FrancophonIA/ELRC3.0 huggingface dataset:
English: The harmonised dose of 50 mg/kg bw is overall the lowest approved one among the national authorisations and the most frequent recommendation for treatment only.
Danish: Den harmoniserede dosis på 50 mg/kg kropsvægt er generelt den laveste godkendte dosis i de nationale godkendelser og den oftest anbefalede dosis til behandling alene.
English: Discussion of data available
Danish: Diskussion af de foreliggende data
English: Not authorised for use in birds producing or intended to produce eggs for human consumption.
Danish: Må ikke anvendes til fugle, der producerer eller skal producere æg, der er bestemt til menneskeføde.
English: It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal.
Danish: Det er fornuftig klinisk praksis at basere behandlingen på undersøgelser af følsomheden af bakterier, der er isoleret fra dyret.
English: Strains with chromosomal resistance do not show cross-resistance with aminoglycosides.
Danish: Stammer med kromosomal resistens udviser ikke krydsresistens med aminoglycosider.
English: To ensure a correct dosage and avoid underdosing, mean body weights in the group of animals and daily water consumption should be determined as accurately as possible.
Danish: For at sikre korrekt dosering og undgå underdosering, bør besætningens gennemsnitlige legemsvægt og det daglige vandforbrug bestemmes så præcist som muligt.
English: Although this risk has not been unequivocally assessed, the possibility of impact on human health through cross-resistance to clindamycin and other substances of the macrolides, lincosamides and streptogramins (MLS) group is a reality.
Danish: Denne risiko ikke er entydigt vurderet, men der er reel mulighed for indvirkning på menneskers sundhed gennem krydsresistens mod clindamycin og andre stoffer i gruppen af makrolider, lincosamider og streptograminer (MLS).
English: Combination with anaesthetics may lead to possible neuromuscular blocking.
Danish: Kombination med anæstetika kan føre til eventuel neuromuskulær blokade.
English: The results of the literature MIC data, which concern only a few isolates, overall indicate high MIC values for both lincomycin and spectinomycin.
Danish: MIC-dataene fra litteraturen, der kun vedrører få isolater, viser generelt høje MIC-værdier for både lincomycin og spectinomycin.
English: The efficacy appeared better than with lincomycin alone, and slightly better than with spectinomycin alone.
Danish: Virkningen syntes at være bedre end med lincomycin alene, og en smule bedre end med spectinomycin alene.
English: Use the following indications as a basis for the precise calculation of incorporation rate of the veterinary medicinal product in drinking water.
Danish: Anvend følgende indikationer som grundlag for en præcis beregning af den mængde veterinærlægemiddel, der skal iblandes drikkevandet.
English: The table below shows the volume of water to be used for dilution of 150 g of the veterinary medicinal product.
Danish: Tabellen nedenfor angiver det vandvolumen, der skal anvendes til fortynding af 150 g veterinærlægemiddel.
English: Spectinomycin has no significant clinical effect on B. hyodysenteriae.
Danish: Spectinomycin har ingen nævneværdig klinisk virkning på B. hyodysenteriae.
English: Further to the assessment of the available data, the CVMP considered that the benefit-risk balance for the target species pigs remains positive.
Danish: Efter vurdering af de foreliggende data anså CVMP fortsat benefit/risk-forholdet for måldyrearten svin for positivt.
English: Literature data indicate that decreased susceptibility in B. hyodysenteriae could be overcome to some extent by the high concentrations attained locally.
Danish: Litteraturdata peger på, at nedsat følsomhed af B. hyodysenteriae i nogen grad kan tænkes at modsvares af de høje koncentrationer, der opnås lokalt.
English: In case of disease accompanied with significant decrease in water intake, parenteral treatment may have to be initiated.
Danish: I tilfælde af at sygdom er ledsaget af en signifikant nedsat indtagelse af drikkevand, kan det blive nødvendigt at initiere parenteral behandling.
English: Indirect benefits
Danish: Indirekte fordele
English: Do not allow rabbits, rodents (e.g. chinchillas, hamsters, guinea pigs), horses or ruminants to access to water or feeds containing lincomycin.
Danish: Lad ikke kaniner, gnavere (f.eks. chinchillaer, hamstere, marsvin), heste eller drøvtyggere få adgang til drikkevand eller foder, der indeholder lincomycin.
English: * The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 Special warnings for each target species, 4.5 (i) Special precautions for use in animals and 5.1 Pharmacodynamic properties.
Danish: • indsættelse af oplysninger om resistensstatus og advarsler om forsvarlig brug hvad angår resistens i produktresuméets punkt 4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til, 4.5 (i) Særlige forsigtighedsregler vedrørende brug til dyr og 5.1 Farmakodynamiske egenskaber.
English: It is speculated by the marketing authorisation holder that spectinomycin might have an effect on associated pathogens related to swine dysentery; however, such an effect has not been formally demonstrated in vivo on specific pathogens.
Danish: Indehaveren af markedsføringstilladelsen antager spekulativt, at spectinomycin kan tænkes at have effekt på tilknyttede patogener ved svinedysenteri, men en sådan virkning er ikke formelt påvist in vivo på specifikke patogener.
English: In a GCP-compliant, multicentre field study, pigs were treated as recommended and medication with Linco-Spectin 100 for 7 and 14 days was efficacious for the treatment of ileitis in pigs; there was no benefit of treating pigs suffering from ileitis longer than 7 days.
Danish: I en GCP-overensstemmende feltmulticenterundersøgelse blev svin behandlet som anbefalet, og medicinering med Linco-Spectin 100 i 7 og 14 dage var effektiv til behandling af ileitis hos svin, og der sås ingen fordele ved at behandle ileitis hos svin længere end 7 dage.
English: Do not leave access to the medicated water for other animals.
Danish: Lad ikke andre dyrearter få adgang til det medicinerede vand.
English: Likewise, information about the lack of data on the development of resistance in L. intracellularis should be included in the above mentioned sections of the SPC.
Danish: Ligeledes bør der indsættes oplysninger om de manglende data om resistensudvikling over for L. intracellularis i de ovennævnte punkter af produktresuméet.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.
Danish: Hvis det ikke er muligt, skal behandlingen baseres på lokal (regional, bedriftsplan) epidemiologisk information om målbakteriers følsomhed.
English: If co-administration is mandatory, respect a delay of two hours between intakes.
Danish: Hvis samtidig administration er påkrævet, skal der gå to timer mellem indtagelserne.
English: In a GLP challenge study, pigs were treated with the recommended 10 mg/kg bw dose, but for 21 days instead of 7 days.
Danish: I en GLP-belastningsundersøgelse blev svin behandlet med den anbefalede dosis på 10 mg/kg kropsvægt, men i 21 dage i stedet for 7 dage.
English: This powder is for use in drinking water only and should be dissolved before use.
Danish: Dette pulver er kun til anvendelse i drikkevand og skal opløses før anvendelse.
English: Thus, it is unclear as to the value of a combination product for this indication versus a monotherapy product (e.g. lincomycin).
Danish: Der er derfor uklarhed om værdien af et kombinationsprodukt sammenlignet med monoterapi (f.eks. lincomycin) til denne indikation.
English: Several old challenge laboratory studies showed efficacy of the combination against experimental inoculations with Mycoplasma spp.
Danish: Flere ældre laboratorieundersøgelser med belastning viste virkning af kombinationen mod eksperimentel inokulation med Mycoplasma spp.
English: Taking into account all data, the CVMP considered that this indication can be accepted.
Danish: I betragtning af samtlige data kunne CVMP godtage denne indikation.
English: Taking into account all data, the CVMP considered that this indication can be maintained.
Danish: På baggrund af samtlige data fandt CVMP, at denne indikation kan opretholdes.
English: Cases of diarrhoea or soft faeces and/or perianal region inflammation have been encountered in healthy pigs at the start of treatment.
Danish: Der har været tilfælde med diarré eller blød fæces og/eller inflammation i det perianale område hos raske svin i starten af behandlingen.
English: In addition efficacy might be influenced by the conditions established in the gut by various associated enteric bacteria.
Danish: Desuden kan virkningen være påvirket af de betingelser, der tilvejebringes i tarmen af forskellige tilknyttede enterobakterier.
English: Peak serum levels were observed at 4 hours after dosing.
Danish: Maksimale serumkoncentrationer blev observeret 4 timer efter dosering.
English: * There are no new clinical trials, field trials or publications demonstrating the effectiveness of the lincomycin-spectinomycin combination against modern outbreaks of swine dysentery, and based on current approved dosing regimens.
Danish: • Der er ingen nye kliniske undersøgelser, feltundersøgelser eller publikationer, der påviser effektiviteten af kombinationen lincomycin-spectinomycin ved moderne udbrud af svinedysenteri ved anvendelse af de aktuelt godkendte dosisregimer.
English: Also in one of the field studies the target condition was a mixed enteric and respiratory infection involving Salmonella and Mycoplasma, which is only poorly relevant to the claimed indication.
Danish: Desuden omhandlede den ene af feltundersøgelserne en blandet tarm- og luftvejsinfektion med Salmonella og Mycoplasma, hvilket kun har ringe relevans for den påberåbte indikation.
English: “Product name (to be completed nationally)” is a combination of two antibiotics, lincomycin and spectinomycin, having a complementary spectrum of activity.
Danish: “Lægemidlets særnavn (udfyldes nationalt)” er en kombination af to antibiotika, lincomycin og spectinomycin, med et komplimentært virkningsspektrum.
English: 2,000 x [daily water consumption per bird (L)] average body weight of one bird (kg)
Danish: 2.000 x [daglig vandindtagelse pr. fugl (l)] Gennemsnitlig legemsvægt af én fugl (kg)
English: In vitro studies as well as clinical efficacy data show that the lincomycin-spectinomycin combination is active against Lawsonia intracellularis.
Danish: In vitro studier samt kliniske effektdata viser, at lincomycin-spectinomycin-kombinationen er virksom over for Lawsonia intracellularis.
English: Sick animals have a reduced appetite and an altered drinking pattern, and severely affected animals may therefore require parenteral treatment.
Danish: Syge dyr har nedsat ædelyst og ændret drikkemønster og meget syge dyr kan derfor have behov for parenteral behandling.
English: Clinical efficacy against proliferative enteropathy is substantiated through one GLP laboratory study and one GCP multicenter field study, except that in the laboratory study the animals were treated for 21 days.
Danish: Den kliniske virkning mod proliferativ enteropati underbygges af én GLP-laboratorieundersøgelse og én GCP-multicenterfeltundersøgelse, dog blev dyrene i laboratorieundersøgelsen behandlet i 21 dage.
English: The discrepancy might be related to the fact that various enteric bacteria may contribute to the pathogenesis of the disease, and efficacy could be obtained in strains with relatively high MIC values due to high local antimicrobial concentration in the gut.
Danish: Afvigelsen kan hænge sammen med, at forskellige enterobakterier kan bidrage til sygdommens patogenese, og at der kan tænkes at opnås virkning mod stammer med relativt høje MIC-værdier på grund af den høje antimikrobielle koncentration i tarmen.
English: Pigs: for administration via drinking water.
Danish: Svin: til administration i drikkevand.
English: Use only accordingly to benefit-risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-benefitforholdet.
English: Tolerance is still adequately reflected by the harmonised texts for SPC sections 4.5 (i) Special precautions for use in animals, 4.6 Adverse reactions (frequency and seriousness) and 4.10 Overdose.
Danish: Tolerancen er fortsat tilfredsstillende dækket af de harmoniserede tekster til produktresuméets punkt 4.5 (i) Særlige forsigtighedsregler vedrørende brug til dyr, 4.6 Bivirkninger (forekomst og sværhedsgrad) og 4.10 Overdosering.
English: It has little or no action against gram-negative bacteria such as Escherichia coli.
Danish: Det har ringe eller ingen virkning mod gramnegative bakterier såsom Escherichia coli.
English: Since the dosing regimens recommended by the CVMP have not been increased, and the indications have not been extended with regard to those approved in most SPCs, the assessment of the tolerance in the target species does not present new issues.
Danish: Da de af CVMP foreslåede dosisregimer ikke er blevet øget, og indikationerne ikke er blevet udvidet i forhold til de godkendte indikationer i de fleste produktresuméer, giver vurderingen af tolerancen hos måldyrearterne ikke anledning til nye betænkeligheder.
English: For the preparation of drinking water, the incorporation rate of the veterinary medicinal product in water will depend on the body weight of the animals and their actual daily intake of water.
Danish: Ved tilberedning af drikkevand afhænger blandingsmængden af veterinærlægemidlet i drikkevandet af dyrenes legemsvægt og deres faktiske, daglige indtagelse af vand.
English: These were not GLP or good clinical practice (GCP)-compliant and the target clinical and bacteriological condition was not well defined in the study reports.
Danish: Undersøgelserne var ikke overensstemmende med GLP eller god klinisk praksis (GCP), og den behandlede kliniske og bakteriologiske lidelse var ikke veldefineret i rapporterne over undersøgelserne.
English: The medicated drinking water should be the sole source of drinking water for the treatment duration.
Danish: Det medicinerede drikkevand bør være den eneste adgang til drikkevand i behandlingsperioden.
English: Personal protective equipment consisting of approved dust masks (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN 140 with a filter EN 143), gloves and safety glasses should be worn when handling and mixing the product.
Danish: Personligt beskyttelsesudstyr i form af godkendte støvmasker (enten en engangsstøvmaske, der er i overensstemmelse med den europæiske standard EN 149, eller et genbrugeligt åndedrætsværn, der er i overensstemmelse med den europæiske standard EN 140, med et filter, der er i overensstemmelse med EN 143), handsker og sikkerhedsbriller bør anvendes ved håndtering og blanding af lægemidlet.
English: The product is used in the proposed indications (swine dysentery and proliferative enteropathy) for several decades in many EU Member States, on the basis of the complementary activity spectra of lincomycin and spectinomycin on the primary pathogens B. hyodysenteriae and L. intracellularis and the potentially associated enteric pathogens such as E. coli.
Danish: Produktet har i flere tiår været anvendt i mange EU-medlemsstater til de ansøgte indikationer (svinedysenteri og proliferativ enteropati) på grundlag af de komplementære aktivitetsspektre af lincomycin og spectinomycin over for de primære patogener B. hyodysenteriae og L. intracellularis og de potentielle tilknyttede enteropatogener såsom E. coli.
English: Lincomycin distributes well into tissues and is known to produce high intracellular concentrations.
Danish: Lincomycin fordeles godt i vævene og vides at frembringe høje intracellulære koncentrationer.
English: The combination lincomycin-spectinomycin was also shown to be superior to each individual active substance.
Danish: Kombinationen lincomycin-spectinomycin blev desuden påvist at være overlegen i forhold til hvert af de aktive stoffer for sig.
English: If symptoms such as skin rash or persistent eye irritation appear after exposure, seek medical advice immediately and show the package leaflet or label to the physician.
Danish: Hvis der forekommer symptomer såsom hududslæt eller vedvarende øjenirritation efter eksponering, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: * In the newly provided clinical efficacy study the product clearly induced improvement of clinical signs of CRD and reduced the extent of bacterial invasion.
Danish: • I den nyligt forelagte undersøgelse af klinisk virkning bevirkede produktet en klar bedring i de kliniske tegn på kronisk luftvejssygdom og mindskede omfanget af bakteriel invasion.
English: Animal species
Danish: Dyrearter,
English: White HDPE bottle containing 150 g or 1.5 kg powder for oral solution with a white tamper evident LDPE lid.
Danish: Hvid HDPE-flaske med 150 g eller 1,5 kg pulver til oral opløsning med et hvidt, forseglet LDPE-låg.
English: Lincomycin may be either bactericidal or bacteriostatic.
Danish: Lincomycin kan være enten baktericidt eller bakteriostatisk.
English: On the basis of in vitro tests, it has been hypothesised that a metabolite or degradation product of spectinomycin was produced in the gut and was able to reach the infection site and interfere with E. coli adherence to the respiratory mucosa, but this has not been validated (Goren et al., 1988)2.
Danish: In vitro-test har givet anledning til en hypotese om, at der i tarmen dannes en metabolit eller et nedbrydningsprodukt af spectinomycin, som er i stand til at nå frem til infektionsfokus og interferere med vedhæftningen af E. coli til luftvejsslimhinden, men dette er ikke blevet valideret (Goren et al., 1988)2.
English: Special precautions for use in animals:
Danish: Særlige forholdsregler for brug hos dyr:
English: In chickens treated with “product name (to be completed nationally)” in drinking water at the target dose of 50 mg/kg body weight of total activity (at a ratio of 1:2 lincomycin:spectinomycin) for seven consecutive days, Cmax after first offering of medicated water was calculated to be 0.0631 µg/ml.
Danish: Hos kyllinger i behandling med “Lægemidlets særnavn (udfyldes nationalt)” i drikkevand med måldoser på 50 mg/kg legemsvægt af total aktivitet (lincomycin:spectinomycin i forholdet 1:2) i 7 på hinanden følgende dage, var Cmax efter første administration af medicineret vand beregnet til at være 0,0631 µg/ml.
English: Do not use in case of hypersensitivity to the active substances or any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne.
English: Co. Cork
Danish: Ringaskiddy, Co. Cork
English: The oral use of preparations containing lincomycin is only indicated in swine and chickens.
Danish: Peroral anvendelse af formuleringer indeholdende lincomycin er kun indiceret til svin og kyllinger.
English: Not authorised for use in birds producing eggs for human consumption, including replacement chicks which are intended to produce eggs for human consumption.
Danish: Må ikke anvendes til fugle, hvis æg er bestemt til menneskeføde, herunder erstatningskyllinger, der skal producere æg, der er bestemt til menneskeføde.
English: This reflects the ready acquisition of resistance determinants by the bacterium.
Danish: Dette afspejler, at bakterien let erhverver resistensdeterminanter.
English: It is mainly active against Gram-positive bacteria and obligate anaerobes, and against mycoplasmas.
Danish: Det er hovedsagelig aktivt mod grampositive bakterier og obligate anaerobe samt mod mycoplasma.
English: 150 g of the veterinary medicinal product corresponds to the dose for 2,000 kg of body weight per day.
Danish: 150 g veterinærlægemiddel svarer til en dosis til 2.000 kg legemsvægt pr. dag.
English: Linco-Spectin 100 (and associated names) is a powder for use in drinking water containing the active substances lincomycin (222 mg/g) and spectinomycin (444.7 mg/g).
Danish: Linco-Spectin 100 (og relaterede navne) er et pulver til opløsning i drikkevand og indeholder de aktive stoffer lincomycin (222 mg/g) og spectinomycin (444,7 mg/g).
English: * A dose of 50 mg/kg bw is the most frequent recommendation for “treatment” among the concerned SPCs.
Danish: • En dosis på 50 mg/kg kropsvægt er den oftest anbefalede dosis til “behandling” i de berørte produktresuméer.
English: However, the most prevalent mechanism in B. hyodysenteriae and mycoplasmas is the alteration of the binding site through mutational events (chromosomal resistance).
Danish: Den mest udbredte mekanisme hos B. hyodysenteriae og mykoplasmer er ændring af bindingsstedet ved mutation (kromosomal resistens).
English: For use in drinking water.
Danish: Til anvendelse i drikkevand.
English: Manufacturer responsible for batch release: To be completed nationally
Danish: Fremstiller ansvarlig for batchfrigivelse: Udfyldes nationalt
English: Literature and the proprietary old in vitro susceptibility data show that the overall lincomycin minimum inhibitory concentration (MIC) range for B. hyodysenteriae is very wide and the population MIC50 and MIC90 values are high.
Danish: Litteraturdata og de ældre interne in vitro-følsomhedsdata viser, at den mindste hæmmende koncentration (MIC) af lincomycin for B. hyodysenteriae generelt varierer meget bredt, og at MIC50-og MIC90-værdierne i populationen er høje.
English: The activity spectrum of spectinomycin includes mycoplasmas, aerobic gramnegative bacteria, and gram-positive cocci.
Danish: Aktivitetsspektret af spectinomycin omfatter mycoplasma, aerobe gramnegative bakterier og grampositive kokker.
English: Rare cases of irritability/excitation, skin rash/pruritus were also observed.
Danish: Der blev også observeret sjældne tilfælde med irritabilitet/ophidselse, hududslæt/pruritus.
English: 1348 Louvain-la-Neuve Belgium
Danish: 1348 Louvain-la-Neuve Belgien
English: However, the used dosing regimens were very unclear and possibly range from the proposed dose of 50 mg/kg bw/day to the highest approved dose of 150 mg/kg bw.
Danish: De anvendte dosisregimer var imidlertid meget uklare og spænder antagelig fra den ansøgte dosis på 50 mg/kg kropsvægt/dag til den højeste godkendte dosis på 150 mg/kg kropsvægt.
English: Despite the poor in vitro activity of the active substances against L. intracellularis, the combination might be effective due to combined intra- and extracellular action of lincomycin and spectinomycin, respectively.
Danish: Trods den ringe in vitro-aktivitet af de aktive stoffer mod L. intracellularis kan kombinationen tænkes at være effektiv på grund af den kombinerede intra- og ekstracellulære virkning af henholdsvis lincomycin og spectinomycin.
English: Double LDPE bag containing 4.5 kg powder inside a tamper evident polypropylene tub with a polypropylene lid.
Danish: Dobbelt LDPE-pose med 4,5 kg pulver i et forseglet polypropylen-kar med et polypropylen-låg.
English: Overall, considering also older literature data, the relatively narrow MIC ranges and low MIC50 and MIC90 values, together with a monomodal distribution are indicative of a low resistance level which seems not to be evolving.
Danish: De ældre litteraturdata sammen med de forholdsvis smalle MIC-områder og lave MIC50- og MIC90-værdier og den monomodale fordeling tyder samlet på et lavt resistensniveau, der ikke synes at ændre sig.
English: * Resistance to the concerned compounds in the target bacteria shows no unfavourable evolution over time and no greater concern than for other compounds used similarly;
Danish: • Der var ikke tendens til ugunstig resistensudvikling med tiden hos målbakterierne, og ingen større problemer end med andre stoffer med tilsvarende anvendelse.