FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Marketing authorisation holder: To be completed nationally.
Danish: Indehaver af markedsføringstilladelse: Udfyldes nationalt.
English: Further data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is up to 12%.
Danish: 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%.
English: 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.
Danish: 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.
English: Pigs (weaned piglets)
Danish: Svin (fravænnede smågrise)
English: 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.
Danish: 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.
English: In support of the proposed indication, ‘Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Danish: Til støtte for den anførte indikation "Behandling af bakteriel enteritis forårsaget af Escherichia coli og kliniske udbrud forårsaget af Salmonella enterica subsp.
English: Girolan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
Danish: Girolan er et pulver, der indeholder det aktive stof apramycinsulfat, og som skal opblandes i drikkevand/mælk.
English: 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.
Danish: 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
English: MIC90 values from a large pan-European study have been calculated for apramycin against E. coli from pigs as 16 μg/ml.
Danish: I en stor fælleseuropæisk undersøgelse har man beregnet, at MIC90-værdien for apramycin mod E. coli fra svin er 16 μg/ml.
English: Denmark Elanco Animal Health A/S
Danish: Danmark Elanco Animal Health A/S Eli Lilly Danmark A/S Lyskær 3E, 2 tv.
English: A wild-type cut-off value of ≥32 μg/ml for E. coli of pig origin has been proposed.
Danish: Der er anført en cut-offværdi på ≥32 μg/ml for E. coli-vildtypen fra svin.
English: 50019 Sesto Fiorentino (Firenze) Italy
Danish: Eli Lilly Italia SpA Via A. Gramsci, 731/733 50019 Sesto Fiorentino (Firenze)
English: Pigs (piglets and growers)
Danish: Grise (smågrise og slagtesvin)
English: (sachet)
Danish: Ferkel),
English: Pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits.
Danish: Grise (fravænnede), præ-ruminante kalve, kyllinger (slagtekyllinger) og kaniner.
English: TARGET SPECIES Pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits.
Danish: DYREARTER Grise (fravænnede), præ-ruminante kalve, kyllinger (slagtekyllinger) og kaniner.
English: 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.
Danish: 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.
English: STATEMENT OF ACTIVE SUBSTANCES 1 g contains 552,000 IU apramycin (as apramycin sulfate)
Danish: ANGIVELSE AF AKTIVE STOFFER 1 g indeholder 552.000 IE apramycin (som apramycinsulfat)
English: Pigs (weaned piglets):
Danish: Svin (fravænnede smågrise):
English: MIC90 values from a large pan-European study have been calculated for apramycin against E. coli from calves as 16 μg/ml.
Danish: I en stor fælleseuropæisk undersøgelse har man beregnet, at MIC90-værdien for apramycin mod E. coli fra kalve er 16 μg/ml.
English: Abt. Elanco Animal Health
Danish: Tyskland Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Straße
English: Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Danish: Behandling af bakteriel enteritis forårsaget af Escherichia coli og kliniske udbrud forårsaget af Salmonella enterica subsp.
English: enterica serovar Dublin susceptible to apramycin', the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Danish: enterica serotype Dublin med følsomhed over for apramycin" fremlagde indehaveren af markedsføringstilladelse in vitrofølsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
English: Pre-ruminant calves
Danish: Præ-drøvtyggende kalve
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 x 106 IE
English: • 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.
Danish: CHMP anbefaler ændring af markedsføringstilladelserne for Girolan og det relaterede navn Apralan, jf. bilag I. Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: 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.
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER 1 g indeholder 552.000 IE apramycin (som apramycinsulfat) Lyst til mellembrunt granulært pulver.
English: Apramycin sulfate equivalent to 1000 g apramycin activity per bag.
Danish: Apramycinsulfat svarende til 1000 g apramycinaktivit et pr.
English: Calves, pigs, rabbits
Danish: Kalve, grise, kaniner
English: Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom
Danish: Elanco Animal Health Priestley Road Basingstoke Hampshire RG24 9NL
English: Pigs (weaned piglets): Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Danish: Grise (fravænnede): Behandling af bakteriel enteritis forårsaget af Escherichia coli følsom for apramycin.
English: Priestly Road Basingstoke Hampshire RG24 9NL United Kingdom
Danish: Elanco Animal Health Priestly Road Basingstoke Hampshire RG24 9NL
English: Rabbits: Meat and offal: Zero days.
Danish: Kaniner: Kød og indvolde: Nul dage.
English: 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.
Danish: 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.
English: PACKAGE LEAFLET: (Invented name of veterinary medicinal product) Powder for use in drinking water/milk for pigs, calves, chickens and rabbits
Danish: INDLÆGSSEDDEL Apralan Vet., Pulver til anvendelse i drikkevand/mælk til grise, kalve, kyllinger og kaniner
English: Shelf life after first opening the immediate packaging: use immediately.
Danish: Efter første åbning af den indre emballage: Anvendes straks.
English: Each sachet contains 2 x 106 IU apramycin sulfate and weight of 3.6 g of product.
Danish: Hver pose indeholder 2 x 106 IE apramycinsulfat og en vægt på 3,6 g produkt.
English: Treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Danish: Behandling og metafylakse af bakteriel enteritis forårsaget af Escherichia coli følsom for apramycin.
English: Calves, pigs, chickens
Danish: Kalve, grise, kyllinger
English: Administer 12,500 IU apramycin sulfate per kilogram of bodyweight (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Danish: Indgiv 12.500 IE apramycinsulfat pr. kg legemsvægt (svarende til 22,5 mg produkt/kg legemsvægt) dagligt i 7 sammenhængende dage.
English: 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.
Danish: Sygdom forårsaget af Salmonella pullorum anses dog for at være et ekstraordinært tilfælde, der vil kræve behandling (eller slagtning) af klinisk berørte besætninger.
English: Each bag contains 1,000 x 106 IU apramycin sulfate and weight of 1,812 g of product.
Danish: Hver pose indeholder 1.000 x 106 IE apramycinsulfat og vægt på 1.812 g produkt.
English: Meat and offal: Zero days.
Danish: Kød og indvolde: Nul dage.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 1 g contains 552,000 IU apramycin (as apramycin sulfate)
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 1 g indeholder 552.000 IE apramycin (som apramycinsulfat)
English: Cattle, pigs, chickens, rabbits
Danish: Kalve, grise, kyllinger, kaniner
English: Chickens: Treatment of colibacillosis caused by Escherichia coli susceptible to apramycin.
Danish: Kyllinger: Behandling af colibacillose forårsaget af Escherichia coli følsom for apramycin.
English: TARGET SPECIES Pigs, calves, chickens and rabbits.
Danish: DYREARTER Grise, kalve, kyllinger og kaniner
English: EXPIRY DATE EXP {month/year} Once diluted, use within 24 hours.
Danish: Efter fortynding: anvendes indenfor 24 timer.
English: Administer 80,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 144 mg of product/kg bw), daily for 5 consecutive days.
Danish: Indgiv 80.000 IE apramycinsulfat pr. kg legemsvægt (svarende til 144 mg produkt/kg legemsvægt) dagligt i 5 sammenhængende dage.
English: To support it, the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Danish: For at understøtte dette har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
English: 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.
Danish: 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).
English: Whereas
Danish: I henhold
English: Pigs: Meat and offal: Zero days.
Danish: Grise: Kød og indvolde: Nul dage.
English: In support of the indication for treatment of colibacillosis the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Danish: Til støtte for indikationen "behandling af colibacillose" har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
English: 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).
Danish: Salmonella Dublin) kan forårsage sygdom hos mennesker (Evangelopoulou et al., 20142; Singh, 20133).
English: High density polyethylene bottle with polypropylene screw cap. Each bottle contains 50 x 106 IU
Danish: Højdensitets polyethylenflaske med polypropylen skruehætte.
English: 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.
Danish: 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).
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: Administer 20,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days.
Danish: Indgiv 20.000 IE apramycinsulfat pr. kg legemsvægt (svarende til 36 mg produkt/kg legemsvægt) dagligt i 5 sammenhængende dage.
English: Chickens: Meat and offal: Zero days.
Danish: Kyllinger: Kød og indvolde: Nul dage.
English: To support this indication, the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Danish: For at understøtte denne indikation har indehaveren af markedsføringstilladelse fremlagt in vitrofølsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
English: Each sachet contains 1 x 106 IU apramycin sulfate and weight of 1.8 g of product.
Danish: Hvert brev indeholder 1 x 106 IE apramycinsulfat og en vægt på 1,8 g produkt.
English: INN Strength
Danish: Styrke
English: In support of the indication for treatment of bacterial enteritis caused by E. coli and clinical outbreaks due to Salmonella Dublin the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Danish: Til støtte for indikationen "behandling af bakteriel enteritis forårsaget af E. coli og kliniske udbrud forårsaget af Salmonella Dublin" har indehaveren af markedsføringstilladelse fremlagt in vitrofølsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
English: Administer 40,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
Danish: Indgiv 40.000 IE apramycinsulfat pr. kg legemsvægt (svarende til 72 mg produkt/kg legemsvægt) dagligt i 5 sammenhængende dage.
English: The provided clinical data demonstrated that Girolan was effective in the treatment of bacterial enteritis caused by E. coli when administered at 12,500 IU apramycin per kg bw (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Danish: De fremlagte kliniske data viste, at Girolan var effektivt til behandling af bakteriel enteritis forårsaget af E. coli ved daglig administration af apramycin i 7 dage i træk i en dosis på 12.500 IE pr. kg kropsvægt (svarende til 22,5 mg produkt/kg kropsvægt).
English: Calves: Calves were given apramycin in milk replacer daily for five days, at doses up to 120 mg/kg of bodyweight.
Danish: Kalve: Hos kalve, som i 5 dage fik doser på op til 120 mg apramycin/kg legemsvægt gennem mælkeerstatning, påvistes ingen toksisk effekt.
English: EXPIRY DATE EXP {month/year}> Once diluted, use within 24 hours.
Danish: UDLØBSDATO EXP (måned/år)
English: Treatment of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Danish: Behandling af bakteriel enteritis forårsaget af apramycin-følsom Escherichia coli.
English: In support of the indication for treatment of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Danish: Til støtte for indikationen "behandling af bakteriel enteritis forårsaget af E. coli" har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
English: Treatment of colibacillosis caused by Escherichia coli susceptible to apramycin.
Danish: Behandling af colibacillose forårsaget af apramycin-følsom Escherichia coli.
English: In support of the indication for treatment and metaphylaxis of bacterial enteritis caused by E. coli the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Danish: Til støtte for indikationen "behandling og metafylakse af bakteriel enteritis forårsaget af E. coli" har indehaveren af markedsføringstilladelse fremlagt in vitro-følsomhedsdata og kliniske data, herunder data fra feltundersøgelser.
English: High density polyethylene bottle with polypropylene screw cap. Each bottle contains 50 x 106 IU apramycin and weight of 91 g of product.
Danish: Hver flaske indeholder 50 x 106 IE apramycinsulfat og en vægt på 91 g produkt.
English: Cardboard box (sachet)
Danish: Produktresumé, pkt.
English: The results
Danish: BIVIRKNINGER
English: Furthermore the blood pressure of patients should be carefully monitored.
Danish: Derudover bør patienternes blodtryk overvåges nøje.
English: This information can be coordinated at individual Member States level.
Danish: Formidlingen af denne information kan koordineres af de enkelte medlemsstater.
English: Overall summary of the scientific evaluation of bromocriptine containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder bromocriptin (se bilag I)
English: This is considered an appropriate risk minimisation measure to reduce the misuse of the product.
Danish: Dette anses for en passende risikominimeringsforanstaltning over for fejlanvendelse af produktet.
English: The analysis of case reports from the literature was hampered by the limited information available.
Danish: Analysen af case-rapporter fra litteraturen vanskeliggjordes af, at der kun forelå begrænsede oplysninger.
English: The PRAC concluded that these should not be mentioned in the product information as examples of situations where bromocriptine could be used.
Danish: PRAC konkluderede, at disse indikationer ikke bør nævnes i produktinformationen som eksempler på situationer, hvor bromocriptin kan anvendes.
English: Nevertheless, further information and awareness among the healthcare professionals is advisable to ensure safe use of the product.
Danish: Alligevel tilrådes yderligere information og årvågenhed blandt sundhedspersoner af hensyn til sikkerheden ved anvendelsen af produktet.
English: The PRAC also considered the available data on the efficacy of these products;
Danish: PRAC vurderede desuden de foreliggende data om virkningen af disse produkter
English: The second survey conducted in France retrieved a higher number of AEs, however this might not reflect an absolute increase in occurrence of those events but be the consequence of a change in post-marketing reporting of these events as more breastfeeding mothers were closely followed.
Danish: I den anden undersøgelse i Frankrig fandtes et højere antal bivirkninger, som dog ikke nødvendigvis afspejler en absolut stigning i forekomsten af disse hændelser, men kan skyldes en ændring i indberetningen efter markedsføring for disse hændelser, idet flere ammende mødre blev overvåget tæt.
English: In the clinical trial assessing the efficacy of bromocriptine in late post-partum, treatment was initiated at times covering adequately the late post-partum period (10 to 13.8 days post-partum and 38.9 days to 16.7 weeks post-partum).
Danish: I den kliniske undersøgelse til vurdering af virkningen af bromocriptin i den sene post partum-periode blev behandlingen påbegyndt på et tidspunkt, der tilstrækkeligt dækker den sene post partum-periode (10-13,8 dage post partum og 38,9 dage til 16,7 uger post partum ).
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: In the European Union (EU) it is also used to treat other conditions, such as hyperprolactinaemia and Parkinson's disease; however these indications are not in the scope of this European review.
Danish: Desuden anvendes det i EU til behandling af sygdomme såsom hyperprolaktinæmi og Parkinsons sygdom, men disse indikationer er ikke omfattet af denne europæiske gennemgang.
English: Following assessment of all the data, the PRAC concluded the contraindications already in place in most Member States (MSs) were valid and should be included in the PIs across all MSs.
Danish: Efter vurdering af alle data konkluderede PRAC, at de kontraindikationer, der allerede var gældende i størstedelen af medlemsstaterne, var gyldige og burde indgå i produktinformationen i alle medlemsstater.
English: No causal association was shown in the three observational studies investigating the risk of seizures, (Rothman, 1990) cardio- and cerebrovascular events, (Herings, 1995) and hypertension (Watson, 1989).
Danish: Der blev ikke påvist kausal sammenhæng i de tre observationsundersøgelser vedrørende risikoen for krampeanfald (Rothman, 1990), kardiovaskulære og cerebrovaskulære hændelser (Herings, 1995) og hypertension (Watson, 1989).
English: In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
Danish: Hos nogle patienter var udviklingen af krampeanfald eller apopleksi forudgået af svær hovedpine og/eller forbigående synsforstyrrelser.