FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT “Product name” (to be completed nationally) intramammary suspension for lactating cattle
Danish: Produktnavn (Udfyldes nationalt) Intramammær suspension til diegivende kvæg
English: Cattle Meat: 6 days Milk: 5 days
Danish: Kvæg Kød: 6 dage Mælk: 5 dage
English: DATE OF REVISION OF THE TEXT To be completed nationally
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: • Withdrawal periods.
Danish: • Tilbageholdelsesperioder
English: Cattle Edible tissues: 4 days Milk: 60 hours
Danish: Kvæg Spiselige væv: 4 dage Mælk: 60 timer
English: Therefore overall treatment length must be at the veterinarian's discretion but should be long enough to ensure complete resolution of intramammary infection.” A longer duration of treatment would not impact the recommended withdrawal periods for meat and milk.
Danish: Derfor skal den samlede behandlingstid være efter dyrlægens skøn, men længe nok til at sikre, at den intramammære infektion er forsvundet fuldstændigt.”
English: STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS Active ingredients:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER
English: The product is intended for the treatment of bovine clinical mastitis in lactating cows, including cases of infections associated with the following pathogens:
Danish: Lægemidlet er beregnet til behandling af klinisk bovin mastitis hos diegivende køer, herunder tilfælde med infektioner forbundet med følgende patogener:
English: • Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis)
Danish: • Streptokokker (herunder S. agalactiae, S. dysgalactiae og S. uberis)
English: Inappropriate use of the product may increase the prevalence of bacteria resistant to ß-lactam antibiotics and may decrease the effectiveness of treatment with ß-lactam antibiotics, due to the potential for cross-resistance.” Regarding the possibility for combined therapy with Synulox RTU, data to support this recommendation were not provided.
Danish: Ukorrekt brug af lægemidlet kan øge forekomsten af bakterier, som er resistente over for ß-lactam-antibiotika, og kan mindske effekten af behandling med ß-lactam-antibiotika på grund af potentialet for krydsresistens."
English: • Escherichia coli (including β-lactamase producing strains) A review of the susceptibility of the mastitis pathogens against amoxicillin-clavulanic acid indicates that the major bacterial causes of bovine mastitis continue to be susceptible to clavulanate potentiated amoxicillin.
Danish: En gennemgang af mastitispatogenernes modtagelighed for amoxicillin-clavulansyre tyder på, at de vigtigste bakterielle årsager til bovin mastitis stadig er modtagelige for clavulanforstærket amoxicillin.
English: Swab teat end with appropriate disinfectant before treatment.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Aftør pattens spids med et passende desinfektionsmiddel før behandling.
English: Amoxicillin trihydrate equivalent to amoxicillin
Danish: Amoxicillintrihydrat svarende til amoxicillin
English: PFIZER HELLAS A.E Mesogion Av 242 15451 N.Psichiko Greece
Danish: Grækenland PFIZER HELLAS A.E Mesogion Av 242
English: When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking).
Danish: Når andre malkerutiner følges, kan mælk bestet til menneskeføde først udtages efter samme periode fra sidste behandling (f. eks. ved malkning 3 gange dagligt kan mælk bestemt til menneskeføde først udtages ved 8. malkning).
English: Where any other milking routine is followed, milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk may be taken for human consumption at the 11th milking).
Danish: Hvor andre malkningsrutiner følges, må mælk bestemt til menneskeføde først tages efter samme periode fra sidste behandling (f.eks. ved malkning 3 gange dagligt kan mælk bestemt til menneskeføde udtages ved 11. malkning).
English: Cattle Edible tissues: 4 days
Danish: Kvæg Spiselige væv: 4 dage
English: SPECIAL WARNING(S), IF NECESSARY The product should be used for treatment of clinical mastitis only.
Danish: Anbefalinger for forsvarlig anvendelse Produktet må kun anvendes til behandling af klinisk mastitis.
English: PFIZER, S.A.
Danish: Spanien PFIZER, S.A. Avd.
English: PHARMACEUTICAL FORM Intramammary suspension.
Danish: Intramammær suspension.
English: However it was noted that the self-cure effect was not considered regarding
Danish: Det blev imidlertid bemærket, at den selvhelbredende effekt ikke var taget i betragtning med hensyn til Escherichia coli-tilfældene.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Amoxicillin
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER)
English: The mean differential white blood cell counts were not significantly different at sampling times post treatment suggesting that the low levels of prednisolone did not markedly affect white blood cell counts.
Danish: Den gennemsnitlige differentialtælling af hvide blodlegemer var ikke signifikant anderledes på tidspunktet for prøvetagning efter behandlingen.
English: Lithuania Pfizer Animal Health MA EEIG
Danish: Litauen Pfizer Animal Health MA EEIG
English: Potassium clavulanate (equivalent to clavulanic acid)
Danish: Kaliumclavulanat (svarende til clavulansyre)
English: Cattle Meat: 7 days Milk: 4 days
Danish: Kvæg Kød: 7 dage Mælk: 4 dage
English: Cattle Meat: 7 days Milk: 84 hours (7 milkings)
Danish: Kvæg Kød: 7 dage Mælk: 84 timer (7 malkninger)
English: Cattle Meat: 7 days Milk 84 hours (7 milkings)
Danish: Kvæg Kød: 7 dage Mælk 84 timer (7 malkninger)
English: • Escherichia coli (including β-lactamase producing strains).
Danish: • Escherichia coli (herunder β-lactamase-producerende stammer)
English: Cattle Meat: 7 days Milk: 2 days
Danish: Kvæg Kød: 7 dage Mælk: 2 dage
English: TARGET SPECIES Cattle (lactating cows)
Danish: Kvæg (diegivende køer)
English: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Gram negative bacteria.
Danish: Synulox Lactating Cow var ikke ringere end sammenligningslægemidlet klinisk og bakteriologisk set, hvad angår virkningen mod Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis og gramnegative bakterier.
English: Cattle Meat and offal: 4 days, milk: 3 days
Danish: Kvæg Slagtning: 4 dage, mælk: 3 dage
English: Potassium clavulanate equivalent to clavulanic acid
Danish: Kaliumclavulanat svarende til clavulansyre
English: Strengths Pharmaceutical form
Danish: LÆGEMIDDELFORM
English: Staphylococci (including -lactamase producing strains) Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis) Arcanobacteria (including A. pyogenes)
Danish: Staphylococci (inklusive -lactamaseproducerende stammer) Streptococci (inklusive S. agalactiae, S. dysgalactiae og S. uberis) Arcanobacteria (inklusive A. pyogenes)
English: Ramstage Road Sandwich
Danish: Sandwich, Kent
English: Cattle Meat and offal: 14 days
Danish: Kvæg Slagtning: 14 dage
English: Amoxicillin trihydrate (equivalent to amoxicillin)
Danish: Amoxicillintrihydrat (svarende til amoxicillin)
English: Avd.
Danish: oC.
English: Meat and offal: 7 days.
Danish: Slagtning: 7 dage.
English: In regard to public health risk, gastrointestinal bacteria are not significantly exposed to antimicrobials after this intramammary administration and milk is (nearly always) pasteurised prior to human consumption so the risk to human health from potential resistant pathogens after intramammary treatment is far lower than that which would arise following systemic use.
Danish: Derfor er risikoen for menneskers helbred på grund af potentielle resistente patogener efter intramammær behandling langt lavere end den, som ville opstå efter systemisk brug.
English: Pfizer Animal Health MA EEIG
Danish: Letland Pfizer Animal Health MA EEIG
English: • Staphylococci (including β-lactamase producing strains)
Danish: • Stafylokokker (herunder β-lactamase-producerende stammer)
English: Staphylococci (including -lactamase producing strains) Streptococci (including S.agalactiae, S.dysgalactiae and S.uberis) Escherichia coli (including -lactamase producing strains)
Danish: Staphylococci (inklusive -lactamaseproducerende stammer) Streptococci (inklusive S. agalactiae, S. dysgalactiae og S. uberis) Escherichia coli (inklusive -lactamaseproducerende stammer)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramammary use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: 4.4 Special warnings
Danish: 4.3 Kontraindikationer
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: 4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
English: Consequently the CVMP considered that the recommendations for prudent use in the SPC under section 4.5 Special precautions for use, should be amended as follows: “The product should be used for treatment of clinical mastitis only.
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen, bør ændres som følger:
English: Meat and offal: 7 days Milk: 84 hours
Danish: Tilbageholdelsestid: Slagtning: 7 dage Mælk: 84 timer
English: Clavulanic acid
Danish: Clavulansyre
English: Staphylococci (including -lactamase producing strains) Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis) Escherichia coli (including -lactamase producing strains).
Danish: Stafylokokker (herunder β-lactamase-producerende stammer) Streptokokker (herunder S. agalactiae, S. dysgalactiae og S. uberis) Escherichia coli (herunder β-lactamase-producerende stammer)”
English: Cattle Meat and offal: 4 days
Danish: Kvæg Slagtning: 4 dage
English: Cattle Meat and offal: 7 Days
Danish: Kvæg Slagtning: 7 dage
English: Consequently the CVMP agreed on the following indications for the product: “For use in clinical cases of mastitis including cases associated with infections with the following pathogens: Staphylococci (including -lactamase producing strains) Streptococci (including S.agalactiae, S.dysgalactiae and S.uberis) Escherichia coli (including -lactamase producing strains)” As it is generally recommended to treat clinical mastitis in the first instance with a narrow spectrum antimicrobial and where possible after bacteriological diagnosis, recommendations on prudent use were proposed to be included in the SPC.
Danish: Da det generelt anbefales i første omgang at behandle klinisk mastitis med et smalspektret antimikrobielt middel og, hvor det er muligt, efter bakteriologisk diagnose, blev det foreslået at medtage anbefalinger om forsigtig brug i produktresuméet.
English: 10 mg
Danish: 1 dosis (3 g)
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN”
English: • Posology;
Danish: • Dosering
English: Meat and offal: 7 days
Danish: Slagtning: 7 dage
English: A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Danish: Forbigående temperaturforhøjelse, der normalt ikke overstiger et gennemsnit på 1,1 °C, kan forekomme inden for 24 timer efter vaccination.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their 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 henhold til national lovgivning, forbyde fremstilling, indførsel, besiddelse af, salg, levering og/eller anvendelse af et immunologisk veterinært lægemiddel på hele eller en del af sit område, hvis det godtgøres:
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på ydre emballage efter EXP.
English: BATCH NUMBER Lot{number}
Danish: BATCHNUMMER Lot{nummer}
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Danish: Hjælpestofferne (inklusive adjuvanser), som er anført i punkt 6.1 af SPC'et er tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Danish: En beslutning om at anvende denne vaccine før eller efter et andet veterinært lægemiddel skal derfor tages fra gang til gang.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control and 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 lægemidlet 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: Active substances:
Danish: Aktivt stof (Aktive stoffer):
English: Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days).
Danish: Vaccination kan forårsage en mindre lokal hævelse på injektionsstedet (max. 32 cm²) i en kort periode (max. 14 dage).
English: Any person intending to import, sell, supply and/or use BTVPUR AlSap 8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Danish: Enhver person, som har til hensigt at indføre, sælge, levere og/eller anvende BTVPUR AlSap 8, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden indførsel, salg, levering og/eller anvendelse finder sted.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EU) 470/2009, når de anvendes som i dette veterinære lægemiddel.
English: Aluminium hydroxide Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection
Danish: Aluminiumhydroxid Renset saponin Silikone antifoam Fosfatbuffer Glycinbuffer Vand til injektion
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml of vaccine contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis på 1 ml vaccine indeholder:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/094/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/09/094/001
English: PHARMACEUTICAL FORM Suspension for injection
Danish: LÆGEMIDDELFORM Suspension til injektion
English: In cattle and sheep - 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young cattle and sheep born to immune animals).
Danish: Hos kvæg og får - Første injektion: fra 1-månedsalderen hos naive dyr (eller fra 2,5 måneders-alderen for ungkvæg og får født af immune dyr).
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C-8 °C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares og transporteres nedkølet (2 °C-8 °C).
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Danish: Farmakoterapeutisk gruppe: Vaccine mod bluetonguevirus, ATCvet kode: QI04AA02 (får) og QI02AA08 (kvæg).
English: Shelf life after first opening the immediate packaging: immediately after broaching.
Danish: Opbevaringstid efter første åbning af den indre emballage: umiddelbart efter anbrud.
English: The import, sale, supply and/or use of BTVPUR AlSap 8 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Danish: Indførsel, salg, levering og/eller anvendelse af BTVPUR AlSap 8 er eller kan være forbudt i visse medlemsstater på dele af eller hele deres område.
English: Each dose of 1 ml of vaccine contains:
Danish: Hver dosis på 1 ml vaccine indeholder:
English: Can be used during pregnancy and lactation in cows.
Danish: Kan anvendes under drægtighed og laktation hos køer.
English: 4.11 Withdrawal period Zero days.
Danish: 4.11 Tilbageholdelsestid 0 dage.
English: The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Danish: Immunitetens varighed er 1 år for kvæg og får efter basisvaccinationsprogrammet.
English: * (below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission)
Danish: * (under detektionsgrænsen for den validerede RT-PCR- metode på 3,14 log10 RNA-kopier/ml, der indikerer, at der ikke er nogen infektiøs virustransmission).
English: The safety and the efficacy of the vaccine has not been established in breeding males.
Danish: Sikkerhed og effekt af vaccinen er endnu ikke fastlagt hos avlshanner.
English: *below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission
Danish: *under detektionsgrænsen for den validerede RT-PCR-metode på 3,14 log10 RNA-kopier/ml, der indikerer, at der ikke er nogen infektiøs virustransmission.
English: WITHDRAWAL PERIOD Withdrawal period: zero days.
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 dage.
English: Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue virus serotype 8 (BTV 8).
Danish: Aktiv immunisering af får og kvæg for at forebygge viræmi* og nedsætte kliniske symptomer forårsaget af bluetonguevirus serotype 8.
English: It induces an active and specific immunity against bluetongue virus serotype 8 in the vaccinated animal.
Danish: Den inducerer en aktiv og specifik immunitet over for bluetonguevirus serotype 8 i vaccinerede dyr.
English: Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (**) Haemolytic units
Danish: Aluminiumhydroxid ....................................................................................................................... 2,7 mg Saponin ........................................................................................................................................ 30 HU** (**) hæmolytiske enheder
English: PACKAGE SIZE 100 doses (100 ml)
Danish: PAKNINGSSTØRRELSE 100 doser (100 ml)
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains Bluetongue virus serotype 8 antigen ................. ≥ 2.1 log10 pixels
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Hver dosis på 1 ml vaccine indeholder Bluetonguevirus serotype 8 antigen ................. ≥ 2,1 log10 pixel
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for Bluetongue virus (BTV).
English: Shelf life of the veterinary medicinal product as package for sale (50-ml and 100-ml bottles): 2 years.
Danish: Opbevaringstid for det veterinære lægemiddel i salgspakning (50 ml og 100 ml flasker): 2 år.
English: Shelf life of the veterinary medicinal product as package for sale (10-ml bottle): 18 months.
Danish: Opbevaringstid for det veterinære lægemiddel i salgspakning (10 ml flaske): 18 måneder.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Subkutan brug.
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants:
Danish: Bluetonguevirus serotype 8 antigen ............................................................................. ≥ 2,1 log10 pixel* (*) antigenindhold (VP2 protein) fastsat ved immunoassay Adjuvans (Adjuvanser):
English: TARGET SPECIES Sheep and cattle.
Danish: DYREARTER Får og kvæg.
English: The vaccine contains inactivated Bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Danish: Vaccinen indeholder inaktiveret bluetonguevirus serotype 8 med aluminiumhydroxid og saponin som adjuvans.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml of vaccine contains: BTV8 antigen............................................... ≥ 2.1 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Hver dosis på 1 ml vaccine indeholder BTV 8 antigen ............................................... ≥ 2,1 log10 pixel* Aluminiumhydroxid, Saponin qs 1 dosis (*) (*) se indlægssedlen
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 8 suspension for injection
Danish: INDLÆGSSEDDEL BTVPUR AlSap 8 suspension til injektion
English: Avoid multiple vial broaching.
Danish: Undgå anbrud af flere flasker på samme tid.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 8 suspension for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN BTVPUR AlSap 8 suspension til injektion.
English: The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxide and saponin adjuvants.
Danish: Vaccinen indeholder dræbt bluetonguevirus serotype 8 med aluminiumhydroxid og saponin som adjuvans.
English: Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* Aluminium hydroxide .................................................................................................................... 2.7 mg Saponin ........................................................................................................................................ 30 HU** (*) antigen content (VP2 protein) by immuno-assay (**) Haemolytic units
Danish: Bluetonguevirus serotype 8 antigen ............................................................................. ≥ 2,1 log10 pixel* Aluminiumhydroxid ....................................................................................................................... 2,7 mg Saponin ........................................................................................................................................ 30 HU** (*) antigenindhold (VP2protein) fastsat ved immunoassay (**) hæmolytiske enheder
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) BTV 8 antigen ...................................................................................................... ≥ 2.1 log10 pixels/dose
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) BTV 8 antigen ....................................................................................................... ≥ 2,1 log10 pixel/dosis