natgillin/translations-raw huggingface dataset:
I den nye MIC-undersøgelse af 25 isolater fra Belgien fandtes et MIC-område for lincomycin-spectinomycin på 32:64 µg/ml svarende til forholdet 1:2 med en MIC50 på 16:32 og en MIC90 på 32:64 µg/ml.
In the new MIC survey using 25 isolates from Belgium, a lincomycinspectinomycin MIC range of 1:2 to 32:64 µg/ml was obtained, with a MIC50 of 16:32 and a MIC90 of 32:64 µg/ml.
Skønt de sparsomme foreliggende data tyder på, at de aktive stoffers in vitro-aktivitet mod L. intracellularis er ringe, kan det hævdes, at den kliniske situation ikke hænger direkte sammen med produktets kliniske virkning, når det tages i betragtning, at produktet er almindelig anvendt i EU, og at der ikke er indberetninger om manglende virkning i lægemiddelovervågningen.
Although the scarce data available indicates that in vitro activity of the active substances against L. intracellularis is poor, considering the well-established use of the product in the EU and that the pharmacovigilance reports do not show any reports for lack of efficacy, it can be argued that the clinical situation is not directly correlated with the clinical efficacy of the product.
Ved E. coli udviser en signifikant del af stammerne høje MIC-værdier (minimale inhibitoriske koncentrationer) over for lincomycin-spectinomycin-kombinationen og kan være klinisk resistente, selvom der ikke er defineret breakpoints.
In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincospectin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
• Hvis produktets anvendelse til kyllinger trækkes tilbage, kan dette tænkes at ville føre til en skadelig overgang til brug af andre molekyler (f.eks. fluorquinoloner), der tillægges større betydning for den offentlige sundhed.
* A detrimental shift to the use of other molecules considered as more important to public health (e.g. fluoroquinolones) might occur in case the product is withdrawn in chickens.
Lincomycin er et lincosamidantibiotikum, fremstillet af Streptomyces lincolnensis, som hæmmer proteinsyntesen.
Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Tilbageholdelsestiden bygger på en undersøgelse, hvor kyllinger blev behandlet med 500 mg/kg kropsvægt i den første leveuge og med 60 mg/kg i den tredje leveuge.
The withdrawal time is supported by a study where chickens were treated at 500 mg/kg bw during their first week of life and at 60 mg/kg during their third week of life; depletion follow-up was conducted only after the second phase.
De farmakokinetiske egenskaber af spectinomycin viser, at der kun optages ubetydelige mængder fra tarmen, og at blodkoncentrationen efter oral administration under alle omstændigheder ikke når op på MIC i kyllingernes luftveje.
It is known from the pharmacokinetic properties of spectinomycin that only negligible amounts are absorbed from the gut and that in any case, blood levels do not reach MIC concentrations within the respiratory tract of chickens after oral administration; in addition, spectinomycin is polar and does not readily cross membranes and distribute into the intracellular compartment.
I denne undersøgelse var MIC-området fra 4:8 µg/ml op til ≥256:512 med høje MIC90-værdier på >256 µg/ml for spectinomycin og en tilsyneladende bimodal fordeling, hvilket tyder på en betydelig andel med høj resistens, skønt der ikke er fastlagt en klinisk tærskelværdi.
In this study the MIC range was from 4:8 µg/ml up to ≥256:512, with high MIC90 values of >256 µg/ml for spectinomycin, and a seemingly bimodal distribution.
Opløseligt pulver er en formulering til administration i drikkevand.
Soluble Powder is formulated for administration via drinking water.
<Lægemidlets særnavn > 222 mg/g + 444,7 mg/g pulver til anvendelse i drikkevand Lincomycin (som lincomycinhydrochlorid)/ spectinomycin (som spectinomycinsulfat)
NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water lincomycin (as lincomycin hydrochloride)/spectinomycin (as spectinomycin sulphate).
B. hyodysenteriae kan hurtig udvikle resistens over for lincomycin og de fleste isolater, der er undersøgt, viser nedsat følsomhed in vitro.
Resistance to lincomycin can readily develop in B. hyodysenteriae and most of the isolates studied show decreased susceptibility in vitro.
Farmakoterapeutisk gruppe: antibakterica til systemtisk brug, lincomycin, kombinationer ATCvet-kode: QJ01FF52
Pharmacotherapeutic group: antibacterials for systemic use, lincomycin combinations.
afskæringspunkt, og de forelagte data viser ikke, at in vitro-følsomheden er korreleret med den kliniske virkning.
However, no precise clinical breakpoint has been established and from the data provided it seems that in vitro susceptibility was not correlated to clinical efficacy.
Slagtning: 5 dage.
Meat and offal: 5 days.
Opbevares tørt.
Store in a dry place.
Anvendelse af veterinærlægemidlet, der afviger fra instruktionerne i produktresuméet, kan forøge risikoen for udvikling af resistente bakterier over for lincomycin og spectinomycin og kan nedsætte den effektive virkning af behandling med andre antibiotika af samme eller lignende typer på grund af risikoen for krydsresistens.
Use of the product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to lincomycin and spectinomycin and may decrease the effectiveness of treatment with other antimicrobials of the same or related classes, due to the potential for cross resistance.
INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt.
MARKETING AUTHORISATION HOLDER To be completed nationally.
LÆGEMIDDELFORM Pulver til anvendelse i drikkevand.
PHARMACEUTICAL FORM Powder for use in drinking water.
Kyllinger:
Chickens:
Desuden bør der i punkt 5.1 Farmakodynamiske egenskaber indsættes oplysninger om udbredt nedsat følsomhed af B. hyodysenteriae og om den bimodale fordeling hos E. coli.
Also, information as to widespread decreased susceptibility in B. hyodysenteriae and as to the bimodal distribution in E. coli should be added to section 5.1.
Dette pulver er til anvendelse i drikkevand og skal opløses i vand.
This powder is for use in drinking water and must be dissolved in water and cannot be used as such.
Spectinomycin har en lav tendens til proteinbinding og har en ringe fedtopløselighed.
Spectinomycin exhibits little tendency to protein binding and is poorly liposoluble.
På grund af tekniske begrænsninger er det vanskeligt at teste følsomheden af Lawsonia intracellularis in vitro og der er ingen data for status af resistens hos disse arter.
Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro, and data about the resistance status in that species are lacking.
Fjerkræ: Til dosering i drikkevand.
Poultry: For dosing via the drinking water.
Skønt der ikke ses nogen negativ tendens i de forelagte litteraturdata, kan det derfor ikke udelukkes, at resultaterne fra de ældre kliniske undersøgelser, der blev udført under produktets udvikling, ikke afspejler den kliniske virkning ved nutidige udbrud af svinedysenteri.
Therefore, even though no evolution over time appears from the provided literature data, it cannot be excluded that the results obtained in the old clinical studies conducted at the time of product development do not reflect clinical efficacy in modern outbreaks of swine dysentery.
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) Udfyldes nationalt.
MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
Svin og fjerkræ (bortset fra læggehøns)
Pigs and poultry (nonlayers)
Lincomycin og spectinomycin blev påvist at være mere effektive i kombination end som monoterapi.
Lincomycin and spectinomycin were shown to be more effective than each individual substance.
I enkelte produktresuméer anbefales 150 mg/kg kropsvægt, og i visse andre angives kun en koncentration i vandet tilnærmelsesvis svarende til 50 mg/kg kropsvægt.
The most frequent dosing recommendation for treatment is 50 mg/kg bw/day; few SPCs recommend 150 mg/kg bw and some other ones give only a concentration in water, which corresponds approximately to 50 mg/kg bw.
MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) Udfyldes nationalt
MARKETING AUTHORISATION NUMBER(S) To be completed nationally
Trods ringe absorption er virkningsmekanismen af peroralt administreret spectinomycin over for patogene bakterier på systemisk niveau ikke fuldstændig klarlagt og kan muligvis delvist skyldes virkning på tarmfloraen eller virkning på metabolit(ter).
The mechanism by which spectinomycin administered orally acts on pathogens at the systemic level despite a poor absorption is not fully elucidated, and might rely partly on indirect effects on the gut flora, or on effects of metabolite(s).
Svin Kyllinger
Pigs Poultry
DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Udfyldes nationalt.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
Fjerkræ (slagtekyllin ger, unghøner og kalkuner)
Poultry (broilers, pullets and turkeys)
Denne undersøgelse var den eneste formelle påvisning af fordelene ved doseringen på 50 mg/kg kropsvægt, og den opnåede belastning var kun let til moderat uden observeret dødelighed.
This study was the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Svin: Slagtning: 0 dage.
Pigs: Meat and offal: Zero days.
• CVMP gennemgik det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren af markedsføringstilladelsen, og tog alle de forelagte data i betragtning, anbefalede CHMP ændring af de markedsføringstilladelser for Linco-Spectin 100 og relaterede navne, som er angivet i bilag I. Produktresumé, etikettering og indlægsseddel for disse fremgår af bilag III.
the CVMP has recommended the amendment of the marketing authorisations for Linco-Spectin 100 and its associated names as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
Bortskaffelse: se indlægssedlen
Disposal: read package leaflet.
Skønt de foreliggende data ikke viser tendens til negativ udvikling, kan det af disse grunde ikke udelukkes, at resultaterne af de ældre kliniske undersøgelser fra produktets udvikling ikke afspejler den kliniske virkning under et nutidigt udbrud af svinedysenteri.
For those reasons, despite that the available data show no negative evolution over time, it could not be excluded that the results obtained in the old clinical studies conducted at the time of product development do not reflect clinical efficacy in modern outbreaks of swine dysentery.
Denne undersøgelse er den eneste formelle påvisning af fordelen ved doseringen på 50 mg/kg kropsvægt, og den opnåede belastning var kun let til moderat, og uden observeret dødelighed.
This study is the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Til behandling og forebyggelse af dysenteri forårsaget af Brachyspira hyodysenteria og til behandling og forebyggelse af porcin proliferativ enteropati (ileitis) forårsaget af Lawsonia intracellularis samt associerede enteropatogener (Escherichia coli).
For the treatment and prevention of dysentery caused by Brachyspira hyodysenteria and for the treatment and prevention of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli).
Pulver til oral anvendelse i drikkevand
Oral powder for use in drinking water
Gentagne doser til svin med daglige orale doser på 22 mg lincomycin/kg legemsvægt i 3 dage indikerede ingen lincomycinakkumulation hos arterne.
Repeated dosing of pigs with daily oral doses of 22 mg lincomycin/kg body weight for 3 days indicated no accumulation of lincomycin in the species, with no detectable serum levels of antibiotic after 24 hours post administration.
Flasker med 150 g eller 1,5 kg og et kar med 4,5 kg
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg and tub containing 4.5 kg
I ældre feltundersøgelser anvendtes typisk et dosisregime på 150 mg/kg kropsvægt i første fase, efterfulgt af 50 mg/kg kropsvægt i anden fase.
Older field studies typically used a dose regimen of 150 mg/kg bw in a first phase followed by 50 mg/kg bw in a second phase; they were considered poorly relevant as they focus on systematic prophylaxis and zootechnical/economical endpoints.
På grund af tekniske begrænsninger er det vanskeligt at teste følsomheden af L. intracellularis in vitro og der er ingen data for status af lincomycin-spectinomycin-resistens hos disse arter.
Due to technical constraints the susceptibility of L. intracellularis is difficult to test in vitro, and data about the lincomycin-spectinomycin resistance status in that species are lacking.
Slagtning: 0 dage.
Meat and offal: Zero days.
Lincomycin (som lincomycinhydrochlorid)
Lincomycin (as lincomycin hydrochloride)
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgien
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium
DYREARTER Svin og kyllinger
TARGET SPECIES Pigs and chickens
Deres virkning afhænger af organismens følsomhed og koncentrationen af antibiotikummet.
While the lincosamides are generally considered to be bacteriostatic agents, the activity is depending on the sensitivity of the organism and concentration of the antibiotic.
LÆGEMIDDELFORM Pulver til anvendelse i drikkevand
PHARMACEUTICAL FORM Powder for use in drinking water
Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgien
Slovenia Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Farmakokinetiske egenskaber
Pharmacokinetic particulars
Må ikke anvendes til æglæggende fugle.
Do not use in birds in lay.
Den ansøgte indikation til L. intracellularis hos svin kunne godtages i betragtning af området for denne artikel 34-indbringelsesprocedure.
Taking into account the scope of this Article 34 referral procedure, the proposed indication for L. intracellularis in pigs was deemed acceptable.
VETERINÆRLÆGEMIDLETS NAVN <Lægemidlets særnavn > 222 mg/g + 444,7 mg/g pulver til anvendelse i drikkevand til svin og kyllinger
NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
Zoetis Deutschland GmbH Schellingstraße 1, D-10785 Berlin Tyskland
Germany Zoetis Deutschland GmbH Schellingstraße 1,
Til behandling og forebyggelse af kronisk respiratorisk sygdom (CRD) forårsaget af Mycoplasma gallisepticum og Escherichia coli og forbundet med lav dødelighed.
For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
Benefit/risk-vurdering
Benefit-Risk assessment
CVMP kunne godtage den ansøgte tilbageholdelsestid på 0 dage, der var velunderbygget med en restkoncentrationsundersøgelse, hvor svin blev behandlet med det ansøgte harmoniserede dosisregime 10 mg/kg kropsvægt/dag i 7 dage.
The proposed withdrawal time of 0 days was well supported by a residue study where pigs were treated using the proposed harmonised dosing regimen 10 mg/kg bw/day for 7 days, and is considered acceptable by the CVMP.
I en ny GCP-belastningsundersøgelse blev produktet anvendt i en dosering på 50 mg/kg/dag i 7 dage og var effektivt til at reducere kliniske tegn, forandringer og bakteriologisk reisolation ved eksperimentel infektion med E. coli og/eller M. gallisepticum hos kyllinger.
In a newly provided GCP challenge study the product used at 50 mg/kg bw/day for 7 days was shown to be effective in reducing clinical signs, lesions and bacteriological re-isolation associated to E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high, with a non-statistically significant reduction for E. coli, and the MIC of the infective strains was low when compared to most field strains.
Fjerkræhøner, kyllinger og kalkuner
Poultryhens, chickens and turkeys
INDLÆGSSEDDEL TIL: <Lægemidlets særnavn > 222 mg/g + 444,7 mg/g pulver til anvendelse i drikkevand til svin og kyllinger
PACKAGE LEAFLET FOR: <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
Det skal klarlægges, om sygdommen er til stede i besætningen, inden lægemidlet anvendes.
The presence of the disease in the flock must be established before the product is used.
Svin Kyllinger Kalkuner Ænder Duer
Chickens Turkeys Duck Pigeon
1.500 l drikkevand
1,500 L of drinking water
2.500 l drikkevand
2,500 L of drinking water
Opløseligt pulver Svin Fjerkræ (bortset fra læggehøns)
Soluble Powder Pigs Poultry (nonlayers)
6.4 Særlige opbevaringsforhold
SPECIAL STORAGE PRECAUTIONS
For kyllinger foreslås indikationen ændret som følger for at afspejle, at der kun var tale om let til moderat belastning uden dødelighed i den eneste undersøgelse, der formelt påviser virkning af 50 mg/kg dosen mod de kliniske tegn og forandringer ved kronisk luftvejsinfektion:
In chickens, in order to reflect the fact that in the only study formally demonstrating efficacy of the 50 mg/kg dose against CRD clinical signs and lesions, the challenge was mild to moderate with no mortality recorded, it is proposed to amend the indication as follows:
Pulver til oral opløsning.
Powder for oral solution.
Anvend følgende beregning til bestemmelse af fortyndingsvolumenet (i liter af drikkevand) til 150 g veterinærlægemiddel:
To determine the volume of dilution (in litres of drinking water) for 150 g of the veterinary medicinal product, use the following formula:
“Behandling og forebyggelse af kronisk luftvejssygdom forårsaget af Mycoplasma gallisepticum og Escherichia coli forbundet med lav dødelighed.
“For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
Opløseligt pulver Svin Kyllinger
Soluble powder Pigs Chickens
Kyllinger (slagtekyllin ger)
Poultry (broilers)
2.000 l drikkevand
2,000 L of drinking water
Anvend følgende beregning til bestemmelse af påkrævet fortyndingsvolumen (i liter af drikkevand) til 150 g veterinærlægemiddel:
To determine the volume of dilution (in litres of drinking water) required for 150 g of the veterinary medicinal product, use the following formula:
Doseringsregimerne i disse undersøgelser kan dog kun anslås skønsmæssigt og spænder antagelig fra den harmoniserede dosis på 50 mg/kg kropsvægt/dag til mindst den højeste godkendte dosis på 150 mg/kg kropsvægt/dag.
Although the mechanism of action at the systemic level of spectinomycin administered orally is not elucidated, its clinical benefit and the benefit of the combination seems to be demonstrated in several older laboratory challenge studies; however, the dosing regimens applied in these studies can only be estimated and likely range from the harmonised dose of 50 mg/kg bw/day to at least the highest approved dose of 150 mg/kg bw/day.
hyodysenteriae over for lincomycin, skønt der ikke findes nogen klinisk tærskelværdi, og det ikke vides, i hvilket omfang bakteriestammer med forhøjet MIC-værdi er klinisk resistente.
* All modern authors appear to agree that there is widespread resistance of B. hyodysenteriae to lincomycin, although there is no clinical breakpoint available and it is not known to which extent strains with increased MICs are clinically resistant;
Spectinomycin er klassificeret som et aminocyclitol-antibiotikum nært beslægtet med aminoglykosider.
Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides; it inhibits protein synthesis by binding to the 30S ribosomal subunit.
1.000 l drikkevand
1,000 L of drinking water
Fjerkræ, bortset fra æg, der er bestemt til menneskefø de
Poultry, not eggs for human consumptio n oral
Æglægning:
Lay:
DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For use in drinking water.
Vandindtagelse
Water consumption
I en nyligt forelagt GCPoverensstemmende belastningsundersøgelse blev produktet anvendt i en dosering på 50 mg/kg/dag i 7 dage og var effektivt til at reducere kliniske tegn og forandringer ved eksperimentel infektion med E. coli og/eller M. gallisepticum hos kyllinger.
In a newly provided GCP-compliant challenge study the product used at 50 mg/kg/day for 7 days was shown to be effective in reducing clinical signs and lesions associated with E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high - and its reduction was non statistically significant for E. coli - and the MIC values of the infective strains were at the very lower end of the range determined in the MIC surveys.
0,1 l/kg legemsvægt/dag
0.1 L/kg bw/day
Dette fandtes dog ikke at være grundlag for at slette indikationen i forbindelse med denne artikel 34-indbringelsesprocedure, der har til formål at harmonisere betingelserne for markedsføringstilladelsen for et i forvejen godkendt produkt.
The possible impact on clinical efficacy of the high in vitro resistance rate evidenced in B. hyodysenteriae was not assessed in recent clinical studies; however, in the context of this Article 34 referral procedure, aiming at harmonising the conditions of authorisation of an already approved product, it was considered that the indication should not be removed on that basis.
Spectinomycin er et aminocyclitolantibiotikum, fremstillet af Streptomyces spectabilis.
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
CVMP godtog 50 mg/kg kropsvægt i 7 dage som den harmoniserede dosis til kyllinger efter at have foretaget en samlet vurdering i forbindelse med harmonisering for et allerede godkendt produkt og af følgende grunde:
After an overall assessment in the context of the harmonisation of an already approved product, and for the reasons listed below, the CVMP considered that 50 mg/kg bw for 7 days can be accepted as the harmonised dose in chickens:
Pulver til opløsning i drikkevand
Powder for solution in drinking water
Den kliniske virkning ved svinedysenteri ved et doseringsregime tæt på det anbefalede harmoniserede regime på 10 mg/kg kropsvægt i 7 dage underbygges af ældre laboratorieundersøgelser og kliniske feltundersøgelser.
Clinical efficacy in swine dysentery at a dosing regimen close to the recommended harmonised regimen of 10 mg/kg bw for 7 days is supported by older laboratory and field clinical studies, despite the fact that these are not GLP or GCP-compliant and that the clinical and bacteriological criteria for inclusion are not always precisely defined in the study reports.
Pulver til oral opløsning
Powder for oral solution
0,2 l/kg legemsvægt/dag
0.2 L/kg bw/day
Lincomycin er et antibiotikum i lincosamidgruppen og er nært beslægtet med antibiotika af typen makrolider og streptogramin B. Det hæmmer proteinsyntesen ved at bindes til den bakterielle 50S ribosom-subunit.
Lincomycin is a lincosamide antibiotic, closely related to macrolide and streptogramin B antimicrobials.
I de ældre feltundersøgelse, der blev udført i forbindelse med systemisk profylakse, anvendtes tofasede doseringsregimer.
The older field studies were conducted in a context of systematic prophylaxis and used two-phase dosing regimens; the conditions of those studies do not provide support for the proposed 50 mg/kg bw dose.
0,25 l/kg legemsvægt/dag
0.25 L/kg bw/day
0,15 l/kg legemsvægt/dag
0.15 L/kg bw/day
synes at være bimodal med et signifikant antal stammer med høje værdier.
the MIC distribution appears to be bimodal, with a significant number of strains showing high values; this could partly correspond to natural (intrinsic) resistance.
Lysegul til lysebrunt opløseligt pulver
Pale yellow to light tan soluble powder
EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING Opbevares utilgængeligt for børn
Special precautions for storage
Kyllinger (slagtekyllin ger, unghøner) Kalkuner
Pigs Chicken (broiler, pullet) Turkey