FrancophonIA/ELRC3.0 huggingface dataset:
English: For multidose presentations (bottle and bag):
Danish: For flerdosis-pakninger (flaske og pose):
English: Oral doses of apramycin administered from 6th to the 18th day of pregnancy (including doses below the therapeutic doses), have shown evidence of foetotoxic effects.
Danish: Orale doser af apramycin indgivet fra 6.-18. dag i drægtigheden (inklusiv doser under terapeutisk dosis) har afsløret føtal toksicitet.
English: Salmonella strains were considered generally susceptible to apramycin (MIC≤16 μg/ml) and <5% of Salmonella Dublin strains were shown to be resistant to apramycin.
Danish: Det blev vurderet, at Salmonella-stammerne generelt var følsomme over for apramycin (MIC ≤16 μg/ml), og <5% af Salmonella Dublin-stammerne var påviseligt resistente over for apramycin.
English: These trials were conducted in Greece, Italy, Spain, the United Kingdom, USA and Canada.
Danish: Disse undersøgelser blev udført i Grækenland, Italien, Spanien, Storbritannien, USA og Canada.
English: 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: Når diagnosen Salmonella Dublin stilles i en besætning, bør kontrolmetoder overvejes, inklusiv løbende overvågning af sygdomsstatus, vaccination, smittebeskyttelse og kontrol af transport.
English: 1 g powder contains 500 mg apramycin as apramycin sulfate in 2.2 ml equivalent to 1 g powder
Danish: 1 g pulver indeholder 500 mg apramycin som apramycinsulfat i 2,2 ml svarende til 1 g pulver
English: Treatment resulted in an almost linear dose/response in percent survival for apramycin dosages up to 22 mg/kg bw.
Danish: Resultaterne viste et næsten lineært dosis/respons-forhold, hvad angår overlevelsesprocent, ved apramycin-doser på op til 22 mg/kg kropsvægt.
English: Some strains of Salmonella Typhimurium DT104 in addition to resistance against betalactams, streptomycin, tetracyclines and sulphonamides carry a conjugative resistance plasmid against apramycin.
Danish: Nogle stammer af Salmonella Typhimurium DT104 bærer et konjugativt resistensplasmid mod apramycin ud over resistens mod beta-laktamer, streptomycin, tetracycliner og sulfonamider.
English: Marketing authorisation holder
Danish: Indehaver af markedsføringstilladel se
English: Farmacêuticos, Lda
Danish: Lilly Portugal Produtos Farmacêuticos, Lda
English: Moreover, Regulation (EU) No 2016/429 (‘Animal Health Law')12, states 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.
Danish: nr. 2016/429 (dyresundhedsloven)12, 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.
English: • If antimicrobials are used in breeding flocks or their immediate descendants there is a risk that any resistant bacteria which are selected may be disseminated to multiple flocks via contamination of hatching eggs and the hatchery environment.
Danish: • Hvis antimikrobielle stoffer anvendes i besætninger eller deres direkte afkom, er der risiko for, at eventuelle selekterede resistente bakterier kan spredes til mange besætninger ved kontaminering af rugeæggene og rugeriet.
English: Apramycin is mainly excreted through faeces, under active form, and only a small quantity is excreted in the urine.
Danish: Fordeling, metabolisme og udskillelse: Apramycin udskilles primært i den aktive form gennem fæces og kun en lille mængde udskilles i urinen.
English: The limited MIC data indicated a MIC90 for apramycin of 3.5 μg/ml for E. coli isolates of rabbit origin and a proportion of <20% resistant strains.
Danish: De begrænsede MIC-data viste en MIC90-værdi for apramycin på 3,5 μg/ml for E. coli-isolater fra kaniner og en andel af resistente stammer på <20%.
English: Dosing 10 kg pigs with 14C apramycin resulted in approximately 83% being recovered from the faeces, and 4% from the urine, as 14C apramycin.
Danish: Ved indgift af 14C apramycin i grise på 10 kg blev omkring 83% 14C apramycin genfundet i afføringen og 4%
English: Concerning the withdrawal period, the residue depletion data indicated that apramycin is generally not well-absorbed from the gut after oral administration at the posology proposed in the product information.
Danish: Hvad angår tilbageholdelsestiden, viste restkoncentrationsdata, at apramycin generelt ikke absorberes godt i tarmen efter oral administration ved den dosering, der er anført i produktinformationen.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE -KOMBINERET ETIKET OG INDLÆGSSEDDEL
English: The CVMP noted that throughout the product information of Girolan the active substance was expressed as ‘g of apramycin activity'.
Danish: CVMP bemærkede, at det aktive stof blev udtrykt som "g apramycin-aktivitet" i hele produktinformationen for Girolan.
English: Rabbits have been previously authorised in France, Italy and Spain.
Danish: Kaniner er tidligere blevet godkendt som måldyreart i Frankrig, Italien og Spanien.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Pigs: Pigs have been given up to nine times the recommended use level in their drinking water for 28 days with no untoward reaction.
Danish: Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt: Grise: Der er ikke påvist bivirkninger hos grise, som fik op til ni gange den anbefalede dosis gennem drikkevandet i 28 dage.
English: Pre-ruminant calves:
Danish: Præ-ruminante kalve:
English: Apramycin is effective against Gram-negative bacteria (Salmonella and Escherichia coli).
Danish: Apramycin har effekt på Gram-negative bakterier (Salmonella og Escherichia coli).
English: enterica serovar Dublin (Salmonella Dublin) susceptible to apramycin.
Danish: enterica serovar Dublin (Salmonella Dublin) følsom for apramycin.
English: Light to medium brown granular powder.
Danish: Lyst til mellembrunt granulært pulver.
English: Calves.
Danish: Kalve.
English: The total clinical score in the 40 mg apramycin/kg bw group improved more rapidly than the 20 mg apramycin/kg bw group which improved more rapidly than the 0 mg apramycin/kg bw group.
Danish: Den samlede kliniske score i den gruppe, der fik 40 mg apramycin/kg kropsvægt, steg hurtigere end i den gruppe, der fik 20 mg apramycin/kg kropsvægt, hvis score igen steg hurtigere end i den gruppe, der fik 0 mg apramycin/kg kropsvægt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt.
English: Powder for use in drinking water
Danish: Pulver til anvendelse i drikkevand
English: Apramycin sulfate
Danish: Apramycin (als Apramycinsulfat
English: 100 g powder contain 100 g apramycin sulfate
Danish: 100 g pulver indeholder 100 g apramycinsulfat
English: Discussion of data available
Danish: Vurdering af de foreliggende data
English: in bovine species.
Danish: hos kvæg.
English: Eli Lilly and Company Limited Elanco Animal Health
Danish: Eli Lilly and Company Limited
English: • Any use of antimicrobials in poultry will increase the risk of emergence and spread of resistance in zoonotic bacteria such as Salmonella spp.
Danish: • Anvendelse af antimikrobielle stoffer hos fjerkræ vil øge risikoen for udvikling og spredning af resistens i zoonotiske bakterier som f.eks.
English: Apramycin was administered at a dose rate of 0, 20, and 40 mg apramycin activity per kg bw once daily for 5 consecutive days.
Danish: Apramycin blev administreret i doser på 0, 20 og 40 mg apramycin-aktivitet pr. kg kropsvægt én gang dagligt i 5 dage i træk.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation in sows.
Danish: Lægemidlets sikkerhed under drægtighed og laktation hos søer er ikke fastlagt.
English: It was demonstrated that 22 to 44 mg apramycin per kg bw during 5-10 consecutive days resulted in effective therapy against experimental salmonellosis in calves.
Danish: Det blev påvist, at 22-44 mg apramycin pr. kg kropsvægt i 5-10 dage i træk effektivt behandlede eksperimentelt induceret salmonellose hos kalve.
English: Elanco Europe Ltd Lilly House Priestley Road Basingstoke RG24 9NL United Kingdom
Danish: Elanco Europe Ltd Lilly House Priestley Road Basingstoke RG24 9NL
English: Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programs for the control of salmonella in poultry - link 10 Regulation (EC) No 1177/2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the
Danish: Regulation (EC) No 1177/2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry - link
English: Apralan soluble, 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine (Läufer, Ferkel), Apramycin (als Apramycinsulfat)
Danish: Apralan soluble, 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine (Läufer,
English: The results obtained from these trials showed that for both treatment and prevention of experimental salmonellosis in calves, apramycin sulfate and apramycin base perform equally.
Danish: Resultaterne af disse undersøgelser viste, at apramycinsulfat og apramycinbase er lige effektivt ved både behandling og forebyggelse af eksperimentelt induceret salmonellose hos kalve.
English: PHARMACEUTICAL FORM Powder for use in drinking water/milk.
Danish: LÆGEMIDDELFORM Pulver til anvendelse i drikkevand/mælk.
English: Lilly France 24 Boulevard Vital Bouhot
Danish: Frankrig Lilly France 24 Boulevard Vital Bouhot 92200 Neuilly Sur Seine France
English: • the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Danish: • CVMP henviser til, at formålet med indbringelse af sagen var at opnå harmonisering af produktresuméet, etiketteringen og indlægssedlen.
English: Chicken: There was no mortality when chickens were given a single oral dose of 1,000 mg/kg of bodyweight.
Danish: Kyllinger: Hos kyllinger, som fik en enkelt oral dosis på 1.000 mg/kg legemsvægt, sås ingen dødelighed.
English: In case of onset of symptoms after exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af symptomer efter eksponering såsom udslæt skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: ADVICE ON CORRECT ADMINISTRATION The intake of medicated water depends on the clinical condition of the animals.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Indtag af medicineret vand afhænger af dyrets kliniske tilstand.
English: If irritation persists, seek medical advice.
Danish: Søg lægehjælp hvis irritationen fortsætter.
English: 1 g powder contains 1 g apramycin (as sulfate)
Danish: 1 g pulver indeholder 1 g apramycin (som sulfat)
English: In this sense, in a recent EFSA scientific opinion (June 2017)13 Salmonella infection in poultry (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae) has been assessed according to the criteria of the Animal Health Law.
Danish: I en nylig videnskabelig udtalelse fra EFSA (juni 2017)13 er Salmonella-infektion hos fjerkræ (Salmonella pullorum, Salmonella gallinarum og Salmonella arizonae) således blevet vurderet i henhold til kriterierne i dyresundhedsloven.
English: Chicken:
Danish: Kyllinger:
English: Torre Ocidente Rua Galileu Galilei, N.º 2, Piso 7
Danish: Torre Ocidente Rua Galileu Galilei, N.º 2, Piso 7 Fracção A/D 1500-392 Lisboa Portugal
English: Do not use during pregnancy.
Danish: Må ikke anvendes under drægtighed.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Danish: VETERINÆRLÆGEMIDLETS NAVN Veterinærlægemidlets (sær)navn
English: Taking into account the available information the proposed withdrawal period of zero days for chicken meat and offal was considered acceptable.
Danish: Ud fra de tilgængelige data vurderes den anførte tilbageholdelsestid på nul dage for kød og indmad fra kyllinger at være acceptabel.
English: PHARMACEUTICAL FORM Powder for use in drinking water/milk
Danish: LÆGEMIDDELFORM Pulver til anvendelse i drikkevand/mælk
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name>
Danish: VETERINÆRLÆGEMIDLETS NAVN <Veterinærlægemidlets (sær)navn>
English: Do not use within 4 weeks of the start of the laying period.
Danish: Må ikke anvendes indenfor 4 uger forud for æglægningsperiodens begyndelse.
English: In this sense, in a scientific opinion (2017) of EFSA13, Salmonella infection in poultry (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae) has been assessed according to the criteria of the Animal Health Law.
Danish: I en videnskabelig udtalelse fra EFSA (2017) er Salmonella-infektion hos fjerkræ (Salmonella pullorum, Salmonella gallinarum og Salmonella arizonae) således blevet vurderet i henhold til kriterierne i dyresundhedsloven.
English: Do not use in animals suffering from kidney disorders.
Danish: Bør ikke anvendes til dyr med nyrelidelser.
English: The proposed indication was ‘Treatment of colibacillosis caused by Escherichia coli and not zoonotic Salmonella (Salmonella Pullorum and Salmonella Gallinarum) susceptible to apramycin'.
Danish: Den anførte indikation er "behandling af colibacillose forårsaget af apramycin-følsom Escherichia coli og ikke-zoonotisk Salmonella (Salmonella pullorum og Salmonella gallinarum)".
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 8 μg/ml or less and the resistance proportion of E. coli of chicken origin against apramycin was below 10%.
Danish: Dataene viste, at MIC90-værdien for apramycin ved europæiske isolater af E. coli var 8 μg/ml eller mindre, og at andelen af resistens over for apramycin hos E. coli fra kyllinger var under 10%.
English: In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Chickens: Do not use in laying hens and within 4 weeks before the onset of the laying period.
Danish: Kyllinger: Må ikke anvendes hos æglæggende høner eller indenfor 4 uger forud for æglægningsperiodens begyndelse.
English: Shelf life after first opening the immediate packaging: 28 days.
Danish: Efter første åbning af den indre emballage: 28 dage.
English: Chickens have been authorised in Ireland, Italy, the Netherlands, Portugal, Spain and the UK.
Danish: Kyllinger er blevet godkendt som måldyreart i Irland, Italien, Holland, Portugal, Spanien og Storbritannien.
English: Girolan and its associated name Apralan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
Danish: Girolan og det relaterede navn Apralan er et pulver, der indeholder det aktive stof apramycinsulfat, og som skal opblandes i drikkevand/mælk.
English: The daily administration of apramycin at a dose of 12,500 IU apramycin per kg bw (corresponding to 22.5 mg of product/kg bw), via drinking water, during seven days was shown to be an efficacious method to control the post-weaning colibacillosis in piglets.
Danish: Daglig administration af apramycin i en dosis på 12.500 IE pr. kg kropsvægt (svarende til 22,5 mg produkt/kg kropsvægt) via drikkevand i 7 dage var en påviseligt effektiv metode til bekæmpelse af colibacillose hos fravænnede smågrise.
English: Seven trials were conducted as a blind study in Greece, Italy, Spain and the UK.
Danish: Der blev gennemført syv blindundersøgelser i Grækenland, Italien, Spanien og Storbritannien.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to apramycin or any other aminoglycoside should avoid contact with the product.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ved overfølsomhed over for apramycin eller andre aminoglykosider, bør kontakt med lægemidlet undgås.
English: Calves have been authorised in Denmark, France, Ireland, the Netherlands, Portugal, Spain and the UK.
Danish: Kalve er blevet godkendt som måldyreart i Danmark, Frankrig, Irland, Holland, Portugal, Spanien og Storbritannien.
English: In those studies, the animals were examined to confirm the diagnosis prior to the initiation of treatment, bacteriologically and with lesions in different organs; treatment decreased mortality and carcases showed absence of lesions.
Danish: I disse undersøgelser blev dyrene inden behandlingens påbegyndelse vurderet bakteriologisk og med henblik på eventuelle læsioner i forskellige organer for at bekræfte diagnosen.
English: Calves: Meat and offal: 28 days.
Danish: Kalve: Kød og indvolde: 28 dage.
English: INDICATION(S) Read the package leaflet before use.
Danish: INDIKATION(ER) Læs indlægssedlen før brug.
English: Special precautions for use in animals:
Danish: Særlige forsigtighedsregler for dyret:
English: However, no storage conditions are provided for these stability studies and it is therefore not clear if they have been conducted at 25 °C/60% RH in accordance with the requirements of the ‘Guideline on stability testing of existing active substances and related finished products (EMEA/CVMP/846/99-Rev.1)'15.
Danish: Der er dog ikke angivet nogen opbevaringsbetingelser, hvad angår disse stabilitetsundersøgelser, og det fremgår derfor ikke tydeligt, om de er udført ved 25 °C/60 % relativ fugtighed i overensstemmelse med kravene i "Guideline on
English: Use of the veterinary medicinal product deviating from the instructions given in the Summary of product characteristics may increase the prevalence of bacteria resistant to the apramycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross-resistance.
Danish: Anvendelse af veterinærlægemidlet afvigende fra instruktionerne i produktresuméet kan øge prævalensen af bakteriel resistens over for apramycin og kan reducere behandlingseffektiviteten af aminoglykosider pga. risiko for krydsresistens.
English: Licence: CC BY-NC-SA 3.0 IGO - link show that the finished product is stable over 36 months with no significant change in active substance content.
Danish: Resultaterne viser, at det færdige produkt er stabilt over 36 måneder uden signifikante ændringer i indholdet af aktivt stof.
English: Apramycin sulfate equivalent to 1 g apramycin activity per sachet.
Danish: Apramycinsulfat svarende til 1 g apramycinaktivit et pr. sachet.
English: Pigs.
Danish: Grise.
English: Powder for use in drinking water/milk for pigs, calves, chickens and rabbits Apramycin (sulfate)
Danish: Pulver til anvendelse i drikkevand/mælk til grise, kalve, kyllinger og kaniner Apramycin (sulfat)
English: For single-dose presentations (sachets):
Danish: For enkeltdosis-pakninger (breve):
English: Apramycin is bactericidal at minimum inhibitory concentrations and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
Danish: Apramycin er baktericidt ved mindste hæmmende koncentration og er effektivt mod både Gram-negative og Gram-positive bakterier samt visse mycoplasma-stammer.
English: Apramycin is bactericidal at minimum inhibitory concentrations (MICs) and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
Danish: Apramycin er baktericidt ved mindste hæmmende koncentration (MIC) og er effektivt mod både Gram-negative og Gram-positive bakterier samt visse mycoplasma-stammer.
English: Furthermore, taking into account the data provided and in line with the ‘Note for guidance on start of shelf life of the finished dosage form (EMEA/CVMP/453/01)1', the shelf life period of the veterinary medicinal product as packaged for sale, which was 3 years, was reduced to 18 months.
Danish: Endvidere blev veterinærlægemidlets opbevaringstid i salgspakningen, der oprindeligt var anført som 3 år, reduceret til 18 måneder på grundlag af de fremlagte data og i overensstemmelse med "Note for guidance on start of shelf life of the finished dosage form (EMEA/CVMP/453/01)"1 (vejledning vedrørende start af opbevaringstid for endelig doseringsform).
English: The oral administration of apramycin at 20 mg/kg bw or at 40 mg/kg bw during five consecutive days was shown to be efficacious for the treatment of colibacillosis and salmonellosis in young calves under field conditions.
Danish: Oral administration af apramycin i en dosis på 20 eller 40 mg/kg kropsvægt i 5 dage i træk var i en feltundersøgelse påviseligt effektivt til behandling af colibacillose og salmonellose hos unge kalve.
English: mg product per litre of drinking water/milk
Danish: gennemsnitlig legemsvægt (kg) af dyr der skal behandles mg produkt pr. liter drikkevand/mælk
English: A wild-type cut-off value of ≥32 μg/ml for E. coli of cattle origin has been proposed.
Danish: Der er anført en cut-off-værdi på ≥32 μg/ml for E. coli-vildtypen fra kvæg.
English: Shelf life after first opening the container: use immediately.
Danish: Holdbarhed efter første åbning af beholderen: Anvendes straks.
English: Pigs: Pigs have been given up to nine times the recommended use level in their drinking water for 28 days with no untoward reaction.
Danish: Grise: Der er ikke påvist bivirkninger hos grise, som fik op til ni gange den anbefalede dosis gen-nem drikkevandet i 28 dage.
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 16 μg/ml with a wild-type cut-off value of ≥32 μg/ml.
Danish: Dataene viste, at MIC90-værdien for apramycin ved europæiske isolater af E. coli var 16 μg/ml med en cut-off-værdi på ≥32 μg/ml for vildtypen.
English: CVMP noted that data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is below 10%.
Danish: CVMP bemærkede, at data fra kliniske isolater fra forskellige europæiske lande har vist, at andelen af E. coli-bakterier, der er resistente over for apramycin, er under 10%.
English: The potential risk of resistance development, which might impact product efficacy, and overall animal and human health, is limited through:
Danish: Risikostyring og risikominimerende foranstaltninger Følgende foranstaltninger begrænser den potentielle risiko for resistensudvikling med betydning for lægemidlets virkning og generel betydning for dyrs og menneskers sundhed:
English: Do not use in laying hens and within 4 weeks before the onset of the laying period.
Danish: Må ikke anvendes hos æglæggende høner eller inden for 4 uger forud for æglægningsperioden begyndelse.
English: Recent data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is increasing.
Danish: Nylige data fra kliniske isolater fra forskellige europæiske lande har vist, at andelen af E. coli-bakterier, der er resistente over for apramycin, er stigende.
English: Therefore, the proposed withdrawal period of zero days for rabbit meat and offal was considered acceptable.
Danish: Den anførte tilbageholdelsestid på nul dage for kød og indmad fra kaniner vurderes derfor at være acceptabel.
English: • The use of antimicrobials is never totally effective for the control of Salmonella spp.
Danish: • Anvendelse af antimikrobielle stoffer er aldrig fuldt ud effektivt ved bekæmpelse af Salmonella spp., fordi det ikke er muligt at eliminere alle organismerne i en smittet besætning.
English: Therefore the proposed withdrawal period of zero days for pig meat and offal was considered acceptable.
Danish: Den anførte tilbageholdelsestid på nul dage for kød og indmad fra grise vurderes derfor at være acceptabel.
English: Apramycin sulfate equivalent to 50 g apramycin activity per bottle.
Danish: Apramycinsulfat svarende til 50 g apramycinaktivit et pr. Flaske.