FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration conditions: Administration under the control or direct responsibility of a veterinary surgeon.
Danish: Administrationsbetingelser: Må kun administreres af en dyrlæge eller under dennes ansvar.
English: With regard to the clinical data, several of the studies submitted by the marketing authorisation holder were conducted with an in-feed formulation of lincomycin.
Danish: Hvad angår de kliniske data, blev flere af de undersøgelser, som indehaveren af markedsføringstilladelsen fremlagde, foretaget med en formulering af lincomycin til administration i foderet.
English: The active substance lincomycin is a lincosamide antibiotic and is produced by Streptomyces lincolnensis.
Danish: Det aktive stof lincomycin er et lincosamid-antibiotikum, der produceres af Streptomyces lincolnensis.
English: These conditions are usually selfcorrecting within 5-8 days without discontinuing the lincomycin treatment.
Danish: Disse tilstande forsvinder sædvanligvis spontant i løbet af 5-8 dage uden seponering af behandlingen med lincomycin.
English: White high density polyethylene (HDPE) bottle containing 150 g or 1.5 kg powder for use in drinking water with a tamper evident low density polyethylene (LDPE) lid.
Danish: Hvid beholder af HDPE (højdensitetspolyethylen) indeholdende 150 g eller 1,5 kg pulver til brug i drikkevand med et forseglet låg af LDPE (lavdensitetspolyethylen).
English: Medicated drinking water should be freshly prepared every 24 hours.
Danish: En frisk mængde medicineret vand bør klargøres hver 24. time.
English: For chickens, the currently authorised dose and the harmonised proposal was to administer 3-6 mg lincomycin per kg of body weight daily for 7 consecutive days.
Danish: For kyllingers vedkommende var den aktuelle tilladte dosis og det harmoniserede forslag at administrere 3-6 mg lincomycin pr. kg kropsvægt dagligt i 7 på hinanden følgende dage.
English: In addition, there is a lack of clinical breakpoints for both M. hyopneumoniae and C. perfringens.
Danish: Derudover er der mangel på kliniske breakpoints for både M. hyopneumoniae og C. perfringens.
English: Therefore, it was considered that the proposed withdrawal period of 5 days can be regarded as safe for the recommended dosing regimen of 5 mg of lincomycin per kg of body weight per day for 7 days.
Danish: Man var således af den opfattelse, at den foreslåede tilbageholdelsestid på 5 dage kan betragtes som sikker for det anbefalede dosisregime på 5 mg lincomycin pr. kg kropsvægt dagligt i 7 dage.
English: Macrolides, lincosamides and streptogramins antimicrobials are listed by WHO (2017)3 as critically important for the treatment of certain zoonotic infections in humans (such as Campylobacter infections).
Danish: WHO (2017)3 har angivet antimikrobielle stoffer i form af makrolider, lincosamider og streptograminer som værende af afgørende betydning for behandlingen af visse zoonotiske infektioner hos mennesker (f.eks. infektioner med Campylobacter).
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 EN140 with a filter EN143), gloves and safety glasses should be worn when handling and mixing the product.
Danish: Personligt beskyttelsesudstyr i form af godkendt støvmaske (enten halvmaske anvendt som åndedrætsværn til engangsbrug i henhold til European Standard 149 (EN149) eller en maske anvendt som åndedrætsværn til flergangsbrug i henhold til EN140 med filter i henhold til EN143), handsker og sikkerhedsbriller bør anvendes ved håndtering og opblandning af lægemidlet.
English: Nevertheless, based on the MIC data provided including the study conducted by the marketing authorisation holder in 2016, it could be concluded that the susceptibility pattern of M. hyopneumoniae to lincomycin has not changed significantly over the last 20-25 years.
Danish: På baggrund af de fremlagte MIC-data, herunder den undersøgelse, som indehaveren af markedsføringstilladelsen foretog i 2016, kunne det dog konkluderes, at mønsteret for M. hyopneumoniaes følsomhed over for lincomycin ikke har ændret sig væsentligt i de seneste 20-25 år.
English: Special precautions for use in animals:
Danish: Specielle forholdsregler til brug hos dyr:
English: People with known hypersensitivity to lincomycin or any other lincosamide, or to lactose monohydrate, should avoid contact with the veterinary medicinal product.
Danish: Personer, der er overfølsomme over for lincomycin, et andet lincosamid eller laktosemonohydrat, bør undgå kontakt med veterinærlægemidlet.
English: Although these risks have 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 group is a reality.
Danish: Disse risici er ikke 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.
English: 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.
Danish: Gentagen dosering af svin med daglige orale doser lincomycin på 22 mg/kg kropsvægt i 3 dage indikerede ingen ophobning af lincomycin hos arter, der ikke fremviste antibiotika i registrerbare serumværdier 24 timer efter administration.
English: On rare occasions, pigs given lincomycin-medicated water may develop diarrhoea/soft stools and/or mild swelling of the anus within the first 2 days after onset of treatment.
Danish: Svin, der gives vand indeholdende lincomycin, kan i sjældne tilfælde udvikle diarré/tynd afføring og/eller svag hævelse af tarmåbningen i løbet af de første 2 dage efter behandlingsstart.
English: Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Danish: Lincomycin er et lincosamid-antibiotikum, der produceres af Streptomyces lincolnensis, som hæmmer proteinsyntese.
English: Lincocin is a powder for oral solution containing 400 mg lincomycin per gram product.
Danish: Lincocin er et pulver til oral opløsning, som indeholder 400 mg lincomycin pr. gram af lægemidlet.
English: Section 4.9 ‘Amounts to be administered and route of administration' of the SPC was nevertheless modified, mainly for the purpose of increased clarity.
Danish: Punkt 4.9 "Dosering og indgivelsesvej" i produktresuméet blev dog ændret, hovedsagelig for at skabe større klarhed.
English: Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to the lincomycin and may decrease the effectiveness of treatment with other lincosamides, macrolides and streptogramin B due to the potential for cross-resistance.
Danish: Brug af veterinærlægemidlet på anden måde end ifølge anvisningerne i produktresuméet kan øge udbredelsen af bakterier, der er resistente over for lincomycin, og kan nedsætte effekten af behandlingen med andre lincosamider, macrolider og streptogramin B som følge af risikoen for krydsresistens.
English: A dose titration study investigated the therapeutic effect of various levels of lincomycin administered via drinking water on necrotic enteritis in broilers under simulated natural conditions.
Danish: Ved hjælp af en dosistitreringsundersøgelse undersøgte man den terapeutiske effekt af forskellige niveauer af lincomycin administreret via drikkevand på nekrotisk enteritis hos slagtekyllinger under simulerede naturlige betingelser.
English: A dosage greater than 10 mg lincomycin per kg of body weight may cause diarrhoea and loose stools in pigs.
Danish: En dosis på mere end 10 mg lincomycin pr. kg kropsvægt kan medføre diarré og tynd afføring hos svin.
English: The benefit-risk balance in relation to the use of Lincocin against swine dysentery caused by B. hyodysenteriae is considered to be negative due to development of acquired resistance and high uncertainty about its impact in terms of in vivo efficacy.
Danish: Benefit/risk-forholdet for anvendelse af Lincocin mod svinedysenteri forårsaget af B. hyodysenteriae anses for negativt på grund af udviklingen af erhvervet resistens og stor usikkerhed omkring betydningen heraf for virkningen in vivo.
English: As there were no data to support a withdrawal period in laying hens, the use of the product should not be authorised in laying birds producing eggs for human consumption.
Danish: Da der ikke var nogen data til at støtte en tilbageholdelsestid for æglæggende høns, bør brugen af lægemidlet ikke tillades til æglæggende fugle, som producerer æg til menneskeligt konsum.
English: Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Chickens were administered lincomycin hydrochloride in the drinking water at a level of approximately 34 mg/litre (5.1-6.6 mg/kg body weight) for seven days.
Danish: Der blev administreret lincomycinhydrochlorid i drikkevandet til kyllinger med ca. 34 mg/l (5,16,6 mg/kg kropsvægt) i 7 dage.
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 oral dosis lincomycinhydrochlorid på ca. 22, 55 og 100 mg/kg kropsvægt til svin medførte dosisrelaterede serumværdier for lincomycin registreret 24-36 timer efter indgivelsen.
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 lægemidlets virkning og generel betydning for dyrs og menneskers sundhed:
English: Additionally the wording of section 4.9 ‘Amounts to be administered and route of administration' of the SPC was extensively modified, with the main aim of increasing clarity.
Danish: Desuden blev ordlyden i punkt 4.9 "Dosering og indgivelsesvej" i produktresuméet i vid udstrækning ændret, hovedsagelig for at skabe større klarhed.
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: I tilfælde af symptomer som hududslæt eller vedvarende øjenirritation efter eksponering skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: In conclusion, considering that the susceptibility pattern of C. perfringens to lincomycin has not changed significantly over the last 25 years and the lack of a definite correlation between MICs and clinical efficacy and in the context of the procedure, the CVMP considered that the indication is adequately justified and hence chickens can be retained as a target species.
Danish: Som konklusion var CVMP af den opfattelse, i betragtning af at mønsteret for C. perfringens følsomhed over for lincomycin ikke har ændret sig væsentligt i de seneste 25 år, og at der ikke er en endelig sammenhæng mellem MIC-værdier og klinisk virkning i forbindelse med proceduren, at indikationen er tilstrækkeligt begrundet, og at kyllinger dermed kan forblive måldyreart.
English: Despite the lack of standardised procedures for MIC testing of antimicrobial agents against mycoplasmas and clinical breakpoints, based on the MIC data provided it could be concluded that the susceptibility pattern of M. hyopneumoniae to lincomycin has not changed significantly over the last 20-25 years.
Danish: På trods af at der ikke eksisterer nogen standardiserede procedurer for MIC-test af antimikrobielle stoffer mod mycoplasma, og at der ikke er fastsat nogen kliniske afskæringspunkter, kunne det ud fra de fremlagte MIC-data konkluderes, at mønsteret for M. hyopneumoniaes følsomhed over for lincomycin ikke har ændret sig væsentligt i de seneste 20-25 år.
English: The dosing regimen for the indication was not changed and remained at 10 mg lincomycin/kg body weight daily for 21 consecutive days.
Danish: Dosisregimet for indikationen forblev uændret og var stadig 10 mg lincomycin/kg kropsvægt dagligt i 21 på hinanden følgende dage.
English: PHARMACEUTICAL FORM Powder for use in drinking water.
Danish: LÆGEMIDDELFORM Pulver til brug i drikkevand.
English: With regard to the withdrawal period, a satisfactory residue depletion study in pigs was provided by the marketing authorisation holder.
Danish: Med hensyn til tilbageholdelsestiden fremlagde indehaveren af markedsføringstilladelsen en tilfredsstillende restkoncentrationsundersøgelse hos svin.
English: It was calculated that a concentration of 16.9 mg/l was the minimal dose that would give the maximum effect; this corresponds with a calculated dose of 3.9 mg/kg body weight.
Danish: Det blev beregnet, at en koncentration på 16,9 mg/l var den minimale dosis, der ville give den maksimale effekt.
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 macrolides, lincosamides and streptogramins group.
Danish: Modstandsdygtighed over for lincomycin skyldes ofte plasmidbårne faktorer (erm-gener) med kodning for methylaser, der ændrer det ribosomale bindingssted og ofte fører til krydsresistens over for andre antimikrobielle stoffer i macrolid-, lincosamid- og streptogramingruppen.
English: Oral use (via drinking water)
Danish: Oral anvendelse (i drikkevand)
English: There is no specific antidote, treatment is symptomatic.
Danish: Behandlingen er symptomatisk.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Videnskabelige konklusioner og begrundelser for ændring af produktresuméet, etiketteringen og indlægssedlen
English: Do not administer, and do not allow access to water containing lincomycin, to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-intestinal disturbance.
Danish: Undlad at indgive samt give adgang til vand indeholdende lincomycin til kaniner, hamstre, marsvin, chinchillaer, heste eller drøvtyggere, eftersom det vil kunne medføre alvorlige gastrointestinale forstyrrelser.
English: With regard to the in vitro susceptibility data, although there is no standardised methodology for determination of the MIC for antibiotics against B. hyodysenteriae, it was evident that the majority of isolates fall outside the apparent wild-type population.
Danish: Selv om der ikke er nogen standardiseret metode til bestemmelse af MIC for antibiotika mod B. hyodysenteriae, stod det med hensyn til in vitro-følsomhedsdataene klart, at størstedelen af isolaterne falder uden for den tilsyneladende vildtypepopulation.
English: If respiratory symptoms develop following exposure, seek medical advice and show this warning to the physician.
Danish: Ved tegn på åndedrætssymptomer efter eksponering søges lægehjælp og denne advarsel bør vises til lægen.
English: The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Danish: Følsomheden af Mycoplasma hyopneumoniae over for antimikrobielle stoffer er vanskelig at teste in vitro som følge af tekniske begrænsninger.
English: The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay in the target species.
Danish: Lægemidlets sikkerhed under drægtighed, laktation eller æglægning er ikke fastlagt for de dyrearter, som lægemidlet er beregnet til.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1
Danish: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-laNeuve
English: The in vitro data from published literature and from the marketing authorisation holder's own study indicated that the MIC distribution for lincomycin was wide and not unimodal.
Danish: In vitro-dataene fra offentliggjort litteratur og fra indehaveren af markedsføringstilladelsens egen undersøgelse viste, at MIC-fordelingen for lincomycin var bred og ikke unimodal.
English: “The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints.
Danish: "Mycoplasma hyopneumoniaes følsomhed over for antimikrobielle stoffer er vanskelig at teste in vitro som følge af tekniske begrænsninger.
English: 470,6 mg lincomycin HCl/g (corresponding to 400 mg lincomycin/g)
Danish: Lincomycinhydrochlorid 470,6 mg lincomycin HCl/g (corresponding to 400 mg lincomycin/g)
English: Bottle of 150 g Bottle of 1.5 kg
Danish: Pakningsstørrelser: Flaske med 150 g Flaske med 1,5 kg
English: Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.”
Danish: Hvor det er muligt, bør behandlingen være baseret på lokal epidemiologisk information (på regionalt niveau og bedriftsniveau) om responsen af enzootisk pneumoni/nekrotisk enteritis på behandling med lincomycin."
English: Shelf life after first opening the container: use immediately.
Danish: Opbevaringstid efter første åbning af beholderen: anvendes straks.
English: In order to obtain the correct dosage, the concentration of the lincomycin has to be adjusted accordingly.
Danish: Koncentrationen af lincomycin skal reguleres i henhold til dette for at opnå den rigtige dosis.
English: CVMP opinion for a referral procedure (EMEA/V/A/110) under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry - link procedure, the CVMP concluded that this indication should also be deleted from the product information for Lincocin.
Danish: CVMP opinion for a referral procedure (EMEA/V/A/110) under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry - link
English: Concerning the indication for treatment and metaphylaxis of swine dysentery caused by Brachyspira hyodysenteriae and/or other bacteria susceptible to lincomycin, the marketing authorisation holder presented Minimum Inhibitory Concentration (MIC) data from several studies (including recent proprietary studies performed in 2016), clinical trials and studies from the scientific literature.
Danish: Hvad angår indikationen for behandling og metafylakse af svinedysenteri forårsaget af Brachyspira hyodysenteriae og/eller andre bakterier, der er følsomme over for lincomycin, fremlagde indehaveren af markedsføringstilladelse data om minimale inhibitoriske koncentrationer (MIC) fra flere undersøgelser (herunder nylige interne undersøgelser foretaget i 2016), kliniske undersøgelser og undersøgelser fra den videnskabelige litteratur.
English: preferable; based on the data available and taking into account the variability of water intake and hence the dose ingested by the treated animals, a dose rate of 5 mg lincomycin per kg of body weight for 7 days was proposed.
Danish: På baggrund af de tilgængelige data og i betragtning af variabiliteten i vandindtaget og dermed de behandlede dyrs dosis blev en dosis på 5 mg lincomycin pr. kg kropsvægt i 7 dage foreslået.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Danish: TEKSTEN ”KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Lincomycin undergoes enterohepatic circulation.
Danish: Lincomycin indgår i det enterohepatiske kredsløb.
English: Lincocin 40% Lincomycin (as lincomycin hydrochloride)
Danish: Lincocin 40% Lincomycin (som lincomycinhydrochlorid)
English: Lincocin has been shown to be efficacious for the treatment and metaphylaxis of enzootic pneumonia caused by M. hyopneumoniae in pigs.
Danish: Det er påvist, at Lincocin er effektivt til behandling og metafylakse af enzootisk pneumoni forårsaget af M. hyopneumoniae hos svin.
English: The provided clinical data demonstrated that Lincocin was effective in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens at a dose rate of 5 mg lincomycin per kg of body weight for 7 consecutive days.
Danish: De fremlagte kliniske data viste, at Lincocin var effektivt til behandling og metafylakse af nekrotisk enteritis forårsaget af C. perfringens i en dosis på 5 mg lincomycin pr. kg kropsvægt i 7 på hinanden følgende dage.
English: The provided clinical data demonstrated that Lincocin was effective in the treatment and metaphylaxis of enzootic pneumonia caused by M. hyopneumoniae when administered at 10 mg lincomycin per kg of body weight for 21 consecutive days.
Danish: De fremlagte kliniske data viste, at Lincocin var effektivt til behandling og metafylakse af enzootisk pneumoni forårsaget af M. hyopneumoniae, når det blev administreret i en dosis på 10 mg lincomycin pr. kg kropsvægt i 21 på hinanden følgende dage.
English: The in vitro data from published literature and from the marketing authorisation holder's own study indicated that the MICs for lincomycin had wide ranges and were not unimodal.
Danish: In vitro-dataene fra offentliggjort litteratur og fra indehaveren af markedsføringstilladelsens egen undersøgelse viste, at MIC-værdierne for lincomycin var brede og ikke var unimodale.
English: Do not use in cases of hepatic dysfunction.
Danish: Må ikke anvendes i tilfælde nedsat leverfunktion.
English: Do not mix with any other veterinary medicinal product
Danish: Må ikke blandes med lægemidler til dyr.
English: Lincocin has also been proven to be efficacious in the treatment and metaphylaxis of necrotic enteritis caused by C. perfringens in chickens.
Danish: Det er ligeledes dokumenteret, at Lincocin er effektivt til behandling og metafylakse af nekrotisk enteritis forårsaget af C. perfringens hos kyllinger.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt.
English: Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.
Danish: Behandlingen bør så vidt muligt baseres på lokale epidemiologiske oplysninger (på regionalt niveau, for det enkelte landbrug) om, hvordan enzootisk pneumoni/nekrotisk enteritis reagerer på behandling med lincomycin.
English: The CVMP acknowledged the difficulties in determining a single dose and agreed that although somewhat arbitrarily selected, the proposal for a dose rate of 5 mg lincomycin per kg of body weight for 7 days is acceptable.
Danish: CVMP anerkendte, at det var vanskeligt at fastlægge en enkelt dosis og fastslog, at forslaget om en dosis på 5 mg lincomycin pr. kg kropsvægt i 7 dage var acceptabelt, selv om dosis var en smule vilkårligt valgt.
English: SPECIAL STORAGE CONDITIONS
Danish: 6.4 Særlige opbevaringsforhold
English: Colloidal anhydrous silica Lactose monohydrate
Danish: Silica, vandfri, kolloid Laktosemonohydrat
English: • the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Danish: • indbringelsen vedrørte harmoniseringen af produktresuméet, etiketteringen og indlægssedlen
English: It seemed to be in line with the posology assessed in the studies provided; however, the two-fold dose range with no clear guidance for the end-user as to when to administer the product at either the higher or lower limit of the range was considered to be ambiguous.
Danish: Det dobbelte dosisinterval uden en klar vejledning til slutbrugeren om, hvornår lægemidlet skal administreres i henholdsvis den højeste og den laveste dosis, blev dog anset for at være uklart.