FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee reviewed the bibliographic data submitted by the marketing authorisation holder to address the potential serious risk to public health with regard to the impact of the observed batch variability on the efficacy of Nanotop in comparison with Nanocoll, which is the product referred to in the submitted literature.
Danish: • udvalget gennemgik de bibliografiske data, der er forelagt af indehaveren af markedsføringstilladelsen vedrørende den potentielle alvorlige risiko for den offentlige sundhed som følge af den iagttagne batchvariabilitets betydning for virkningen og sikkerheden af Nanotop i forhold til Nanocoll, som er det produkt, der er omhandlet i den forelagte litteratur,
English: • The Committee therefore concluded that the MAH has satisfactorily demonstrated that Nanotop is comparable to Nanocoll, and that therefore an impact on clinical efficacy is not expected.
Danish: • udvalget konkluderede derfor, at indehaveren af markedsføringstilladelsen tilfredsstillende har godtgjort, at Nanotop er sammenligneligt med Nanocoll, og at der derfor ikke forventes nogen indflydelse på den kliniske virkning,
English: This additional supportive data was considered acceptable by the CHMP to demonstrate that the particles size distribution for the studied size ranges as well as the batch variability is in the same range as for Nanocoll, the product referred to in the submitted literature.
Danish: Disse supplerende støttende data fandt CHMP kunne godtages til påvisning af, at partikelstørrelsesfordelingen for de undersøgte størrelsesområder samt batchvariabiliteten er i samme område som for Nanocoll, der er det produkt, der er omhandlet i den forelagte litteratur.
English: Since the references included in this submission were studies conducted with Nanocoll, the MAH provided arguments that these data are relevant for Nanotop.
Danish: Da litteraturhenvisningerne i ansøgningen var undersøgelser udført med Nanocoll, argumenterede indehaveren af markedsføringstilladelsen for, at disse data er relevante for Nanotop.
English: The impact of radiopharmaceutical particle size on the visualization and identification of sentinel nodes in breast cancer.
Danish: 4 Leidenius MH, et al. The impact of radiopharmaceutical particle size on the visualization and identification of sentinel nodes in breast cancer.
English: The HSA nanocolloid has the prerogative to be made up of particles smaller than other colloidal agents for SLN detection.
Danish: HSA-nanokolloidet har den fordel at bestå af partikler, der er mindre end andre kolloidale midler til detektion af sentinel lymph nodes.
English: Eur J Nucl Med Mol Imaging (2007)
Danish: Eur J Nucl Med Mol
English: • The Committee was of the view that further analysis of the supportive data from additional batches of Nanotop and Nanocoll have demonstrated acceptably that the particles size distribution for the
Danish: • udvalget var af den opfattelse, at yderligere analyse af de støttende data fra supplerende batcher af Nanotop og Nanocoll tilfredsstillende har godtgjort, at partikelstørrelsesfordelingen for de undersøgte størrelsesområder og batchvariabiliteten for Nanotop er i samme område som for Nanocoll,
English: Based on this, an optimal particle size range has been established for SLN detection.
Danish: På dette grundlag er der fastlagt en optimal partikelstørrelsesfordeling til detektion af sentinel lymph nodes.
English: As mentioned previously, the efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc-99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging.
Danish: Som nævnt består virkningen af et Tc-99m-albuminkolloid i dets evne til at identificere den første drænende sentinel lymph node.
English: The efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging.
Danish: Efter administration af Tc-99m-albuminkolloid registreres sporstoffets passage af lymfesystemet ved hjælp af billeddannelse.
English: Member State EU/EEA
Danish: Medlemslande EU/EEA
English: Via the drinking water.
Danish: Via drikkevand.
English: 1123 Budapest HUNGARY
Danish: 1123 Budapest UNGAREN
English: Determine the bodyweight of the birds as accurately as possible in order to avoid underdosing.
Danish: Bestem legemsvægten på fuglene så præcist som muligt for at undgå underdosering.
English: This is consistent with the withdrawal period that has been in force in the majority of Member States, in which the product has been authorised for many years.
Danish: Det er i overensstemmelse med den tilbageholdelsesperiode, der har været gældende i de fleste medlemsstater, hvor lægemidlet har været godkendt i mange år.
English: 1, 2006) and from commercial poultry in the Netherlands (Landman
Danish: 1, 2006) og fra erhvervsdrivende fjerkræbedrifter i Nederlandene (Landman
English: The results of those studies should be provided to the relevant Authorities for assessment not later than 18 months after the Commission Decision on this referral procedure.
Danish: Resultaterne af disse undersøgelser skal indsendes til de kompetente myndigheder til vurdering senest 18 måneder efter Kommissionens afgørelse vedrørende denne indbringelsesprocedure.
English: Pumping systems should be checked constantly to assure proper medication.
Danish: Pumpesystemer bør regelmæssigt tjekkes for at sikre korrekt medicinering.
English: Always make sure that the entire dose offered has been consumed.
Danish: Vær altid sikker på at hele den givne dosis er indtaget.
English: The National Competent Authorities shall ensure that the following condition is fulfilled by the marketing authorisation holders:
Danish: De kompetente nationale myndigheder skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelserne:
English: Empty the water system and fill it with medicated water before starting the treatment.
Danish: Tøm vandsystemet og fyld det med medicineret vand før opstart af behandling.
English: Bravničarjeva 13 Ljubljana SLOVENIA
Danish: Bravničarjeva 13 Ljubljana SLOVENIEN
English: Satisfactory withdrawal periods have been set to provide assurance of consumer safety.
Danish: Der er blevet fastsat tilfredsstilende tilbageholdelsesperioder for at sikre forbrugersikkerheden.
English: The paper states that the high values for 2005-6 were due to the high level of resistance in Spain (24%), which was not included in 1999-2000.
Danish: Det anføres i rapporten, at de høje værdier for 2005-2006 skyldes det høje resistensniveau i Spanien (24 %), der ikke var medtaget i 1999-2000.
English: Journal of Applied Microbiology, 112: 239-245.
Danish: Journal of Applied Microbiology, 112: s. 239-245.
English: Viale Certosa 130 I-20156 Milan ITALY
Danish: Viale Certosa 130 I-20156 Milan ITALIEN
English: EFSA Journal 2012; 10(3):2598 [233 pp.] doi:10.2903/j.efsa.2012.2598.
Danish: EFSA Journal 2012; 10(3):2598 [233 s.] doi:10.2903/j.efsa.2012.2598.
English: Types and mechanisms of resistance
Danish: Resistenstyper og mekanismer
English: Medicated water should be made up on a daily basis.
Danish: Medicinering i vand bør ske dagligt.
English: Avoid contact with skin and eyes.
Danish: Undgå kontakt med hud og øjne.
English: 3641 RT Mijdrecht THE NETHERLANDS
Danish: 3641 RT Mijdrecht HOLLAND
English: This is also consistent with the dose for this species/indication stated in the SPC for other comparable EU authorised products.
Danish: Det er også i overensstemmelse med dosis for denne art/indikationen i produktresuméet for andre sammenlignelige EU-godkendte midler.
English: Protein binding in poultry is approximately 25 %.
Danish: Proteinbindingen i fjerkræ er ca. 25 %.
English: By limiting the use of the product, these warnings are intended to minimise the potential impact on human and animal health from antimicrobial resistance.
Danish: Ved at begrænse brugen af lægemidlet er formålet med disse advarsler at minimere de potentielle virkninger på menneskers og dyrs sundhed som følge af antimikrobiel resistens.
English: This veterinary medicinal product does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen
English: European Food Safety Authority and European Centre for Disease Prevention and Control; The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010.
Danish: 3 Det Europæiske Lægemiddelagentur og Det Europæiske Center for Forebyggelse af og Kontrol: The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2010.
English: Official and local antimicrobial policies should be taken into account when the product is used.
Danish: Officielle og lokale antibiotika politikker bør tages i betragtning før anvendelse af produktet.
English: • Residue depletion studies should be provided for any proposed new dosage regimen.
Danish: • Der skal tilvejebringes undersøgelser af nedbrydningen af restkoncentrationer ved ethvert nyt forslag til dosering.
English: Do not eat, drink or smoke whilst using the product.
Danish: Spis, drik eller ryg ikke under håndteringen af produktet
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, withdrawal period, marketing authorisation holders in the Member States
Danish: Oversigt over navne, doseringsformer, styrker of det veterinærmedicinske lægemiddel, dyrearter, tilbageholdelsestid, indehaver af markedsføringstilladelser i medlemslandene
English: The containers are provided with a graduated polypropylene measuring cup.
Danish: Pakningerne forsynes med et gradueret polypropylen målebæger.
English: Overall summary of the scientific evaluation of Baytril 10% oral solution and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Baytril 10 % oral opløsning og relaterede navne (se bilag I)
English: The product shows good physical and chemical stability over a 48 month storage period, and the data support the proposed shelf life of 48 months without any special storage precautions
Danish: Lægemidlet har god fysisk og kemisk stabilitet ved lagring i 48 måneder, og dataene støtter den foreslåede holdbarhed på 48 måneder uden særlige forsigtighedsregler ved opbevaring.
English: Vet. Res., 37, 415-154.
Danish: Vet. Res., 37, s. 415-154.
English: Resistance has also been reported in Mycoplasma synoviae in the EU.
Danish: Resistens er også rapporteret i Mycoplasma synoviae indenfor EU.
English: “Product name” (to be completed nationally) may be put directly into the header tank or introduced via a water proportioner pump.
Danish: ”Produkt navn” (færdiggøres nationalt) kan kommes direkte i hovedtanken eller tilføres via en vanddoserings pumpe.
English: Not all indications were included in the product information for all Member States.
Danish: Nogle af indikationerne var ikke medtaget i produktoplysningerne i alle medlemsstater.
English: The hazards associated with use of the product are developmental reactions which will not become apparent at the low accidental exposure levels assumed.
Danish: De farer, der er forbundet med anvendelse af produktet, er udviklingsmæssige reaktioner, som ikke vil opstå ved de lave utilsigtede eksponeringsniveauer, der lægger til grund for vurderingen.
English: Environmental Risk Assessment
Danish: Miljørisikovurdering
English: Rabbits were included as a target species in the product information for Italy, only.
Danish: Kaniner blev kun medtaget som en målart i produktoplysningerne for Italien.
English: Bottle or canister
Danish: Flaske eller beholder
English: The main areas of disharmony in the existing SPCs relate to:
Danish: De områder, der især er uenighed om i de eksisterende produktresuméer, er:
English: Provided this PECsoil is not exceeded, exposure of the environment to enrofloxacin will not increase and the product is not expected to pose a risk for the environment.
Danish: Forudsat at denne PECsoil ikke overskrides, vil eksponeringen af miljøet for enrofloxacin ikke stige, og lægemidlet forventes ikke at udgøre en miljørisiko.
English: The veterinary medicinal product has been appropriately formulated and the harmonised shelf life is appropriate to ensure that quality is maintained during use.
Danish: Veterinærlægemidlet er blevet korrekt formuleret, og den harmoniserede holdbarhed sikrer, at kvaliteten bevares under brug.
English: The marketing authorisation holders have provided a user risk assessment which, although not fully compliant with the current guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)
Danish: Indehaverne af markedsføringstilladelserne har fremsendt en vurdering af brugerrisikoen, der - om end den ikke fuldt ud overholder den nuværende retningslinje for brugers sikkerhed ved farmaceutiske veterinærlægemidler (EMA/CVMP/543/03-Rev.1)
English: There is no evidence of chondrotoxicity in chickens, turkeys or rabbits from Periodic Safety Update Reports over the last 10 years.
Danish: Der har ikke været indberettet tilfælde af chondrotoksicitet hos kyllinger, kalkuner eller kaniner i de periodiske, opdaterede sikkerhedsberetninger gennem de seneste 10 år.
English: Do not use for prophylaxis.
Danish: Må ikke anvendes forebyggende.
English: Avian Path., 37, 415-420.
Danish: Avian Path., 37, s. 415-420.
English: Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms.
Danish: Behandling i 3-5 dage; 5 dage i tilfælde af blandingsinfektioner og kronisk progressive tilfælde.
English: This study was conducted using two breeds of chickens, one fast growing and one slower growing, which together cover the range of chickens used for food in Europe.
Danish: Denne undersøgelse var baseret på to kyllingeracer, en hurtigvoksende og en langsommere voksende race, der tilsammen repræsenterer de kyllingeracer, der anvendes til konsum i Europa.
English: The United Kingdom referred the issue due to divergent national decisions having been taken by EU countries resulting in discrepancies in the product information for Baytril 10% oral solution and associated names.
Danish: Det Forenede Kongerige indbragte sagen på grund af de divergerende nationale beslutninger truffet af EU-medlemsstaterne, der havde resulteret i uoverensstemmelser i produktoplysningerne for Baytril 10 % oral opløsning og relaterede navne.
English: However evidence of widespread resistance in the European Union or lack of efficacy of the dose in the treatment of mycoplasmosis is difficult to find.
Danish: Det er imidlertid vanskeligt at påvise omfattende resistens i EU eller doseringens manglende effekt ved behandling af mykoplasmose.
English: There are not enough data to either determine the optimum dose rate for treatment or to propose an alternative dose rate for poultry, and new studies are required.
Danish: Der er ikke tilstrækkelige data til at bestemme den optimale behandlingsdosis eller foreslå en alternativ dosis for fjerkræ, og der skal udføres nye undersøgelser.
English: The references concluded that administration of the proposed dose rate was safe for the proposed dose duration.
Danish: Det blev konkluderet, at indgivelsen af den foreslåede dosering var sikker i den foreslåede doseringsperiode.
English: Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANCE
Danish: Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANKRIG
English: Concerns were raised by CVMP regarding references highlighting emergence of resistant strains of M. synoviae both under experimental conditions (Le Carrou et al
Danish: CVMP var betænkelig ved de kildehenvisninger, der understregede fremkomsten af resistente M. synoviae-stammer, både under forsøgsbetinger (Le Carrou et al
English: The overall benefit-risk balance for this product is deemed positive subject to the recommended changes in the product information (see annex III) and subject to condition affecting the marketing authorisations (see annex IV).
Danish: Det generelle risk/benefit-forhold for dette produkt anses for at være positivt, under forudsætning af at de anbefalede ændringer indføres i produktoplysningerne (se bilag III), og at betingelsen for markedsføringstilladelserne opfyldes (se bilag IV).
English: The drinking water must be medicated throughout the treatment period, and no other water source should be available.
Danish: Drikkevandet skal medicineres i hele behandlingsperioden og ingen anden vand tilgang må være mulig.
English: Wash hands and exposed skin after use.
Danish: Vask hænder og udsat hud efter brug.
English: Therefore, a 3-day meat withdrawal period can be adopted for the harmonised product information for both chickens and turkeys.
Danish: Der kan således indføres en tilbageholdelsesperiode på fjerkrækød på tre dage i de harmoniserede produktoplysninger for både kyllinger og kalkuner.
English: Regarding the indications for P. multocida and E. coli, the marketing authorisation holders submitted challenge studies and minimal field data from studies conducted 20 years ago.
Danish: For så vidt angår indikationerne for P. multocida og E. coli, forelagde indehaverne af markedsføringstilladelserne challenge-forsøg og minimale feltdata fra 20 år gamle undersøgelser.
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Danish: Krydsresistens indenfor klassen af antimikrobielle fluoroquinoloner er almindelig.
English: If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing.
Danish: Hvis der ikke ses klinisk bedring indenfor 2-3 dage, bør alternativ antimikrobiel behandling baseret på følsomhedstest overvejes.
English: User safety warnings:
Danish: Bruger advarsler:
English: Maximum plasma concentrations of 2 mg/L are reached within 1.5 hours after a single bolus dose rate of 10 mg/kg body weight with a total systemic availability of 14.4 mg·hr/L.
Danish: Maximum plasmakoncentration på 2 mg/L opnås indenfor 1,5 timer efter en enkelt bolus dosis på 10 mg/kg legemsvægt med en total systemisk tilgængelighed på 14,4 mg·time/L.
English: The proposed SPC contains the warnings regarding prudent use of fluoroquinolones in food producing animals in line with the CVMP reflection paper 2006
Danish: Det foreslåede produktresumé indeholder advarsler vedrørende forsigtig brug af fluoroquinoloner i førevareproducerende dyr i overensstemmelse med CVMP's oplæg fra 2006
English: Card box (100 ml bottle)
Danish: Æske (100 ml flaske)
English: The product is well tolerated by the target species, and presents a low risk for users and the environment when used in accordance with the harmonised warnings included in the SPC.
Danish: Lægemidlet tolereres godt af målarterne og udgør en lav risiko for brugerne og miljøet, når det anvendes i overensstemmelse med de harmoniserede advarsler i produktresuméet.
English: The CVMP has proposed further amendments to the warnings regarding resistance in section 4.5 of the SPC (Special precautions for use).
Danish: CVMP har foreslået yderligere ændringer af advarslerne vedrørende resistens i punkt 4.5 i produktresuméet (Særlige forsigtighedsregler vedrørende brugen).
English: A high mean volume of distribution (5 L/kg) indicates good tissue penetration of enrofloxacin.
Danish: Et højt gennemsnitligt distributionsvolumen (5L/kg) indikerer en god vævspenetration af enrofloxacin.
English: Calculations in broiler chickens produce the highest exposure of the environment (PECsoil 887 µg/kg).
Danish: Beregningerne vedrørende slagtekyllinger viser den største miljøeksponering (PECsoil 887 µg/kg).
English: Some concerns remain in relation to the dosing regimens for all species, and whether they are optimal in terms of minimising the risk for development of antimicrobial resistance.
Danish: Udvalget har stadig visse betænkeligheder, hvad angår doseringerne for alle arter og spørgsmålet om, hvorvidt de er optimale i forhold til at minimere risikoen for udvikling af antimikrobiel resistens.
English: Clinical resistance of E. coli in chickens to ciprofloxacin was 1.9% in 1999-2000 and increased through 2002-3 to 5.9% in 2005-6.
Danish: Den kliniske resistens af E. coli i kyllinger over for ciprofloxacin var 1,9 % i 1999-2000 og steg i 2002-2003 til 5,9 % i 2005-2006.
English: In this paper, clinical resistance was assessed against the Clinical Laboratory and Standards Institute (CLSI) breakpoint for ciprofloxacin of ≥ 4 mg/l.
Danish: I rapporten blev den kliniske resistens vurderet i forhold til brydningspunktet fastsat af Clinical Laboratory and Standards Institute (CLSI) for ciprofloxacin på ≥ 4 mg/l.
English: However, as there are limited data available for treatment of E. coli in this minor species, and extrapolation is made from the data provided for chickens, some concerns still remain.
Danish: Da der kun foreligger begrænsede data om behandling af E. coli i denne mindre art, og da der ekstrapoleres fra dataene for kyllinger, er der imidlertid fortsat en række betænkeligheder.
English: Since only MIC and minimal field data relating to a mixed infection are provided for the indication of Bordetella, this indication should not be included on the product information.
Danish: Da der kun foreligger MIC-data og minimale feltdata for indikationen Bordetella, bør denne indikation ikke medtages i produktoplysningerne.
English: The marketing authorisation holders have conducted a basic PK/PD analysis regarding E. coli, but no consideration has been given to an antimutant dosing strategy or to the potential to select for resistant food-borne organisms of significance to public health (Campylobacter, Salmonella).
Danish: Indehaverne af markedsføringstilladelser har foretaget en grundlæggende PK/D-analyse vedrørende E. coli, men der blev ikke taget højde for en antimutant doseringsstrategi eller muligheden for at udvælge resistente organismer i fødevarer, der har indvirkning på folkesundheden (Kampylobakter, Salmonella).
English: • the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data;
Danish: • CVMP vurderede produktresuméet, etiketteringen og indlægssedlen, som indehaverne af markedsføringstilladelserne havde foreslået, og tog alle de samlede indsendte data i betragtning
English: Enrofloxacin does not have a maximum residue limit for eggs, and therefore birds laying eggs for human consumption must not be treated with Baytril 10% oral solution and its associated names.
Danish: Enrofloxacin har ikke maksimalgrænseværdier for restkoncentrationer for æg, og fugle, der lægger æg til konsum, må derfor ikke behandles med Baytril 10 % opløsning og relaterede navne.
English: Risks of use of this product have been illustrated in chickens and turkeys by two comprehensive and recent references.
Danish: Risiciene ved brug af dette lægemiddel er blevet påvist i kyllinger og kalkuner gennem to omfattende nylige undersøgelser.
English: Therefore, and taking account of the scope of this Article 34 referral, the indication can be retained in the harmonised SPC.
Danish: I lyset af formålet med denne indbringelsesprocedure i henhold til artikel 34 kan indikationen derfor bibeholdes i det harmoniserede produktresumé.
English: The marketing authorisation holders provided a basic PK/PD analysis for enrofloxacin/E.
Danish: Indehaverne af markedsføringstilladelserne forelagde en grundlæggende PK/Danalyse for enrofloxacin/E.
English: A shorter or lower dose regimen than the current 10 mg/kg for 5 days needs to be substantiated by new clinical data.
Danish: En kortere eller lavere dosering end den nuværende dosering på 10 mg/kg i fem dage skal underbygges af nye kliniske data.