FrancophonIA/ELRC3.0 huggingface dataset:
English: At the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently monitored.
Danish: I den første periode af behandlingen skal blodtrykket kontrolleres regelmæssigt.
English: Suggested measures include induction of emesis and / or gastric lavage.
Danish: Provokeret opkastning og/eller maveudskylning er mulige behandlinger.
English: Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 214 235 910
Danish: Tel: (351) 214 235 910
English: Member State (EU/EEA)
Danish: Medlemsland (EU/EEA)
English: For the mutual recognition procedure (MRP), Hungary acted as a reference Member State and Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom were concerned Member States.
Danish: Ved den gensidige anerkendelsesprocedure var Ungarn referencemedlemsstat, og Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Estland, Finland, Tyskland, Grækenland, Island, Irland, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Sverige og Det Forenede Kongerige var berørte medlemsstater.
English: Product name Strength
Danish: Produktnavn Styrke
English: Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Danish: Nærmere bestemt er p-værdien under 0,0001, dvs. at sandsynligheden for en falsk positiv korrelation er under 0,01 %.
English: Furthermore, it was confirmed that standardisation of variables was applied.
Danish: Desuden blev det bekræftet, at de variable var standardiseret.
English: Duration of immunity
Danish: Immunitetens varighed
English: Monograph 1360.
Danish: monografi 1360.
English: Efficacy of the vaccine under practical conditions of use
Danish: Vaccinens virkning under praktiske anvendelsesforhold
English: The total quantity is 20 x 109 inactivated germs per dose.
Danish: Det totale antal er 20 x 109 inaktiverede bakterier pr. dosis.
English: Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Danish: Desuden blev der rejst tvivl om formuleringen af det færdige produkt, enten hvad angår antigenindhold eller andre indholdsstoffer.
English: Having considered all data submitted the CVMP concluded that:
Danish: Efter gennemgang af alle de forelagte oplysninger konkluderede CVMP følgende:
English: 831 53 Bratislava Slovakia
Danish: 831 53 Bratislava Slovakiet
English: Ceva Hellas LLC 15, Agiou Nikolaou str.
Danish: Grækenland Ceva Hellas LLC 15, Agiou Nikolaou str.
English: All the strains express also ApxII.
Danish: Alle stammer udtrykker også ApxII.
English: These batches had been tested according to the requirements when the product was first authorised in Hungary.
Danish: Disse batcher var testet efter de krav, der var gældende ved første godkendelse af produktet i Ungarn.
English: 40472 Düsseldorf Germany
Danish: 40472 Düsseldorf Tyskland
English: Monograph 04/2013:1360.
Danish: monografi 04/2013:1360.
English: Pharmaceutical form
Danish: Farmaceuticsk form
English: The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Danish: Vaccinationsplanen omfatter 2 doser, der gives til dyr fra 7-ugers alderen med et interval på 3 uger mellem doserne.
English: Viale Colleoni 15, 20864 Agrate Brianza (MB)
Danish: Viale Colleoni 15, 20864 Agrate Brianza (MB) Italien
English: Tiendweg 8 c, 2670 AB Naaldwijk The Netherlands
Danish: Tiendweg 8 c, 2670 AB Naaldwijk Holland
English: Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions.
Danish: Sundere vaccinerede svin forventes at have bedre tilvækst, hvilket dog ikke blev påvist under feltbetingelser.
English: Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures.
Danish: Der blev forelagt statistiske detaljer for hver serotype til støtte for størrelsen af den positive korrelation mellem de to pågældende parametre.
English: 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.
Danish: Hovedforskellen er, at den anvendte vaccinebatch i disse undersøgelser havde højere antigenindhold end det ansøgte minimum til EU markedet.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Danish: Liste med navne, farmaceutisk form, styrke af veterinærlægemidlet, dyrearter, administrationsvej(e), indehaver af Markedsføringstilladelser i medlemslandene
English: Since the issues raised by Italy remained unresolved, the Member States concerned failed to reach agreement regarding the efficacy of Coglapix and consequently the matter was referred to the CVMP on 24 October 2014 under Article 33(4) of Directive 2001/82/EC.
Danish: Da de af Italien rejste spørgsmål forblev uafklarede, var de berørte medlemsstater ikke i stand til at nå til enighed om virkningen af Coglapix, hvorfor sagen blev indbragt for CVMP den 24. oktober 2014 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF.
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.
Danish: Indikationen blev desuden fundet acceptabel i betragtning af den påtænkte anvendelse af vaccinen og de eksisterende data fra laboratorieundersøgelserne.
English: Furthermore, the information gathered from Periodic Safety Update Reports was similarly considered to be only supportive and did not substantiate the claims.
Danish: Heller ikke oplysningerne fra de periodiske opdaterede sikkerhedsindberetninger kunne betragtes som andet end støttende eller lægges til grund for påstandene.
English: These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Danish: Disse spørgsmål forblev uafklarede, hvorfor der blev foretaget en indbringelse i medfør af artikel 33, stk. 1, i direktiv 2001/82/EF, for CMD(v) (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - veterinær).
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Danish: Det gyldige Produktresumé, etikettering og indlægsseddel er de endelige versioner modtaget under proceduren i Coordination Group med følgende ændringer:
English: 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.
Danish: Indehaveren af markedsføringstilladelsen, Ceva-Phylaxia Veterinary Biologicals Co. Ltd., indgav en ansøgning om gensidig anerkendelse af den markedsføringstilladelse, der er udstedt af Ungarn i overensstemmelse med artikel 32 i direktiv 2001/82/EF.
English: Romania Ceva Santé Animale Romania
Danish: Rumænien Ceva Santé Animale Romania
English: Bulgaria Ceva Animal Health Bulgaria ul.
Danish: Bulgarien Ceva Animal Health Bulgaria ul.
English: Monograph 04/2013:1360, Porcine Actinobacillosis Vaccines (inactivated)).
Danish: monografi 04/2013:1360, vacciner mod porcin actinobacillose (inaktiverede)).
English: Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Danish: Denne indbringelsesprocedure omfatter ikke kvalitet eller sikkerhed, da referencemedlemsstaten ikke anmeldte betænkeligheder herved.
English: Correlation between the reduction of lung lesions and the reduction of clinical signs
Danish: Korrelation mellem reduktion af lungeforandringer og reduktion af kliniske tegn
English: Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII.
Danish: Stamme NT3 tilhører serotype 1, der udtrykker ApxI medens stamme SzII, PO, U3 og B4 tilhører serotype 2, der udtrykker ApxIII.
English: 17455 ALIMOS Greece
Danish: 17455 ALIMOS
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.
Danish: Til påvisning af vaccinens immunogenicitet blev der udført seks laboratorieundersøgelse af virkning i henhold til en acceptabel standard og udformning til fastlæggelse af immunitetens indsætten og varighed og til opfyldelse af kriterierne i Ph. Eur.
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.
Danish: CVMP blev anmodet om at vurdere de foreliggende data til støtte for virkningen af Coglapix og konkludere, om veterinærlægemidlet kan udgøre en potentiel alvorlig risiko for dyrs sundhed.
English: 040185 Bucharest Romania
Danish: 040185 Bucharest
English: Efficacy was demonstrated under laboratory but not under field conditions.
Danish: Virkning blev demonstreret under laboratorieforhold men ikke under feltbetingelser.
English: During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health.
Danish: Under den gensidige anerkendelsesprocedure fandt Italien som berørt medlemsstat, at Coglapix kan udgøre en potentiel alvorlig risiko for dyrs helbred.
English: Pharmacotherapeutic group: Actinobacillus/Haemophilus vaccine.
Danish: Farmakoterapeutisk gruppe: Actinobacillus/Haemophilus vaccine.
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).
Danish: CVMP konkluderede, at de af Italien udtrykte betænkeligheder ikke bør forhindre udstedelse af markedsføringstilladelserne for Coglapix, og anbefalede ændringer i de relevante afsnit af produktresuméet og indlægssedlen (se bilag III).
English: The vaccine is supplied in multidose containers as a suspension for injection containing an aluminium hydroxide-based adjuvant.
Danish: Vaccinen leveres i flerdosisbeholdere som en injektionsvæske, suspension, med et adjuvans baseret på aluminiumhydroxid.
English: The market sales over the past 15 years provided by the MAH were not considered sufficient to support the claims.
Danish: Markedsføringstilladelsesindehaverens oplysninger om salgstal for de sidste 15 år fandtes ikke at være tilstrækkeligt grundlag for påstandene.
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.
Danish: Italien fandt således, at (i) korrelationen mellem reduktion af lungeforandringer og reduktion af kliniske tegn ikke var tilfredsstillende godtgjort, at (ii) fordelene ved vaccinen ikke var påvist under praktiske anvendelsesbetingelser (dvs. at reduktion af lungeforandringer og kliniske tegn nedsatte vægttabet hos de vaccinerede dyr), og (iii) at undersøgelserne af immunitetens varighed ikke gav samstemmende resultater.
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.
Danish: På grundlag af vurderingen af den overordnede virkning af Coglapix vaccine blev varigheden af immuniteten for begge serotyper (1 og 2) op til 16 uger efter vaccination bestemt ved relevante belastningsundersøgelser, der blev udført efter 16 og 24 uger.
English: Onset of immunity: 21 days following second vaccination Duration of immunity: 16 weeks following second vaccination
Danish: Påvisning af immunitet: 21 dage efter anden vaccination Varighed af immunitet: 16 uger efter anden vaccination
English: 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.
Danish: Skønt der må forventes positiv korrelation mellem reduktion af lungeforandringer og reduktion af kliniske tegn som følge af vaccinationen, kunne størrelsen af en sådan korrelation ikke bestemmes.
English: Duration of immunity is 16 weeks following second vaccination.
Danish: Immunitetens varighed er 16 uger efter den anden vaccination.
English: 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.
Danish: Feltundersøgelserne har ikke bekræftet resultaterne fra laboratorieundersøgelserne, og der var betænkelighed vedrørende fordelen ved vaccinen under praktiske anvendelsesforhold.
English: Coglapix suspension for injection for pigs (hereafter called ‘Coglapix') is an inactivated bacterial vaccine against porcine actinobacillosis.
Danish: Coglapix, injektionsvæske, suspension, til svin (herefter benævnt "Coglapix") er en inaktiveret bakteriel vaccine mod porcin actinobacillose.
English: Overall summary of the scientific evaluation of Coglapix suspension for injection for pigs (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Coglapix, injektionsvæske, suspension, til svin (se bilag I)
English: Unit 3, Anglo Office Park, White Lion Road Amersham, Bucks HP7 9FB
Danish: Unit 3, Anglo Office Park, White Lion Road
English: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Danish: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne Frankrig
English: 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.
Danish: Desuden blev indehaveren af markedsføringstilladelsen anmodet om at kommentere, hvorvidt den påviste signifikans (for både serotype 1 og 2) af resultaterne (for indvirkning på tilvækst) i to laboratorieundersøgelser er tilstrækkelig til at opveje den manglende signifikans af resultaterne i tre "ikke-signifikante" laboratorieundersøgelser.
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.
Danish: Indehaveren af markedsføringstilladelsen fremlagde desuden en præcisering vedrørende uoverensstemmende data fra en sammenlignende analyse af batchprotokollerne for de to vacciner.
English: • This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Danish: • Denne indbringelse blev indledt på grund af betænkeligheder vedrørende vaccinens overordnede virkning.
English: Marketing authorisation holder
Danish: Indehaver af Markedsføringstilladelsen
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.
Danish: Indehaveren af markedsføringstilladelsen blev derfor anmodet om yderligere at underbygge konklusionen om, at vaccinens virkning under praktiske anvendelsesforhold er tilstrækkeligt godtgjort.
English: Therefore the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to clearly reflect this conclusion.
Danish: De pågældende afsnit af produktresuméet og indlægssedlen bør derfor rettes, så denne konklusion klart fremgår.
English: The MAH submitted data from 12 laboratory studies and 3 field studies to support the efficacy claim.
Danish: Indehaveren af markedsføringstilladelsen forelagde data fra 12 laboratorieundersøgelser og 3 feltundersøgelser til støtte for den påberåbte virkning.
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.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om skriftligt at bekræfte, at den statistiske analyse var udformet på grundlag af resultaterne af relevante undersøgelser, at skaffe sikkerhed for, at den anvendte analysemetode var velegnet, og om muligt at forelægge en metaanalyse af resultaterne fra de forskellige undersøgelser.
English: The strains belong to the serotype 1 or serotype 2 groups.
Danish: Stammerne er af serotype 1 og serotype 2.
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.
Danish: Under den gensidige anerkendelsesprocedure indskrænkede markedsføringstilladelsesindehaveren den oprindelige indikation fra fire kliniske parametre (kliniske tegn, tab, lungeforandringer og infektion forbundet med sygdommen) til kun to, dvs. reduktion af kliniske tegn og lungeforandringer (som begge indgår i Den Europæiske Farmakopé (Ph.
English: The reduction of the indication to two clinical parameters required a further demonstration of significance for these two remaining efficacy parameters between vaccinates and controls.
Danish: Begrænsningen af indikationen til to kliniske parametre krævede yderligere påvisning af signifikant forskel mellem vaccinerede dyr og kontroldyr i disse to øvrige virkningsparametre.
English: Major issues concerning the complex nature of A. pleuropneumaniae infections, and compliance with the requirements of European Pharmacopoeia was also addressed.
Danish: Derudover blev der redegjort for væsentlige problemer forbundet med den komplekse karakter af infektioner med A. pleuropneumaniae og overholdelsen af kravene i Ph.Eur.
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).
Danish: Indehaveren af markedsføringstilladelsen fastslog, at den statistiske analyse til påvisning af korrelation med reduktion af lungeforandringer og kliniske tegn var udført på grundlag af resultaterne fra relevante undersøgelser (dvs. 12 belastningsundersøgelser, 6 for hver serotype).
English: 03-715 Warszawa Poland
Danish: Okrzei 1A, 03-715 Warszawa Polen
English: To complement the answer, the batch release protocols for two batches were provided revealing consistent germ-count-based target formulation.
Danish: I tilslutning til dette svar blev der fremlagt protokoller for frigivelse af to batcher, som udviste ensartet formulering baseret på kimtal.
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.
Danish: Da korrelationskoefficienten var højsignifikant i hvert tilfælde, konkluderede indehaveren af markedsføringstilladelsen, at det er meget usandsynligt, at den iagttagne sammenhæng mellem klinisk score og score for lungeforandringer skyldes en tilfældighed.
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.
Danish: Indehaveren af markedsføringstilladelsen fastslog, at batcherne var fremstillet med en ensartet fremstillingsproces i henhold til EU's standarder for god fremstillingspraksis (GMP) og var af tilstrækkelig kvalitet til anvendelse i undersøgelser af virkning.
English: Onset of immunity is 21 days following second vaccination.
Danish: Immunitet opnås 21 dage efter den anden vaccination.
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.
Danish: Som konklusion fandt CVMP, at indehaveren af markedsføringstilladelsen havde forelagt tilfredsstillende dokumentation for, at Coglapix fremstilles og testes efter en acceptabel kvalitetsstandard for batchernes styrke, og at forekomsten af kliniske tegn dermed er korreleret med tilstedeværelsen af lungeforandringer.
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.
Danish: Indehaveren af markedsføringstilladelsen bekræftede, at fremtidige produktionsbatcher til EU-markedet vil blevet fremstillet på grundlag af faste målværdier og kontrolleret i henhold til de specifikationer for det færdige produkt, der er vedtaget ved den gensidige anerkendelsesprocedure.
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.
Danish: Uanset markedsføringstilladelsesindehaverens begrundelse vedrørende emnets kompleksitet og de tekniske vanskeligheder gav sagen anledning til det vigtige spørgsmål, om påvisning af signifikans af en parameter i én relevant undersøgelse kan begrunde, at der ses bort fra manglende signifikans af samme parameter i en "ikke-signifikant" undersøgelse.
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.
Danish: Ved vurderingen af resultaterne fra undersøgelserne af virkning blev der yderligere rejst et problem vedrørende overensstemmelsen mellem de anvendte vaccinebatcher i disse undersøgelser.
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).
Danish: De pågældende afsnit af produktresuméet og indlægssedlen bør rettes, så de afspejler dette (se bilag III).
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.
Danish: CVMP anbefalede derfor udstedelse af markedsføringstilladelse for de i bilag I angivne veterinærlægemidler, idet referencemedlemsstatens produktresumé og indlægsseddel ændres.