FrancophonIA/ELRC3.0 huggingface dataset:
English: - the overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base
Danish: - Den overordnede kontrolstrategi for at sikre en passende og reproducerbar lægemiddelkvalitet er blevet dokumenteret med hensyn til håndtering af clopidogrelbasens viskøse masse.
English: - the Applicant's choice of the clopidogrel base and consequently the use of BHA has been sufficiently explained
Danish: Ud fra følgende betragtninger: - Ansøgerens valg af clopidogrelbasen og dermed brugen af BHA er blevet tilstrækkeligt forklaret.
English: Therefore justification that the overall control strategy ensured suitable and reproducible quality of the product with regard to the handling of the viscous mass of clopidogrel base was requested from the Applicant and justification also for the absence of specifications for the clopidogrel base.
Danish: Derfor blev ansøgeren anmodet om dokumentation for, at den overordnede kontrolstrategi sikrede en passende og reproducerbar kvalitet af lægemidlet med hensyn til håndtering af clopidogrelbasens viskøse masse, og der blev ligeledes anmodet om en begrundelse for, at der ikke fandtes specifikationer for clopidogrelbasen.
English: BHA is present in amounts less than the ADI, which is generally deduced from the No Effect Level of the substance; therefore a biological action or effect on the patients is not expected.
Danish: BHA findes i mængder under ADI, som generelt udledes af nuleffektniveauet for stoffet.
English: The CHMP noted that the primary purpose for the addition of BHA was to prevent the initiation of free radicals, by blocking the oxidative pathway, and was assured by the Applicant that the lowest level possible had been used.
Danish: CHMP bemærkede, at det primære formål med tilsætningen af BHA var at forhindre udviklingen af frie radikaler ved at blokere oxideringen, og ansøgeren forsikrede om, at den lavest mulige mængde var blevet anvendt CHMP konkluderede, at anvendelsen af BHA og produktionsprocessen ikke indebar nogen potentiel alvorlig risiko for folkesundheden, selv om valget af clopidogrelbasen ikke blev anset for at være optimal.
English: are stable in comparison to clopidogrel bisulphate, which is sensitive to hydrolytic degradation.
Danish: er stabile sammenlignet med clopidogrelbisulfat, som er følsomt over for hydrolytisk nedbrydning er bioækvivalente med referencelægemidlet clopidogrelbisulfat
English: - the Applicant's Clopidogrel Base Tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
Danish: - Ansøgerens clopidogrelbasetabletter 75 mg er af tilstrækkelig kvalitet og har et tilstrækkeligt benefit/riskforhold og er sammenlignelige med referencelægemidletanbefaler CHMP, at der udstedes markedsføringstilladelse.
English: ENGLISH
Danish: DANISH
English: STORING X
Danish: HVORDAN DE OPBEVARER X
English: <This medicine does not require any special storage conditions>
Danish: <Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen>
English: <This medicine does not require any special temperature storage conditions>*****
Danish: <Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel>*****
English: <Store in a refrigerator>
Danish: <Opbevares i køleskab>
English: <Store in a refrigerator (2(C - 8(C)
Danish: <Opbevares i køleskab (2 °C - 8 °C)>
English: <Store and transport frozen>**
Danish: <Opbevares og transporteres nedfrosset>**
English: <Store and transport frozen {temperature range}>**
Danish: <Opbevares og transporteres nedfrosset {temperaturinterval}>**
English: <Store in a freezer {temperature range}>
Danish: <Opbevares i dybfryser {temperaturinterval}>
English: <Store and transport refrigerated (2(C - 8(C)>*
Danish: <Opbevares i køleskab og transporteres nedkølet (2 °C - 8 °C)>*
English: <Store and transport refrigerated>*
Danish: <Opbevares i køleskab og transporteres nedkølet>*
English: <Store in a freezer>
Danish: <Opbevares i dybfryser>
English: ATC-vet code: QI01AA23.
Danish: ATCvet-kode: QI01AA23.
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Danish: Hvis smerten fortsætter i over 12 timer efter lægeundersøgelsen, skal du søge lægehjælp igen.
English: 4.8 Interactions with other medicinal products and other forms of interaction
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion
English: This product contains mineral oil.
Danish: Dette veterinærlægemiddel indeholder mineralolie.
English: It is recommended to use a closed multiject vaccination system.
Danish: Det anbefales at bruge et lukket multiinjektions-vaccinations system.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres koldt.
English: Serum antibodies could be expected to persist for at least 12 months after administration of two doses of vaccine.
Danish: Serumantistoffer kan forventes at være tilstede i mindst 12 måneder efter administration af to doser vaccine.
English: This vaccine has been tested for safety in chickens.
Danish: Vaccinen er testet for sikkerhed i kyllinger.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Lot: {nummer}
English: To the user:
Danish: Til brugeren:
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: Registreringsindehaveren skal informere den Europæiske Kommission om planer for markedsføring for det medicinske produkt, som er autoriseret ved denne beslutning.
English: The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Danish: Flaskerne er lukket med nitryl-gummiprop og forseglet med en kodet aluminiumshætte.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibitthe manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
Danish: Anvendelse af dette veterinære lægemiddel er kun tilladt under de særlige betingelser, som er udstedt i det Europæiske Fællesskabs lovgivning om kontrol af fugleinfluenza.
English: Immunisation of progeny from vaccinated birds should therefore be delayed until such antibodies have declined.
Danish: Immunisering fra afkom af vaccinerede fugle bør derfor udsættes indtil dette antistofniveau er faldet.
English: Reduction of clinical signs, mortality and excretion of virus after challenge were shown by three weeks after vaccination.
Danish: Reduktion af kliniske symptomer, dødelighed og udskillelse af virus efter belastningsforsøg blev vist 3 uger efter vaccination.
English: Chickens.
Danish: Kyllinger.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 01/09/2006
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 01/09/2006 Dato for seneste fornyelse af markedsføringstilladelse:
English: If you notice any serious effects or other effects not mentioned in this leaflet, 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: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusiv adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRLværdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: The level of efficacy for other species may differ from that observed in chickens.
Danish: Graden af effekt på andre arter kan være forskellig fra det, der er observeret i kyllinger.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Danish: b) at den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: Efficacy has been evaluated on the basis of preliminary results in chickens.
Danish: Effekten er blevet vurderet på baggrund af foreløbige resultater i kyllinger.
English: Any person intending to manufacture, import, possess, sell, supply and/or use Nobilis Influenza H5N2 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende Nobilis Influenza H5N2, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
English: Glass vials: 1 year.
Danish: Hætteglas: 1 år.
English: DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR
English: 3732 CN De Bilt
Danish: 3732 CN De Bilt Holland
English: The manufacture, import, possession, sale, supply and/or use of Nobilis Influenza H5N2 may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af Nobilis Influenza H5N2 er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: Store and transport refrigerated (2 °C - 8 °C).
Danish: Opbevares og transporteres nedkølet (2°C - 8°C).
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJE
English: MARKETING AUTHORISATION NUMBER EU/2/06/061/001-004
Danish: MARKEDSFØRINGSTILLADELSENS NUMRE EU/2/06/061/001-004.
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Utilsigtet selv-injektion er farlig.
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Danish: Uforsætlig injektion/selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre, og kan i sjældne tilfælde medføre tab af den pågældende finger, hvis den ikke behandles omgående.
English: Pharmacotherapeutic group: Immunologicals for Aves; Inactivated viral vaccines, avian influenza virus.
Danish: Farmakoterapeutisk gruppe: Immunologisk veterinærlægemiddel til hønsefugle; Inaktiveret viral vaccine, fugleinfluenzavirus.
English: Do not mix with any other veterinary medicinal product.
Danish: Må ikke blandes med andre veterinære lægemidler.
English: Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Danish: Selv hvis der er tale om små injicerede mængder, kan uforsætlig injektion af produktet medføre kraftige hævelser, der eksempelvis kan resultere i iskæmisk nekrose og endog tab af en finger.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/061/001-004
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/061/001-04
English: Sorbitane mono-oleate Glycine
Danish: Sorbitan mono-oleat
English: Intervet International BV, site De Bilt Ambachtstraat 4
Danish: Intervet International BV, De Bilt Ambachtstraat 4
English: One dose of 0.5 ml contains:
Danish: En dosis af 0,5 ml indeholder:
English: - 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: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: No information is available on vaccination in the presence of maternally derived antibodies.
Danish: Ingen informationer er tilgængelig om vaccination ved tilstedeværelse af maternelle antistoffer.
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Danish: Hvis du ved et uheld injiceres med dette veterinærlægemiddel, skal du søge omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde, og tag indlægssedlen med dig.
English: Do not administer intramuscularly in chickens less than 2 weeks old.
Danish: Må ikke anvendes intramuskulært på kyllinger, der er yngre end 2 uger.
English: The vaccine stimulates active immunity against avian influenza virus type A, subtype H5.
Danish: Vaccinen stimulerer aktiv immunitet mod fugleinfluenza-virus type A, undertype H5.
English: Allow the vaccine to reach a temperature of 15 °C - 25 °C.
Danish: Lad vaccinen opnå stuetemperatur (15 - 250C).
English: If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Danish: Hvis det cirkulerende, vilde fugleinfluenza -virus har en anden N -komponent i forhold til N2, som findes i vaccinen, er det muligt at differentiere mellem vaccinerede og inficerede fugle ved at bruge en diagnostisk test til bestemmelse af neuraminidase antistoffer.
English: Shelf life after first opening the container: 8 hours.
Danish: Opbevaringstid efter første åbning af beholderen: 8 timer.
English: Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Danish: Der kræves ØJEBLIKKELIG kirurgisk behandling, og der kan opstå behov for tidlig incision og irrigation af det injicerede område, navnlig når det drejer sig om fingerbløddele eller -sener.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) 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 almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: To the physician:
Danish: Til lægen:
English: If used in other avian species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of birds prior to mass vaccination.
Danish: Hvis vaccinen bruges til andre fuglearter, som er i risiko for at få infektion, skal vaccinationen af disse fuglearter foretages med forsigtighed, og det er tilrådeligt at teste vaccinen på et lille antal fugle, før man foretager en massevaccination.
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Intervet International B.V.
English: Do not freeze.
Danish: Beskyttes mod frost.
English: For active immunisation of chickens against avian influenza type A, subtype H5.
Danish: Aktiv immunisering af kyllinger mod fugleinfluenza type A, undertype H5.
English: Future laying hens and breeders: administer a second 0.5 ml dose 4-6 weeks after the first vaccination.
Danish: Kommende æglæggere og avlsdyr; indgives en anden vaccination af 0,5 ml, 4 - 6 uger efter første vaccination.
English: Use sterile syringes and needles.
Danish: Brug sterile injektionssprøjter og kanyler.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular or subcutaneous use (0.25 to 0.5 ml, depending on the age).
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intramuskulær eller subkutan anvendelse af 0,25 til 0,5 ml, afhængigt af alder.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIG FOR BATCHFRIGIVELSE
English: Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥6.0 log2 as tested according to the potency test.
Danish: Inaktiveret helt fugleinfluenza-virusantigen af undertype H5N2 (stamme A/duck/Potsdam/1402/86), inducerer en HI titer på > 6.0 log2 som testet i henhold til potency test.
English: Incompatibilities Do not mix with any other veterinary medicinal product.
Danish: Uforligeligheder: Må ikke blandes med andre veterinære lægemidler.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton
English: A transient diffuse swelling may very commonly occur at the vaccination site, which persists for about 14 days.
Danish: En forbigående hævelse, som vedvarer i cirka 14 dage, kan meget almindeligt opstå på injektionsstedet.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Netherlands
Danish: Intervet International BV Wim de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: INDICATION(S)
Danish: INDGIVELSESVEJ(E)
English: THE WORDS “KEEP OUT OF THE SIGHTAND REACH OF CHILDREN” Keep out of the sight and reach of children.
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
English: Shake well before use.
Danish: Omryst grundigt før brug.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 0.5 ml contains:
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER En dosis af 0,5 ml indeholder:
English: Zero days.
Danish: 0 dage
English: Cardboard box with 250 or 500 ml hydrolytical type II glass or polyethylene terephthalate (PET) bottles.
Danish: Karton med 250 eller 500 ml flasker af hydrolytisk glas type II eller af polyethylen terephthalat (PET).
English: The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains.
Danish: Det opnåede virkningsniveau kan variere mellem vaccinestammer og cirkulerende stammer afhængig af graden af ensartethed i antigener.
English: Special warnings for each target species
Danish: Særlige advarsler for hver dyreart:
English: 6.2 Incompatibilities
Danish: 6.2 Væsentlige uforligeligheder
English: For subcutaneous or intramuscular use.
Danish: Til subkutan eller intramuskulær anvendelse.
English: Shelf life after first opening the immediate packaging: use within 8 hours.
Danish: Opbevaringstid efter første åbning af den indre emballage: Bruges inden for 8 timer.
English: EXPIRY DATE EXP {month/year} Once broached, use within 8 hours.
Danish: BATCHNUMMER Lot: {nummer} UDLØBSDATO EXP {måneder/år} Efter anbrud anvendes inden 8 timer.
English: White homogeneous emulsion.
Danish: LÆGEMIDDELFORM Injektionsvæske, emulsion Hvid homogen emulsion.
English: The safety of the veterinary medicinal product has not been established during lay.
Danish: Lægemidlets sikkerhed under æglægning er ikke fastlagt.
English: EXPIRY DATE
Danish: 10. UDLØBSDATO
English: Following the administration of a double dose, no adverse reactions other than those described in section 4.6 have been observed.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt Der er ikke observeret andre symptomer efter administration af dobbelt dosis end dem, der er beskrevet i afsnit 4.6.
English: WITHDRAWAL PERIOD Withdrawal period: Zero days.
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 døgn.
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only.
Danish: UDLEVERING OG BRUG, OM NØDVENDIGT Til dyr - kræver recept.
English: Liquid light paraffin: 234.8 mg.
Danish: Paraffinolie, tynd: 234,8 mg.
English: Liquid light paraffin Polysorbate 80
Danish: Polysorbat 80
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Til brugeren:
English: From 8 - 14 days old: 0.25 ml subcutaneously.
Danish: Fra 8 - 14 dage gamle: 0,25 ml subkutant.
English: EXP {month/year} Once broached, use within 8 hours.
Danish: Efter anbrud anvendes inden 8 timer.
English: Adjuvant:Liquid light paraffin 234.8 mg
Danish: Adjuvans: Paraffinolie, tynd 234,8 mg
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BOTTLE LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ INDRE PAKNINGER
English: Cardboard box with 250 or 500 ml multidose PET bottle.
Danish: Karton med 250 ml eller 500 ml multidosis PET flasker.
English: Name and address of the manufacturer responsible for batch release Intervet International BV
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Intervet International B.V.
English: Veterinary medicinal product subject to prescription.
Danish: Må kun udleveres efter veterinærrecept.