FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En eventuel beslutning om at anvende vaccine umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 10/04/2013
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse:
English: In case of accidental self-injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion indgift ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Between the withdrawals the vaccine should be stored at 2 °C - 8 °C.
Danish: Mellem seponeringerne skal vaccinen opbevares ved 2°C - 8°C.
English: STATEMENT OF ACTIVE SUBSTANCES 1 dose (1 ml) contains:
Danish: ANGIVELSE AF AKTIVE STOFFER 1 dosis (1 ml) indeholder:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/001 PET bottle of 50 ml EU/2/13/149/002 PET bottle of 100 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER EU/2/13/149/001 PET-flaske med 50 ml EU/2/13/149/002 PET-flaske med 100 ml
English: Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by E. coli (STEC).
Danish: Aktiv immunisering af smågrise, der er over 4 dage gamle, for at reducere dødelighed og kliniske tegn på ødemsygdom som følge af Stx2e-toksin, der er dannet af E. coli (STEC).
English: Prior to administration, shake the vaccine carefully.
Danish: Omryst vaccinen grundigt før indgivelse.
English: Excipient: Thiomersal max. 0.115 mg Appearance after shaking: yellowish to brownish, homogenous suspension.
Danish: 0,115 mg Udseende efter rystning: gullig til brunlig, homogen suspension
English: PACKAGE SIZE 50 ml (50 doses) 100 ml (100 doses)
Danish: PAKNINGSSTØRRELSE 50 ml (50 doser) 100 ml (100 doser)
English: Appearance after shaking: yellowish to brownish, homogenous suspension.
Danish: Udseende efter rystning: gullig til brunlig, homogen suspension.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof, adjuvansen eller over for et eller flere af hjælpestofferne.
English: 4.2 Indications for use, specifying the target species Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by E. coli (STEC).
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af smågrise, der er over 4 dage gamle, for at reducere dødelighed og kliniske tegn på ødemsygdom som følge af Stx2e-toksin, der er dannet af E. coli (STEC).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/13/149/002 PET bottle
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER EU/2/13/149/002 PET-flaske
English: SPECIAL WARNINGS Special precautions for use in animals:
Danish: Særlige forholdsregler for anvendelse på dyr:
English: Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines.
Danish: Farmakoterapeutisk gruppe: Immunologiske for svin, inaktiverede bakterielle vacciner ATCvet-kode: QI09AB02.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (with PET bottle of 50 ml or 100 ml)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske (med PET-flaske med 50 ml eller 100 ml)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ecoporc SHIGA suspension for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Ecoporc SHIGA injektionsvæske, suspension til svin
English: Once opened use within 24 hours (store at 2 °C - 8 °C).
Danish: Anvendes inden for 24 timer efter åbning (opbevares ved 2°C -8°C).
English: Date of latest renewal:
Danish: Dato for seneste fornyelse af markedsføringstilladelse:
English: 21 days after vaccination Duration of immunity: 105 days after vaccination
Danish: 105 dage efter vaccination
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains:
Danish: ANGIVELSE AF DE AKTIVE STOF OG ANDRE INDHOLDSSTOFFER Hver dosis på 1 ml indeholder:
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): zero days
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 dage
English: PACKAGE LEAFLET: Ecoporc SHIGA suspension for injection for pigs
Danish: INDLÆGSSEDDEL Ecoporc SHIGA Injektionsvæske, suspension til svin
English: Pack sizes: Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml).
Danish: Pakningsstørrelser: Papæske med 1 PET-flaske med 50 doser (50 ml) eller 100 doser (100 ml).
English: WITHDRAWAL PERIOD(S) Withdrawal period(s): zero days.
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 dage.
English: Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml).
Danish: Papæske med 1 PET-flaske med 50 doser (50 ml) eller 100 doser (100 ml).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml
Danish: PÅ DEN INDRE EMBALLAGE 100 ml
English: ≥ 3.2 x 106 ELISA units/ml CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 50 doses
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Pregnancy and lactation: The use is not recommended during pregnancy and lactation.
Danish: Anvendelse frarådes under drægtighed og laktation diegivning.
English: In case of accidental self injection or ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forholdsregler, der skal træffes af den person, der administrerer veterinærlægemidlet til dyr: Søg omgående lægehjælp og vis indlægssedlen eller etiketten til lægen i tilfælde af utilsigtet selvinjicering eller indtagelse.
English: Shelf life after first opening the container: 24 hours (store at 2 °C - 8 °C).
Danish: Opbevaringstid efter første åbning af beholderen: 24 timer.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 24 hours Between the withdrawals, the vaccine should be stored at 2 °C - 8 °C.
Danish: Opbevaringstid efter første åbning af den indre emballage: 24 timer.
English: Excipient: Thiomersal max. 0.115 mg For the full list of excipients, see section 6.1.
Danish: 0,115 mg Alle hjælpestoffer er anført under pkt.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: 4.11 Withdrawal period Zero days.
Danish: 10. TILBAGEHOLDELSESTID 0 dage
English: IM.
Danish: maks.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that:
Danish: I overensstemmelse med artikel 31 og 32 i direktiv 2001/83/EF konkluderer CHMP derfor:
English: • Reanalysis and audits of data for specific studies did not point to any irregularity.
Danish: • Fornyet analyse og gennemgang af data fra specifikke undersøgelser viste ingen uregelmæssigheder.
English: The condition for the lifting of the suspension of the marketing authorisations is set out in Annex III.
Danish: Betingelsen for at ophæve suspenderingen af markedsføringstilladelserne fremgår af bilag III.
English: The CHMP was requested in particular to provide its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products should be maintained, varied, suspended, or revoked.
Danish: CHMP blev navnlig anmodet om at afgive en udtalelse i henhold til artikel 31 i direktiv 2001/83/EF om, hvorvidt markedsføringstilladelserne for disse produkter bør fastholdes, ændres, suspenderes eller tilbagekaldes.
English: This does not change the fact that any data generated at Semler is considered unreliable and therefore cannot be used to demonstrate bioequivalence.
Danish: Dette ændrer ikke det faktum, at alle data, der er genereret af Semler, anses for upålidelige og som følge deraf ikke kan anvendes til at påvise bioækvivalens.
English: The WHO concluded that the findings indicate the existence of a general or systematic deviation from commonly accepted quality standards, and cannot be ascribed to a single person or two working outside of the quality management system.
Danish: WHO har konkluderet, at fundene indikerer, at der er tale om en generel eller systematisk afvigelse fra almindeligt anerkendte kvalitetsstandarder, og at fundene ikke kan tilskrives en enkelt eller to personer, der arbejder uden for kvalitetssikringssystemet.
English: A number of corrective and preventive actions (CAPA) are proposed or have already been already implemented to address the findings of the FDA and WHO inspections.
Danish: En række korrigerende og forebyggende handlinger er foreslået eller allerede implementeret for at håndtere de problemstillinger, der blev konstateret under FDA's og WHO's inspektioner.
English: On these grounds, the WHO pre-qualification team (PQT) recommended an immediate stop to all submissions of dossiers relying in whole or in part on involvement from Semler until the underlying issues have been verified to have been adequately resolved.
Danish: Derfor har WHO's prækvalifikationsteam (PQT) anbefalet et øjeblikkeligt stop for alle indsendte ansøgninger, der er baseret helt eller delvist på arbejde udført af Semler, indtil det er bekræftet, at de underliggende problemer er blevet løst på tilfredsstillende vis.
English: The inspections revealed critical and major deviations which led to the publishing of a WHO notice of concern2.
Danish: Inspektionerne afslørede kritiske og alvorlige afvigelser, der har ført til offentliggørelsen af en meddelelse om betænkeligheder2.
English: The findings reported during this inspection cast serious doubts on the reliability of the data of bioequivalence studies (clinical and bioanalytical part) generated at the site.
Danish: De forhold, der blev konstateret under inspektionen, giver anledning til alvorlig tvivl om pålideligheden af dataene fra de bioækvivalens-undersøgelser (den kliniske og bioanalytiske del), der er foretaget i denne virksomhed.
English: Therefore, bioequivalence of the products concerned by this procedure has to be established using alternative data.
Danish: Derfor er det nødvendigt at undersøge bioækvivalensen for de pågældende produkter ved brug af alternative data.
English: The World Health Organisation (WHO) also inspected the same bioanalytical facility and the Semler clinical facility located at PA Arcade #21,22,23 Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, India between 27 and 31 January 2015, and performed a follow-up inspection between 2 and 5 December 2015 to verify compliance with GLP and GCP.
Danish: Verdenssundhedsorganisationen (WHO) har også inspiceret den samme bioanalytiske virksomhed og Semlers kliniske enhed, der er beliggende på adressen PA Arcade #21,22,23 Kodigehali Main Road, Sahakaranagar Post, Bangalore 560 092, Karnataka, Indien, i perioden 27-31. januar 2015 og gennemført en opfølgende inspektion i perioden 2-5. december 2015 for at verificere overholdelsen af GLP og GCP.
English: The Committee recommends that these marketing authorisations (annex IB) should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
Danish: Udvalget anbefaler derfor, at disse markedsføringstilladelser (bilag IB) suspenderes, medmindre lægemidlet anses for kritisk nødvendigt af de pågældende kompetente nationale myndigheder.
English: In view of the findings described above and the necessity to protect public health in the EU, the United Kingdom, Germany, Spain, the Netherlands and Denmark considered that it is in the interest of the Union to refer the matter to the CHMP and request that it assesses the impact of the findings mentioned above on the benefit-risk balance of the medicinal products which have been authorised by the Member States on the basis of relevant trials performed at these sites and also that of pending marketing authorisation applications (MAA).
Danish: I lyset af de ovenfor beskrevne fund og behovet for at beskytte den offentlige sundhed i EU har Storbritannien, Tyskland, Spanien, Nederlandene og Danmark vurderet, at det er i EU's interesse at indgive sagen for CHMP, idet disse lande anmoder om, at udvalget vurderer betydningen af fundene for benefit/risk-forholdet for de lægemidler, der er godkendt af medlemsstaterne på basis af undersøgelser, der er udført i disse enheder, og for de ansøgninger om markedsføringstilladelse, der endnu ikke er afsluttet.
English: • In some cases, MAHs pointed out that only certain parts of the study had been conducted at Semler, with the remaining tasks conducted at a different site.
Danish: • I nogle tilfælde påpegede indehaverne af markedsføringstilladelse, at kun visse dele af undersøgelsen var udført af Semler, mens de øvrige opgaver var udført af en anden virksomhed.
English: However, no formal request was submitted and the detailed information necessary to assess the appropriateness of a biowaiver was not made available by the MAHs/applicants.
Danish: Der blev imidlertid ikke indsendt nogen formel ansøgning, og de detaljerede oplysninger, der var nødvendige for at vurdere en dispensations berettigelse, blev ikke stillet til rådighed af indehaverne af markedsføringstilladelse/ansøgerne.
English: • Pharmacovigilance data on specific products included in this procedure have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability.
Danish: • Lægemiddelovervågningsdata for specifikke produkter, der er omfattet af denne procedure, har ikke påvist problemer, der kunne tilskrives manglende bioækvivalens, såsom nedsat virkning eller nedsat sikkerhed og tolerabilitet.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Semler, Bangalore, India;
Danish: • Udvalget fulgte proceduren i henhold til artikel 31 i direktiv 2001/83/EF for markedsføringstilladelser og ansøgninger om markedsføringstilladelser for lægemidler, for hvilke de kliniske og/eller bioanalytiske dele af bioækvivalensundersøgelserne blev udført af Semler i Bangalore, Indien.
English: • The CHMP reviewed available data and information provided by the MAHs/applicants, as well as information provided by Semler Research Centre Private Ltd;
Danish: • Udvalget gennemgik alle tilgængelige data og oplysninger fra indehaverne af markedsføringstilladelse/ansøgerne samt oplysninger fra Semler Research Centre Private Ltd.
English: • In some cases it was pointed out that products containing certain active substances could be eligible for biowaiver.
Danish: • Det blev i nogle tilfælde påpeget, at produkter med visse aktive stoffer kunne påberåbes en dispensation for bioækvivalensundersøgelse.
English: The inspection found significant instances of misconduct, including the substitution and manipulation of study subject samples.
Danish: Under inspektionen blev der fundet tilfælde af grov uredelighed, herunder erstatning af og manipulation med prøver fra forsøgspersoner.
English: The findings of the FDA and WHO inspections raise serious concerns relating to the suitability of the quality management system in place at the Semler JP Nagar and Sakar Nagar sites.
Danish: FDA's og WHO's fund rejser alvorlige betænkeligheder ved egnetheden af kvalitetssikringssystemet i Semler JP Nagar og Sakar Nagar.
English: Between 29 September 2015 and 9 October 2015, the United States Food and Drug Administration (FDA) performed a Good Clinical Practice (GCP) inspection at the bioanalytical facility Semler Research Centre Private Ltd, 75A, 15th Cross, 1st Phase, J.P. Nagar, Bangalore - 560 078 India.
Danish: USA's sundhedsmyndigheder (FDA) har mellem den 29. september 2015 og 9. oktober 2015 gennemført en GCP-inspektion af den bioanalytiske virksomhed Semler Research Centre Private Ltd., 75A, 15th Cross, 1st Phase, J.P. Nagar, Bangalore, 560 078, Indien.
English: • For some products, results from bioequivalence data using non-EU Reference Medicinal Products may be available.
Danish: • For nogle produkter kan data fra bioækvivalens-undersøgelser, der omfatter ikke-EUreferencelægemidler, være tilgængelige.
English: d. Bioequivalence vis-à-vis the EU reference medicinal product has been established for marketing authorisation applications listed in annex IA.
Danish: d. Bioækvivalensen med EU-referencelægemidlet er fastlagt for de ansøgninger om markedsføringstilladelse, der er anført i bilag IA.
English: Data from all bioequivalence studies performed at Semler Research Private Limited in Bangalore India and submitted to the Competent Authorities to demonstrate bioequivalence of medicinal products with their originator is considered unreliable.
Danish: Dataene fra alle bioækvivalens-undersøgelser, der er udført af Semler Research Private Ltd. i Bangalore, Indien, og som er indsendt til de kompetente myndigheder som dokumentation for lægemidlers bioækvivalens med originalproduktet, anses derfor for at være upålidelige.
English: Under Article 10(1) of Directive 2001/83/EC, these data are not acceptable to support a positive benefit-risk balance for the concerned products and cannot substitute the requirement to demonstrate bioequivalence between test product and a suitable EU reference product.
Danish: I henhold til artikel 10, stk. 1, i direktiv 2001/83/EF kan disse data ikke accepteres som dokumentation for et positivt benefit/risk-forhold for de pågældende produkter, og de kan ikke erstatte kravet om dokumentation af bioækvivalensen mellem det aktuelle produkt og et egnet EU-referencelægemiddel.
English: In view of the failures of the quality management system in place at the sites, results and controls of data integrity of individual studies by MAHs cannot make the bioequivalence studies performed at Semler Research Center acceptable as basis for a marketing authorisation.
Danish: I betragtning af de fejl, der er i kvalitetssikringssystemet i enhederne, kan resultaterne og dataintegritetskontrollen i individuelle undersøgelser foretaget af markedsføringstilladelsesindehaverne ikke gøre bioækvivalens-undersøgelserne udført af Semler Research Center acceptable som grundlag for en markedsføringstilladelse.
English: 1 http://www.fda.gov/Drugs/DrugSafety/ucm495778.htm 2 http://apps.who.int/prequal/info_applicants/NOC/2016/NOC_Semler12April2016.pdf substance between the two medicinal products may differ.
Danish: 1 http://www.fda.gov/Drugs/DrugSafety/ucm495778.htm 2 http://apps.who.int/prequal/info_applicants/NOC/2016/NOC_Semler12April2016.pdf
English: Nevertheless, any CAPAs implemented after the FDA and WHO inspections cannot retrospectively correct the quality system failures observed during these two inspections.
Danish: Ikke desto mindre kan korrigerende og forebyggende handlinger ikke med tilbagevirkende kraft rette op på de fejl i kvalitetssikringssystemet, som blev konstateret under disse to inspektioner.
English: The findings of the FDA and WHO inspections raise serious concerns relating to the suitability of the quality management system at these sites and, consequently, the reliability of data submitted in applications for marketing authorisations submitted in European Union (EU) Member States.
Danish: FDA's og WHO's fund rejser alvorlige betænkeligheder ved egnetheden af kvalitetssikringssystemet i disse enheder og derfor også ved pålideligheden af de data, der er indsendt i ansøgninger om markedsføringstilladelse til medlemsstaterne i EU.
English: For those products for which no alternative data is available to establish bioequivalence to an EU reference medicinal product, the main arguments put forward by the MAHs/applicants were as follows:
Danish: For de produkter, for hvilke der ikke findes alternative data til dokumentation af bioækvivalensen med et EU-godkendt referencelægemiddel, var hovedargumenterne fra indehaverne af markedsføringstilladelse/ansøgerne følgende:
English: Therefore the FDA concluded that clinical and bioanalytical studies conducted by Semler Research Private Limited in Bangalore, India are not acceptable as a result of data integrity concerns1.
Danish: FDA har således konkluderet, at de kliniske og bioanalytiske undersøgelser, der er gennemført af Semler Research Private Ltd. i Indien, ikke er acceptable, da der er betænkeligheder ved dataintegriteten1.
English: The CHMP therefore recommends the suspension of the marketing authorisations for all remaining medicinal products concerned by this referral procedure (annex IB), as bioequivalence vis-à-vis the EU reference medicinal products has not been demonstrated.
Danish: CHMP anbefaler derfor suspendering af markedsføringstilladelsen for alle øvrige lægemidler, der er omfattet af denne procedure (bilag IB), da der ikke er påvist bioækvivalens med EU-referencelægemidlerne.
English: In their own investigation and analysis of the studies concerned by the FDA inspection, and also in their investigation for similar anomalies or patterns in other studies, Semler found no conclusive evidence of inappropriate data manipulation, substitution or dilution.
Danish: Semler gennemførte selv en undersøgelse og en analyse af de undersøgelser, der var genstand for FDA's inspektion, samt en undersøgelse for lignende fejl eller mønstre i andre undersøgelser, men fandt ingen afgørende beviser for datamanipulation, prøveudskiftning eller prøvefortynding.
English: Alternative data were submitted to demonstrate the bioequivalence of abacavir/lamivudine-containing medicinal products to an EU reference medicinal product.
Danish: Der blev indsendt alternative data til påvisning af bioækvivalensen mellem lægemidler indeholdende abacavir/lamivudin og et EU-referencelægemiddel.
English: • The CHMP concluded that the particulars supporting the marketing authorisation/marketing authorisation application are incorrect and that the benefit-risk balance is considered not favourable for:
Danish: • Udvalget konkluderede, at oplysningerne til dokumentation af markedsføringstilladelsen/ansøgningen om markedsføringstilladelsen er urigtige, og at benefit/riskforholdet ikke er positivt for:
English: For all other marketing authorisation applications (annex IB), the CHMP considers that the applicants did not submit information which allows to establish bioequivalence to the EU reference medicinal product, and therefore the marketing authorisation applications do not currently fulfil the criteria for authorisation.
Danish: For så vidt angår alle andre ansøgninger om markedsføringstilladelse (bilag IB), finder CHMP, at ansøgerne ikke har fremsendt oplysninger, der gør det muligt at fastslå bioækvivalens med EUreferencelægemidlet, og ansøgningerne om markedsføringstilladelse opfylder derfor ikke aktuelt kriterierne for godkendelse.
English: Having assessed the alternative data, the CHMP recommends the maintenance of the marketing authorisations for abacavir/lamivudinecontaining medicinal products (annex IA) and concludes that, with regards to marketing authorisation applications for abacavir/lamivudine-containing medicinal products, bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product using alternative data.
Danish: Efter vurdering af de alternative data anbefaler CHMP opretholdelse af markedsføringstilladelserne for lægemidler, der indeholder abacavir/lamivudin (bilag IA) og konkluderer, at med hensyn til ansøgninger om markedsføringstilladelse for lægemidler, der indeholder abacavir/lamivudin er der påvist bioækvivalens med EU-referencelægemidlet ved anvendelse af alternative data.