natgillin/translations-raw huggingface dataset:
Girolan og det relaterede navn Apralan er et pulver, der indeholder det aktive stof apramycinsulfat, og som skal opblandes i drikkevand/mælk.
Girolan and its associated name Apralan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
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.
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.
Der blev gennemført syv blindundersøgelser i Grækenland, Italien, Spanien og Storbritannien.
Seven trials were conducted as a blind study in Greece, Italy, Spain and the UK.
Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ved overfølsomhed over for apramycin eller andre aminoglykosider, bør kontakt med lægemidlet undgås.
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.
Kalve er blevet godkendt som måldyreart i Danmark, Frankrig, Irland, Holland, Portugal, Spanien og Storbritannien.
Calves have been authorised in Denmark, France, Ireland, the Netherlands, Portugal, Spain and the UK.
I disse undersøgelser blev dyrene inden behandlingens påbegyndelse vurderet bakteriologisk og med henblik på eventuelle læsioner i forskellige organer for at bekræfte diagnosen.
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.
Kalve: Kød og indvolde: 28 dage.
Calves: Meat and offal: 28 days.
INDIKATION(ER) Læs indlægssedlen før brug.
INDICATION(S) Read the package leaflet before use.
Særlige forsigtighedsregler for dyret:
Special precautions for use in animals:
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
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.
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.
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.
Resultaterne viser, at det færdige produkt er stabilt over 36 måneder uden signifikante ændringer i indholdet af aktivt stof.
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.
Apramycinsulfat svarende til 1 g apramycinaktivit et pr. sachet.
Apramycin sulfate equivalent to 1 g apramycin activity per sachet.
Grise.
Pigs.
Pulver til anvendelse i drikkevand/mælk til grise, kalve, kyllinger og kaniner Apramycin (sulfat)
Powder for use in drinking water/milk for pigs, calves, chickens and rabbits Apramycin (sulfate)
For enkeltdosis-pakninger (breve):
For single-dose presentations (sachets):
Apramycin er baktericidt ved mindste hæmmende koncentration og er effektivt mod både Gram-negative og Gram-positive bakterier samt visse mycoplasma-stammer.
Apramycin is bactericidal at minimum inhibitory concentrations and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
Apramycin er baktericidt ved mindste hæmmende koncentration (MIC) og er effektivt mod både Gram-negative og Gram-positive bakterier samt visse mycoplasma-stammer.
Apramycin is bactericidal at minimum inhibitory concentrations (MICs) and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
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).
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.
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.
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.
gennemsnitlig legemsvægt (kg) af dyr der skal behandles mg produkt pr. liter drikkevand/mælk
mg product per litre of drinking water/milk
Der er anført en cut-off-værdi på ≥32 μg/ml for E. coli-vildtypen fra kvæg.
A wild-type cut-off value of ≥32 μg/ml for E. coli of cattle origin has been proposed.
Holdbarhed efter første åbning af beholderen: Anvendes straks.
Shelf life after first opening the container: use immediately.
Grise: Der er ikke påvist bivirkninger hos grise, som fik op til ni gange den anbefalede dosis gen-nem drikkevandet i 28 dage.
Pigs: Pigs have been given up to nine times the recommended use level in their drinking water for 28 days with no untoward reaction.
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.
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.
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%.
CVMP noted that data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is below 10%.
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:
The potential risk of resistance development, which might impact product efficacy, and overall animal and human health, is limited through:
Må ikke anvendes hos æglæggende høner eller inden for 4 uger forud for æglægningsperioden begyndelse.
Do not use in laying hens and within 4 weeks before the onset of the laying period.
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.
Recent data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is increasing.
Den anførte tilbageholdelsestid på nul dage for kød og indmad fra kaniner vurderes derfor at være acceptabel.
Therefore, the proposed withdrawal period of zero days for rabbit meat and offal was considered acceptable.
• 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.
• The use of antimicrobials is never totally effective for the control of Salmonella spp.
Den anførte tilbageholdelsestid på nul dage for kød og indmad fra grise vurderes derfor at være acceptabel.
Therefore the proposed withdrawal period of zero days for pig meat and offal was considered acceptable.
Apramycinsulfat svarende til 50 g apramycinaktivit et pr. Flaske.
Apramycin sulfate equivalent to 50 g apramycin activity per bottle.
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 til forordning (EF) nr. 1177/200610 bør antimikrobielle stoffer ikke anvendes som en del af de nationale programmer for bekæmpelse af Salmonella, da det kan medføre risici for folkesundheden i form af udvikling, selektion og spredning af resistens.
According to Regulation (EC) No 1177/200610, antimicrobials should not be used as part of national control programs of Salmonella due to public health risks associated with development, selection and spread of resistance.
Det fremgår af rapporten, at de udviklede lande sjældent anvender antimikrobielle stoffer i industribesætninger til behandling af Salmonella pullorum og Salmonella gallinarum, da disse stoffer ikke eliminerer infektionen i besætningerne.
The report states that in developed countries antimicrobials are rarely used in commercial flocks for treatment of Salmonella Pullorum and Salmonella Gallinarum as they do not eliminate the infection from flocks and other control measures such as high level biosecurity, movement restrictions and depopulation are used instead.
Indehaver af markedsføringstilladelse: Udfyldes nationalt.
Marketing authorisation holder: To be completed nationally.
Yderligere data fra kliniske isolater fra forskellige europæiske lande har vist, at andelen af E. coli-bakterier, der er resistente over for apramycin, er op til 12%.
Further data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is up to 12%.
Apramycin administreret oralt til kalve én gang dagligt i 5 dage i en dosis på 20 eller 40 mg/kg kropsvægt var effektivt til at reducere dødeligheden.
Apramycin administered orally to calves once daily for five days at 20 mg apramycin/kg bw or 40 mg apramycin/kg bw was effective in reducing mortality.
Svin (fravænnede smågrise)
Pigs (weaned piglets)
I denne blindede, randomiserede undersøgelse blev Girolan administreret dagligt i 5 dage i træk i en dosis på 20.000 IE apramycin pr. kg kropsvægt (svarende til 36 mg produkt/kg kropsvægt) og sammenlignet med et referenceprodukt indeholdende colistin i en dosis på 100.000 IE colistin/kg kropsvægt/dag hos kontrolgruppen.
In this blind, randomised trial Girolan administered at 20,000 IU apramycin per kg bw (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days, was compared with a reference product containing colistin at a dose of 100,000 IU colistin/kg bw/day as the control group.
Til støtte for den anførte indikation "Behandling af bakteriel enteritis forårsaget af Escherichia coli og kliniske udbrud forårsaget af Salmonella enterica subsp.
In support of the proposed indication, ‘Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Girolan er et pulver, der indeholder det aktive stof apramycinsulfat, og som skal opblandes i drikkevand/mælk.
Girolan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
The EFSA Journal (2004) 115, 1-76 12 Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law') - link
Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law') - link 13 EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), 2017.
I en stor fælleseuropæisk undersøgelse har man beregnet, at MIC90-værdien for apramycin mod E. coli fra svin er 16 μg/ml.
MIC90 values from a large pan-European study have been calculated for apramycin against E. coli from pigs as 16 μg/ml.
Danmark Elanco Animal Health A/S Eli Lilly Danmark A/S Lyskær 3E, 2 tv.
Denmark Elanco Animal Health A/S
Der er anført en cut-offværdi på ≥32 μg/ml for E. coli-vildtypen fra svin.
A wild-type cut-off value of ≥32 μg/ml for E. coli of pig origin has been proposed.
Eli Lilly Italia SpA Via A. Gramsci, 731/733 50019 Sesto Fiorentino (Firenze)
50019 Sesto Fiorentino (Firenze) Italy
Grise (smågrise og slagtesvin)
Pigs (piglets and growers)
Ferkel),
(sachet)
Grise (fravænnede), præ-ruminante kalve, kyllinger (slagtekyllinger) og kaniner.
Pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits.
DYREARTER Grise (fravænnede), præ-ruminante kalve, kyllinger (slagtekyllinger) og kaniner.
TARGET SPECIES Pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits.
Den godkendte harmoniserede dosis for de to indikationer var 40.000 IE apramycin pr. kg kropsvægt (svarende til 72 mg produkt/kg kropsvægt) dagligt i 5 dage i træk.
The agreed harmonised dose for both indications was 40,000 IU apramycin per kg bw (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
ANGIVELSE AF AKTIVE STOFFER 1 g indeholder 552.000 IE apramycin (som apramycinsulfat)
STATEMENT OF ACTIVE SUBSTANCES 1 g contains 552,000 IU apramycin (as apramycin sulfate)
Svin (fravænnede smågrise):
Pigs (weaned piglets):
I en stor fælleseuropæisk undersøgelse har man beregnet, at MIC90-værdien for apramycin mod E. coli fra kalve er 16 μg/ml.
MIC90 values from a large pan-European study have been calculated for apramycin against E. coli from calves as 16 μg/ml.
Tyskland Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Straße
Abt. Elanco Animal Health
Behandling af bakteriel enteritis forårsaget af Escherichia coli og kliniske udbrud forårsaget af Salmonella enterica subsp.
Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
enterica serotype Dublin med følsomhed over for apramycin" fremlagde indehaveren af markedsføringstilladelse in vitrofølsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
enterica serovar Dublin susceptible to apramycin', the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Præ-drøvtyggende kalve
Pre-ruminant calves
PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 x 106 IE
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
CHMP anbefaler ændring af markedsføringstilladelserne for Girolan og det relaterede navn Apralan, jf. bilag I. Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
• the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP has recommended the amendment of the marketing authorisations for Girolan and its associated name Apralan as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER 1 g indeholder 552.000 IE apramycin (som apramycinsulfat) Lyst til mellembrunt granulært pulver.
STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS 1 g contains 552,000 IU apramycin (as apramycin sulfate) Light to medium brown granular powder.
Apramycinsulfat svarende til 1000 g apramycinaktivit et pr.
Apramycin sulfate equivalent to 1000 g apramycin activity per bag.
Kalve, grise, kaniner
Calves, pigs, rabbits
Elanco Animal Health Priestley Road Basingstoke Hampshire RG24 9NL
Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom
Grise (fravænnede): Behandling af bakteriel enteritis forårsaget af Escherichia coli følsom for apramycin.
Pigs (weaned piglets): Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Elanco Animal Health Priestly Road Basingstoke Hampshire RG24 9NL
Priestly Road Basingstoke Hampshire RG24 9NL United Kingdom
Kaniner: Kød og indvolde: Nul dage.
Rabbits: Meat and offal: Zero days.
1 Note for guidance on start of shelf life of the finished dosage form (EMEA/CVMP/453/01) - link mellem 3,45 og 75 mg/kg kropsvægt/dag via drikkevandet i 3, 5 eller 7 dage i træk.
The studies analysed the effect of apramycin dosages between 3.45 mg/kg bodyweight (bw)/day and 75 mg/kg bw/day, via drinking water, during 3, 5 or 7 consecutive days.
INDLÆGSSEDDEL Apralan Vet., Pulver til anvendelse i drikkevand/mælk til grise, kalve, kyllinger og kaniner
PACKAGE LEAFLET: (Invented name of veterinary medicinal product) Powder for use in drinking water/milk for pigs, calves, chickens and rabbits
Efter første åbning af den indre emballage: Anvendes straks.
Shelf life after first opening the immediate packaging: use immediately.
Hver pose indeholder 2 x 106 IE apramycinsulfat og en vægt på 3,6 g produkt.
Each sachet contains 2 x 106 IU apramycin sulfate and weight of 3.6 g of product.
Behandling og metafylakse af bakteriel enteritis forårsaget af Escherichia coli følsom for apramycin.
Treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Kalve, grise, kyllinger
Calves, pigs, chickens
Indgiv 12.500 IE apramycinsulfat pr. kg legemsvægt (svarende til 22,5 mg produkt/kg legemsvægt) dagligt i 7 sammenhængende dage.
Administer 12,500 IU apramycin sulfate per kilogram of bodyweight (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Sygdom forårsaget af Salmonella pullorum anses dog for at være et ekstraordinært tilfælde, der vil kræve behandling (eller slagtning) af klinisk berørte besætninger.
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 disease caused by Salmonella Pullorum is considered an exceptional circumstance that would require to treat (or slaughter) clinically affected flocks.
Hver pose indeholder 1.000 x 106 IE apramycinsulfat og vægt på 1.812 g produkt.
Each bag contains 1,000 x 106 IU apramycin sulfate and weight of 1,812 g of product.
Kød og indvolde: Nul dage.
Meat and offal: Zero days.
MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 1 g indeholder 552.000 IE apramycin (som apramycinsulfat)
QUANTITY OF THE ACTIVE SUBSTANCE(S) 1 g contains 552,000 IU apramycin (as apramycin sulfate)
Kalve, grise, kyllinger, kaniner
Cattle, pigs, chickens, rabbits
Kyllinger: Behandling af colibacillose forårsaget af Escherichia coli følsom for apramycin.
Chickens: Treatment of colibacillosis caused by Escherichia coli susceptible to apramycin.
DYREARTER Grise, kalve, kyllinger og kaniner
TARGET SPECIES Pigs, calves, chickens and rabbits.
Efter fortynding: anvendes indenfor 24 timer.
EXPIRY DATE EXP {month/year} Once diluted, use within 24 hours.
Indgiv 80.000 IE apramycinsulfat pr. kg legemsvægt (svarende til 144 mg produkt/kg legemsvægt) dagligt i 5 sammenhængende dage.
Administer 80,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 144 mg of product/kg bw), daily for 5 consecutive days.
For at understøtte dette har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
To support it, the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
De fremlagte kliniske data viste, at Girolan var effektivt til behandling af bakteriel enteritis forårsaget af E. coli og kliniske udbrud forårsaget af Salmonella Dublin ved daglig administration af apramycin i 5 dage i træk i en dosis på 40.000 IE pr. kg kropsvægt (svarende til 72 mg produkt/kg kropsvægt).
The clinical data provided demonstrated that Girolan was effective in the treatment of bacterial enteritis caused by E. coli and clinical outbreaks due to Salmonella Dublin when administered at 40,000 IU apramycin per kilogram of bodyweight (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
I henhold
Whereas
Grise: Kød og indvolde: Nul dage.
Pigs: Meat and offal: Zero days.
Til støtte for indikationen "behandling af colibacillose" har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
In support of the indication for treatment of colibacillosis the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Salmonella Dublin) kan forårsage sygdom hos mennesker (Evangelopoulou et al., 20142; Singh, 20133).
Even host-adapted serovars (as Salmonella Dublin) might cause disease in humans (Evangelopoulou et al., 20142; Singh, 20133) so the use of antimicrobials in food producing animals should consider the zoonotic role of Salmonella and the consequences for public health (EFSA and ECDC, 20164).
Højdensitets polyethylenflaske med polypropylen skruehætte.
High density polyethylene bottle with polypropylene screw cap. Each bottle contains 50 x 106 IU
De fremlagte kliniske data viste, at Girolan var effektivt til behandling af colibacillose ved daglig administration af apramycin i 5 dage i træk i en dosis på 80.000 IE pr. kg kropsvægt (svarende til 144 mg produkt/kg kropsvægt).
The provided clinical data demonstrated that Girolan was effective in the treatment of colibacillosis when administered at 80,000 IU apramycin per kilogram of bodyweight (corresponding to 144 mg of product/kg bw), daily for 5 consecutive days.
De fremlagte kliniske data viste, at Girolan var effektivt til behandling og metafylakse af bakteriel enteritis forårsaget af Escherichia coli ved daglig administration af apramycin i 5 dage i træk i en dosis på 20.000 IE pr. kg kropsvægt (svarende til 36 mg produkt/kg kropsvægt).
The provided clinical data demonstrated that Girolan was effective in the treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli when administered at 20,000 IU apramycin per kilogram of bodyweight (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days.
Til støtte for den anførte indikation "behandling og metafylakse af bakteriel enteritis forårsaget af apramycin-følsom Escherichia coli" fremlagde indehaveren af markedsføringstilladelse in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
In support of the proposed indication ‘Treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli susceptible to apramycin', the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Indgiv 20.000 IE apramycinsulfat pr. kg legemsvægt (svarende til 36 mg produkt/kg legemsvægt) dagligt i 5 sammenhængende dage.
Administer 20,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days.
Kyllinger: Kød og indvolde: Nul dage.
Chickens: Meat and offal: Zero days.
For at understøtte denne indikation har indehaveren af markedsføringstilladelse fremlagt in vitrofølsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
To support this indication, the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Hvert brev indeholder 1 x 106 IE apramycinsulfat og en vægt på 1,8 g produkt.
Each sachet contains 1 x 106 IU apramycin sulfate and weight of 1.8 g of product.
Styrke
INN Strength