za prašiče
English: Rua Doutor António Loureiro Borges 9/9A - 9°A, Miraflores, 1495131 Algès Portugal
Slovenian: Miraflores, 1495131 Algès
English: Onset of immunity: 21 days following second vaccination Duration of immunity: 16 weeks following second vaccination
Slovenian: Trajanje imunosti: 16 tednov po drugem cepljenju
English: The CVMP agreed that although the incidence of typical clinical signs and lung lesions were not significantly lower for vaccinates, when compared with controls, in all laboratory efficacy studies, the overall results of the efficacy of the vaccine were supportive for reduction of lung lesions and clinical signs.
Slovenian: Odbor CVMP se je strinjal, da so skupni rezultati vseh laboratorijskih študijah za učinkovitost cepiva podprli zmanjšanje pljučnih lezij in kliničnih znakov, čeprav pojavnost značilnih kliničnih znakov in pljučnih lezij ni bila pomembno manjša pri cepivih v primerjavi s kontrolnimi skupinami.
English: The concern related to the overall efficacy of the vaccine have been assessed and it is concluded that Coglapix is expected to be efficacious in immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Slovenian: Ocenili so pomislek glede splošne učinkovitosti cepiva in sklenili, da je pričakovati, da bo zdravilo Coglapix učinkovito pri imunizaciji prašičev, kar bo pomagalo nadzorovati plevropnevmonijo, ki jo povzročata serotipa 1 in 2 A. pleuropneumoniae, saj omogoča zmanjšanje kliničnih znakov in pljučnih lezij, povezanih z boleznijo.
English: Coglapix is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Slovenian: Zdravilo Coglapix je namenjeno aktivni imunizaciji prašičev proti plevropnevmoniji, ki jo povzročata serotipa 1 in 2 A. pleuropneumoniae.
English: 1130 Brussel
Slovenian: Metrologielaan 6 1130 Brussel Belgija
English: For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Slovenian: Za aktivno imunizacijo prašičev kot pomoč pri nadzoru pleuropnevmonije povzročene z Actinobacillus pleuropneumoniae serotip 1 in 2, z zmanjšanjem kliničnih znakov in poškodb pljuč, povezanih z boleznijo.
English: Coglapix is intended for active immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, and reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory studies.
Slovenian: Zdravilo Coglapix je namenjeno aktivni imunizaciji prašičev kot pomoč pri nadzorovanju plevropnevmonije, ki jo povzročajo serotipi 1 in 2 A. pleuropneumoniae, zmanjšanje kliničnih znakov ter pljučnih lezij, povezanih s to boleznijo, pa so dokazali v laboratorijskih študijah.
English: The vaccine is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, in order to reduce the clinical signs and lung lesions associated with the disease.
Slovenian: Cepivo je namenjeno aktivni imunizaciji prašičev proti plevropnevmoniji, ki jo povzročajo serotipi 1 in 2 A. pleuropneumoniae, s čimer se zmanjšajo klinični znaki in pljučne lezije, povezani s to boleznijo.
English: Iceland Ceva Santé Animale 10, av. de La
Slovenian: Islandija Ceva Santé Animale 10, av. de La
English: Slovenia Ceva Santé Animale 10, av. de La
Slovenian: Slovenija Ceva Santé Animale 10, av. de La
English: Okrzei 1A,
Slovenian: 9/9A - 9°A,
English: Croatia
Slovenian: Litva
English: Lithuania Ceva Santé Animale 10, av. de La
Slovenian: Hrvaška Ceva Santé Animale 10, av. de La