FrancophonIA/ELRC3.0 huggingface dataset:
English: de la Industria, nº 30 Polígono Industrial de Alcobendas 28108 Alcobendas (Madrid)
Danish: Polígono Industrial de Alcobendas 28108 Alcobendas (Madrid)
English: Zoonotic Salmonella is listed in this Regulation.
Danish: Zoonotisk Salmonella står på forordningens liste.
English: The study was conducted under the principles of Good Clinical Practice.
Danish: Undersøgelsen var gennemført i henhold til god klinisk praksis.
English: Swelling of the face, lips and eyes or difficult breathing are more serious symptoms and require urgent medical assistance.
Danish: Hævelser i ansigt, læber og øjne eller vejrtrækningsvanskeligheder er mere alvorlige symptomer og kræver akut lægehjælp.
English: Surviving calves in the untreated control group failed to gain weight in the twelve days period whereas the survivors in the treated groups showed significant increases in average daily weight gain.
Danish: Overlevende kalve i den ubehandlede kontrolgruppe tog ikke på i vægt i 12-dages perioden, mens overlevende kalve i de behandlede grupper udviste signifikante stigninger i den gennemsnitlige daglige vægtforøgelse.
English: However, as the dosing regimens and indications have not been extended, there is no increase in the exposure of the environment to the active substance.
Danish: Da dosisregimerne og indikationerne ikke er blevet udvidet, er der dog ingen stigning i miljøets eksponering for det aktive stof.
English: MIC90 was 8 μg/ml or less.
Danish: MIC90-værdien var 8 μg/ml eller mindre.
English: In this sense, it should be taken into account that the efficacy of the product was supported by various studies, where the veterinary medicinal product was administered for treatment and not for prevention.
Danish: I den sammenhæng bør der tages hensyn til, at produktets effekt blev understøttet af en række undersøgelser, hvor veterinærlægemidlet blev administreret som behandling og ikke som forebyggelse.
English: Pharmacotherapeutic group: Intestinal antiinfectives, antibiotics.
Danish: Farmakoterapeutisk gruppe: intestinale antiinfectiva, antibiotika.
English: Overall summary of the scientific evaluation of Girolan and its associated name Apralan (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Girolan og det relaterede navn Apralan (se bilag I)
English: Therefore, the CVMP concluded that the proposed indication was justified.
Danish: Derfor vurderer CVMP, at den anførte indikation er berettiget.
English: In order to obtain the correct dose, the concentration of the veterinary medicinal product has to be adjusted accordingly.
Danish: For at sikre den rette dosis skal koncentrationen af veterinærlægemidlet tilpasses tilsvarende.
English: Solutions in milk and reconstituted milk replacer should be prepared immediately before use.
Danish: Opløsninger i mælk og mælkeerstatninger skal tilberedes umiddelbart før anvendelse.
English: In this respect, it is to be noted that colibacillosis in chickens is essentially a systemic infection, involving a variety of organs, and its main entry route is the respiratory system.
Danish: I den forbindelse skal det bemærkes, at colibacillose hos kyllinger hovedsageligt er en systemisk infektion, der omfatter flere organer, og at den primære indgangsvej er åndedrætssystemet.
English: It is therefore recommended to take such an effect into account when anaesthetising treated animals.
Danish: Det anbefales derfor at tage højde for dette ved bedøvelse af behandlede dyr.
English: This product may cause irritation or sensitisation after skin or eye contact or inhalation.
Danish: Produktet kan forårsage irritation eller sensibilisering ved hud- eller øjenkontakt eller inhalation.
English: In case of eye contact, rinse the affected area with plenty of water.
Danish: I tilfælde af øjenkontakt skylles området med rigeligt vand.
English: Absorption: Absorption may be high in new-born animals but rapidly decreases in the first weeks of life.
Danish: Optagelse: Optagelsen kan være høj hos nyfødte dyr men aftager hurtigt i løbet af de første leveuger.
English: • No specific advantages were identified for the use of antimicrobials in the case of meat-producing flocks.
Danish: • Der blev ikke identificeret specifikke fordele ved anvendelse af antimikrobielle stoffer i kødproducerende besætninger.
English: Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.
Danish: Ved anvendelse i ekstraordinære tilfælde af hensyn til dyresundheden og dyrevelfærden skal der tages højde for konsekvenserne for folkesundheden.
English: DK-2730 Herlev Denmark
Danish: DK-2730 Herlev
English: To be completed nationally.
Danish: Udfyldes nationalt.
English: No data were presented for Salmonella Pullorum.
Danish: Der blev ikke fremlagt data for Salmonella pullorum.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Danish: Hvis dette ikke er muligt, bør behandlingen baseres på lokale (regionale, besætningsniveau) epidemiologiske informationer om følsomheden af bakterien.
English: Although the respiratory route is considered a significant mode of entry, antimicrobials are expected to act at the site of infection.
Danish: Selvom åndedrætssystemet vurderes at være en væsentlig indgangsvej, forventes antimikrobielle stoffer at virke på infektionsstedet.
English: This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the veterinary medicinal product Girolan.
Danish: Denne benefit/risk-vurdering finder sted inden for rammerne af artikel 34 i direktiv 2001/82/EF og har i denne procedure til formål at harmonisere godkendelsesbetingelserne i EU for veterinærlægemidlet Girolan.
English: With regard to Salmonella, a series of twenty-seven further experiments were conducted in calves, 15 of which therapeutic and 12 prophylactic.
Danish: Hvad angår Salmonella, blev der gennemført yderligere 27 undersøgelser af kalve, hvoraf 15 var terapeutiske og 12 profylaktiske.
English: • The harmonised product information of Girolan contains the necessary information to ensure the safe and effective use of the product.
Danish: • Den harmoniserede produktinformation for Girolan indeholder de nødvendige oplysninger til at sikre risikofri og effektiv anvendelse af lægemidlet.
English: Sachets are packed in cardboard boxes containing 50 sachets.
Danish: Breve er pakket i kartoner indeholdende 50 breve.
English: A pivotal recently-conducted clinical field trial was provided.
Danish: Der blev fremlagt en nyligt gennemført central klinisk feltundersøgelse.
English: In addition use of apramycin was considered preferable to the potential use of more critical antimicrobials such as fluoroquinolones.
Danish: Desuden vurderes anvendelse af apramycin at være at foretrække frem for potentiel anvendelse af mere kritiske antimikrobielle stoffer som f.eks. fluoroquinoloner.
English: In all trials, the animals were examined to confirm the diagnosis prior of to the initiation of treatment.
Danish: I alle undersøgelserne blev dyrene vurderet for at bekræfte diagnosen inden behandlingens påbegyndelse.
English: Following the CVMP opinion of 5 October 2017 on this referral procedure, the marketing authorisation holders requested a re-examination of the CVMP opinion.
Danish: CVMP's afgav den 5. oktober 2017 en udtalelse vedrørende denne indbringelsesprocedure, og indehaverne af markedsføringstilladelse har anmodet om revurdering af CVMP's udtalelse.
English: Animals with acute or severe clinical conditions that cannot drink, should receive adequate parenteral treatment.
Danish: Alvorligt syge dyr, der ikke kan drikke, bør gives passende parenteral behandling.
English: The scope of the re-examination was the shelf life of the product prior to first opening which was reduced from 3 years to 18 months.
Danish: Revurderingen omfattede produktets opbevaringstid inden anbrud, der blev nedsat fra 3 år til 18 måneder.
English: The testing timepoints for these batches are not all in accordance with current guidelines but in all cases, data is provided for at last 5 time-points over the course of the stability study and trending of data is therefore possible.
Danish: Testtidspunkterne for disse batcher stemmer ikke alle overens med de gældende retningslinjer, men i alle tilfælde fremlægges der data for mindst 5 tidspunkter i løbet af stabilitetsundersøgelsen, og det er derfor muligt at følge datatendenserne.
English: Data for 36 months was presented for 3 batches of finished product packaged in the final containers (bottles, bags and two different size sachets).
Danish: Der blev fremlagt data for 36 måneder vedrørende 3 batcher af færdigt produkt i de endelige beholdere (flasker, poser og breve i to forskellige størrelser).
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States
Danish: Liste over navne, lægemiddelform, veterinærlægemidlets styrke, dyrearter, indgivelsesvej, indehavere af markedsføringstilladelser i medlemslandene
English: The CVMP accepted this deletion of Salmonella.
Danish: CVMP accepterede sletningen af Salmonella.
English: Although it is acknowledged that Salmonella Dublin is an uncommon cause of salmonellosis in man, infection can be severe.
Danish: Selvom det er anerkendt, at Salmonella Dublin er en ikke-almindelig årsag til salmonellose hos mennesker, kan der være tale om svære infektioner.
English: It should be noted that in some Member States Girolan was also authorised for use against Salmonella in pigs, however the marketing authorisation holder decided to remove this indication, as it could not be supported.
Danish: Det skal bemærkes, at Girolan i nogle medlemsstater også var godkendt til anvendelse mod Salmonella hos svin, men indehaveren af markedsføringstilladelse besluttede at fjerne denne indikation, da den ikke var tilstrækkeligt dokumenteret.
English: The treatment period was initiated two weeks after weaning, when the signs of colibacillosis were clearly established.
Danish: Behandlingsforløbet blev påbegyndt to uger efter fravænning, da tegnene på colibacillose var tydeligt til stede.
English: Again, no data for Salmonella Gallinarum was presented and in view of this it was not considered further for this indication.
Danish: Heller ikke her var der fremlagt data for Salmonella gallinarum, og på den baggrund blev denne indikation ikke overvejet yderligere.
English: This was not considered acceptable, as the active substance strength should be expressed in IU/g product, since the assay is determined by means of a microbiological method.
Danish: Dette blev ikke vurderet acceptabelt, da det aktive stofs styrke bør udtrykkes i IE/g produkt, idet analyseresultatet bestemmes ved hjælp af en mikrobiologisk metode.
English: These data are consistent with the published literature.
Danish: Disse data er konsistente med den publicerede litteratur.
English: Aminoglycosides are listed by WHO (2017)14 as critically important for the treatment of certain zoonotic infections in humans (such as Enterococcus infections).
Danish: Aminoglykosider er anført på WHO's liste (2017)14 som kritisk vigtige til behandling af visse zoonotiske infektioner hos mennesker (f.eks. Enterococcusinfektioner).
English: Block bottomed laminated paper bag closed by pressurized heat-sealing jaws.
Danish: Blokbundet lamineret papirpose lukket af trykforseglede kæber.
English: All the bacteria isolated from treated and untreated animals were sensitive to 16 μg/ml or less of apramycin.
Danish: Alle de bakterier, der var isoleret fra behandlede og ubehandlede dyr, var følsomme over for 16 μg/ml apramycin eller mindre.
English: Aminoglycosides may cause neuromuscular blockade.
Danish: Aminoglykosider kan forårsage neuromuskulær blokade.
English: The presence of the disease in the herd must be established before the product is used.
Danish: Sygdommens forekomst i besætningen skal bekræftes, før produktet anvendes.
English: as well as resistant commensal bacteria, which may also transfer resistance genes to other bacteria.
Danish: samt resistente kommensale bakterier, der også kan overføre resistensgener til andre bakterier.
English: The amount of product (mg) to be incorporated per 1 l of water or milk should be established according to the following formula:
Danish: Mængden af produkt (mg) der skal anvendes pr. liter vand eller mælk bør bestemmes ved hjælp af følgende ligning:
English: Whenever possible, susceptibility testing and serotyping of bacterial isolates were carried out.
Danish: Hvor det var muligt, blev der foretaget følsomhedstest og serotypebestemmelse af bakterieisolater.
English: Whilst it is not clear if the stability data was generated under controlled conditions or not, given the lack of significant change in active substance content and the fact that the product historically had a shelf life of 3 years, the data is considered adequate to support a 2 year shelf life for the finished product as proposed by the MAH.
Danish: Det fremgår ikke klart, om stabilitetsdataene er genereret under kontrollerede forhold eller ej, men med fravær af signifikante ændringer i indholdet af aktivt stof og i betragtning af, at produktet historisk har haft en opbevaringstid på 3 år, vurderes dataene at være tilstrækkelige til at understøtte en opbevaringstid på 2 år for det færdige produkt som foreslået af indehaveren af markedsføringstilladelse.
English: From the study it could be concluded that Salmonella Pullorum infections could be controlled with apramycin.
Danish: Det kunne ud fra undersøgelsen konkluderes, at Salmonella pullorum-infektioner kan kontrolleres med apramycin.
English: Avoid contact with the eyes, skin and mucous membranes and inhalation of dust while preparing the medicated water/milk.
Danish: Undgå kontakt med øjne, hud og slimhinder samt inhalation af støv under tilberedning af medicineret vand/mælk.
English: With regard to the withdrawal period, of all the residue depletion studies provided, only one was considered adequate to be statistically analysed.
Danish: Hvad angår tilbageholdelsestiden, var der kun én ud af alle de fremlagte restkoncentrationsundersøgelser, der blev vurderet egnet til statistisk analyse.
English: The following indications for Girolan and its associated names can be supported based on the data provided:
Danish: Vurdering af fordele Følgende indikationer for Girolan og relaterede navne kan støttes på baggrund af de fremlagte data:
English: Since the dosing regimens recommended by the CVMP have not been increased, and the indications have not been extended with regard to those approved in most summaries of product characteristics, the assessment of target animal safety and user safety did not present new issues.
Danish: Da de af CVMP anbefalede dosisregimer ikke er blevet øget, og indikationerne ikke er blevet udvidet i forhold til de godkendte indikationer i de fleste produktresuméer, gav vurderingen af sikkerheden for måldyrearterne og brugersikkerheden ikke anledning til nye betænkeligheder.
English: Thus the data provided includes a sufficient number of batches in each of the container types for the full duration of the proposed shelf life.
Danish: De fremlagte data omfatter således et tilstrækkeligt antal batcher af hver af beholdertyperne for hele den anførte opbevaringstid.
English: However, recent publications in the scientific literature indicate that the disease is present in cattle in Europe, e.g. in Ireland (O´Leary, 20145) and the UK (Henderson and Mason, 20176).
Danish: Nylige publikationer i den videnskabelige litteratur viser imidlertid, at sygdommen findes hos kvæg i Europa, f.eks. i Irland (O'Leary, 20145) og Storbritannien (Henderson og Mason, 20176).
English: All references to ‘g of apramycin activity' or measuring devices have been removed from the product information.
Danish: Alle forekomster af "g apramycin-aktivitet" eller "måleanordning" er blevet fjernet fra produktinformationen.
English: From this study, a withdrawal period of 28 days for calves meat and offal has been established, which is supported by the other references provided.
Danish: På baggrund af denne undersøgelse er der fastsat en tilbageholdelsestid på 28 dage for kød og indvolde fra kalve, hvilket understøttes af andre fremlagte referencer.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on this matter and to harmonise the product information for Girolan and its associated name Apralan (thereafter called Girolan).
Danish: Udvalget for Veterinærlægemidler (CVMP) blev anmodet om at udtale sig i sagen og harmonisere produktinformationerne for Girolan og det relaterede navn Apralan (i det følgende benævnt Girolan).
English: Several residues depletion studies in the different target species were made available, which were variable in terms of reliability of the data, study design and reporting, and subsequently their outcomes.
Danish: Der blev fremlagt en række restkoncentrationsundersøgelser, der omfattede de forskellige måldyrearter, og som var af varierende pålidelighed, hvad angår data, undersøgelsesdesign og rapportering og dermed resultater.
English: Use personal protective equipment consisting of gloves, mask, goggles and protective clothing while handling the product.
Danish: Personligt beskyttelsesudstyr i form af handsker, maske, beskyttelsesbriller og beskyttende tøj bør anvendes ved håndtering af lægemidlet.
English: Apramycin ……………………………552,000 IU* (as apramycin sulfate) * IU - international units
Danish: Apramycin……………………..552.000 IE* (som apramycinsulfat) * IE - internationale enheder
English: According to the assessment performed, Salmonella can be considered eligible to be listed for Union intervention as laid down in Article 5(3) of the Animal Health Law.
Danish: Ud fra den gennemførte vurdering kan Salmonella blive betragtet som egnet til EU-indgriben, jf. artikel 5, stk. 3, i dyresundhedsloven.
English: Additional data provided from 2014 indicate that Salmonella Dublin was mostly susceptible to apramycin (96.5% of isolates susceptible to all antimicrobials in the panel, including apramycin).
Danish: Yderligere data fra 2014 peger på, at Salmonella Dublin overvejende var følsom over for apramycin (96,5% af de isolater, der var følsomme over for alle antimikrobielle stoffer i panelet, herunder apramycin).
English: In case of skin contact, wash thoroughly with soap and water.
Danish: I tilfælde af kontakt med huden vaskes huden grundigt med vand og sæbe.
English: Resistance developed by chromosomal resistance is minimal for most of the aminoglycosides.
Danish: Resistens som følge af kromosomal resistens er minimal for de fleste aminoglykosider.
English: Medicated water must be renewed every 24 hours.
Danish: Det medicinerede vand skal fornyes 24 timer efter tilberedning.
English: Having reviewed the relevant information submitted during the initial assessment procedure and the detailed grounds for re-examination put forward by the MAH, the Committee concluded that the previous CVMP opinion should be revised as follows:
Danish: Efter gennemgang af de relevante oplysninger, der blev indsendt under den oprindelige vurderingsprocedure, og de detaljerede begrundelser for revurdering, der blev fremlagt af indehaveren af markedsføringstilladelse, vurderer udvalget, at den forrige CVMP-udtalelse bør revideres som følger:
English: To be administered via the drinking water.
Danish: Skal indgives via drikkevandet.
English: These were conducted in Greece, Italy and Jordan, and involved 27-29 days old broilers from commercial farms with natural E. coli infection.
Danish: Disse undersøgelser blev gennemført i Grækenland, Italien og Jordan og omfattede slagtekyllinger i alderen 27-29 dage fra industrielt landbrug med naturligt erhvervet E. coli-infektion.
English: The assay results are presented as % of a target value of 552,000 IU/g.
Danish: Analyseresultaterne er vist som % af en målværdi på 552.000 IE/g.
English: Resistance mechanisms: Different aminoglycoside 3-N acetyltransferase enzymes (AAC-3) have been related with resistance to apramycin.
Danish: Resistensmekanismer: Forskellige aminoglykosid 3-N acetyltransferase enzymer (AAC-3) har været forbundet med resistens overfor apramycin.
English: European Control programmes of Salmonella in poultry in Europe have been focused on Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Hadar, Salmonella Virchow and Salmonella Infantis, as the five most frequent serovars in human salmonellosis (Regulation (EC) No 2160/20039).
Danish: De europæiske programmer for bekæmpelse af Salmonella hos fjerkræ i Europa har haft fokus på Salmonella enteritidis, Salmonella typhimurium, Salmonella hadar, Salmonella virchow og Salmonella infantis, der er de fem hyppigste serotyper ved human salmonellose (forordning (EF) nr. 2160/20039).
English: The marketing authorisation holders' grounds for the re-examination were submitted on 18 December
Danish: Markedsføringstilladelsesindehaverens begrundelser for ønsket om revurdering blev fremsendt den 18. december 2017.
English: Treatment should be based on prior confirmation of the Salmonella serovars involved or at least the availability of epidemiological data confirming the presence of this serovar.
Danish: Behandling bør baseres på bekræftelse af involverede Salmonella serovarianter eller i det mindste epidemiologiske data, der bekræfter den pågældende serovariant.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk-forholdet.
English: 4-ply polyethylene terephthalate (PET)/polyethylene/aluminium foil/surlyn ionomer sachet, sealed by heat and pressure.
Danish: 4-lags polyethylenterephthalat (PET) / polyethylen / aluminiumfolie / surlyn ionomerbrev, forseglet ved varme og tryk.
English: The presence of E. coli was demonstrated by previous bacteriological or clinical results and was confirmed in samples taken from rabbits sacrificed or found dead after inclusion.
Danish: Tilstedeværelsen af E. coli blev påvist ved forudgående bakteriologiske eller kliniske test og blev bekræftet i prøver fra kaniner, der blev slagtet eller selv døde efter inklusion.
English: This was also not considered acceptable, as dosing by product weight was considered the most appropriate in terms of reproducibility of the dose and therefore any reference to the measuring device was deleted from the product information.
Danish: Dette blev heller ikke vurderet acceptabelt, da dosering ud fra vægt blev anset for at være det mest hensigtsmæssige med henblik på ensartede doser, og derfor blev alle forekomster af "måleanordning" slettet fra produktinformationen.
English: The main animal species to be listed are all species of domestic poultry and wild species of mainly Anseriformes and Galliformes.
Danish: De vigtigste dyrearter, der skal opføres på listen, er alle arter af tamfjerkræ og vilde arter af navnlig andefugle og hønsefugle.
English: PACKAGE SIZE 50 sachets
Danish: PAKNINGSSTØRRELSE 50 breve
English: With regard to the use of Girolan against Salmonella it was considered that in line with Regulation (EC) No. 1177/200610, antimicrobials should not be used for control and treatment of Salmonella in poultry except in exceptional circumstances.
Danish: Hvad angår anvendelse af Girolan mod Salmonella, blev det i overensstemmelse med forordning (EF) nr. 1177/200610 vurderet, at antimikrobielle stoffer ikke bør bruges til bekæmpelse og behandling af Salmonella hos fjerkræ, bortset fra i ekstraordinære tilfælde.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på kartonen efter EXP. Udløbsdatoen refererer til den sidste dag i den pågældende måned.