FrancophonIA/ELRC3.0 huggingface dataset:
English: There is evidence that the concentration of macrolides is higher at the site of infection than in plasma, in particular in neutrophils, alveolar macrophages and alveolar epithelial cells.
Danish: Nogle undersøgelser har vist, at makrolidkoncentrationen er højere på infektionsstedet end i plasma, især neutrofiler, alveolære makrofager og alveolære epitelceller
English: Magazynowa 5, 66-446 Deszczno Tel: +48 95 7214521 fax: +48 95 7214532 E-mail: calierpolska@calier.com.pl
Danish: ul.Magazynowa 5 66-446 Deszczno Tel: +48 95 7214521 fax: +48 95 7214532 E-mail: calierpolska@calier.com.pl
English: Scoops of 2 sizes are provided for measuring the correct amount of Aivlosin for mixing with the daily ration, according to the schedule below.
Danish: Der leveres måleskeer i 2 størrelser til udmåling af den korrekte dosis Aivlosin til iblanding i den daglige foderration i henhold til nedenstående skema.
English: Medicated drinking water should be replaced every 24 hours.
Danish: Medicineret drikkevand skal udskiftes efter 24 timer.
English: 2 kg/tonne* * Important: these inclusion rates assume a pig eats equivalent of 5% bodyweight per day.
Danish: * Vigtigt: Disse tilsætningsprocenter forudsætter, at et svin æder svarende til 5 % af sin legemsvægt pr. dag.
English: One aluminium foil/polyester laminated bag containing 5 or 20 kg. Not all pack sizes may be marketed.
Danish: En aluminiumsfolie/polyester-lamineret sæk indeholdende 5 eller 20 kg. Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Mixing instructions
Danish: Blandingsvejledning
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer veterinærlægemidlet til dyr:
English: Eggs: zero days
Danish: Æg: nul dage.
English: Shelf life after incorporation into feed: 1 month in meal or pellets.
Danish: Opbevaringstid efter indarbejdelse i foder: 1 måned i formalet eller granuleret foder.
English: Six hours after treatment, the concentration of tylvalosin in the gastrointestinal tract mucosa has a mean concentration of 133 ng/g and in the gastrointestinal contents of 1,040 ng/g.
Danish: Seks timer efter behandlingen er den gennemsnitlige koncentration af tylvalosin i mavetarm-kanalens slimhinde 133 ng/g og i mave-tarm-kanalens indhold 1.040 ng/g.
English: Tylvalosin has activity against the following mycoplasma species found in poultry: Mycoplasma gallisepticum.
Danish: Tylvalosin er aktiv mod følgende mycoplasma-arter, der findes i fjerkræ: Mycoplasma gallisepticum.
English: Turkeys: Not for use in birds producing or intended to produce eggs for human consumption.
Danish: Kalkuner: Må ikke anvendes til fugle, hvis æg er bestemt til menneskeføde.
English: Swine enzootic pneumonia
Danish: Enzootisk pneumoni hos svin
English: Shelf life of the veterinary medicinal product as packaged for sale: 40 g sachet - 3 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 40 g pose - 3 år.
English: As an aid in reducing the development of clinical signs and mortality from respiratory disease in flocks, where infection in ovum with Mycoplasma gallisepticum is likely because the disease is known to exist in the parent generation.
Danish: Som en hjælp til at reducere udviklingen af kliniske symptomer og mortalitet af luftvejssygdomme i flokke, hvor infektion in ovum med Mycoplasma gallisepticum er sandsynlig, fordi sygdommen vides at eksistere i forældregenerationen.
English: Chickens/Turkeys
Danish: Kyllinger/kalkuner
English: Pheasants.
Danish: Fasaner.
English: The safety of Aivlosin during pregnancy and lactation has not been established in pigs.
Danish: Aivlosins sikkerhed under drægtighed og laktation er ikke fastlagt hos svin.
English: Tylvalosin is a macrolide antibiotic.
Danish: Tylvalosin er et makrolid-antibiotikum.
English: It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal.
Danish: Det er god klinisk praksis at basere behandlingen på følsomhedstest af bakterierne, som isoleres fra dyret.
English: Macrolides are metabolites or derivatives of metabolites of soil organisms obtained by fermentation.
Danish: Makrolider er metabolitter eller derivater af metabolitter fra jordorganismer fremkommet ved fermentation.
English: Treatment of respiratory disease associated with tylvalosin sensitive strains of Ornithobacterium rhinotracheale in turkeys.
Danish: Behandling af luftvejssygdom i forbindelse med tylvalosinfølsomme stammer af Ornithobacterium rhinotracheale hos kalkuner.
English: Available in sachets containing 40 g or 400 g of product.
Danish: Fås i poser indeholdende 40 g eller 400 g produkt.
English: Macrolides are generally considered bacteriostatic and mycoplasmastatic.
Danish: Makrolider betragtes i reglen som bakteriostatiske og mykoplasmatiske.
English: Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a nondisposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing the product.
Danish: Der skal anvendes personligt sikkerhedsudstyr ved håndtering af veterinærlægemidlet og ved håndtering af foder med tilsat lægemiddel bestående af uigennemtrængelige handsker og 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 den europæiske standard EN 143.
English: (as tylvalosin tartrate) A beige granular powder
Danish: (som tylvalosintartrat) Et beige granuleret pulver.
English: • Treatment of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results.
Danish: • Behandling af porcin proliferativ enteropati (ileitis) forårsaget af Lawsonia intracellularis i besætninger, hvor der er en diagnose baseret på klinisk forløb, post mortem-fund og resultater af kliniske patologiske undersøgelser.
English: In vivo studies have shown tylvalosin to be present in higher concentrations in the mucous lining of the respiratory and gut tissues compared to the plasma.
Danish: In vivo-undersøgelser har vist, at tylvalosin er til stede i højere koncentrationer i slimhinderne i luftvejs- og tarmvæv sammenlignet med plasma.
English: Withdrawal period(s): Meat and offal: 2 days.
Danish: Tilbageholdelsestid(er): Kød og indvolde: 2 dage.
English: Cross-resistance between tylvalosin and other macrolide antibiotics cannot be excluded.
Danish: Krydsresistens mellem tylvalosin og andre makrolidantibiotika kan ikke udelukkes.
English: Major incompatibilities:
Danish: Uforligeligheder:
English: Treatment of respiratory disease associated with Mycoplasma gallisepticum in pheasants.
Danish: Behandling af respiratorisk sygdom forårsaget af Mycoplasma gallisepticum hos fasaner.
English: Determine the combined bodyweight (in kg) of all the chickens to be treated.
Danish: Bestem den kombinerede legemsvægt (i kg) af alle de kyllinger, der skal behandles.
English: Withdrawal period(s): Meat and offal: 1 day.
Danish: Tilbageholdelsestid(er): Kød og indvolde: 1 dag.
English: Tylvalosin has been shown to concentrate in phagocytic cells and gut epithelial cells.
Danish: Det er påvist, at tylvalosin koncentreres i fagocytceller og tarmepitelceller.
English: Aluminium foil laminated sachet containing 40 g or 400 g. Not all pack sizes may be marketed.
Danish: Lamineret aluminiumfoliepose indeholdende 40 g eller 400 g. Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: No adverse effects on egg production, egg fertility, hatchability and chick viability were observed in broiler breeder stock administered 75 mg tylvalosin/kg bodyweight per day for 28 consecutive days.
Danish: Der er ikke observeret uønskede virkninger på produktion af æg, æggenes fertilitet, klækkeevne og kyllingers levedygtighed hos avlsfugle, der producerer æg til slagtekyllinger, ved administration af 75 mg tylvalosin pr. kg legemsvægt pr. dag i 28 på hinanden følgende dage.
English: The minimum inhibitory concentration of tylvalosin for M. gallisepticum ranges from 0.007 to 0.25 µg/ml.
Danish: Tylvalosins minimale inhibitoriske koncentration (minimum inhibitory concentration) for M. gallisepticum ligger i intervallet 0,007 til 0,25 µg/ml.
English: A beige granular powder.
Danish: Et beige granuleret pulver.
English: Do not store above 25 ºC.
Danish: Må ikke opbevares over 25 ºC.
English: Hydrated magnesium silicate (sepiolite) Wheat flour
Danish: Hydreret magnesiumsilikat (sepiolit) Hvedemel
English: The minimal inhibitory concentration (MIC) of tylvalosin for M. gallisepticum ranges from 0.007 to 0.25 µg/ml.
Danish: Tylvalosins minimale inhibitoriske koncentration (MIC) over for M. gallisepticum ligger i intervallet fra 0,007 til 0,25 µg/ml.
English: Aluminium foil laminated sachet containing 40 g, 160 g or 400 g of granules.
Danish: Lamineret aluminiumfoliepose indeholdende 40 g, 160 g eller 400 g granulat.
English: Porcine 50 µg/kg 50 µg/kg
Danish: 50 µg/kg 50 µg/kg 50 µg/kg 50 µg/kg
English: Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly Gram-positive organisms and mycoplasma but also some Gram-negative organisms, including Lawsonia intracellularis.
Danish: Tylvalosin er aktiv mod patogene organismer isoleret fra en række dyrearter, hovedsageligt grampositive organismer og mycoplasma, men også visse gramnegative organismer, herunder Lawson intracellularis.
English: D.
Danish: UDL.D.
English: Granules for use in drinking water.
Danish: Granulat til brug i drikkevand.
English: Pigs.
Danish: Svin.
English: Dose of active substance
Danish: Dosis af aktiv substans
English: Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms obtained by fermentation.
Danish: Makrolidantibiotika er metabolitter eller halvsyntetiske derivater af metabolitter fra jordbakterier fremstillet ved fermentering.
English: Treatment and metaphylaxis of swine enzootic pneumonia
Danish: Behandling og metafylakse af enzootisk pneumoni hos svin
English: Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit.
Danish: Makrolider interfererer med proteinsyntesen ved at binde sig reversibelt til ribosomunderenheden 50S.
English: • Treatment and metaphylaxis of swine dysentery, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed.
Danish: • Behandling og metafylakse af svinedysenteri forårsaget af Brachyspira hyodysenteriae i besætninger, hvor sygdommen er blevet diagnosticeret.
English: NB: A level scoop of the product should be measured As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the potential build-up of resistance.
Danish: NB: Der udmåles en strøgen skefuld af veterinærlægemidlet Som supplement til medicinering bør der introduceres god behandlings- og hygiejnepraksis for at reducere risikoen for infektion og for at kontrollere den potentielle udvikling af resistens.
English: Treatment and metaphylaxis of respiratory infections caused by Mycoplasma gallisepticum in chickens.
Danish: Behandling og metafylakse af luftvejsinfektioner forårsaget af Mycoplasma gallisepticum hos kyllinger.
English: Not for use in birds producing or intended to produce eggs for human consumption.
Danish: Må ikke anvendes til fugle, hvis æg er bestemt til menneskeføde.
English: Available in sachets containing 40 g, 160 g or 400 g of granules.
Danish: Fås i poser med 40 g, 160 g eller 400 g granulat.
English: Shelf life after first opening of the immediate packaging: use immediately.
Danish: Opbevaringstid efter første åbning af den indre emballage: skal anvendes med det samme.
English: Dose of active ingredient
Danish: Dosis af aktivt indholdsstof
English: Special warnings for each target species
Danish: Særlige advarsler for hver dyreart
English: Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some Gram-negative organisms and mycoplasma.
Danish: Tylvalosintartrat er et makrolidantibiotikum, som har antibakteriel virkning over for grampositive organismer og visse gramnegative organismer samt mykoplasma.
English: The parent compound is widely distributed in the tissues with the highest concentrations found in the lungs, bile, intestinal mucosa, spleen, kidney and liver.
Danish: Udgangsstoffet fordeles i stor udstrækning i vævene, og de højeste koncentrationer findes i lungerne, galden, tarmslimhinden, milten, nyrerne og leveren.
English: Chickens and Turkeys EU/2/04/044/018 - 40 g EU/2/04/044/019 - 400 g
Danish: Kyllinger og kalkuner EU/2/04/044/018 - 40 g EU/2/04/044/019 - 400 g
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter ”EXP”.
English: Do not use this veterinary medicinal product after the expiry date, which is stated on the label as “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten som “EXP”.
English: Determine the combined bodyweight (in kg) of all the birds to be treated.
Danish: Beregn den samlede legemsvægt (i kg) af alle de fugle, der skal behandles.
English: Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly Gram-positive organisms and mycoplasma but also some Gram-negative organisms.
Danish: Tylvalosin er aktiv mod patogene organismer isoleret fra en række dyrearter, hovedsageligt grampositive organismer og mycoplasma, men også visse gramnegative organismer.
English: They interfere with protein synthesis by reversibly binding to the 50S ribosome subunit.
Danish: De interfererer med proteinsyntesen ved at binde sig reversibelt til ribosomsubunit 50S.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG 1 PRODUKTRESUME
English: When mixing the product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes).
Danish: Når produktet blandes direkte i drikkevandssystemet, skal posernes indhold strøs ud over vandoverfladen og blandes omhyggeligt, indtil der er fremstillet en klar opløsning (som regel i løbet af 3 minutter).
English: MRL Target tissues
Danish: MRL Målvæv
English: • Treatment and metaphylaxis of swine dysentery in herds, where the disease has been diagnosed.
Danish: • Behandling af metafylakse af svinedysenteri i besætninger, hvor sygdommen er blevet diagnosticeret.
English: Only to be added to dry food.
Danish: Må kun tilsættes til tørfoder.
English: • Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae in pigs.
Danish: • Behandling og metafylakse af enzootisk pneumoni hos svin forårsaget af følsomme stammer af Mycoplasma hyopneumoniae hos svin.
English: NB: A level scoop of the product should be measured.
Danish: NB: Der udmåles en strøgen skefuld af veterinærlægemidlet.
English: 2.125 mg/kg bodyweight/day
Danish: 2,125 mg/kg legemsvægt/dag
English: • Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae.
Danish: • Behandling og metafylakse af enzootisk pneumoni hos svin forårsaget af følsomme stammer af Mycoplasma hyopneumoniae.
English: Aivlosin 42.5 mg/g oral powder for pigs Tylvalosin (as tylvalosin tartrate)
Danish: Aivlosin 42,5 mg/g, oralt pulver til svin Tylvalosin (som tylvalosintartrat)
English: Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above.
Danish: Der er set maternel toksicitet hos gnavere ved doser på 400 mg tylvalosin pr. kg legemsvægt og derover.
English: Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs
Danish: Aivlosin 42,5 mg/g premix til foderlægemiddel til svin.
English: In drinking water use
Danish: Anvendelse i drikkevand
English: Chickens and Turkeys EU/2/04/044/018
Danish: Kyllinger/kalkuner EU/2/04/044/018
English: For treatment of respiratory disease associated with Mycoplasma gallisepticum: The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days.
Danish: Til behandling af luftvejssygdom i forbindelse med Mycoplasma gallisepticum: Dosis er 25 mg tylvalosin pr. kg legemsvægt pr. dag i drikkevand 3 på hinanden følgende dage.
English: Determine the combined bodyweight (in kg) of all the turkeys to be treated.
Danish: Bestem den kombinerede legemsvægt (i kg) af alle de kalkuner, der skal behandles.
English: Pheasants
Danish: Fasaner
English: The safety of the veterinary medicinal product has not been established during lay in turkeys.
Danish: Veterinærlægemidlets sikkerhed under æglægning er ikke fastslået hos kalkuner.
English: Hydrated magnesium silicate, wheat flour.
Danish: Hydreret magnesiumsilikat, hvedemel
English: For use in drinking water.
Danish: Til brug i drikkevand.
English: When mixing the veterinary medicinal product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes).
Danish: Når veterinærlægemidlet blandes direkte i drikkevandssystemet, skal brevets indhold strøs ud over vandoverfladen og blandes omhyggeligt, indtil der er fremstillet en klar opløsning (i reglen i løbet af 3 minutter).
English: Special precautions for use in animals Good management and hygiene practices should be followed to reduce the risk of re-infection.
Danish: Særlige forholdsregler til brug hos dyr: God behandlings- og hygiejnepraksis bør følges for at reducere risikoen for re-infektion.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Aktivt stof:
English: For treatment of respiratory disease associated with Ornithobacterium rhinotracheale: The dose is 25 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days.
Danish: Til behandling af luftvejssygdom i forbindelse med Ornithobacterium rhinotracheale: Dosis er 25 mg tylvalosin pr. kg legemsvægt pr. dag i drikkevand 5 på hinanden følgende dage.
English: The veterinary medicinal product should be added to a volume of water that the birds will consume in one day.
Danish: Veterinærlægemidlet skal blandes med den mængde vand, som fuglene vil drikke i løbet af et døgn.
English: Tylvalosin has activity against the following mycoplasma species found in chickens: Mycoplasma gallisepticum.
Danish: Kyllinger Tylvalosin er aktivt mod følgende mycoplasmaspecies, der er fundet i kyllinger: M. gallisepticum.
English: Number of scoops
Danish: Antal skefulde
English: Chickens and Turkeys EU/2/04/044/019
Danish: Kyllinger/kalkuner EU/2/04/044/019
English: Treatment and metaphylaxis of swine dysentery
Danish: Behandling og metafylakse af svinedysenteri
English: No signs of intolerance have been observed in poultry species at up to 150 mg tylvalosin per kg bodyweight per day for 5 days.
Danish: Der er ikke set nogen tegn på intolerance hos kyllinger ved op til 150 mg tylvalosin pr. kg legemsvægt pr. dag i 5 dage.
English: No signs of intolerance have been observed in pigs at up to 100 mg tylvalosin per kg bodyweight per day for 5 days.
Danish: Der er ikke observeret tegn på intolerans hos svin ved doser på op til 100 mg tylvalosin pr. kg legemsvægt pr. dag i 5 dage.
English: 4.25 mg/kg bodyweight/day
Danish: 4,25 mg/kg legemsvægt/dag
English: Granules for use in drinking water
Danish: Granulat til anvendelse i drikkevand
English: The product should be added to a volume of water that the chickens will consume in one day.
Danish: Produktet skal tilsættes en mængde vand, som kyllingerne vil drikke på et døgn.
English: For example, one sachet of 40 g is sufficient to treat a total of 1,000 birds with an average bodyweight of 1 kg; one sachet of 400 g is sufficient to treat a total of 10,000 birds with an average bodyweight of 1 kg.
Danish: Eksempelvis er et brev med 40 g tilstrækkeligt til at behandle 1.000 fugle med en gennemsnitlig legemsvægt på 1 kg; 400 g tilstrækkeligt til at behandle 10.000 fugle med en gennemsnitlig legemsvægt på 1 kg.
English: 11 MARKETING AUTHORISATION NUMBERS
Danish: 11 MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE)
English: Aivlosin 42.5 mg/g oral powder for pigs
Danish: Aivlosin 42,5 mg/g, oralt pulver til svin
English: In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the potential development of resistance.
Danish: Som supplement til medicinering bør der introduceres god behandlings- og hygiejnepraksis på bedriften for at reducere risikoen for infektion og for at kontrollere den potentielle udvikling af resistens.
English: In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 2,500 kg total pig weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used).
Danish: For at opnå en korrekt dosering kan det være nødvendigt at tilberede en koncentreret (stam-)opløsning (f.eks. skal der kun bruges 50% af den tilberedte stamopløsning fra en 40 g-pose til at behandle svin med en samlet vægt på 2.500 kg).
English: PACKAGE LEAFLET: Aivlosin 42.5 mg/g oral powder for pigs
Danish: INDLÆGSSEDDEL: Aivlosin 42,5 mg/g, oralt pulver til svin
English: As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the build-up of resistance.
Danish: Som supplement til medicinering bør der introduceres god behandlings- og hygiejnepraksis for at reducere risikoen for infektion og for at kontrollere udviklingen af resistens.
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSES NUMMER (NUMRE)
English: The product should be added to a volume of water that the pigs will consume in one day.
Danish: Produktet skal tilsættes en mængde vand, som svinene vil drikke i løbet af et døgn.
English: Use of the veterinary medicinal product deviating from the instructions may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance.
Danish: Brug af veterinærlægemidlet, der ikke overholder retningslinjerne, kan øge risikoen for udvikling og selektion af resistente bakterier og nedsætte virkningen af behandling med andre makrolider på grund af potentialet for krydsresistens.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Granules for use in drinking water for pigs - 160 g sachet
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Granulat til brug i drikkevand til svin - 160 g pose
English: Marker residue
Danish: Restmarkør
English: Good management and hygiene practices should be followed to reduce the risk of re-infection.
Danish: God behandlings- og hygiejnepraksis bør følges for at reducere risikoen for re-infektion.
English: Hydroxypropyl cellulose Non-fat soyabean powder
Danish: Hydroxypropylcellulose Fedtfrit sojapulver
English: Generally, strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides, such as tylosin.
Danish: Generelt har stammer af B. hyodysenteriae højere MIC-værdier i tilfælde af resistens over for andre makrolider, såsom tylosin.