FrancophonIA/ELRC3.0 huggingface dataset:
English: However, for the use of the product confirmation of the presence of a specific infection and confirmation of a bacteriological cure is required.
Danish: Men for at produktet kan anvendes, skal tilstedeværelsen af en specifik infektion påvises og bakteriologisk helbredelse bekræftes.
English: 5.2: protein binding for TMP and SMX is not high (TMP 50, SMX 60), but the overall proposal of the MAH can be accepted.
Danish: 5.2: Proteinbindingen for TMP og SMX er ikke stærk (TMP 50, SMX 60), men det overordnede forslag fra indehaveren af markedsføringstilladelsen kan godtages.
English: Austria received a dossier similar to the original sent to Germany.
Danish: I Østrig blev indsendt en dokumentation, der svarede til den originale dokumentation indsendt i Tyskland.
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre en korrekt dosering skal legemsvægten bestemmes så præcist som muligt for at undgå underdosering.
English: 5.1: Delete MIC data
Danish: 5.1: MIC-data slettes
English: Germany considered that the efficacy of Methoxasol-T as proposed by the applicant was not adequately justified, therefore resulting in a potential serious risk for the target animals.
Danish: Tyskland fandt, at den af ansøgeren påberåbte virkning af Methoxasol-T ikke var tilstrækkeligt velunderbygget, hvorfor der var potentiel alvorlig risiko for de behandlede dyr.
English: The drug is primarily excreted through the kidneys (both actively and passively), but elimination also occurs through the faeces.
Danish: Lægemidlet udskilles primært gennem nyrerne (både aktivt og passivt), men udskillelse sker også i fæces.
English: MANUFACTURER'S BATCH NUMBER Batch.
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: To detail differences that exist between the dossiers with respect to the information as requested under point 1 and 2.
Danish: Redegørelse for forskellene mellem dossiererne hvad angår de i punkt 1 og 2 anmodede oplysninger.
English: ATC vet classification (of the combination): QJ01E W
Danish: ATCvet-kode (for kombinationen): QJ01E W.
English: On the basis of further additional MIC data from various publications (including two 2004 published papers showing susceptibility of various isolates from pig respiratory samples from Denmark) and from resistance monitoring by the BVL in Germany in 2006, the CVMP can accept the proposed revision of the indication:
Danish: På grundlag af yderligere MIC-data fra forskellige publikationer (herunder to publikationer, der viser følsomhed af isolater fra luftvejsprøver fra svin i Danmark) og fra resistensovervågning foretaget af BVL i Tyskland i 2006 kan CVMP godtage den foreslåede reviderede ordlyd af indikationen:
English: To provide information on any addition, deletion or change made to the information as requested under point 1, after the initial application.
Danish: Oplysninger om eventuelle tilføjelser, slettelser eller ændringer, der er foretaget af de under punkt 1 anmodede oplysninger siden den oprindelige ansøgning.
English: Differences between dossiers
Danish: Forskellene mellem dokumentationssættene
English: Since no freezing studies have been performed the SPC must contain the note: Do not freeze.
Danish: Da der ikke er udført undersøgelser med frysning af produktet, skal produktresuméet indeholde bemærkningen: Må ikke nedfryses.
English: As to where Methoxasol-T is also authorised in Austria, Poland, Hungary, and Lithuania, these marketing authorisations have been included in the scope of the procedure.
Danish: Methoxasol-T er derudover godkendt i Østrig, Polen, Ungarn og Litauen, og disse markedsføringstilladelser er ligeledes omfattet af proceduren.
English: In pigs, elimination half-life for both substances is approximately 2.5 hours.
Danish: I svin er halveringstiden for begge stoffer cirka 2,5 timer.
English: The Marketing Authorisation Holder has proposed a new harmonised SPC.
Danish: Indehaveren af markedsføringstilladelsen har foreslået et nyt, harmoniseret produktresumé.
English: In respect of the benefit/risk balance for target species poultry, the CVMP concludes that:
Danish: Vedrørende benefit/risk forholdet for måldyrearten fjerkræ konkluderede CVMP følgende:
English: Based on a residue study in pigs a 3 days withdrawal period was recommended.
Danish: På grundlag af en restkoncentrationsundersøgelse hos svin anbefaledes en tilbageholdelsestid på tre dage.
English: To justify compliance of the dossier, as it exists in each Member State or EEA country, with respect to the requirements of Annex I of Directive 2001/82/EC, as amended.
Danish: Godtgørelse af, at dokumentation, som den foreligger i hver medlemsstat eller EØS-stat, er i overensstemmelse med kravene i bilag I til direktiv 2001/82/EF, med senere ændringer.
English: • the availability of an authorised veterinary medicinal product containing active substances other than fluoroquinolones might be regarded an indirect benefit and not directly relevant to the scope of this referral procedure (as efficacy must be shown for each product independently);
Danish: • rådighed over et godkendt veterinærmedicinsk produkt indeholdende andre aktive stoffer end fluorquinoloner kan anses for en indirekte fordel, hvilket dog ikke er direkte relevant i forbindelse med denne indbringelse (idet virkning kræves godtgjort for hvert produkt for sig),
English: Finally a 24 hours in-use shelf-life is demonstrated for concentrated and therapeutic solutions of the product Methoxasol-T.
Danish: Endelig er 24 timers holdbarhed under brug godtgjort for de koncentrerede og terapeutiske opløsninger af produktet Methoxosol-T.
English: To provide the dossier submitted upon application for a marketing authorisation, for each Member State mentioned above (including Germany) and, if applicable, for any other Member State or country of the European Economic Area (EEA): a. Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; b. Part IV Preclinical and clinical information.
Danish: Forelæggelse af den dokumentation, der blev indsendt ved ansøgning om markedsføringstilladelse i hver af ovenstående medlemsstater (herunder Tyskland) og, hvis det er relevant, i eventuelle andre medlemsstater eller stater i Det Europæiske Økonomiske Samarbejdsområde (EØS): a. del I: Sammenfatning af dokumentationen, herunder produktresuméet, ekspertrapporterne og produktets kvantitative og kvalitative sammensætning, b. del IV, prækliniske og kliniske oplysninger.
English: Shelf-life after dilution or reconstitution according to directions: 24 hours
Danish: Opbevaringstid efter fortynding eller rekonstituering ifølge anvisning: 24 timer.
English: If necessary the concentration of the VMP in the drinking water should be adjusted to make sure that the recommended dosage is being consumed.
Danish: Hvis det er nødvendigt, skal koncentrationen af lægemidlet i drikkevandet justeres for at sikre indtagelse af den anbefalede dosis.
English: The sentence "Not permitted for use in laying birds..." should be changed to "Not authorised for use in laying birds..." in accordance with the SPC guideline.
Danish: Sætningen "Må ikke anvendes til æglæggende fugle..." ændres til: "Ikke godkendt til anvendelse hos æglæggende fugle..." i overensstemmelse med retningslinjerne for produktresuméer.
English: Member State Applicant or Marketing
Danish: Medlemsstat Ansøger eller indehaver af markedsføringstilladelse
English: Elimination is relatively fast both in poultry and pigs.
Danish: Udskillelsen er relativt hurtig i både svin og slagtekyllinger.
English: Methoxasol-T should be administered daily in drinking water over a period of 3-4 days:
Danish: Methoxasol-T indgives dagligt i drikkevandet i en periode på 3-4 dage:
English: In the event of eye contact, rinse the eye with copious amounts of clean water and if irritation occurs, seek medical attention.
Danish: Hvis produktet kommer i kontakt med øjnene, skal man skylle med store mængder rent vand, og hvis der opstår irritation, skal man søge læge.
English: In vitro trimethoprim is generally bacteriostatic and has a broad spectrum of activity against both grampositive and gram-negative bacteria.
Danish: In vitro er trimethoprim generelt bakteriostatisk og har et bredt aktivitetsspektrum over for både grampositive og gramnegative bakterier.
English: Hypersensitivity reactions can occur rarely.
Danish: Der kan opstå sjældne tilfælde af overfølsomhedsreaktioner.
English: High trimethoprim concentrations are found in the kidneys, the liver and the lungs.
Danish: Høje trimethoprim-koncentrationer ses i nyrerne, leveren og lungerne.
English: Do not use in animals suffering from severe liver or kidney disease, oliguria or anuria.
Danish: Må ikke anvendes til dyr, der lider af alvorlig lever- eller nyresygdom, oliguri eller anuri.
English: Solubility and stability of Methoxasol-T in drinking water are pH-dependent.
Danish: Methoxasol-T's opløselighed og stabilitet i drikkevand er pH-afhængig.
English: To consider in particular the issues to which reference is made in the Annex to the referral notification from Germany as to the grounds for refusing an authorisation.
Danish: Nærmere redegørelse for de punkter, der er omhandlet i bilaget til indbringelsesanmeldelsen fra Tyskland som begrundelse for afslaget på ansøgningen om markedsføringstilladelse.
English: A 2 ½ fold overdose is well tolerated by pigs.
Danish: En overdosering på 2 ½ gange tåles godt af svin.
English: The residues were rapidly depleted.
Danish: Restkoncentrationen faldt hurtigt.
English: As for Germany
Danish: Som for Tyskland
English: To propose and justify a harmonised SPC text, including posology and method of administration as well as withdrawal periods for pigs and poultry.
Danish: Forslag til og begrundelse af en harmoniseret tekst til produktresumeet, herunder dosering og administrationsmetode samt tilbageholdelsestider for svin og fjerkræ.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND IMMEDIATE PACKAGING
Danish: BILAG III PRODUKTRESUME OG INDRE EMBALLAGE
English: Severely diseased animals can have a decreased appetite and water consumption.
Danish: Alvorligt syge dyr kan have nedsat appetit og vandindtagelse.
English: SPC guideline states: "Situations, which arise from a set of circumstances where the veterinary medicinal products must not be used for target animal safety reasons, i.e. absolute contraindications, are the subject of this section."
Danish: I retningslinjerne for produktresuméer angives følgende: "Dette afsnit omhandler situationer, der skyldes et sæt omstændigheder, hvor veterinærlægemidlet ikke må anvendes af hensyn til de behandlede dyrs sikkerhed, dvs. absolutte kontraindikationer."
English: In case of allergy to trimethoprim or sulfonamides, special care should be taken when handling this product or the medicated solution.
Danish: I tilfælde af allergi over for trimethoprim eller sulfonamider skal der udvises særlig forsigtighed under håndteringen af dette produkt eller den medicintilsatte opløsning.
English: HDPE bottle / can: volume 1000 ml / 5000 ml.
Danish: HDPE-flaske/-dunk: volumen 1000 ml/5000 ml.
English: Since there is no high tissue accumulation for any of the compounds it is expected that the depletion in broiler tissues is as rapid as the depletion in pigs.
Danish: Da ingen af stofferne udviser stærk vævsakkumulation, forventes depletionen af vævet hos fjerkræ at være lige så hurtig som hos grise.
English: To justify with field data, the use of the product and the adequacy of the recommended dose for each of the claimed indications in poultry.
Danish: Feltdata, der underbygger produktets anvendelse og tilstrækkeligheden af den anbefalede dosis for hver af de påberåbte indikationer hos fjerkræ.
English: Resistance against potentiated sulphonamides may vary.
Danish: Resistensen over for stærke sulfonamider kan variere.
English: Comment is required on the current use of the product in poultry and in particular on the dose used or prescribed by veterinary surgeons under field conditions.
Danish: Kommentarer til produktets nuværende anvendelse hos fjerkræ, specielt den anvendte eller dyrlægeordinerede dosis under feltbetingelser.
English: Plasma elimination half-life for trimethoprim in poultry is less than 1 hour and that of sulfamethoxazole, approximately 1.5 hours.
Danish: Plasmahalveringstiden for trimethoprim i fjerkræ er mindre end 1 time og for sulfamethoxazol er den cirka 1,5 time.
English: As for The Netherlands
Danish: Som for Nederlandene
English: Efficacy in pigs
Danish: Virkning hos grise
English: The results of the in-use stability testing of the product after 15 months storage at 25°C/60% RH and in-use of 12 months after opening showed acceptable stability.
Danish: Resultaterne af holdbarhedsundersøgelserne udført med produktet efter 15 måneders opbevaring ved 25°C og 60 % relativ fugtighed samt af holdbarheden under brug 12 måneder efter åbning kan godtages.
English: Consequently, the proposed withdrawal of 6 days in broilers is on the safe side.
Danish: Den ansøgte tilbageholdelsestid på seks dage hos fjerkræ er derfor på den sikre side.
English: The CVMP has assessed a pilot study, a main experimental study, 2 field trial reports as well as other efficacy, pharmacokinetics and tolerance data submitted by the marketing authorisation holder.
Danish: CVMP vurderede en forundersøgelse, en eksperimentel hovedundersøgelse, to rapporter over feltundersøgelser samt andre oplysninger om virkning, farmakokinetik og tolerance, der blev indsendt af indehaveren af markedsføringstilladelsen.
English: MARKETING AUTHORISATION HOLDER Eurovet Animal Health B.V.
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Eurovet Animal Health B.V.
English: The Cmax of trimethoprim is 0.29 µg/g.
Danish: Cmax for trimethoprim er 0,29 µg/g.
English: • notwithstanding the fact that a definitive clinical field study using the recommended dosage of the product has not been provided, taking into account the pre-clinical studies, the artificial infection model, the history of use and the other pertinent information provided, the various risk management steps now set out in the proposed SPC and noting the fact that the indications for use are restricted, the benefit / risk balance is positive;
Danish: • skønt der ikke er forelagt en definitiv klinisk feltundersøgelse med anvendelse af produktet i den anbefalede dosering, anses benefit/risk forholdet for positivt på baggrund af de prækliniske undersøgelser, den eksperimentelle infektionsmodel, den historiske anvendelse og de øvrige forelagte relevante oplysninger, de forskellige risikohåndteringsforanstaltninger, der nu er indeholdt i det foreslåede produktresumé, og det forhold, at indikationerne for anvendelsen er blevet begrænset,
English: However if the concentration of the product is increased too much, the intake of the medicated drinking water decreases for palatability reasons.
Danish: Hvis koncentrationen af produktet øges for meget, vil indtagelsen af det medicintilsatte drikkevand dog falde på grund af smagen.
English: Interactions Do not combine with other veterinary medicinal products.
Danish: Interaktioner Må ikke kombineres med andre veterinærlægemidler.
English: With the exception of the kidneys, sulfamethoxazole concentrations in the tissues are significantly lower than in the plasma.
Danish: Med undtagelse af nyrerne er sulfamethoxazol-kconcentrationerne i vævet betydeligt lavere end i plasma.
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concludes that the benefit/risk balance of the product is positive for use in both pigs and broilers subject to the recommended changes to Summary of the Product Characteristics and product information.
Danish: Efter at have gennemgået begrundelsen for indbringelsen og besvarelsen fra indehaveren af markedsføringstilladelsen konkluderede CVPM, at risk/benefit-forholdet for produktet er positivt til anvendelse hos grise og fjerkræ, forudsat at der foretages de anbefalede ændringer i produktresuméet og i produktoplysningerne.
English: Based on these studies a 36 months shelf life for Methoxasol-T is claimed.
Danish: På grundlag af undersøgelserne påberåbes en holdbarhedsperiode af Methoxasol-T på 36 måneder.
English: Handelsweg 25, P.O.Box 179, 5530 AD Bladel, The Netherlands
Danish: Handelsweg 25, P.O. Box 179, 5530 AD Bladel, Holland
English: The CVMP accepts that a claim for efficacy at a dose of 25mg/kg for 4 days for the treatment of respiratory infections in pigs has been demonstrated.
Danish: CVMP kan godtage, at den påberåbte terapeutiske virkning af en dosis på 25 mg/kg i fire dage til behandling af luftvejsinfektioner hos grise er blevet påvist.
English: Plasma elimination of both TMP and suphamethoxazole in broilers is more rapid than in pigs (TMP t½: <1 h in broilers vs 2.5 h in pigs; SMX t½: 1.7 h in broilers vs 2.3 h in pigs).
Danish: Plasmaeliminationen af både TMP og suphamethoxazol hos fjerkræ er hurtigere end hos grise (t½ for TMP < 1 h hos fjerkræ, mod 2,5 h hos svin; t½ for SMX: < 1,7 h hos fjerkræ, mod 2,3 h hos svin.
English: The data show that skin was a marker tissue and sulfamethoxazole the marker residue.
Danish: Dataene viser, at huden var markørvæv, og at sulfamethoxazol var markør for restkoncentrationen.
English: Do not combine with other veterinary medicinal products.
Danish: Må ikke kombineres med andre veterinærlægemidler.
English: The uptake of medicated water depends on the clinical condition of the animals.
Danish: Dyrenes indtagelse af det medicintilsatte drikkevand afhænger af deres kliniske tilstand.
English: Recommended dose Frequency and route of administration
Danish: Anbefalet dosis Doseringshyppighed og indgivelsesvej
English: In broilers water intake should be checked regularly.
Danish: Ved slagtekyllinger skal vandindtagelsen kontrolleres jævnligt.
English: A diminished water intake in chickens may occur occasionally.
Danish: Der kan lejlighedsvist ses en nedsat vandindtagelse hos kyllinger.
English: Trimethoprim and sulfamethoxazole.
Danish: Trimethoprim og sulfamethoxazol.
English: Trimethoprim 20 mg/ml Sulfamethoxazole 100 mg/ml N-Methyl-2
Danish: Trimethoprim 20 mg/ml Sulfamethoxa zol 100 mg/ml N-Methyl-2pyrrolidone
English: The CVMP agrees that as long as the treatment is directed against respiratory infections in pigs, it is not necessary to perform additional field studies to demonstrate efficacy against other organisms with similar MIC levels as A. pleuropleumonia.
Danish: CVMP kan tilslutte sig, at det for luftvejsinfektioner hos grise er unødvendigt at foretage yderligere feltundersøgelser til påvisning af virkningen mod andre organismer med tilsvarende MIC-værdier som A. pleuropleumonia.
English: Sulfamethoxazole is a broadspectrum antimicrobial agent belonging to the sulfonamides.
Danish: Sulfamethoxazol er et bredspektret antimikrobielt middel, der hører til gruppen af sulfonamider.
English: Trimethoprim is a diaminopyrimidine, a synthetic folic acid antagonist.
Danish: Trimethoprim er et diaminopyrimidin, en syntetisk folinsyreantagonist.
English: IMMEDIATE PACKAGING
Danish: INDRE EMBALLAGE
English: To propose and justify with data a suitable shelf life for the product, including an in-use shelf life where relevant.
Danish: Forslag til en passende holdbarhedsperiode for produktet, herunder en holdbarhed under brug, når det er relevant.
English: A synergistic and bactericidal effect occurs when trimethoprim is combined with sulfamethoxazole, because trimethoprim and sulfamethoxazole inhibit sequential steps in the synthesis of tetrahydrofolic acid, an essential metabolic cofactor in bacterial synthesis of purine and, subsequently, DNA.
Danish: Der opstår en synergistisk og baktericid effekt, når trimethoprim kombineres med sulfamethoxazol, fordi trimethoprim og sulfamethoxazol hæmmer to efter hinanden følgende led i syntesen af tetrahydrofolsyre, en essentiel metabolisk cofaktor i bakteriernes syntese af purin og dermed af DNA.
English: The Marketing Authorisation Holder presented 3 studies on shelf life and in-use shelf life.
Danish: Indehaveren af markedsføringstilladelsen forelagde tre undersøgelser af holdbarhed og holdbarhed under brug.
English: In order to obtain the correct dosage the concentration of Methoxasol has to be adjusted accordingly.
Danish: For at opnå en korrekt dosering skal koncentrationen af Methoxasol-T justeres i overensstemmelse med denne.
English: • the conditions of use as proposed in the SPC preclude use in laying birds and restrict use of the product based on culture and sensitivity testing of micro-organisms from diseased farms.
Danish: • i det foreslåede produktresumé forbydes anvendelse hos æglæggende fugle, og anvendelsen gøres betinget af dyrkning og følsomhedsbestemmelse af mikroorganismer fra de sygdomsramte bedrifter.
English: Following oral administration both active ingredients are rapidly absorbed from the gut.
Danish: Efter oral indgivelse absorberes begge stoffer hurtigt fra mave-tarmkanalen.
English: The Cmax of sulfamethoxazole in pigs is approximately 6.2 µg/g.
Danish: Cmax for sulfamethoxazol i svin er cirka 6,2 µg/g.
English: The CVMP has assessed an experimental study on clinical efficacy of Methoxasol-T for treatment of a respiratory infection caused by E.coli in chickens, as well as bibliographic and pharmacovigilance data provided by the marketing authorisation holder.
Danish: CVMP vurderede en eksperimentel hovedundersøgelse af den kliniske virkning af Methoxasol-T til behandling af luftvejsinfektioner hos kyllinger forårsaget af E.coli, samt bibliografiske data og lægemiddelovervågningsdata, som blev indsendt af indehaveren af markedsføringstilladelsen.
English: Overdose in chicken will result in a strongly diminished water- and feed intake and retarded growth.
Danish: Overdosering hos kyllinger vil føre til en kraftigt nedsat vand- og foderindtagelse og langsom vækst.
English: Do not use in animals with impaired haematopoietic systems.
Danish: Må ikke anvendes til dyr med svækkelse af det hæmatopoietiske system.
English: Chronic overdose in chicken will result in a strongly diminished water- and feed intake and retarded growth.
Danish: Kronisk overdosering hos kyllinger vil føre til en kraftigt nedsat vand- og foderindtagelse og langsom vækst.
English: 6 days Not authorised for use in laying birds producing eggs for human consumption
Danish: Slagtekyllinger: 6 dage Ikke tilladt til æglæggende fugle, hvis æg er bestemt til menneskeføde.
English: A residue depletion study in broilers was conducted following use of Methoxasol-T at a dose of 70mg/kg/day for 5 days.
Danish: Der blev udført en restkoncentrationsundersøgelse hos fjerkræ efter anvendelse af Methoxasol-T i en dosis på 70 mg/kg/dag i fem dage.
English: No statistical approach was followed because both TMP and SMX concentrations in muscle, liver, kidney and fat + skin were below limit of quantification at the first sampling point 2 days after cessation of Methoxasol- T medication.
Danish: Der blev ikke anvendt statistiske metoder, da koncentrationen af både TMP og SMX i muskel, lever, nyre og fedt + hud var under kvantificeringsgrænsen ved det først prøvetagningspunkt to dage efter ophør af medicineringen med Methoxasol-T. En tilbageholdelsesperiode på fem dage for svin synes således at være acceptabel.
English: The withdrawal period for Methoxasol-T varied between EU countries, pigs 3-5 days and non-laying hens 610 days.
Danish: Tilbageholdelsestiden for Methoxasol-T afveg EU-staterne imellem: tre til fem dage for svin og seks til ti dage for ikke æglæggende høns.
English: A GLP study on pharmacokinetics following water medication of 35 mg TMP/SMX per kg per day was carried out.
Danish: Der blev udført en farmakokinetisk GLP-undersøgelse efter dosering af 35 mg TMP/SMX pr. kg. pr. dag gennem drikkevandet.