FrancophonIA/ELRC3.0 huggingface dataset:
English: Viale Corassori 62 41100 Modena ITALY
Danish: Viale Corassori 62 41100 Modena ITALIEN
English: The use of suitably calibrated weighing equipment is recommended if part packs are used.
Danish: Det anbefales at benytte vejeudstyr med en passende kalibrering, hvis der anvendes delpakninger.
English: ReusCambrils, Km.
Danish: Cambrils, Km.
English: Mean body weight (kg) of birds to be treated
Danish: Gennemsnitlig legemsvægt (kg) af fugle, som skal behandles
English: Doxycycline tends to be more active against some of these species that other tetracyclines.
Danish: Doxycyclin har en tendens til at være mere aktiv mod nogle af disse arter end andre tetracycliner.
English: 05-651 Drwalew POLAND
Danish: 05-651 Drwalew POLEN
English: The documentation of the original proprietary studies was very heterogeneous and in many cases did not comply with current standards.
Danish: Dokumentationen fra de oprindelige undersøgelser, som tilhører virksomhederne og ikke er offentligt tilgængelig, var meget uensartet og overholdt i mange tilfælde ikke de gældende standarder.
English: 831 02 Bratislava SLOVENIA
Danish: 831 02 Bratislava SLOVAKIET
English: 76505 Saue Harjumaa ESTONIA
Danish: 76505 Saue Harjumaa ESTLAND
English: The other studies provide with indicative support for the target dose, since a subjective primary endpoint - clinical improvement - was used, and since these studies were poorly documented.
Danish: De øvrige undersøgelser tyder på en bekræftelse af måldosis, da der blev anvendt et subjektivt primært endepunkt - klinisk bedring - og da disse undersøgelser var dårligt dokumenterede.
English: Clinical symptoms following infection were almost absent even at the highest infectious dose.
Danish: Der var så godt som ingen kliniske symptomer efter infektion, selv med den højeste infektiøse dosis.
English: To support the efficacy of the products concerned altogether 11 original proprietary studies were submitted by the Applicants/Marketing Authorisation Holders including 3 experimental infection studies and 8 clinical field studies.
Danish: For at understøtte virkningen af de pågældende lægemidler blev resultaterne af i alt 11 oprindelige undersøgelser, som tilhører virksomheden, indsendt af ansøgerne/indehaverne af markedsføringstilladelse, inklusive tre eksperimentale infektionsundersøgelser og otte eksterne kliniske undersøgelser.
English: 10 rue Clement Ader
Danish: Frankrig Noe 10 rue Clement Ader
English: The results indicated that doxycycline effectively improved the clinical performance of the chickens and reduced gradually mortality.
Danish: Resultaterne tydede på, at doxycyclin effektivt forbedrede kyllingernes kliniske ydeevne og gradvis nedsatte dødeligheden.
English: Romania CEVA PHYLAXIA VETERINARY
Danish: Rumænien CEVA PHYLAXIA VETERINARY
English: Only the above mentioned nineteen responses that contained full dossiers developed in accordance with the Article 12(3) of Directive 2001/82/EC were considered of adequate quality for the purpose of answering to the specific issues raised.
Danish: Kun de ovennævnte 19 svar med komplette dossierer udarbejdet i overensstemmelse med artikel 12, stk. 3, i direktiv 2001/82/EF blev betragtet som værende af tilstrækkelig kvalitet til at kunne besvare de specifikke spørgsmål, som var blevet rejst.
English: LAB. DR ESTEVE Avda Mare de Deu de Montserrat
Danish: Spanien LAB. DR ESTEVE Avda Mare de Deu de Montserrat
English: • the CVMP considered that the use of doxycycline hyclate was well established.
Danish: • CVMP vurderede, at anvendelsen af doxycyclinhyclat var veldokumenteret.
English: Skierniewice POLAND
Danish: Skierniewice POLEN
English: Nine responses were with generic dossiers developed in accordance with the Article 13 of Directive 2001/82/EC.
Danish: Ni besvarelser omfattede generiske dossierer udarbejdet i overensstemmelse med artikel 13 i direktiv 2001/82/EF.
English: Romania S.C. VIM SPECTRUM SRL 409 Sighisoarei Targu Mures ROMANIA
Danish: Rumænien S.C. VIM SPECTRUM SRL 409 Sighisoarei Targu Mures RUMÆNIEN
English: Bulgaria Farmavet OOD 40 Otec Paisij Str.
Danish: Bulgarien Farmavet OOD 40 Otec Paisij Str.
English: Residue studies were mainly conducted in chickens.
Danish: Restkoncentrationsundersøgelser blev primært gennemført med kyllinger.
English: De Adelaar BV Hosterweg 26a 5811 Ccastenray THE
Danish: De Adelaar BV Hosterweg 26a 5811 Ccastenray NEDERLANDENE
English: In some studies the residue depletion kinetics of doxycycline were not demonstrated because tissue residues were detected at one or two time points after drug withdrawal only.
Danish: I nogle undersøgelser var restkoncentrationskinetikken for doxycyclin ikke påvist, fordi der kun blev påvist rester i væv på et eller to tidspunkter efter seponering af lægemidlet.
English: A high resistance rate of E. coli, isolated from chickens, against tetracyclines has been documented.
Danish: En høj resistensrate af E. coli, isoleret fra kyllinger, over for tetracycliner, er dokumenteret.
English: Bulgaria Farma Sis OOD 4 San Stefano Str.
Danish: Bulgarien Farma Sis OOD 4 San Stefano Str.
English: Powder for oral administrati on
Danish: Pulver til oral administrati on
English: Should be administered for a period of 5 days in chicken and turkeys together with drinking water.
Danish: Bør administreres i en periode på 5 dage til kyllinger og kalkuner sammen med drikkevandet.
English: Prevention of secundary becterial infections due to stress conditions, vaccination, change of housing, transport.
Danish: Forebyggelse af sekundære bakterieinfektioner på grund af stressforhold, vaccination, flytning, transport.
English: Riudoms 43330 (Tarragona) SPAIN
Danish: Riudoms 43330 (Tarragona) SPANIEN
English: INN Strength Pharmaceutical form
Danish: Styrke Lægemidd elform
English: Therefore the product should be used for the treatment of infections caused by E. coli only after susceptibility testing has been carried out.
Danish: Derfor bør lægemidlet kun anvendes til behandling af infektioner forårsaget af E. coli, efter at der er udført følsomhedstest.
English: There was no documented evidence indicating a new risk associated with the use of doxycycline in poultry in relation to lack of efficacy.
Danish: Der var ingen dokumentation, som indikerede en ny risiko i forbindelse med anvendelse af doxycyclin til fjerkræ i relation til manglende virkning.
English: Pharmagal s.r.o., Murgašova 5, 949 01 Nitra, Slovak Republic
Danish: Pharmagal s.r.o., Murgašova 5, 949 01 Nitra, Den Slovakiske Republik
English: NEW VET A.E Fleming 15
Danish: Grækenland NEW VET A.E Fleming 15
English: 4.5 Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brug til dyr
English: It is primiraly a bacteriostatic antibiotic and has its main mechanism of action on inhibition of protein synthesis.
Danish: Det er primært et bakteriostatisk antibiotikum, og den primære virkningsmekaniske er hæmning af proteinsyntesen.
English: The data packages submitted consist of bibliographic data available in the public domain and proprietary data.
Danish: De indsendte datapakker bestod af bibliografiske data, som er offentligt tilgængelige, og data, der tilhører virksomhederne og ikke er offentligt tilgængelige.
English: In particular, information about the study conditions (medical history of the study site, housing and feeding conditions, light/dark cycle) as well as the treatment schedule (medication ad libitum for 24 hours/ pulse medication) was missing or very limited.
Danish: Især manglede der oplysninger om undersøgelsesbetingelserne (undersøgelsesstedets medicinske historie, stald- og foderforhold, lys-/mørkecyklus) og behandlingsplanen (medicin ad libitum i 24 timer/pulsmedicinering) eller oplysningerne var meget begrænsede.
English: In the confirmatory phase, both the clinical and pathological response to artificial O. rhinotracheale infection was low in un-medicated controls.
Danish: I bekræftelsesfasen var både det kliniske og det patologiske respons på kunstig O. rhinotracheale-infektion lavt i ikkemedicinerede kontroller.
English: However the article of George et al. (1977)2 does not include sufficient information (body weights and water consumption) to calculate the daily actual dose intake of the study animals.
Danish: Imidlertid indeholder artiklen fra George et al. (1977)2 ikke tilstrækkelig information (legemsvægt og vandindtagelse) til at gøre det muligt at beregne forsøgsdyrenes daglige aktuelle dosisindtagelse.
English: Arendonk BELGIUM
Danish: Arendonk BELGIEN
English: Barcelona SPAIN
Danish: Barcelona SPANIEN
English: CVMP Note for guidance: Approach towards harmonisation of withdrawal periods http://www.ema.europa.eu/pdfs/vet/swp/003695en.pdf
Danish: 6 CVMP's Note for guidance: Approach towards harmonisation of withdrawal periods http://www.ema.europa.eu/pdfs/vet/swp/003695en.pdf.
English: Romania PHARMATEKA BT 1046 Budapest
Danish: Rumænien PHARMATEKA BT 1046 Budapest
English: Indications: For the prevention and treatment of several bacterial infections.
Danish: Indikationer: Til forebyggelse og behandling af flere bakterieinfektioner.
English: In conclusion, no therapeutic dose can be confirmed for the treatment of respiratory disease caused by O. rhinotracheale on basis of the data submitted.
Danish: Der kan således ikke bekræftes nogen terapeutisk dosis til behandling af luftvejssygdom forårsaget af O. rhinotracheale på basis af de fremlagte data.
English: 2370 Arendonk BELGIUM
Danish: 2370 Arendonk BELGIEN
English: Prevention 1 - 3 days
Danish: Forebyggende 1-3 dage
English: Bulgaria Biovet AD 39 Petar Rakov Str.
Danish: Bulgarien Biovet AD 39 Petar Rakov Str.
English: As regards P. multocida infections, results of an experimental model study indicate a treatment dose of 10 mg/kg body weight for 4 or 5 days, but no confirmatory clinical data obtained under commercial conditions has been made available.
Danish: Vedrørende P. multocida-infektioner indicerer resultater fra en undersøgelse med en forsøgsmodel en behandlingsdosis på 10 mg/kg legemsvægt i fire eller fem dage, men der er ikke fremlagt nogen bekræftende kliniske data indhentet under kommerciel brug.
English: This was the only study submitted in support of the O. rhinotracheale claim.
Danish: Det var den eneste undersøgelse, som blev fremlagt, som støttede påstanden om effekt ved O. rhinotracheale.
English: However there was no documented evidence for lack of efficacy in the treatment of respiratory infection associated with Mycoplasma gallisepticum with any other of the approved dosage regimens (10-25 mg/kg body weight).
Danish: Der var imidlertid ingen dokumentation for manglende virkning ved behandling af luftvejsinfektion i tilknytning til Mycoplasma gallisepticum med nogen af de andre godkendte dosisregimer (10-25 mg/kg legemsvægt).
English: 1093 Budapest HUNGARY
Danish: 1093 Budapest UNGARN
English: Laboratoires Biove 3 rue de Lorraine 62510 Arques FRANCE
Danish: Frankrig Laboratoires Biove 3 rue de Lorraine 62510 Arques
English: 71 08503 GURB - VIC SPAIN
Danish: 71 08503 GURB - VIC SPANIEN
English: Despite the deficiencies in the submitted studies and lack of data for some indications and dosages on the basis of well established use and the lack of any new pharmacovigilance information in relation to lack of efficacy it can be concluded that the current dosages and indications for the doxycycline containing products can be considered safe and effective.
Danish: På trods af manglerne i de fremlagte undersøgelser og de manglende data for nogle indikationer og doseringer kan det på basis af veletableret anvendelse og manglen på ny information fra lægemiddelovervågning vedrørende manglende effekt konkluderes, at de aktuelle doseringer og indikationer for lægemidlerne, som indeholder doxycyclin, kan betragtes som sikre og effektive.
English: 12 days in case of Ornithrobacterium rhinotracheale infection.
Danish: 12 dage i tilfælde af Ornithrobacterium rhinotrachealeinfektion.
English: However, the publication did not include the necessary information to derive a daily actual dose intake of the study birds.
Danish: Imidlertid indeholdt publikationen ikke den nødvendige information til, at man kunne udlede en daglig aktuel dosisindtagelse for forsøgsfuglene.
English: Doxycycline was also shown to be superior to chlortetracycline used as positive control.
Danish: Doxycyclin viste sig også at være bedre end chlortetracyclin, der blev anvendt som positiv kontrol.
English: AFOI TETOROU ABE
Danish: Grækenland AFOI TETOROU ABE
English: Hungary Animal-Med Kft. 1029 Budapest
Danish: Animal-Med Kft. 1029 Budapest UNGARN
English: In the submitted Periodic Safety Update Reports neither lack of efficacy nor any resistance problem has been reported for any of the approved indications in any of the approved species.
Danish: I de indsendte periodiske, opdaterede sikkerhedsindberetninger er der ikke rapporteret om manglende effekt eller problemer med resistens for nogen af de godkendte indikationer hos nogen af de godkendte arter.
English: In case of Chlamydia psittaci infection for 30-45 days.
Danish: I tilfælde af infektion med Chlamydia psittaci i 3045 dage.
English: It is recommended to prepare a concentrated pre-solution - approximately 100 grams product per litre drinking water - and to dilute this further to therapeutic concentrations if required.
Danish: Det anbefales at klargøre en koncentreret for-opløsning - cirka 100 gram lægemiddel pr. liter drikkevand - og om nødvendigt fortynde det yderligere til terapeutiske koncentrationer.
English: 08028 Barcelona SPAIN
Danish: 08028 Barcelona SPANIEN
English: As regards Escherichia coli infections, three publications of experimental model studies (George et al., 19772; Goren et al., 19883, Velkers et al., 20054) and one clinical efficacy study were presented.
Danish: Vedrørende Escherichia coli infektioner blev der fremlagt tre publikationer af undersøgelser med eksperimentale modeller (George et al., 19772; Goren et al., 19883, Velkers et al., 20054) og en klinisk
English: Therefore, CVMP recommends that the product literature for all concerned products in this procedure should include appropriate prudent use statements in line with what is recommended in the CVMP Guideline on the SPC for antimicrobials (EMEA/CVMP/SAGAM/383441/2005)8 and information on correct administration.
Danish: Derfor anbefaler CVMP, at produktlitteraturen for alle de pågældende lægemidler i denne procedure indeholder relevante formuleringer om forsigtig brug i overensstemmelse med anbefalingerne i CVMP's retningslinjer for produktresumé for antimikrobielle midler (EMEA/CVMP/SAGAM/383441/2005)8 og information om korrekt administration.
English: Comparison of these infection studies that investigate Colibacillosis was problematic due to considerable differences in the experimental conditions such as the use of different challenge strains and infectious dose levels, different time of treatment initiation, and differences in the chickens (age, weight, and breed) used.
Danish: Sammenligning med disse infektionsundersøgelser, som undersøger Colibacillosis, var problematisk på grund af store forskelle i forsøgsforholdene, f.eks. brug af forskellige provokationsstammer og infektiøse dosisniveauer, forskellige tidspunkter for behandlingsstart og forskelle hos kyllingerne (alder, vægt og race).
English: From the overall data submitted by the Applicants/Marketing Authorisation Holders only nineteen responses were with full dossiers developed in accordance with the Article 12(3) of Directive 2001/82/EC.
Danish: Ud af de samlede data, der var fremlagt af ansøgerne/indehaverne af markedsføringstilladelse, var der kun 19 besvarelser, som omfattede komplette dossierer, der var udarbejdet i overensstemmelse med artikel 12, stk. 3, i direktiv 2001/82/EF.
English: All tetracyclines have a broad spectrum of activity which include Gram-positive and Gram-negative bacteria, chlamydias, rickettsias, mycoplasmas and spirochaetes.
Danish: Alle tetracycliner har et bredt aktivitetsspektrum, som omfatter Gram-positive og Gram-negative bakterier, chlamydier, rickettsier, mycoplasmer og spirochaeter.
English: The study published by Goren et al. (1988)3 was designed as a dose titration study with doxycycline administered at dosages of 25-1000 ppm in drinking water for 5 consecutive days.
Danish: Undersøgelsen, som er publiceret af Goren et al. (1988)3, var designet som en dosistitreringsundersøgelse, hvor doxycyclin blev administreret i doser på 25-1000 ppm i drikkevand i fem på hinanden følgende dage.
English: Bucharest ROMANIA
Danish: Bucharest RUMÆNIEN
English: 2600 Antwerpen BELGIUM
Danish: 2600 Antwerpen BELGIEN
English: Member state/EEA
Danish: Medlemsst at/EØS
English: While the data submitted by Applicants/Marketing Authorisation Holders failed to provide sufficient documented evidence to support the established doses for all other indications and species, there was, however, no new information indicating any new risk associated with the use of doxycycline in poultry in relation to lack of efficacy.
Danish: Selvom data, som var fremlagt af ansøgerne/indehaverne af markedsføringstilladelserne, ikke gav tilstrækkelig dokumentation til støtte for de fastlagte doser for alle andre indikationer og arter, var der imidlertid ingen ny information, som indicerede nogen ny risiko i forbindelse med anvendelses af doxycyclin hos fjerkræ i relation til manglende virkning.
English: in drinking water
Danish: I drikkevand
English: It is efficient on the several bacteria resistant to first generation tetracyclines.
Danish: Det er effektivt over for flere bakterier, som er resistente over for førstegenerationstetracykliner.
English: Hungary Kon-Pharma GmbH.
Danish: Kon-Pharma GmbH.
English: Budapest Ottó u. 14, Hungary
Danish: Budapest Ottó u. 14, Ungarn
English: Scientific conclusions and grounds for amendment of the summary of product characteristics
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET
English: SUPER´S DIANA, S.L
Danish: Spanien SUPER´S DIANA, S.L
English: CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf
Danish: 8 CVMP's revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)http://www.ema.europa.eu/pdfs/vet/sagam/38344105enfin.pdf.
English: 47100 Forli ITALY
Danish: 47100 Forli ITALIEN
English: The daily doses administered to chickens ranged between 10.36 mg/kg body weight, 14.47 mg/kg body weight and 25 mg/kg body weight.
Danish: Den daglige dosis, som blev givet til kyllinger, lå i området mellem 10,36 mg/kg legemsvægt, 14,47 mg/kg legemsvægt og 25 mg/kg legemsvægt.
English: The use of doxycycline hyclate for all claimed indications in chickens as well as the use of doxycycline hyclate in other poultry species was considered well-established.
Danish: Anvendelse af doxycyclinhyclat til alle påståede indikationer hos kyllinger samt anvendelse af doxycyclinhyclat til andre fjerkræarter blev betragtet som veldokumenteret.
English: In an experimental setting testing homeopathic medication in the treatment of Colibacillosis in broiler chickens, doxycycline was used for control (Velkers et al., 2005)4.
Danish: I et forsøgsmiljø med test af homøopatisk medicin ved behandling af Colibacillosis hos slagtekyllinger blev doxycyclin anvendt som kontrol (Velkers et al., 2005)4.
English: Slovenia Novartis Veterina d.o.o.
Danish: Slovenien Novartis Veterina d.o.o.
English: One of these studies serve as the confirmatory evidence for the efficacy of this target dose, based on objective parameters such as a significant reduction of the percentage of animals with pathological lesions and total lesion scores typical of the disease and significant reduction in the recovery rate of M. gallisepticum after treatment.
Danish: En af disse undersøgelser fungerede som bekræftende dokumentation for virkningen af denne måldosis baseret på objektive parametre såsom en signifikant reduktion af procentandelen af dyr med patologiske læsioner og totale læsionsscorer, som er typisk for sygdommen, samt en signifikant reduktion i genfindingsgraden af M. gallisepticum efter behandling.
English: Treatment of chronic respiratory disease Turkey: Treatment of infective synusitis
Danish: Behandling af kronisk luftvejssygdom Kalkuner: Behandling af infektiøs sinusitis
English: This one study was performed in turkeys.
Danish: Denne ene undersøgelse blev gennemført med kalkuner.
English: It could be argued that doxycycline can be effectively used in the treatment of E. coli infections in broilers provided, however, that susceptibility to doxycycline is confirmed before initiation of treatment.
Danish: Det kan fremføres, at doxycyclin effektivt kan anvendes til behandling af E. coli-infektioner hos slagtekyllinger, forudsat at følsomheden over for doxycyclin bekræftes, før behandlingen indledes.
English: The United Kingdom expressed concerns that differences in the posology, dose range, duration of treatment and withdrawal periods established across the European Union for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water may present a potential serious risk to both animal health and human health, and requested the CVMP to give its opinion on the matter.
Danish: Det Forenede Kongerige har udtrykt betænkelighed ved, at forskelle i dosering, dosisområde, behandlingsvarighed og tilbageholdelsestid, som er fastlagt i EU for alle styrker af vandopløselige pulvere og orale opløsninger indeholdende doxycyclinhyclat, som er indiceret til brug i fjerkræ og beregnet til administration via drikkevand, kan udgøre en potentielt alvorlig risiko for både dyrs og menneskers sundhed, og har anmodet CVMP om at afgive en udtalelse herom.
English: Romania s.c. romvac company s.a.Şos.
Danish: Rumænien s.c. romvac company s.a.Şos.
English: No therapeutic dosage regimen could be derived from the two submitted experimental E. coli infection studies in chickens.
Danish: Der kunne ikke udledes nogen terapeutiske dosisregimer af de to fremlagte undersøgelser af E. coli-infektioner med kyllinger.
English: BOX 205
Danish: P.O. BOX 205
English: Czech republic
Danish: Tjekkiske Republik
English: 4-7 days with drinking water
Danish: 4-7 dage sammen med drikkevand
English: - ORT - meat: 12 days.
Danish: - ORT - kød: 12 dage.
English: At this dose levels mean plasma doxycycline levels of 3.6 µg/ml (measured on the 2nd treatment day were achieved.
Danish: Ved det dosisniveau blev der opnået et gennemsnitligt doxycyclin-plasmaniveau på 3,6 µg/ml (målt på behandlingens 2. dag).
English: For oral administration in drinking water, milk or feed
Danish: Til oral administration via drikkevand, mælk eller foder
English: 5530 AD Bladel THE
Danish: 5530 AD Bladel NEDERLANDENE
English: Via W. Tobagi n.7 20068 Peschiera Borromeo (Milano) ITALY
Danish: Via W. Tobagi n.7 20068 Peschiera Borromeo (Milano) ITALIEN
English: mg/kg/day (pigs)
Danish: mg/kg/dag (svin)
English: DOXYVIT 40% per 3-6 L of drinking water
Danish: DOXYVIT 40 % pr. 3-6 l drikkevand
English: Mean daily water consumption (l) per bird
Danish: Gennemsnitlig daglig indtagelse af vand (l) pr. fugl
English: Via drinking water 1kg DoxyWS in 2000
Danish: Fjerkræ Via drikkevand 1 kg DoxyWS i 2000
English: As no need for revision of the dose was identified consequently the withdrawal periods of the products concerned do not need revision.
Danish: Da der ikke blev identificeret noget behov for ændring af dosen, er det heller ikke nødvendigt at ændre tilbageholdelsestiden for lægemidlet.
English: Indications: respiratory diseases
Danish: Indikationer: luftvejssygdomme
English: However the publication does not provide sufficient information to calculate the actual dose intake of the study animals.
Danish: Imidlertid indeholder publikationen ikke tilstrækkelige oplysninger til at gøre det muligt at beregne forsøgsdyrenes aktuelle dosisindtagelse.
English: Via Colleoni n.15 20041 Agrate Brianza (Milano) ITALY
Danish: Via Colleoni n.15 20041 Agrate Brianza (Milano) ITALIEN
English: Indications: Used for the treatment of the secondary bacterial infections following to viral origin diseases.
Danish: Anvendes til behandling af sekundære bakterieinfektioner efter sygdomme af viral oprindelse.