FrancophonIA/ELRC3.0 huggingface dataset:
English: The reason for this was that the national competent authorities of Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the ground that the efficacy has not been sufficiently substantiated in the dossier.
Danish: Begrundelsen herfor var, at de nationale kompetente myndigheder i Belgien og Norge fandt, at produktet kan udgøre en alvorlig risiko for dyrs sundhed, fordi dets virkning ikke er tilstrækkelig velunderbygget i ansøgningens dokumentation.
English: This is also the indication applied for at the start of the mutual recognition procedure (MRP).
Danish: Dette var også den ansøgte indikation ved indledningen af den gensidige anerkendelsesprocedure.
English: Reducing of pyrexia or fever and alleviation of inflammation are considered important clinical claims that should be retained as they have been demonstrated clearly enough.
Danish: Reduktion af pyreksi eller feber og lindring af inflammation anses for at være vigtige kliniske indikationer, som bør bibeholdes, da de er tilstrækkeligt veldokumenterede.
English: Both pain in the infected quarter and increased size are indicative of inflammation.
Danish: Både smerte i den inficerede bagfjerding og øget størrelse er tegn på inflammation.
English: Concentrations over 0,1 µg/ml in plasma were measured 24 hours after the administration of the drug.
Danish: Koncentrationer over 0,1 µg/ml i plasma blev målt 24 timer efter indgift.
English: However, a dose confirmation study, submitted with the response, is considered pivotal for the assessment of the efficacy: “Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006”.
Danish: Sammen med besvarelsen blev der imidlertid forelagt en undersøgelse til bekræftelse af dosis, som anses for at være af afgørende betydning for vurderingen af virkningen: "Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006".
English: An anti-oedemic effect is usually evaluated over several days, and an NSAID may be considered limited in its efficacy here.
Danish: En ødemnedsættende virkning kræver sædvanlig vurdering gennem flere dage, og et NSAID kan anses for at have begrænset virkning her.
English: Somatic cell counts were affected by the challenge, and few differences exist between the groups.
Danish: Det somatiske celletal blev påvirket af provokationen med kun ringe forskel mellem grupperne.
English: The anti-inflammatory effect in tissues has been documented to continue even after the plasma concentration has decreased.
Danish: Det er dokumenteret, at den antiinflammatoriske effekt i væv fortsætter, selv efter at plasmakoncentrationen er faldet.
English: That a difference in udder size in the inoculated quarter is reported at all under these experimental conditions is noteworthy.
Danish: At der i det hele taget rapporteres om forskel i yverets størrelse i den inokulerede bagfjerding under sådanne eksperimentelle forhold, er bemærkelsesværdigt.
English: Applicant or Marketing Authorisation Holder
Danish: Ansøger eller indehaver af markedsføringstilladelse
English: Do not use in animals which have completely lost their appetite because this could lead to insufficient absorption of ketoprofen.
Danish: Må ikke anvendes til dyr, som helt har mistet appetitten, da dette kan medføre utilstrækkelig absorption af ketoprofen.
English: Thromboxane levels were measured in both milk and plasma.
Danish: Koncentrationen af thromboxan blev målt både i mælk og plasma.
English: Although not all effects of ketoprofen are covered by thromboxane activity (ketoprofen also has lipooxygenase activity), thromboxane activity is a sensitive parameter, not only for evaluating inflammation in this experimental model, but also for allowing extrapolation to the field condition up to a certain point.
Danish: Skønt ketoprofens virkninger ikke kun gælder thromboxan-aktiviteten (ketoprofen har også lipoxygenase-aktivitet), er thromboxan-aktiviteten en følsom parameter, ikke kun for bedømmelsen af inflammationen i denne eksperimentelle model, men også når det gælder muligheden for at ekstrapolere til feltbetingelser i et vist omfang.
English: In these cases take immediate contact to a doctor.
Danish: Søg straks lægehjælp i sådanne tilfælde.
English: However, given that the pharmacokinetic data allowed to optimise the dose (keeping overall exposure comparable between the two products), it is concluded that a bridge exists that allows wellestablished use to apply to Dolovet.
Danish: Men eftersom de farmakokinetiske data gav mulighed for at optimere dosis (så at den totale eksponering fra de to produkter var den samme), kan det konkluderes, at der foreligger en sammenhæng, der giver grundlag for, at den velunderbyggede anvendelse også anses for at gælde for Dolovet.
English: If one accepts that a bridge exists, then the clinical indications that exist for Ketofen, as evidence in the literature, should apply in large part to Dolovet.
Danish: Hvis man accepterer, at der foreligger en sådan sammenhæng, bør de kliniske indikationer for Ketofen, der er dokumenteret i litteraturen, for en stor del også kunne gøres gældende for Dolovet.
English: Even though equivalence has not been formally shown, the two products perform similarly when compared to placebo in regards to a number of critical parameters, both clinical and otherwise (thromboxane B2 levels in plasma).
Danish: Skønt de to produkters ækvivalens ikke er formelt godtgjort, svarer de til hinanden i virkning sammenlignet med placebo, hvad angår en række kritiske parametre, både kliniske og af anden art (thromboxan B2indholdet i plasma).
English: The induction of parturition can be delayed when ketoprofen is given just before parturition.
Danish: Indledningen af kælvning kan forsinkes, når ketoprofen gives umiddelbart før kælvning.
English: Opposed to injectable ketoprofen the results for milk are not “as clear” for Dolovet as what they are for plasma.
Danish: I modsætning til, hvad der gør sig gældende for ketoprofen som injektion, er resultaterne for Dolovet ikke så "klare" for mælk som for plasma.
English: In cattle, after the recommended dose of 4 mg/kg of ketoprofen per os before feeding the concentrate, the highest concentration of ketoprofen in plasma (Cmax3,9 µg/ml) was achieved in about 2 hours.
Danish: Efter oral indgift af den anbefalede dosis på 4 mg/kg til kvæg, før tildeling af kraftfoder, blev den højeste plasmakoncentration af ketoprofen (Cmax 3,9 µg/ml) opnået på ca. 2 timer.
English: For generic applications bioequivalence must be demonstrated.
Danish: Ved ansøgninger for generiske lægemidler skal deres bioækvivalens godtgøres.
English: Considering then the data provided and the well-established use of ketoprofen, CVMP is of the opinion that the following claim can be substantiated:
Danish: På grundlag af de forelagte oplysninger og den veldokumenterede anvendelse af ketoprofen finder CVMP følgende indikation for behørigt begrundet:
English: Milk yield dropped for all groups and rose again after challenge, similarly for all groups.
Danish: Mælkeydelsen faldt i alle grupper og steg efter provokationen lige meget i alle grupper.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: The CVMP during its meeting of 14-16 March 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Dolovet vet 2.4g oral powder.
Danish: CVMP indledte på sit møde den 14.-16. marts 2006 en indbringelsesprocedure i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer, for Dolovet vet, 2,4 g oralt pulver.
English: Treatment was conducted two hours after challenge and the groups were Group A: Saline, Group B: 2 mg/kg ketoprofen orally, Group C: 4 mg/kg ketoprofen orally, and Group D: 3 mg/kg ketoprofen intramuscularly.
Danish: To timer efter provokationen blev dyrene behandlet efter inddeling i følgende grupper: Gruppe A: saltvand, Gruppe B: ketoprofen 2 mg/kg oralt, Gruppe C: ketoprofen 4 mg/kg oralt, Gruppe D: ketoprofen 3 mg/kg intramuskulært.
English: PHARMACEUTICAL FORM Oral powder.
Danish: LÆGEMIDDELFORM Oralt pulver.
English: 36 healthy lactating cows were challenged in one hindquarter, infused with endotoxin Bacto E. coli 026:B6 lipopolysaccharide B (LPS).
Danish: 36 raske, lakterende køer blev provokeret ved infusion i den ene bagfjerding af endotoxin Bacto E. coli 026:B6 lipopolysaccharid B (LPS).
English: General and local clinical signs, milk production, somatic cell counts, thromboxane B2 levels in milk and in plasma, and serum levels of zinc, calcium, magnesium, and copper were studied.
Danish: Dyrene blev overvåget for generaliserede og lokale kliniske tegn og mælkeproduktion, og der blev bestemt somatiske celletal, thromboxan B2 i mælk og plasma samt indholdet i serum af zink, calcium, magnesium og kobber.
English: For example, in generic applications, a preclinical bridge is made that allows extrapolation to the field situation.
Danish: For ansøgninger for generiske produkter er der for eksempel etableret en præklinisk sammenhæng, der giver mulighed for ekstrapolation til feltbetingelser.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: No teratogenic or embryotoxic effects in laboratory animals with the recommended dose of ketoprofen has been recorded.
Danish: Der foreligger ingen oplysninger om teratogen eller embryotoksisk effekt hos forsøgsdyr ved den anbefalede ketoprofendosis.
English: Ketroprofen inhibits the secretion of bradykinin, which is a chemical mediator of pain and inflammation.
Danish: Ketoprofen hæmmer sekretionen af bradykinin, som er en kemisk mediator for smerte og inflammation.
English: 4.5 Special precautions for use Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler for dyret
English: The results are clearly better for the treated groups when compared to non-treated animals for respiratory rate, rectal temperature, and ruminal contractions.
Danish: Resultaterne var klart bedre for behandlede end ubehandlede dyr med hensyn til respirationsfrekvens, rektaltemperatur og vomkontraktioner.
English: The Reference Member State for the Mutual Recognition Procedure regarding Dolovet vet 2.4g oral powder, Finland, notified the EMEA on 2 March 2006 that the CMD(v) failed to reach an agreement regarding the product.
Danish: Finland, der er referencemedlemsstaten for den gensidige anerkendelsesprocedure vedrørende Dolovet vet, 2,4 g oralt pulver, meddelte den 2. marts 2006 til EMEA, at der ikke var opnået enighed om produktet i den veterinærmedicinske gruppe for fremme af gensidig anerkendelse (CMD(v)).
English: Ketoprofen has been documented to stabilise lysosomal cell membranes.
Danish: Det er dokumenteret, at ketoprofen stabiliserer lysosomernes cellemembraner.
English: After challenge and treatment, rectal temperature, ruminal contractions, and respiratory rate were significantly higher in the non-treated group than in the treated groups.
Danish: Efter provokation og behandling var rektaltemperatur, vomkontraktioner og respirationsfrekvens betydeligt højere i ubehandlede end i behandlede dyr.
English: The inhibition of lipo-oxygenase enzyme reduces the synthesis of leucotriens.
Danish: Hæmningen af enzymet lipooxygenase reducerer syntesen af leukotriener.
English: The powder should be mixed with water e.g. in a bottle using ½ litres of water, shaked well and administered immediately per orally to an animal.
Danish: Pulveret blandes med vand, f.eks. i en flaske med ½ liter vand, omrystes grundigt og gives straks oralt til dyret.
English: One bag of 15g once daily for 1 - 3 days.
Danish: Én pose a 15 g én gang dagligt i 1-3 dage.
English: The elimination half life after per oral administration was about 4,5 hours.
Danish: Eliminationshalveringstiden var ca. 4,5 timer efter oral indgift.
English: This corresponds to 4 mg ketoprofen /kg.
Danish: Dette svarer til 4 mg ketoprofen/kg.
English: Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “For the treatment of painful disorders (lameness; abdominal pain) in individual animals”.
Danish: Efter drøftelser i den veterinærmedicinske gruppe for fremme af gensidig anerkendelse (CMD(v)) blev den ansøgte indikation under den gensidige anerkendelsesprocedure ændret til "smertelindring (halten, abdominalsmerter) hos enkeltdyr".
English: The experimental design of the study mimics an acute toxic mastitis.
Danish: Undersøgelsen består i efterligning af en akut toksisk mastitis.
English: The statistical report indicates that the number of animals used does not allow to establish equivalence (nor non-inferiority) between Dolovet containing ketoprofen administered orally at the dose of 4 mg/kg bodyweight, and Ketofen containing ketoprofen administered intramuscularly at the dose of 3 mg/kg.
Danish: Den statistiske rapport viser, at det med det anvendte antal dyr ikke kan fastslås, om der er ækvivalens (manglende forskel) mellem oral indgift af Dolovet indeholdende ketoprofen i en dosis af 4 mg/kg kropsvægt og intramuskulær injektion af Ketofen indeholdende ketoprofen i en dosis af 3 mg/kg.
English: To restrict the indications of Dolovet to only those that were tested (endotoxemic mastitis control) would be inappropriate.
Danish: Det ville være uhensigtsmæssigt at indskrænke indikationerne for Dolovet til de her undersøgte (begrænsning af endotoksisk virkning ved mastitis).
English: Alleviation of inflammation and reduction of fever in individual animals.
Danish: Lindring af inflammation og feberreduktion hos individuelle dyr.
English: A 15 g aluminium-laminate sachet, which are further packed to a cardboard box.
Danish: Breve af aluminium-laminat der indeholder 15 g, pakket i æske.
English: ATCvet code: QM01AE03
Danish: ATCvet kode: QM 01 AE 03.
English: The blocking of cyclo-oxygenase enxyme inhibits the formation of the inflammation mediators PGE2 and PGI2.
Danish: Blokeringen af enzymet cyclooxygenase hæmmer dannelsen af mediatorerne for inflammation PGE2 og PGI2.
English: Other non steroidal anti-inflammatory drugs (NSAID) must not be used simultaneously with the product and within 24 hours after the last dose of Dolovet because the substances may compete in binding with proteins thus leading to toxic effects.
Danish: Andre nonsteroide antiinflammatoriske lægemidler (NSAID) må ikke anvendes samtidig med præparatet og inden for 24 timer efter den sidste Dolovet Vet.-dosis, fordi stofferne kan konkurrere om proteinbinding, hvorved der kan opstå toksiske effekter.
English: Udder size, poor milk aspect, and pain also showed to be generally higher in the non-treated group.
Danish: Yverstørrelse, forringelse af mælkens udseende og smerter var ligeledes generelt højere i den ubehandlede gruppe.
English: 4.4 Special warnings for each target species
Danish: 4.4 Særlige advarsler for hver dyreart
English: In his response the Marketing Authorisation Holder (MAH)did not develop any further the preclinical argument already presented during the mutual recognition procedure.
Danish: I sin besvarelse udbyggede ansøgeren ikke den prækliniske argumentation, som indehaveren af markedsføringstilladelsen blev fremlagt under den gensidige anerkendelsesprocedure.
English: Do not use for animals with gastrointestinal ulcers or severe renal insufficiency, coagulation disorders or severe hypovolemia.
Danish: Må ikke anvendes til dyr med gastrointestinale sår, alvorlig nyreinsufficiens, koagulationsforstyrrelser eller alvorlig hypovolæmi.
English: For well-established use dossiers the bridge can be constructed a bit more tentatively.)
Danish: Når der er tale om veldokumenteret anvendelse, kan sammenhængen godtgøres på lidt mere tentativ måde.
English: Dolovet vet 2.4g oral powder is a powder presented in sachets of 15g, containing 2.4g ketoprofen each.
Danish: Dolovet vet, 2,4 g oralt pulver, er et pulver, der leveres i poser a 15 g, hver indeholdende 2,4 g ketoprofen.
English: This corresponds to 4mg ketoprofen per kg body weight.
Danish: Denne dosis svarer til 4 mg ketoprofen pr. kg kropsvægt.
English: If a person accidentally swallows a 2.4 g bag of Dolovet powder (= 2400 mg ketoprofen), it may cause a serious intoxication.
Danish: Hvis en person ved et uheld indtager et brev Dolovet Vet. 2,4 g oralt pulver (der svarer til 2400 mg ketoprofen), kan det give en alvorlig forgiftning.
English: Ketoprofen is a non steroid anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic and analgesic effect.
Danish: Ketoprofen hører til gruppen af nonsteroide antiinflammatoriske lægemidler (NSAID) med antiinflammatorisk, antipyretisk og analgetisk effekt.
English: Therefore the use of the product in cattle close to parturition should be avoided.
Danish: Derfor bør anvendelse af præparatet undgås til kvæg før kælvning.
English: To the target species:
Danish: Vedrørende dyrearten:
English: The Marketing Authorisation Holder (MAH) was requested to substantiate the indication and posology as discussed during the recent MRP.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at godtgøre indikation og dosering som drøftet under den seneste gensidige anerkendelsesprocedure.
English: The MAH was also requested to substantiate the bridging of pharmacokinetic studies and dose-confirmation studies data to prove efficacy.
Danish: For at dokumentere virkningen blev indehaveren af markedsføringstilladelsen desuden anmodet om at bevise sammenhængen mellem de farmakokinetiske undersøgelser og data fra den foretagne undersøgelse til bekræftelse af dosis.
English: Ketoprofen has been shown to inhibit the intravenously injected E.coli endotoxin induced tromboxane B2 production in the bovine.
Danish: Det er påvist, at ketoprofen hæmmer dannelsen af tromboxan B2, induceret af intravenøst indgivet E. coli endotoksin, hos kvæg.
English: People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAID) should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for nonsteroide antiinflammatoriske lægemidler (NSAID) bør undgå kontakt med det veterinærmedicinske lægemiddel.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Ketoprofen 2.4 g
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Ketoprofen 2,4 g.
English: Simultaneous use of loop-diuretics (for example furosemid) may decrease the effect of the diuretic.
Danish: Ved samtidig brug af loop-diuretika (f.eks. furosemid) kan virkningen af dette vanddrivende lægemiddel nedsættes.
English: The anti-inflammatory action of ketoprofen is based on the inhibition of cyclo-oxygenase and lipo-oxygenase enzymes.
Danish: Ketoprofens antiinflammatoriske virkning skyldes hæmning af enzymerne cyclooxygenase og lipooxygenase.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Danish: Lægemidlets særnavn
English: 10 DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN [Dato]
English: If you notice any other side effects, please inform your veterinary surgeon.
Danish: Hvis du bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes du kontakte din dyrlæge.
English: Pharmaceutical form
Danish: Lægemiddelform Styrke
English: Simultaneous use of glucocorticoids may add undesirable effects on GI-canal.
Danish: Samtidig brug af glukokortikoider kan forstærke bivirkninger på mavetarmkanalen.
English: A trend exists for udder size of the inoculated quarter, pain as reported on a visual analog scale (VAS) after palpation, and poorer milk aspect (milk production was equally affected in all groups).
Danish: Der var sammenhæng mellem yverstørrelsen i den inokulerede bagfjerding, smerte, registreret på en visuel analog skala (VAS) efter forudgående palpation, og forringelse af mælkens udseende
English: Do not use for animals hypersensitive to ketoprofen or other non steroid anti-inflammatory (NSAID) drugs (like aspirin or flunixin).
Danish: Må ikke bruges til dyr, som er overfølsomme over for ketoprofen eller andre nonsteroide antiinflammatoriske lægemidler (NSAID), som f.eks. acetylsalicylsyre eller flunixin.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Aluminium-laminat-breve
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dolovet vet 2.4 g oral powder.
Danish: VETERINÆRLÆGEMIDLETS NAVN Dolovet Vet. 2,4 g oralt pulver Ketoprofen
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN ”TIL DYR” Til dyr (kvæg).
English: To be supplied only on veterinary prescription.
Danish: Til dyr - kræver recept.
English: Ketoprofen 2.4 g For a full list of excipients, see section 6.1.
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Rifen 2.4g As above
Danish: Rifen 2,4 g Som ovenstående Som ovenstående
English: Do not use after the expiry date stated on the carton and bag.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen Må ikke anvendes efter den udløbsdato, som er angivet på æsken og brevet.
English: - Maltodextrin - Carmellose sodium
Danish: Maltodextrin
English: Dolovet vet 2.4 g oral powder.
Danish: INDLÆGSSEDDEL Dolovet Vet. 2,4 g oralt pulver
English: Manufacturer for the batch release: Oy Galena Ltd, P.O.Box 1450, 70501 Kuopio, Finland NAME OF THE VETERINARY MEDICINAL PRODUCT Dolovet vet 2.4 g oral powder.
Danish: Fremstiller af batchfrigivelse: Galena Oy, P.O. Box 1450, FI-70501 Kuopio, Finland.
English: MARKETING AUTHORISATION NUMBER(S) : FI 17182
Danish: MARKEDSFØRINGSTILLADELSESNUMMER [MT nr.]
English: This medicinal product does not require any special storage conditions.
Danish: Ingen særlige opbevaringsbetingelser.
English: STATEMENT OF THE ACTIVE AND OTHER INGREDIENTS 1 sachet= 15 g powder contains of 2.4 g ketoprofen and exipients to 15 g. INDICATION(S) Alleviation of inflammation and reduction of fever in individual animals
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER 1 brev = 15 g indeholder ketoprofen 2,4 g og hjælpestoffer til 15 g.
English: People with known hypersensitivity to non steroidal anti-inflammatory drugs (NSAID) should avoid contact with the veterinary medicinal product.
Danish: Særlige forsigtighedsregler for personer, der administrerer lægemidlet Personer med kendt overfølsomhed over for nonsteroide antiinflammatoriske lægemidler (NSAID) bør undgå kontakt med det veterinærmedicinske lægemiddel.
English: Cattle (adult cattle weighing about 600 kg).
Danish: Kvæg (voksent kvæg, som vejer ca. 600 kg).
English: Do not use for animals hypersensitive to ketoprofen or other non steroid anti-inflammatory (NSAID) drugs.
Danish: Må ikke anvendes til dyr, som er overfølsomme over for nonsteroide antiinflammatoriske lægemidler (NSAID).
English: MARKETIN AUTHORISATION NUMBER XXXXX
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER MTnr 38443 DK
English: Vetcare Oy, P.O.
Danish: D. {MM/ÅÅÅÅ}
English: The induction of parturition in laboratory animals have been found to be delayed when ketoprofen was given just before parturition.
Danish: Når ketoprofen blev givet til forsøgsdyr lige før fødsel, sås forsinket fødselsinduktion.
English: 1 sachet= 15 g powder contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 brev = 15 g oralt pulver indeholder Aktivt indholdsstof:
English: Cattle (adult animals weighing about 600 kg).
Danish: Kvæg (voksne dyr med en vægt på ca. 600 kg).
English: WITHDRAWAL PERIOD
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid:
English: CLINICAL PARTICULARS 4.1 Target species
Danish: 4.1 Dyrearter