FrancophonIA/ELRC3.0 huggingface dataset:
English: On 12 June 2013 the CVMP adopted a final opinion confirming the recommendation included in its opinion of 7 March 2013, that the variation of the marketing authorisations for Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002) can be granted and a withdrawal period of 9 days is appropriate for chickens for the dose of 20 mg/kg bw for 4 consecutive days.
Danish: Den 12. juni 2013 vedtog CVMP en endelig udtalelse, der bekræfter anbefalingen i udvalgets udtalelse af 7. marts 2013 om godkendelse af ændring af markedsføringstilladelserne for Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger (NL/V/0141/001/WS/002) og Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger (UK/V/0349/001/WS/002) og fastsættelse af en tilbageholdelsestid på 9 dage som passende for kyllinger ved en dosis på 20 mg/kg kropsvægt i 4 på hinanden følgende dage.
English: Based on the evaluation of the available data the CVMP adopted, on 7 March 2013, an opinion recommending the granting of the variation of the marketing authorisations for Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002).
Danish: Efter vurdering af de foreliggende data vedtog CVMP den 7. marts 2013 en udtalelse, der anbefalede ændring af markedsføringstilladelserne for Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger (NL/V/0141/001/WS/002) og Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger (UK/V/0349/001/WS/002).
English: The marketing authorisation holder, Eurovet Animal Health BV submitted an application for a type II variation to shorten the withdrawal period in chickens to 6 days for Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names, which has been subject to a worksharing procedure by the CMDv according to Article 20 of Commission Regulation (EC) No 1234/2008.
Danish: Indehaveren af markedsføringstilladelsen, Eurovet Animal Health BV, indgav en ansøgning om en type II-ændring med henblik på at nedsætte tilbageholdelsestiden for kyllinger til 6 dage for Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger, og relaterede navne.
English: Opinion following an Article 131 referral for Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names
Danish: 1-henvisning for Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger, og relaterede navne
English: The European Commission issued a decision on 29 January 2010.
Danish: Europa-Kommissionen traf en afgørelse den 29. januar 2010.
English: London, 22 October 2009 rev. Doc.
Danish: London, den 22. oktober 2009 rev. Dok.
English: Initial Assessment
Danish: Oprindelig vurdering
English: When an antibiotic is produced using a natural source, as in this instance, there can be some differences in the composition of the finished product.
Danish: Når et antibiotikum fremstilles ved hjælp af en naturlig kilde, sådan som det er tilfældet her, kan der være visse forskelle i det færdige lægemiddels sammensætning.
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 22 October 2009.
Danish: Efter at have drøftet begrundelserne for denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede anbefalingen af afslag på ansøgningen om markedsføringstilladelse den 22. oktober 2009.
English: Re-examination
Danish: Revurdering
English: The CHMP opinion was confirmed after re-examination.
Danish: CHMP bekræftede udtalelsen efter at have revurderet den.
English: On 25 June 2009, the European Medicines Agency (EMEA) completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Teicoplanin Hospira.
Danish: Den 25. juni 2009 gennemførte Det Europæiske Lægemiddelagentur (EMEA) en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Teicoplanin Hospira.
English: It is use to treat patients with serious infections due to Grampositive bacteria.
Danish: Det anvendes til at behandle patienter med alvorlige infektioner, der skyldes grampositive bakterier.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Ireland, Italy, Portugal, Spain and the United Kingdom).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Tyskland) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder i dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Irland, Italien, Portugal, Spanien og Det Forenede Kongerige).
English: Questions and answers on the referral for Teicoplanin Hospira powder and solvent for injection containing 200 or 400 mg teicoplanin
Danish: Spørgsmål og svar vedrørende indbringelsen af sagen om Teicoplanin Hospira pulver og solvens til injektionsvæske, opløsning, indeholdende 200 eller 400 mg teicoplanin
English: Company responses provided on: 23 January 2009 and 27 May 2009
Danish: 23. januar 2009 og 27. maj 2009
English: However, the Member States were not able to reach an agreement and the German Regulatory Agency referred the matter to the CHMP for arbitration on 8 October 2008.
Danish: Medlemsstaterne kunne imidlertid ikke nå til enighed, og den tyske lægemiddelkontrolmyndighed indbragte den 8. oktober 2008 sagen for CHMP med henblik på voldgift.
English: Teicoplanin Hospira is a generic medicine based on a ‘reference medicine' authorised in Germany (Targocid 400 mg).
Danish: Teicoplanin Hospira er et generisk lægemiddel, der er baseret på et "referencelægemiddel", som er godkendt i Tyskland (Targocid 400 mg).
English: There were also concerns that the composition of the teicoplanin in Teicoplanin Hospira was different to that in Targocid, with a potential impact on the effectiveness of the medicine.
Danish: Der var ligeledes betænkeligheder med hensyn til, at sammensætningen af teicoplanin i Teicoplanin Hospira var anderledes end i Targocid, hvilket har en potentiel indvirkning på lægemidlets virkning.
English: By disrupting this barrier, teicoplanin kills the bacteria that are causing the infection.
Danish: Ved at nedbryde denne barriere kan teicoplanin dræbe de bakterier, der er årsag til infektionen.
English: The company that makes Teicoplanin Hospira, Hospira UK Limited, requested a re-examination of the opinion.
Danish: Den virksomhed, der fremstiller Teicoplanin Hospira, Hospira UK Limited, anmodede om en revurdering af udtalelsen.
English: Gram-positive bacteria include bacteria such as staphylocci (Staphylococcus aureus), streptococci (Streptococcus pneumoniae), Listeria, Clostridium difficile.
Danish: Grampositive bakterier omfatter bakterier som stafylokokker (Staphylococcus aureus), streptokokker (Streptococcus pneumoniae), Listeria og Clostridium difficile.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Teicoplanin Hospira do not outweigh its risks, and the marketing authorisation cannot be granted in Germany and in other Member States of the EU (Austria, Ireland, Italy, Portugal, Spain and the United Kingdom).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Teicoplanin Hospira ikke opvejer risiciene, og at der ikke kan udstedes markedsføringstilladelse i Tyskland eller i andre EU-medlemsstater (Østrig, Irland, Italien, Portugal, Spanien og Det Forenede Kongerige).
English: The grounds for the referral were concerns from Ireland and the United Kingdom that Teicoplanin Hospira had not been shown to be bioequivalent to Targocid.
Danish: Begrundelserne for indbringelsen var Irlands og Det Forenede Kongeriges betænkeligheder med hensyn til, at Teicoplanin Hospira ikke havde vist sig at være bioækvivalent med Targocid.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Teicoplanin Hospira do not outweigh its risks, and therefore the marketing authorisation should not be granted in the concerned Member States.
Danish: På basis af en vurdering af de nuværende tilgængelige data og de faglige drøftelser i udvalget er CHMP af den opfattelse, at fordelene ved Teicoplanin Hospira ikke opvejer risiciene, og at der derfor ikke bør udstedes markedsføringstilladelse for Teicoplanin Hospira i de berørte medlemsstater.
English: It works by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Danish: Det virker ved at forhindre bakterierne i at danne cellevægge og ved at nedbryde deres cellemembraner.
English: Teicoplanin Hospira can only be used in patients who cannot receive penicillin or cephalosporins antibiotics, or if these antibiotics have stopped working or the infection is due to a Staphylococcus that is resistant to other antibiotics.
Danish: Teicoplanin Hospira kan udelukkende anvendes til patienter, som ikke må få penicillin eller cefalosporinantibiotika, eller hvis disse antibiotika er holdt op med at virke, eller infektionen skyldes en stafylokok, der er resistent over for andre antibiotika.
English: These bacteria can cause skin infections, lung infections, joint and bone infections, heart infections or infections of the urinary tract (structures that carry urine).
Danish: Disse bakterier kan forårsage hudinfektioner, lungeinfektioner, led- og knogleinfektioner, hjerteinfektioner eller infektioner i urinvejene (de strukturer, som leder urinen).
English: Teicoplanin Hospira can also be used to prevent infections in patients undergoing surgery of the bones, joint or blood vessels.
Danish: Teicoplanin Hospira kan ligeledes anvendes til at forebygge infektioner hos patienter, der bliver opereret i knogler, led eller blodkar.
English: Hospira UK Limited submitted Teicoplanin Hospira to the German Regulatory Agency for a decentralised procedure.
Danish: Hospira UK Limited indgav en ansøgning om Teicoplanin Hospira til den tyske lægemiddelkontrolmyndighed via den decentrale procedure.
English: What is Teicoplanin Hospira?
Danish: Hvad er Teicoplanin Hospira?
English: Why was Teicoplanin Hospira reviewed?
Danish: Hvorfor blev Teicoplanin Hospira vurderet igen?
English: The active substance in Teicoplanin Hospira, teicoplanin, is an antibiotic that belongs to the group ‘glycopeptides'.
Danish: Det aktive stof i Teicoplanin Hospira, teicoplanin, er et antibiotikum, som tilhører gruppen "glycopeptider".
English: Teicoplanin Hospira is an antibiotic.
Danish: Teicoplanin Hospira er et antibiotikum.
English: This is because teicoplanin in Teicoplanin Hospira is made by fermentation, using a bacterium called Actinoplanes to produce the antibiotic.
Danish: Det skyldes, at teicoplanin i Teicoplanin Hospira er fremstillet ved gæring, hvor man har anvendt en bakterie ved navn Actinoplanes til antibiotikummets fremstilling.
English: What you need to know before you take X
Danish: 2.Det skal du vide, før du begynder at tage X
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 behandlede)
English: Adopted at the 14-17 January 2019 PRAC
Danish: Vedtaget på PRAC's møde 14.-17. januar 2019
English: The risk of interference is higher in children and patients with renal impairment and increases with higher doses.
Danish: Risikoen for interferens er højere hos børn og patienter med nedsat nyrefunktion og stiger med højere doser.
English: The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.
Danish: Laboratoriepersonalet bør konsulteres ved bestilling af laboratorieanalyser hos patienter, der tager biotin.
English: For medicinal products for oral use containing ≥150 microgram biotin per dose unit and medicinal products for parenteral use containing ≥60 microgram biotin per dose unit
Danish: Vedrører lægemidler til oral anvendelse, der indeholder ≥ 150 mikrogram biotin pr. dosisenhed, og lægemidler til parenteral anvendelse, der indeholder ≥ 60 mikrogram biotin pr. dosisenhed
English: Gabapentin - Dysphagia (EPITT no 19296)
Danish: Gabapentin - dysfagi (EPITT nr. 19296)
English: [Product name] contains <quantity> biotin per <dose unit>.
Danish: [Særnavn] indeholder <mængde> biotin pr. <dosisenhed>.
English: Interference with clinical laboratory tests
Danish: Interferens med kliniske laboratorieanalyser
English: Please inform your doctor or the laboratory personnel, if you are taking such products.
Danish: Fortæl det til din læge eller laboratoriepersonalet, hvis du tager sådanne produkter.
English: Biotin - Interference with clinical laboratory tests (EPITT no 19156)
Danish: Biotin - interferens med kliniske laboratorieanalyser (EPITT nr. 19156)
English: Your doctor may ask you to stop taking [Product name] before performing laboratory tests.
Danish: Lægen kan bede dig om at holde op med at tage [særnavn], før du får lavet en laboratorieanalyse.
English: You should also be aware that other products that you may take, such as multivitamins or supplements for hair, skin, and nails could also contain biotin and affect the results of laboratory tests.
Danish: Du bør også være opmærksom på, at andre produkter, som du måske tager (f.eks. multivitaminer eller kosttilskud for hår, hud og negle), kan indeholde biotin og dermed påvirke resultaterne af laboratorieanalyser.
English: If you are about to undergo laboratory testing you must tell your doctor or the laboratory personnel that you are taking or have recently taken [Product name], because biotin may affect results of such tests.
Danish: Hvis du snart skal have taget en laboratorieprøve, skal du fortælle det til lægen eller laboratoriepersonalet, at du tager eller for nylig har taget [særnavn], da biotin kan påvirke resultaterne af testen.
English: Undesirable effects Gastrointestinal disorders Uncommon: dysphagia
Danish: Bivirkninger Mave-tarm-kanalen Ikke almindelig: dysfagi
English: When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin).
Danish: Ved tolkning af resultaterne af laboratorieanalyser skal der tages hensyn til mulig biotininterferens, især hvis der observeres manglende kohærens med den kliniske præsentation (f.eks. kan resultaterne fra skjoldbruskkirteltest hos asymptomatiske patienter, der tager biotin, udvise symptomatisk lighed med Graves sygdom, ligesom der kan ses falsk negative analyseresultater for troponin hos patienter med myokardieinfarkt, der tager biotin).
English: Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected.
Danish: Der bør om muligt anvendes alternative analyser, som ikke er følsomme for biotin-interferens, i de tilfælde, hvor der er mistanke
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/905277/2019
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/37000/2019
English: Depending on the test, the results may be falsely elevated or falsely low due to biotin.
Danish: Afhængigt af testen kan resultaterne vise en falsk stigning eller et falsk fald på grund af biotin.
English: Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay.
Danish: Biotin kan påvirke laboratorieanalyser, der er baseret på en interaktion mellem biotin/streptavidin, hvilket medfører enten falske fald eller falske stigninger i laboratorieresultater, afhængigt af analysen.
English: Because of the delta, a control group is necessary.
Danish: På grund af deltaet er en kontrolgruppe påkrævet.
English: Member State / EEA
Danish: Medlemsstat / EØS
English: In addition, ramipril was well tolerated in all treated cats.
Danish: Ramipril var desuden veltolereret hos alle behandlede katte.
English: A placebo effect must always be assumed to be present.
Danish: Det skal altid antages, at en placebovirkning er til stede.
English: Improvement in hypertension in the absence of a negative control group
Danish: Forbedring i hypertension ved fravær af en negativ kontrolgruppe
English: Thus, the benefit/risk assessment is deemed unfavourable for the proposed indication in cats.
Danish: Benefit/risk-vurderingen anses for at være ugunstig for den foreslåede indikation hos katte.
English: • Untreated hypertension is associated with a significant risk of target organ damage.
Danish: • Ubehandlet hypertension er forbundet med en betydelig risiko for skade på målorganet.
English: It is agreed that the effect noted by the MAH in a follow-up response (see 2.3) is bigger than that.
Danish: Der er enighed om, at den virkning, der bemærkes af indehaveren af markedsføringstilladelsen i et opfølgende svar (se 2.3), er større end dette.
English: Percentage of cats with different number of clinical signs and their response to the treatment
Danish: Procentdel af katte med forskelligt antal kliniske tegn og deres respons på behandlingen
English: It is agreed that the white coat effect, when big, is up to 20 % or so.
Danish: Der er enighed om, at "white coat"-effekten er op til omkring 20 %, når den er stor.
English: Following the absence of agreement between the Reference Member State and one Concerned Member State (Belgium) at Day 90 of the CMD(v) procedure, the matter was referred to CVMP.
Danish: På grund af fortsat uenighed mellem referencemedlemsstaten og en berørt medlemsstat (Belgien) på dag 90 i indbringelsesproceduren for CMD(v) blev sagen indbragt for CVMP.
English: However, the sheer chance factor cannot be quantified in this study without placebo group.
Danish: Faktoren for ren chance kan dog ikke kvantificeres i denne undersøgelse uden placebogruppe.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REFUSAL OF THE VARIATION
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR AFSLAG PÅ ÆNDRINGEN
English: No statistical difference was observed in the distribution of clinical signs among cases when stratified by risk category (p=0.5296).
Danish: Der blev ikke observeret statistiske forskelle i fordelingen af kliniske tegn mellem tilfælde ved stratificering efter risikokategori (p=0,5296).
English: the CVMP agreed that the benefit/risk balance for Vasotop P in this variation currently is unfavourable,
Danish: CVMP fandt, at benefit/risk-balancen for Vasotop P i denne variation er ugunstig på nuværende tidspunkt.
English: From these 26 cats, 14 cats were normotensive by Day 63.
Danish: Af disse 26 katte blev 14 katte normotensive inden dag 63.
English: The CVMP considers that it would be less unethical to risk non-treatment of a small number of animal patients for a shorter time period than to authorise an un-efficacious product.
Danish: CVMP finder, at det ville være mindre uetisk at risikere ikkebehandling af et lille antal dyr i en kortere periode end at godkende et produkt uden virkning.
English: Whilst none could be identified, the CVMP is concerned that the list of factors studied was hardly exhaustive, and in effect, only two such parameters were actually investigated (i.e. diet and concomitant treatment).
Danish: Selv om det ikke var muligt at identificere nogen, er CVMP bekymret for, at listen over undersøgte faktorer ikke er udtømmende, idet kun to sådanne parametre faktisk blev undersøgt (dvs. kost og samtidig behandling).
English: In the context of the current study, a white coat effect should impact both groups equally in order to allow a treatment effect to emerge.
Danish: I forbindelse med dette forsøg bør en white coat-effekt påvirke begge grupper ligeligt, for at en behandlingseffekt kan opnås.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, DYREARTER, INDGIVELSESVEJ OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: In addition, while no authorised reference product exists (positive control), it was argued that it would not have been unethical to have included a negative control group as hypertension is not necessarily life-threatening.
Danish: Eftersom der ikke findes et godkendt referenceprodukt (positiv kontrol), blev det endvidere fremført, at det ikke ville have været uetisk at have inkluderet en negativ kontrolgruppe, da hypertension ikke nødvendigvis er livstruende.
English: Therefore, the clinical signs as mentioned may resolve (except for complete retinal detachment).
Danish: De nævnte kliniske tegn kan dog aftage (med undtagelse af fuldstændig nethindeløsning).
English: There were no significant differences between risk categories III and IV for age, bodyweight, heart rate, and total thyroxine, urea and creatinine concentrations.
Danish: Der var ingen signifikante forskelle mellem risikokategori III og IV for alder, kropsvægt, hjertefrekvens og totale tyroxin-, urinstof- og kreatininkoncentrationer.
English: However, without direct comparison to a negative control group, it is not possible to say if this effect is due to treatment.
Danish: Uden direkte sammenligning med en negativ kontrolgruppe kan det dog ikke fastslås, om denne virkning skyldes behandlingen.
English: How big or small the effect of this placebo effect depends as much on the disease as it does on the clinical setting and can only be determined through comparison with another group.
Danish: Hvor stor eller lille denne placebovirkning er, afhænger i lige så høj grad af sygdommen som af det kliniske miljø og kan kun fastlægges ved sammenligning med en anden gruppe.
English: GROUNDS FOR THE REFUSAL OF THE VARIATION OF THE MARKETING AUTHORISATIONS
Danish: BEGRUNDELSE FOR AFSLAG PÅ ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSEN
English: • Even a short placebo treatment of 28 or 63 days could be associated with irreversible pathological changes to organs such as the eye (e.g. detached retina/blindness).
Danish: • Selv en kort placebobehandling i 28 eller 63 dage kan have sammenhæng med irreversible patologiske forandringer i organer, som f.eks. øjnene (f.eks. nethindeløsning/blindhed).
English: • Some recent studies report low median survival times for hypertension in cats - 4-7 months if untreated (Chetboul et al., 2003) and approximately 9 months even with treatment.
Danish: • Nogle nylige undersøgelser viser lave gennemsnitlige overlevelsestider for katte med hypertension - 4-7 måneder, hvis ubehandlet (Chetboul et al., 2003), og ca. 9 måneder, hvis behandlet.
English: However, the prolonged duration of effect over the course of 6 months, in addition to its efficacy during the entire inter-dosage interval, was noted.
Danish: Den forlængede varighed af effekten over seks måneder blev ud over virkningen i hele intervallet mellem doserne dog bemærket.
English: Box 31
Danish: P.O. Box 31
English: 22 % (17 out of 76) of included cats had creatinine concentrations above the threshold.
Danish: 22 % (17 ud af 76) af de inkluderede katte havde kreatininkoncentrationer over tærskelen.