FrancophonIA/ELRC3.0 huggingface dataset:
English: The reason for this was that the national competent authority of Germany considered that this veterinary medicinal product could present a potential serious risk to animal health on the grounds that the efficacy has not been sufficiently substantiated in the dossier.
Danish: Begrundelsen herfor var, at de nationale kompetente myndigheder i Tyskland fandt, at produktet kan udgøre en alvorlig risiko for dyrs sundhed, fordi dets virkning ikke er tilstrækkelig velunderbygget i ansøgningens dokumentation.
English: The clinical end points were ”Time to clinical cure” and ”overall clinical cure”.
Danish: De kliniske endepunkter var "tid til klinisk helbredelse" og "samlet klinisk helbredelse".
English: All the results show a clear improvement of Doxyprex treated pigs, with no relapses and no deaths, compared to a negative control.
Danish: Alle resultaterne viser en klar forbedring hos de Doxyprex-behandlede svin uden recidiv eller dødsfald, sammenlignet med en negativ kontrolgruppe.
English: Doxycycline is widely distributed throughout the organism due to its physico-chemical characteristics, provided that is highly lipid-soluble.
Danish: Doxycyclin distribueres bredt i hele organismen på grund af dets fysisk-kemiske karakteristika, fordi det er meget lipid-opløseligt.
English: If symptoms appear after exposition as a skin eruption, a doctor should be consulted showing these warnings.
Danish: Hvis der opstår symptomer efter eksponeringen, såsom udslæt, skal der søges læge og disse advarsler fremvises.
English: Food can slightly modify oral bioavailability of doxycycline.
Danish: Mad kan ændre doxycyclins orale biotilgængelighed en smule.
English: The applicant justifies that the presence of M.hyopneumoniae was not determined by bacteriological methods because it was difficult to isolate at that time.
Danish: Ansøgeren fremfører som begrundelse, at tilstedeværelsen af M. hyopneumoniae ikke blev bestemt med bakteriologiske metoder, da denne bakterie vanskeligt kunne isoleres på daværende tidspunkt.
English: It is due to the establishment of an elimination route by pumping the antibacterial agent or to an alteration in the transport system, resulting in a limited tetracycline energy-dependent capture to the exterior of the cell.
Danish: Det skyldes etableringen af en eliminationsvej ved at pumpe det antibakterielle stof eller en ændring i transportsystemet, som fører til en begrænset tetracyclin energiafhængig indfangning til cellens ydre.
English: Following single dose administration, Cmax was 1.70 µg/ml with a Tmax of 6 hours.
Danish: Efter enkeltdosis administration var Cmax 1,70 µg/ml med en Tmax på 6 timer.
English: In feed use.
Danish: Anvendes i foder.
English: Doxycycline is a broad spectrum antibiotic with bacteriostatic activity that acts by interfering on the bacterial protein synthesis of the sensitive species.
Danish: Doxycyclin er et bredspektret antibiotikum med bakteriostatisk aktivitet, som agerer ved at gribe ind i de følsomme arters bakterielle proteinsyntese.
English: To be supplied only on veterinary prescription
Danish: Må kun udleveres efter veterinærrecept
English: The lack of evidence of bacteriological cure should be justified and may affect the wording of the indication.
Danish: Den manglende dokumentation af mikrobiologisk helbredelse bør begrundes og kan få indflydelse på ordlyden af indikationen.
English: (2) Five expert opinions written by veterinarians who work closely with large pigs farms in Spain, all containing positive comments on their use of this product.
Danish: (2) fem ekspertudtalelser fra dyrlæger, der har et tæt samarbejde med store svineopdræt.
English: It is active against: Pasteurella multocida and Bordetella bronchiseptica
Danish: Det er aktivt imod: Pasteurella multocida og Bordetella bronchiseptica
English: In the answer to the CVMP question the applicant has not discussed or justified the two doses (200ppm and 300ppm) of Doxyprex applied in the clinical trial.
Danish: I sin besvarelse af spørgsmålet fra CVMP har ansøgeren ikke diskuteret eller begrundet de to doser (200 ppm og 300 ppm) Doxyprex, der er anvendt i den kliniske undersøgelse.
English: In two-by-two analysis, both Doxyprex groups were significantly quicker to cure than the negative control and the positive control groups.
Danish: Ved to gange to analyse fandtes signifikant hurtigere helbredelse af begge Doxyprex-grupper end af de negative og positive kontrolgrupper.
English: At least two mechanisms of resistance to tetracyclines exist.
Danish: Der findes mindst to resistensmekanismer over for tetracyclin.
English: Given that the statistical analysis is appropriate, this study design can conclude that the actual final formulation has shown field efficacy when compared to a negative control group and has produced as least as good results as a comparator product TM550 (oxytetracycline).
Danish: Når den statistiske analyse forudsættes at være tilfredsstillende, giver undersøgelsen med det valgte design mulighed for at konkludere, at den faktiske endelige formulering er påvist effektiv under feltbetingelser ved sammenligning med en negativ kontrolgruppe og har givet mindst lige så gode resultater som sammenligningsproduktet TM550 (oxytetracyclin).
English: It is observed that during the first days of treatment the 300 ppm food incorporation came closest to the recommended dose, but as food consumption picked up this was achieved with 200ppm.
Danish: Det skal bemærkes, at i de første dage af behandlingsperioden kom man med 300 ppm i foderet tættest på den foreslåede dosis, men efterhånden som foderindtagelse tiltog, blev dette opnået med 200 ppm.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Eventuelle ubrugte veterinærlægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de lokale krav.
English: 100 mg/g Pigs (after weaning)
Danish: 100 mg/g Svin (efter fravænning)
English: Therefore, the CVMP considered that the reports mentioned above give favourable evidence for the safety and efficacy of doxycycline in general, but also for the specific final formulation as marketed in Spain.
Danish: CVMP fandt derfor, at ovennævnte rapporter giver gunstigt vidnesbyrd om sikkerheden og virkningen for doxycyclin generelt, men også for færdigproduktet i den i Spanien markedsførte formulering.
English: A 40% of the drug is metabolised and largely excreted in faeces (bile and intestinal route), mostly as conjugates microbiologically inactive.
Danish: 40% af lægemidlet metaboliseres og elimineres hovedsageligt i fæces (galde- og tarmvej), hovedsageligt som mikrobiologisk inaktive konjugater.
English: The other mechanism is evidenced by a reduction in the affinity of the ribosome for the Tetracycline-Mg2+ complex due to mutations in the chromosome.
Danish: Den anden mekanisme viser sig ved en reduktion i ribosomets affinitet for tetracyclin-Mg2+ komplekset på grund af mutationer i kromosomet.
English: The CVMP during its meeting of 21-22 June 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC, as amended, for Doxyprex 100 mg premix.
Danish: CVMP indledte på sit møde den 21.-22. juni 2006 en indbringelsesprocedure i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer, for Doxyprex premix, 100 mg.
English: In order to obtain a correct dosage, the concentration of the antimicrobial agent should be adjusted taking into account the daily feed intake at the onset of treatment.
Danish: For at opnå en korrekt dosering skal det antimikrobielle stofs koncentration justeres under hensyntagen til den daglige foderindtagelse ved behandlingens påbegyndelse.
English: The submitted references supported pharmacodynamics including MIC data (more than 5 years old) and pharmacokinetics of the active substance, doxycycline.
Danish: Farmakodynamikken underbyggedes af de forelagte referencer, herunder MIC-data (over 5 år gamle) og farmakokinetikken af det aktive indholdsstof doxycyclin.
English: Amendments to the pharmacokinetic section of the SPC and the origin of the MIC values included in this section should be inserted, too.
Danish: Der bør desuden foretages ændringer i produktresuméets afsnit om farmakokinetik og om oprindelsen af MIC-værdierne under dette punkt.
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff
Danish: LÆGEMIDDELFORM Premix til medicineret foder
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Industrial Veterinaria, S.A.
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Industrial Veterinaria, S.A.
English: In addition the pharmacokinetics study using their final formulation and more up-to-date (2001) MIC data for respiratory pathogens isolated from pigs in Spain are provided.
Danish: Derudover foreligger den farmakokinetiske undersøgelse med anvendelse af den endelige formulering og nyere (2001) MIC-data for isolater af luftvejspatogener fra svin i Spanien.
English: There are however differences in both dose recommendation (12.5 mg/kg/day versus 10 mg/kg/day) and duration of treatment (8 versus 7 days).
Danish: Der er dog forskelle både i den anbefalede dosis (12,5 mg/kg/dag mod 10 mg/kg/dag) og behandlingsvarighed (8 mod 7 dage).
English: The CVMP considers that the fact that no post treatment bacteriological samples were taken mean that bacteriological cure cannot be assumed or claimed.
Danish: CVMP finder, at den manglende bakteriologiske prøvetagning efter behandlingen indebærer, at bakteriologisk helbredelse ikke kan antages eller påberåbes.
English: In the 5 kg, 20 kg and 25 kg presentations, bags contain an additional intermediate nylon layer.
Danish: I pakkerne med 5 kg, 20 kg og 25 kg indeholder poserne yderligere et mellemlag af nylon.
English: In the introduction to the responses the applicant has given a justification for submission of this application on a “well-established use” basis.
Danish: I indledningen til sin besvarelse har ansøgeren givet en begrundelse for, at ansøgningen indgives på grundlag af "almindelig anerkendt anvendelse".
English: New secondary end points were defined as percentage clinically cured on day 7 relapse and mortality rates.
Danish: Der indførtes de nye sekundære endepunkter procentuel klinisk helbredelse på dag 7 samt recidivprocent og mortalitet.
English: Provided its lipophilic properties doxycycline is easily distributed in animal tissues, showing volumes of distribution of 0.53 l/kg.
Danish: Forudsat dets lipofile egenskaber distribueres doxycyclin let i dyrevæv, idet det udviser distributionsvolumener på 0,53 l/kg.
English: Its hepatic metabolism is scarce, showing traces of some metabolites at kidney level.
Danish: Dets levermetabolisme er sparsom, idet der udvises spor af nogle metabolitter på nyreniveau.
English: For Time to clinical cure, Doxyprex at 200ppm and at 300ppm groups were cured at 3.2 and 3.33 days respectively compared to the TM550 group at 8.2 days, the Stabox group at 11.75 days and the control group at 13.67 days.
Danish: Hvad angår tid til klinisk helbredelse blev grupperne på Doxyprex 200 ppm og 300 ppm helbredt på henholdsvis 3,2 og 3,33 dage sammenholdt med 8,2 dage for TM550-gruppen, 11,75 dage for Staboxgruppen og 13,67 dage for kontrolgruppen.
English: Care should be taken to avoid contact with the product during its incorporation to the feed as well as during the administration of the medicated feed to the animals.
Danish: Kontakt med produktet bør omhyggeligt undgås under dets tilsætning til foderet såvel som under indgiften af det medicinerede foder til dyrene.
English: It is recommended that one part of Doxyprex is first mixed into one part of the feeding stuff, followed by the rest of the feeding stuff and mixed well.
Danish: Det anbefales, at der først blandes én del Doxyprex i én del foder, efterfulgt af resten af fodert, og blandes godt.
English: The applicant demonstrated through these references that the product fulfils the criteria for a well-established use application.
Danish: Ansøgeren godtgjorde ved disse referencer, at produktet opfylder kriterierne for en ansøgning baseret på almindelig anerkendt anvendelse.
English: The justification was considered acceptable, but the dosing section of the SPC should be amended to better reflect the use as proposed and documented by the applicant.
Danish: Begrundelsen fandtes acceptabel, men produktresuméets doseringsafsnit bør rettes, så det bedre afspejler den foreslåede og dokumenterede anvendelse af produktet.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH REALISE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: Adequate measures should be taken to avoid powder dissemination during the incorporation of the product to the feed.
Danish: Der skal træffes tilstrækkelige forholdsregler til at undgå pulverspredning under tilsætningen af produktet til foderet.
English: According to the Clinical and Laboratory Standard (CLSI) regulation, organisms other than streptococci with MIC values ≤ 4 µg/ml are considered sensitive, at 8 µg/ml intermediate and with MIC values ≥ 16 resistant to doxycycline.
Danish: Ifølge Clinical og Laboratory Standard Institute (CLSI) forordningen anses andre organismer end streptococci med MIC værdier ≤ 4 µg/ml for følsomme ved 8 µg/ml gennemsnitligt og med MIC værdier ≥ 16 µg/ml for resistente mod doxycyclin.
English: Administration of the product according to the recommended posology results in a maximum plasmatic concentration at steady of 2.0 ± 0.4 µg/ml .
Danish: Administration af produktet i henhold til den anbefalede dosering fører til en maksimum plasmakoncentration ved steady-state på 2,0 ± 0,4 µg/ml.
English: It was pointed out that even though there are small differences in dosage the mean and maximum steady state plasma concentration are similar.
Danish: Det blev påpeget, at skønt der er små forskelle i dosering, svarer de to produkter til hinanden med hensyn til den gennemsnitlige og maksimale steady state plasmakoncentration.
English: Although the choice of positive controls would not be acceptable when assessed under current standards, the CVMP concluded that the applicant has justified that at the time there were no doxycycline based authorised premix for the proposed indications.
Danish: Skønt valget af aktivt sammenligningsprodukt ikke ville være acceptabelt efter de nuværende normer, konkluderede CVMP, at ansøgeren havde retfærdiggjort dette med, at der på daværende tidspunkt ikke fandtes nogen doxycyclin-baseret premix til de foreslåede indikationer.
English: The closure is by thermosealing.
Danish: Lukningen er varmeforsegling.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: Medicated feed may then be granulated.
Danish: Det medicinerede foder kan dernæst granuleres.
English: It should also be included that the incorporation rate should be based on average food consumption at time of initiating treatment.
Danish: Endvidere bør det angives, at den tilsatte mængde bør baseres på den gennemsnitlige foderindtagelse ved behandlingens begyndelse.
English: In fact the two positive controls were selected because at that time there were no doxycycline based premix reference products available in Spain.
Danish: De to aktive sammenligningsprodukter var derimod valgt, fordi der på daværende tidspunkt ikke fandtes doxycyclinbaserede sammenligningsprodukter som premix på markedet i Spanien.
English: Liquid sorbitol, non-crystallising
Danish: Flydende sorbitol, ikke-krystalliserende Flydende paraffin
English: Shelf-life after first opening the immediate packaging: 3 months.
Danish: Opbevaringstid efter første åbning af den indre emballage: 3 måneder.
English: Thermosealed bags of a complex film made of polyester external layer, aluminium intermediate layer and polyethylene internal layer that is in contact with the product.
Danish: Varmeforseglede poser af sammensat film lavet af polyester ydre lag, aluminium mellemlag og polyethylen indre lag, som er i kontakt med produktet.
English: To sum up the applicant has indeed performed a number of analyses based on the original data and they seem to have been performed appropriately.
Danish: Sammenfattende har ansøgeren altså på grundlag af de oprindelige data foretaget en række analyser, der synes at være tilfredsstillende udført.
English: Adverse reactions (frequency and seriousness)
Danish: Bivirkninger (forekomst og sværhedsgrad)
English: In conclusion the applicant has justified their application as well-established use of the active substance, doxycycline.
Danish: Det kan konkluderes, at ansøgeren har begrundet ansøgningen ved almindelig anerkendt anvendelse af det aktive indholdsstof doxycyclin.
English: The main object was to try to ensure intake of the proposed dose of 10 mg/kg b.w.
Danish: Hovedformålet var at sikre indtagelse af den foreslåede dosis på 10 mg/kg kropsvægt.
English: In order to establish that Doxyprex is similarly bioavailable to the product Pulmodox 5% Premix, the applicant referred to information from the SPC and the hevra.org website.
Danish: For at eftervise, at biotilgængeligheden af Doxyprex svarer til produktet Pulmodox premix, 5 %, henviste ansøgeren til oplysninger i produktresuméet og på webstedet hevra.org.
English: Therapeutic concentrations have been detected in watery humor, myocardium, reproductive tissues, brain and mammary gland.
Danish: Terapeutiske koncentrationer er blevet sporet i kammervandet, myocardium, reproduktive væv, hjerne og brystkirtel.
English: E-08950 Esplugues de Llobregat (Barcelona) Spain
Danish: E-08950 Esplugues de Llobregat (Barcelona) Spanien
English: The premix is only intended to be incorporated into granulated medicated feeding stuffs.
Danish: Forblandingen er kun beregnet til at tilsættes granulerede medicinerede fodermaterialer.
English: Within the EU doxycycline-based premix products for pigs at recommended dose rates of 10mg/kg once daily for 5 days are stated as having been authorised since 1985.
Danish: Det anføres, at doxycyclin-premixprodukter til svin med en anbefalet dosering på 10 mg/kg en gang dagligt i 5 dage har været godkendt i EU siden 1985.
English: Less emphasis should be put on the standard incorporation of 250 ppm.
Danish: Der bør lægges mindre vægt på rutinemæssig tilsætning af 250 ppm svarende til "normal" foderindtagelse.
English: E-08950 Esplugues de Llobregat (Barcelona) Spain Tel: +34 934 706 270
Danish: E-08950 Esplugues de Llobregat (Barcelona) Spanien Tlf: +34 934 706 270
English: Pigs (after weaning)
Danish: Svin (efter fravænning)
English: Mixing instructions:
Danish: Blandingsinstruktioner:
English: The applicant explained that their choice of positive controls in the pivotal field trial was not intended to compare their product with a product, which had been used for the same proposed posology within the Community for at least 10 years.
Danish: Ansøgeren oplyste, at de aktive sammenligningsprodukter i den vigtigste feltundersøgelse ikke var blevet valgt med henblik på at sammenligne det foreslåede produkt med et produkt, der havde været anvendt med samme foreslåede dosering i Fællesskabet i de seneste ti år.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
Danish: BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: Do not administer with oxidant substances.
Danish: Må ikke administreres sammen med oxidanter.
English: The positive control products were chosen on the basis that they were also medicated premixes, indicated for use in pigs, which contained a single active substance, which had a spectrum of activity inclusive of those organisms causing the proposed indications.
Danish: De pågældende aktive sammenligningsprodukter blev valgt, fordi de ligeledes var premixprodukter til svin og indeholdt et enkelt aktivt stof med et aktivitetsspektrum, der dækkede de organismer, der var årsag til de forslåede indikationer.
English: Product invented name
Danish: Produktets særnavn
English: “In Spain during 2001, the in vitro sensitivity to doxycycline has been determined against porcine strains of Pasteurella multocida and Bordetella bronchiseptica resulting in MIC90 values of 0.795µg/ml and 0.053µg/ml respectively.”
Danish: “I Spanien blev in vitro følsomheden over for doxycyclin i 2001 fastslået imod porcine stammer af pasteurella multocida og bordetella bronchiseptica førende til MIC90 værdier på henholdsvis 0,795 µg/ml og 0,053 µg/ml.”
English: Its excretion is carried out through the intestinal mucous and in a lower extent, through bile excretion, resulting in plasmatic clearance values of 1.7 ml/min/kg.
Danish: Dets udskillelse udføres via tarmslimet og i mindre omfang via galdeudskillelse, førende til plasmaclearanceværdier på 1,7 ml/min/kg.
English: Although on the surface the individual numbers of pigs involved looks small, the applicant has justified that because of the large difference in results between the Doxyprex and control groups the small number of animals still allows a 80% power to be achieved.
Danish: Skønt antallene af svin i undersøgelsen overfladisk betragtet er små, har ansøgeren godtgjort, at der som følge af den store forskel i resultaterne for Doxyprex-gruppen og kontrolgruppen alligevel kan opnås en styrke på 80 %.
English: Digestive alterations by intestinal dysbiosis may appear in very long-term treatments.
Danish: Der kan forekomme fordøjelsesændringer ved forskydninger i tarmfloraen under meget langvarige behandlinger.
English: Doxycycline is a semi-synthetic tetracycline derived from oxytetracycline that acts on the 30S ribosomal bacterial subunit in a reversible union, by blocking the binding of aminoacyl-tRNA (transference RNA) to the mRNA/ribosome complex, avoiding the addition of new amino acids to the growing peptide chain and interfering therefore on the protein synthesis.
Danish: Det virker på 30S ribosomale bakterielle subunit i en reversibel forening ved at blokere bindingen af aminoacyl-tRNA (transport-RNA) til mRNA/ribosomkomplekset, hvorved tilføjelsen af nye aminoacider til den voksende peptidkæde undgås, og proteinsyntesen derfor forstyrres.
English: The applicant has a justifiable rational behind the choice of products used as positive controls.
Danish: Ansøgeren har givet et forsvarligt rationale for valget af aktive sammenligningsprodukter.
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff Doxyprex is presented as yellow granules.
Danish: LÆGEMIDDELFORM Premix til medicineret foder Doxyprex fremtræder som små, gule korn.
English: The Applicant has given a full discussion on statistical analyses conducted for the pivotal trial.
Danish: Ansøgeren har fyldestgørende redegjort for de foretagne statistiske analyser af hovedundersøgelsen.
English: A new primary end point was defined as Time to clinical cure, i.e. the time to absence of clinical signs.
Danish: Der indførtes et nyt primært endepunkt, tid til klinisk helbredelse, dvs. tiden til ophør af kliniske symptomer.
English: Avoid handling the product if hypersensitivity to tetracyclines exists.
Danish: Undgå at håndtere produktet, hvis der foreligger overfølsomhed over for tetracycliner.
English: Esmeralda, 19 4º 08950 Esplugues de Ll obregat (Barcelona, Spain)
Danish: Veterinaria, S.A. Esmeralda, 19 4º 08950 Esplugues de Ll obregat (Barcelona, Spanien)
English: The CVMP concluded that according to “current” GCP requirements this pivotal study design has many deficiencies.
Danish: CVMP konkluderede, at denne hovedundersøgelse har mange mangler i forhold til de "aktuelle" GCPkrav.
English: Relapses were assessed.
Danish: Der blev foretaget vurdering af recidiv.
English: In feed use
Danish: Anvendes i foder
English: In addition, a negative control was used.
Danish: Derudover blev der anvendt inaktivt sammenligningsprodukt.