natgillin/translations-raw huggingface dataset:
These batches had been tested according to the requirements when the product was first authorised in Hungary.
Ti seriji je testiral skladno z zahtevami, ki so veljale ob prvi odobritvi zdravila na Madžarskem.
Correlation between the reduction of lung lesions and the reduction of clinical signs
Povezava med zmanjšanjem pljučnih lezij in zmanjšanjem kliničnih znakov
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, dogovorjene med postopkom koordinacijske skupine, z naslednjimi spremembami:
Romania Ceva Santé Animale Romania
Romunija Ceva Santé Animale Romania
Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII.
Sev NT3 pripada serotipu 1 in izraža ApxI, medtem ko sevi SzII, PO, U3 in B4 pripadajo serotipu 2 in izražajo ApxIII.
Monograph 04/2013:1360, Porcine Actinobacillosis Vaccines (inactivated)).
Monografija 04/2013:1360, Cepiva proti prašičji aktinobacilozi (inaktivirana)).
Bulgaria Ceva Animal Health Bulgaria ul.
Bolgarija Ceva Animal Health Bulgaria ul.
Based on the data presented in relation to the concerns notified for this referral procedure, the benefitrisk balance is considered to be favourable.
Na podlagi podatkov, predstavljenih v povezavi s pomisleki pri tem napotitvenem postopku, je razmerje med tveganji in koristmi ugodno.
Although a positive correlation between the reduction of lung lesions and the reduction of clinical signs as a consequence of the vaccination is predictable, it was not possible to evaluate the magnitude of such a correlation.
Čeprav je pozitivna povezava med zmanjšanjem pljučnih lezij in zmanjšanjem kliničnih znakov, ki je posledica cepljenja, pričakovana, ni bilo mogoče oceniti obsežnosti te povezave.
Major issues concerning the complex nature of A. pleuropneumaniae infections, and compliance with the requirements of European Pharmacopoeia was also addressed.
Prav tako je obravnaval velike pomisleke glede kompleksnega značaja okužb z A. pleuropneumaniae in skladnost z zahtevami Evropske farmakopeje.
The marketing authorisation holder (MAH), Ceva-Phylaxia Veterinary Biologicals Co. Ltd., submitted an application for mutual recognition of the marketing authorisation granted by Hungary in accordance with Article 32 of Directive 2001/82/EC.
Imetnik dovoljenja za promet z zdravilom, Ceva-Phylaxia Veterinary Biologicals Co. Ltd., je predložil vlogo za medsebojno priznavanje dovoljenja za promet z zdravilom, ki je bilo izdano na Madžarskem, skladno s členom 32 Direktive 2001/82/ES.
Field trials have not corroborated the results obtained under laboratory conditions and there were concerns regarding the benefit of the vaccine under practical conditions of use.
Terenska preskušanja niso podprla rezultatov, ki so jih pridobili pri laboratorijskih pogojih, zato so se pojavili pomisleki glede koristi cepiva pri praktičnih pogojih uporabe.
The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Razpored cepljenja je 2 odmerka, ki se dajeta živalim, starim 7 tednov in več, v presledku 3 tednov med odmerkoma.
Product name Strength
Ime produkta Jakost
Germany Ceva Tiergesundheit GmbH
Nemčija Ceva Tiergesundheit GmbH
The main difference was that the vaccine batch used in these studies had a higher antigen content than the minimum one proposed for the EU market.
Glavna razlika v teh študijah je bila uporaba serije cepiva, ki je imela večjo vsebnost antigena, kot je najmanjša vsebnost, predlagana za trg v EU.
However, the MAH clarified that the efficacy in the field has only been partially demonstrated and that lack of relevant information could be reflected in the Summary of Product Characteristics.
Vendar je imetnik dovoljenja za promet z zdravilom pojasnil, da so učinkovitost na terenu dokazali samo delno in da je mogoče pomanjkanje zadevnih podatkov navesti v povzetku glavnih značilnosti zdravila.
Efficacy was demonstrated under laboratory but not under field conditions.
Učinkovitost je bila dokazana z laboratorijskimi študijami, a ne na terenu.
Pharmacotherapeutic group: Actinobacillus/Haemophilus vaccine.
Farmakoterapevtska skupina: Actinobacillus/Haemophilus cepivo.
The vaccine is supplied in multidose containers as a suspension for injection containing an aluminium hydroxide-based adjuvant.
Cepivo je na voljo v vsebnikih z več odmerki suspenzije za injiciranje, ki vsebuje adjuvans na podlagi aluminijevega hidroksida.
Regarding the three field studies no significant differences in mortality rate and lung lesion scores were observed between vaccinated and control groups but the level of field challenge from A. pleuropneumoniae in the one significant field study was low.
Pri treh terenskih študijah niso opazili nobenih pomembnih razlik v deležu umrljivosti in rezultatu pljučnih lezij med cepljenimi in kontrolnimi skupinami, vendar pa je bila stopnja terenske provokacije z A. pleuropneumoniae v eni pomembni terenski študiji majhna.
During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health.
Med postopkom z medsebojnim priznavanjem je Italija, zadevna država članica, menila, da lahko zdravilo Coglapix predstavlja morebitno resno tveganje za zdravje živali.
Furthermore, the MAH was requested to comment on whether the significance (for both serotypes 1 and 2) of the results (concerning the impact on weight gain) shown in two laboratory studies is sufficient to erase the nonsignificance of the results in three ‘non-significant' laboratory studies.
Poleg tega so imetnika dovoljenja za promet z zdravilom zaprosili, naj razloži, ali je pomembnost (za serotipa 1 in 2) rezultatov (glede vpliva na pridobivanje telesne mase), ki so jo pokazali v dveh laboratorijskih študijah, zadostna za izbris nepomembnosti rezultatov iz treh „nepomembnih“ laboratorijskih študij.
• This referral was raised due to concerns regarding the overall efficacy of the vaccine.
• Ta napotitveni postopek je bil sprožen zaradi zadržkov v zvezi s splošno učinkovitostjo cepiva.
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.
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.
Overall summary of the scientific evaluation of Coglapix suspension for injection for pigs (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Coglapix suspenzija za injiciranje za prašiče (glejte Prilogo I)
Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne Francija
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.
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.
Coglapix suspension for injection for pigs (hereafter called ‘Coglapix') is an inactivated bacterial vaccine against porcine actinobacillosis.
Zdravilo Coglapix suspenzija za injiciranje za prašiče (v nadaljevanju „Coglapix“) je inaktivirano bakterijsko cepivo proti prašičji aktinobacilozi.
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.
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.
A sentence is included in section 5 Immunological properties of the Summary of Product Characteristics to reflect the lack of data from field trials.
Poglavju 5 Imunološke lastnosti v povzetku glavnih značilnosti zdravila so dodali stavek, ki odraža pomanjkanje podatkov iz terenskih preskušanj.
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.
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.
The amended sections of the Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Spremenjeni poglavji povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice sta navedeni v Prilogi III.
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.
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.
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.
Imetnika dovoljenja za promet z zdravilom so zato zaprosili za dodatno podporo sklepa, da je bila učinkovitost cepiva pri praktičnih pogojih uporabe zadostno dokazana.
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).
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).
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.
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.
The MAH submitted data from 12 laboratory studies and 3 field studies to support the efficacy claim.
Imetnik dovoljenja za promet z zdravilom je v podporo trditvam o učinkovitosti predložil podatke iz 12 laboratorijskih študij in 3 terenskih študij.
03-715 Warszawa Poland
Okrzei 1A, 03-715 Warszawa Polska
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.
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.
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).
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).
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.
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.
Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Spremembe v ustreznih poglavjih Povzetka glavnih značilnostih zdravila in navodila za uporabo
From the available laboratory efficacy studies, there was little evidence, if any, concerning the measurement of the impact of the vaccination on weight gain.
V razpoložljivih laboratorijskih študijah učinkovitosti je bilo malo dokazov (če sploh) glede meritev vpliva cepiva na pridobivanje telesne mase.
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.
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.
The MAH also provided clarification in relation to some discrepant data emerging from a comparative analysis of the batch protocols of the two vaccines.
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.
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.
Predložil je tudi pregled statističnih analiz za dokazovanje pomembnih razlik med cepljenimi in kontrolnimi živalmi glede na zmanjšanje kliničnih znakov in pljučnih lezij.
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.
Pri ocenjevanju rezultatov študij učinkovitosti so odkrili novo vprašanje, povezano z doslednostjo serij cepiva, ki so jih uporabljali v teh preskušanjih.
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.
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.
The strains belong to the serotype 1 or serotype 2 groups.
Sevi spadajo v skupini serotipov 1 ali 2.
The MAH clarified that inferential statistics was used for the data analysis and addressed the relevance of the method used.
Imetnik dovoljenja za promet z zdravilom je pojasnil, da je za analizo podatkov uporabil sklepno statistiko, in obravnaval pomembnost uporabljene metode.
Ceva Saúde Animal Produtos
Portugalska Ceva Saúde Animal Produtos
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.
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.
Therefore the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to clearly reflect this conclusion.
Zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo je treba zato spremeniti, tako da bodo jasno odražala to ugotovitev.
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.
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.
To complement the answer, the batch release protocols for two batches were provided revealing consistent germ-count-based target formulation.
Kot dodatek k odgovoru je predložil protokola sproščanja dveh serij, ki sta pokazala dosledno ciljno formulacijo na podlagi števila mikroorganizmov.
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.
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.
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.
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.
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.
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.
This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Ta napotitveni postopek je bil sprožen zaradi zadržkov v zvezi s splošno učinkovitostjo cepiva.
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.
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.
Non-significant results have been obtained in 3 out of 5 studies carried out for both serotypes 1 and 2.
V 3 študijah od 5, ki so jih izvedli za oba serotipa, 1 in 2, so pridobili nepomembne rezultate.
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.
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.
The MAH confirmed that a meta-analysis of all the results obtained from the different studies has been provided.
Imetnik dovoljenja za promet z zdravilom je potrdil, da je predložil metaanalizo vseh rezultatov, pridobljenih iz različnih študijah.
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.
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.
Scientific conclusions and grounds for the granting of the marketing authorisation for Coglapix suspension for injection for pigs
Znanstveni zaključki in podlaga za izdajo dovoljenja za promet z zdravilom Coglapix suspenzija za injiciranje za prašiče
Duration of immunity is 16 weeks following second vaccination.
Trajanje imunosti je 16 dni po drugem cepljenju.
Therefore, the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to reflect this (see Annex III).
Zadevna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo je treba zato spremeniti, tako da bodo odražala to ugotovitev (glejte Prilogo III).
Slovakia Ceva Animal Health Slovakia, s.r.o.
Slovaška Ceva Animal Health Slovakia, s.r.o.
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.
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.
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.
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.
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.
„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.
The vaccine contains inactivated Actinobacillus pleuropneumoniae bacteria.
Cepivo vsebuje inaktivirano bakterijo Actinobacillus pleuropneumoniae.