FrancophonIA/ELRC3.0 huggingface dataset:
English: It is clear that there are very limited scientific data available to support many of the proposed indications for use of the product, however it could be considered to have “well established use”.
Danish: Det fremgår klart, at der foreligger meget begrænsede videnskabelige data til støtte for mange af de foreslåede indikationer for brug af lægemidlet, men det kan dog anses for at være "almindeligt anvendt".
English: In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.
Danish: For at opnå en korrekt dosering kan det være nødvendigt at justere koncentrationen i drikkevandet.
English: MANUFACTURER'S BATCH NUMBER Batch <<number>>
Danish: FREMSTILLERENS BATCHNUMMER Batch <<partijnummer>>
English: The final conclusion for the benefit: risk balance for the use of the product remains positive.
Danish: Endelig konklusion med hensyn til benefit-forholdet: Risikoforholdet for brugen af lægemidlet er fortsat positiv.
English: The uptake of medicated water is dependant on the clinical conditions of the animals.
Danish: Optagelsen af det medicinerede vand afhænger af dyrenes kliniske tilstand.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN "KUN TIL DYR" SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Administration at up to 5 X Recommended Treatment Dose was well tolerated.
Danish: Indgivelse af op til 5 x den anbefalede behandlingsdosis var veltolereret.
English: SPECIAL STORAGE CONDITIONS Store below 25 ºC.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares under 25 ºC.
English: The daily amount is to be added to the drinking water such that all medication will be consumed in 24 hours.
Danish: Den daglige mængde skal tilsættes drikkevandet, så al medicinen er optaget inden for 24 timer.
English: No health abnormalities were detected.
Danish: Der sås ingen abnormiteter i sundhedstilstanden.
English: In view of the weaknesses in the existing data, the indications have been made more precise and SPC warnings and advice related to antimicrobial resistance have been strengthened.
Danish: På baggrund af svaghederne i de eksisterende data er indikationerne gjort mere præcise, og produktresuméernes advarsler og vejledninger med hensyn til antimikrobiel resistens er blevet styrket.
English: Doxycycline is listed as a “highly important antimicrobial” for human use, and “critically important” for veterinary use according to the WHO criteria, 2007.
Danish: Doxycyclin er opført som et "yderst vigtigt antimikrobielt middel" til mennesker, og af "kritisk betydning" til veterinær brug i henhold til WHO-kriterierne, 2007.
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 opløsningmed ca. 100 gram produkt pr. liter drikkevand - og fortynde denne yderligere til den terapeutiske koncentration, hvis det er nødvendigt.
English: Any unused product or waste material should be disposed of in accordance with national requirements.
Danish: Eventuelle ubrugte lægemidler eller affald fra sådanne produkter skal destrueres i overensstemmelse med de nationale krav.
English: The use of suitably calibrated weighing equipment is recommended if part packs are used.
Danish: Det anbefales at bruge behørigt kalibreret vejeudstyr, hvis der anvendes delpakker.
English: There are no proposals to alter the dose regimen for chickens, pigs and calves thus the exposure of the environment to doxycycline will not increase.
Danish: Der er ikke nogen forslag om ændringer i dosisregimenet til kyllinger, svin eller kalve, og derfor vil eksponeringen af miljøet for doxycyclin ikke øges.
English: To ensure a correct dosage body weight should be determined as accurately as possible.
Danish: For at sikre en korrekt dosering skal legemsvægten bestemmes så præcist som muligt.
English: Do not use after the expiry date stated on the label after exp.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten.
English: The study highlighted the importance of susceptibility testing prior to treatment with doxycycline.
Danish: Undersøgelsen fremhævede betydningen af følsomhedstest før behandling med doxycyclin.
English: Overall summary of the scientific evaluation of Doxycycline 50% WSP and associated names (see annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Doxycyclin 50% WSP og relaterede navne (se bilag I)
English: It was accepted that this level of resistance could not be directly extrapolated to doxycycline.
Danish: Der var accept af, at dette resistensniveau ikke kunne ekstrapoleres direkte til doxycyclin.
English: PHARMACEUTICAL FORM Powder for oral solution.
Danish: LÆGEMIDDELFORM Pulver til oral opløsning.
English: Mean body weight (kg) of animals to be treated
Danish: Gennemsnitlig legemsvægt (kg) af dyr, der skal behandles
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER Aktivt stof:
English: Shelf life after reconstitution in drinking water: 24 hours.
Danish: Opbevaringstid efter rekonstituering i drikkevand: 24 timer.
English: No data were provided in relation to poultry species other than chickens.
Danish: Der blev ikke fremlagt data vedrørende andre fjerkræarter end kyllinger.
English: A summary of field trial data (Van Gool, 198612) provided evidence of efficacy of Ronaxan P.S.
Danish: En sammenfatning af data fra feltundersøgelser (Van Gool, 198612) dokumenterede virkningen af Ronaxan P.S.
English: To be administered orally through the milk-replacer and/or the drinking water.
Danish: Skal indtages oralt gennem mælkeerstatningen og/eller drikkevandet.
English: Considering all factors there was insufficient evidence to justify an alteration in the dose rate or regimen.
Danish: Alle faktorer taget i betragtning var der ikke tilstrækkelig dokumentation for at ændre doseringen eller regimenet.
English: There have been no discrepancies across the Member States in the following indications:
Danish: Der har ikke været nogen forskelle fra medlemsstat til medlemsstat i følgende indikationer:
English: There have been no major discrepancies across the Member States in the following indications:
Danish: Der har ikke været nogen større forskelle fra medlemsstat til medlemsstat i følgende indikationer:
English: In addition, no evidence from pharmacovigilance of serious risk has been demonstrated to be associated with the current dosing regimens for chickens, pigs or pre-ruminant calves and as such they can be maintained.
Danish: Desuden har ingen dokumentation fra lægemiddelovervågningen påvist alvorlig risiko i forbindelse med de aktuelle doseringsregimener for kyllinger, svin, eller præ-drøvtyggende kalve, og de kan som sådan bibeholdes.
English: Chickens: 5 days
Danish: Kyllinger: 5 dage
English: Shelf life of the veterinary medicinal product as packaged for sale: 36 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 36 måneder.
English: Cross resistance between tetracyclines has also been described.
Danish: Der er også blevet observeret krydsresistens mellem tetracykliner.
English: Following absorption, tetracyclines are hardly metabolized.
Danish: Efter absorptionen metaboliseres tetracyklinerne næsten ikke.
English: The presence of food in the intestine has no effect on the actual absorption of doxycycline.
Danish: Tilstedeværelsen af mad i tarmsystemet har ingen indflydelse på den reelle absorption af doxycyklin.
English: Alternatively, the concentrated solution can be used in a proportional water medicator.
Danish: Alternativt kan den koncentrerede opløsning anvendes i et proportionelt doseringssystem.
English: As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking.
Danish: Da det er muligt, at målpatogenerne ikke kan udryddes, bør medicineringen kombineres med god håndteringspraksis, som f.eks. god hygiejne, ordentlig udluftning og ingen overbelægning.
English: Doxycycline is quickly and almost completely absorbed from the intestine.
Danish: Doxycyklin absorberes hurtigt og næsten fuldstændigt fra tarmen.
English: Mean daily water consumption (litre) per animal
Danish: Gennemsnitlig dagligt vandforbrug (liter) pr. dyr
English: These warnings have been broadened to take account of resistance to tetracyclines recognised in isolates from pigs and
Danish: Disse advarsler er blevet udvidet til at tage højde for resistens over for tetracykliner, som er blevet fundet i isolater fra svin og kalve.
English: Appropriate definition of indications giving the users of the product clear information on the expected efficacy, together with appropriate dosing for the indications is necessary in order to ensure effective and safe use of the product in the field.
Danish: En tilstrækkelig definition af indikationerne, der giver brugerne af lægemidlet tydelig information om den forventede virkning, samt tilstrækkelige dosisangivelser til indikationerne er påkrævede for at sikre en effektiv og sikker brug af lægemidlet i felten.
English: Treatment was considered to have been effective in 98% of calves treated with Ronaxan (n=361) compared to 85% of calves treated with reference antimicrobial products (n=174).
Danish: Behandlingen blev betragtet som effektiv hos 98 % af de kalve, der blev behandlet med Ronaxon (n=361), sammenlignet med 85 % af de kalve, der blev behandlet med referencelægemidler med antimikrobiel virkning (n=174).
English: In the absence of compatibility studies, this product should 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: It was agreed that the target species should be clarified to be “pre-ruminant calves” in the harmonised product information.
Danish: Det blev vedtaget, at den dyreart, som lægemidlet er beregnet til, skulle præciseres til “præ-drøvtyggende kalve” i den harmoniserede produktinformation.
English: As no data have been provided for species of poultry other than chickens, it was agreed that the target species should be restricted to “chickens” across all Member States where the product is authorised or pending authorisation.
Danish: Da der ikke er fremlagt data for andre fjerkræarter end kyllinger, blev det vedtaget, at dyrearten, som lægemidlet er beregnet til, skal begrænses til ”kyllinger” i alle medlemsstater, hvor lægemidlet er godkendt eller afventer godkendelse.
English: Pharmacotherapeutic group: Antibacterial for systemic use, tetracyclines ATCvet-code: QJ01AA02
Danish: Farmakoterapeutisk gruppe: antibakterielt middel til systemisk brug, tetracykliner ATCvet-kode: QJ01AA02
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Doxycycline 50 % WSP and associated names, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SPC) across the European Union.
Danish: På grund af de divergerende nationale beslutninger truffet af medlemsstaterne vedrørende godkendelse af Doxycyclin 50% WSP og relaterede navne blev sagen indbragt for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF for at løse divergenser mellem de nationalt godkendte produktresuméer i EU.
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 produktet kun anvendes til behandling af infektioner, som er forårsaget af E. coli, efter der er blevet foretaget en følsomhedstest.
English: Kremer, 19889 and Hartman, 199310 & 199411 showed high levels of resistance in Pasteurella spp isolated from veal calves in the Netherlands.
Danish: Kremer, 19889, og Hartman, 199310 & 199411, viste høje resistensniveauer i Pasteurella spp, der var isoleret fra slagtekalve i Nederlandene.
English: Store below 25 ºC.
Danish: Opbevares under 25 ºC.
English: Tetracycline resistance is usually acquired by means of plasmids or other mobile elements (e.g. conjugative transposones).
Danish: Tetracyklinresistens erhverves som regel ved hjælp af plasmider eller andre mobile elementer (f.eks. konjugerbare transposoner).
English: In pigs, no accumulation of doxycycline in plasma was found after treatment via the drinking water.
Danish: Hos svin blev der ikke fundet nogen akkumulering af doxycyklin i plasma efter behandling via drikkevandet.
English: The MIC90s values ranged from 0.03 μg/ml for Mycoplasma hyopneumoniae to 0.5 μg/ml for P. multocida.
Danish: MIC90-værdierne varierede fra 0,03 μg/ml for Mycoplasma hyopneumoniae til 0,5 μg/ml for P. multocida.
English: DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION To be completed nationally
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Udfyldes nationalt - skal udfyldes
English: Doxycycline is a broad spectrum antibiotic.
Danish: Doxycyklin er et bredspektret antibiotikum.
English: List of the names, pharmaceutical form(s), strength of the veterinary medicinal products, animal species, route of administration, applicant/marketing authorisation holder in the member states
Danish: Lægemidlets navn, lægemiddelform, styrke, dyrearter, indgivelsesveje og ansøger/indehaver af markedsføringstilladelse
English: 4941 VX Raamsdonksveer The Netherlands
Danish: 4941 VX Raamsdonksveer NEDERLANDENE
English: Citric acid
Danish: Citronsyre Laktose
English: • the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; the CVMP has recommended the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxycycline 50% WSP and associated names (see Annex I).
Danish: • CVMP vurderede produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen havde foreslået, og tog alle de samlede indsendte data i betragtning; anbefalede CVMP ændringen af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Doxycyclin 50% WSP og relaterede navne (se bilag I).
English: Shelf life after reconstitution in milk replacer: use immediately.
Danish: Opbevaringstid efter rekonstituering i mælkeerstatning: brug med det samme.
English: In order to help to ensure optimal bioavailability in the field, a warning has been included in section 4.8 of the SPC regarding the potential for doxycycline to chelate cations.
Danish: For at bidrage til at sikre en optimal biotilgængelighed i felten er der medtaget en advarsel i produktresuméets punkt 4.8 vedrørende doxycyclins potentiale til at kelere kationer.
English: Although the data provided suggested that that this dose might not be optimal and there is recent literature evidence for resistance development in swine respiratory pathogens to tetracyclines, there was no clear evidence upon which to base a revision of the dose/indications.
Danish: Selvom de fremlagte data tydede på, at denne dosis muligvis ikke er optimal, og den nyere litteratur dokumenterer resistensudvikling over for tetracykliner i luftvejspatogener hos svin, var der ingen tydelig evidens, som en revision af dosis/indikationerne kan baseres på.
English: Although not submitted by the marketing authorisation holder, information from the ARBAO-II7 project reporting on the occurrence of antimicrobial resistance among bacteria causing infections in pigs in the European Union between 2002-2004 showed levels of resistance to tetracylines in Actinobacillus pleuropneumoniae between 0 and 46.0% and in Strep. suis between 48.0 and 92.0%.
Danish: Selvom dette ikke blev rapporteret af indehaveren af markedsføringstilladelsen, viste information fra ARBAO-II7-projektet, der rapporterede om forekomsten af antimikrobiel resistens i de bakterier, der forårsager infektioner hos svin i Den Europæiske Union i perioden 2002-2004, resistensniveauer over for tetracyclin i Actinobacillus pleuropneumoniae på mellem 0 og 46,0 % og i Strep. suis på mellem 48,0 og 92,0 %.
English: INN & Strength
Danish: INN Styrke
English: A high resistance rate of E. coli, isolated from chickens, against tetracyclines has been documented.
Danish: Der er blevet påvist en høj modstandsdygtighed hos E. coli, isoleret fra kyllinger, mod tetracykliner.
English: Data from Goren, 19831, on the in vitro susceptibility of pathogens isolated from poultry between 1978 and 1981 showed that susceptibility of P. multocida was > 70%, but that of E. coli varied between 4 to 34% over the time period studied.
Danish: Data fra Goren, 19831, vedrørende in vitro-følsomheden af patogener, der blev isoleret fra fjerkræ mellem 1978 og 1981, viste, at følsomheden af P. multocida var >70 %, men at E. coli varierede mellem 4 og 34 % i løbet af undersøgelsesperioden.
English: Food-borne, direct as well as environmental transmission of resistant microorganisms (resistant determinants) has to be considered a risk related to the use of the product despite the fact that quantification of transmission of zoonotic agents and horizontal transfer of resistance genes between animal and human bacteria is extremely difficult in vivo (F. J. Angulo et al., 2004)14.
Danish: Fødebåren, direkte såvel som miljømæssig overførsel af resistente mikroorganismer (resistente determinanter) må anses for at udgøre en risiko i forbindelse med brugen af lægemidlet, til trods for at kvantificering af overførslen af zoonotiske midler og horisontal overførsel af resistensgener mellem humane og animalske bakterier er uhyre vanskelig in vivo (F. J. Angulo et al., 2004)14.
English: The doxycycline plasma level reached an average of 2.2 to 2.5 μg/ml.
Danish: Doxycyklinplasmanivauet nåede op på et gennemsnit på 2,2 til 2,5 μg/ml.
English: A study by Kuttler, 197813 showed that doxycycline was effective in moderating anaplasmosis in splenectomised calves infected with Anaplasma marginale.
Danish: En undersøgelse udført af Kuttler, 197813, viste, at doxycyclin var effektivt til at moderere anaplasmose hos splenektomerede kalve, der var inficeret med Anaplasma marginale.
English: No field trial data were submitted to support the use of the product in pigs.
Danish: Ingen data fra feltundersøgelser blev indsendt til støtte for anvendelse af lægemidlet hos svin.
English: However, administration at 5 X and 10 X Recommended Treatment Dose was not well tolerated with animals showing anorexia, diarrhoea and evidence of renal failure necessitating euthanasia.
Danish: Indgivelse af doser på 5 x og 10 x den anbefalede behandlingsdosis var dog ikke veltolereret, idet dyrene udviste anoreksi, diarré og evidens for nyresvigt, hvilket gjorde eutanasi nødvendig.
English: Interactions with other medicinal products and other forms of interaction Do not use in conjunction with bactericidal antibiotics, such as penicillins and cephalosporins.
Danish: Interaktion med andre lægemidler og andre former for interaktion Må ikke bruges sammen med bakteriedræbende antibiotika som penicilliner og cefalosporiner.
English: METHOD AND ROUTE OF ADMINISTRATION Oral use, after dissolution in drinking water/milk replacer.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral anvendelse efter opløsning i drikkevand/mælkeerstatning.
English: Due to the greater liposolubility and greater facility to pass through cell membranes (in comparison to tetracycline), doxycycline retains a certain degree of efficacy against microorganisms with acquired resistance to tetracyclines.
Danish: På grund af større lipidopløselighed og bedre mulighed for passage gennem cellemembraner (sammenlignet med tetracykliner) har doxycyklin stadig en vis effekt mod mikroorganismer, der er blevet resistente over for tetracykliner.
English: This interferes with binding of aminoacetyl-tRNA to the acceptor site on the mRNA ribosome complex and prevents coupling of amino acids to the elongating peptide chains.
Danish: Dette forstyrrer bindingen af aminoacetyl-tRNA til mRNA-ribosomkompleksets receptor og forhindrer kobling af aminosyrer til lange peptidkæder.
English: Medicated drinking water should be freshly prepared every 24 hours.
Danish: Der bør fremstilles friskt medicineret drikkevand én gang i døgnet.
English: The summary of PSURs data indicated no safety concerns or suspected lack of expected efficacy in relation to this indication or dose duration.
Danish: Sammenfatningen af PSUR-data gav ikke anledning til betænkeligheder vedrørende sikkerheden eller formodning om manglende forventet virkning ved denne indikation eller dosisvarighed.
English: 4941 VX Raamsdonksveer The Netherlands research@dopharma.com
Danish: 4941 VX Raamsdonksveer Holland research@dopharma.com
English: It inhibits bacterial protein synthesis intracellularly by binding on the 30-S ribosome subunits.
Danish: Det hæmmer bakteriel proteinsyntese intracellulært ved at binde sig til 30-S-underenhederme på ribosomerne.
English: For the administration through the drinking water, the exact daily amount of product should be calculated, based on the recommended dose, and the number and weight of the animals to be treated, according to the following formula:
Danish: Ved dosering gennem drikkevandet skal den præcise daglige mængde produkt beregnes baseret på den anbefalede dosis og antallet og vægten af de dyr, der skal behandles, i henhold til følgende formel:
English: Two literature references reported that doxycycline at 50 mg per litre in drinking water for 3 - 5 days was effective in treating challenge infections with E. coli (George, 19772) and E. coli and M. gallisepticum (Migaki, 19773).
Danish: I to litteraturreferencer blev det rapporteret, at 50 mg doxycyclin pr. liter i drikkevandet i 3-5 dage var effektivt til behandling af vanskelige infektioner med E. coli (George, 19772), E. coli og M. gallisepticum (Migaki, 19773).
English: Four resistance mechanisms acquired by microorganisms against tetracyclines in general have been reported: Decreased accumulation of tetracyclines (decreased permeability of the bacterial cell wall and active efflux), protein protection of the bacterial ribosome, enzymatic inactivation of the antibiotic and rRNA mutations (preventing the tetracycline binding to ribosome).
Danish: Der har været rapporteret fire resistensmekanismer hos mikroorganismer mod tetracykliner generelt: Nedsat akkumulering af tetracykliner (nedsat permeabilitet af bakteriens cellevæg og aktiv udstrømning), proteinbeskyttelse af det bakterielle ribosom, enzymatisk deaktivering af antibiotikummet og rRNA-mutationer (hvilket hindrer tetracykliner i at binde sig til ribosomet).
English: The distribution of doxycycline and penetration of doxycycline throughout most body tissues is good.
Danish: Distributionen af doxycyklin og penetrationen af doxycyklin er god i de fleste typer knoglevæv.
English: In contrast to the other tetracyclines, doxycycline is mainly excreted via the faeces.
Danish: I modsætning til andre tetracykliner udskilles doxycyklin hovedsagligt via afføring.
English: In this study, doses of doxycycline equivalent to 16, 7.5 and 3.6 mg/kg body weight/day were effective in preventing disease in 6/6, 5/6 and 1/6 pigs, respectively.
Danish: I denne undersøgelse var doxycyclindoser svarende til 16, 7,5 og 3,6 mg/kg kropsvægt dagligt effektive til forebyggelse af sygdom hos henholdsvis 6/6, 5/6 og 1/6 svin.
English: Due to deposit of doxycycline in young bone tissue, use of the product should be limited during pregnancy and lactation.
Danish: På grund af aflejringen af doxycyklin i ungt knoglevæv bør produktets anvendelse begrænses under drægtighed og laktation.
English: Additional information has been added to the SPC regarding mechanisms of resistance totetracyclines in general.
Danish: Der er føjet yderligere information til produktresuméet vedrørende resistensmekanismer over for tetracykliner generelt.