FrancophonIA/ELRC3.0 huggingface dataset:
English: Formed from a polyester/polyethylene/aluminium/polyethylene or a polyester/ polyethylene/aluminium/ionomer laminate.
Danish: Fremstillet af et laminat af polyester/polyethylen/aluminium/polyethylen eller polyester/polyethylen/aluminium/ionomer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Udfyldes nationalt
English: The Marketing Authorisation Holder was requested to submit data to support the target species and indications in pigs.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at fremsende data til støtte for de dyrearter, som lægemidlet er beregnet til, og indikationer for svin.
English: None.
Danish: Ingen
English: These antibiotics have a broad spectrum of antimicrobial activity, sharing the same basic structure of polycyclic naphthacenecarboxamide.
Danish: Disse antibiotika har en bredspektret antimikrobiel aktivitet og har den samme grundlæggende struktur som polycyklisk naphthacencarboxamid.
English: Shelf-life after dilution or reconstitution according to directions: After reconstitution with water any product remaining after 24 hours should be discarded.
Danish: Opbevaringstid efter fortynding eller rekonstituering ifølge anvisning: Efter rekonstituering med vand skal eventuelt resterende produkt kasseres efter 24 timer.
English: Significantly no cross resistance was observed between oxytetracycline and doxycycline.
Danish: Det er værd at bemærke, at der ikke blev observeret nogen krydsresistens mellem oxytetracyclin og doxycyclin.
English: Cross resistance between tetracyclines has also been described.
Danish: Der har også været beskrevet krydsresistens mellem tetracycliner.
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: Eftersom det ikke er sikkert, at der kan opnås en fuldstændig udryddelse af målpatogenet, skal medicineringen kombineres med god håndteringspraksis, dvs. god hygiejne, passende ventilation og ingen ovebelægning.
English: It is advised that the interval between the administration of other products containing polyvalent cations should be 1-2 hours because they limit the absorption of tetracyclines.
Danish: Det anbefales, at der holdes en pause på 1-2 timer efter indgivelse af andre produkter, der indeholder polyvalente kationer, da disse begrænser optagelsen af tetracycliner.
English: Shelf-life after first opening the packaging: 9 months.
Danish: Opbevaringstid efter første åbning af den indre emballage: 9 måneder.
English: - Eggs: Not authorised for use in laying birds producing eggs for human consumption.
Danish: - Æg: Må ikke anvendes til æglæggende fugle, hvis æg er bestemt til menneskeføde.
English: Use of the product should be based on culture and sensitivity of micro-organisms from diseased cases on farm.
Danish: Brug af produktet skal baseres dyrkning af mikroorganismer fra sygdomstilfælde på gården og disses følsomhed.
English: In the absence of specific studies the use of the product is not recommended during pregnancy or lactation.
Danish: Da der ikke foreligger specifikke undersøgelser, frarådes det at anvende produktet under drægtighed eller laktation.
English: High levels of resistance to tetracyclines in swine respiratory pathogens have been documented (ARBAO-II study, 2008)6.
Danish: Der er dokumenteret høje resistensniveauer over for tetracyclin i luftvejspatogener hos svin (ARBAO-II study, 2008)6.
English: Do not use within 4 weeks of onset of the laying period.
Danish: Må ikke anvendes inden for 4 uger forud for æglægningsperiodens begyndelse.
English: Inhibition of bacterial protein synthesis results in disturbance of all functions necessary for the life of bacteria.
Danish: Når bakteriens proteinsyntese hæmmes, resulterer det i en forstyrrelse af samtlige de funktioner, der er nødvendige for bakteriens overlevelse.
English: Discussion of data available
Danish: Drøftelse af de foreliggende data
English: The majority of the data quoted related to tetracycline resistance generally, and it was noted that resistance to doxycycline specifically was less commonly documented.
Danish: Størstedelen af de anførte data var relateret til tetracyclinresistens i almindelighed, og det blev bemærket, at resistens over for specifikt doxycyclin var mindre hyppigt dokumenteret.
English: At the time of the Article 35 referral, there was no documented evidence in relation to suspected lack of expected efficacy of doxycycline products in chickens.
Danish: På tidspunktet for indbringelsen i henhold til artikel 35 var der ingen dokumentation i forbindelse med formodning om manglende forventet virkning af doxycyclin-lægemidler hos kyllinger.
English: If suspected adverse reactions occur, treatment should be discontinued.
Danish: Hvis der opstår mistanke om bivirkninger, skal behandlingen seponeres.
English: LABEL TEXT SINGLE SACHETS/BAGS
Danish: ETIKETTERINGSTEKST ENKELTBREVE/-POSER
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 recommends the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxyfar 50 % 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; anbefaler CVMP ændringen af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Doxyfar 50% og relaterede navne (se bilag I).
English: In addition, in the absence of any adverse pharmacovigilance data indicating suspected lack of expected efficacy, it is considered that revision of the dose rate and regimen is not justified.
Danish: Da der desuden ikke foreligger nogen uønskede lægemiddelovervågningsdata, der indikerer formodning om manglende forventet virkning, vurderes det, at revision af dosisrate og doseringsregimen ikke er berettiget.
English: If you notice any serious effects or other effects not mentioned in this product information, please inform your veterinary surgeon or pharmacist.
Danish: Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes De kontakte Deres dyrlæge.
English: To be completed nationally
Danish: Udfyldes nationalt
English: Do not store the drinking water in metallic containers.
Danish: Drikkevandet må ikke opbevares i metalbeholdere.
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: Liste over veterinærlægemidlernes navne, lægemiddelform, styrker, dyreart, indgivelsesvej og indehavere af markedsføringstilladelse i medlemsstaten
English: However, it is accepted that levels of resistance to tetracyclines reported in literature cannot be directly extrapolated to doxycycline, and that the greater liposolubility of doxycycline may explain why in vitro susceptibility of organisms has been maintained despite the emerging resistance to tetracycline.
Danish: Det accepteres dog, at resistensniveauer over for tetracyclin rapporteret i litteraturen ikke direkte kan ekstrapoleres til doxycyclin, og at doxycyclins højere fedtopløselighed måske forklarer, hvorfor organismernes in vitro-følsomhed er blevet opretholdt trods den begyndende resistens over for tetracyclin.
English: Compared to the older tetracyclines the absorption of doxycycline is less affected by the presence of bivalent cations in food.
Danish: Sammenlignet med de ældre tetracycliner påvirkes absorptionen af doxycyclin mindre af tilstedeværelsen af bivalente kationer i foderet.
English: The chicken residue depletion data submitted allowed the setting of meat withdrawal periods in chickens.
Danish: De fremsendte restkoncentrationsdata for kyllinger muliggjorde fastsættelse af tilbageholdelsestider for kyllinger.
English: EXPIRY DATE EXP {month/year}; 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 efter EXP.
English: The precautions to limit the development of resistance, which were recommended by CVMP during the Article 35 referral, have been included in section 4.5 of the SPC.
Danish: Foranstaltninger til risikostyring eller -afhjælpning De forholdsregler til begrænsning af udviklingen af resistens, som blev anbefalet af CVMP under indbringelsen i henhold til artikel 35, er blevet medtaget i punkt 4.5 i produktresuméet.
English: Take measures to avoid producing dust when incorporating the product into water.
Danish: Tag forholdsregler med henblik på at undgå støvdannelse under opblanding af produktet med vand.
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)4.
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)4.
English: In case of severe infections the medication period may be prolonged for a maximum of 8 consecutive days as determined by the attending veterinary surgeon.
Danish: I tilfælde af alvorlige infektioner kan medicineringsperioden forlænges i højst 8 på hinanden følgende dage efter den behandlende dyrlæges skøn.
English: Belgium Eurovet N.V. Poorthoevestraat 4, 3 550 Heusen-Zolder Belgium
Danish: Poorthoevestraat 4, 3 550 Heusen-Zolder Belgien
English: The Marketing Authorisation Holder submitted a body of literature references which supported a prediction that when administered at the proposed dose rate, doxycycline concentration in the relevant tissues would exceed the MIC for most target pathogens.
Danish: Indehaveren af markedsføringstilladelsen fremsendte en række litteraturreferencer, som understøttede den forudsigelse, at når doxycyclin indgives med den foreslåede dosishastighed, vil koncentrationen i de relevante væv overstige MIC, hvad angår de fleste målpatogener.
English: Pigs and chicken
Danish: Svin and Kyllinger
English: Administration orally with the drinking water.
Danish: Administreres oralt med drikkevandet.
English: In addition the Marketing Authorisation Holder submitted Periodic Safety Update Report (PSUR) data which indicated that no adverse events in chickens, including suspected lack of expected efficacy, has been reported for the past 5 years in the European Union.
Danish: Derudover fremsendte indehaveren af markedsføringstilladelsen periodiske sikkerhedsopdateringsdata (PSUR), som viste, at der ikke var blevet rapporteret nogen bivirkninger hos kyllinger, herunder formodning om manglende forventet virkning, i de seneste 5 år i Den Europæiske Union.
English: Excipients: For a full list of excipients, see section 6.1
Danish: Hjælpestoffer: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Poultry tolerate double overdoses of doxycycline (40 mg/kg body weight) without any clinical effect.
Danish: Fjerkræ tåler dobbelt overdosering af doxycyclin (40 mg/kg kropsvægt) uden nogen klinisk effekt.
English: There have been no reports of adverse events in pigs, including suspected lack of expected efficacy, during the last 5 years.
Danish: Der har ikke været nogen rapporter om bivirkninger hos svin, herunder formodning om manglende forventet virkning, i løbet af de sidste 5 år.
English: Composition per gram product Active Substance:
Danish: Sammensætning per gram af produktet Aktivt stof:
English: Doxyfar 50 % and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g.
Danish: Doxyfar 50% og relaterede navne er et pulver til anvendelse i drikkevand, der indeholder det aktive stof doxycyclinhyclat 500 mg/g.
English: Interactions with other medicinal products and other forms of interaction Do not combine with antibiotics that are bactericidal like penicillins or cephalosporins.
Danish: Interaktion med andre lægemidler og andre former for interaktion Må ikke kombineres med bakteriocide antibiotika f.eks. penicilliner eller cefalosporiner.
English: Solubility of the product is pH dependent and it may precipitate if it is mixed in hard alkaline drinking water.
Danish: Produktets opløselighed er pH-afhængig, og det kan præcipitere, hvis det blandes i hårdt, alkalisk drikkevand.
English: From 24 h up to 96 h after start of treatment the doxycycline plasma concentrations exceeded 2 µg/ml.
Danish: Fra 24 timer op til 96 timer efter påbegyndelse af behandling, oversteg doxycyclinkoncentrationen i plasma 2 µg/ml.
English: The main sections of disharmony of the existing SPCs were:
Danish: De områder, der især er uenighed om i de eksisterende produktresuméer, er:
English: Wear impermeable gloves (e.g. rubber or latex) and an appropriate dust mask (e.g. disposable half-mask respirator conforming to European Standard EN149) when applying the product.
Danish: Brug uigennemtrængelige handsker (f.eks. gummi eller latex) og en egnet støvmaske (f.eks. en filtrerende engangshalvmaske i henhold til EN 149) ved håndtering af produktet.
English: • the CVMP considered that the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet;
Danish: • CVMP var af den opfattelse, at formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen;
English: LABELLING 10 x 100 g
Danish: ETIKETTERING 10 x 100 g
English: Based on the dose to be used, and the number and weight of the animals to be treated, the exact daily amount of product can be calculated.
Danish: Den nøjagtige daglige produktmængde kan beregnes baseret på den anvendte dosis og antallet af dyr, der skal behandles, og disses vægt.
English: It was agreed that the target species should be harmonised across all Member States where the product is authorised or pending authorisation and in consistency with the recent Article 35 harmonisation as “chickens (broiler, pullet, breeder)”, and the following indications for Doxyfar 50% and associate names were agreed:
Danish: Det blev vedtaget, at de dyrearter, som lægemidlet er beregnet til, burde harmoniseres i alle medlemsstater, hvor lægemidlet er godkendt eller afventer godkendelse, og i overensstemmelse med den nylige harmonisering i henhold til artikel 35 som "kyllinger (slagtekyllinger, unghøns, avlshøns)" blev følgende indikationer for Doxyfar 50% og relaterede navne vedtaget:
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be administered orally in the drinking water.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til oral administration i drikkevandet.
English: Inform your veterinary surgeon if adverse reactions occur that are not stated.
Danish: Fortæl det til dyrlægen, hvis der opstår bivirkninger, som ikke er nævnt her.
English: Respiratory tract tissue: plasma ratios of 1.3 (healthy lungs), 1.9 (pneumonic lungs) and 2.3 (nasal mucosa) have been reported for doxycycline.
Danish: Luftvejsvæv: Plasmakoncentrationer på 1,3 (rask lunge), 1,9 (betændt lunge) og 2,3 (nasal slimhinde) er rapporteret for doxycyclin.
English: Additional information has been added to the SPC regarding mechanisms of resistance to tetracyclines in general.
Danish: Der er tilføjet yderligere information til produktresuméet vedrørende resistensmekanismer over for tetracycliner generelt.
English: Pharmacotherapeutic group: Antibacterial - Tetracycline.
Danish: FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Antibakterielle midler - tetracyclin.
English: There have been no reports of adverse events, including suspected lack of expected efficacy of the product in pigs in the Periodic Safety Update Report data covering the period of the last 5 years.
Danish: Der har ikke været nogen rapporter om bivirkninger, herunder formodning om manglende forventet virkning, af lægemidlet hos svin i de periodiske sikkerhedsopdateringsdata, der dækker perioden for de seneste 5 år.
English: Doxycycline is bacteriostatic and acts by inhibiting protein synthesis intracellularly by binding to the 30-S subunit of the bacterial ribosome.
Danish: Doxycyclin er bakteriostatisk og virker ved at hæmme proteinsyntesen intracellulært ved at binde sig til 30-S-subunitten i bakterieribosomet.
English: DATE OF REVISION OF THE TEXT To be completed nationally
Danish: DATO FOR ÆNDRING AF TEKSTEN Udfyldes nationalt
English: In human medicine, doxycycline is the treatment of choice for the treatment of acute tracheobronchitis, acute bronchitis and acute bronchiolitis caused by primary bacterial infections (Mycoplasma pneumoniae, Chlamydia pneumoniae) and bacterial superinfections (Pneumococci, Haemophilus spp.).
Danish: I medicin til mennesker er doxycyclin det første valg til behandling af akut trakeobronkitis, akut bronkitis og akut bronkiolitis forårsaget af primære bakterieinfektioner (Mycoplasma pneumoniae, Chlamydia pneumoniae) og bakterielle superinfektioner (Pneumococci, Haemophilus spp.).
English: Prescription only medicine - To be completed nationally.
Danish: Må kun udleveres efter veterinærrecept - udfyldes nationalt.
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 doxycyclins større lipidopløselighed og bedre evne til at passere gennem cellemembranen (sammenlignet med tetracyclin) bibeholder det en vis effekt over for mikroorganismer med erhvervet resistens over for tetracycliner.
English: Doxycycline has a low affinity for forming complexes with calcium and studies have demonstrated that doxycycline scarcely affects skeleton formation.
Danish: Doxycyclin har lav kompleksdannende affinitet med calcium, og undersøgelser har vist, at doxycyclin kun har minimal indvirkning på skeletdannelsen.
English: Bousquet et al. 19973 provides evidence of minimum inhibitory concentrations (MICs) of doxycycline against: P. multocida of 0.13 - 2.0 µg/ml (55 strains), A. pleuropneumoniae 0.25 - 2.0 µg/ml (59 strains), M. hyponeumoniae 0.016 - 2 µg/ml (26 strains).
Danish: Bousquet et al. 19973 leverer dokumentation for mindste hæmmende koncentrationer (MIC'er) af doxycyclin mod: P. multocida på 0,13 - 2,0 µg/ml (55 stammer), A. pleuropneumoniae 0,25 - 2,0 µg/ml (59 stammer), M. hyponeumoniae 0,016 - 2 µg/ml (26 stammer).
English: For the treatment of P. multocida, a dosage regimen of 10 mg/kg body weight for 4 or 5 days was agreed.
Danish: Til behandling af P. multocida blev en dosering på 10 mg/kg kropsvægt i 4 eller 5 dage vedtaget.
English: Doxycycline is scarcely metabolised.
Danish: Doxycyclin metaboliseres stort set ikke.
English: PACKAGE SIZE 100 g (250 g, 500 g, 1 kg)
Danish: PAKNINGSSTØRRELSE 100 g (250 g, 500 g, 1 kg)
English: Benefit Assessment
Danish: Benefit-vurdering
English: The following indications for Doxyfar 50% and associate names were agreed:
Danish: Følgende indikationer for Doxyfar 50% og relaterede navne blev vedtaget:
English: The solubility of the product is pH dependent and will precipitate if mixed in alkaline solution.
Danish: Produktets opløselighed er pH-afhængig, og det præcipiterer, hvis det blandes i en alkalisk opløsning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON 10 X 100 GRAM only
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON, kun 10 X 100 GRAM
English: Doxycycline increases the action of anticoagulants.
Danish: Doxycyclin forstærker virkningen af antikoagulantia.
English: The following recommended dose for Doxyfar 50% and associate names was agreed:
Danish: Følgende anbefalede dosis for Doxyfar 50% og relaterede navne blev vedtaget:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Aluminium Foil Sachet 100g (packed per 10)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Aluminiumsfoliebrev 100 g (pakning med 10)
English: Risk Assessment
Danish: Risikovurdering
English: SPECIAL STORAGE CONDITIONS This veterinary medicinal product does not require any special storage conditions.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Mean daily water consumption (l) per animal
Danish: kropsvægt (kg) på de dyr, der skal behandles Gennemsnitligt vandforbrug (l) per dyr
English: Do not use in case of hypersensitivity to the active substance or to any of excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne.
English: Following oral administration at a dose of 12.8 mg/kg body weight, steady state concentrations during medication range between a Cmin of 0.40 µg/ml in the early morning to a Cmax of 0.87 µg/ml in the late afternoon in pigs.
Danish: Efter administration af en oral dosis på 12,8 mg/kg kropsvægt ligger steady state-koncentrationen under medicinering i området fra et Cmin på 0,40 µg/ml tidligt om morgenen til et Cmax på 0,87 µg/ml sent om eftermiddagen hos svin.
English: Data were provided in support of the indication for P. multocida at a dose of 10 mg doxycycline hyclate per kg body weight per day.
Danish: Der blev fremlagt data til støtte for en indikation for P. multocida med en dosis på 10 mg doxycyclinhyclat pr. kg kropsvægt pr. dag.
English: Prescription only medicine (or similar wording, national issue)
Danish: Må kun udleveres efter veterinærrecept (eller tilsvarende tekst, udfyldes nationalt).
English: Member State EU/EEA
Danish: Medlemsstat/EEA Indehaver af markedsførings-tilladelsen
English: It was identified at the time of the Article 35 referral for water soluble powders and oral solutions containing doxycycline hyclate that a high resistance rate to tetracyclines existed in E. coli isolated from chickens (De Jong et al, 2009)5.
Danish: På tidspunktet for indbringelsen i henhold til artikel 35 af vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat, blev det identificeret, at der forelå en høj resistensrate for E. coli, isoleret fra kyllinger, over for tetracycliner (De Jong et al, 2009)5.
English: Doxycycline is primarily a bacteriostatic drug.
Danish: Doxycyclin er primært et bakteriostatisk lægemiddel.
English: Solubility of doxycycline is pH dependent.
Danish: Doxycyclins opløselighed er pH-afhængig.
English: Powder for use in drinking water
Danish: Pulver til brug i drikkevand
English: Special precautions for use in animals Read the package leaflet before use.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Læs indlægssedlen inden brug.
English: On the basis of well established use and absence of data for suspected lack of expected efficacy the dose regimen for infections caused by P. multocida of 10 mg doxycycline hyclate per kg body weight for 3 to 4 consecutive days and for infections caused by O. rhinotracheale of 20 mg doxycycline hyclate per kg body weight for 3 to 4 consecutive days were considered acceptable.
Danish: På baggrund af veldokumenteret brug, og i mangel af data om formodning om manglende forventet virkning, blev doseringen for infektioner forårsaget af P. multocida på 10 mg doxycyclinhyclat pr. kg kropsvægt i 3 til 4 på hinanden følgende dage og for infektioner forårsaget af O. rhinotracheale på 20 mg doxycyclinhyclat pr. kg kropsvægt i 3 til 4 på hinanden følgende dage anset for at være acceptable.