FrancophonIA/ELRC3.0 huggingface dataset:
English: While the lincosamides are generally considered to be bacteriostatic agents, the activity depends on the sensitivity of the organism and concentration of the antibiotic.
Danish: Mens lincosamider hovedsageligt anses for at være bakteriostatiske stoffer, afhænger aktiviteten af organismens følsomhed samt koncentrationen af antibiotikaen.
English: For example, the results of the study conducted by the marketing authorisation holder in 2016 with 92 European isolates showed a MIC range of 0.5 μg/ml to >256 μg/ml and a tri-modal MIC distribution for lincomycin against C. perfringens (peaks at 1 μg/ml, 8 μg/ml and >256 μg/ml), with the majority of isolates falling outside the apparent wild-type population.
Danish: F.eks. viste resultaterne af den undersøgelse, som indehaveren af markedsføringstilladelsen foretog i 2016 med 92 europæiske isolater, et MIC-interval på 0,5 μg/ml til >256 μg/ml og en trimodal MICfordeling for lincomycin mod C. perfringens (der topper ved 1 μg/ml, 8 μg/ml og >256 μg/ml), hvor størstedelen af isolaterne falder uden for den tilsyneladende vildtypepopulation.
English: Care should be taken not to raise and inhale any dust.
Danish: Der skal udvises forsigtighed, så der ikke ophvirvles eller indåndes støv.
English: Upon comparison to more recent EU isolates (2011-2016), the MIC distributions are similar, being tri-modal with peaks differing by one doubling dilution at the most.
Danish: Når de sammenlignes med nyere EU-isolater (2011-2016), ses der lignende MIC-fordelinger, som er trimodale med toppunkter, der højst adskiller sig med en fordoblingsfortynding.
English: Levels were detectable for 12 to 16 hours, with peak concentrations occurring at 4 hours.
Danish: Værdierne kunne registreres i 12-16 timer, hvor koncentrationen var kraftigst efter 4 timer.
English: Pharmacotherapeutic group: Antibacterials for systemic use; Lincosamides.
Danish: Farmakoterapeutisk gruppe: Antibakterielle midler til systemisk brug; lincosamider.
English: The excreta contained mostly unmetabolised lincomycin (60-85%) during treatment.
Danish: Ekskrementerne indeholdt den største mængde umetaboliseret lincomycin (60-85 %) under behandlingen.
English: In addition, older studies conducted with Lincocin in chickens, and in which a microbiological method was used to measure residues, provide further reassurance that a withdrawal period of 5 days is safe for consumers.
Danish: Endvidere gav ældre undersøgelser, der var foretaget med Lincocin hos kyllinger, og hvor der blev anvendt en mikrobiologisk metode til at måle restkoncentrationer, en yderligere forsikring om, at en tilbageholdelsestid på 5 dage er sikker for forbrugerne.
English: The minimum effective dose would appear to be approximately 4 mg/kg per kg of body weight and selection of this dose would result in a maximal therapeutic index.
Danish: Den minimale effektive dosis viste sig at være ca. 4 mg/kg pr. kg kropsvægt, og valget af denne dosis ville resultere i et maksimalt terapeutisk indeks.
English: It might be the case that local intestinal concentrations of lincomycin exceed the MIC of non-wild-type isolates.
Danish: Det kan være tilfældet, at lokale tarmkoncentrationer af lincomycin overstiger MIC for isolater, der ikke er af vildtypen.
English: Lincomycin and one unknown metabolite comprised >50% of the muscle residue at zero hours.
Danish: Lincomycin og en ukendt metabolit omfattede >50 % af resterne i musklerne ved 0 timer.
English: Use only according to the benefitrisk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk-forholdet.
English: In pigs, lincomycin is rapidly absorbed following oral administration.
Danish: Hos svin absorberes lincomycin hurtigt efter oral indgivelse.
English: The intake of medicated water depends on the physiological and clinical condition of the animals.
Danish: Indtag af medicineret vand afhænger af dyrenes fysiologiske og kliniske tilstand.
English: The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period.
Danish: Medicineret vand bør være dyrenes eneste mulighed for drikkevand i hele behandlingsperioden.
English: Ireland Zoetis Belgium S.A 2nd Floor, Building 10
Danish: Zoetis Belgium S.A 2nd Floor, Building
English: On 5 July 2016 the European Commission sent a referral notification under Article 34 of Directive 2001/82/EC to the European Medicines Agency for Lincocin and its associated names.
Danish: Den 5. juli 2016 foretog Europa-Kommissionen i medfør af artikel 34 i direktiv 2001/82/EF en indbringelse for Det Europæiske Lægemiddelagentur vedrørende Lincocin og relaterede navne.
English: This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the product Lincocin and its associated names.
Danish: Denne benefit/risk-vurdering finder sted inden for rammerne af artikel 34 i direktiv 2001/82/EF og har i denne procedure til formål at harmonisere godkendelsesbetingelserne i EU for lægemidlet Lincocin og relaterede navne.
English: Use of the veterinary medicinal product preferably should be based on identification of the target pathogen and susceptibility testing of the bacteria isolated from the animal.
Danish: Brug af veterinærlægemidlet bør helst baseres på identifikation af målpatogen og følsomhedsbestemmelse af målbakterien isoleret fra dyret.
English: Lincomycin may be either bactericidal or bacteriostatic.
Danish: Lincomycin kan enten være bakteriedræbende eller bakteriostatisk.
English: 02-676 Warsaw
Danish: Postępu 17B 02-676 Warsaw Poland
English: Medicated drinking water uptake can be affected by the severity of the disease.
Danish: Indtag af medicineret drikkevand kan påvirkes af sygdommens sværhedsgrad.
English: Based on the results from the study and the calculations made by the CVMP, it was concluded that a zero-day withdrawal period for pig meat and offal may not be safe for the consumers as the first time point at which all samples were below their respective maximum residue limits (MRLs) was 12
Danish: På baggrund af undersøgelsens resultater og CVMP's beregninger blev det konkluderet, at en tilbageholdelsestid på nul dage for kød og slagteaffald fra svin muligvis ikke er sikker for forbrugerne, eftersom det første tidspunkt, hvor alle prøver var under deres respektive maksimalgrænseværdier for restkoncentration (MRL), var 12 timer.
English: Although the studies were conducted in the USA in the 1980s and MICs of the isolates responsible for necrotic enteritis in two of the studies are not known, the marketing authorisation holder has determined the MICs of C. perfringens isolates obtained from chickens in the USA in the 1990s.
Danish: Selv om undersøgelserne blev gennemført i USA i 1980'erne, og MIC-værdierne for de isolater, der var ansvarlige for nekrotisk enteritis i to af undersøgelserne, ikke er kendt, bestemte indehaveren af markedsføringstilladelsen MIC-værdierne for C. perfringens-isolater fra kyllinger i USA i 1990'erne.
English: A single oral dose of 10 mg/kg body weight was administered to pigs to determine the bioavailability.
Danish: En enkelt oral dosis på 10 mg/kg kropsvægt blev administreret til svin for at bestemme biotilgængeligheden.
English: This exceeded the minimum effective dose rate (3.9 mg/kg) established in the dose evaluation study and was within the range tested in the dose confirmation and target animal safety studies.
Danish: Dette overskred den minimale effektive dosis (3,9 mg/kg), der blev fastsat i dosisevalueringsundersøgelsen, og lå inden for det interval, der blev testet i sikkerhedsundersøgelserne, for så vidt angår dosisbekræftelse og måldyreart.
English: Risk management or mitigation measures
Danish: Risikostyring eller risikoreducerende foranstaltninger
English: Similar results were observed following single oral doses of 4.4 and 11.0 mg/kg body weight in pigs.
Danish: Tilsvarende resultater blev fundet efter indgivelse af en enkelt oral dosis på 4,4 og 11,0 mg/kg kropsvægt til svin.
English: Regarding the determination of the withdrawal period, no residue depletion studies have been conducted with Lincocin in chickens using a modern (HPLC) assay method.
Danish: Hvad angår bestemmelsen af tilbageholdelsestiden, er der ikke foretaget nogen restkoncentrationsundersøgelser med Lincocin hos kyllinger ved hjælp af en moderne (HPLC) analysemetode.
English: Tissue residues levels were measured in composite samples from 4 birds at 0, 2 and 7 days after the end of treatment.
Danish: Restkoncentrationer i væv blev målt i sammensatte prøver fra 4 fugle 0, 2 og 7 dage efter behandlingens afslutning.
English: Having considered the grounds for referral and the data provided by the marketing authorisation holder, the CVMP concluded that the benefit-risk balance of the product remains positive for use in pigs and chickens subject to the recommended changes in the product information.
Danish: Efter at have undersøgt begrundelserne for indbringelsen og de data, som indehaveren af markedsføringstilladelsen har fremlagt, konkluderede CVMP, at benefit/risk-forholdet forbliver positivt for anvendelse hos svin og kyllinger, der er genstand for de anbefalede ændringer i produktinformationen.
English: Indeed, there was evidence, albeit from a subclinical infection model, that MIC values above those for the apparent wild-type population do not necessarily correlate to a lack of clinical effectiveness of lincomycin (Lanckriet et al., 2010)2.
Danish: Der var tværtimod evidens for - omend fra en subklinisk infektionsmodel - at MIC-værdier, som ligger over værdierne for den tilsyneladende vildtypepopulation, ikke nødvendigvis er ensbetydende med lincomycins manglende kliniske virkning (Lanckriet et al., 2010)2.
English: • Indications
Danish: • Indikationer
English: Based on the observed depletion pattern, a 5-day withdrawal period was shown to be appropriate for the combination product.
Danish: På baggrund af det observerede nedbrydningsmønster viste en 5dages tilbageholdelsestid sig at være passende til kombinationslægemidlet.
English: The risks associated with use of Lincocin and its associated names are those generally attributed to antimicrobials which are used in food-producing animals, i.e. development of antimicrobial resistance in target bacteria, dissemination of resistant bacteria/resistance factors etc.
Danish: Risiciene i forbindelse med brugen af Lincocin og relaterede navne er de samme som dem, der generelt tilskrives antimikrobielle stoffer, som anvendes hos dyr til fødevareproduktion, dvs. udvikling af antimikrobiel resistens hos målbakterierne, udbredelse af resistente bakterier/resistensfaktorer osv.
English: Approximately 50% of lincomycin is metabolised in the liver.
Danish: Ca. 50 % af lincomycinen metaboliseres i leveren.
English: Risks for users were considered low and adequate information is included in the product information to ensure the safety for the user.
Danish: Brugerrisikoen vurderes at være lav, og der er anført relevante oplysninger i produktinformationen, så brugeren sikres risikofri anvendelse.
English: Mean body weight (kg) of animals to be treated
Danish: Middel kropsvægt (kg) af behandlede dyr
English: Lincomycin resistance mediated by efflux pumps, or by inactivating enzymes, has also been described.
Danish: Lincomycinresistens medieret af effluxpumper eller af inaktiverende enzymer er også blevet beskrevet.
English: Based on the documentation provided, the proposed withdrawal period of 5 days for chicken meat and offal was considered to be safe for the consumers.
Danish: På baggrund af den fremlagte dokumentation blev den foreslåede tilbageholdelsestid på 5 dage for kød og slagteaffald fra kyllinger anset for at være sikker for forbrugerne.
English: It was concluded that the susceptibility pattern of C. perfringens to lincomycin has not changed significantly over the last 25 years.
Danish: Det blev konkluderet, at mønsteret for C. perfringens følsomhed over for lincomycin ikke har ændret sig væsentligt i de seneste 25 år.
English: Therefore, the high in vitro resistance level in B. hyodysenteriae constitutes a major uncertainty as to the clinical effectiveness of Lincocin.
Danish: Derfor giver det høje in vitro-resistensniveau hos B. hyodysenteriae en væsentlig usikkerhed med hensyn til Lincocins kliniske virkning.
English: In case of accidental exposure to the skin, eyes or mucous membranes, wash the affected area thoroughly with plenty of water.
Danish: I tilfælde af eksponering på huden, i øjnene eller slimhinderne ved et uheld vaskes det pågældende område med rigeligt mængder vand.
English: Once diluted or reconstituted according to directions: use within 24 hours.
Danish: Efter fortynding eller rekonstituering ifølge anvisningerne: anvendes indenfor 24 timer.
English: Pigs: Meat and offal: 1 day.
Danish: Svin: Slagtning: 1 dag.
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 target animal safety and user safety did not present new issues.
Danish: Da de af CVMP anbefalede dosisregimer ikke er blevet øget, og indikationerne ikke er blevet udvidet i forhold til de godkendte indikationer i de fleste produktresuméer, gav vurderingen af sikkerheden for måldyrearterne og brugersikkerheden ikke anledning til nye betænkeligheder.
English: The dosage used (approximately 10 mg lincomycin/kg body weight/day administered in drinking water) was considered to be representative of the maximum amount of lincomycin recommended for the product.
Danish: Den anvendte dosis (ca. 10 mg lincomycin/kg kropsvægt dagligt administreret i drikkevand) blev anset for at være repræsentativt for den maksimale mængde lincomycin, der anbefales for lægemidlet.
English: It should be noted that no standardised procedures for MIC testing of antimicrobial agents against mycoplasmas and no clinical breakpoints exist, which has made the comparison of results of different studies difficult.
Danish: Det skal bemærkes, at der ikke eksisterer nogen standardiserede procedurer for MIC-test af antimikrobielle stoffer mod mycoplasma, og at der ikke er fastsat nogen kliniske afskæringspunkter, hvilket gjorde det vanskeligt at sammenligne resultaterne af de forskellige undersøgelser.
English: However, in light of the fact that the lincomycin dose given in the study provided was several times higher than the recommended dose for Lincocin, and the duration of treatment was similar, it was considered that the available study provides a rather conservative result, even though the possibility of pharmacokinetic interactions between lincomycin and spectinomycin were not addressed.
Danish: I betragtning af at den dosis lincomycin, der blev givet i den fremlagte undersøgelse, var flere gange højere end den anbefalede dosis for Lincocin, og at behandlingsvarigheden var den samme, var man dog af den opfattelse, at den tilgængelige undersøgelse giver et noget konservativt resultat, selv om muligheden for farmakokinetiske interaktioner mellem lincomycin og spectinomycin ikke var omhandlet.
English: It is bacteriostatic and primarily active against Gram-positive bacteria (both aerobic and anaerobic), Gram-negative anaerobic bacteria and mycoplasma.
Danish: Det er bakteriostatisk og er primært aktivt mod grampositive bakterier (både aerobe og anaerobe), gramnegative anaerobe bakterier og mycoplasma.
English: Some of the studies in which lincomycin was administered in feed were considered to demonstrate a therapeutic and/or metaphylactic effect of lincomycin against enzootic pneumonia.
Danish: Nogle af de undersøgelser, hvor lincomycin blev administreret i foder, blev taget i betragtning for at påvise en terapeutisk og/eller metafylaktisk effekt af lincomycin mod enzootisk pneumoni.
English: However, as the pharmacokinetic parameters were greater upon administration of the soluble powder, and it is generally recognised that soluble powders are likely to result in a better bioavailability of the active substance in comparison to in-feed formulations, the CVMP accepted that clinical results relating to the premix formulation could be extrapolated to the soluble powder.
Danish: Da de farmakokinetiske parametre var større efter administration af det opløselige pulver, og da det er almindeligt anerkendt, at opløselige pulvere sandsynligvis medfører en bedre biotilgængelighed af det aktive stof sammenlignet med formuleringer til administration i foderet, accepterede CVMP dog, at de kliniske resultater i forbindelse med premixformuleringen kunne ekstrapoleres til det opløselige pulver.
English: Additionally, the CVMP considered that the following warning needed to be added to section 4.4 ‘Special warnings for each target species' of the summary of product characteristics (SPC):
Danish: CVMP var endvidere af den opfattelse, at følgende advarsel bør tilføjes til punkt 4.4 "Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til" i produktresuméet:
English: However, there was no definitive evidence that strains of C. perfringens with high MICs for lincomycin may be clinically resistant.
Danish: Der var dog ingen endelig evidens for, at stammer af C. perfringens med høje MIC-værdier for lincomycin kan være klinisk resistente.
English: Evaluation and conclusions on the benefit-risk balance
Danish: Vurdering og konklusioner om benefit/risk-forholdet
English: An up-to-date residue depletion study was provided with a soluble powder containing a combination of lincomycin and spectinomycin, and the dose of lincomycin that was administered was approximately 3 to 5 times higher than the recommended dose for Lincocin.
Danish: Der blev fremlagt en ajourført restkoncentrationsundersøgelse med et opløseligt pulver, der indeholder en kombination af lincomycin og spectinomycin, og den administrerede dosis af lincomycin var ca. 3-5 gange højere end den anbefalede dosis for Lincocin.
English: For this reason the above study could be accepted for the determination of the chicken meat and offal withdrawal period for Lincocin.
Danish: Derfor kunne ovennævnte undersøgelse accepteres til fastlæggelse af tilbageholdelsestiden for kød og slagteaffald fra kyllinger, for så vidt angår Lincocin.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Dispensing conditions: Veterinary medicinal product subject to veterinary prescription.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Udleveringsbetingelser: Må kun udleveres efter veterinærrecept.
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 causing premature peptidyl-tRNA dissociation from the ribosome.
Danish: Lincomycin bindes til subunit S50 af det bakterielle ribosom tæt ved peptidyltransferasecenteret og interfererer med forlængelsen af peptiden ved at forårsage præmatur peptidyl-tRNA-dissociering fra ribosomet.
English: Unmetabolised lincomycin declined at a slightly faster half-life (t½ = 5.8 hours) than total residue.
Danish: Umetaboliseret lincomycin faldt med en lidt kortere halveringstiden (t½ = 5,8 timer) end den samle restmængde.
English: However, also see text under section 4.4.
Danish: Se dog også teksten under pkt.
English: Dosage (mg product per kg body weight per day)
Danish: Dosering (mg af lægemidlet pr. kg kropsvægt pr. dag)
English: However, given the variability in active substance intake that can result from dosing via drinking water and the good safety profile for lincomycin, a dose greater than the minimum effective dose was considered to be justifiable.
Danish: I betragtning af den variabilitet i indtaget af det aktive stof, som dosering via drikkevandet kan medføre, og i betragtning af lincomycins gode sikkerhedsprofil blev en dosis, der var større end den minimale effektive dosis, dog anset for at være berettiget.
English: Lincomycin can potentiate neuromuscular effects of anaesthetics and muscle relaxants.
Danish: Lincomycin kan potensere den neuromuskulære effekt af anæstetika og muskelrelaxantia.
English: Overall, considering the scope of procedure the CVMP was of the opinion that the indication ‘Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae' was adequately justified.
Danish: I betragtning af procedurens omfang var CVMP overordnet set af den opfattelse, at indikationen for "behandling og metafylakse af enzootisk pneumoni forårsaget af Mycoplasma hyopneumoniae" var tilstrækkeligt begrundet.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: Laboratory studies in rats have not produced any evidence of teratogenic effects, although foetotoxicity has been reported.
Danish: Laboratorieundersøgelser af rotter har ikke påvist teratogene virkninger, selvom der er indberettet føtal toksicitet.
English: In addition, in a recent referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs or chickens (EMEA/V/A/110)1, the CVMP concluded that indications relating to swine dysentery caused by B. hyodysenteriae were not sufficiently supported and should be deleted from the product information.
Danish: Desuden konkluderede CVMP i en nylig indbringelsesprocedure i medfør af artikel 35 i direktiv 2001/82/EF for alle veterinærlægemidler, der indeholder en kombination af lincomycin og spectinomycin til oral administration hos svin eller kyllinger (EMEA/V/A/110)1, at indikationerne i forbindelse med svinedysenteri forårsaget af B. hyodysenteriae ikke er tilstrækkeligt dokumenteret og bør slettes fra produktinformationen.
English: Shelf life after dilution or reconstitution according to directions: 24 hours.
Danish: Opbevaringstid efter fortynding eller rekonstituering ifølge anvisning: 24 timer.
English: In case of accidental overdose, the treatment must be stopped and restarted at the recommended dose level.
Danish: I tilfælde af en utilsigtet overdosis indstilles behandlingen og startes op igen med den anbefalede dosis.
English: Lincomycin is active against some gram-positive bacteria (Clostridium perfringens) and mycoplasmas (Mycoplasma hyopneumoniae).
Danish: Lincomycin er aktiv mod visse gram-positive bakterier (Clostridium perfringens) og mycoplasmer (Mycoplasma hyopneumoniae).
English: Peak serum levels were observed at 4 hours after dosing.
Danish: De højeste serumværdier blev fundet 4 timer efter indgivelsen.
English: White to off-white powder.
Danish: Hvidt til råhvidt pulver.
English: The marketing authorisation holder also provided additional data from one study which investigated the efficacy of lincomycin as the soluble powder, administered in drinking water to pigs on a farm with known problems with enzootic pneumonia.
Danish: Indehaveren af markedsføringstilladelsen fremlagde ligeledes yderligere data fra en undersøgelse, hvor man undersøgte lincomycins virkning som opløseligt pulver, der blev administreret i drikkevand til svin på en bedrift, som havde kendte problemer med enzootisk pneumoni.
English: The bioavailability of lincomycin may decrease in the presence of gastric antacids or activated charcoal, pectin or kaolin.
Danish: Biotilgængeligheden af lincomycin kan nedsættes ved tilstedeværelse af syreneutraliserende midler eller aktivt kul, pektin eller kaolin.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Flasker indeholdende 150 g eller 1,5 kg
English: However, the most prevalent mechanism in mycoplasmas is the alteration of the binding site through mutational events (chromosomal resistance).
Danish: Den altovervejende mekanisme ved mycoplasmer er dog ændringen af bindingsstedet som følge af mutationer (kromosomal resistens).
English: Withdrawal periods:
Danish: Tilbageholdelsestider: