FrancophonIA/ELRC3.0 huggingface dataset:
English: The actual groups of pigs studied were all showing clinical signs.
Danish: Alle svin i den faktisk undersøgte gruppe viste kliniske symptomer.
English: After withdrawal of medication, half-life of the terminal phase is of 6 h. It is mainly eliminated through the small intestine that supposes an advantage in relation to the rest of tetracyclines provided that it is not accumulated in the organism when renal function is diminished since it is not its mainly route of elimination.
Danish: Det elimineres hovedsageligt gennem tyndtarmen, hvilket udgør en fordel i forhold til resten af tetracyclinerne, fordi det ikke akkumuleres i organismen, når nyrefunktionen er nedsat, eftersom det ikke er dets hovedeliminationsvej.
English: During the MRP the applicant did however explain that the incorporation rates of doxycycline in the feed used in the clinical trial were decided to take into account the variability that would be found in the field in regard to pig body weight and feed consumption.
Danish: Under den gensidige anerkendelsesprocedure forklarede ansøgeren imidlertid, at doxycyclin-indholdet i foderet i den kliniske undersøgelse blev fastsat med henblik på den variation, der under feltforhold vil gøre sig gældende for svinenes vægt og den indtagne mængde foder.
English: Meat and offal: 7 days.
Danish: Kød og indvolde: 7 dage.
English: Based on this information the CVMP agreed that the provided references are not suitable as pivotal evidence of clinical efficacy of the product Doxyprex for the proposed indication and dose regimen for M.Hyopneumoniae
Danish: På grundlag af disse oplysninger fandt CVMP ikke de forelagte referencer velegnede som hoveddokumentation for den kliniske virkning af produktet Doxyprex til den foreslåede indikation og det foreslåede dosisregime for M. Hyopneumoniae.
English: METHOD AND ROUTE(S) OF ADMINISTRATION In feed use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Anvendes i foder
English: A risk:benefit analysis could not be conducted due to the lack of pivotal evidence on clinical efficacy for the indication M. hyopneumoniae.
Danish: Der kunne ikke foretages en benefit-risk analyse, da der savnes hoveddokumentation for den kliniske virkning til indikationen M. hyopneumoniae.
English: Pivotal clinical trial with Doxycyline 10% premix
Danish: Den kliniske hovedundersøgelse med doxycylin premix, 10 %
English: Overdose (symptoms, emergency procedures, antidotes), if necessary No symptoms of intolerance to the speciality have been detected in the studies conducted in which a medicated feed with 600 ppm (2.4 times the recommended dose) was administered to the 20-30 kg animals during twice the recommended period.
Danish: Der er ikke sporet nogen symptomer på intolerance over for specialiteten i de gennemførte undersøgelser, hvor medicineret foder med 600 ppm (2,4 gange den anbefalede dosis) blev administreret til dyr på 20-30 kg i en periode, der var dobbelt så lang som den anbefalede periode.
English: Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and sensitivity testing or recent experience on the farm and take into account official and local antimicrobial policies.
Danish: På grund af bakteriers varierende følsomhed over for doxycyclin bør produktets anvendelse baseres på bakteriologisk prøvetagning og sensitivitetstestning eller nylig erfaring på gården og tage hensyn til officielle og lokale antimikrobielle politikker.
English: For a full list of excipients, see section 6.1.
Danish: Se afsnit 6.1. for en fuldstændig fortegnelse over hjælpestoffer
English: Use during pregnancy, lactation or lay
Danish: Anvendelse under drægtighed, laktation eller æglægning
English: 100 mg of Doxycycline base as hyclate
Danish: 100 mg doxycyclin base som hyclat Hjælpestoffer:
English: Piglet starter feed I (complete feed up to approx. 20 kg body weight) Piglet starter feed II (complete feed up to approx. 35 kg body weight) Complete feed for fattening pigs up to approx. 50 kg body weight Complete feed for fattening pigs of approx. 50 kg body weight Complete feed for fattening pigs of approx. 35 kg body weight A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff.
Danish: Følgende komplette fodertyper til svin kan bruges til fremstilling af medicineret foder: Startfoder til smågrise I (komplet foder op til ca. 20 kg kropsvægt) Startfoder til smågrise II (komplet foder op til ca. 35 kg kropsvægt) Komplet foder til slagtesvin op til ca. 50 kg kropsvægt Komplet foder til slagtesvin på ca. 50 kg kropsvægt Komplet foder til slagtesvin på ca. 35 kg kropsvægt Der bør anvendes en horisontal ribbonblander til at tilsætte produktet til foderet.
English: For pigs with a daily consumption of 40 g of feed/kg b.w./day this dose corresponds to 250 mg of doxycycline per kg of feed which gives a rate of incorporation of 2.5 kg/Ton.
Danish: For svin med en daglig indtagelse på 40 g foder/kg kropsvægt/dag svarer denne dosis til 250 mg doxycyclin pr. kg foder, hvilket giver et tilsætningsforhold på 2,5 kg/ton.
English: For the second clinical study “ Efficacy of the doxycycline in feed for the control of pneumonia caused by P. multocida and Mycoplasma hyopneumoniae
Danish: Til den anden kliniske undersøgelse, "Virkning af doxycyclin i foder til kontrol af pneumoni forårsaget af P. multocida og Mycoplasma hyopneumoniae",
English: Shelf-life after incorporation into pelleted feed: 3 months.
Danish: Opbevaringstid efter opblanding i fodermel eller foderpiller: 3 måneder.
English: Efficacy against M. hyopneumoniae has furthermore not been established in the field study, since its presence was not demonstrated.
Danish: Desuden giver feltundersøgelsen ikke dokumentation for virkningen mod M. hyopneumoniae, da dens tilstedeværelse ikke blev påvist.
English: PACKAGE SIZE 1 kg
Danish: PAKNINGSSTØRRELSE 1 kg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ONTHE IMMEDIATE PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: In the pivotal clinical trial, the presence of P.multocida and B.bronchiseptica was clearly demonstrated in sick pigs, however no post treatment sampling was done to show bacteriological cure.
Danish: I den kliniske hovedundersøgelse blev der klart fundet P. multocida og B. bronchiseptica hos syge svin, men der blev ikke efter behandlingen udtaget prøver til påvisning af bakteriologisk helbredelse.
English: It is not recommended its use in pregnant animals and during lactation periods.
Danish: Anvendelse frarådes til drægtige dyr og under laktation.
English: Doxyprex 100 mg premix presented in 5 kg, 20 kg and 25 kg thermosealed bags containing 100 mg/g doxycycline base as hyclate.
Danish: Doxyprex 100 mg premix, leveret i 5 kg, 20 kg og 25 kg termoforseglede sække indeholdende 100 mg/g doxycyclin base som hyclat.
English: From all this information, a significant potential serious risk for safety or efficacy of Doxyprex, for the treatment or control of clinical signs of porcine respiratory disease caused by P.multocida and B.bronchiseptica cannot be identified.
Danish: Blandt al denne information er der intet, der må påpeges som en væsentlig potentiel alvorlig risiko vedrørende sikkerheden eller virkningen af Doxyprex til behandling eller kontrol af luftvejssygdomme hos svin forårsaget af P. multocida og B. bronchiseptica.
English: DATE OF REVISION OF THE TEXT {<DD/MM/YYYY>}
Danish: DATO FOR ÆNDRING AF TEKSTEN {<DATO/MÅNED/ÅR>}
English: Do not administer in animals with hypersensitivity to tetracyclines.
Danish: Må ikke administreres til dyr med overfølsomhed over for tetracycliner.
English: In Spain the product has been authorised for the indication the treatment of swine respiratory disease caused by Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Danish: I Spanien er produktet godkendt med indikationen behandling af luftvejssygdom hos svin forårsaget af Pasteurella multocida, Bordetella bronchiseptica og Mycoplasma hyopneumoniae.
English: Applicant or Marketing Authorisation Holder
Danish: Ansøger eller indehaver af markedsføringstillade lse
English: The applicant provided evidence of efficacy of the active substance, doxycycline, against M.hyopneumoniae in pigs from published literature and from MIC studies.
Danish: Ansøgeren forelagde dokumentation for virkningen af de aktive indholdsstof doxycyclin mod M. hyopneumoniae hos svin, baseret på publikationer og MICbestemmelser.
English: The Marketing Authorisation Holder (MAH) was requested to substantiate the indication and posology as discussed during the recent MRP.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at underbygge indikation og dosering som drøftet under den nyligt stedfundne gensidige anerkendelsesprocedure.
English: TARGET SPECIES Pigs (after weaning)
Danish: DYREARTER Svin (efter fravænning)
English: Special precautions for storage
Danish: SÆRLIGE OPBEVARINGSBETINGELSER
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {<DD/MM/YYYY>}
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN {<DATO/MÅNED/ÅR>}
English: Do not administer to animals with hepatic damage.
Danish: Må ikke administreres til dyr med leverskader.
English: LABELLING AND PACKAGE INSERT
Danish: ETIKETTERING OG INDLÆGSSEDDEL
English: Pursuant to Article 33(4) of Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Danish: Sagen blev indbragt for CVMP i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF, med senere ændringer.
English: Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Danish: Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: The applicant submitted a target species tolerance study and post marketing pharmacovigilance data to support safety of the product.
Danish: Til dokumentation af produktets sikkerhed forelagde ansøgeren en toleranceundersøgelse i måldyrearten og oplysninger vedrørende lægemiddelovervågning efter markedsføring.
English: The applicant conducted a pivotal controlled, randomized two-centred field trial using their final formulation to demonstrate efficacy for respiratory disease caused by P.multocida and B.bronchiseptica.
Danish: Ansøgeren udførte en kontrolleret, randomiseret hovedundersøgelse, hvor færdigproduktet blev anvendt under feltforhold i to centre, til påvisning af virkningen mod luftvejssygdom forårsaget af P. multocida og B. bronchiseptica.
English: Due to variability in susceptibility of bacteria for doxycycline, use of the product should be based on bacteriological sampling and susceptibility testing or recent experience on the farm.
Danish: Da bakteriers følsomhed over for doxycyclin varierer, bør produktets anvendelse baseres på bakteriologiske prøver og følsomhedsbestemmelse eller på nyere erfaringer fra det pågældende opdræt.
English: WITHDRAWAL PERIOD Meat and offal: 7 days.
Danish: TILBAGEHOLDELSESTID Kød og indvolde: 7 dage.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Doxyprex 100 mg/g Premix
Danish: VETERINÆRLÆGEMIDLETS NAVN Doxyprex 100 mg/g Premix
English: MARKETING AUTHORISATION NUMBER(S)/ MRP PROCEDURE NUMBER
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE)/
English: The recommended dose is 10 mg of doxycycline/kg of body weight/day (equivalent to 1 g of Doxyprex/10 kg of b.w.)
Danish: Den anbefalede dosis er 10 mg doxycyclin/kg kropsvægt/dag (svarende til 1 g Doxyprex/10 kg kropsvægt) i 7 på hinanden følgende dage.
English: Following discussions in the CMD(v), the proposed indication was changed during the course of the MRP to: “For treatment of swine respiratory disease caused by susceptible Pasteurella multocida, Bordetella bronchiseptica and Mycoplasma hyopneumoniae to doxycycline.”
Danish: Efter drøftelser i den veterinærmedicinske gruppe for fremme af gensidig anerkendelse (CMD(v)) blev den foreslåede indikation under den gensidige anerkendelsesprocedure ændret til: "Behandling af luftvejssygdomme hos svin forårsaget af doxycyclin-følsomme stammer af Pasteurella multocida, Bordetella bronchiseptica og Mycoplasma hyopneumoniae".
English: Strength Animal species
Danish: Lægemiddelform Styrke Dyreart
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Doxyprex is presented as yellow granules containing 100 mg of doxycycline base as hyclate per gram of product.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Doxyprex fremtræder som små, gule korn, der indeholder 100 mg doxycyclin base som hyclat pr. gram produkt.
English: Semoline is employed as carrier.
Danish: Semulje anvendes som bærestof.
English: Nature and composition of immediate packaging Containers of 1 kg, 5 kg, 20 kg and 25 kg.
Danish: Pakninger på 1 kg, 5 kg, 20 kg og 25 kg.
English: Absorption of doxycycline may be diminished in the presence of high quantities of Ca, Fe, Mg or Al in the diet. Do not administer together with antacids, kaolin and iron preparations.
Danish: Absorbtionen af doxycyclin kan være formindsket ved tilstedeværelsen af store mængder Ca, Fe, Mg eller Al i kosten.
English: In the practical situation, the premix is usually fed to pigs showing clinical signs and incontact pigs, therefore this active substance is for controlling the clinical signs of disease.
Danish: Under praktiske forhold gives premixen sædvanligvis til svin med kliniske symptomer og de svin, de er i kontakt med.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Doxyprex is presented as yellow granules containing 100 mg of doxycycline base as hyclate per gram of product.
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Doxyprex fremtræder som små, gule korn, der indeholder 100 mg doxycyclin base som hyclat pr. gram produkt.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Danish: TEKSTEN “OPBEVARES´UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for bøn.
English: It is concentrated in liver, kidney, bones and intestine; in this last case it is due to an enterohepatic cycle.
Danish: Det koncentreres i lever, nyre, knogler og tarm.
English: PACKAGE LEAFLET Doxyprex 100 mg/g Premix
Danish: INDLÆGSSEDDEL Doxyprex 100 mg/g Premix
English: For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Danish: Til behandling og forebyggelse af porcin luftvejssygdom forårsaget af Pasteurella multocida og Bordetella bronchiseptica, som er påvirkelig af doxycyclin, når sygdommen er blevet diagnosticeret i besætningen.
English: Withdrawal period
Danish: Opbevaringstid
English: Indications for use, specifying the target species For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Danish: Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til behandling og forebyggelse af porcin luftvejssygdom forårsaget af Pasteurella multocida og Bordetella bronchiseptica, som er påvirkelig af doxycyclin, når sygdommen er blevet diagnosticeret i besætningen.
English: 1 mg Doxyprex/kg feed = 10 mg doxycycline/kg b.w.
Danish: 1 mg Doxyprex/kg foder = 10 mg doxycyclin/kg kropsvægt x 10 x kropsvægt (kg)/daglig foderindtagelse (kg)
English: Deficiencies in the pivotal clinical trial demonstrating efficacy of the product for the treatment of P.multocida and B. bronchiseptica were compensated for by a discussion of the field data in the literature reference provided.
Danish: Ved at foretage en gennemgang af data fra feltundersøgelser i de forelagte litteraturreferencer blev der kompenseret for manglerne i den kliniske hovedundersøgelse til påvisning af produktets virkning til behandling af P. multocida and B. bronchiseptica.
English: Frequency and route of administration
Danish: Doseringshyppighed og indgivelsesvej
English: The CVMP recommendation is to grant the marketing authorisation to Doxyprex 100 mg/g Premix for medicated feeding stuff for pigs the following suggested indication because a positive risk:benefit analysis has been demonstrated and no potential serious risk has been identified.
Danish: Da benefit-risk forholdet er godtgjort at være positivt, og da der er ikke er fundet nogen potentiel alvorlig risiko, anbefaler CVMP udstedelse af markedsføringstilladelse for Doxyprex premix, 100 mg/g, til medicineret foder til svin, idet der foreslås følgende indikation:
English: No dose confirmation studies appear to have been presented the above mentioned study, therefore it is important that the references provided should present robust evidence for the field efficacy of the product.
Danish: Det er derfor vigtigt, at de forelagte referencer giver forsvarlig dokumentation for produktets virkning under feltforhold.
English: SPECIAL STORAGE CONDITIONS Keep out of the reach and sight of children.
Danish: Opbevares utilgængeligt for børn.
English: Incompatibilities
Danish: Væsentlige uforligeligheder
English: Excipients:
Danish: PRODUKTRESUME
English: “For the treatment and prevention of porcine respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to doxycycline, when the disease has been diagnosed in the herd.
Danish: "Behandling og forebyggelse af luftvejssygdomme hos svin forårsaget af følsomme stammer af Pasteurella multocida og Bordetella bronchiseptica, når sygdommen er påvist i besætningen".
English: The product must not be administered more than once.
Danish: Produktet må ikke administreres mere end én gang.
English: Hypersensitivity reactions can occur.
Danish: Overfølsomhedsreaktioner kan forekomme.
English: Poultry 100
Danish: Fjerkræ 100
English: Interactions with other medicinal products and other forms of interaction: None known.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Ingen kendte.
English: If more injections than that are needed, the use of a multiple-dose syringe is recommended.
Danish: Hvis det er nødvendigt med flere injektioner end dette, anbefales brug af en multidosis-sprøjte.
English: Iron (III)
Danish: Jern (III)
English: Shake well (for 20 seconds) before use.
Danish: Omrystes grundigt (i 20 sekunder) inden brug.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after "EXP".
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på æsken efter ”EXP”.
English: Iron is an essential micronutrient.
Danish: Jern er et essentielt mikronæringsstof.
English: The tolerance of the product after repeated administrations has not been assessed.
Danish: Tolerance ved gentagne administrationer er ikke undersøgt.
English: Hygienic measures may reduce the risk of porcine coccidiosis.
Danish: Hygiejniske tiltag kan reducere risikoen for coccidiose hos svin.
English: As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.
Danish: Som for alle antiparasitære lægemidler kan hyppig og gentagen brug af antiprotozo-midler fra samme klasse medføre resistensudvikling.
English: Dark brown suspension.
Danish: Mørkebrun suspension.
English: It is recommended to administer the product to all the piglets in a litter.
Danish: Det anbefales at administrere produktet til alle pattegrise i et kuld.
English: Since iron is recycled in the body little of the absorbed iron is excreted.
Danish: Eftersom jern genanvendes i kroppen, udskilles kun en lille del af det absorberede.
English: The recommended dose should not be exceeded, given the relatively low margin of safety for the veterinary medicinal product.
Danish: Den anbefalede dosis bør ikke overskrides, baseret på den relativt lave sikkerhedsmargen for dette veterinærlægemiddel.
English: Excess iron is stored principally in the liver.
Danish: Overskudsjern oplagres hovedsageligt i leveren.
English: Pregnancy and lactation: Not applicable.
Danish: Drægtighed og laktation: Ikke relevant.
English: The product is recommended in piglets weighing between 0.9 and 3 kg.
Danish: Produktet er anbefalet til pattegrise, der vejer mellem 0,9 og 3 kg.
English: Accidental self-injection may cause local reactions such as irritation, granulomas, or severe anaphylactic reactions in sensitive people.
Danish: Selvinjektion ved hændeligt uheld kan give lokale reaktioner såsom irritation, granulomer eller svære anafylaktiske reaktioner hos følsomme personer.
English: It plays a major role in the transport of oxygen via haemoglobin and myoglobin, as well as having a key role in enzymes, such as cytochromes, catalases, and peroxidases.
Danish: Det har en central rolle i oxygentransport via hæmoglobin og myoglobin og er desuden af stor betydning i enzymer såsom cytochromer, katalaser og peroxidaser.
English: Toltrazuril and toltrazuril sulfone were eliminated slowly with a half-life of 3 days each.
Danish: Toltrazuril og toltrazurilsulfon elimineredes langsomt med en halveringstid på 3 dage hver især.
English: Very small losses occur in the faeces, sweat and urine.
Danish: Der findes meget små mængder i fæces, sved og urin.
English: It is therefore recommended to concomitantly improve the hygiene conditions in the farm concerned, particularly by increasing dryness and cleanliness.
Danish: Det anbefales derfor at forbedre de hygiejniske forhold sideløbende i den gældende besætning, især med hensyn til rengøring og udtørring.
English: For porcine species the fat MRL relates to ‘skin and fat in natural proportions'.
Danish: For alle arter af svinefamilien relaterer MRL-værdi for fedtvæv sig til 'fedt og hud i naturlige proportioner'.
English: Therefore, the product should be administered to all animals before the expected onset of clinical signs, that is, in the prepatent period.
Danish: Derfor bør alle dyr behandles, før der forventes udbrud af kliniske symptomer, dvs. i præpatensperioden.
English: Pigs (piglets 24 to 96 hours after birth)
Danish: Svin (pattegrise 24 til 96 timer efter fødsel)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/04/2019
Danish: Dato for første markedsføringstilladelse: 23/04/2019
English: Toltrazuril is a triazinon derivative and an antiprotozoal agent.
Danish: Toltrazuril er et triazinon-derivat og antiprotozo-middel.
English: Once clinical signs of coccidiosis are evident, damage to the small intestine will have already occurred.
Danish: Når kliniske symptomer på coccidiose er tilstede, vil der allerede være sket skade på tyndtarmen.
English: 4.7 Use during pregnancy or lactation
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning
English: Piglet deaths have been reported which have been attributed to an increased susceptibility to infection due to temporary blocking of the reticuloendothelial system.
Danish: Der er rapporteret om dødsfald hos pattegrise, som er blevet sammenkædet med øget modtagelighed for infektioner grundet midlertidig blokering af det retikuloendotheliale system.
English: Pregnant women and women intending to conceive should avoid contact with the veterinary medicinal product, especially accidental self-injection.
Danish: Gravide kvinder og kvinder, der ønsker at blive gravide, bør undgå kontakt med dette veterinærlægemiddel, i særdeleshed selvinjektion ved hændeligt uheld.
English: Deaths have been reported very rarely in piglets following the administration of parenteral iron injections.
Danish: Der er meget sjældent rapporteret dødsfald hos pattegrise efter parenteral injektion med jern.
English: Not for use in animals from which eggs are produced for human consumption.
Danish: Må ikke anvendes til dyr hvis æg produceres til konsum.
English: These deaths have been associated with genetic factors or deficiencies of vitamin E and/or selenium.
Danish: Disse dødsfald er blevet associeret med genetiske faktorer eller E-vitamin- og/eller selen-mangel.