FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding bovine mastitis pathogens such as S. aureus and S. uberis, there exists already a resistant proportion of strains, as evident from recent surveillance programs.
Danish: For patogener, der forårsager mastitis hos kvæg, såsom S. aureus og S. uberis, er en del af stammerne allerede resistente, således som det fremgår af nylige overvågningsprogrammer.
English: • on the on basis of the available data, the CVMP considered that all other indications and dosage regimens in cattle and all indications in pigs should be deleted from the product information;
Danish: • CVMP ud fra de foreliggende data fandt, at alle andre indikationer og doseringsregimer for kvæg og alle indikationer for svin bør slettes fra produktinformationen,
English: Spiramicin proved to be more efficacious and with a lower relapse rate compared to the positive controls.
Danish: Spiramycin var mere effektivt og resulterede i lavere recidivfrekvens end hos de positive kontroller.
English: While for S. aureus this fraction amounted to less than 10% of the strains examined, the tri-modal MIC-distribution pattern obtained for S. uberis indicated that in addition to the susceptible fraction 10% of the strains examined had intermediate susceptibility and 20% were resistant.
Danish: Mens denne andel for S. aureus var under 10 % af de undersøgte stammer, viste det trimodale MIC-fordelingsmønster for S. uberis, at der ud over den følsomme andel af de undersøgte stammer var 10 % med følsomhed i mellemområdet, og 20 % resistente.
English: Using the statistical analysis1 the residues depletion at the injection sites suggested a withdrawal period of 52 days.
Danish: Statistisk analyse1 af depletionen af restkoncentrationer på injektionsstederne viste en tilbageholdelsestid på 52 dage.
English: Spirovet has been shown to be bioequivalent to Suanovil 20 and consequently the time taken for residue levels in non-injection site muscle, liver, fat, kidney and milk can be assumed to be the same as for the two products.
Danish: Spirovet er påvist at være bioækvivalent med Suanovil 20, hvorfor tidsforløbet af restkoncentrationer i andet muskelvæv end injektionsstedet, lever, fedt, nyrer og mælk kan anses for at være det samme for de to produkter.
English: The comparison of earlier with more recently determined MIC-data is, more over, complicated by the different laboratory methods used, and the fact that no break points validated for veterinary medicine exist.
Danish: Sammenligning af ældre og nyere bestemmelser af MIC-værdier kompliceres desuden af, at de anvendte laboratoriemetoder er forskellige, og det forhold, at der ikke findes validerede afskæringspunkter for veterinære lægemidler.
English: Mannheimia haemolytica Cattle Staphylococcus aureus
Danish: Mannheimia haemolytica Kvæg Staphylococcus aureus
English: Spiramycin is metabolised in the liver; its primary metabolite, neospiramycin, possesses antimicrobial activity.
Danish: Spiramycin metaboliseres i leveren; den primære metabolit, neospiramycin, har antimikrobiel aktivitet.
English: Particularly high spiramycin concentrations were determined in lung macrophages.
Danish: Særligt høj koncentration af spiramycin blev bestemt i makrofager i lungerne.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.
Danish: Udvalget for Veterinærlægemidler (CVMP) blev anmodet om at fremsætte en udtalelse om indikationer, doseringsregimer og tilbageholdelsestider hos kvæg og svin for at sikre effektiv behandling og mindske risikoen for udvikling af antimikrobiel resistens over for spiramycin under hensyntagen til de foreliggende data og for at harmonisere tilbageholdelsestiderne hos kvæg og svin for de omhandlede produkter.
English: Use of the product deviating from the instructions given in the product information may increase the prevalence of bacteria resistant to spiramycin.
Danish: Hvis anvendelsen af produktet ikke sker i henhold til anvisningerne i produktinformationen, kan det øge forekomsten af spiramycinresistente bakterier.
English: Ceva Animal Health Bulgaria Ltd 26 Elemag Str., ent.B, app.1 Sofia 1113
Danish: Bulgarien Ceva Animal Health Bulgaria Ltd 26 Elemag Str., ent.B, app.1
English: Spiramycin is a weak base, not ionized and liposoluble which crosses easily cellular membranes by passive diffusion.
Danish: Spiramycin er en svag base, som er uioniseret og lipidopløselig, så den let gennemtrænger cellemembraner ved passiv diffusion.
English: Data from clinical surveillance monitoring programs (VetPath I: 1997-2004, VetPath III: 2007-2012) show that a considerable proportion of bovine mastitis strains of S. aureus were susceptible to spiramycin in vitro, with MIC50 and MIC90 of 4 µg/ml and 8 µg/ml, respectively.
Danish: Data fra kliniske overvågningsprogrammer (VetPath I: 1997-2004, VetPath III: 2007-2012) viser, at en betydelig del af de S. aureus-stammer, som forårsager mastitis hos køer, var følsomme for spiramycin in vitro med MIC50 og MIC90 på hhv. 4 µg/ml og 8 µg/ml.
English: Spiramycin levels in tissues and fluids were further increased when spiramycin was injected for a second time after 48 hours.
Danish: Koncentrationen at spiramycin i væv og væsker steg yderligere, når spiramycin blev injiceret endnu en gang efter 48 timer.
English: Lung levels determined following this treatment regime reached a multiple of the corresponding plasma levels from 4 hours after injection onwards and persisted on a high level for 32 hours after a single injection.
Danish: Lungekoncentrationen ved dette behandlingsregime nåede op på flere gange den tilsvarende plasmakoncentration fra 4 timer efter injektionen og var fortsat høj i 32 timer efter en enkelt injektion.
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Danish: Hvis dette ikke er muligt, skal behandlingen baseres på lokale epidemiologiske oplysninger (fra den pågældende region eller det pågældende brug) om følsomheden af målbakterien.
English: In addition, clinical efficacy data have been presented to support the aforementioned indication.
Danish: Til støtte for denne indikation er der desuden forelagt kliniske data om virkning.
English: If more than two injections are needed, a distance of at least 15 cm should be maintained between injections given on the same side of the neck.
Danish: Hvis der behøves mere end to injektioner, skal der være mindst 15 cm mellem dem, der gives på samme side af nakken.
English: Based on a residue depletion study performed in accordance with the current guidance2 for the determination of withdrawal periods for milk, a withdrawal period of 27 milkings (13.5 days) can be recommended for milk.
Danish: På grundlag af en restkoncentrationsundersøgelse, der er udført i overensstemmelse med de gældende retningslinjer2 for bestemmelse af tilbageholdelsestider for mælk, kan der anbefales en tilbageholdelsestid på 27 malkninger (13,5 dage).
English: Earlier and more recent in vitro susceptibility data of the target pathogens had been derived from a large number of strains collected from cattle in several EU Member States.
Danish: Der foreligger ældre og nyere in vitro-følsomhedsdata for målpatogenerne for en lang række stammer indsamlet fra kvæg i en række EU-medlemsstater.
English: Regarding bovine respiratory pathogens like Pasteurella multocida and Mannheimia haemolytica, in vitro MIC-values of spiramycin are generally high, but their mono-modal distribution pattern does not indicate a relevant resistant fraction.
Danish: For bovine luftvejspatogener som Pasteurella multocida og Mannheimia haemolytica er in vitro-MICværdierne for spiramycin generelt høje, men deres monomodale fordelingsmønster tyder ikke på en betydelig resistensandel.
English: It is assumed that compared to cattle the pharmacokinetic profile of spiramycin in calves would be similar or even more favourable.
Danish: Hos kalve antages det, at den farmakokinetiske profil af spiramycin svarer til forholdene hos kvæg eller er endnu gunstigere.
English: Spiramycin is weakly bound to plasma proteins.
Danish: Spiramycin udviser svag plasmaproteinbinding.
English: Although results from different laboratories can be compared only with reservation because of the different methods used, Minimum Inhibitory Concentrations (MIC) of spiramycin for the relevant respiratory tract pathogens such as Pasteurella and Mannheimia spp.
Danish: Skønt sammenligning af resultaterne fra forskellige laboratorier må ske med forbehold på grund af de forskellige anvendte metoder, var de mindste hæmmende koncentrationer (MIC) af spiramycin for de pågældende luftvejspatogener såsom Pasteurella og Mannheimia spp.
English: de la Ballastiere, BP 126 33500 Libourne Cedex FRANCE
Danish: de la Ballastiere, BP 126 33500 Libourne Cedex FRANKRIG
English: Delete, target species pigs and any information related to these species from the product information.
Danish: Slet måldyrearten svin og alle oplysninger om denne art fra produktinformationen.
English: • on the basis of the available residue depletion data in cattle, the CVMP considered that withdrawal periods should be amended to provide assurance for consumer safety;
Danish: • CVMP på grundlag af de foreliggende restkoncentrationsdata hos kvæg fandt, at tilbageholdelsesti derne bør ændres af hensyn til forbrugersikkerheden,
English: However since the assessment identified some deficiencies such as no surrounding injection site samples in adult cattle, it was considred necessary to use the alternative approach1 and add a 20% safety span.
Danish: Da undersøgelsen imidlertid var behæftet med visse mangler såsom manglende prøver af vævet omkring injektionsstedet hos voksent kvæg, blev det fundet nødvendigt at bruge den alternative metode1 og tillægge en sikkerhedsmargin på 20 %.
English: Merial Portuguesa - Saúde Animal, LDA Av. Maria Lamas, lote 19 - BL.
Danish: Merial Portuguesa - Saúde Animal, LDA Av. Maria Lamas, lote 19 - BL. A Piso 2 Parque Industrial e Comercial Serra das Minas
English: • on the basis of the available data, the CVMP considered that indications as provided in Annex III
Danish: • CVMP fandt indikationerne i henhold til bilag III velbegrundede ud fra de foreliggende data,
English: As no residue depletion study was provided following administration of 100 000 IU/kg intramuscularly twice with 48 hours of interval, no withdrawal period for milk is recommended for this dosage regimen.
Danish: Da der ikke blev forelagt en restkoncentrationsundersøgelse efter administration af 100 000 IE/kg intramuskulært to gange med 48 timers mellemrum, kan der ikke fastsættes en anbefalet tilbageholdelsestid for mælk for dette dosisregime.
English: were generally distributed in a mono-modal pattern on the right side of the MIC distribution curve with MIC90-values around 64 µg/ml for bovine isolates, suggesting limited in vitro susceptibility of these bacteria to spiramycin.
Danish: sædvanligvis monomodalt fordelt på højre side af MIC-fordelingskurven med MIC90-værdier omkring 64 µg/ml for isolater fra kvæg, hvilket viser begrænset in vitro-følsomhed af disse bakterier over for spiramycin.
English: La Ballastière 33500 Libourne France
Danish: La Ballastière 33500 Libourne Frankrig
English: Lactating cows
Danish: Lakterende køer
English: Withdrawal period(s)
Danish: 4.11 Tilbageholdelsestid(er)
English: The pharmacokinetic properties of spiramycin at the dose of 30 000 IU/kg body weight have been examined in one study.
Danish: De farmakokinetiske egenskaber af spiramycin i en dosis på 30 000 IE/kg kropsvægt har været omfattet af én undersøgelse.
English: Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne France
Danish: Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne Frankrig
English: Using the statistical analysis the calculated withdrawal period for cattle meat and offal is 75 days.
Danish: Ved statistisk analyse kan der udledes en tilbageholdelsestid på 75 dage for kød og indmad fra kvæg.
English: The clinical data on bovine mastitis consisted primarily of an experimental S. aureus mastitis study using a challenge strain with a spiramycin MIC of 4 µg/ml.
Danish: De kliniske data for mastitis hos køer bestod hovedsagelig i en eksperimentel undersøgelse af S. aureus-mastitis, hvor dyrene blev belastet med en stamme med en spiramycin-MIC på 4 µg/ml.
English: Spiramycin is active against Staphylococcus aureus, Mannheimia haemolytica and Pasteurella multocida.
Danish: Spiramycin er aktivt mod Staphylococcus aureus, Mannheimia haemolytica og Pasteurella multocida.
English: Rue de Bourgelat 17 69002 Lyon France
Danish: Rumænien Merial Rue de Bourgelat 17 69002 Lyon Frankrig
English: For the second dose (after 24 h or 48 h) the same practice should be followed, ensuring that a distance of at least 15 cm is maintained between all injections administered as part of the treatment.
Danish: Til den anden dosis (efter 24 timer eller 48 timer) følges samme praksis, idet der holdes en afstand på mindst 15 cm mellem alle injektioner, der gives ved behandlingen.
English: For the second dose (after 48 h) the same practice should be followed, ensuring that a distance of at least 15 cm is maintained between all injections administered as part of the treatment.
Danish: Til den anden dosis (efter 48 timer) følges samme praksis, idet der holdes en afstand på mindst 15 cm mellem alle injektioner, der gives ved behandlingen.
English: The maximal volume to be injected is 15 ml per injection site as this was the maximal volume administered at the residue depletion study.
Danish: Der må højst injiceres et volumen på 15 ml på hvert injektionssted, da dette var det største volumen, der blev indgivet ved restkoncentrationsundersøgelsen.
English: Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml.
Danish: Captalin, injektionsvæske, opløsning, indeholder 31,25 g spiramycin/100 ml, svarende til 1 000 000 IE spiramycin/ml.
English: Spiramycin acts on bacterial protein synthesis by binding to the 50S ribosomal subunits, inhibiting the translocation step.
Danish: Spiramycin virker på bakteriernes proteinsyntese ved at bindes til 50S ribosomale subunits, så translokationstrinnet hæmmes.
English: One study was conducted at the recommended dose of 100 000 IU/kg body weight twice at 48 hours of interval, which showed that the injection site muscle residues were still above the maximum residue limit for muscle (200 μg/kg) at Day 49 post-treatment.
Danish: En undersøgelse med den anbefalede dosis på 100 000 IE/kg kropsvægt to gange med 48-timers mellemrum viste, at restkoncentrationerne i muskelvæv på injektionsstedet stadig var over grænseværdien for muskel (200 μg/kg) på dag 49 efter behandlingen.
English: Only acute cases of mastitis caused by S. aureus with clinical signs observed for less than 24 h should be treated.
Danish: Kun akutte tilfælde af mastitis forårsaget S. aureus, hvor der er observeret kliniske tegn i mindre end 24 timer, bør behandles.
English: Origin Number of strains
Danish: Antal stammer
English: Quality, target animal safety, user safety and environmental risk were not assessed in this referral procedure.
Danish: Denne henvisningsprocedure omfatter ikke sikkerhed for måldyrearten, brugersikkerhed eller miljørisiko.
English: Therefore Suanovil 20 should not be used for treatment of respiratory infections in animals producing milk for human consumption.
Danish: Suanovil 20 bør derfor ikke anvendes til behandling af luftvejsinfektioner hos dyr, der producerer mælk til konsum.
English: The pharmacokinetic characteristics derived from specific studies demonstrated that in plasma relatively low spiramycin levels (Cmax: 6-10 IU/ml corresponding to 2-3 µg/ml) were reached with the treatment regime, whereas considerably higher spiramycin levels were reached in bronchoalveolar lavage (4-5-fold of the plasma levels) and in lung tissue (100-fold of the plasma levels).
Danish: De farmakokinetiske karakteristika udledt af specifikke undersøgelser viste, at plasmakoncentrationerne af spiramycin ved det pågældende behandlingsregime var forholdsvis lave (Cmax: 6-10 IU/ml svarende til 2-3 µg/ml), hvorimod der opnåedes væsentligt højere koncentration af spiramycin i bronkoalveolær lavage (4-5 gange plasmakoncentrationen) og i lungevæv (100 gange plasmakoncentrationen).
English: Withdrawal periods
Danish: Tilbageholdelsestider
English: It should be noted that the generic product, Spirovet, has been authorised in several Member States for a restricted list of indications, only i.e. in adult cattle for the treatment of respiratory diseases, mastitis, metritis and interdigital necrobacillosis at a dose of 30 000 IU/kg once or twice in 24 hour interval.
Danish: Det skal bemærkes, at det generiske produkt, Spirovet, i flere medlemsstater er godkendt til en begrænset række indikationer, dvs. kun til voksent kvæg til behandling af luftvejssygdomme, mastitis, metritis og interdigital necrobacillose i en dosis på 30 000 IE/kg én eller to gange med 24 timers mellemrum.
English: Meat and offal: 75 days.
Danish: Kød og indmad: 75 dage.
English: One study conducted at the recommended dose showed that the injection site muscle residues were below the maximum residue limit (200 μg/kg) at Day 52.
Danish: I den ene undersøgelse, der blev udført ved den anbefalede dosis, var restkoncentrationerne i muskelvæv på injektionsstedet på dag 52 under maksimalgrænseværdien for restkoncentrationer (200 µg/kg).
English: The maximal volume to be injected is 20 ml per injection site as this was the maximal volume administered at the residue depletion study.
Danish: Der må højst injiceres et volumen på 20 ml på hvert injektionssted, da dette var det største volumen, der blev indgivet ved restkoncentrationsundersøgelsen.
English: In pigs, the products has been authoresed for the treatment of respiratory infections, pig house cough, atrophic rhinitis, infections caused by Streptococcus spp., erysipelas, arthritis, treatment and prevention of mastitis, prevention of neonatal infections in piglets and infectious gastro-enteritis at 75 000 IU/kg body weight once or twice in 24 hour interval.
Danish: Hos svin er produkterne godkendt til behandling af luftvejsinfektioner, staldhoste, atrofisk rhinitis, infektioner forårsaget af Streptococcus spp., erysipelas, artritis, behandling og forebyggelse af mastitis, forebyggelse af neonatale infektioner hos smågrise samt infektiøs gastroenteritis i en dosering på 75 000 IE/kg kropsvægt én eller to gange med 24 timers mellemrum.
English: Since the study has shortcomings (no data for tissues other than injection site and in some samples residues in the surrounding injection site were higher than in the core), it was considered necessary to use the alternative approach and add a 30% safety span which resulted in a withdrawal period of 68 days for cattle meat and offal.
Danish: Da undersøgelsen er behæftet med mangler (ingen data for andre væv end injektionsstedet, og i nogle prøver højere restkoncentrationerne i vævet omkring injektionsstedet end i kernen), fandtes det nødvendigt at bruge den alternative tilgang og tillægge en 30 % sikkerhedsmargin.
English: Meat and offal: 62 days.
Danish: Kød og indmad: 62 dage.
English: Mastitis caused by S. aureus should be treated once clinical signs are observed.
Danish: Mastitis forårsaget S. aureus bør behandles, når der iagttages kliniske tegn.
English: The indication was substantiated by in vitro susceptibility data for Pasteurella multocida and Mannheimia haemolytica and by pharmacokinetic data of spiramycin in the target species, on the basis of which a detailed pharmacokinetic/pharmacodynamic (PK/PD) assessment has been performed.
Danish: Denne indikation var underbygget af in vitro-følsomhedsdata for Pasteurella multocida og Mannheimia haemolytica og farmakokinetiske data for spiramycin hos måldyrearterne, på grundlag af hvilke der er foretaget en detaljeret farmakokinetisk/farmakodynamisk vurdering.
English: The pharmacokinetic characteristics derived from this study demonstrate that in plasma relatively low spiramycin levels (Cmax: 1.44 IU/ml corresponding to 0.45 µg/ml) were reached with the treatment regime, whereas considerably higher spiramycin levels were reached in milk (50-fold of the plasma levels).
Danish: Denne farmakokinetiske undersøgelse viser, at dette behandlingsregime resulterede i forholdsvis lav koncentration af spiramycin i plasma (Cmax: 1,44 IE/ml svarende til 0,45 µg/ml), men langt højere koncentration i mælk (50 gange plasmakoncentrationen).
English: By using the pharmacodynamic and pharmacokinetic data mentioned abobe, a detailed PK/PD assessment was performed, which was based on two parameters: the T>MIC (time during which the concentration exceeds the MIC), which is recommended for time-dependent antibiotics like the macrolides, and the AUC/MIC (area under the curve to MIC), which is recommended for specific macrolides like azithromycin.
Danish: Ved hjælp af de nævnte farmakodynamiske og farmakokinetiske data blev der udført en detaljeret farmakokinetisk/farmakodynamisk vurdering baseret på to parametre: T>MIC (det tidsrum, hvor koncentrationen er over MIC-værdien), der anbefales anvendt for tidsafhængige antibiotika som makroliderne, og AUC/MIC (forholdet mellem arealet under kurven og MIC-værdien), der anbefales anvendt for specifikke makrolider såsom azithromycin.
English: Spiramycin is a macrolide antibiotic exerting bacteriostatic action against Mycoplasma, Gram-negative and Gram-positive bacteria which cause infections in cattle and pigs.
Danish: Spiramycin er et makrolidantibiotikum med bakteriostatisk virkning over for Mycoplasma og gramnegative og grampositive bakterier, der forårsager infektioner hos kvæg og svin.
English: In sows has been authoresed for the treatment of mastitis at 75 000 IU/kg once or twice in 24 hour interval.
Danish: Hos søer er det godkendt til behandling af mastitis i en dosering på 75 000 IE/kg én eller to gange med 24 timers mellemrum.
English: Its tissue distribution is extensive, with high concentration particularly in bronchial secretions, lung parenchyma, alveolar macrophages, udders and milk.
Danish: Dets fordeling i vævene er udbredt, med høje koncentrationer navnlig i bronkiesekret, lungeparenchym, alveolære makrofager, yver og mælk.
English: The veterinary medicinal product Suanovil 20 and its associated names has been authorised by several Member States for use in cattle for the treatment and prevention of respiratory infections and gastrointestinal infections, mastitis, metritis, omphalitis and omphalophlebitis, arthritis and interdigital abscesses at a dose of 30 000 IU/kg body weight once or twice in 24 hour interval for adult cattle and at 75 000 IU/kg body weight once or twice in 24 hour interval for calves.
Danish: Veterinærlægemidlet Suanovil 20 og relaterede navne er godkendt i flere medlemsstater til anvendelse hos kvæg til behandling og forebyggelse af luftvejsinfektioner, gastrointestinale infektioner, mastitis, metritis, omfalitis og omfaloflebitis, artritis og interdigitale abscesser, i en dosering på 30 000 IE/kg kropsvægt én eller to gange med 24 timers mellemrum til voksent kvæg og 75 000 IE/kg kropsvægt én eller to gange med 24 timers mellemrum til kalve.
English: Milk: In case of treatment at the dose required for respiratory diseases the product is not authorised for use in animals producing milk for human consumption.
Danish: Mælk: Produktet er ikke godkendt til behandling med den nødvendige dosis til luftvejssygdomme hos dyr, der producerer mælk til konsum.
English: C. For Captalin and its associated names listed in Annex I containing 1 000 000 IU spiramycin per ml
Danish: C. For Captalin og relaterede navne opført i bilag I indeholdende 1 000 000 IE spiramycin/ml