FrancophonIA/ELRC3.0 huggingface dataset:
English: In controlled trials in susceptible animals, mortality was less than 1%.
Danish: I kontrollerede forsøg med modtagelige dyr var dødeligheden mindre end 1 %.
English: Larger groups should be treated with medicated feeding stuff containing the premix.
Danish: Større grupper bør behandles med medicineret foder indeholdende premixen.
English: Econor 10% premix and Econor 10% oral powder Elanco France S.A.S
Danish: Econor 10 % premix og Econor 10 % oralt pulver Elanco France S.A.S
English: Valnemulin has activity against a range of bacteria including those responsible for enteric and respiratory disease in pigs.
Danish: Valnemulin er virksomt mod en række bakterier, herunder dem, der giver anledning til tarm- og luftvejssygdomme hos svin.
English: Toxic signs have not been seen in pigs given 5 times the recommended dose.
Danish: Tegn på forgiftning er ikke konstateret hos svin, der har fået 5 gange den anbefalede dosis.
English: There appears to be no resistance development to valnemulin to date by M. hyopneumoniae and L. intracellularis.
Danish: Der synes ikke at være resistensudvikling mod valnemulin af M. hyopneumoniae og L. intracellularis til dato.
English: In liver, traces of valnemulin were observed.
Danish: Der blev observeret spor af valnemulin i leveren.
English: At a dose of 3.8 mg/kg administration, the total colon contents concentration was 1.6 µg/g.
Danish: Ved en dosis på 3,8 mg/kg var den totale tarmkoncentration 1,6 µg/g
English: Responsible use of antimicrobials
Danish: Ansvarsbevidst brug af antimikrobielle midler
English: In a field trial, treated rabbits showed a lower frequency of impaction and diarrhoea than untreated rabbits (4% and 12% vs 9% and 13%, respectively).
Danish: I en felttest udviste behandlede kaniner en lavere forekomst af impaktion og diarré end ubehandlede kaniner (hhv. 4 % og 12 % vs. 9 % og 13 %).
English: In pigs, after a single oral dose of radiolabelled material more than 90% absorption was demonstrated.
Danish: Efter en enkelt oral dosis af radioaktivt mærket materiale påvistes mere end 90 % absorption hos svin.
English: NB: a level scoop of the veterinary medicinal product should be measured.
Danish: NB: der bør anvendes strøgne skefulde af veterinærlægemidlet.
English: Plastic scoops: 50% HIPS (High Impact Polystyrene) and 50% GPPS (General Purpose Polystyrene).
Danish: Aluminiumforede plastposer á 1 kg. Plastskeer: 50 % HIPS (High Impact Polystyren) og 50 % GPPS (General Purpose Polystyren).
English: Inclusion levels may also need to be increased in older pigs or pigs on restricted feed to achieve target dosage.
Danish: Det kan også være nødvendigt at øge inklusionsniveauerne til ældre svin på restriktiv fodring for at opnå den ønskede dosering.
English: This is achieved by thoroughly mixing the required amount of Econor oral powder into the daily ration for each individual pig.
Danish: Dette opnås ved at blande den krævede mængde Econor oralt pulver grundigt med den daglige ration foder til hvert enkelt svin.
English: For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment should be considered.
Danish: Til alvorligt påvirkede dyr, som ikke reagerer på behandlingen inden for 3-5 dage, bør parenteral behandling overvejes.
English: In rabbits, valnemulin is extensively metabolised with the same metabolites being found as in pigs.
Danish: I kaniner metaboliseres valnemulin i udstrakt grad med de samme metabolitter som i svin.
English: Econor 10%, Econor 50%: 1 kg and 25 kg aluminium-lined plastic bags.
Danish: Econor 10%, Econor 50%: 1 kg og 25 kg i aluminiumforede plastposer.
English: The correct quantity of Econor oral powder should be added to the estimated quantity of the daily ration for each pig, in a bucket or suitable receptacle and thoroughly mixed.
Danish: Den korrekte mængde af Econor oralt pulver bør tilsættes den anslåede mængde af daglig ration foder til hvert svin i en spand eller passende beholder og blandes omhyggeligt.
English: However, mortality in affected rabbits is reduced by administering the product.
Danish: Dog reduceres dødeligheden blandt de syge kaniner ved indgivelse af produktet.
English: MIC of wild-type population (µg/ml)
Danish: MIC af vild-type population (µg/ml)
English: Aggressive pelleting conditions such as temperatures in excess of 80 °C, and the use of abrasive substances for pre- mixture should be avoided.
Danish: Aggressive foderpelleteringsforhold ved temperaturer over 80 °C bør undgås, ligesom anvendelse af slibestoffer til forblanding.
English: Feed consumption may be reduced in clinically sick animals and also in older pigs therefore feed intake may need to be adjusted to achieve target dosage intake.
Danish: Foderindtagelsen kan være reduceret hos klinisk syge dyr og også i ældre svin, hvorfor det kan være nødvendigt at justere foderindtagelsen for at opnå den dosis, der er målet.
English: No radio-labelled metabolism studies were conducted in rabbits.
Danish: Der er ikke udført metabolisme-forsøg med radioaktivt mærket materiale med kaniner.
English: The veterinary medicinal product may be mixed in liquid feeds containing water, or milk-based co-products only.
Danish: Veterinærlægemidlet kan blandes i vådfoder indeholdende alene vand- eller mælkebaserede biprodukter.
English: Only use in the case of confirmed epizootic rabbit enteropathy (ERE) outbreaks when diagnosis has been made clinically and confirmed by necropsy.
Danish: Anvendes udelukkende i tilfælde af bekræftede udbrud af epizootisk enteropati hos kaniner (ERE), når der er stillet en klinisk diagnose, som er bekræftet med nekropsi.
English: For severely affected animals, which fail to respond to treatment within 3-5 days, parenteral treatment should be considered.
Danish: For svært angrebne dyr, der ikke responderer på behandlingen indenfor 3-5 dage, bør parenteral behandling overvejes.
English: and spirochaetes such as Brachyspira hyodysenteriae and Brachyspira pilosicoli and Lawsonia intracellularis.
Danish: og spirochæter som f. eks. Brachyspira hyodysenteriae og Brachyspira pilosicoli og Lawsonia intracellularis.
English: METHOD AND ROUTE(S) OF ADMINISTRATION In-feed use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Anvendelse i foder.
English: Treatment of swine enzootic pneumonia caused by Mycoplasma hyopneumoniae.
Danish: Behandling af enzootisk pneumoni forårsaget af Mycoplasma hyopneumoniae.
English: Reduction of mortality during an outbreak of epizootic rabbit enteropathy (ERE).
Danish: Reduktion af dødeligheden under et udbrud af epizootisk enteropati hos kaniner (Epizootic Rabbit Enteropathy - ERE).
English: Scoops - two scoops measuring 1 g and 3 g of Econor 10% oral powder are supplied.
Danish: Skeer - to skeer, der kan indeholde 1 g og 3 g Econor 10 % oralt pulver, er vedlagt.
English: Indication Dosage (active substance)
Danish: Indikation Dosering (aktiv substans)
English: Treatment of swine dysentery caused by Brachyspira hyodysenteriae.
Danish: Behandling af svinedysenteri forårsaget af Brachyspira hyodysenteriae.
English: Application in feed
Danish: Indgivelse i foder
English: In pigs valnemulin is extensively metabolised and excretion of parent molecule and metabolites occurs mainly via bile.
Danish: I svin metaboliseres valnemulin i udstrakt grad, og udskillelse af udgangsstoffet og metabolitter sker hovedsagelig via galden.
English: Overdose (symptoms, emergency procedures, antidotes): Toxic signs have not been seen in pigs given 5 times the recommended dose.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift): Der er ikke set toksiske tegn hos svin, som har fået 5 gange den anbefalede dosis.
English: In the case of an adverse reaction, immediate withdrawal of medication is recommended.
Danish: I tilfælde af bivirkninger anbefales øjeblikkelig ophør af medicinering.
English: Rabbits may still show clinical signs of Epizootic Rabbit Enteropathy (ERE) even when treated with the product.
Danish: Kaniner kan stadig udvise kliniske tegn på epizootisk enteropati hos kaniner (ERE), selvom de behandles med produktet.
English: The veterinary medicinal product can be used in dry or liquid feeds, where water or milk co-products have been added.
Danish: Veterinærlægemidlet kan anvendes i tør- eller vådfoder, hvor der er tilsat vand- eller mælkebaserede biprodukter.
English: Do not overdose in rabbits - increased doses may disturb gastrointestinal flora leading to the development of enterotoxaemia.
Danish: Undgå at overdosere til kaniner - øgede doser kan forstyrre den gastrointestinale flora, hvilket kan medføre enterotoxæmi.
English: In-feed use.
Danish: Anvendelse i foder.
English: Adverse reactions have occurred following the use of Econor.
Danish: Bivirkninger er forekommet efter brug af Econor.
English: The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE ALUMINIUM-LINED PLASTIC BAGS
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ALUMINIUMFOREDE PLASTPOSER
English: The amount of feed mixed with Econor 10% oral powder which is necessary for treatment should be freshly prepared daily.
Danish: Den for behandlingen nødvendige mængde foder blandet med Econor 10 % oralt pulver bør forberedes frisk dagligt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Econor contains valnemulin in the form of valnemulin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Econor indeholder valnemulin i form af valnemulin hydrochlorid.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: Teksten “Kun til dyr” samt betingelser eller begrænsninger for udlevering og brug om nødvendigt
English: Kidney Liver Muscle
Danish: Nyre Lever Muskel
English: Pharmacologically active substance
Danish: Farmakolog isk aktive stof
English: Two hours after withdrawal of product given in feed twice daily for 4 weeks at a dose of 15 mg/kg bodyweight/day, liver concentration was 1.58 µg/g and lung concentration 0.23 µg/g whereas concentrations in plasma were below the limit of detection.
Danish: To timer efter sidste indgift af produkt givet i foder to gange daglig i 4 uger med en dosis på 15 mg/kg legemsvægt/dag, var leverkoncentrationen 1,58 µg/g og lungekoncentrationen 0,23 µg/g, hvorimod koncentrationerne i plasma var under detektionsgrænsen.
English: Scoops of 2 sizes are provided for measuring the correct amount of the veterinary medicinal product for mixing with the daily ration, according to the dosage guidance table below.
Danish: Der er sørget for skeer i 2 størrelser til afmåling af den korrekte mængde af veterinærlægemidlet, der skal blandes med den daglige ration foder ifølge doseringsvejledningen herunder.
English: Especially in the case of swine dysentery, a targeted early eradication programme of the disease should be considered.
Danish: Særligt i forbindelse med svinedysenteri bør man overveje et målrettet tidligt udryddelsesprogram af sygdommen.
English: The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd.
Danish: Forebyggelse af kliniske tegn på porcin colonic spirochaetose (colitis), når sygdommen er diagnosticeret i besætningen.
English: Two hours after withdrawal of premix given in feed twice daily for 4 weeks at a dose of 15 mg/kg bodyweight/day, liver concentration was 1.58 µg/g and lung concentration 0.23 µg/g whereas concentrations in plasma were below the limit of detection.
Danish: To timer efter den sidste indgift af premix givet i foder to gange daglig i 4 uger med en dosis på 15 mg/kg legemsvægt/dag, var leverkoncentrationen 1,58 µg/g og lungekoncentrationen 0,23 µg/g, hvorimod koncentrationerne i plasma var under detektionsgrænsen.
English: For rabbits it is indicated to reduce the mortality during an outbreak of epizootic rabbit enteropathy (ERE) when the disease has been diagnosed in the herd.
Danish: For kaniner er det indiceret til at reducere dødeligheden under et udbrud af epizootisk enteropati hos kaniner (ERE), hvor sygdommen er diagnosticeret i besætningen.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: A. FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: Econor 50% Hypromellose Talc
Danish: Econor 50% Hypromellose Talkum
English: Hypromellose Talc
Danish: Hypromellose Talkum
English: Valnemulin has little activity against Enterobacteriaceae, such as Salmonella spp.
Danish: Valnemulin har ringe effekt mod Enterobacteriaceae, som f.eks.
English: Econor 10% Hypromellose Talc
Danish: Econor 10% Hypromellose Talkum
English: Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific treatment.
Danish: Sekundær infektion af organismer som f.eks. Pasteurella multocida og Actinobacillus pleuropneumoniae kan komplicere enzootisk pneumoni og kræve specifik behandling.
English: Treatment of swine enzootic pneumonia The recommended dose of valnemulin is 10-12 mg/kg bodyweight/day for up to 3 weeks.
Danish: Behandling af enzootisk pneumoni Den anbefalede dosis af valnemulin er 10-12 mg/kg legemsvægt/dag i op til 3 uger.
English: Extreme care should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds thereof, especially in younger pigs.
Danish: Der bør derfor udvises meget stor forsigtighed ved anvendelse af Econor til svin af dansk eller svensk landrace, eller krydsninger heraf, specielt til yngre svin.
English: When treating infections caused by Brachyspira spp., therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Danish: bør behandling baseres på lokal (regional, gårdniveau) epidemiologisk information om målbakteriernes følsomhed.
English: Rabbits: Meat and offal: Zero days.
Danish: Kaniner: Kød og indmad: 0 dage.
English: The recommended dose of valnemulin is 3-4 mg/kg bodyweight/day for a minimum of 7 days and up to 4 weeks, or until signs of disease disappear.
Danish: Den anbefalede dosis af valnemulin er 3-4 mg/kg legemsvægt/dag i minimum 7 dage og op til 4 uger, eller indtil symptomerne på sygdommen forsvinder.
English: Valnemulin is an antibiotic belonging to the pleuromutilin group, which act by the inhibition of the initiation of protein synthesis at the level of the bacterial ribosome.
Danish: Valnemulin er et antibiotikum tilhørende pleuromutilin-gruppen, hvis virkning består i, at det blokerer påbegyndelsen af proteinsyntesen på bakterieribosomniveau.
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Danish: -Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger ) -Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) -Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) -Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) -Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: People with known hypersensitivity to valnemulin should administer the veterinary medicinal product with caution.
Danish: Personer med kendt overfølsomhed overfor valnemulin skal behandle det veterinærmedicinske produkt med forsigtighed.
English: Extreme care should be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds thereof, especially in younger pigs.
Danish: Der bør udvises meget stor forsigtighed ved anvendelse af Econor til svin af dansk eller svensk landrace, eller krydsninger heraf, specielt til yngre 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 potential build-up of resistance.
Danish: Som et supplement til medicinering bør man introducere god håndterings- og hygiejnepraksis for at reducere risikoen for infektion og for at kontrollere den potentielle opbygning af resistens.
English: Maximum plasma concentrations (Cmax) of radio-labelled or ‘cold' material were obtained 1-4 hours after dosing (Tmax) with a plasma half-life (t½), estimated from non-radioactive data, between 1 and 4.5 hours.
Danish: Maksimale plasmakoncentrationer (Cmax) af radioaktivt mærket eller ikke radioaktivt mærket materiale blev opnået 1-4 timer efter dosering (Tmax) med en plasmahalveringstid (t½) mellem 1 og 4,5 timer, vurderet på basis af data fra ikke radioaktivt mærket materiale.
English: Do not overdose in rabbits - increased doses may disturb gastrointestinal flora leading to the development of enterotoxaemia (see section 4.3).
Danish: Undgå at overdosere til kaniner - øgede doser kan forstyrre den gastrointestinale flora, hvilket kan medføre enterotoxæmi (se pkt.
English: Package size
Danish: PAKNINGSSTØRRELSE
English: The required quantity of Econor is thoroughly mixed with the feed in the proportion: 1 part Econor oral powder to 10 parts feed before the final addition of the remainder of the feed.
Danish: Den ønskede mængde af Econor blandes grundigt med foderet i forholdet: 1 del Econor oralt pulver til 10 dele foder, før det sidste af foderet iblandes.
English: In-feed use for rabbits:
Danish: Anvendelse i foder til kaniner:
English: Valnemulin hydrochloride
Danish: Valnemulin hydrochlorid
English: Mixing instructions:
Danish: Blandevejledning:
English: Treatment of clinical signs of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis.
Danish: Behandling af kliniske tegn på porcin proliferativ enteritis (ileitis) forårsaget af Lawsonia intracellularis.
English: Maximum plasma concentrations (Cmax) of radio-labelled or ‘cold' material were obtained 1-4 hours after dosing (Tmax) with a plasma half-life (t½), estimated from non-radioactive data, between 1 and 4½ hours.
Danish: Maksimale plasmakoncentrationer (Cmax) af radioaktivt mærket eller ikke radioaktivt mærket materiale blev opnået 1-4 timer efter dosering (Tmax) med en plasmahalveringstid (t½) mellem 1 og 4½ timer, vurderet på basis af data fra ikke radioaktivt mærket materiale.
English: Treatment of clinical signs of porcine proliferative enteropathy (ileitis) The recommended dose of valnemulin is 3-4 mg/kg bodyweight/day for 2 weeks or until signs of disease disappear.
Danish: Behandling af kliniske tegn på porcin proliferativ enteritis (ileitis) Den anbefalede dosis af valnemulin er 3-4 mg/kg legemsvægt/dag i 2 uger, eller indtil tegnene på sygdommen forsvinder.
English: Adverse reactions have occurred in pigs following the use of Econor.
Danish: Bivirkninger er forekommet hos svin efter brug af Econor.
English: Econor 10% oral powder for pigs is available in 1 kg bags.
Danish: Econor 10% oralt pulver til svin fås i poser med 1 kg.
English: Use of the product deviating from the instructions given in the leaflet may increase the prevalence of bacteria resistant to valnemulin and may decrease the effectiveness of pleuromutilins.
Danish: Anvendelse af produktet på en måde, der afviger fra vejledningen i indlægssedlen, kan øge forekomsten af bakterier, der er resistente over for valnemulin, og reducere pleuromutiliners effektivitet.
English: WITHDRAWAL PERIOD(S) Withdrawal period:
Danish: TILBAGEHOLDELSESTID() Tilbageholdelsestid:
English: As an adjunct to treatment, 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: Som et supplement til behandling bør der indføres god håndterings- og hygiejnepraksis for at reducere risikoen for infektion og for at kontrollere den potentielle opbygning af resistens.
English: The pig to be treated should be weighed to calculate the correct dose of the veterinary medicinal product to be given and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight for growing pigs.
Danish: Grisen, som skal behandles, bør vejes, så den korrekte dosis af veterinærlægemidlet kan udregnes, og mængden af foder, som det er sandsynligt, grisen konsumerer, skal vurderes baseret på et dagligt indtag svarende til 5 % af legemsvægten for ungsvin.
English: Silica, colloidal anhydrous Isopropyl myristate Lactose
Danish: Silica, kolloid vandfri Isopropylmyristat Laktose
English: MARKETING AUTHORISATION NUMBER(S) EU/2/98/010/017-018 (Econor 10%)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/98/010/017-018 (Econor 10%)
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Econor 50% premix contains valnemulin in the form of valnemulin hydrochloride.
Danish: ANGIVELSE AF DET AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Econor 50% Premix indeholder valnemulin i form af valnemulin hydrochlorid.
English: Date of last renewal: 06/03/2009.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 06. marts 2009
English: Clinical signs of porcine colonic spirochaetosis (colitis)
Danish: Kliniske tegn på porcin colonic spirochaetosis (colitis)
English: Feed to which Econor oral powder has been added should be replaced if not consumed within 24 hours.
Danish: Foder iblandet Econor oralt pulver bør kasseres, hvis ikke det er opbrugt inden for 24 timer.
English: The pigs to be treated should be weighed to calculate the correct dose of Econor oral powder to be given and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight for growing pigs.
Danish: Grisene, som skal behandles, bør vejes, så den korrekte dosis af Econor oralt pulver kan udregnes, og mængden af foder, som det er sandsynligt, grisen konsumerer, skal vurderes baseret på et dagligt indtag svarende til 5 % af legemsvægten for ungsvin.
English: Treatment and prevention of swine enzootic pneumonia
Danish: Behandling og forebyggelse af enzootisk pneumoni hos svin
English: At the recommended dosage of 10-12 mg/kg bodyweight, lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.
Danish: Ved den anbefalede dosis på 10-12 mg/kg legemsvægt, reduceres lungelæsioner og vægttab, men infektion med Mycoplasma hyopneumoniae elimineres ikke.
English: At the recommended dosage of 10-12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.
Danish: Ved den anbefalede dosis på 10-12 mg/kg legemsvægt reduceres lungelæsioner og vægttab, men infektion med Mycoplasma hyopneumoniae elimineres ikke.
English: When mixing the veterinary medicinal product, and handling the final feed containing the product, direct contact with the skin and mucous membranes should be avoided.
Danish: Ved iblanding af det veterinærmedicinske produkt og håndtering af det færdige foder bør man undgå direkte kontakt med huden og slimhinderne.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: Navn og adresse på indehaveren af markedsføringstilladelsen samt på den indehaver af virksomhedsgodkendelse, som er ansvarlig for batchfrigivelse, hvis forskellig herfra
English: Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: Prevention of swine dysentery clinical signs of porcine colonic spirochaetosis (colitis)
Danish: Forebyggelse af svinedysenteri kliniske tegn på porcin colonic spirochaetosis (colitis)