FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial contains 2 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 2 g/22 g gel).
Danish: Et hætteglas indeholder 2 g koncentrat af proteolytiske enzymer oprenset i bromelain, svarende til 0,09 g/g koncentrat af proteolytiske enzymer oprenset i bromelain efter blanding (eller 2 g/22 g gel).
English: • Dressing soaked with an antibacterial solution must be applied for 2 hours.
Danish: • Gaze vædet med en antibakteriel opløsning skal lægges i 2 timer.
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 0.9%, 0.9%, and 1.8% of patients, respectively.
Danish: I NexoBrid-gruppen blev bivirkningen klassificeret som let, moderat eller svær hos hhv. 0,9 %, 0,9 % og 1,8 % af patienterne.
English: What NexoBrid looks like and contents of the pack NexoBrid is provided as a powder and gel for gel (powder in a vial (2 g) and gel in a bottle (20 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel)
Danish: NexoBrid leveres som et pulver og en gel til gel (pulver i et hætteglas (2 g) og gel i en flaske (20 g)), pakningsstørrelse på 1 (en pakning indeholder et hætteglas med pulver og en flaske gel).
English: Before prescribing NexoBrid
Danish: Før ordination af NexoBrid
English: Wound infection
Danish: Sårinfektion
English: What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 2 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Danish: NexoBrid indeholder: - Aktivt stof: (i pulveret i hætteglasset) er et koncentrat af proteolytiske enzymer oprenset i bromelain: 2 g, svarende til 0,09 g/g koncentrat af proteolytiske enzymer oprenset i bromelain efter blanding.
English: In studies implementing routine antibacterial soaking of the treatment area before and after NexoBrid application (see section 4.2) pyrexia or hyperthermia was reported in 19.1% of patients treated with NexoBrid and in 15.8% of the control patients treated according standard of care.
Danish: 4.2) blev pyreksi eller hypertermi rapporteret hos 19,1 % af patienterne behandlet med NexoBrid, og hos 15,8 % af kontrolpatienterne, der blev behandlet i henhold til standardpraksis.
English: Excipients: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Danish: Hjælpestoffer: Carbomer 980, dinatriumphosphat, vandfri, natriumhydroxid, vand til injektionsvæsker.
English: Excipients for the gel: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Danish: Hjælpestoffer for gelen: Carbomer 980, dinatriumphosphat, vandfri, natriumhydroxid, vand til injektionsvæsker.
English: Mixed wounds (deep partial and full thickness) Non-autografted mixed wounds
Danish: Blandede sår (af dyb, partiel og fuld tykkelse)
English: What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 5 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Danish: NexoBrid indeholder: - Aktivt stof: (i pulveret i hætteglasset) er et koncentrat af proteolytiske enzymer oprenset i bromelain: 5 g, svarende til ,09 g/g koncentrat af proteolytiske enzymer oprenset i bromelain efter blanding.
English: NexoBrid application
Danish: Applikation af NexoBrid
English: Hepatic impairment
Danish: Sårpleje efter débridement
English: In case of skin exposure, rinse NexoBrid off with water.
Danish: Hvis der forekommer hudeksponering, skylles NexoBrid af med vand.
English: In case of skin contact, rinse NexoBrid off with water.
Danish: Hvis der forekommer hudkontakt skylles NexoBrid af med vand.
English: % wound area autografted 55.5% (n=48)
Danish: 55,5 % (n=48)
English: In studies where the NexoBrid regimen included recommended preventive analgesia as routinely practiced for extensive dressing changes in burn patients (see section 4.2) local pain was reported in 3.6% of patients treated with NexoBrid and in 4.0% of the control patients treated according to standard of care.
Danish: 4.2) blev lokale smerter rapporteret hos 3,6 % af patienterne behandlet med NexoBrid, og hos 4,0 % af kontrolpatienterne, der blev behandlet i henhold til standardpraksis.
English: Carbomer 980 disodium phosphate anhydrous Sodium hydroxide Water for injections
Danish: Dinatriumphosphat, vandfri Natriumhydroxid Vand til injektionsvæsker
English: General disorders and administration site conditions Very common:
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: Pyreksi/hypertermi* Almindelig:
English: For the full list of excipients, see section 6.1.
Danish: 4.4), eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: • Pain management must be used as commonly practiced for an extensive dressing change; it should be initiated at least 15 minutes prior to NexoBrid application.
Danish: • Smertebehandling skal anvendes efter sædvanlig praksis for en omfattende udskiftning af bandagen.
English: Based on:
Danish: På baggrund af:
English: GROUNDS FOR NEGATIVE OPINION
Danish: BEGRUNDELSER FOR DEN NEGATIVE UDTALELSE
English: • the rapporteur's and co-rapporteur's assessment reports
Danish: • rapportørens og co-rapportørens vurderingsrapporter og
English: Scientific conclusions and grounds for refusal and suspension presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelser for afslag og suspendering fremlagt af Det Europæiske Lægemiddelagentur
English: Isotretinoin Ranbaxy 10 mg & 20 mg, capsules (soft) was authorised in the reference member state (UK) under Article 10 of Directive 2001/83/EC and the application was submitted in the concerned member states (France and Spain) under the mutual recognition procedure.
Danish: Isotretinoin Ranbaxy 10 mg og 20 mg, kapsler (bløde) blev godkendt i referencemedlemsstaten (Det Forenede Kongerige) i henhold til artikel 10 i direktiv 2001/83/EF, og ansøgningen blev indgivet i de berørte medlemsstater (Frankrig og Spanien) i henhold til en gensidig anerkendelsesprocedure.
English: The totality of data submitted does not support the conclusion that the product is bioequivalent.
Danish: Den samlede mængde fremlagt data understøtter ikke konklusionen om, at produktet er bioækvivalent.
English: At the time of the initial authorisation, bioequivalence was shown under fasting conditions (study No 237/00).
Danish: På tidspunktet for den oprindelige godkendelse blev der påvist bioækvivalens i fastende tilstand (undersøgelse nr. 237/00).
English: Therefore, the Committee adopted an opinion recommending the refusal of the marketing authorisations in the concerned member states and the suspension of the marketing authorisations in the reference member state, subject to the conditions outlined in annex III of the Opinion.
Danish: Derfor vedtog udvalget en udtalelse, der anbefaler afslag på ansøgninger om markedsføringstilladelse i de berørte medlemsstater og suspendering af markedsføringstilladelserne i referencemedlemsstaten med forbehold af vilkårene beskrevet i bilag III til udtalelsen.
English: Results of a study in healthy adult human male subjects under fed conditions (study No 122_ISOTR_10) were subsequently provided by the marketing authorisation holder.
Danish: Resultaterne af en undersøgelse af raske, voksne mandlige forsøgspersoner i ikke-fastende tilstand (undersøgelse nr. 122_ISOTR_10) blev efterfølgende fremlagt af indehaveren af markedsføringstilladelsen.
English: However, the results failed to show that the Isotretinoin Ranbaxy generic is bioequivalent to the originator product in real conditions of use (fed conditions), as the 90% confidence intervals (CI) fell outside the predefined interval of 80-125%, which constitutes a risk to public health.
Danish: Resultaterne viste imidlertid ikke, at det generiske lægemiddel Isotretinoin Ranbaxy er bioækvivalent med det oprindelige lægemiddel under faktiske anvendelsesforhold (ikkefastende tilstand), da konfidensintervallet (KI) på 90 % ligger uden for det forhåndsbestemte interval på 80-125 %, som udgør en risiko for folkesundheden.
English: Isotretinoin is effective against severe acne via a direct effect on the size and activity of sebaceous glands, plus a probable dermal anti-inflammatory effect.
Danish: Isotretinoin er virkningsfuld mod svær acne, idet det har en direkte virkning på sebaceus-kirtlernes størrelse og aktivitet samt en formodet antiinflammatorisk virkning på huden.
English: Having regard to the fact that the absorption of Isotretinoin in fed state is larger than that observed in fasted state (which motivates the SPC recommendation of intake with food (as clearly mentioned in the Posology section of the SPC), the CHMP agreed that a study in the fed state was essential.
Danish: I lyset af, at optagelsen af Isotretinoin i ikke-fastende tilstand er større end i fastende tilstand (hvilket ligger til grund for produktresuméets anbefaling om indtagelse sammen med føde, som tydeligt angivet i afsnittet Dosering), erklærede CHMP sig enig i vigtigheden af at foretage en undersøgelse i ikkefastende tilstand.
English: It is therefore considered that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Danish: Det konkluderes derfor, at oplysningerne fremlagt til støtte for ansøgningen ikke er i overensstemmelse med artikel 10 i direktiv 2001/83/EF med senere ændringer.
English: Isotretinoin is a vitamin A derivative indicated for the treatment of severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.
Danish: Isotretinoin er et A-vitamin-derivat indiceret til behandling af svære former for acne (herunder acne nodosa eller acne conglobata med risiko for blivende ar), som er resistent over for passende systemisk antibakteriel behandling og topisk behandling.
English: The CHMP considered that the data submitted in support of this application failed to show bioequivalence between the test and the reference product, and that therefore the product is not approvable for the sought indications.
Danish: CHMP besluttede, at dataene fremlagt til støtte for ansøgningen ikke påviste bioækvivalens mellem test- og referencelægemidlet, og at produktet derfor ikke kan godkendes til de ønskede indikationer.
English: • and scientific discussion within the Committee the CHMP was of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Danish: • den videnskabelige drøftelse med udvalget konkluderede CHMP, at oplysningerne fremlagt til støtte for ansøgningen ikke er i overensstemmelse med artikel 10 i direktiv 2001/83/EF med senere ændringer.
English: However, during the mutual recognition procedure, demonstration of bioequivalence in fed state was considered essential by the Concerned Member States and the matter was referred to the CHMP.
Danish: Under den gensidige anerkendelsesprocedure besluttede de berørte medlemsstater imidlertid, at det var vigtigt at påvise bioækvivalens i ikke-fastende tilstand, og sagen blev henvist til CHMP.
English: The Committee further considered that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and, in these circumstances, the marketing of the product constitutes a risk to public health.
Danish: Udvalget konkluderede ligeledes, at det på baggrund af dataene fremlagt til støtte for ansøgningen ikke er muligt at opnå et positivt benefit/risk-forhold for dette produkt, og at markedsføringen af produktet derfor udgør en risiko for folkesundheden.
English: • the results of the bioequivalence study in fed conditions provided by the MAH,
Danish: • resultaterne af bioækvivalensundersøgelsen i ikke-fastende tilstand udført af indehaveren af markedsføringstilladelsen,
English: This should be borne in mind when planning vaccination programmes for calves, which receive Locatim.
Danish: Dette bør overvejes, når der planlægges vaccinationsprogrammer for kalve, der modtager Locatim.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof
English: * microagglutination method
Danish: * mikroagglutinationsmetode
English: ATCvet code: QI02AT01.
Danish: ATCvet-kode: QI02AT01
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Danish: Brug ikke dette vetrinærlægemiddel efter den udløbsdato, der står på etiketten.
English: Chemin de la Chatanérie 2 1023 Crissier-Lausanne SWITZERLAND
Danish: Chemin de la Chatanérie 2 1023 Crissier-Lausanne SCHWEIZ
English: In the absence of information specifically demonstrating the safety of more than one repeated dose, it is recommended that calves should only be dosed once.
Danish: Da dokumentation, der specielt demonstrerer sikkerheden ved mere end en enkelt dosis, ikke foreligger, anbefales det, at kalve kun behandles een gang.
English: WITHDRAWAL PERIOD Withdrawal period: Zero days.
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: nul dage.
English: The excipients 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 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/03/1999.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 29/03/1999
English: If the calf is reluctant to take the product, it may be administered via an ordinary syringe placed in the mouth.
Danish: Hvis kalven ikke er i stand til at optage produktet selv, bør det administreres med en almindelig sprøjte anbragt i munden.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/011/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER EU/2/99/011/001
English: MANUFACTURER'S BATCH NUMBER Batch{number}
Danish: FREMSTILLERENS BATCHNUMMER (NUMRE) Lot {nummer}
English: Date of last renewal: 05/12/2008.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 05/12/2008
English: Keep the bottle in the outer carton.
Danish: Opbevar flaske i den ydre karton.
English: BATCH NUMBER Batch {number}
Danish: BATCHNUMMER Lot {nummer}
English: Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
Danish: Temperaturforhøjelse og øget åndedrætshastighed af kort varighed er blevet konstateret efter administration af dobbel dosis.
English: This product may contain antibodies against BVD virus.
Danish: Dette produkt kan indeholde antistoffer mod BVD pestivirus.
English: The active substance being a principle of biological origin intended to produce passive 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 passiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
English: Pregnancy and lactation: The product is not intended for use during pregnancy and lactation.
Danish: Drægtighed og laktation: Produktet er ikke beregnet til anvendelse under drægtighed og laktation.
English: The product is produced from colostrum collected from cows kept under field conditions.
Danish: Produktet fremstilles af colostrum fra køer i naturlige omgivelser.
English: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Danish: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Frankrig
English: The product is not intended for use during pregnancy and lactation.
Danish: Produktet er ikke beregnet til anvendelse under drægtighed og laktation.
English: Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/or exposure of the donor cows to organisms in their environment.
Danish: Derfor indeholder det, foruden antistoffer overfor E. coli F5 (K99) også antistoffer over for andre organismer, som følge af vaccination af donorkøer og/eller disses udsættelse for organismer i miljøet.
English: Methyl parahydroxybenzoate ≤ 0.8 mg/ml.
Danish: Methylparahydroxybenzoat ≤ 0,8 mg/ml.
English: Special precautions for use in animals: This product may contain antibodies against BVD virus.
Danish: Særlige forsigtighedsregler vedrørende brugen: Dette produkt kan indeholde antistoffer mod BVD pesti virus.
English: Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, Fürstentum LIECHTENSTEIN
Danish: Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, Liechtenstein
English: LIECHTENSTEIN
Danish: FYRSTENDØMMET LIECHTENSTEIN
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER FLASKE
English: 4.7 Use during pregnancy or lactation
Danish: 4.7 Anvendelse under drægtighed og laktation
English: The product should be administered neat or diluted in milk or in milk replacer within the first 12 hours of the calf's life, preferably, as soon as it is receptive.
Danish: Administrer produktet rent eller opløst i mælk eller mælkeerstatning inden for de første 12 timer af kalvens liv, helst så hurtigt som kalven kan drikke selv.
English: A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En eventuel beslutning om at anvende det immunologiske veterinærlægemiddel umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: Pack size: 60 ml bottle.
Danish: Pakningsstørrelse: 60 ml flaske.
English: Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 30 måneder
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN "TIL DYR" Kun til dyr.
English: No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af det immunologiske veterinærlægemiddel sammen med andre veterinære lægemidler til dyr.
English: Incompatibilities:
Danish: Væsentlige uforligeligheder:
English: PHARMACEUTICAL FORM Oral solution
Danish: LÆGEMIDDELFORM Peroral opløsning
English: The product supplements the protective properties of normal colostrum against E. coli F5 (K99) adhesin.
Danish: Produktet supplerer de beskyttende egenskaber af normal colostrum mod E. coli F5 (K99) adhesin.
English: 6.5 Nature and composition of immediate packaging Cardboard box with one 60 ml type III glass bottle closed with a polypropylene stopper with a polyethylene seal and a detachable lock-ring.
Danish: Karton med et styk type III glasflaske á 60 ml lukket med polypropylenprop med polyethylen forsejling og aftagelig låsering.
English: The calf must be given other normal colostrum in addition to the product.
Danish: Almindelig colostrum skal administreres i tilslutning til produktet.
English: In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke blandes med andre lægemidler.
English: Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam.
Danish: Reduktion af antallet af dødsfald forårsaget af enterotoxicosis forbundet med E. coli F5 (K99) adhesin i løbet af de første levedage og i tilslutning til colostrum fra moderen.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER OM NØDVENDIGT Læs indlægssedlen inden brug.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Methyl parahydroxybenzoate
Danish: Methylparahydroxybenzoat
English: Any person intending to manufacture, import, possess, sell, supply and use Locatim 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 anvende Locatim, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted.
English: The manufacture, import, possession, sale, supply and/or use of Locatim may be prohibited in a Member State on the whole or part of their territory pursuant to national legislation.
Danish: Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af Locatim er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: STATEMENT OF THE MRLs
Danish: C. ANGIVELSE AF DE MRL-VÆRDIER
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Danish: TEKSTEN "OPBEVARES UTILGÆNGELIGT FOR BØRN" Opbevares utilgængeligt for børn.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
Danish: Til peroral indgift : 60 ml så hurtigt som muligt, inden for de første 4, men ikke senere end 12 levetimer.
English: TARGET SPECIES Neonatal calves less than 12 hours of age.
Danish: DYREARTER Nyfødte kalve under 12 timer gamle.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Locatim oral solution for neonatal calves less than 12 hours of age
Danish: VETERINÆRLÆGEMIDLETS NAVN Locatim oral opløsning til nyfødte kalve under 12 timer gamle.
English: PACKAGE LEAFLET FOR: Locatim oral solution for neonatal calves less than 12 hours of age
Danish: INDLÆGSSEDDEL TIL: Locatim oral opløsning til nyfødte kalve under 12 timer gamle.
English: Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
Danish: INDGIVELSESVEJ(E) Dosis: 60 ml så hurtigt som muligt, inden for de første 4, men ikke senere end 12 levetimer.
English: SPECIAL STORAGE PRECAUTIONS
Danish: EVENTUELLE, SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
English: Fürstentum
Danish: Hjælpestof
English: Neonatal calves less than 12 hours of age.
Danish: Nyfødte kalve under 12 timer gamle
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2°C - 8°C).
English: Dispose of waste material in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier
English: WITHDRAWAL PERIOD Zero days.
Danish: 10. TILBAGEHOLDELSESTID Ingen.