FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the recommended harmonised indications in pigs.
Danish: Ved lægemiddelovervågning har der ikke været indberetninger om manglende virkning af LincoSpectin 100 til de anbefalede harmoniserede indikationer hos svin.
English: Therefore it was considered by the CVMP that the indication in chickens should be maintained, however it should be adapted as follows: “For the treatment and prevention of CRD caused by Mycoplasma gallisepticum and E. coli, associated with a low mortality rate.
Danish: CVMP fandt derfor, at indikationen til kyllinger bør opretholdes, men tilpasses på følgende måde: “Behandling og forebyggelse af kronisk luftvejssygdom, der er forårsaget af Mycoplasma gallisepticum og E. coli og er forbundet med lav dødelighed.
English: In support of the indication for proliferative enteropathy caused by Lawsonia intracellularis, a literature review on in vitro susceptibility data was provided, as well as two older clinical efficacy studies.
Danish: For indikationen proliferativ enteropati forårsaget af Lawsonia intracellularis blev der fremlagt en litteraturgennemgang af in vitro-følsomhedsdata samt to ældre undersøgelser af klinisk virkning.
English: Romania Pfizer Animal Health MA EEIG
Danish: Rumænien Pfizer Animal Health MA EEIG
English: Additionally, the long-term use of the product and the absence of reported lack of efficacy in the pharmacovigilance data have been noted.
Danish: Desuden bemærkes det, at produktet har været anvendt i lang tid, og at lægemiddelovervågningsdataene ikke indeholder indberetninger om manglende virkning.
English: Pigs: LincoSpectin 100
Danish: Svin: LincoSpectin 100
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: In chickens treated at several times the recommended dose, enlargement of the caecum and abnormal caecum content was observed.
Danish: Hos kyllinger, der blev behandlet med en dosis flere gange højere end den anbefalede dosis, kunne der observeres udvidelse af coecum og unormalt indhold i coecum.
English: Laboratory studies in dogs and rats have not produced any evidence of reproductive, foetotoxic or teratogenic effects for lincomycin or spectinomycin.
Danish: Laboratorieundersøgelser af hunde og rotter har ikke afsløret reproduktionstoksicitet, føtal toksicitet eller teratognene virkninger med lincomycin eller spectinomycin.
English: As spectinomycin is poorly absorbed by the gastro-intestinal tract and does not readily cross membranes, its efficacy might relate at least partly to non-specific effects on the gut flora or to the effects of a metabolite.
Danish: Da spectinomycin absorberes dårligt fra mave-tarmkanalen og ikke let passerer igennem membraner, kan dets virkning tænkes i det mindste delvis at hænge sammen med ikke-specifikke effekter på tarmfloraen eller effekterne af en metabolit.
English: In several other SPCs, the dose is expressed as a drinking water concentration which amounts to about 50 mg/kg bw in a significant part of the animals;
Danish: I flere andre produktresuméer angives dosis som en koncentration i drikkevandet, der for en betydelig del af dyrene svarer til omkring 50 mg/kg kropsvægt.
English: Resistance to lincomycin is frequently conferred by plasmid-borne factors (erm genes) coding for methylases modifying the ribosomal binding site and frequently leading to cross-resistance to other antimicrobials of the MLSb group.
Danish: Resistens over for lincomycin forekommer ofte som følge af plasmidbårne faktorer (erm-gener), der koder for methylaser som modificerer det ribosomale bindingssted og hyppigt forårsager krydsresistens over for andre antibiotika i MLSb-gruppen.
English: The combination was superior to lincomycin alone.
Danish: Kombinationen var overlegen i forhold til lincomycin alene.
English: Lincomycin binds to the 50S sub-unit of the bacterial ribosome close to the peptidyl transfer centre and interferes with the peptide chain elongation process by inhibiting the formation of the 50S sub-unit and by stimulating ribosomal peptidyl-tRNA dissociation.
Danish: Lincomycin bindes til bakterielle ribosomers 50S subenhed tæt ved peptidyloverførselscentret og interfererer med peptidkædens forlængelsesproces ved hæmning af dannelsen af 50S subenheden og ved stimulering af ribosomal peptidyl-tRNA-dissociation.
English: This could be due to combined intra- and extracellular action of lincomycin and spectinomycin, respectively.
Danish: Dette kan skyldes kombineret intra- og ekstracellulær virkning af henholdsvis lincomycin og spectinomycin.
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the proposed harmonised indication in chicken.
Danish: Ved lægemiddelovervågning er der ikke indberettet om manglende virkning af Linco-Spectin 100 til den anbefalede harmoniserede indikation hos kyllinger.
English: 10,000 x [daily water consumption per animal (L)] average body weight of one pig (kg) In pigs 150 g of the veterinary medicinal product corresponds to the dose for 10,000 kg of body weight per day.
Danish: 10.000 x [daglig vandindtagelse pr. dyr (l)] Gennemsnitlig legemsvægt af ét svin (kg) Hos svin svarer 150 g veterinærlægemiddel til en dosis til 10.000 kg legemsvægt pr. dag.
English: Special warnings for each target species: Lincomycin resistance is widespread in B. hyodysenteriae and may lead to clinical treatment failure.
Danish: Særlige advarsler for hver dyreart: Lincomycin-resistens er udbredt for B. hyodysenteriae og kan forårsage klinisk behandlingssvigt.
English: Ingestion by these species may result in severe gastrointestinal effects.
Danish: Hvis disse dyrearter indtager dette, kan det forårsage alvorlige gastrointestinale bivirkninger.
English: Lincomycin may lead to severe gastrointestinal disturbances in other animal species.
Danish: Lincomycin kan medføre alvorlige forstyrrelser i mave-tarm-kanalen hos andre dyrearter.
English: The presence of the disease in the flock must be established before the product is used.”
Danish: Tilstedeværelse af sygdommen i flokken skal være fastslået, før produktet anvendes.”
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr udviser bivirkninger i løbet af en behandling) - Almindelig (mere end 1, men færre end 10 dyr ud af 100 dyr) - Ikke almindelig (mere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjælden (mere end 1, men færre end 10 dyr ud af 10.000 dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 dyr, herunder enkeltstående rapporter)
English: Chickens: Meat and offal: 5 days.
Danish: Kyllinger: Slagtning: 5 dage.
English: 10 DATE OF REVISION OF THE TEXT To be completed nationally.
Danish: DATO FOR ÆNDRING AF TEKSTEN Udfyldes nationalt.
English: Do not administer with kaolin or pectin as they impair lincomycin absorption.
Danish: Må ikke administreres sammen med kaolin eller pectin, da disse kan nedsætte absorptionen af lincomycin.
English: The veterinary medicinal product should be used based on antimicrobial susceptibility testing.
Danish: Anvendelse af veterinærlægemidlet bør baseres på undersøgelser af følsomheden af bakterier.
English: In Brachyspira hyodysenteriae nearly all isolates are resistant at least regarding the wild-type in vitro susceptibility.
Danish: Næsten alle isolater af Brachyspira hyodysenteriae er resistente, i det mindste ved in vitro-bestemmelse for vildtypen.
English: Chromosomal one-step mutation to high-level spectinomycin resistance develops in many enteric bacteria (such as E. coli).
Danish: Kromosomal et-trins mutation til høj-niveau spectomycinresistens udvikles i mange enterobakterier (såsom E. coli).
English: In chicken the product is already indicated in many EU Member States for the treatment of CRD, associated to Mycoplasma and/or E. coli.
Danish: Hos kyllinger er produktet i forvejen indiceret til behandling af kronisk luftvejssygdom forbundet med Mycoplasma og/eller E. coli i mange EU medlemsstater.
English: People with known hypersensitivity to lincomycin, spectinomycin or soybean millfeed should avoid contact with the veterinary medicinal product.
Danish: Ved overfølsomhed over for lincomycin, spectinomycin eller sojafodermel, bør kontakt med lægemidlet undgås.
English: Resistance against macrolides and lincosamides has emerged among animal pathogens and is common in some species.
Danish: Hos dyrepatogener har der vist sig resistens over for makrolider og lincosamider, som hos nogle arter er almindelig.
English: The indication for chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum and E. coli was supported by two recent MIC surveys and by older literature MIC data.
Danish: Indikationen kronisk luftvejssygdom i forbindelse med Mycoplasma gallisepticum og E. coli blev støttet af to nye MIC-undersøgelser og af ældre MIC-data fra litteraturen.
English: As an indication, standard water intake varies around 0.15 L/kg bw/day.
Danish: Som indikation varierer den normale vandindtagelse omkring 0,15 l/kg legemsvægt/dag.
English: There is no established clinical breakpoint.
Danish: Der er ikke fastlagt en klinisk tærskelværdi.
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria (such as Brachyspira hyodysenteriae) and mycoplasmas.
Danish: Lincomycin er virksomt mod grampositive bakterier, visse anaerobe gramnegative bakterier (såsom Brachyspira hyodysenteriae) og mykoplasmer.
English: Pigs and chickens.
Danish: Svin og kyllinger.
English: Excipients: Sodium benzoate, lactose.
Danish: Hjælpestoffer: Natriumbenzoat, lactose
English: For E. coli, a newly conducted pan-European MIC survey, involving 67 chicken isolates and 33 turkey isolates, showed a wide MIC range (from 2:4 to ≥256:512 µg/ml), a high spectinomycin MIC90 (256 µg/ml) and a bimodal distribution.
Danish: For E. coli viste en nyudført paneuropæisk MIC-undersøgelse af 67 isolater fra kyllinger og 33 isolater fra kalkuner et bredt MIC-område (fra 2:4 til ≥256:512 µg/ml), en høj MIC90 for spectinomycin (256 µg/ml) og bimodal fordeling.
English: The proposed withdrawal time of 5 days is considered sufficient by the CVMP when chickens are treated using the proposed harmonised dosing regimen 50 mg/kg bw/day for 7 days.
Danish: CVMP finder den ansøgte tilbageholdelsestid på 5 dage tilstrækkelig, når kyllingerne er behandlet med det ansøgte harmoniserede dosisregime på 50 mg/kg kropsvægt/dag i 7 dage.
English: The indication for swine dysentery caused by Brachyspira hyodysenteriae and associated pathogens was substantiated trough a review of literature and old proprietary in vitro susceptibility data, a newly conducted B. hyodysenteriae MIC survey, and old clinical studies.
Danish: Indikationen svinedysenteri forårsaget af Brachyspira hyodysenteriae og tilknyttede patogener blev underbygget med en gennemgang af litteraturdata og ældre interne in vitro-følsomhedsdata, en nylig MIC-undersøgelse for B. hyodysenteriae samt ældre kliniske undersøgelser.
English: Spectinomycin is poorly absorbed by the gastro-intestinal tract and does not easily cross membranes.
Danish: Spectinomycin absorberes dårligt fra mave-tarmkanalen og passerer ikke let gennem membraner.
English: Lincomycin resistance is widespread in B. hyodysenteriae and may lead to clinical treatment failure.
Danish: Lincomycin-resistens er udbredt for B. hyodysenteriae og kan forårsage klinisk behandlingssvigt.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Lincomycin (as lincomycin hydrochloride)
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Lincomycin (som lincomycinhydrochlorid)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals)
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr ud af 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr ud af 1.000 dyr)
English: The potential risk of resistance development which might impact product efficacy, and overall animal and human health, is limited through:
Danish: Følgende foranstaltninger begrænser den potentielle risiko for resistensudvikling med betydning for produktets virkning og generel betydning for dyrs og menneskers sundhed:
English: Pigs: 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Danish: Svin: 3,33 mg lincomycin og 6,67 mg spectinomycin/kg legemsvægt/dag i 7 dage.
English: Chickens: 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days.
Danish: Kyllinger: 16,65 mg lincomycin og 33,35 mg spectinomycin/kg legemsvægt/dag i 7 dage.
English: Use of the veterinary medicinal product deviating from the instructions in the SPC may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with macrolides due to the potential for cross-resistance.
Danish: Anvendelse af veterinærlægemidlet, der afviger fra instruktionerne i produktresuméet (SPC´et), kan forøge risikoen for udvikling og selektion af resistente bakterier og reducere den effektive virkning af behandling med makrolider, på grund af risikoen for krydsresistens.
English: Nevertheless, a clear warning as to the possibility of treatment failure due to clinically resistant strains in B. hyodysenteriae and associated Enterobacteriaceae (E. coli) should be included in section 4.4.
Danish: Alligevel bør der indsættes en klar advarsel om muligheden for behandlingssvigt på grund af klinisk resistente stammer af B. hyodysenteriae og tilknyttede Enterobacteriaceae (E. coli) i produktresuméets punkt 4.4 Særlige advarsler for hver måldyreart.
English: It was the only available trial where the 50 mg/kg bw dose was firmly shown to be beneficial in a treatment context, although the challenge was rather mild (e.g. no mortality was recorded);
Danish: Dette var den eneste foreliggende undersøgelse, hvor doseringen på 50 mg/kg kropsvægt med sikkerhed blev påvist at være gavnlig i behandlingssammenhæng, skønt belastningen var ret let (f.eks. uden registreret dødelighed).
English: A single oral administration of lincomycin hydrochloride, at dose levels of approximately 22, 55 and 100 mg/kg body weight in pigs, resulted in dose related lincomycin serum levels, detected for 24-36 hours after administration.
Danish: En enkelt peroral administration af lincomycinhydrochlorid i dosisniveauer på cirka 22, 55 og 100 mg/kg legemsvægt hos svin, resulterede i dosisrelaterede lincomycinkoncentrationer i plasma, detekteret 24-36 timer efter administration.
English: Chickens Do not use in birds in lay.
Danish: Kyllinger Må ikke anvendes til æglæggende fugle.
English: It inhibits protein synthesis through binding to the 50S bacterial ribosome subunit.
Danish: Det hæmmer proteinsyntesen ved at bindes til 30S ribosom-subunit'en.
English: Lincomycin pharmacokinetic studies in pigs show that lincomycin is bioavailable when given intravenously, intramuscularly or orally.
Danish: Farmakokinetiskestudier med lincomycin med svin viser, at lincomycin er biotilgængeligt efter intravenøs, intramuskulær eller peroral administration.
English: The combination was shown to be superior to lincomycin alone.
Danish: Kombinationen blev påvist at være overlegen i forhold til lincomycin alene.
English: Furthermore, in addition to old experimental and field clinical efficacy studies, a recent proprietary challenge study was presented, where a total of 210 chickens were used to test efficacy of the product against induced E. coli and/or M. gallisepticum infection.
Danish: Foruden de ældre eksperimentelle undersøgelser og kliniske feltundersøgelser af virkningen blev der forelagt en nylig intern belastningsundersøgelse, hvor produktets virkning ved kunstig infektion med E. coli og/eller M. gallisepticum blev testet på i alt 210 kyllinger.
English: Among in vitro susceptibility data for M. gallisepticum, a new MIC survey of lincomycin-spectinomycin (1:2 ratio) was carried out on 60 isolates, and showed a MIC range of [0.25:0.5 - 8:16 µg/ml], and MIC50/MIC90 values of 0.5:1 and 2:4 µg/ml, respectively.
Danish: For in vitro-følsomhedsdata for M. gallisepticum var der foretaget en ny MIC-undersøgelse med lincomycin-spectinomycin (i forholdet 1:2) for 60 isolater, som viste et MIC-område på [0,25:0,5; 8:16 µg/ml] og MIC50/MIC90-værdier på henholdsvis 0,5:1 og 2:4 µg/ml.
English: Clinical efficacy at the proposed dosing regimen of 10 mg/kg body weight (bw) for 7 days in swine dysentery was supported by two duplicate trials in laboratory conditions, and by two field clinical studies.
Danish: Den kliniske virkning ved det ansøgte dosisregime på 10 mg/kg kropsvægt i 7 dage ved svinedysenteri var underbygget af to ens laboratorieundersøgelser og to kliniske feltundersøgelser.
English: clinical data were provided to substantiate this claim.
Danish: Der er ikke forelagt kliniske data til underbygning af denne indikation.
English: The in vitro susceptibility data for Escherichia coli and Salmonella were not extensive but among them there were data from a newly conducted good laboratory practice (GLP)-compliant pan-European MIC survey involving 100 E. coli and 100 Salmonella isolates from clinical cases.
Danish: Der forelå ikke omfattende in vitro-følsomhedsdata for Escherichia coli Salmonella, men en nylig GLPoverensstemmende paneuropæisk MIC-undersøgelse af 100 isolater af E. coli og 100 isolater af Salmonella fra kliniske tilfælde.
English: This amounts to 15 mg powder/kg bw/day for 7 days.
Danish: Det svarer til 15 mg pulver/kg legemsvægt/dag i 7 dage.
English: This amounts to 75 mg powder/kg bw/day for 7 days.
Danish: Det svarer til 75 mg pulver/kg legemsvægt/dag i 7 dage.
English: Do not use in laying hens.
Danish: Bør ikke anvendes til læggehøns.
English: Chicken
Danish: Kyllinger
English: Oral powder
Danish: Oralt pulver
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: June http://www.who.int/foodsafety/foodborne_disease/AGISAR_2009_report_final.pdf?ua=1
Danish: 3 Report of the first meeting of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR), 15-19 June 2009. http://www.who.int/foodsafety/foodborne_disease/AGISAR_2009_report_final.pdf?ua=1
English: 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.
Danish: 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.
English: * 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.
Danish: • 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.
English: Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Danish: Lincomycin er et lincosamidantibiotikum, fremstillet af Streptomyces lincolnensis, som hæmmer proteinsyntesen.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Soluble Powder is formulated for administration via drinking water.
Danish: Opløseligt pulver er en formulering til administration i drikkevand.
English: 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).
Danish: <Lægemidlets særnavn > 222 mg/g + 444,7 mg/g pulver til anvendelse i drikkevand Lincomycin (som lincomycinhydrochlorid)/ spectinomycin (som spectinomycinsulfat)
English: Resistance to lincomycin can readily develop in B. hyodysenteriae and most of the isolates studied show decreased susceptibility in vitro.
Danish: B. hyodysenteriae kan hurtig udvikle resistens over for lincomycin og de fleste isolater, der er undersøgt, viser nedsat følsomhed in vitro.