FrancophonIA/ELRC3.0 huggingface dataset:
English: The CMDh considered the below PRAC recommendation with regard to testosterone containing medicinal products:
Danish: CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået nedenstående anbefaling fra PRAC (Udvalget for Risikovurdering inden for Lægemiddelovervågning) om lægemidler indeholdende testosteron:
English: • The PRAC concluded that based on the overall currently available data, the suggested risk for cardiovascular events associated with the testosterone therapy remains a weak signal.
Danish: • PRAC konkluderede, at den formodede risiko for kardiovaskulære hændelser ved behandling med testosteron fortsat er et svagt signal, når alle foreliggende data tages i betragtning.
English: • The PRAC also concluded that there was the need for all MAHs to closely monitor cardiovascular risk and discuss the findings including venous thromboembolic events and possible mechanism(s) and usage pattern and adverse events in patients older than 65 years in the next PSUR.
Danish: • PRAC konkluderede, at var nødvendigt, at alle indehavere af markedsføringstilladelserne overvåger den kardiovaskulære risiko og i den næste PSUR drøfter resultaterne heraf, herunder venøse tromboemboliske hændelser og mulig(e) mekanisme(r) herfor samt anvendelsesmønster og bivirkninger hos patienter over 65 år anbefalede PRAC på ovennævnte baggrund ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende testosteron (se bilag I), for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III, og betingelserne af bilag IV til PRAC's anbefaling.
English: This summary was last updated in March 2016
Danish: Dette sammendrag blev sidst ajourført i marts 2016.
English: The whole flock should be vaccinated at the same time.
Danish: Hele flokken bør vaccineres samtidig.
English: Protection starts four weeks after vaccination.
Danish: Beskyttelsen starter fire uger efter vaccinationen.
English: The vaccine has no known side effects.
Danish: Vaccinen har ingen kendte bivirkninger.
English: The field study did not bring additional information.
Danish: Feltundersøgelsen gav ingen yderligere information.
English: It should not be used in birds in lay or within five weeks of the start of the laying period.
Danish: Den må ikke bruges til æglæggende fugle eller inden for fem uger efter æglægningsperiodens start.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for MS-H vaccine on 14 June 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for MS-H Vaccine den 14. juni 2011.
English: The company presented data from laboratory studies and from one field trial.
Danish: Virksomheden fremlagde data fra laboratorieundersøgelser og fra en feltundersøgelse.
English: Protection against damage to air sacs lasts for 40 weeks, but the duration of protection against abnormal shells forming is not known.
Danish: Beskyttelsen mod skader på luftsækkene varer i 40 uger, men varigheden af beskyttelsen mod dannelse af unormal skal kendes ikke.
English: The full EPAR for MS-H Vaccine can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for MS-H Vaccine findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The withdrawal period for MS-H vaccine for meat and eggs is zero days.
Danish: Tilbageholdelsestiden for MS-H Vaccine for kød og æg er nul dage.
English: ‘Attenuated' means that the strain has first been weakened so that it does not cause disease.
Danish: "Svækket" betyder, at stammen først er blevet svækket, så den ikke er sygdomsfremkaldende.
English: This is a summary of the European public assessment report (EPAR) for MS-H Vaccine.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for MS-H Vaccine.
English: This bacterium causes infections in birds, generally in the lungs and the ‘air sacs', the specialised bags within the bird's body where air is stored during breathing.
Danish: Denne bakterie forårsager infektion hos fugle, almindeligvis i lungerne og i "luftsækkene", som er de særlige sække i fuglens krop, hvor luften opbevares under vejrtrækningen.
English: MS-H Vaccine, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Ligesom alle andre vacciner virker MS-H Vaccine ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal beskytte sig mod en sygdom.
English: In the future, if the animals are exposed to Mycoplasma synoviae, the immune system will be able to respond more quickly.
Danish: Hvis dyrene senere udsættes for Mycoplasma synoviae, vil immunsystemet hurtigere kunne reagere.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that MS-H Vaccine's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved MS-H Vaccine opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The person administering the vaccine should wear protective equipment, consisting of gloves and safety glasses to avoid skin and eye injuries which may occur by manipulating the vaccine bottle which is frozen.
Danish: Personen, der administrerer lægemidlet, skal bruge værnemidler bestående af handsker og sikkerhedsbriller for at undgå hud- og øjenskader som følge af håndteringen af den frosne flaske med vaccine.
English: Any accidental splashing to the face and eyes should be thoroughly washed with water.
Danish: Hvis vaccinen ved et uheld kommer i berøring med ansigtet eller øjnene, skal der vaskes grundigt med vand.
English: Infection with Mycoplasma synoviae may result in difficulty breathing and is also associated with poor quality of the eggshell.
Danish: Infektion med Mycoplasma synoviae kan give vejrtrækningsbesvær og forbindes ligeledes med dårlig æggeskalskvalitet.
English: Mycoplasma synoviae strain MS-H vaccine (live attenuated)
Danish: Mycoplasma synoviae-stamme MS-H-vaccine (levende, svækket)
English: When MS-H Vaccine is given to chickens the immune system recognises the weakened strain as ‘foreign' and makes defences against it.
Danish: Når MS-H Vaccine gives til kyllinger, opfatter immunsystemet den svækkede stamme som "fremmed" og danner antistoffer mod den.
English: MS-H Vaccine is given as one eye drop into one eye.
Danish: MS-H Vaccine gives som en øjendråbe pr. øje.
English: MS-H Vaccine is used in young chickens intended to produce eggs for broilers (for meat) and layers (for egg production) to reduce the damage to air sacs and reduce the number of eggs with abnormal shells.
Danish: MS-H Vaccine anvendes til unge kyllinger, der opdrættes til at være slagtekyllinger (til kødproduktion) og æglæggende høns (til ægproduktion) for at mindske skaderne på luftsækkene og reducere antallet af æg med unormal skal.
English: It is not intended to provide practical advice on how to use MS-H Vaccine.
Danish: Det er ikke en praktisk vejledning i, hvordan MS-H Vaccine bør anvendes.
English: The laboratory studies showed that MS-H Vaccine reduces damage to the air sacs and reduces the number of eggs with shell abnormalities.
Danish: Laboratorieundersøgelserne viste, at MS-H Vaccine mindsker skaderne på luftsækkene og reducerer antallet af æg med unormal skal.
English: MS-H Vaccine is available as eye drops and can only be obtained with a prescription.
Danish: MS-H Vaccine fås som øjendråber og udleveres kun efter recept.
English: The laboratory studies included a challenge model of Mycoplasma synoviae infection as well as a study looking at the effect of vaccination on eggshell abnormalities.
Danish: Laboratorieundersøgelsen omfattede en belastningsundersøgelse af Mycoplasma synoviae-infektion samt en undersøgelse, hvor man så på vaccinationens virkning på uregelmæssige æggeskaller.
English: What is MS-H Vaccine and what is it used for?
Danish: Hvad er MS-H Vaccine, og hvad anvendes det til?
English: MS-H Vaccine contains a live, attenuated strain of Mycoplasma synoviae.
Danish: MS-H Vaccine indeholder en levende, svækket stamme af Mycoplasma synoviae.
English: MS-H Vaccine is a vaccine used in chickens from five weeks of age to protect them against Mycoplasma synoviae.
Danish: MS-H Vaccine anvendes til kyllinger fra femugersalderen for at beskytte dem mod Mycoplasma synoviae.
English: Why is MS-H Vaccine approved?
Danish: Hvorfor er MS-H Vaccine blevet godkendt?
English: What are the risks associated with MS-H Vaccine?
Danish: Hvilke risici er der forbundet med MS-H Vaccine?
English: The field study looked at how vaccinated chickens fared when moved to flocks with a history of Mycoplasma synoviae infection.
Danish: I feltundersøgelsen så man på, hvordan vaccinerede kyllinger klarede sig, når de blev flyttet til flokke, der tidligere havde haft en Mycoplasma synoviae-infektion.
English: Other information about MS-H Vaccine:
Danish: Andre oplysninger om MS-H Vaccine
English: For more information about treatment with MS-H Vaccine, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med MS-H Vaccine, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using MS-H Vaccine, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af MS-H Vaccine, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is MS-H Vaccine used?
Danish: Hvordan anvendes MS-H Vaccine?
English: What benefits of MS-H Vaccine have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved MS-H Vaccine?
English: How does MS-H Vaccine work?
Danish: Hvordan virker MS-H Vaccine?
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/114)
Danish: Resultatet af en procedure i henhold til artikel 34 i direktiv 2001/82/EF (EMEA/V/A/114)
English: 14 July 2017
Danish: 14. juli 2017
English: The European Commission issued a decision on 14 July 2017.
Danish: Europa-Kommissionen traf en afgørelse den 14. juli 2017.
English: The amended product information is available on the 'All documents' tab.
Danish: Den berigtigede produktinformation er tilgængelig på fanebladet "Alle dokumenter".
English: Denagard 45% (and associated names such as Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovak Republic and Spain.
Danish: Denagard 45 % (og relaterede navne som Tiamutin 45 %, Denagard 450 mg/g og Denagard vet 450 mg/g) markedsføres i Østrig, Belgien, Tjekkiet, Finland, Tyskland, Grækenland, Ungarn, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Rumænien, Slovakiet og Spanien.
English: Denagard 45% is authorised in the EU via national procedures.
Danish: Denagard 45 % blev godkendt i EU via nationale procedurer.
English: Questions and answers on Denagard 45% and its associated names
Danish: Spørgsmål og svar om Denagard 45 % og relaterede navne
English: On 12 April 2017, the European Medicines Agency (the Agency) completed a review of Denagard 45%.
Danish: Den 12. april 2017 afsluttede Det Europæiske Lægemiddelagentur (agenturet) en gennemgang af Denagard 45 %.
English: Germany noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Denagard 45% is marketed.
Danish: Tyskland bemærkede, at der er forskelle medlemsstaterne imellem med hensyn til den måde, veterinærlægemidlet kan anvendes på, hvilket fremgår af forskellene i produktinformationen i de lande, hvor Denagard 45 % markedsføres.
English: What is Denagard 45%?
Danish: Hvad er Denagard 45 %?
English: Denagard 45% is indicated for the treatment of swine dysentery, colitis, ileitis, enzootic pneumonia and pleuropneumonia in pigs; chronic respiratory disease in chickens and infectious sinusitis and airsacculitis in turkeys.
Danish: Denagard 45 % er indiceret til behandling af svinedysenteri, colitis, ileitis, enzootisk pneumoni og pleuropneumoni hos grise, kronisk luftvejssygdom hos kyllinger og smitsom sinuitis og luftsæklæsioner hos kalkuner.
English: Why was Denagard 45% reviewed?
Danish: Hvorfor blev Denagard 45 % undersøgt?
English: Questions and answers on Denagard 45% and its associated names EMA/275123/2017
Danish: Spørgsmål og svar om Denagard 45 % og relaterede navne EMA/491884/2017
English: Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and works by inhibiting bacterial protein synthesis.
Danish: Det tilhører antibiotikagruppen pleuromutilin og fungerer ved at hæmme bakteriel proteinsyntese.
English: On 24 August 2016, Germany referred the matter to the CVMP in order to harmonise the product information for Denagard 45% (and associated names) in the EU.
Danish: Den 24. august 2016 henviste Tyskland sagen til CVMP med henblik på at harmonisere produktinformationen for Denagard 45 % (og relaterede navne) i EU.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Denagard 45% and its associated names should be harmonised across the EU.
Danish: Baseret på evalueringen af de foreliggende data konkluderede CVMP, at produktinformationen for Denagard 45 % og relaterede navne bør harmoniseres i EU.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information (summary of product characteristics (SPC), labelling and package leaflet) for Denagard 45% in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at der er behov for at harmonisere produktinformationen (produktresuméet, etiketteringen og indlægssedlen) for Denagard 45 % i Den Europæiske Union (EU).
English: Denagard 45% is a veterinary medicinal product available as granules for use in drinking water and contains 450 mg tiamulin hydrogen fumarate per gram product.
Danish: Det indeholder 450 mg tiamulinhydrogenfumarat pr. gram produkt.
English: The adequacy of these provisional measures will be reviewed as part of the ongoing Article 20.
Danish: Spørgsmålet om, hvorvidt disse midlertidige foranstaltninger er tilstrækkelige, vil blive taget op til fornyet vurdering som led i den igangværende procedure i henhold til artikel 20.
English: In addition, the EC requested the Agency to give its opinion, as to whether provisional measures were necessary to protect public health.
Danish: Desuden anmodede Kommissionen EMA om en udtalelse om, hvorvidt det er nødvendigt at iværksætte midlertidige foranstaltninger af hensyn til folkesundheden.
English: This recommendation is without prejudice to the final conclusions of the ongoing procedure under Article 20 of Regulation (EC) No 726/2004.
Danish: Anbefalingen er med forbehold af de endelige konklusioner i den igangværende procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zinbryta (daclizumab).
Danish: Udvalget anbefaler derfor ændring af betingelserne for markedsføringstilladelsen for Zinbryta (daclizumab).
English: The current recommendation relates only to provisional measures recommended by the PRAC for daclizumab based on the preliminary data available at this time.
Danish: Den nuværende anbefaling vedrører kun midlertidige foranstaltninger, som PRAC har anbefalet for daclizumab på grundlag af de foreløbige data, der er til rådighed på nuværende tidspunkt.
English: In addition, consideration should be given to discontinue treatment if an adequate therapeutic response is not achieved.
Danish: Desuden bør det overvejes at afbryde behandlingen, hvis der ikke opnås en tilstrækkelig terapeutisk reaktion.
English: The threshold of transaminases elevation for patients not included in clinical trials, and therefore in which treatment initiation is not recommended, should be corrected from above two times the upper normal limit to above or equal to two times that limit.
Danish: Tærsklen for transaminaseforhøjelse hos patienter, der ikke deltog i de kliniske forsøg, og hos hvem det derfor ikke anbefales at påbegynde behandling, bør korrigeres fra over to gange den normale grænse til over eller lig to gange denne grænse.
English: While liver function monitoring continues to be an important measure to detect liver injury, and likely reduce the incidence of severe cases, it is unclear at this stage whether any alternative monitoring regimen would necessarily prevent further severe cases.
Danish: Selv om overvågning af leverfunktionen fortsat er en vigtig foranstaltning med henblik på at afsløre leverskade og sandsynligvis mindske forekomsten af alvorlige tilfælde, er det på nuværende tidspunkt uklart, om en alternativ overvågningsordning nødvendigvis ville forhindre yderligere alvorlige tilfælde.
English: In addition 4 cases of serious liver injury were reported from clinical trials, in the first periodic safety update report (PSUR).
Danish: Derudover blev der indberettet fire tilfælde af alvorlig leverskade fra kliniske forsøg i den første periodiske, opdaterede sikkerhedsberetning.
English: Patients exhibiting signs and symptoms suggestive of liver injury should be promptly referred to a hepatologist.
Danish: Patienter, der viser tegn og symptomer på leverskade, bør omgående henvises til en hepatolog.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Zinbryta (daclizumab).
Danish: • På baggrund af lægemiddelovervågningsdata gennemgik PRAC proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004, navnlig med hensyn til behovet for midlertidige foranstaltninger i overensstemmelse med artikel 20, stk. 3, i forordning (EF) nr. 726/2004 for Zinbryta (daclizumab).
English: Since the initial marketing authorisation further serious cases of liver injury have been reported, including a fatal case despite an attempted liver transplant.
Danish: Siden den første markedsføringstilladelse er der blevet indberettet yderligere alvorlige tilfælde af leverskade, herunder et tilfælde med dødelig udgang til trods for et forsøg på levertransplantation.
English: Zinbryta (daclizumab) is a centrally authorised medicinal product indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Danish: Zinbryta (daclizumab) er et centralt godkendt lægemiddel, der er indiceret til voksne patienter til behandling af recidiverende former for multipel sklerose.
English: The above provisional measures should be reflected in the product information of daclizumab and communicated to HCPs via a dedicated letter.
Danish: Ovennævnte midlertidige foranstaltninger bør afspejles i produktinformationen for daclizumab og meddeles sundhedspersonerne ved et særligt brev.
English: On 9 June 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Zinbryta (daclizumab) and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Danish: På baggrund af disse lægemiddelovervågningsdata indledte Kommissionen derfor den 9. juni 2017 en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004 og bad PRAC om at vurdere ovenstående problemstillings betydning for benefit/risk-forholdet for Zinbryta (daclizumab) og fremsætte en anbefaling om, hvorvidt de pågældende markedsføringstilladelser bør opretholdes, ændres, suspenderes eller tilbagekaldes.
English: On 7 June 2017, the European Commission (EC) was informed of a fatal case of fulminant liver failure in a patient treated with daclizumab in an ongoing observational study, despite monthly liver function testing performed in accordance with recommendations in the product information.
Danish: Den 7. juni 2017 blev Europa-Kommissionen (herefter "Kommissionen") underrettet om et tilfælde af fulminant leversvigt med dødelig udgang hos en patient, der blev behandlet med daclizumab som led i en løbende observationsundersøgelse, til trods for at der hver måned blev udført leverfunktionstest i overensstemmelse med anbefalingerne i produktinformationen.
English: Further, the PRAC took into consideration that interrupting treatment in patients whose disease is well-controlled with daclizumab may induce relapses.
Danish: PRAC tog endvidere i betragtning, at afbrydelse af behandlingen hos patienter, hvis sygdom er velkontrolleret med daclizumab, kan medføre tilbagefald.
English: Finally, physicians should consider discontinuing daclizumab treatment if an adequate therapeutic response has not been achieved.
Danish: Endelig bør lægerne overveje at afbryde daclizumabbehandlingen, hvis der ikke er opnået en tilstrækkelig terapeutisk reaktion.
English: Therefore, monitoring of serum transaminases levels should continue to be performed at least monthly and more frequently as clinically indicated, further, bilirubin levels should also be tested.
Danish: Der bør derfor fortsat udføres overvågning af serumtransaminaseniveauerne mindst én gang om måneden eller hyppigere afhængigt af den kliniske indikation.
English: In view of the above, the Committee considers that the benefit-risk balance of Zinbryta (daclizumab) remains favourable subject to the agreed provisional amendments to the product information.
Danish: I lyset af ovenstående finder udvalget, at benefit/risk-forholdet for Zinbryta (daclizumab) fortsat er positivt under forudsætning af, at de vedtagne midlertidige ændringer indføres i produktinformationen.
English: During the clinical development, transaminases elevations and serious hepatic injury were identified as important identified risks.
Danish: Under den kliniske udvikling blev transaminaseforhøjelser og alvorlig leverskade identificeret som store risici.
English: In view of this and while the magnitude and nature of the risk of liver injury is being further investigated, the PRAC considered that provisional measures are needed to limit the use of daclizumab.
Danish: I betragtning heraf, og selv om omfanget og arten af risikoen for leverskade bliver undersøgt nærmere, fandt PRAC, at der var behov for midlertidige foranstaltninger for at begrænse anvendelsen af daclizumab.
English: Analyses performed in the clinical development program to assess potential interactions of daclizumab with potentially hepatotoxic medications showed no clear evidence of increased risk of liver injury with concomitant hepatotoxic medications.
Danish: Analyser udført i forbindelse med det kliniske udviklingsprogram for at vurdere daclizumabs mulige interaktioner med potentielt hepatotoksiske lægemidler viste intet klart bevis på forhøjet risiko for leverskade som følge af samtidig behandling med hepatotoksiske lægemidler.
English: Cases of serious liver injury occurred at any time point between early after treatment initiation to several month after discontinuation and no window of susceptibility to could be defined from cases observed in clinical trials.
Danish: Tilfælde af alvorlig leverskade opstod på et hvilket som helst tidspunkt mellem tidligt efter påbegyndelsen af behandlingen til flere måneder efter afbrydelsen af behandlingen, og der kunne ikke konkluderes noget om modtageligheden ud fra de tilfælde, der blev iagttaget ved kliniske forsøg.