FrancophonIA/ELRC3.0 huggingface dataset:
English: Spain CENAVISA Camí Pedra Estela s/n 43205 Reus Tarragona) Spain
Danish: Spanien CENAVISA Camí Pedra Estela s/n 43205 Reus Tarragona) Spanien
English: Croatia Krka - Farma d.o.o.
Danish: Kroatien Krka - Farma d.o.o.
English: Spain MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
Danish: Spanien MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
English: Since the reference product is only authorised in Ireland, the concept of the European reference product has been applied in this MRP.
Danish: Da referencelægemidlet kun er godkendt i Irland, er begrebet europæisk referencelægemiddel blevet anvendt ved denne gensidige anerkendelsesprocedure.
English: The marketing authorisations of the products concerned by this referral procedure are assumed to have been granted by the national competent authorities on the basis of Article 6(3) of Directive 2001/82/EC.
Danish: Markedsføringstilladelserne for lægemidlerne omfattet af denne henvisningsprocedure antages at være udstedt af de nationale kompetente myndigheder på grundlag af artikel 6, stk. 3, i direktiv 2000/82/EF.
English: Additionally, development of antimicrobial resistance towards gentamicin would present a serious risk both to human and animal health.
Danish: Desuden vil udvikling af eventuel antimikrobiel resistens over for gentamicin udgøre en alvorlig risiko for både menneskers og dyrs sundhed.
English: The use of the products has been limited to an indication for which gentamicin is considered efficacious on the basis of the data and information available.
Danish: Lægemidlernes anvendelse er blevet begrænset til en indikation, som gentamicin anses for at være effektivt til på grundlag af de foreliggende data og oplysninger.
English: ATCvet code: QJ01GB03
Danish: ATCvet-kode: QJ01GB03
English: Enzymatic modification results in highlevel resistance.
Danish: Enzymatisk modifikation resulterer i høj resistens.
English: Lithuania LABORATORIOS SYVA, S.A. Av. Párroco Pablo Díez, 49-57 24010, León
Danish: Litauen LABORATORIOS SYVA, S.A. Av. Párroco Pablo Díez, 49-57 24010, León
English: 43206 Tarragona Spain
Danish: 43206 Tarragona Spanien
English: Close monitoring of horses being treated with gentamicin is strongly advised.
Danish: Tæt overvågning af heste i behandling med gentamicin anbefales kraftigt.
English: As such, gentamicin has a narrow margin of safety.
Danish: Gentamicin har som sådant en snæver sikkerhedsmargin.
English: Dosing regimen
Danish: Doseringsregime
English: All other dosing regimens appear to be approved based on expert reports, scientific publications and PK/PD characteristics.
Danish: Alle andre doseringsregimer synes at være godkendt på grundlag af ekspertrapporter, videnskabelige publikationer og farmakokinetiske/farmakodynamiske egenskaber.
English: The safety in pregnant horses is unknown.
Danish: Sikkerheden hos drægtige heste er ukendt.
English: This leads to incorrect amino acid sequencing and nonsense proteins.
Danish: Dette fører til ukorrekt aminosyresekvens og nonsensproteiner.
English: Thus, the use of these products may present a serious risk to animal health in terms of lack of efficacy, as well as target animal safety.
Danish: Anvendelsen af disse lægemidler kan derfor udgøre en alvorlig risiko for dyrs sundhed i form af manglende virkning og for måldyreartens sikkerhed.
English: Do not use in known cases of renal dysfunction.
Danish: Må ikke anvendes ved kendt renal dysfunktion.
English: Most of the injectable products for horses containing gentamicin were initially approved in the 1980s and 1990s, and (compared to current requirements) only very limited data are available to support indications or dosing regimens in horses.
Danish: De fleste injektionspræparater indeholdende gentamicin til heste blev oprindelig godkendt i 1980'erne og 1990'erne, og der foreligger kun meget begrænset dokumentation (i forhold til de nuværende krav) for indikationer eller doseringsregimer for heste.
English: Latvia Huvepharma AD 33 James Boucher Blvd. Sofia 1407
Danish: Letland Huvepharma AD 33 James Boucher Blvd. Sofia 1407
English: Ozzano Emilia (Bologna) Italy
Danish: Ozzano Emilia (Bologna) Italien
English: Austria Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien
Danish: Østrig Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien
English: To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under- or over-dosing.
Danish: For at sikre korrekt dosis bør kropsvægten bestemmes så nøjagtigt som muligt, således at under- eller overdosering undgås.
English: Spain B.BRAUN VETCARE, S.A. Crta.
Danish: Spanien B.BRAUN VETCARE, S.A. Crta.
English: The CVMP Antimicrobials Working Party (AWP) and Efficacy Working Party (EWP) were consulted on several aspects of a safe dosing regimen of gentamicin in horses.
Danish: CVMP's arbejdsgruppe vedrørende antibiotika (AWP) og arbejdsgruppe vedrørende virkning (EWP) blev konsulteret om flere aspekter vedrørende et sikkert doseringsregime for gentamicin hos heste.
English: Spain POLICHEM S.L.U.
Danish: Spanien POLICHEM S.L.U.
English: With relation to the already approved target species horses, the wording below should be used:
Danish: Vedrørende den godkendte måldyreart heste bør nedenstående ordlyd anvendes:
English: • on the basis of the available data, the CVMP considered that all other indications and dosage regimens in horses should be deleted from the product information;
Danish: • CVMP fandt ud fra de foreliggende data, at alle andre indikationer og doseringsregimer for heste bør slettes fra produktinformationen.
English: The substance is highly polar, hydrophilic and transport appears to be an active process closely linked to electron transport, oxidative phosphorylation and the respiratory quinones in the cell membrane.
Danish: Stoffet er stærkt polært og hydrofilt og synes at transporteres ved en aktiv proces, som er tæt koblet til elektrontransport, oxidativ fosforylering og de respiratoriske quinoner i cellemembranen.
English: Studies on the margin of safety of the currently approved dosing regimens were neither submitted by the MAHs nor could be identified in the scientific literature.
Danish: Undersøgelser af sikkerhedsmarginen af de nuværende godkendte doseringsregimer blev ikke forelagt af markedsføringstilladelsesindehaverne og kunne heller ikke findes i den videnskabelige litteratur.
English: Therefore, on 14 February 2014, Denmark presented to the European Medicines Agency (‘the Agency') a referral notification under Article 35 of Directive 2001/82/EC, for all veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Danish: Den 14. februar 2014 anmeldte Danmark derfor i medfør af artikel 35 i direktiv 2001/82/EF en indbringelse til Det Europæiske Lægemiddelagentur (“agenturet”) for alle veterinærlægemidler indeholdende gentamicin leveret som injektionsvæske, opløsning, til anvendelse hos heste.
English: Thus only the scientific questions posed to the CVMP in the referral notification have been considered and are reported below.
Danish: Derfor er der kun taget stilling til de videnskabelige spørgsmål, der stilles til CVMP i anmeldelsen af indbringelsen, og som der redegøres for i det følgende.
English: The approved dosing regimens vary widely, ranging between doses of 2-10 mg/kg bw at intervals of 8-24 hours over 3-5 days.
Danish: De godkendte doseringsregimer er vidt forskellige og spænder over doser på 2-10 mg/kg kropsvægt med intervaller på 8-24 timer i 3-5 dage.
English: Spain Industrial Veterinaria, S.A. Esmeralda, 19
Danish: Spanien Industrial Veterinaria, S.A. Esmeralda, 19
English: There are three types of aminoglycoside modifying enzymes:
Danish: Der er tre typer aminoglykosidmodificerende enzymer:
English: The genes encoding for aminoglycoside modifying enzymes are usually found on plasmids and transposons.
Danish: De gener, der koder for aminoglykosidmodificerende enzymer, findes sædvanligvis på plasmider og transposoner.
English: Latvia CP - Pharma Handelsges.
Danish: Letland CP - Pharma Handelsges.
English: Spain LABIANA LIFE SCIENCE, S.A. C/ Venus, 26
Danish: Spanien LABIANA LIFE SCIENCE, S.A. C/ Venus, 26
English: The CVMP considered that this dose was supported by clinical experiences, taking into account that a single daily administration would reduce the risk of nephrotoxicity in adult horses (compared to more frequent daily administrations) and also the risk of the theoretical concept of adaptive resistance.
Danish: CVMP fandt, at denne dosering var underbygget af kliniske erfaringer, når det tages i betragtning, at en enkelt daglig administration vil nedsætte risikoen for nefrotoksicitet hos voksne heste (i forhold til flere doser dagligt) og desuden mindske den teoretiske risiko for adaptiv resistens.
English: The dosing regimen must not be exceeded.
Danish: Doseringsregimet må ikke overskrides.
English: As only very limited data are available to support all the current indications in horses the CVMP focused in their review mainly on the assessment of current scientific literature and minimum inhibitory concentration (MIC) data.
Danish: Da der kun foreligger meget begrænsede data til støtte for alle de nuværende indikationer hos heste, var CVMP's gennemgang hovedsagelig rettet mod vurdering af oplysninger fra den nuværende videnskabelige litteratur og MIC-data (mindste hæmmende koncentration).
English: In order to reduce the nephrotoxic risk, adequate hydration of animals under treatment should be ensured, and fluid therapy should be instituted, if required.
Danish: For at mindske risikoen for nefrotoksicitet bør der sikres tilstrækkelig hydrering af dyrene under behandlingen, og om nødvendigt bør væsketerapi institueres.
English: An application for the product Genta Equine 10% solution for injection for horses, containing gentamicin as the active substance was submitted to Denmark as a concerned Member State in a mutual recognition procedure (MRP) under the legal basis of Article 13(1) of Directive 2001/82/EC, i.e. a generic application.
Danish: En ansøgning for lægemidlet Genta Equine, injektionsvæske, 10 %, til heste, der indeholder gentamicin som det aktive stof, blev indgivet til Danmark som berørt medlemsstat ved den gensidige anerkendelsesprocedure i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, dvs. en generisk ansøgning.
English: Spain SUPER´S DIANA, S.L Ctra.
Danish: Spanien SUPER´S DIANA, S.L Ctra.
English: There are several mechanisms by which various strains of bacteria have developed resistance against aminoglycosides like gentamicin.
Danish: Der er flere mekanismer, ved hvilke forskellige bakteriestammer har udviklet resistens mod aminoglykosider som gentamicin.
English: Warning sentences and advice for safe use have been included in the product information, which reflect the lack of target animal safety data in horses and foals.
Danish: I produktinformationen er indsat advarsler og anvisninger for sikker brug, som afspejler de manglende data om sikkerheden hos måldyrene heste og føl.
English: It was understood that the indications would not be unique to these two products and other injectable veterinary medicinal products containing gentamicin for use in horses authorised in the EU have approved different doses, and the concers and considerations would apply equally to these.
Danish: Det blev nævnt, at indikationerne ikke kun gjaldt for disse to lægemidler, og at andre veterinærmedicinske injektionspræparater indeholdende gentamicin til heste er godkendt i EU med andre doseringer, og at betænkelighederne og overvejelserne ligeledes gælder for dem.
English: Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke anvendes ved kendt overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne.
English: Gentamicin is used for first or second choice treatments in a variety of clinical situations in horses.
Danish: Vurdering af fordele gentamicin anvendes som første- eller andetvalgsbehandling ved en række kliniske situationer hos heste.
English: However, studies in laboratory animals have shown evidence of fetal nephrotoxicity.
Danish: Undersøgelser hos laboratoriedyr har imidlertid vist føtal nefrotoksicitet.
English: Furthermore, higher approved doses (e.g. Genta Equine 10% solution for injection) may pose a threat to target animal safety due to the known nephrotoxicity of gentamicin.
Danish: Desuden kan højere godkendte doser (f.eks. Genta Equine, injektionsvæske, opløsning, 10 %) være en trussel mod sikkerheden for måldyrearten pga. den kendte nefrotoksicitet af gentamicin.
English: Pharmacotherapeutic group: Antibacterials for systemic use, gentamicin.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, gentamicin.
English: Spain LABORATORIOS SYVA, S.A.U.
Danish: Spanien LABORATORIOS SYVA, S.A.U.
English: Whenever possible, use of the product should be based on susceptibility testing of the bacteria isolated from the animal.
Danish: Når det er muligt, bør lægemidlets anvendelse baseres på følsomhedsbestemmelse af bakterier isoleret fra dyret.
English: Belgium EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium
Danish: Belgien EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgien
English: No margin of safety has been established under the approved dosing regimen.
Danish: Der er ikke fastlagt en sikkerhedsmargin ved det godkendte doseringsregime.
English: In addition, gentamicin is known to be one of the most nephrotoxic aminoglycosides, with a very narrow margin of safety, which is of particular concern in young aninmals, i.e. foals.
Danish: Desuden vides gentamicin at være et af de mest nefrotoksiske aminoglykosider og har en meget snæver sikkerhedsmargin, hvilket medfører særlig betænkelighed vedrørende unge dyr, dvs. føl.
English: However, foals, especially neonates, were recognised as significantly different from adult horses with regard to both an effective dosing regimen and target animal safety.
Danish: Det blev imidlertid taget i betragtning, at føl, navnlig nyfødte, adskiller sig væsentligt fra voksne heste, både hvad angår et effektivt doseringsregime og sikkerheden for måldyret.
English: The CVMP recommended a dosing regimen for adult horses of 6.6 mg/kg once daily for 3-5 days, accompanied by strong warnings in the product literature about the lack of target animal safety data.
Danish: CVMP anbefalede et doseringsregime for voksne heste på 6,6 mg/kg kropsvægt én gang dagligt i 3-5 dage, ledsaget af stærke advarsler i produktoplysningerne om de manglende data om sikkerheden hos måldyrearten.
English: Two other mechanisms of resistance include ribosomal mutations of the binding site of aminoglycosides, the 30S subunit, and the bacteria decreasing the permeability of aminoglycosides.
Danish: To andre resistensmekanismer omfatter ribosomale mutationer på aminoglykosidernes bindingssted, 30S-subunit'en, og nedsat permeabilitet af bakterierne for aminoglykosider.
English: Only very limited data are available to support the range of indications and dose regimens and the CVMP was asked to review the data available and to recommend scientifcally justified indications and a safe and efficacious dosing regimen in horses.
Danish: Der foreligger kun meget begrænsede data til dokumentation af de forskellige indikationer, og CVMP blev anmodet om at gennemgå de foreliggende data og anbefale videnskabeligt begrundede indikationer og et sikkert og effektivt doseringsregime til heste.
English: In addition, there are only limited choices available for the treatment of Gram-negative infections in horses, and clinical experience has shown that gentamicin is effective in adult horses at a single daily dose of 6.6 mg/kg bw (intravenously) over 3-5 days.
Danish: Desuden er der kun begrænsede behandlingsmuligheder til gramnegative infektioner hos heste, og de kliniske erfaringer har vist, at gentamicin er effektivt til voksne heste i en enkelt daglig dosis på 6,6 mg/kg kropsvægt (intravenøst) i 3-5 dage.
English: Safety of gentamicin has not been established in foals and there is a lack of knowledge of the extra effects of gentamicin on foal kidneys, especially neonates.
Danish: Sikkerheden af gentamicin er ikke fastlagt hos føl, og der savnes viden om de ekstra virkninger af gentamicin på nyrerne hos føl, navnlig hos nyfødte dyr.
English: Pharmacokinetics of gentamicin change considerably in the first 2 weeks of a foal's life - plasma concentrations of gentamicin are more difficult to achieve in neonatal foals and gentamicin is retained longer in the body, especially kidneys, compared to adults leading to a higher likelihood of gentamicin-induced nephrotoxicity.
Danish: Farmakokinetikken af gentamicin ændres betydeligt i de første to uger af føllets liv - plasmakoncentrationer af gentamicin nås vanskeligere hos nyfødte føl, og gentamicin persisterer længere i kroppen, navnlig i nyrerne, end hos voksne dyr, hvilket medfører større sandsynlighed for gentamicininduceret nefrotoksicitet.
English: Over-use of gentamicin products might result in an increased risk of the theoretical concept of adaptive resistance.
Danish: Overforbrug af lægemidler indeholdende gentamicin vil kunne medføre teoretisk øget risiko for adaptiv resistens.
English: • on the basis of the available data, the CVMP considered that the dosage regimen should be amended as described in Annex III;
Danish: • CVMP fandt på grundlag af de foreliggende data, at doseringsregimet bør rettes som beskrevet i bilag III.
English: During this MRP Denmark noted that the originator and the generic products have different indications and dosing regimens.
Danish: Under den gensidige anerkendelsesprocedure bemærkede Danmark, at originallægemidlet og det generiske lægemiddel ikke har samme indikationer og dosisregimer.
English: The relatively low approved dose and the target pathogens indicated for Gentaject 10% solution for injection gave grounds for Denmark to be concerned as to whether the proposed indications and dosage regimen for this product are supported by adequate data, given evidence from recent scientific publications.
Danish: Den relativt lave godkendte dosis og de målpatogener, der er indiceret for Gentaject, injektionsvæske, opløsning, 10 %, medførte i Danmark betænkelighed ved, om indikationer og dosisregime for det ansøgte lægemiddel underbygges af tilstrækkelige data på baggrund af evidens fra nyere videnskabelige publikationer.
English: The reference product is Gentaject 10% solution for injection for horses which has been authorised in Ireland since 1988 (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
Danish: Det har været godkendt i Irland siden 1988 (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
English: 4.7 Use during pregnancy, lactation or lay The safety in pregnant horses is unknown.
Danish: Anvendelse under drægtighed, laktation eller æglægning Sikkerheden hos drægtige heste er ukendt.
English: Spain FATRO IBERICA, S.L.
Danish: Spanien FATRO IBERICA, S.L.
English: A harmonised dosing regimen to be used in adult horses is proposed, that conforms to the desired PK/PD characteristics of a concentration-dependent antibiotic and reflects data available in horses.
Danish: Til voksne heste foreslås et harmoniseret doseringsregime, som svarer til de ønskede farmakokinetiske/farmakodynamiske egenskaber af et koncentrationsafhængigt antibiotikum og afspejler de foreliggende data hos heste.
English: Gentamicin sulphate is bactericidal in action by irreversibly binding to 30S ribosomal subunits, and acts through two different mechanisms.
Danish: Den baktericide virkning af gentamicinsulfat skyldes irreversibel binding til ribosomale 30S-subunits og virker ved to forskellige mekanismer.
English: It was questioned whether the product is effective for these indications and if the low approved doses may in turn increase resistance rates among equine bacteria towards gentamicin.
Danish: Det blev betvivlet, om lægemidlet er effektivt ved disse indikationer, og om de lave godkendte doser kan øge resistensraterne over for gentamicin hos ekvine bakterier.
English: Spain LABORATORIOS MAYMO, S.A.
Danish: Spanien LABORATORIOS MAYMO, S.A.
English: Therefore, the CVMP considers that no dosing regimen should be specified for foals, and currently approved dosing regimens for foals should be deleted from the product information, due to lack of target animal safety data especially concerning nephrotoxicity.
Danish: CVMP finder derfor, at der ikke bør angives et doseringsregime for føl, og at de nuværende godkendte doseringsregimer for føl bør slettes fra produktoplysningerne pga. manglende data om sikkerheden hos måldyrearten, navnlig vedrørende nefrotoksicitet.
English: The Committee considered that for any other indications for horses for injectable products contaning gentamicin, applicants/marketing authorisation holders (MAHs) would need to submit appropriate data, following up-to-date requirements.
Danish: Udvalget fandt, at alle andre indikationer til heste for injektionspræparater indeholdende gentamicin ville kræve, at ansøgere/markedsføringstilladelsesindehaveren forelægger tilstrækkelige data i henhold til nutidige krav.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af veterinærlægemidler indeholdende gentamicin leveret som injektionsvæske, opløsning, til anvendelse hos heste (se bilag I)
English: The CVMP notes that there is no MRL for gentamicin for horses.
Danish: CVMP konstaterer, at der ikke er nogen maksimalgrænseværdi for restkoncentrationer af gentamicin for heste.
English: Gentamicin does not penetrate intracellularly, or into abscesses.
Danish: Gentamicin trænger ikke ind i cellerne eller i abscesser.
English: Gentamicin is deactivated in the presence of inflammatory debris, low oxygen environments and low pH. Gentamicin is eliminated unchanged by the kidney via glomerular filtration, including 85-95% of the dose.
Danish: gentamicin deaktiveres ved tilstedeværelse af inflammatorisk debris, lav iltkoncentration og lavt pH. gentamicin udskilles uændret i nyrerne ved glomerulær filtration, hvilket gælder 85-95 % af dosis.
English: Currently injectable veterinary medicinal products containing gentamicin for use in horses are authorised in the EU for the treatment of a variety of indications, including broad ones such as infections of the respiratory tract, gastrointestinal, and genito-urinary tract, caused by various target pathogens.
Danish: Veterinære injektionspræparater indeholdende gentamicin til heste er aktuelt godkendt i EU til en række indikationer, herunder brede indikationer såsom infektioner af luftveje, mave-tarmsystemet og køns- og urinveje forårsaget af forskellige målpatogener.
English: Slovakia Fatro S.p.A.
Danish: Slovakiet Fatro S.p.A.
English: Gentamicin is well known to induce nephrotoxicity even at therapeutic doses.
Danish: Det er velkendt, at gentamicin inducerer nefrotoksicitet selv i terapeutiske doser.
English: Extra caution is advised if using gentamicin in old horses, or with fever, endotoxemia, sepsis and dehydration.
Danish: Særlig forsigtighed anbefales ved brug af gentamicin hos heste, der er gamle eller har feber, endotoksæmi, sepsis eller dehydrering.
English: Spain LABORATORIOS CALIER, S.A. C/ Barcelonés, 26
Danish: Spanien LABORATORIOS CALIER, S.A. C/ Barcelonés, 26
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to harmonise the indication(s) and dosing regimens of the concerned products, taking into account the available data and in particular with regard to target animal safety.
Danish: Udvalget for Veterinærlægemidler (CVMP) blev anmodet om at harmonisere indikationer og doseringsregimer for de omhandlede lægemidler under hensyntagen til de foreliggende data og navnlig under sikkerheden for måldyrearten.
English: As such, no margin of safety has been established in neonatal foals.
Danish: Som sådan er der ikke fastlagt en sikkerhedsmargin hos nyfødte føl.
English: In one mechanism, gentamicin can interfere with the correct amino acid polymerisation and elongation.
Danish: Ved den ene kan gentamicin interferere med aminosyrernes korrekte polymerisering og forlængelsen af kæden.