FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.8 Interaction with other veterinary medicinal products and other forms of interaction
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion
English: Treatment of:
Danish: Til behandling af:
English: The administration must be continued for 5 days.
Danish: Indgiften skal fortsættes i 5 dage.
English: Blister label
Danish: Blister etiket
English: Cattle: None.
Danish: Kvæg: Ingen
English: Bodyweight (kg)
Danish: Kropsvægt (kg)
English: After subcutaneous administration the bioavailability is 96%.
Danish: Efter subkutan administration er biotilgængeligheden 96%.
English: Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona Spain
Danish: Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona Spanien
English: Dogs: Not applicable
Danish: Hunde: Ikke relevant
English: Official and local antimicrobial policies should be taken into account when the product is used.
Danish: De officielle og lokale krav vedrørende håndtering af antimikrobielt materiale bør tages i betragtning, når dette produkt anvendes.
English: For oral administration in drinking water.
Danish: Oral administration via drikkevandet.
English: ATC vet code: QJ01MA94
Danish: ATCvet-kode: QJ01MA94
English: number of animals in the house X mean weight of individual animal(kg) X 100
Danish: antallet af dyr i huset X gennemsnitlig vægt af individuelle dyr (kg) X 100
English: Approximately 95 % of the oral dose was absorbed.
Danish: Ca. 95% af den orale dosis absorberes.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af denne markedsføringstilladelse skal oplyse Den Europæiske Kommission om markedsføringsplanerne for det lægemiddel, er autoriseret i henhold til denne godkendelse.
English: If there is insufficient improvement after 3 days, the treatment can be continued for another 2 days.
Danish: Hvis der ikke er tilstrækkelig bedring efter tre dage, kan behandlingen fortsætte i yderligere 2 dage.
English: Antagonism may be observed with nitrofurantoin.
Danish: Der kan observeres antagonisme med nitrofurantoin .
English: Water for injections
Danish: Vand til injektionersvæsker
English: These adverse reactions were self-limiting within one or two days and did not require additional treatment.
Danish: Disse bivirkninger gik over af sig selv inden for en eller to dage og krævede ingen yderligere behandling.
English: PVC/aluminium blisters with 10 tablets per blister.
Danish: PVC/aluminium blisterpakninger med 10 tabletter pr. blisterkort.
English: Difloxacin concentrations equal to or greater than the MICs for the relevant pathogens are achieved in all relevant tissues and maintained for as long as medication is continued.
Danish: Der opnås difloxacin-koncentrationer svarende til eller større end MIC for de aktuelle patogener i alle relevante væv og opretholdes, så længe medicineringen vedvarer.
English: The clearance of difloxacin after subcutaneous administration to cattle is 229 ml/h/kg.
Danish: Clearance af difloxacin efter subkutan indgivelse til kvæg er 229 ml/h/kg.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu/
English: Therapy should be re-evaluated if no improvement is seen within 5 days, or 10 days in the case of superficial pyoderma.
Danish: Behandlingen bør evalueres, hvis tilstanden ikke bedres inden for 5 dage, eller 10 dage i tilfælde af overfladisk pyoderma.
English: Dicural coated tablets should be given once a day for at least 5 days.
Danish: Dicural overtrukne tabletter skal gives én gang dagligt i mindst 5 dage .
English: All food-producing species
Danish: Alle arter bestemt til levnedsmiddelproduktion
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products
Danish: Da der ikke findes kompatibilitetsstudier, bør man ikke blande dette veterinærlægemiddel med andre veterinærlægemidler.
English: Each strength of the product is available in packs of 10, 20 and 100 tablets.
Danish: Alle styrker af præparatet findes i pakninger med 10, 20 eller 100 tabletter.
English: Do not use in epileptic dogs.
Danish: Må ikke bruges til epileptiske hunde.
English: A half-life time of 5.8 hours has been observed.
Danish: Halveringstiden er 5,8 timer.
English: The observed reactions were inappetence, emesis, diarrhoea, and anal irritation.
Danish: De observerede bivirkninger var appetitløshed, emesis, diarré og anal irritation.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER LOT {nummer}
English: In target animal safety studies, subcutaneous administration was generally well tolerated.
Danish: I sikkerhedsundersøgelser blev subkutan injektion generelt tolereret godt.
English: In chickens difloxacin is nearly completely absorbed after oral administration (approx. 96%).
Danish: Hos kyllinger absorberes difloxacin næsten fuldstændigt efter oral indgift (ca. 96 %).
English: D. STATEMENT OF THE MRLs which are accepted in accordance with Council Regulation (EEC) No 2377/90 and in accordance with Article 31 (3b) of Council Regulation (EEC) No 2309/93 of 22 July 1993, as amended.
Danish: I henhold til Rådets Forordning (EØF) nr. 2377/90 med senere ændringer, og i overensstemmelse med artikel 34,4b i Rådets Forordning (EØF) nr. 726/2004 af 31. marts 2004..
English: Cardboard boxes of 1, 2 or 10 blisters.
Danish: Yderkarton med 1, 2 eller 10 blisterkort.
English: Annex I of Council Regulation (EEC) No 2377/90 Pharmacologically active substance residue
Danish: Bilag I til Rådets Forordning nr. 2377/90 Det farmakologisk aktive stof
English: In turkeys difloxacin has a moderate oral bioavailability (approx. 58%).
Danish: Hos kalkuner har difloxacin moderat oral biotilgængelighed (ca. 58%).
English: Pruritis and/or local swellings and occasionally a slight pain reaction on injection have been observed.
Danish: Der er observeret kløe og/eller lokal hævelse og af og til svage smerter i forbindelse med injektionen.
English: Do not use in birds in lay and/or within 4 weeks before the onset of the laying period.
Danish: Må ikke anvendes i æglægningsperioden til og/eller inden for 4 uger forud for æglægningsperiodens begyndelse.
English: Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Danish: Når det er muligt, bør fluoroquinoloner kun anvendes, når der foreligger sensitivitetstest.
English: WITHDRAWAL PERIOD [Not applicable.]
Danish: TILBAGEHOLDELSESTID [Ikke relevant]
English: The elimination half-life averaged 9.3 hours.
Danish: Halveringstiden er 9,3 timer i gennemsnit.
English: Taking into account the content of difloxacin in the oral solution (10%w/v), the following calculation should be made to determine the volume (ml) to be added for each 1000 litres of water:
Danish: Idet det tages i betragtning, at indholdet af difloxacin i opløsningen er 10% (w/v), bør følgende beregning foretages for at fastsætte den mængde i ml, der skal tilsættes pr. 1000 liter vand:
English: The volume of distribution is 2.6 l/kg.
Danish: Fordelingsvolumenet er 2,6 l/kg.
English: Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones
Danish: Der kan udvikles resistens mod quinoloner ved mutationer i bakteriernes gyrase-gen og ved ændringer i cellernes permeabilitet over for quinoloner.
English: A half-life time of 7.7 hours has been observed.
Danish: Halveringstiden er 7,7 timer.
English: Difloxacin is rapidly absorbed after oral administration to reach steady state plasma concentrations in a few hours after initiation of medication.
Danish: Difloxacin absorberes hurtigt efter oral indgift og steady state plasmakoncentration indtræder få timer efter påbegyndt medicinering.
English: Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential of cross resistance.
Danish: Hvis dette produkt ikke anvendes i overensstemmelse med anvisningerne i produktresumeet, kan det øge udbredelsen af bakterier, der er resistente over for fluoroquinoloner, og det kan nedsætte effekten af behandling med andre quinoloner på grund af potentiel krydsresistens.
English: In both species difloxacin may be conjugated (glucuronidated or sulphated), desmethylated into sarafloxacin or oxidised into N-oxide-difloxacin.
Danish: Hos begge arter kan difloxacin konjugeres (glucuronideres eller sulfateres), demetyleres til sarafloxacin eller oxideres til N-oxid-difloxacin.
English: A new injection site should be used each day.
Danish: Der bør anvendes et nyt injektionssted hver dag.
English: The tablets should be administered for at least 2 days beyond the cessation of clinical signs.
Danish: Tabletterne skal gives i mindst 2 dage, efter at symptomerne er ophørt.
English: Heavy reliance on a single class of antibiotics may result in the induction of resistance in a bacterial population.
Danish: Stærk afhængighed af en enkelt gruppe antibiotika kan resultere i resistensudvikling i en bakteriel population.
English: A fraction of difloxacin (i.e. 7 - 18%) is eliminated via the urine.
Danish: En lille mængde difloxacin (dvs. 7-18%) udskilles via urinen.
English: The majority of difloxacin (i.e. 68 - 82%) is excreted via the faeces.
Danish: Størstedelen af difloxacin (dvs. 68 - 82%) udskilles via fæces.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: The following organisms were found to be of intermediate susceptibility:
Danish: De følgende organismer blev fundet at være middel følsomme:
English: Overdosage may also give rise to oedema and swelling in the knee joints.
Danish: Overdosering kan også resultere i ødem og hævelser i knæleddene.
English: Propylene glycol 9 Benzyl alcohol 10 Arginine 11
Danish: Propylenglykol 9 Benzylalkohol 10 Arginin 11
English: Keep the container in the outer carton.
Danish: Opbevar beholderen i den ydre karton
English: Adverse reactions were rare in dogs treated with difloxacin.
Danish: Bivirkninger var sjældne hos hunde, blev behandlet med difloxacin.
English: At concentrations in the water of 0.03% (= 300 ml in 1000 litres) or greater, palatability for turkeys may be affected.
Danish: Ved koncentrationer på 0,03 % (=300 ml i 1000 liter) og derover i vandet kan smagen af kalkunkødet påvirkes.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml indeholder:
English: Solution for injection: Pharmacologically active substance
Danish: Injektionsvæske opløsning: Farmakologisk aktivt stof
English: The screw cap on the 1 litre bottle can be used as measuring device.
Danish: Skruelåget på 1 literflasken kan bruges som målebæger.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktiv stof:
English: No additional chlorine, for example from the use of water chlorinators, or hydrogen peroxide should be added to the drinking water used with this product.
Danish: Der bør ikke tilsættes klor (f.eks. ved anvendelse af vand-klorerende stoffer) eller brintoverilte til det drikkevand, der anvendes med dette produkt.
English: Dicural coated tablets consist of a core tablet containing difloxacin hydrochloride and a highly palatable coating.
Danish: Dicural overtrukne tabletter består af en tabletkerne, der indeholder difloxacinhydrochlorid og et velsmagende overtræk.
English: 6.5 Nature and contents of container
Danish: 6.5 Den indre emballagens art og indhold
English: Histopathological changes were noted in the articular cartilage of weight bearing joints of young (3.5 months old) beagle dogs after the oral administration of difloxacin at doses of greater than 5 mg/kg/day (as the hydrochloride) for 90 days.
Danish: Der blev observeret histopatologiske ændringerne i ledbrusken i de vægtbærende led hos unge (3,5 måneder gamle) beagle hunde efter oral administration af difloxacin (som hydrochlorid) ved doser over 5 mg/kg/dag i 90 dage.
English: Medicated water must be freshly prepared daily.
Danish: Medicineret vand bør tilberedes frisk hver dag.
English: Tissue to plasma ratios range from 2.5 (abdominal fat), 3.7 (muscle), 4.8 (lung) to 36.5 (liver).
Danish: Væv-til-plasma-forholdet spænder fra 2,5 (abdominalfedt), 3,7 (muskel), 4,8 (lunge) til 36,5 (lever).
English: Tissue to plasma ratios range from 0.6 (abdominal fat), 2.4 (lung), 4.5 (muscle) to 14.1 (liver).
Danish: Væv-til-plasma-forholdet spænder fra 0,6 (abdominalfedt), 2,4 (lunge), 4,5 (muskel) til 14,1 (lever).
English: White HDPE bottles with a screw cap containing 250ml or 1litre of Dicural oral solution.
Danish: Hvide HDPE-flasker med skruelåg indeholdende 250 ml eller 1 liter Dicural oral opløsning.
English: Nitrofurantoin may impair quinolone efficacy if used concurrently in the treatment of urinary tract infections.
Danish: Nitrofurantoin kan nedsætte effekten af quinolonet, hvis det anvendes samtidigt til behandling af urinvejsinfektioner.
English: The parent compound difloxacin is the major component in the faeces and tissues.
Danish: Stamsubstansen difloxacin er hovedbestanddelen i fæces og væv.
English: For a full list of excipients, see section 6.1
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Dicural oral solution is a yellowish clear aqueous solution and is supplied in plastic white bottles with a screw cap containing 250 or 1000 ml oral solution.
Danish: Dicural oral opløsning er en gullig, klar vandig opløsning, der fås i hvide plastflasker med skruelåg og indeholdende 250 eller 1000 ml oral opløsning.
English: Dicural 15 mg coated tablets for dogs Dicural 50 mg coated tablets for dogs Dicural 100 mg coated tablets for dogs Dicural 150 mg coated tablets for dogs
Danish: Dicural 15 mg overtrukne tabletter til hunde Dicural 50 mg overtrukne tabletter til hunde Dicural 100 mg overtrukne tabletter til hunde Dicural 150 mg overtrukne tabletter til hunde
English: Do not use after the expiry date stated on the carton after EXP.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på æsken efter EXP.
English: The reproductive safety of the veterinary medicinal product has only been evaluated in laboratory animals, the use of difloxacin in pregnant or lactating bitches or male stud dogs is therefore not recommended.
Danish: Veterinærlægemidlets sikkerhed vedrørende reproduktion er kun undersøgt hos forsøgsdyr, og difloxacin bør derfor ikke anvendes under drægtighed, laktation eller til avlshanhunde.
English: It is very well distributed in the body (Vd = 9.9 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Danish: Det fordeles godt i kroppen (Vd = 9,9 l/kg) og har en halveringstid på ca. 7 timer.
English: It is well distributed in the body (Vd = 4.7 l/kg) and has a plasma elimination half-life of approximately 7 hours.
Danish: Det fordeles godt i kroppen (Vd = 4,7 l/kg) og har en halveringstid på ca. 7 timer.
English: If filled to the brim the measuring device provides 50ml.
Danish: Hvis det fyldes til randen indeholder målebægeret 50 ml.
English: DATE OF RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Long term daily oral treatment over 180 days at 5 mg/kg bodyweight did not influence difloxacin kinetics, neither by accumulation nor by increased drug metabolism.
Danish: Langtidsbehandling i mere end 180 dage med 5 mg/kg legemsvægt havde ingen indflydelse på difloxacins farmakokinetiske egenskaber, hverken i form af akkumulering eller forøget metabolisme.
English: 4 OJ No. L 272 of 25.10.96
Danish: L 272 af 25.10.96
English: [Not required on the immediate label] Dispose of waste material in accordance with local requirements.
Danish: [Not required on the immediate label] Ubrugte lægemidler skal destrueres i overensstemmelse med de lokale krav.
English: Strains of Escherichia coli, Pasteurella multocida, Mycoplasma gallisepticum isolated from broilers and turkeys have been shown to be sensitive to difloxacin.
Danish: Bakteriestammer af Escherichia coli, Pasteurella multocida og Mycoplasma gallisepticum isoleret fra slagtekyllinger og kalkuner har vist sig at være følsomme over for difloxacin.
English: The following organisms were tested and found to be susceptible to difloxacin in vitro:
Danish: Følgende organismer er testet og fundet følsomme for difloxacin in vitro:
English: METHOD AND ROUTE OF ADMINISTRATION For oral administration in drinking water.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral administration via drikkevandet.
English: Pharmacotherapeutic group: general anti-infectives for systemic use; antibacterials for systemic use, quinolone antibacterials.
Danish: Farmakoterapeutisk gruppe: Infektionssygdomme, systemiske midler; antimikrobielle midler til systemisk brug, quinoloner.
English: Dicural Coated Tablets should only be used based on susceptibility testing.
Danish: Dicural overtrukne tabletter bør kun anvendes, når der foreligger sensitivitetstest.
English: Measuring lines indicate the volume supplied.
Danish: Målestregerne angiver det afmålte volumen.
English: The medicated drinking water should be prepared freshly each day.
Danish: Der bør tilberedes frisk medicineret drikkevand frisk hver dag.
English: Difloxacin can be bactericidal against many Gram-negative micro-organisms and a selection of Gram-positive microorganisms.
Danish: Difloxacin kan have baktericid effekt over for de fleste Gram-negative mikroorganismer og en række Gram-positive mikroorganismer.
English: Difloxacin is an aryl-fluoroquinolone with a broad spectrum of antimicrobial activity.
Danish: Difloxacin er et aryl-fluorocinolon med bredtspektret antimikrobiel aktivitet.
English: CARTON OF 10 TABLETS / 20 TABLETS / 100 TABLETS
Danish: Karton etiket Æske med 10 tabletter / Æske med 20 tabletter / Æske med 100 tabletter
English: A fraction of difloxacin is eliminated by the urine.
Danish: En lille mængde difloxacin udskilles via urinen.
English: 3 OJ No. L 290 of 5.12.95
Danish: L 290 af 5.12.95
English: In order to avoid irritation of skin and/or eyes, use gloves and a face-protecting device when handling this product.
Danish: For at undgå irritation af hud og/eller øjne anbefales det at bruge handsker og ansigtsmaske under håndtering af præparatet.
English: 1 OJ No. L 172 of 02.07.02
Danish: L 172 af 02.07.02
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Dicural oral solution
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Dicural Oral opløsning
English: Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight.
Danish: Dicural, oral opløsning skal indgives dagligt via drikkevandet i en sådan mængde, at dosis er 10 mg/kg kropsvægt.
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. INDEHAVERE AF VIRKSOMHEDSGODKENDELSE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Target animal safety studies in chickens and turkeys demonstrated that, when administered in drinking water at 30 mg/kg (chickens) or 22 mg/kg (turkeys) for three times the recommended duration (15 consecutive days), difloxacin hydrochloride appeared to be safe for the birds.
Danish: Sikkerhedsundersøgelser med kyllinger og kalkuner har vist, at difloxacinhydrochlorid synes at være ufarlig for fuglene ved indgivelse i drikkevandet af 30 mg/kg (kyllinger) eller 22 mg/kg (kalkuner) i tre gange den anbefalede behandlingsvarighed (15 på hinanden følgende dage).
English: Therefore, do not use in small and medium-sized breeds of dogs up to and including 8 months of age, in large breeds up to 1year of age and in giant breeds up to 18 months of age.
Danish: Derfor bør difloxacin ikke anvendes til små og middelstore hunderacer op til og med 8 måneders alderen, til store hunderacer op til 1 års alderen, og til meget store hunderacer op til 18 måneders alderen.
English: 5 OJ No. L 45 of 15.02.97
Danish: L 45 af 15.02.97
English: DOSAGE FOR EACH SPECIES, METHOD AND ROUTE OF ADMINISTRATION Dicural oral solution must be administrated daily via the drinking water in such a concentration that the dose is 10 mg/kg bodyweight.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Dicural, oral opløsning skal indgives dagligt via drikkevandet i en sådan mængde, at dosis er 10 mg/kg kropsvægt.
English: The use of fluoroquinolones in combination with non-steroidal anti-inflammatory drugs (NSAIDs) may cause seizures.
Danish: Anvendelsen af fluoroquinoloner i kombination med NSAID kan fremkalde krampeanfald.
English: For complicated respiratory disease the dose can be doubled to 5 mg/kg bodyweight / day.
Danish: Ved komplicerede luftvejssygdomme kan dosis fordobles til 5 mg/kg legemsvægt/dag.
English: In the urine, liver, fat and kidneys the metabolites desmethyl-difloxacin and difloxacin N-oxide can be found in small amounts in addition to the major (parent) compound.
Danish: I urinen, lever, fedtvæv og nyrer forekommer der, udover stamsubstansen, små mængder af metabolitterne desmethyl-difloxacin og difloxacin N-oxid.
English: At very high doses adverse effects on the nervous system (ataxia, unsteadiness, twitching, tremors, convulsions, etc) may occur in cattle.
Danish: Ved meget høje doser kan der forekomme bivirkninger i nervesystemet (ataksi, vaklen, muskeltrækninger, rysten, kramper, osv.) hos kvæg.
English: It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics.
Danish: Fluoroquinolonerne bør forbeholdes behandling af kliniske tilstande, som har responderet dårligt eller forventes at respondere dårligt på andre grupper af antibiotika.
English: Small
Danish: Lille
English: Not permitted for use in laying birds producing eggs for human consumption.
Danish: Må ikke anvendes til æglæggende fugle, hvis æg er bestemt til menneskeføde.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Difloxacin (as hydrochloride)
Danish: ANGIVELSE AF AKTIV STOFFER OG ANDRE STOFFER Difloxacin (som hydrochlorid)
English: Annex II of Council Regulation (EEC) No 2377/90 Oral solution:
Danish: Bilag II til Rådets Forordning (EØF) nr. 2377/90 Oral opløsning: Det farmakologisk aktive stof
English: Turkeys:
Danish: Kalkuner:
English: Muscle Skin + fat Liver Kidney
Danish: Muskel Hud + fedt Lever Nyre
English: The recommended dose is 2.5mg difloxacin/kg bodyweight/day for 3 days (i.e. 5ml/100 kg bodyweight/day).
Danish: Den anbefalede dosis er 2,5 mg difloxacin/kg legemsvægt/dag i 3 dage (dvs. 5 ml/100 kg legemsvægt/dag).
English: Not for use in animals from which eggs are produced for human consumption
Danish: Må ikke anvendes til dyr, hvis æg er bestemt til menneskeføde
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if any
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: Dogs: Cardboard box with one glass vial of 50ml with a rubber stopper and aluminium cap.
Danish: Hunde: Æske med et hætteglas á 50 ml med gummiprop og aluminiumshætte.
English: CARTON LABEL - 1 X 250 ML BOTTLE / 1 X 1000 ML BOTTLE / 6 X 1000 ML BOTTLE VIAL LABEL 250 ml bottle / 1000 ml bottle
Danish: Yderpakning 1 x 250 ml / 1 x 1000 ml / 6 x 1000 ml - Etiket til 250 ml / 1000 ml
English: PACKAGE SIZE 100 ml
Danish: PAKNINGSSTØRRELSE 100 ml
English: Not for use in animals from which milk is produced for human consumption
Danish: Må ikke anvendes til dyr, hvis mælk er bestemt menneskeføde