FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: antibacterials for systemic use, lincomycin combinations.
Danish: Farmakoterapeutisk gruppe: antibakterica til systemtisk brug, lincomycin, kombinationer ATCvet-kode: QJ01FF52
English: However, no precise clinical breakpoint has been established and from the data provided it seems that in vitro susceptibility was not correlated to clinical efficacy.
Danish: afskæringspunkt, og de forelagte data viser ikke, at in vitro-følsomheden er korreleret med den kliniske virkning.
English: Meat and offal: 5 days.
Danish: Slagtning: 5 dage.
English: Store in a dry place.
Danish: Opbevares tørt.
English: Use of the product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to lincomycin and spectinomycin and may decrease the effectiveness of treatment with other antimicrobials of the same or related classes, due to the potential for cross resistance.
Danish: Anvendelse af veterinærlægemidlet, der afviger fra instruktionerne i produktresuméet, kan forøge risikoen for udvikling af resistente bakterier over for lincomycin og spectinomycin og kan nedsætte den effektive virkning af behandling med andre antibiotika af samme eller lignende typer på grund af risikoen for krydsresistens.
English: MARKETING AUTHORISATION HOLDER To be completed nationally.
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt.
English: PHARMACEUTICAL FORM Powder for use in drinking water.
Danish: LÆGEMIDDELFORM Pulver til anvendelse i drikkevand.
English: Chickens:
Danish: Kyllinger:
English: Also, information as to widespread decreased susceptibility in B. hyodysenteriae and as to the bimodal distribution in E. coli should be added to section 5.1.
Danish: Desuden bør der i punkt 5.1 Farmakodynamiske egenskaber indsættes oplysninger om udbredt nedsat følsomhed af B. hyodysenteriae og om den bimodale fordeling hos E. coli.
English: This powder is for use in drinking water and must be dissolved in water and cannot be used as such.
Danish: Dette pulver er til anvendelse i drikkevand og skal opløses i vand.
English: Spectinomycin exhibits little tendency to protein binding and is poorly liposoluble.
Danish: Spectinomycin har en lav tendens til proteinbinding og har en ringe fedtopløselighed.
English: Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro, and data about the resistance status in that species are lacking.
Danish: På grund af tekniske begrænsninger er det vanskeligt at teste følsomheden af Lawsonia intracellularis in vitro og der er ingen data for status af resistens hos disse arter.
English: Poultry: For dosing via the drinking water.
Danish: Fjerkræ: Til dosering i drikkevand.
English: Therefore, even though no evolution over time appears from the provided literature data, it cannot be excluded that the results obtained in the old clinical studies conducted at the time of product development do not reflect clinical efficacy in modern outbreaks of swine dysentery.
Danish: Skønt der ikke ses nogen negativ tendens i de forelagte litteraturdata, kan det derfor ikke udelukkes, at resultaterne fra de ældre kliniske undersøgelser, der blev udført under produktets udvikling, ikke afspejler den kliniske virkning ved nutidige udbrud af svinedysenteri.
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally.
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) Udfyldes nationalt.
English: Pigs and poultry (nonlayers)
Danish: Svin og fjerkræ (bortset fra læggehøns)
English: Lincomycin and spectinomycin were shown to be more effective than each individual substance.
Danish: Lincomycin og spectinomycin blev påvist at være mere effektive i kombination end som monoterapi.
English: The most frequent dosing recommendation for treatment is 50 mg/kg bw/day; few SPCs recommend 150 mg/kg bw and some other ones give only a concentration in water, which corresponds approximately to 50 mg/kg bw.
Danish: I enkelte produktresuméer anbefales 150 mg/kg kropsvægt, og i visse andre angives kun en koncentration i vandet tilnærmelsesvis svarende til 50 mg/kg kropsvægt.
English: MARKETING AUTHORISATION NUMBER(S) To be completed nationally
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) Udfyldes nationalt
English: The mechanism by which spectinomycin administered orally acts on pathogens at the systemic level despite a poor absorption is not fully elucidated, and might rely partly on indirect effects on the gut flora, or on effects of metabolite(s).
Danish: Trods ringe absorption er virkningsmekanismen af peroralt administreret spectinomycin over for patogene bakterier på systemisk niveau ikke fuldstændig klarlagt og kan muligvis delvist skyldes virkning på tarmfloraen eller virkning på metabolit(ter).
English: Pigs Poultry
Danish: Svin Kyllinger
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Udfyldes nationalt.
English: Poultry (broilers, pullets and turkeys)
Danish: Fjerkræ (slagtekyllin ger, unghøner og kalkuner)
English: This study was the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Danish: Denne undersøgelse var den eneste formelle påvisning af fordelene ved doseringen på 50 mg/kg kropsvægt, og den opnåede belastning var kun let til moderat uden observeret dødelighed.
English: Pigs: Meat and offal: Zero days.
Danish: Svin: Slagtning: 0 dage.
English: the CVMP has recommended the amendment of the marketing authorisations for Linco-Spectin 100 and its associated names as referred in Annex I for which the summary of product characteristics, labelling and package leaflet are set out in Annex III.
Danish: • CVMP gennemgik det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren af markedsføringstilladelsen, og tog alle de forelagte data i betragtning, anbefalede CHMP ændring af de markedsføringstilladelser for Linco-Spectin 100 og relaterede navne, som er angivet i bilag I. Produktresumé, etikettering og indlægsseddel for disse fremgår af bilag III.
English: Disposal: read package leaflet.
Danish: Bortskaffelse: se indlægssedlen
English: For those reasons, despite that the available data show no negative evolution over time, it could not be excluded that the results obtained in the old clinical studies conducted at the time of product development do not reflect clinical efficacy in modern outbreaks of swine dysentery.
Danish: Skønt de foreliggende data ikke viser tendens til negativ udvikling, kan det af disse grunde ikke udelukkes, at resultaterne af de ældre kliniske undersøgelser fra produktets udvikling ikke afspejler den kliniske virkning under et nutidigt udbrud af svinedysenteri.
English: This study is the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Danish: Denne undersøgelse er den eneste formelle påvisning af fordelen ved doseringen på 50 mg/kg kropsvægt, og den opnåede belastning var kun let til moderat, og uden observeret dødelighed.
English: For the treatment and prevention of dysentery caused by Brachyspira hyodysenteria and for the treatment and prevention of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli).
Danish: Til behandling og forebyggelse af dysenteri forårsaget af Brachyspira hyodysenteria og til behandling og forebyggelse af porcin proliferativ enteropati (ileitis) forårsaget af Lawsonia intracellularis samt associerede enteropatogener (Escherichia coli).
English: Oral powder for use in drinking water
Danish: Pulver til oral anvendelse i drikkevand
English: Repeated dosing of pigs with daily oral doses of 22 mg lincomycin/kg body weight for 3 days indicated no accumulation of lincomycin in the species, with no detectable serum levels of antibiotic after 24 hours post administration.
Danish: Gentagne doser til svin med daglige orale doser på 22 mg lincomycin/kg legemsvægt i 3 dage indikerede ingen lincomycinakkumulation hos arterne.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg and tub containing 4.5 kg
Danish: Flasker med 150 g eller 1,5 kg og et kar med 4,5 kg
English: Older field studies typically used a dose regimen of 150 mg/kg bw in a first phase followed by 50 mg/kg bw in a second phase; they were considered poorly relevant as they focus on systematic prophylaxis and zootechnical/economical endpoints.
Danish: I ældre feltundersøgelser anvendtes typisk et dosisregime på 150 mg/kg kropsvægt i første fase, efterfulgt af 50 mg/kg kropsvægt i anden fase.
English: Due to technical constraints the susceptibility of L. intracellularis is difficult to test in vitro, and data about the lincomycin-spectinomycin resistance status in that species are lacking.
Danish: På grund af tekniske begrænsninger er det vanskeligt at teste følsomheden af L. intracellularis in vitro og der er ingen data for status af lincomycin-spectinomycin-resistens hos disse arter.
English: Meat and offal: Zero days.
Danish: Slagtning: 0 dage.
English: Lincomycin (as lincomycin hydrochloride)
Danish: Lincomycin (som lincomycinhydrochlorid)
English: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium
Danish: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgien
English: TARGET SPECIES Pigs and chickens
Danish: DYREARTER Svin og kyllinger
English: While the lincosamides are generally considered to be bacteriostatic agents, the activity is depending on the sensitivity of the organism and concentration of the antibiotic.
Danish: Deres virkning afhænger af organismens følsomhed og koncentrationen af antibiotikummet.
English: PHARMACEUTICAL FORM Powder for use in drinking water
Danish: LÆGEMIDDELFORM Pulver til anvendelse i drikkevand
English: Slovenia Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Danish: Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgien
English: Pharmacokinetic particulars
Danish: Farmakokinetiske egenskaber
English: Do not use in birds in lay.
Danish: Må ikke anvendes til æglæggende fugle.
English: Taking into account the scope of this Article 34 referral procedure, the proposed indication for L. intracellularis in pigs was deemed acceptable.
Danish: Den ansøgte indikation til L. intracellularis hos svin kunne godtages i betragtning af området for denne artikel 34-indbringelsesprocedure.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
Danish: VETERINÆRLÆGEMIDLETS NAVN <Lægemidlets særnavn > 222 mg/g + 444,7 mg/g pulver til anvendelse i drikkevand til svin og kyllinger
English: Germany Zoetis Deutschland GmbH Schellingstraße 1,
Danish: Zoetis Deutschland GmbH Schellingstraße 1, D-10785 Berlin Tyskland
English: For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
Danish: Til behandling og forebyggelse af kronisk respiratorisk sygdom (CRD) forårsaget af Mycoplasma gallisepticum og Escherichia coli og forbundet med lav dødelighed.
English: Benefit-Risk assessment
Danish: Benefit/risk-vurdering
English: The proposed withdrawal time of 0 days was well supported by a residue study where pigs were treated using the proposed harmonised dosing regimen 10 mg/kg bw/day for 7 days, and is considered acceptable by the CVMP.
Danish: CVMP kunne godtage den ansøgte tilbageholdelsestid på 0 dage, der var velunderbygget med en restkoncentrationsundersøgelse, hvor svin blev behandlet med det ansøgte harmoniserede dosisregime 10 mg/kg kropsvægt/dag i 7 dage.
English: In a newly provided GCP challenge study the product used at 50 mg/kg bw/day for 7 days was shown to be effective in reducing clinical signs, lesions and bacteriological re-isolation associated to E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high, with a non-statistically significant reduction for E. coli, and the MIC of the infective strains was low when compared to most field strains.
Danish: I en ny GCP-belastningsundersøgelse blev produktet anvendt i en dosering på 50 mg/kg/dag i 7 dage og var effektivt til at reducere kliniske tegn, forandringer og bakteriologisk reisolation ved eksperimentel infektion med E. coli og/eller M. gallisepticum hos kyllinger.
English: Poultryhens, chickens and turkeys
Danish: Fjerkræhøner, kyllinger og kalkuner
English: PACKAGE LEAFLET FOR: <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
Danish: INDLÆGSSEDDEL TIL: <Lægemidlets særnavn > 222 mg/g + 444,7 mg/g pulver til anvendelse i drikkevand til svin og kyllinger
English: The presence of the disease in the flock must be established before the product is used.
Danish: Det skal klarlægges, om sygdommen er til stede i besætningen, inden lægemidlet anvendes.
English: Chickens Turkeys Duck Pigeon
Danish: Svin Kyllinger Kalkuner Ænder Duer
English: 1,500 L of drinking water
Danish: 1.500 l drikkevand
English: 2,500 L of drinking water
Danish: 2.500 l drikkevand
English: Soluble Powder Pigs Poultry (nonlayers)
Danish: Opløseligt pulver Svin Fjerkræ (bortset fra læggehøns)
English: SPECIAL STORAGE PRECAUTIONS
Danish: 6.4 Særlige opbevaringsforhold
English: In chickens, in order to reflect the fact that in the only study formally demonstrating efficacy of the 50 mg/kg dose against CRD clinical signs and lesions, the challenge was mild to moderate with no mortality recorded, it is proposed to amend the indication as follows:
Danish: For kyllinger foreslås indikationen ændret som følger for at afspejle, at der kun var tale om let til moderat belastning uden dødelighed i den eneste undersøgelse, der formelt påviser virkning af 50 mg/kg dosen mod de kliniske tegn og forandringer ved kronisk luftvejsinfektion:
English: Powder for oral solution.
Danish: Pulver til oral opløsning.
English: To determine the volume of dilution (in litres of drinking water) for 150 g of the veterinary medicinal product, use the following formula:
Danish: Anvend følgende beregning til bestemmelse af fortyndingsvolumenet (i liter af drikkevand) til 150 g veterinærlægemiddel:
English: “For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
Danish: “Behandling og forebyggelse af kronisk luftvejssygdom forårsaget af Mycoplasma gallisepticum og Escherichia coli forbundet med lav dødelighed.
English: Soluble powder Pigs Chickens
Danish: Opløseligt pulver Svin Kyllinger
English: Poultry (broilers)
Danish: Kyllinger (slagtekyllin ger)
English: 2,000 L of drinking water
Danish: 2.000 l drikkevand
English: To determine the volume of dilution (in litres of drinking water) required for 150 g of the veterinary medicinal product, use the following formula:
Danish: Anvend følgende beregning til bestemmelse af påkrævet fortyndingsvolumen (i liter af drikkevand) til 150 g veterinærlægemiddel:
English: Although the mechanism of action at the systemic level of spectinomycin administered orally is not elucidated, its clinical benefit and the benefit of the combination seems to be demonstrated in several older laboratory challenge studies; however, the dosing regimens applied in these studies can only be estimated and likely range from the harmonised dose of 50 mg/kg bw/day to at least the highest approved dose of 150 mg/kg bw/day.
Danish: Doseringsregimerne i disse undersøgelser kan dog kun anslås skønsmæssigt og spænder antagelig fra den harmoniserede dosis på 50 mg/kg kropsvægt/dag til mindst den højeste godkendte dosis på 150 mg/kg kropsvægt/dag.
English: * All modern authors appear to agree that there is widespread resistance of B. hyodysenteriae to lincomycin, although there is no clinical breakpoint available and it is not known to which extent strains with increased MICs are clinically resistant;
Danish: hyodysenteriae over for lincomycin, skønt der ikke findes nogen klinisk tærskelværdi, og det ikke vides, i hvilket omfang bakteriestammer med forhøjet MIC-værdi er klinisk resistente.
English: Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides; it inhibits protein synthesis by binding to the 30S ribosomal subunit.
Danish: Spectinomycin er klassificeret som et aminocyclitol-antibiotikum nært beslægtet med aminoglykosider.
English: 1,000 L of drinking water
Danish: 1.000 l drikkevand
English: Poultry, not eggs for human consumptio n oral
Danish: Fjerkræ, bortset fra æg, der er bestemt til menneskefø de
English: Lay:
Danish: Æglægning:
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For use in drinking water.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG
English: Water consumption
Danish: Vandindtagelse
English: In a newly provided GCP-compliant challenge study the product used at 50 mg/kg/day for 7 days was shown to be effective in reducing clinical signs and lesions associated with E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high - and its reduction was non statistically significant for E. coli - and the MIC values of the infective strains were at the very lower end of the range determined in the MIC surveys.
Danish: I en nyligt forelagt GCPoverensstemmende belastningsundersøgelse blev produktet anvendt i en dosering på 50 mg/kg/dag i 7 dage og var effektivt til at reducere kliniske tegn og forandringer ved eksperimentel infektion med E. coli og/eller M. gallisepticum hos kyllinger.
English: 0.1 L/kg bw/day
Danish: 0,1 l/kg legemsvægt/dag
English: The possible impact on clinical efficacy of the high in vitro resistance rate evidenced in B. hyodysenteriae was not assessed in recent clinical studies; however, in the context of this Article 34 referral procedure, aiming at harmonising the conditions of authorisation of an already approved product, it was considered that the indication should not be removed on that basis.
Danish: Dette fandtes dog ikke at være grundlag for at slette indikationen i forbindelse med denne artikel 34-indbringelsesprocedure, der har til formål at harmonisere betingelserne for markedsføringstilladelsen for et i forvejen godkendt produkt.
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
Danish: Spectinomycin er et aminocyclitolantibiotikum, fremstillet af Streptomyces spectabilis.
English: After an overall assessment in the context of the harmonisation of an already approved product, and for the reasons listed below, the CVMP considered that 50 mg/kg bw for 7 days can be accepted as the harmonised dose in chickens:
Danish: CVMP godtog 50 mg/kg kropsvægt i 7 dage som den harmoniserede dosis til kyllinger efter at have foretaget en samlet vurdering i forbindelse med harmonisering for et allerede godkendt produkt og af følgende grunde:
English: Powder for solution in drinking water
Danish: Pulver til opløsning i drikkevand
English: Clinical efficacy in swine dysentery at a dosing regimen close to the recommended harmonised regimen of 10 mg/kg bw for 7 days is supported by older laboratory and field clinical studies, despite the fact that these are not GLP or GCP-compliant and that the clinical and bacteriological criteria for inclusion are not always precisely defined in the study reports.
Danish: Den kliniske virkning ved svinedysenteri ved et doseringsregime tæt på det anbefalede harmoniserede regime på 10 mg/kg kropsvægt i 7 dage underbygges af ældre laboratorieundersøgelser og kliniske feltundersøgelser.
English: Powder for oral solution
Danish: Pulver til oral opløsning
English: 0.2 L/kg bw/day
Danish: 0,2 l/kg legemsvægt/dag
English: Lincomycin is a lincosamide antibiotic, closely related to macrolide and streptogramin B antimicrobials.
Danish: Lincomycin er et antibiotikum i lincosamidgruppen og er nært beslægtet med antibiotika af typen makrolider og streptogramin B. Det hæmmer proteinsyntesen ved at bindes til den bakterielle 50S ribosom-subunit.
English: The older field studies were conducted in a context of systematic prophylaxis and used two-phase dosing regimens; the conditions of those studies do not provide support for the proposed 50 mg/kg bw dose.
Danish: I de ældre feltundersøgelse, der blev udført i forbindelse med systemisk profylakse, anvendtes tofasede doseringsregimer.
English: 0.25 L/kg bw/day
Danish: 0,25 l/kg legemsvægt/dag
English: 0.15 L/kg bw/day
Danish: 0,15 l/kg legemsvægt/dag
English: the MIC distribution appears to be bimodal, with a significant number of strains showing high values; this could partly correspond to natural (intrinsic) resistance.
Danish: synes at være bimodal med et signifikant antal stammer med høje værdier.
English: Pale yellow to light tan soluble powder
Danish: Lysegul til lysebrunt opløseligt pulver
English: Special precautions for storage
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING Opbevares utilgængeligt for børn
English: Pigs Chicken (broiler, pullet) Turkey
Danish: Kyllinger (slagtekyllin ger, unghøner) Kalkuner
English: Marketing authorisation holder and manufacturer responsible for batch release: To be completed nationally
Danish: Indehaver af markedsføringstilladelsen: Udfyldes nationalt
English: To be supplied only on veterinary prescription.
Danish: Kræver recept.
English: Chickens Turkeys
Danish: Kyllinger Kalkuner
English: 1 vial
Danish: Navn
English: MA (EU) number (Invented) name
Danish: EU-nummer
English: Seasonique is authorised in some countries outside the European Union (EU).
Danish: Seasonique er godkendt i visse lande uden for EU.
English: No additional modifications were made by the CHMP.
Danish: CHMP foretog ingen yderligere ændringer.
English: Bleeding pattern
Danish: Blødningsmønster
English: Overall summary of the scientific evaluation of Seasonique and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Seasonique og relaterede navne (se bilag I)
English: Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Danish: Tysklands fandt, at udstedelsen af markedsføringstilladelsen udgør en potentiel alvorlig risiko for den offentlige sundhed
English: Risk management plan
Danish: Risikostyringsplan
English: For the analysis, this period was split in two 28-day and a 35-day periods.
Danish: Ved analysen blev denne periode opdelt i to perioder på 28 dage og én periode på 35 dage.
English: Critical evaluation
Danish: Kritisk vurdering
English: The overall treatment compliance for all treated patients was ≥ 97% in the pivotal study and ≥ 98% in the supportive study.
Danish: Den totale compliance for alle behandlede patienter var ≥ 97 % i hovedundersøgelsen og ≥ 98 % i den støttende undersøgelse.
English: The decentralised marketing authorisation application was submitted under Article 28(3) of Directive 2001/83/EC in accordance with Article 10b of Directive 2001/83/EC.
Danish: Den decentrale ansøgning om markedsføringstilladelse blev indgivet i henhold til artikel 28, stk. 3, i direktiv 2001/83/EF, i overensstemmelse med artikel 10b i direktiv 2001/83/EF.
English: • The Committee considered the notification of the referral triggered by France under Article 29(4) of Directive 2001/83/EC.
Danish: • udvalget behandlede anmeldelsen af den indbringelse, der var indledt af Frankrig i medfør af artikel 29, stk. 4, i direktiv 2001/83/EF.
English: The proposed indication for Seasonique was “oral contraception”.
Danish: Den ansøgte indikation for Seasonique var »oral antikonception«.
English: The CHMP requested advice from the Biostatistics Working Party (BSWP) on the validity of this method in the present case.
Danish: CHMP forhørte sig hos arbejdsgruppen vedrørende biostatistik (BSWP) om validiteten af denne metode i det pågældende tilfælde.