FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 multiple dose vial, 6 injection syringes of 1 mL, 6 injection needles and 12 cleansing swabs 1 multiple dose vial, 6 injection syringes with attached needle and needle protection device of 1 mL and 12 cleansing swabs
Danish: 1 flerdosis hætteglas, 6 injektionssprøjter a 1 ml, 6 kanyler og 12 renseservietter 1 flerdosis hætteglas, 6 injektionssprøjter a 1 ml med påsat kanyle og kanylehætte og 12 renseservietter 2 flerdosis hætteglas
English: th percentile).
Danish: § Se pkt.
English: IntronA 5 million IU/0.5 mL solution for injection or infusion Interferon alfa-2b
Danish: IntronA 5 millioner IE/0,5 ml injektionsvæske-/infusionsvæske, opløsning interferon alfa-2b
English: IntronA 3 million IU/0.5 mL solution for injection or infusion interferon alfa-2b
Danish: IntronA 3 millioner IE/0,5 ml injektionsvæske-/infusionsvæske, opløsning interferon alfa-2b
English: Pack of 1 vial, 1 injection syringe of 1 mL, 1 injection needle and 1 cleansing swab Pack of 6 vials, 6 injection syringes of 1 mL, 6 injection needles and 6 cleansing swabs Pack of 12 vials, 12 injection syringes of 1 mL, 12 injection needles and 12 cleansing swabs Not all pack sizes may be marketed.
Danish: - Pakning med 1 hætteglas, 1 injektionssprøjte a 1 ml, 1 kanyle og 1 renseserviet - Pakning med 6 hætteglas, 6 injektionssprøjter a 1 ml, 6 kanyler og 6 renseservietter - Pakning med 12 hætteglas, 12 injektionssprøjter a 1 ml, 12 kanyler og 12 renseservietter.
English: Retinal haemorrhages
Danish: Retinal blødning
English: Potential remaining risks will be minimised to an acceptable level by the
Danish: De tilbageværende potentielle risici vil blive minimeret til et acceptabelt
English: These changes, in principle, address the concerns raised by the CHMP and its Working Parties.
Danish: Disse ændringer imødekommer i princippet de betænkeligheder, der er rejst af CHMP og
English: The clinical issues were discussed with the MAH at the Vaccine Working Party (VWP) during its February 2006 meeting, while the quality issues were discussed at the February BWP meeting.
Danish: De kliniske spørgsmål blev drøftet med indehaveren af markedsføringstilladelsen i arbejdsgruppen vedrørende vacciner (VWP) på dennes møde i februar 2006, mens spørgsmålene vedrørende kvalitet blev drøftet på mødet i BWP i februar 2006.
English: On 13 February 2006, the European Commission (EC) triggered the procedure under Article 20 of Regulation (EC) No 726/2004, after the CHMP expressed concerns on the low immunogenicity of the HepB component of Procomvax.
Danish: Den 13. februar 2006 indledte Kommissionen proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004, efter at CHMP havde udtrykt betænkelighed vedrørende den lave immunogenicitet af HepB-komponenten i PROCOMVAX.
English: The CHMP was requested to give an opinion as to whether the marketing authorisation for Procomvax should be maintained, varied, suspended or withdrawn in the context of an Article 20 of Regulation (EC) No726/2004 procedure.
Danish: CHMP blev anmodet om at afgive en udtalelse om, hvorvidt markedsføringstilladelsen for PROCOMVAX burde opretholdes, ændres, suspenderes eller inddrages ved en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004.
English: The CHMP debated the current lack of knowledge about the clinical significance of the findings and immune memory in general and agreed that these issues needed to be carefully explored before deciding on regulatory action.
Danish: CHMP drøftede den aktuelle manglende viden om resultaternes kliniske betydning og immunhukommelsen i almindelighed og vedtog, at disse spørgsmål, måtte undersøges nøje, før der blev truffet afgørelse om
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF PROCOMVAX PRESENTED BY THE EMEA
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF MARKEDSFØRINGSTILLADELSEN FOR PROCOMVAX FREMLAGT AF EMEA
English: The CHMP is of the Opinion that the Product Information of PROCOMVAX, should be varied in order to maintain the safe and effective clinical use for the following reasons:
Danish: CHMP finder, at produktoplysningerne for PROCOMVAX bør ændres af hensyn til fortsat sikker og effektiv klinisk anvendelse af følgende grunde:
English: As there are currently no reports on increased numbers of Hepatitis B breakthrough cases after PROCOMVAX vaccination, considering that the EU is a low endemic region, no immediate safety signal could be identified by the CHMP.
Danish: Da der aktuelt ikke findes indberetninger om et stigende antal Hepatitis B-gennembrud efter vaccination med PROCOMVAX, og i betragtning af, at EU er et område med lav endemisk forekomst af sygdommen, har CHMP ikke fundet noget umiddelbart faresignal vedrørende sikkerheden.
English: Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with PROCOMVAX and, further to the assessment of the data provided by the MAH, the CHMP concluded that the MA of PROCOMVAX should be varied in accordance with Article 5(2) of Regulation (EC) No 726/2004.
Danish: I betragtning af alle de rejste punkter, herunder den nødvendige tid til fuldstændig undersøgelse af alle spørgsmål vedrørende for lav HepB-immunogenicitet efter vaccination med PROCOMVAX, og i fortsættelse af vurderingen af de oplysninger, der er fremlagt af indehaveren af markedsføringstilladelsen, konkluderede CHMP, at markedsføringstilladelsen for PROCOMVAX bør ændres i overensstemmelse med artikel 5, stk. 1, i forordning (EF) nr. 726/2004.
English: The CHMP reviewed all the technical and clinical data available for PROCOMVAX extensively.
Danish: CHMP har gennemgået alle de tekniske og kliniske oplysninger, der foreligger om PROCOMVAX.
English: • The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component and that following extensive review of the manufacturing process the MAH has identified the current adjuvantation process as a potential root cause for decreased immunogenicity of the HepB vaccine
Danish: • CHMP fandt, at den nedsatte immunogenicitet af den HepB-komponent, der frigives af indehaveren af markedsføringstilladelsen, synes at skyldes variabilitet i produktionsprocessen for denne komponent, og at indehaveren af markedsføringstilladelsen efter en tilbundsgående gennemgang af produktionsprocessen har udpeget den nuværende adjuveringsproces som en mulig grundårsag til nedsat immunogenicitet af HepB-vaccinekomponenten.
English: These noninfectious substances protect infants against invasive disease caused by Haemophilus influenzae type b (infection of brain and spinal cord tissues, infection of the blood, etc.) and against infection caused by all known subtypes of hepatitis B virus, by stimulating an immune response (immunogenic activity) against these infections.
Danish: Disse ikke-infektiøse stoffer beskytter spædbørn mod invasive infektioner forårsaget af Haemophilus influenzae type b (hjerne- og rygmarvsbetændelse, infektioner i blodet osv.) og mod infektioner forårsaget af alle kendte subtyper af hepatitis B-virus ved at stimulere immunforsvaret (den immunogene aktivitet) mod disse infektioner.
English: GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF PROCOMVAX
Danish: BEGRUNDELSE FOR ÆNDRING AF MARKEDSFØRINGSTILLADELSEN FOR PROCOMVAX
English: In addition, a review of clinical performance as assessed by protection against disease as noted in the V121-018 trial supports the conclusion that the hepatitis B vaccines remain effective in decreasing hepatitis B infection and its serious sequelae.
Danish: En gennemgang af den kliniske virkning, vurderet på den opnåede beskyttelse mod sygdom som anført i V121-018-undersøgelsen, giver desuden støtte for den konklusion, at hepatitis B-vaccinerne fortsat er effektive til at reducere infektion med hepatitis B og de
English: • Considering the data on low immunogenicity available today, the CHMP identified the need for further studies to ensure long-term protection against Hepatitis B with the current vaccine in
Danish: • Ud fra de aktuelt foreliggende data om lav immunogenicitet fandt CHMP yderligere undersøgelser nødvendige for at sikre langtidsbeskyttelse mod Hepatitis B med den aktuelle vaccine fremover.
English: • The CHMP considered that the benefit/risk balance of PROCOMVAX concerning protection against hepatitis B virus infection caused by all known subtypes in all age categories considered at risk of exposure to hepatitis B virus remains favourable.
Danish: • CHMP fandt, at benefit/risk forholdet for PROCOMVAX fortsat er positivt til beskyttelse mod infektion med Hepatitis B virus forårsaget af alle kendte undertyper i alle aldersgrupper, som anses for at have en risiko for at blive eksponeret for hepatitis B virus,
English: The CHMP also considered the commitments given by the MAH in response to CHMP's requests to meticulously control the performance of PROCOMVAX from now on in a broad array of appropriate clinical trials including all age and risk categories.
Danish: CHMP har desuden taget hensyn til de forpligtelser, som indehaveren af markedsføringstilladelsen har påtaget sig for at imødekomme CHMP's anmodninger om fremtidig minutiøs kontrol af virkningen af PROCOMVAX i en bred vifte af kliniske undersøgelser hos alle alders- og risikokategorier.
English: The CHMP agreed with the MAH on revised product information for all presentations of PROCOMVAX, reflecting advice and suggestions made during the procedure.
Danish: CHMP aftalte med indehaveren af markedsføringstilladelsen, at produktoplysningerne for alle pakningsformer af PROCOMVAX skal revideres, så de afspejler de anvisninger og forslag, der er fremsat under proceduren.
English: The interim outcome of a clinical trial with the ‘process upgraded' recombinant Hepatitis B batches confirms that the immunogenicity of the current PROCOMVAX vaccine is at the historic standard, and provides evidence for a consistent trend to higher GMTs with PROCOMVAX manufactured with the process modification.
Danish: Det foreløbige resultat af en klinisk undersøgelse med de "procesopgraderede" Hepatitis B-lots bekræfter, at immunogeniciteten af den nuværende PROCOMVAX-vaccine er af den tidligere standard, og giver vidnesbyrd om en ensartet tendens i retning af højere gennemsnitlige antistoftitre (GMT) med PROCOMVAX fremstillet med den ændrede proces.
English: The active substances of Procomvax consist of polyribosylribitol phosphate (PRP) purified from Haemophilus influenzae and chemically coupled to the outer membrane protein complex (OMPC) of Neisseria meningitidis, and the hepatitis B surface antigen (HBsAg) of the hepatitis B virus, derived from a recombinant strain of yeast.
Danish: De aktive stoffer i Procomvax er polyribosylribitolphosphat (PRP) oprenset fra Haemophilus influenzae, der er kemisk bundet til ydermembran proteinkomplekset (OMPC) af Neisseria meningitidis og til hepatitis B overfladeantigenet (HBsAg) af hepatitis Bvirusset, som er fremstillet på basis af en rekombinant gærstamme.
English: In addition to the immunogenicity data generated in the past 5 years from clinical trials with the PROCOMVAX data, the acceptable performance of these vaccines are supported from findings of surveillance for hepatitis B cases in the United States and New Zealand and from an analysis of the trend in vaccine failures reported to the MAH safety database.
Danish: Foruden af de immunogenicitetsdata, der de seneste 5 år er genereret i kliniske undersøgelser med HBVAXPRO og PROCOMVAX, bekræftes vaccinernes tilfredsstillende virkning af overvågningsresultater vedrørende hepatitis B i USA og New Zealand og af en trend-analyse af tilfælde af vaccinesvigt indberettet til sikkerhedsdatabasen hos indehaveren af markedsføringstilladelsen.
English: In view of the lack of analytical tools to predict immunogenicity in man, the need for regular testing of recombinant HepB batches in clinical trials was considered, in order to ensure consistent high immunogenicity of PROCOMVAX produced in particular according to the new updated/improved process.
Danish: På baggrund af de manglende analytiske muligheder for at forudsige immunogeniciteten hos mennesker blev det overvejet, om rekombinante HepB-lots regelmæssigt bør testes i kliniske undersøgelser for at sikre vedholdende høj immunogenicitet af PROCOMVAX, specielt de lots, der er produceret med den nye opdaterede/forbedrede proces.
English: Pending the outcome of the studies, the MAH committed to amend the SPC section 5.1 in order to update this section with the latest results from clinical studies regarding anti-HBs responses in individuals previously vaccinated and not vaccinated with Hepatitis B Vaccine as well as anti-PRP responses.
Danish: I afventning af resultatet af undersøgelserne forpligtede indehaveren af markedsføringstilladelsen sig til at ændre afsnit 5.1 i produktresuméet, så det opdateres med de seneste resultater af kliniske undersøgelser af virkningen af anti-HB hos personer, som henholdsvis er og ikke er blevet vaccineret med Hepatitis B-vaccine, og virkningen af anti-PRP blev ligeledes undersøgt.
English: Concerns were expressed on the low immunogenicity of the HepB component of Hexavac and the potential consequences on long-term protection against Hepatitis B infection and boostability post primary course of vaccination with this vaccine.
Danish: Der blev udtrykt betænkelig ved den ringe immunogenicitet af HepBkomponenten i Hexavac og de mulige konsekvenser for den langsigtede beskyttelse mod infektion med Hepatitis B og for muligheden af senere boosting, når den vaccinerede har gennemgået det første
English: The approved indication of Procomvax is for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age.
Danish: Den godkendte indikation for Procomvax er vaccination af spædbørn i alderen 6 uger til 15 måneder mod invasive infektioner forårsaget af Haemophilus influenzae type b samt infektioner forårsaget af alle kendte subtyper af hepatitis B-virus.
English: Notwithstanding, the new proposed model will have only predictive value once it has been fully validated and has shown to be able to discriminate batches of the Hepatitis B component that have elicited a high vs. a low immune response during clinical trials.
Danish: Imidlertid vil den foreslåede nye model først have prædiktiv værdi, når den er fuldt valideret og er påvist at kunne skelne mellem de lots af PROCOMVAX, der har fremkaldt høj
English: The CHMP has recommended the variation of the Marketing Authorisations for PROCOMVAX in accordance with Article 5(2) of Regulation (EC) No 726/2004.
Danish: har CHMP anbefalet ændring af markedsføringstilladelsen for PROCOMVAX i henhold til artikel 5,
English: The data reviewed by CHMP included data from 7 studies with HBVAXPRO and Procomvax, one of which is on-going at present.
Danish: De af CHMP gennemgåede oplysninger omfatter data fra syv undersøgelser med HBVAXPRO og Procomvax, hvoraf en er i gang på nuværende tidspunkt, Disse undersøgelser er udført hos forskellige risikogrupper og alderskategorier, dvs. børn født af Hepatitis B-positive mødre, spædbørn, raske unge,
English: The Commission Decision C(2014)5053 was issued on 11 July 2014.
Danish: Kommissionens afgørelse C(2014)5053 blev udstedt den 11. juli 2014.
English: The treatment durations were unclear but were probably of several weeks.
Danish: Behandlingsvarigheden var uklar, men var antagelig flere uger.
English: Add, to all products: 12.
Danish: For alle produkter tilføjes: 12.
English: This CVMP decision should also be taken into account in the present referral procedure.
Danish: Denne CVMP-afgørelse bør også tages i betragtning i nærværende indbringelsesprocedure.
English: Animals must not be slaughtered for human consumption during treatment.
Danish: Dyrene må ikke slagtes til menneskeligt konsum under behandlingen.
English: Some of the strains might be naturally resistant.
Danish: Nogle af stammerne kan være naturligt resistente.
English: The results are favourable but the treatment was metaphylactic.
Danish: Resultaterne er gunstige, men behandlingen var metafylaktisk.
English: This is however difficult to interpret in terms of field efficacy since this study was based on an experimental infection model.
Danish: Dette er imidlertid vanskeligt at fortolke hvad angår effektivitet i felten, da undersøgelsen byggede på en model med eksperimentel infektion.
English: Kiril I Metodiy No. 5
Danish: Kiril I Metodiy No. 5 Zavet
English: Following a referral procedure (EMEA/V/A/088)
Danish: Efter en indbringelsesprocedure (EMEA/V/A/088)
English: It is likely that at the beginning, the product was developed and used in the same manner as a growth promoter and to prevent mortality and performance loss.
Danish: Produktet er antagelig i begyndelsen udviklet og anvendt på samme måde som en vækstfremmer og til forebyggelse af dødelighed og nedsat ydeevne.
English: In those trials, it seems that the treatment is used for prevention in a non-specific manner, maybe even as a growth promoter.
Danish: I disse undersøgelser synes behandlingen at være anvendt til ikke-specifik forebyggelse, måske endda som vækstfremmer.
English: Add, to all products and delete the existing text: 5.1 Pharmacodynamic properties
Danish: For alle produkter indsættes følgende, og den eksisterende tekst slettes: 5.1 Farmakodynamiske egenskaber
English: Bacteria were frequently re-isolated in the treated animals and in the case of E. coli, the reduction in the percentage of positive animals is not statistically significant.
Danish: Bakterierne blev hyppigt reisoleret hos de behandlede dyr, og for E. coli var reduktionen i procentdelen af positive dyr ikke statistisk signifikant.
English: For use in drinking water.
Danish: Opløsning til brug i drikkevand.
English: The presence of the disease in the flock must be established before the product is used.
Danish: Tilstedeværelse af sygdommen i flokken skal være fastslået, før produktet anvendes.
English: Chickens: To be completed nationally.
Danish: Kyllinger: Udfyldes nationalt.
English: Pigs: To be completed nationally.
Danish: Svin: Udfyldes nationalt.
English: The risk for possible in vitro resistant strains should be included in the product information.
Danish: Risikoen for eventuelle in vitro-resistente stammer bør fremgå af produktinformationen.
English: 3, although the two situations are not directly comparable since the MIC values for tylosin are, overall, higher, and the doses used and pharmacokinetics may also differ.
Danish: 3, skønt de to situationer ikke er direkte sammenlignelige, da MIC-værdierne for tylosin overordnet er højere, og de anvendte doser og farmakokinetikken også kan være forskellige.
English: Not authorised for use in birds producing eggs for human consumption, including replacement chicks which are intended to produce eggs for human consumption.
Danish: Ikke godkendt til anvendelse hos fugle, der producerer æg til menneskeligt konsum, herunder levekyllinger, der er bestemt til at producere æg til menneskeligt konsum.
English: Most importantly, these studies are very old (they were conducted in the context of the development and marketing of the combination more than 40 years ago) and the in vitro susceptibility of the B. hyodysenteriae strains is unknown.
Danish: Vigtigst er, at de pågældende undersøgelser er meget gamle (de er udført i forbindelse med udvikling og markedsføring af kombinationen over 40 år siden), og in vitro-følsomheden af stammer af B. hyodysenteriae er ukendt.
English: The indication against swine dysentery caused by B. hyodysenteriae, can no longer be maintained and should be removed.
Danish: Indikationen svinedysenteri forårsaget af B. hyodysenteriae kan ikke længere opretholdes og bør slettes.
English: PROVET AE 19300, Aspropyrgos Attikis
Danish: Grækenland PROVET AE 19300, Aspropyrgos Attikis
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, and marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsvej og indehavere af markedsføringstilladelse i medlemsstaterne
English: Thus the overall benefit-risk balance for such product formulations is considered negative.
Danish: Det overordnede benefit/risk-forhold for sådanne produktformuleringer anses således for negativt,
English: Zoetis UK Limited 5th Floor, 6 St.
Danish: Zoetis UK Limited 5th Floor, 6 St. Andrew Street
English: Delete, where applicable, any references to systematic/prophylactic use.
Danish: Enhver omtale af systematisk/profylaktisk anvendelse slettes, hvor det er relevant.
English: In E. coli and Salmonella, based on in vitro data, spectinomycin resistance rates of about 30-50% can be expected.
Danish: Hos E. coli og Salmonella kan der på grundlag af in vitro-data forventes resistensrater over for spectinomycin på omkring 30-50 %.
English: Andrew Street London, EC4A 3AE United Kingdom
Danish: London, EC4A 3AE United Kingdom
English: Therefore there is no need to change the currently approved withdrawal periods for the products under assessment.
Danish: Der er derfor ikke behov for at ændre de aktuelt godkendte tilbageholdelsestider for de produkter der omfattes af vurderingen.
English: Powder for use in drinking water or milk
Danish: Pulver til opløsning i drikkevand eller mælk
English: Poligono Industrial El Segre
Danish: Poligono Industrial El Segre Parc.
English: In addition, some mutations in that area can confer increased MICs to both pleuromutilins and lincosamides.
Danish: Desuden kan visse mutationer i det pågældende område medføre øgede MIC-værdier over for både pleuromutiliner og lincosamider.
English: In those bacterial species there is no evidence of an important resistant population or of an evolving resistance status.
Danish: I disse bakteriearter er der ikke tegn på en stor resistent population eller på, at resistensstatus udvikler sig.
English: Moreover, product use in such conditions is associated with a risk of further resistance selection or co-selection.
Danish: Desuden er anvendelse af produktet under sådanne betingelser forbundet med risiko for yderligere selektion eller co-selektion af resistente organismer.
English: The associated aetiology of B. hyodysenteriae and its role in pathogenesis is however not fully clear and no bacteriological follow-up has been performed in those studies.
Danish: Den tilknyttede ætiologi for B. hyodysenteriae og dens rolle i patogenesen er dog ikke helt klar, og der er ikke foretaget bakteriologisk opfølgning i disse undersøgelser.
English: It appears however that this represents a minority of strains; also, this is based on sparse data and on several estimations, and no firm clinical breakpoint has been established up until now.
Danish: Det fremgår dog, at dette repræsenterer et mindretal af stammer og desuden er baseret på sparsomme data og flere estimater, og indtil nu er der ikke fastlagt et klart klinisk afskæringspunkt.
English: Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Danish: Den 5. maj 2015 indledte Belgien derfor en procedure i medfør af artikel 35 i direktiv 2001/82/EF for veterinærlægemidler indeholdende en kombination af lincomycin og spectinomycin til oral administration til svin og/eller fjerkræ.
English: Subsequent to the outcome of the aforementioned Article 34 referral procedure for Linco-Spectin 100, Belgium considered that it is in the interest of the Union to promote effective and rational use of the lincomycin-spectinomycin combination in orally administered veterinary medicinal products, and thereby limit the risk of resistance development.
Danish: Efter udfaldet af den nævnte artikel 34-indbringelsesprocedure for Linco-Spectin 100 fandt Belgien det i Unionens interesse at fremme effektiv og rationel anvendelse af kombinationen lincomycinspectinomycin i orale veterinærlægemidler og derved begrænse risikoen for resistensudvikling.