FrancophonIA/ELRC3.0 huggingface dataset:
English: Tildipirosin Bovine 400 μg/kg
Danish: Tildipirosin Tildipirosin Kvæg 400 µg/kg 200 µg/kg
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25˚C
English: The mean total excretion of the total dose administered within 14 days was about 17% in urine and 57% in faeces.
Danish: Den gennemsnitlige totale udskillelse inden for 14 døgn af den samlede indgivne dosis var ca. 17% i urin og 57% i fæces.
English: The rubber stopper of the vial may be safely punctured up to 20 times.
Danish: Hætteglassets gummimembran kan penetreres op til 20 gange uden problemer.
English: SPECIAL STORAGE PRECAUTIONS
Danish: SÆRLIGE OPBEVARINGSBETINGELSER
English: For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1-> 64 µg/ml).
Danish: For E. coli, Campylobacter og Enterococci, blev både vild- og ikke vild-fænotyper observerede (MIC-værdier mellem 1->64µg/ml).
English: For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1- > 64 µg/ml).
Danish: For E. coli, Campylobacter og Enterococci, blev både vild- og ikke vild-fænotyper observerede (MIC-værdier mellem 1- >64µg/ml).
English: The mean total excretion of the total dose administered within 14 days was about 24% in urine and 40% in faeces.
Danish: Den gennemsnitlige totale udskillelse inden for 14 døgn af den samlede indgivne dosis var ca. 24% i urin og 40% i fæces.
English: Another animal developed treatment related shock after the first administration and was euthanised on welfare grounds.
Danish: Et andet dyr udviklede behandlingsrelateret shock efter første injektion og blev aflivet af dyreværnsmæssige hensyn.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: Do not use in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.
Danish: Må ikke anvendes i tilfælde af overfølsomhed for makrolid-antibiotika, citronsyremonohydrat eller propylenglykol.
English: Muscle Skin+fat Liver Kidney
Danish: Muskel Hud+fedt Lever Nyrer
English: The efficacy of metaphylactic use of Zuprevo was demonstrated in a placebo controlled multi-centre field study, when outbreak of clinical disease was confirmed (i.e. animals in at least 30% of the pens sharing the same airspace showed clinical signs of SRD, including at least 10% animals per pen within 1 day; or 20% within 2 days or 30% within 3 days).
Danish: Virkningen af metafylaktisk brug af Zuprevo blev påvist i en placebo-kontrolleret multicenterfeltundersøgelse, hvor udbrud af klinisk sygdom var bekræftet (dvs. at dyr i mindst 30% af stierne, som delte samme luftrum, havde kliniske symptomer på SRD, herunder mindst 10% dyr pr. sti inden for 1 dag; eller 20% inden for 2 dage; eller 30% inden for 3 dage).
English: 5831 AN Boxmeer The NETHERLANDS
Danish: 5831 AN Boxmeer
English: Special caution should be taken to avoid accidental self-injection, as toxicology studies in laboratory animals showed cardiovascular effects after intramuscular administration of tildipirosin.
Danish: Der bør udvises særlig opmærksomhed for at undgå selvinjektion ved hændeligt uheld, da toksikologiske studier på laboratoriedyr har vist kardiovaskulære virkning efter intramuskulær administration af tildipirosin.
English: In very rare cases, individual shock reactions with a potentially fatal outcome might occur.
Danish: I meget sjældne tilfælde kan der hos det enkelte dyr forekomme symptomer på shock med potentiel dødelig udgang.
English: Recommended needle size and diameter per production stage Needle length (cm)
Danish: Anbefalet størrelse og diameter af nål pr. produktionstrin Nålens længde (cm)
English: If accidental skin exposure occurs, wash the skin immediately with soap and water.
Danish: I tilfælde af kontakt med huden vaskes øjeblikkeligt med vand og sæbe.
English: Minimum inhibitory concentration (MIC) data for the target pathogens (wild type distribution) are presented in the table below.
Danish: Mindste hæmmende koncentration (MIC) for relevante patogener (vildtypefordelt) er angivet i nedenstående skema:
English: Piglet, newborn Piglet, 3-4 weeks Growing
Danish: Grise, 3-4 uger
English: Pain on injection and injection site swellings are very common in treated animals.
Danish: Injektionssmerter og hævelse på injektionsstedet forekommer meget hyppigt hos behandlede dyr.
English: It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Danish: Det anbefales at behandle dyrene i sygdommens tidlige fase og evaluere respons på behandlingen inden for 48 timer efter injektion.
English: Special attention should be paid to using the appropriate injection site and to use the appropriate needle size and length (adjusted to the size and weight of animal) according to good veterinary practice.
Danish: Der skal udvises god veterinærfaglig praksis med særlig opmærksomhed på brug af korrekt injektionssted samt kanylestørrelse og længde (passende til dyrets størrelse og vægt).
English: In target animal safety studies, administration of the maximum recommended injection volume (5 ml) very commonly caused slight swellings at the injection site that were not painful on palpation.
Danish: Sikkerhedsstudier hos målgruppen af dyr viste, at det var meget almindeligt forekommende, at injektion af det maksimalt anbefalede volumen (5 ml) forårsagede let hævelse på injektionsstedet, som ved palpation var uden smerter.
English: Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Danish: Må ikke anvendes til drægtige dyr, som er beregnet til at producere mælk til konsum, inden for 2 måneder før forventet kælvning.
English: It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 2 to 3 days after injection.
Danish: Det anbefales at behandle dyrene i sygdommens tidlige fase og evaluere respons på behandlingen inden for 2 til 3 døgn efter injektion.
English: Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Danish: Farmakoterapeutisk gruppe: Antibakterica til systemisk brug, macrolider.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Danish: FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: antibakterica til systemisk brug, macrolider.
English: B. bronchiseptica
Danish: P. multocida B. bronchiseptica
English: Official, national and regional antimicrobial policies should be taken into account when the product is used.
Danish: Ved brug af lægemidlet bør officiel, national og lokal antibiotikapolitik følges.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Tildipirosin Porcine 1,200 μg/kg
Danish: Tildipirosin Tildipirosin Svin 1.200 µg/kg 800 µg/kg
English: Following the maximum recommended injection site volume of 5 ml, injection site reactions resolved completely within 21 days.
Danish: Efter dosering af det maksimalt anbefalede volumen på 5 ml pr. injektionssted forsvandt forandringerne på injektionsstedet helt inden for 21 døgn.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - meget almindelige (mere end 1 ud af 10 dyr får bivirkninger i løbet af en behandling) - almindelige (mere end 1, men færre end 10 dyr ud af 100 dyr) - ualmindelige (mere end 1, men færre end 10 dyr ud af 1.000 dyr) - sjældne (mere end 1, men færre end 10 dyr ud af 10.000 dyr) - meget sjældne (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter).
English: Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Danish: Derfor må produktet ikke administreres samtidig med antibiotika med samme virkningsmekanisme, såsom andre makrolider eller lincosamider.
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid (collected post mortem), which far exceed those in blood plasma.
Danish: At akkumulering sker, hvor luftvejsinfektionen foregår, er påvist ved høje og vedvarende tildipirosinkoncentrationer i lunge og bronchialvæske (indsamlet post mortem), som langt overstiger dem i blodplasma.
English: In vitro, the effect of tildipirosin is bactericidal against M. haemolytica and H. somni, and bacteriostatic against P. multocida.
Danish: In vitro er virkningen af tildipirosin baktericid over for M. haemolytica og H. somni, og bakteriostatisk over for P. multocida.
English: Cattle (meat and offal): 47 days.
Danish: Kvæg (slagtning): 47 dage
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid, which far exceed those in blood plasma.
Danish: At akkumulering sker, der hvor luftvejsinfektionen foregår, er påvist ved høje og vedvarende tildipirosinkoncentrationer i lunge og bronchialvæske, som langt overstiger dem i blodplasma.
English: Intramuscular use.
Danish: Til intramuskulær anvendelse.
English: Once opened, use by:
Danish: Efter anbrud anvendes inden: ……….
English: Injection site reactions will largely resolve within 35 days.
Danish: Forandringerne på injektionsstedet vil stort set forsvinde inden for 35 døgn.
English: In calves, a single subcutaneous injection of 10 times the recommended dose (40 mg/kg body weight) and repeated subcutaneous administration of tildipirosin (on three occasions in intervals of 7 days) at 4, 12 and 20 mg/kg (1, 3 and 5 times the recommended clinical dose) were well tolerated, apart from transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals.
Danish: Hos kalve behandlet med én subkutan injektion med 10 gange den anbefalede dosis (40 mg/kg kropsvægt) og med gentagen subkutan administration af tildipirosin (3 gange med et interval på 7 døgn) på 4, 12 og 20 mg/kg (1, 3 og 5 gange den anbefalede kliniske dosis) blev tildipirosin tolereret godt, bortset fra forbigående kliniske symptomer, som kan skyldes ubehag fra og hævelse på injektionsstedet forbundet med smerte hos nogle dyr.
English: Not authorised for use in lactating animals producing milk for human consumption.
Danish: Ikke godkendt til lakterende dyr, der producerer mælk til konsum.
English: Do not administer simultaneously with other macrolides or lincosamides (see section 12).
Danish: Må ikke administreres samtidig med andre makrolider eller lincosamider (se pkt.
English: 4.2 Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer, med angivelse af dyrearter, som lægemidlet er beregnet til
English: WITHDRAWAL PERIOD Withdrawal period:
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid:
English: Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the veterinary medicinal product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Danish: Metafylakse indebærer, at veterinærlægemidlet administreres til klinisk raske dyr, som er i tæt kontakt med syge dyr, samtidig med behandlingen af de klinisk syge dyr, for at reducere risikoen for udvikling af kliniske symptomer.
English: Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Danish: Metafylakse indebærer, at produktet administreres til klinisk raske dyr, som er i tæt kontakt med syge dyr, samtidig med behandlingen af de klinisk syge dyr, for at reducere risikoen for udvikling af kliniske symptomer.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Danish: Ved brug af lægemidlet bør officiel national og lokal antibiotikapolitik følges.
English: Resistance to macrolides generally results from three mechanisms: (1) the alteration of the ribosomal target site (methylation), often referred to as MLSB resistance as it affects macrolides, lincosamides and group B streptogramins, (2) the utilisation of active efflux mechanism; (3) the production of inactivating enzymes.
Danish: Resistens over for makrolider skyldes almindeligvis tre mekanismer: (1) Ændringen af det ribosomale angrebspunkt (methylering), som ofte kaldes MLSB-resistens, da det påvirker makrolider, lincosaminer og gruppe B streptograminer.
English: The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.
Danish: Tilstedeværelse af sygdommen i bestanden bør konstateres, før metafylakse indledes.
English: Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with bovine respiratory disease (BRD).
Danish: Mannheimia haemolytica, Pasteurella multocida og Histophilus somni, som er de bakterielle patogener, der hyppigst er involveret i luftvejsinfektioner hos kvæg (BRD).
English: Needle diameter (mm)
Danish: Zone-diameter (mm)
English: In vitro, the effect of tildipirosin is bacteriostatic against Pasteurella multocida and B. bronchiseptica, and bactericidal for A. pleuropneumoniae and H. parasuis.
Danish: In vitro er virkningen af tildipirosin bakteriostatisk over for Pasteurella multocida og B. bronchiseptica, og baktericid over for A. pleuropneumoniae og H. parasuis.
English: Needle length (cm)
Danish: Nålens længde (cm)
English: In pigs, it is postulated that the metabolism of tildipirosin proceeds by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by dihydroxylation and by S-cysteine and S-glutathione conjugation.
Danish: Det antages, at metaboliseringen af tildipirosin hos svin foregår ved reduktion og sulfatkonjugation efterfulgt af hydrering (eller ringåbning), ved demethylering, ved dihydroxylering samt ved S-cystein og S-glutation konjugation.
English: Box
Danish: Æske
English: In cattle, it is postulated that metabolism of tildipirosin proceeds by cleavage of the mycaminose sugar moiety, by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by mono- or dihydroxylation with subsequent dehydration and by S-cysteine and Sglutathione conjugation.
Danish: Det antages at metaboliseringen af tildipirosin hos kvæg foregår ved frakløvning af mycaminosesukkerdelen, ved reduktion og sulfatkonjugation efterfulgt af hydrering (eller ringåbning), ved demethylering, ved mono- eller dihydroxylering efterfulgt af dehydrering samt ved S-cystein og Sglutation konjugation.
English: To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre korrekt dosis og undgå underdosering skal kropsvægten bestemmes så præcist som muligt.
English: Type I amber glass vial with chlorobutyl rubber stopper and an aluminium cap.
Danish: Type I brune hætteglas med chlorobutyl-gummiprop og en aluminiumshætte.
English: Tildipirosin administered subcutaneously to cattle at a single dose of 4 mg/kg body weight resulted in rapid absorption with average peak plasma concentration of 0.7 µg/ml within 23 minutes (Tmax) and high absolute bioavailability (78.9%).
Danish: Efter behandling af kvæg med en enkelt subkutan dosis på 4 mg/kg kropsvægt blev tildipirosin hurtigt absorberet med en gennemsnitlig maksimal plasmakoncentration på 0,7 µg/ml inden for 23 minutter (Tmax) og en høj total biotilgængelighed (78,9%).
English: Tildipirosin administered intramuscularly to pigs at a single dose of 4 mg/kg body weight was rapidly absorbed reaching average peak plasma concentration of 0.9 µg/ml within 23 minutes (Tmax).
Danish: Efter behandling af svin med en enkelt intramuskulær dosis på 4 mg/kg kropsvægt blev tildipirosin hurtigt absorberet og nåede en gennemsnitlig maksimal plasmakoncentration på 0,9 µg/ml inden for 23 minutter (Tmax).
English: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis, which are the bacterial pathogens most commonly associated with swine respiratory disease (SRD).
Danish: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica og Haemophilus parasuis, som er de bakterielle patogener, der hyppigst er involveret i luftvejsinfektioner hos svin (SRD).
English: At 20 mg/kg body weight one out of eight animals showed transient generalized body tremors with inability to stand after the first administration and the animal showed transient unsteadiness on its feet after the third administration.
Danish: Et ud af de 8 dyr, der fik 20 mg/kg kropsvægt, viste forbigående generaliseret tremor med manglende evne til at stå efter første injektion, og dyret viste forbigående ustabilitet på benene efter tredje injektion.
English: Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for makrolid-antibiotika eller over for et eller flere af hjælpestofferne.
English: Overdoses of 10 times the recommended dose as well as repeated subcutaneous administration of the veterinary medicinal product only led to transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in calves.
Danish: Ved såvel brug af 10 gange den anbefalede dosis som ved gentagne injektioner under huden, sås kun forbigående symptomer på bivirkninger, som kan skyldes ubehag fra og hævelse på injektionsstedet forbundet med smerte hos kalve.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cattle
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kvæg
English: Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg BW group.
Danish: Muskelsitren i bagbenene blev observeret efter første behandling hos en gris i hver af 12- og 20 mg/kg KV-grupperne.
English: Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.
Danish: Æske indeholdende 1 hætteglas på 20 ml, 50 ml, 100 ml eller 250 ml.
English: Meat and offal: 9 days
Danish: Slagtning: 9 dage
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) ZUPREVO is a clear yellowish solution for injection containing 180 mg/ml of tildipirosin
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER ZUPREVO er en klar, gullig injektionsvæske, opløsning, indeholdende 180 mg/ml tildipirosin
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) The veterinary medicinal product is a clear yellowish solution for injection containing 40 mg/ml of tildipirosin
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER Dette veterinærlægemiddel er en klar, gullig injektionsvæske, opløsning, indeholdende 40 mg/ml tildipirosin.
English: Bovine respiratory disease
Danish: Luftvejsinfektioner hos svin
English: Vial (100 ml, 250 ml)
Danish: Hætteglas (100 ml, 250 ml)
English: MARKETING AUTHORISATION NUMBERS
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE)
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.
Danish: Giv kun én dosis af 4 mg tildipirosin/kg kropsvægt (svarende til 1 ml/45 kg kropsvægt).
English: In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg bodyweight (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg bodyweight group and 2 piglets from the 20 mg/kg bodyweight group following the first or second injection.
Danish: Behandling af smågrise med tildipirosin intramuskulært med dosis på 8, 12 og 20 mg/kg kropsvægt (KV) (svarende til 2, 3 og 5 gange den anbefalede dosis) (3 gange med et interval på 4 døgn) resulterede i forbigående let dæmpet adfærd hos en gris i hver af 8- og 12 mg/kg KV-grupperne og hos to grise i 20 mg/kg KV-gruppen efter den første eller anden injektion.
English: Not for use in animals from which milk is produced for human consumption.
Danish: Ikke godkendt til dyr, der producerer mælk til konsum.
English: Muscle Fat
Danish: Muskel Fedt Lever Nyrer
English: Accidental injection is dangerous.
Danish: Selvinjektion ved et hændeligt uheld kan være farlig.
English: In vitro binding of tildipirosin to bovine plasma and bronchial fluid proteins is limited with approximately 30%.
Danish: In vitro er binding af tildipirosin til proteiner i plasma og bronchialvæske hos kvæg begrænset til ca.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Cattle
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Kvæg
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only.
Danish: Giv kun én dosis af 4 mg tildipirosin/kg kropsvægt (svarende til 1 ml/10 kg kropsvægt).
English: Other provisions
Danish: Målvæv Andre bestemmelser
English: Meat and offal: 47 days
Danish: Slagtning: 47 dage
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pigs
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Svin
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pigs
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Svin
English: Pathomorphological injection site reactions will largely resolve within 35 days.
Danish: De histopatologiske forandringer på injektionsstedet vil stort set forsvinde inden for 35 døgn.
English: If clinical signs of respiratory disease persist or increase, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Danish: Hvis de kliniske symptomer på luftvejssygdom persisterer eller forværres, bør behandlingen ændres til brug af et andet antibiotikum og fortsættes indtil de kliniske symptomer er ophørt.
English: METHOD AND ROUTE OF ADMINISTRATION Intramuscular injection
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær injektion
English: Pathomorphological injection site reactions resolved completely within 21 days.
Danish: De histopatologiske forandringer på injektionsstedet forsvandt helt inden for 21 døgn.
English: If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Danish: Hvis de kliniske symptomer på luftvejsinfektion persisterer eller forværres, eller hvis der kommer tilbagefald, bør behandlingen ændres til brug af et andet antibiotikum og fortsættes, indtil de kliniske symptomer er ophørt.
English: Vial (20 ml, 50 ml)
Danish: Hætteglas (20 ml, 50 ml)
English: METHOD AND ROUTE OF ADMINISTRATION Subcutaneous injection
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Subkutan injektion
English: Swellings persisted for up to 3 days.
Danish: Hævelsen forsvandt inden for 3 døgn.
English: The presence of the disease in the herd should be confirmed before preventive treatment.
Danish: Sygdommen bør være diagnosticeret i besætningen, før forebyggende behandling indledes.