FrancophonIA/ELRC3.0 huggingface dataset:
English: The risks associated with use of Girolan are those generally attributed to antimicrobials which are used in food-producing animals, i.e. development of antimicrobial resistance in target bacteria, dissemination of resistant bacteria/resistance factors etc.
Danish: Risiciene ved brug af Girolan er de samme som dem, der generelt tilskrives antimikrobielle stoffer, som anvendes hos dyr til fødevareproduktion, dvs. udvikling af antibiotikaresistens hos målbakterierne, udbredelse af resistente bakterier/resistensfaktorer osv.
English: Although these risks have not been unequivocally assessed, the possibility of impact on human health through cross-resistance to gantamicin and other substances of the aminoglycoside group is a reality.
Danish: Disse risici er ikke entydigt vurderet, men der er reel mulighed for indvirkning på menneskers sundhed gennem krydsresistens mod gantamicin og andre stoffer i gruppen af aminoglykosider.
English: Apramycin sulfate 333 mg/ml equivalent to apramycin 230 mg/ml
Danish: Apramycinsulfat 333 mg / ml svarende til apramycin 230 mg / ml
English: Apramycin was shown to be effective as measured by increased weight gain, improved feed efficiency, reduction of mortality rate, and the reduction in severity of diarrhoea and clinical signs.
Danish: Apramycin blev påvist at være effektivt med henblik på større vægtforøgelse, bedre foderudnyttelse, reduceret dødelighed samt reduceret sværhedsgrad af diarré og kliniske tegn.
English: Apramycin resistance can be influenced by co-selection (resistance to apramycin has been described to be located in the same mobile genetic element that other resistant determinants in Enterobacteriaceae) and cross resistance (e. g. with gentamicin).
Danish: Apramycinresistens kan påvirkes af co-selektion (resistens overfor apramycin er blevet beskrevet som værende placeret i det samme mobile genetiske element som andre resistente determinanter i Enterobacteriaceae) og krydsresistens (f.eks. med gentamicin).
English: Withdrawal periods: Pigs:
Danish: Tilbageholdelsestider: Grise:
English: The referral notification was based on concerns related to divergent national decisions having been taken by EU Member States resulting in discrepancies in the product information with respect to e.g. target species, indications for use, posology (dosage and duration) and withdrawal periods.
Danish: Indbringelsesanmeldelsen skyldtes bekymringer på grund af divergerende nationale beslutninger fra medlemsstaternes side, der har medført divergerende oplysninger i produktinformationerne, hvad angår f.eks. måldyrearter, indikationer for anvendelse, dosering (doser og varighed) og tilbageholdelsestider.
English: Once opened, use immediately.
Danish: Efter åbning: Anvendes straks.
English: Some studies pointed out resistance percentages of 38% (MIC data) or even higher for disk diffusion (up to
Danish: Nogle undersøgelser har vist en resistens på 38% (MIC-data) eller endda højere med diskdiffusionsmetoden (op til 82,1%).
English: • Should antimicrobial resistance be already present, develop or be acquired, then the use of antimicrobials for the treatment of clinically infected flocks, for the prevention of Salmonella infection, or for the treatment of infected flocks without clinical signs, will enhance the selection and spread of resistant bacterial strains throughout the production pyramid.
Danish: • Hvis antibiotikaresistens allerede er til stede, udvikles eller erhverves, vil anvendelse af antimikrobielle stoffer til behandling af klinisk smittede besætninger, til forebyggelse af Salmonella infektion eller til behandling af smittede besætninger uden kliniske tegn fremme selektion og spredning af resistente bakteriestammer gennem hele produktionspyramiden.
English: Once opened, use within 28 days.
Danish: Efter åbning: anvendes indenfor 28 dage.
English: The results obtained showed statistically significant difference on mortality between all the apramycin medicated groups and the unmedicated control groups.
Danish: Resultaterne udviste en statistisk signifikant forskel i dødelighed i de apramycin-behandlede grupper på den ene side og de ubehandlede kontrolgrupper på den anden side.
English: All studies have been performed with the maximal dose proposed in the product information.
Danish: I alle undersøgelserne blev den maksimale dosis i henhold til produktinformationen anvendt.
English: Colloquially, those five serovars are known as zoonotic in national control programmes established in poultry in Europe.
Danish: Disse fem serotyper omtales typisk som zoonotiske i de nationale programmer for bekæmpelse af Salmonella hos fjerkræ i Europa.
English: Elanco Valquímica, S.A.
Danish: Spanien Elanco Valquímica, S.A. Avda.
English: This is also supported by statistical analysis presented by the MAH which demonstrates that there is no change in assay over time.
Danish: Dette understøttes også af en statistisk analyse fremlagt af indehaveren af markedsføringstilladelse, der påviser, at der ikke sker ændringer i analyseresultaterne over tid.
English: On 24 June 2016 Spain submitted a referral notification in accordance with Article 34 of Directive 2001/82/EC to the European Medicines Agency (the Agency) for Girolan and its associated name Apralan.
Danish: Den 24. juni 2016 indsendte Spanien en indbringelsesanmeldelse til Det Europæiske Lægemiddelagentur (agenturet) vedrørende Girolan og det relaterede navn Apralan, jf. artikel 34 i direktiv 2001/82/EF.
English: These studies involved male calves of approximately one week of age naturally infected by E. coli and/or Salmonella spp.
Danish: Disse undersøgelser omfattede tyrekalve, der var ca. en uge gamle, og som var naturligt smittet med E. coli og/eller Salmonella spp.
English: The administration of aminoglycosides to animals suffering from renal impairment or in combination with substances that also affect renal function may therefore present a risk of intoxication.
Danish: Indgivelsen af aminoglykosider til dyr, der lider af nedsat nyrefunktion eller i kombination med stoffer, der også påvirker nyrefunktionen, kan derfor udgøre en risiko for forgiftning.
English: Apramycin is a broad-spectrum aminocyclitol antibiotic produced by a strain of Streptomyces tenebrarius.
Danish: Apramycin er et bredspektret aminocyclitol-antibiotikum, der er produceret ud fra Streptomyces tenebrarius-stammen.
English: In various European monitoring programs, E. coli isolate from chickens were susceptible to apramycin.
Danish: I diverse europæiske overvågningsprogrammer var E. coli-isolater fra kyllinger følsomme over for apramycin.
English: Salmonella is one of the most frequent microorganisms causing foodborne zoonoses outbreaks and cases in Europe in humans (EFSA and ECDC, 20164).
Danish: Salmonella er en af de mikroorganismer, der hyppigst forårsager fødevarebårne zoonotiske udbrud og sygdomstilfælde hos mennesker i Europa (EFSA og ECDC, 20164).
English: Regarding the indication in Salmonella, recent data were provided indicating good susceptibility to apramycin for Salmonella spp., however the only data specific to Salmonella Gallinarum was from Nigeria (Agbaje et al., 20107) and Korea (Kang et al., 20108) and the epidemiological situation in Europe might be different.
Danish: Hvad angår indikationen Salmonella, er der fremlagt nylige data, der peger på god følsomhed over for apramycin hos Salmonella spp., men de eneste data, der specifikt gælder Salmonella gallinarum, kommer fra Nigeria (Agbaje et al., 20107) og Korea (Kang et al., 20108), og den epidemiologiske situation i Europa kan være en anden.
English: D-61352 Bad
Danish: D-61352 Bad Homburg Germany
English: Dose (mg product per kg bodyweight per day)
Danish: Dosis (mg produkt pr. kg legemsvægt pr. dag)
English: No recent data about susceptibility of Salmonella Gallinarum or Salmonella Pullorum isolates obtained in clinical cases in Europe were available as salmonellosis caused by these serovars has not been detected in Europe since 2007.
Danish: Der forelå ingen nylige data om følsomheden hos Salmonella gallinarum- eller Salmonella pullorum-isolater i kliniske tilfælde i Europa, da man i Europa ikke har identificeret salmonellose forårsaget af disse serotyper siden
English: Section 6.4 of the agreed SPC for the product states that no specific storage precautions are required for the product.
Danish: Det fremgår af punkt 6.4 i det godkendte produktresumé for veterinærlægemidlet, at der ikke kræves nogen særlige forholdsregler vedrørende opbevaring.
English: Therefore, the CVMP concluded that the indication for the treatment of Salmonella in poultry could not be justified and should be deleted from the product information for Girolan.
Danish: Derfor vurderer CVMP, at indikationen "behandling af Salmonella hos fjerkræ" ikke er berettiget og bør slettes fra produktinformationen for Girolan.
English: These data are consistent with the information available in published literature.
Danish: Disse data er konsistente med oplysningerne i den publicerede litteratur.
English: IU 2 x 106 IU
Danish: 2 x 106 IE
English: The oral administration of apramycin is intended for antimicrobial activity within the gut; apramycin is poorly absorbed, but absorption may be increased in young animals and in animals with disrupted intestinal barrier.
Danish: Oral indgivelse af apramycin er beregnet til antimikrobiel aktivitet i fordøjelseskanalen; apramycin optages dårligt, men optagelse kan være forhøjet hos unge dyr og hos dyr med en defekt tarmbarriere.
English: These enzymes confer different cross-resistance against other aminoglycosides.
Danish: Disse enzymer bidrager med forskellige former for krydsresistens over for andre aminoglykosider.
English: In the detailed grounds for re-examination the MAH requested a shelf life of 24 months based on stability data provided during the referral.
Danish: I sine detaljerede begrundelser for revurdering anmodede indehaveren af markedsføringstilladelse om en opbevaringstid på 24 måneder på grundlag af stabilitetsdata fremlagt under indbringelsen.
English: Cattle: The use is not intended during pregnancy or lactation.
Danish: Kvæg: Lægemidlet er ikke beregnet til brug under drægtighed eller laktation.
English: National control programmes should be followed where available.‘
Danish: Eventuelle nationale bekæmpelsesprogrammer bør følges."
English: • In general, from a food safety/public health viewpoint, using antimicrobials to control Salmonella spp.
Danish: • Ud fra et fødevaresikkerheds- og folkesundhedsperspektiv har anvendelse af antimikrobielle stoffer til bekæmpelse af Salmonella spp.
English: These studies involved one to three days old calves experimentally challenged with either Salmonella Dublin or Salmonella typhimurium, the most frequent serovars of Salmonella spp.
Danish: Undersøgelserne omfattede kalve i alderen 1-3 dage, der blev eksperimentelt eksponeret for enten Salmonella Dublin eller Salmonella typhimurium, som er de hyppigste serotyper af Salmonella spp.
English: After the beginning of medication, the cumulative mortality increased similarly, with noinferiority results in the apramycin group versus colistin group.
Danish: Efter medicineringsstart steg den kumulative dødelighed tilsvarende, idet testresultaterne viste non-inferioritet i apramycin-gruppen vs. colistin-gruppen.
English: The CVMP considered that the use of antimicrobials in Salmonella would increase selective pressure and potentially promote antimicrobial resistance dissemination.
Danish: CVMP vurderede, at anvendelse af antimikrobielle stoffer mod Salmonella vil øge selektionspresset og potentielt fremme udbredelsen af antibiotikaresistens.
English: Possible intoxications can be recognised by the following symptoms: soft faeces, diarrhoea, vomiting (weight loss, anorexia, and similar), renal impairment and effects on the central nervous system (reduced activity, loss of reflexes, convulsions, etc.).
Danish: Mulige forgiftningssymptomer kan ses som: blød afføring, diarre, opkast (vægttab, anoreksi o.lign.), nedsat nyrefunktion og påvirkning af centralnervesystemet (nedsat aktivitet, tab af reflekser, kramper etc.).
English: With regard to the withdrawal period, the residue depletion data indicated that apramycin is generally not well-absorbed from the gut after oral administration, which is consistent with the information available in published literature.
Danish: Hvad angår tilbageholdelsestiden, viste restkoncentrationsdata, at apramycin generelt ikke absorberes godt i tarmen efter oral administration, hvilket er konsistent med oplysningerne i publiceret litteratur.
English: Based on historical batch data, a target potency of 552,000 IU/g apramycin was established and all references to ‘g of apramycin activity' in the product information were replaced with the equivalent in IU/g product.
Danish: På grundlag af historiske batchdata blev en målpotens på 552,000 IE/g apramycin fastsat, og alle forekomster af "g apramycin-aktivitet" i produktinformationen blev erstattet med den tilsvarende værdi udtrykt i IE/g produkt.
English: The marketing authorisation holder provided one field trial including chickens artificially infected with Salmonella Pullorum.
Danish: Indehaveren af markedsføringstilladelse fremlagde én feltundersøgelse, der omfattede kyllinger med kunstigt induceret Salmonella pullorum-infektion.
English: Apramycin has been shown to be efficacious in the treatment of Salmonella infections in calves where its use reduced mortality and may therefore be justified on animal welfare grounds.
Danish: Apramycin er påviseligt effektivt til behandling af Salmonella-infektioner hos kalve, hvor anvendelse af lægemidlet har reduceret dødeligheden og kan være berettiget af hensyn til dyrevelfærden.
English: Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal.
Danish: Brugen af veterinærlægemidlet bør baseres på følsomhedstest af bakterier dyrket fra dyret.
English: Bottle (booklet) and bag (label)
Danish: Flaske (foldeetiket) og pose (etiket)
English: Aminoglycosides may have a negative influence on the kidney function.
Danish: Aminoglykosider kan have en negativ effekt på nyrefunktionen.
English: In this respect, it was considered necessary to add the following sentence in section 4.5 of the summary of product characteristics (SPC) ‘Special precautions for use in animals': ‘Where a diagnosis of Salmonella Dublin is made on the farm, then control measures including on-going monitoring of disease status, vaccination, biosecurity and movement controls should be considered.
Danish: I den forbindelse vurderes det at være nødvendigt at tilføje følgende sætning i produktresuméets punkt 4.5, "Særlige forsigtighedsregler vedrørende brugen": "Hvis diagnosen Salmonella Dublin stilles på bedriften, bør der indføres bekæmpelsesforanstaltninger, herunder løbende overvågning af sygdomsstatus, vaccination, biosikkerhed og kontrol med flytning af dyr.
English: In the case of calves it can be administered in milk or milk replacer.
Danish: Til kalve kan det indgives gennem mælk eller mælkeerstatning.
English: With regard to quality, a target potency of 552,000 IU/g of apramycin sulfate has been established for the medicinal product, based on the historical batch data provided.
Danish: Hvad angår lægemidlets kvalitet, er der fastlagt en målpotens på 552.000 IE/g apramycinsulfat på baggrund af de fremlagte historiske batchdata.
English: The data provided also indicated that resistance to apramycin is not very common among E. coli isolates of cattle origin.
Danish: De fremlagte data viste også, at resistens over for apramycin ikke er særlig udbredt hos E. coli-isolater fra kvæg.
English: Therefore, the CVMP considered it justified to retain the indication for Salmonella Dublin for Girolan.
Danish: Derfor vurderer CVMP, at det er berettiget at bibeholde indikationen "behandling af Salmonella Dublin" for Girolan.
English: The marketing authorisation holder has provided twelve field trials in support of the efficacy for the indication against E. coli.
Danish: Indehaveren af markedsføringstilladelse har fremlagt 12 feltundersøgelser til understøttelse af effekt i indikationen E. coli.
English: EFSA Journal 2017;15(8):4954, 50 pp. https://doi.org/10.2903/j.efsa.2017.4954
Danish: EFSA Journal 2017;15(8):4954, 50 pp. https://doi.org/10.2903/j.efsa.2017.4954 14 World Health Organization (2017).
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant.
English: The dosages of apramycin base or apramycin sulfate used were 0, 5.5, 11, 22 and/or 44 mg/kg bw/day during 5 or 10 consecutive days.
Danish: De anvendte doser af apramycinbase eller apramycinsulfat var 0, 5,5, 11, 22 og/eller 44 mg/kg kropsvægt/dag i 5 eller 10 dage i træk.
English: DATE ON WHICH THE LABEL WAS LAST APPROVED <DD/MM/YYYY>
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN DD/MM/YYYY
English: With regard to the withdrawal periods for chicken meat and offal, a number of residues depletion studies have been presented by the marketing authorisation holder.
Danish: Hvad angår tilbageholdelsestiden for kød og indvolde fra kyllinger, har indehaveren af markedsføringstilladelse fremlagt en række restkoncentrationsundersøgelser.
English: The intake of medicated water depends on the clinical condition of the animals.
Danish: Indtag af medicineret vand afhænger af dyrets kliniske tilstand.
English: In conclusion, the documentation provided supports the therapeutic use of Girolan for collibacilosis in chickens.
Danish: Det konkluderes, at den fremlagte dokumentation understøtter terapeutisk anvendelse af Girolan ved colibacilose hos kyllinger.
English: PACKAGE SIZE 50 x 106 IU (bottle) 1,000 x 10
Danish: 50 x 106 IE (flaske) 1.000 x 106 IE (pose)
English: Very little metabolism of apramycin takes place in the animal.
Danish: Metabolisme i dyret er meget begrænset.
English: With regard to field studies, twenty-three trials were provided using Girolan soluble powder for the treatment of post-weaning colibacillosis.
Danish: Hvad angår feltundersøgelser, blev der udført 23 undersøgelser til vurdering af opløseligt Girolan-pulver til behandling af colibacillose efter fravænning.
English: Antimicrobial treatment of meat-producing birds increases the risk of carcase contamination with resistant Salmonella spp.
Danish: Antimikrobiel behandling af kødproducerende fjerkræ øger risikoen for smitte af slagtekroppene med resistente Salmonella spp.
English: The dosage, route and frequency of administration are those proposed in the product information.
Danish: Dosis, administrationsvej og doseringshyppighed er som angivet i produktinformationen.
English: While it was considered that Salmonella strains are generally susceptible to apramycin (MIC≤16 μg/ml) it should be noted that only Salmonella outbreaks with clinical signs (in the case of calves, caused by Salmonella Dublin) should be treated with apramycin.
Danish: Selvom det vurderes, at Salmonella-stammer generelt er følsomme over for apramycin (MIC ≤16 μg/ml), skal det bemærkes, at kun Salmonella-udbrud med kliniske tegn (hos kalve udbrud forårsaget af Salmonella Dublin) bør behandles med apramycin.
English: Shelf life after dilution in drinking water/milk replacer according to directions: 24 hours.
Danish: Opbevaringstid efter fortynding i drikkevand/mælkeerstatning i henhold til anvisningerne: 24 timer.
English: Manufacturer responsible for batch release: To be completed nationally.
Danish: Fremstiller ansvarlig for batchfrigivelse: Udfyldes nationalt.
English: Moreover, Regulation (EU) No 2016/429 (‘Animal Health Law')12, that lays down rules for the prevention and control of animal diseases which are transmissible to animals or to humans, in Article 46 it is stated that the Member States may take measures concerning the use of veterinary medicinal products for listed diseases to ensure the most efficient prevention or control of those diseases, provided that such measures are appropriate or necessary.
Danish: Desuden fastsætter forordning (EU) nr. 2016/429 (dyresundhedsloven)12 regler for forebyggelse og bekæmpelse af dyresygdomme, der kan smitte andre dyr eller overføres til mennesker, og i artikel 46 fastslås det, at medlemsstaterne kan træffe foranstaltninger, hvad angår anvendelse af veterinærlægemidler mod oplistede sygdomme, for at sikre så effektiv forebyggelse eller bekæmpelse af sygdommene som muligt, forudsat at disse foranstaltninger er relevante eller nødvendige.
English: Having considered the grounds for referral and the data provided by the marketing authorisation holder, the CVMP concluded that the benefit-risk balance of the product remains positive subject to the recommended changes in the product information.
Danish: Efter at have gennemgået begrundelserne for indbringelsen og de data, som indehaveren af markedsføringstilladelse har fremlagt, vurderer CVMP, at benefit/risk-forholdet stadig er positivt, under forudsætning af, at de anbefalede ændringer indføres i produktinformationen.
English: Pigs have been authorised as a target species for all products concerned by this referral procedure, as was the proposed indication, ‘Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.'
Danish: Svin er blevet godkendt som måldyreart for alle de produkter, der er berørt af denne indbringelsesprocedure, ligesom den anførte indikation "Behandling af bakteriel enteritis forårsaget af apramycin-følsom Escherichia coli".
English: Serum levels peak at approximately 6 hours with a value of 2.4 µg/ml following oral administration of 40 mg apramycin/kg of bodyweight.
Danish: Serumkoncentrationer er højest efter omkring 6 timer med 2,4 µg/ml efter oral indgift af 40 mg apramycin/kg legemsvægt.
English: Apramycin is a broad-spectrum bactericidal aminoglycoside antibiotic whose action results from the binding to the 30S subunit of the ribosome, preventing protein synthesis and disrupting the membrane permeability of bacteria.
Danish: Apramycin er et bredspektret baktericidt aminoglykosid-antibiotikum, som virker ved at binde til 30S underenheden af ribosomet og derved forebygger proteinsyntese og forstyrrer bakteriens membranpermeabilitet.
English: National control programmes should be followed where available.
Danish: Såfremt nationale kontrolprogrammer er tilgængelige bør disse følges.
English: The objectives were to evaluate the efficacy of apramycin sulfate, administered in the drinking water for five consecutive days, at dose levels of 75, 150 and 225 mg/litre as treatment for these infections.
Danish: Formålet var at vurdere effekten af apramycinsulfat administreret i drikkevand i 5 dage i træk i doser på 75, 150 og 225 mg/l til behandling af disse infektioner.
English: Evaluation and conclusions on the benefit-risk balance Girolan and its associated name Apralan has been shown to be efficacious in the indications in pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits listed above.
Danish: Vurdering af benefit/risk-forholdet og konklusioner Det er påvist, at Girolan og det relaterede navn Apralan har effekt i de ovenfor anførte indikationer hos svin (fravænnede smågrise), præ-drøvtyggende kalve, kyllinger (slagtekyllinger) og kaniner.
English: The data provided also indicated that resistance to apramycin is increasing among E. coli isolates of pig origin, so the wording ‘susceptible to apramycin' was added to the indication.
Danish: De fremlagte data viste også, at resistensen over for apramycin er stigende hos E. coli-isolater fra svin, hvorfor "med følsomhed over for apramycin" er blevet føjet til indikationen.
English: Do not use in calves with functional rumen.
Danish: Bør ikke anvendes til kalve med funktionel vom.
English: Apralan Solubile polvere per soluzione orale per Suini, Polli da carne e Conigli
Danish: Solubile polvere per soluzione orale per Suini, Polli da carne e Conigli
English: Do not use in case of hypersensitivity to apramycin.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for apramycin.
English: Chickens were given up to 5 times the recommended level for 15 days with no untoward reaction.
Danish: Hos kyllinger, der fik fem gange den anbefalede dosis i 15 dage, påvistes ingen bivirkninger.